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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. 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

    , and improve their quality of life. METHODS/DESIGN: We will study the effects of the ACP program Respecting Choices on the quality of life of patients with advanced lung or colorectal cancer. In a phase III multicenter cluster randomised controlled trial, 22 hospitals in 6 countries will be randomised...... care as received is aligned with patients' preferences, patients' evaluation of decision-making processes, quality of end-of-life care and cost-effectiveness of the intervention. A complementary qualitative study will be carried out to explore the lived experience of engagement with the Respecting...

  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

    BACKGROUND: Awareness of preferences regarding medical care should be a central component of the care of patients with advanced cancer. Open communication can facilitate this but can occur in an ad hoc or variable manner. Advance care planning (ACP) is a formalized process of communication between......, and improve their quality of life. METHODS/DESIGN: We will study the effects of the ACP program Respecting Choices on the quality of life of patients with advanced lung or colorectal cancer. In a phase III multicenter cluster randomised controlled trial, 22 hospitals in 6 countries will be randomised...... care as received is aligned with patients' preferences, patients' evaluation of decision-making processes, quality of end-of-life care and cost-effectiveness of the intervention. A complementary qualitative study will be carried out to explore the lived experience of engagement with the Respecting...

  6. 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.

  7. Balance exercise for persons with multiple sclerosis using Wii games: a randomised, controlled multi-centre study.

    Science.gov (United States)

    Nilsagård, Ylva E; Forsberg, Anette S; von Koch, Lena

    2013-02-01

    The use of interactive video games is expanding within rehabilitation. The evidence base is, however, limited. Our aim was to evaluate the effects of a Nintendo Wii Fit® balance exercise programme on balance function and walking ability in people with multiple sclerosis (MS). A multi-centre, randomised, controlled single-blinded trial with random allocation to exercise or no exercise. The exercise group participated in a programme of 12 supervised 30-min sessions of balance exercises using Wii games, twice a week for 6-7 weeks. Primary outcome was the Timed Up and Go test (TUG). In total, 84 participants were enrolled; four were lost to follow-up. After the intervention, there were no statistically significant differences between groups but effect sizes for the TUG, TUGcognitive and, the Dynamic Gait Index (DGI) were moderate and small for all other measures. Statistically significant improvements within the exercise group were present for all measures (large to moderate effect sizes) except in walking speed and balance confidence. The non-exercise group showed statistically significant improvements for the Four Square Step Test and the DGI. In comparison with no intervention, a programme of supervised balance exercise using Nintendo Wii Fit® did not render statistically significant differences, but presented moderate effect sizes for several measures of balance performance.

  8. 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....

  9. 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.

  10. 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.

  11. 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

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

    Directory of Open Access Journals (Sweden)

    Freeman Jennifer

    2012-04-01

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

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

    Directory of Open Access Journals (Sweden)

    Sietske J Tamminga

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

  14. 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.

    Science.gov (United States)

    Cuthbertson, Brian H; Campbell, Marion K; Stott, Stephen A; Vale, Luke; Norrie, John; Kinsella, John; Cook, Jonathan; Brittenden, Julie; Grant, Adrian

    2010-04-16

    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. 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. 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 number - ISRCTN32188676.

  15. 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

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

    Science.gov (United States)

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

    2015-12-15

    Post-operative pulmonary complications are a significant problem following open upper abdominal surgery. Preliminary evidence suggests that a single pre-operative physiotherapy education and preparatory lung expansion training session alone may prevent respiratory complications more effectively than supervised post-operative breathing and coughing exercises. However, the evidence is inconclusive due to methodological limitations. No well-designed, adequately powered, randomised controlled trial has investigated the effect of pre-operative education and training on post-operative respiratory complications, hospital length of stay, and health-related quality of life following upper abdominal surgery. The Lung Infection Prevention Post Surgery - Major Abdominal- with Pre-Operative Physiotherapy (LIPPSMAck POP) trial is a pragmatic, investigator-initiated, bi-national, multi-centre, patient- and assessor-blinded, parallel group, randomised controlled trial, powered for superiority. Four hundred and forty-one patients scheduled for elective open upper abdominal surgery at two Australian and one New Zealand hospital will be randomised using concealed allocation to receive either i) an information booklet or ii) an information booklet, plus one additional pre-operative physiotherapy education and training session. The primary outcome is respiratory complication incidence using standardised diagnostic criteria. Secondary outcomes include hospital length of stay and costs, pneumonia diagnosis, intensive care unit readmission and length of stay, days/h to mobilise >1 min and >10 min, and, at 6 weeks post-surgery, patient reported complications, health-related quality of life, and physical capacity. The LIPPSMAck POP trial is a multi-centre randomised controlled trial powered and designed to investigate whether a single pre-operative physiotherapy session prevents post-operative respiratory complications. This trial standardises post-operative assisted ambulation and

  17. 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

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

    DEFF Research Database (Denmark)

    Juul, AB; Gluud, C; Wetterslev, J

    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....

  19. One year follow-up of a pragmatic multi-centre randomised controlled trial of a group-based fatigue management programme (FACETS) for people with multiple sclerosis.

    Science.gov (United States)

    Thomas, Peter W; Thomas, Sarah; Kersten, Paula; Jones, Rosemary; Slingsby, Vicky; Nock, Alison; Davies Smith, Angela; Baker, Roger; Galvin, Kathleen T; Hillier, Charles

    2014-05-19

    Fatigue is one of the most common and debilitating symptoms of multiple sclerosis (MS). The aim was to evaluate the effectiveness at 1-year follow-up of a manualised group-based programme ('FACETS') for managing MS-fatigue. One-year follow-up of a pragmatic multi-centre randomised controlled trial. People with MS and significant fatigue were randomised to FACETS plus current local practice (FACETS) or current local practice alone (CLP), using concealed computer-generated randomisation. Participant blinding was not possible. Primary outcome measures were fatigue severity (Global Fatigue Severity subscale of the Fatigue Assessment Instrument), self-efficacy (MS-Fatigue Self-Efficacy) and disease-specific quality of life (MS Impact Scale). Between May 2008 and November 2009, 164 participants were randomised. Primary outcome data were available at 1 year for 131 (80%). The benefits demonstrated at 4-months in the FACETS arm for fatigue severity and self-efficacy largely persisted, with a slight reduction in standardised effect sizes (SES) (-0.29, p = 0.06 and 0.34, p = 0.09, respectively). There was a significant difference on the MS Impact Scale favouring FACETS that had not been present at 4-months (SES -0.24, p = 0.046). No adverse events were reported. Improvements in fatigue severity and self-efficacy at 4-months follow-up following attendance of FACETS were mostly sustained at 1 year with additional improvements in MS impact. The FACETS programme provides modest long-term benefits to people with MS-fatigue. ISRCTN76517470.

  20. 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

  1. Guided Internet-based versus face-to-face clinical care in the management of tinnitus: study protocol for a multi-centre randomised controlled trial.

    Science.gov (United States)

    Beukes, Eldré W; Baguley, David M; Allen, Peter M; Manchaiah, Vinaya; Andersson, Gerhard

    2017-04-21

    Innovative strategies are required to improve access to evidence-based tinnitus interventions. A guided Internet-based cognitive behavioural therapy (iCBT) intervention for tinnitus was therefore developed for a U.K. Initial clinical trials indicated efficacy of iCBT at reducing tinnitus severity and associated comorbidities such as insomnia and depression. The aim of this phase III randomised controlled trial is to compare this new iCBT intervention with an established intervention, namely face-to-face clinical care for tinnitus. This will be a multi-centre study undertaken across three hospitals in the East of England. The design is a randomised, two-arm, parallel-group, non-inferiority trial with a 2-month follow-up. The experimental group will receive the guided iCBT intervention, whereas the active control group will receive the usual face-to-face clinical care. An independent researcher will randomly assign participants, using a computer-generated randomisation schedule, after stratification for tinnitus severity. There will be 46 participants in each group. The primary assessment measure will be the Tinnitus Functional Index. Data analysis will establish whether non-inferiority is achieved using a pre-defined non-inferiority margin. This protocol outlines phase III of a clinical trial comparing a new iCBT with established face-to-face care for tinnitus. If guided iCBT for tinnitus proves to be as effective as the usual tinnitus care, it may be a viable additional management route for individuals with tinnitus. This could increase access to evidence-based effective tinnitus care and reduce the pressures on existing health care systems. ClinicalTrials.gov identifier: NCT02665975 . Registered on 22 January 2016.

  2. Reflecting on the methodological challenges of recruiting to a United Kingdom-wide, multi-centre, randomised controlled trial in gynaecology outpatient settings.

    Science.gov (United States)

    Dickson, Sylvia; Logan, Janet; Hagen, Suzanne; Stark, Diane; Glazener, Cathryn; McDonald, Alison M; McPherson, Gladys

    2013-11-15

    Successful recruitment of participants to any trial is central to its success. Trial results are routinely published, and recruitment is often cited to be slower and more difficult than anticipated. This article reflects on the methodological challenges of recruiting women with prolapse attending United Kingdom (UK) gynaecology outpatient clinics to a multi-centre randomised controlled trial (RCT) of physiotherapy, and the systems put in place in an attempt to address them. Gynaecology outpatients with symptomatic prolapse were to be recruited over a 16-month period from 14 UK hospitals and one New Zealand hospital. Eligible women were informed about the trial by their gynaecologist and informed consent was obtained by the central trial office. Recruitment difficulties were encountered early on, and a number of strategies were employed to try to improve recruitment. Some strategies were more successful than others and they differed in the resources required. Actions that facilitated recruitment included increasing recruiting centres to 23 UK and two international hospitals, good centre support, using processes embedded in clinical practice, and good communication between the trial office, collaborators and participants. Collaborator incentives, whereby staff involved received the benefit immediately, were more successful than a nominal monetary payment per woman randomised. Barriers to recruitment included fewer eligible women than anticipated, patient's preference to receive active treatment rather than allocation to the control group, lack of support staff and high staff turnover. Geographical variations in Primary Care Trust Research Management and Governance approval systems and general practitioner (GP) referral procedures also impacted negatively on recruitment. Our article reflects on the methodological challenges of recruiting to a multi-centre RCT in a UK gynaecology setting. Effective interventions included increasing the number of recruiting centres and

  3. 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....... Caesarean section rates and neonatal outcome were similar. Overall, the two methods for induction were comparable with regard to efficacy and safety....

  4. A multi-centre, blinded, randomised, placebo-controlled, laboratory-based study of MQX-503, a novel topical gel formulation of nitroglycerine, in patients with Raynaud phenomenon.

    Science.gov (United States)

    Hummers, Laura K; Dugowson, Carin E; Dechow, Frederick J; Wise, Robert A; Gregory, Jeffrey; Michalek, Joel; Yenokyan, Gayane; McGready, John; Wigley, Fredrick M

    2013-12-01

    MQX-503 is a novel nitroglycerine preparation designed to absorb quickly and allow local vasodilatation in the skin. We examined the efficacy and tolerability of this medication in Raynaud phenomenon (RP) in a laboratory-based study. In this multi-centre, double-blind, randomised, placebo-controlled, cross-over study, subjects were treated with 0.5% or 1.25% nitroglycerine or placebo gel. Subjects received each dose twice in a randomised order. Each study session consisted of baseline laser Doppler measurements, study gel application and 5 min of cold chamber exposure (-20°C). Blood flow (BF) was measured at the end of exposure and for the next 120 min at set intervals. Other outcome measures included achievement of baseline BF; the time to achieve 50% and 70% baseline skin temperature (ST); and pain, tingling and numbness scores. 37 subjects completed 214 treatment periods. Time to achieve baseline BF was significantly shorter in the two treated groups (HR=1.77 and 2.02 for 0.5% and 1.25% vs placebo, respectively). The proportion of subjects achieving baseline BF was 45.8% for placebo, 66.2% for 0.5% and 69% for 1.25% (p=0.01 and p=0.002 for 0.5% and 1.25% vs placebo, respectively). No meaningful differences were seen in ST or pain/numbness/tingling scores. Treatment was well tolerated with no serious adverse events. Treatment with MQX-503 caused a significant improvement in skin BF compared with placebo. Data from this proof of concept study suggest benefit of MQX-503 in subjects with RP.

  5. 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

  6. 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

  7. Induction of labour versus expectant management for nulliparous women over 35 years of age: a multi-centre prospective, randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Walker Kate F

    2012-12-01

    Full Text Available Abstract Background British women are increasingly delaying childbirth. The proportion giving birth over the age of 35 rose from 12% in 1996 to 20% in 2006. Women over this age are at a higher risk of perinatal death, and antepartum stillbirth accounts for 61% of all such deaths. Women over 40 years old have a similar stillbirth risk at 39 weeks as women who are between 25 and 29 years old have at 41 weeks. Many obstetricians respond to this by suggesting labour induction at term to forestall some of the risk. In a national survey of obstetricians 37% already induce women aged 40–44 years. A substantial minority of parents support such a policy, but others do not on the grounds that it might increase the risk of Caesarean section. However trials of induction in other high-risk scenarios have not shown any increase in Caesarean sections, rather the reverse. If induction for women over 35 did not increase Caesareans, or even reduced them, it would plausibly improve perinatal outcome and be an acceptable intervention. We therefore plan to perform a trial to test the effect of such an induction policy on Caesarean section rates. This trial is funded by the NHS Research for Patient Benefit (RfPB Programme. Design The 35/39 trial is a multi-centre, prospective, randomised controlled trial. It is being run in twenty UK centres and we aim to recruit 630 nulliparous women (315 per group aged over 35 years of age, over two years. Women will be randomly allocated to one of two groups: Induction of labour between 390/7 and 396/7 weeks gestation. Expectant management i.e. awaiting spontaneous onset of labour unless a situation develops necessitating either induction of labour or Caesarean Section. The primary purpose of this trial is to establish what effect a policy of induction of labour at 39 weeks for nulliparous women of advanced maternal age has on the rate of Caesarean section deliveries. The secondary aim is to act as a pilot study for a trial to

  8. Vitrectomy with or without encircling band for pseudophakic retinal detachment: a multi-centre, three-arm, randomised clinical trial. VIPER Study Report No. 1--design and enrolment.

    Science.gov (United States)

    Mazinani, B; Baumgarten, S; Schiller, P; Agostini, H; Helbig, H; Limburg, E; Hellmich, M; Walter, P

    2016-03-01

    Scleral buckling is currently used in addition to vitrectomy for the treatment of pseudophakic retinal detachment (PRD) to better support the vitreous base and better visualisation of the periphery. The aims of this study are to evaluate (1) whether the combination of 20 G vitrectomy and scleral buckling is superior to 20 G vitrectomy alone (control) (confirmatory), and (2) whether transconjunctival 23/25 G vitrectomy is non-inferior to 20 G vitrectomy (both without scleral buckling) regarding operation success (exploratory). The VIPER (Vitrectomy Plus Encircling Band Vs. Vitrectomy Alone For The Treatment Of Pseudophakic Retinal Detachment) study is an unmasked, multi-centre, three-arm randomised trial. Patients with PRD were eligible, excluding complicated retinal detachment or otherwise severe ophthalmologic impairment. Patients were randomised to one of three interventions: 20 G vitrectomy alone (control C), combination of 20 G vitrectomy and circumferential scleral buckling (experimental treatment E1) or 23/25 G vitrectomy alone (experimental treatment E2). The primary endpoint is the absence of any indication for a retina re-attaching procedure during 6 months of follow-up. Secondary endpoints include best corrected visual acuity, retina re-attaching procedures, complications and adverse events. From June 2011 to August 2013, 257 patients were enrolled in the study. The internet randomisation service assigned 100 patients each to the treatment arms C and E1, and 57 patients to treatment E2. The imbalance is due to the fact that several retinal surgeons did not qualify for performing E2. The random assignment was stratified and balanced (ie, 1:1 or 1:1:1 ratio) by surgeon. The described study represents a methodologically rigorous protocol evaluating the benefits of three different vitrectomy approaches to PRD. The projected results will help to establish their overall efficacy and will permit conclusions regarding their relative value. DRKS

  9. 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

  10. 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

  11. 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.

  12. 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.

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

    Science.gov (United States)

    Bateman, James; Allen, Maggie E; Kidd, Jane; Parsons, Nick; Davies, David

    2012-08-01

    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). This is a multi-centre randomised 2 x 2 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 both primary outcomes. This trial will provide

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

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    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

  15. 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

  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. 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.

    Science.gov (United States)

    Brorson, Stig; Olsen, Bo Sanderhoff; Frich, Lars Henrik; Jensen, Steen Lund; Johannsen, Hans Viggo; Sørensen, Anne Kathrine; Hrobjartsson, Asbjørn

    2009-07-08

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

  19. 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

    Directory of Open Access Journals (Sweden)

    Johannsen Hans

    2009-07-01

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

  20. 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

  1. Comparing induction of labour with oral misoprostol or Foley catheter at term: cost-effectiveness analysis of a randomised controlled multi-centre non-inferiority trial

    NARCIS (Netherlands)

    ten Eikelder, Mlg; van Baaren, G.-J.; Oude Rengerink, K.; Jozwiak, M.; de Leeuw, J. W.; Kleiverda, G.; Evers, I.; de Boer, K.; Brons, J.; Bloemenkamp, Kwm; Mol, B. W.

    2018-01-01

    To assess the costs of labour induction with oral misoprostol versus Foley catheter. Economic evaluation alongside a randomised controlled trial. Obstetric departments of six tertiary and 23 secondary care hospitals in the Netherlands. Women with a viable term singleton pregnancy in cephalic

  2. Multifactorial day hospital intervention to reduce falls in high risk older people in primary care: a multi-centre randomised controlled trial [ISRCTN46584556

    Directory of Open Access Journals (Sweden)

    Morris Rob

    2006-02-01

    Full Text Available Abstract Falls in older people are a major public health concern in terms of morbidity, mortality and cost. Previous studies suggest that multifactorial interventions can reduce falls, and many geriatric day hospitals are now offering falls intervention programmes. However, no studies have investigated whether these programmes, based in the day hospital are effective, nor whether they can be successfully applied to high-risk older people screened in primary care. The hypothesis is that a multidisciplinary falls assessment and intervention at Day hospitals can reduce the incidence of falls in older people identified within primary care as being at high risk of falling. This will be tested by a pragmatic parallel-group randomised controlled trial in which the participants, identified as at high risk of falling, will be randomised into either the intervention Day hospital arm or to a control (current practice arm. Those participants preferring not to enter the full randomised study will be offered the opportunity to complete brief diaries only at monthly intervals. This data will be used to validate the screening questionnaire. Three day hospitals (2 Nottingham, 1 Derby will provide the interventions, and the University of Nottingham's Departments of Primary Care, the Division of Rehabilitation and Ageing Unit, and the Trent Institute for Health Service Research will provide the methodological and statistical expertise. Four hundred subjects will be randomised into the two arms. The primary outcome measure will be the rate of falls over one year. Secondary outcome measures will include the proportion of people experiencing at least one fall, the proportion of people experiencing recurrent falls (>1, injuries, fear of falling, quality of life, institutionalisation rates, and use of health services. Cost-effectiveness analyses will be performed to inform health commissioners about resource allocation issues. The importance of this trial is that the

  3. 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.

  4. A multi-centre, parallel group superiority trial of silk therapeutic clothing compared to standard care for the management of eczema in children (CLOTHES Trial): study protocol for a randomised controlled trial.

    Science.gov (United States)

    Harrison, Eleanor F; Haines, Rachel H; Cowdell, Fiona; Sach, Tracey H; Dean, Taraneh; Pollock, Ian; Burrows, Nigel P; Buckley, Hannah; Batchelor, Jonathan; Williams, Hywel C; Lawton, Sandra; Brown, Sara J; Bradshaw, Lucy E; Ahmed, Amina; Montgomery, Alan A; Mitchell, Eleanor J; Thomas, Kim S

    2015-09-02

    Eczema is a chronic, itchy skin condition that can have a large impact on the quality of life of patients and their families. People with eczema are often keen to try out non-pharmacological therapies like silk therapeutic garments that could reduce itching or the damage caused by scratching. However, the effectiveness and cost-effectiveness of these garments in the management of eczema has yet to be proven. The CLOTHES Trial will test the hypothesis that 'silk therapeutic garments plus standard eczema care' is superior to 'standard care alone' for children with moderate to severe eczema. Parallel group, observer-blind, pragmatic, multi-centre randomised controlled trial of 6 months' duration. Three hundred children aged 1 to 15 years with moderate to severe eczema will be randomised (1:1) to receive silk therapeutic garments plus standard eczema care, or standard eczema care alone. Primary outcome is eczema severity, as assessed by trained and blinded investigators at 2, 4 and 6 months (using the Eczema Area and Severity Index (EASI)). Secondary outcomes include: patient-reported eczema symptoms (collected weekly for 6 months to capture long-term control); global assessment of severity; quality of life of the child, family and main carer; use of standard eczema treatments (emollients, corticosteroids applied topically, calcineurin inhibitors applied topically and wet wraps); frequency of infections; and cost-effectiveness. The acceptability and durability of the clothing will also be assessed, as will adherence to wearing the garments. A nested qualitative study will assess the views of a subset of children wearing the garments and their parents, and those of healthcare providers and commissioners. Randomisation uses a computer-generated sequence of permuted blocks of randomly varying size, stratified by recruiting hospital and child's age ( 5 years), and concealed using a secure web-based system. The sequence of treatment allocations will remain concealed until

  5. 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

  6. 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

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

    LENUS (Irish Health Repository)

    Murphy, Deirdre J

    2012-09-13

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

  8. 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

  9. Five-year results of a randomised controlled multi-centre study comparing heavy-weight knitted versus low-weight, non-woven polypropylene implants in Lichtenstein hernioplasty.

    Science.gov (United States)

    Smietański, M; Bury, K; Smietańska, I A; Owczuk, R; Paradowski, T

    2011-10-01

    This prospective randomised study evaluated whether non-knitted and non-woven lightweight implants can influence postoperative pain and time of return to normal activity, without increasing the recurrence rate in Lichtenstein inguinal hernioplasty. Patients were operated on in four centres, randomised blindly into two groups with respect to the mesh used: Surgimesh WN (non-woven polypropylene microfibre sheet) and heavy weight polypropylene mesh. The operation was performed according to the Lichtenstein technique. Follow-up was designed for 7 days, and 3, 6, 12 and 60 months. The objectives were to assess the incidence of early and late complications, recurrence rate, and postoperative pain. A total of 220 patients were randomised; after monitoring visits (exclusion of one hospital), 202 qualified for the assessment. At 60 months, the recurrence rate did not differ statistically. Less pain on the 7th postoperative day, and at 3 months, was observed in the WN group. No other differences were observed. Use of a lightweight non-woven polypropylene implant is a valuable alternative to the use of knitted or woven meshes in the Lichtenstein method. Postoperative pain and recurrence were reduced at short term follow-up, but no statistical difference in recurrence rate was observed at 12 and 60 month follow-up in the patient population tested.

  10. A pragmatic parallel arm multi-centre randomised controlled trial to assess the effectiveness and cost-effectiveness of a group-based fatigue management programme (FACETS) for people with multiple sclerosis.

    Science.gov (United States)

    Thomas, Sarah; Thomas, Peter W; Kersten, Paula; Jones, Rosemary; Green, Colin; Nock, Alison; Slingsby, Vicky; Smith, Angela Davies; Baker, Roger; Galvin, Kathleen T; Hillier, Charles

    2013-10-01

    Fatigue is a common and troubling symptom for people with multiple sclerosis (MS). To evaluate the effectiveness and cost-effectiveness of a six-session group-based programme for managing MS-fatigue (Fatigue: Applying Cognitive behavioural and Energy effectiveness Techniques to lifeStyle (FACETS)). Three-centre parallel arm randomised controlled trial with economic evaluation. Patients with MS and significant fatigue were randomised to FACETS plus current local practice (FACETS) or current local practice alone (CLP), using concealed computer-generated randomisation. Participant blinding was not possible. Primary outcomes were fatigue severity (Fatigue Assessment Instrument), self-efficacy (Multiple Sclerosis-Fatigue Self-Efficacy) and disease-specific quality of life (Multiple Sclerosis Impact Scale (MSIS-29)) at 1 and 4 months postintervention (follow-up 1 and 2). Quality adjusted life years (QALYs) were calculated (EuroQoL 5-Dimensions questionnaire and the Short-form 6-Dimensions questionnaire). Between May 2008 and November 2009, 164 patients were randomised; primary outcome data were available for 146 (89%). Statistically significant differences favour the intervention group on fatigue self-efficacy at follow-up 1 (mean difference (MD) 9, 95% CI (4 to 14), standardised effect size (SES) 0.54, p=0.001) and follow-up 2 (MD 6, 95% CI (0 to 12), SES 0.36, p=0.05) and fatigue severity at follow-up 2 (MD -0.36, 95% CI (-0.63 to -0.08), SES -0.35, p=0.01) but no differences for MSIS-29 or QALYs. No adverse events reported. Estimated cost per person for FACETS is £453; findings suggest an incremental cost-effectiveness ratio of £2157 per additional person with a clinically significant improvement in fatigue. FACETS is effective in reducing fatigue severity and increasing fatigue self-efficacy. However, it is difficult to assess the additional cost in terms of cost-effectiveness (ie, cost per QALY) as improvements in fatigue are not reflected in the QALY outcomes

  11. 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...... ten national shoulder units within a two-year period. We plan to include 162 patients. A central randomisation unit will allocate patients. All patients will receive a standardised three-month rehabilitation program of supervised physiotherapy regardless of treatment allocation. Patients...... will be followed at least one year. The primary outcomes will be the overall score on the Constant Disability Scale, and its pain subscale, measured at 12 months. A blinded physiotherapist will carry out the assessments. Other secondary outcomes are Oxford Shoulder Score, and general health status (Short Form-36)....

  12. 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...

  13. A multi-centre, randomised trial to assess whether increased dietary fibre intake (using a fibre supplement or high-fibre foods) produces healthy bowel performance and reduces laxative requirement in free living patients on peritoneal dialysis.

    Science.gov (United States)

    Sutton, Debbie; Ovington, Susan; Engel, Barbara

    2014-09-01

    Constipation is a significant problem for many patients on peritoneal dialysis (PD). Due in part to dietary restrictions it is a common cause of technique failure and poor dialysis efficacy. Both consequences have an economic cost as well as contributing to a poor patient experience. This study aimed to investigate whether an appropriate daily bowel habit could be achieved through a higher fibre intake, minimal use of laxatives and with no adverse effect on potassium, phosphate and fluid balance. One hundred and seven patients who had been on PD for at least three months were recruited from seven renal units. They were asked to record daily bowel habits (Bristol Stool Form Scale: BSFS) and laxative use for four weeks. From this group 41 suitable patients with regular laxative use were identified and invited to enter the Intervention stage, Stage 2. Patients were randomised into one of three intervention arms: high fibre supplement (HFS); high fibre diet (HFD) or placebo. During the intervention stage, intake of HFS increased significantly between week 1 and week 4 (p = 0.04) and in the placebo group between week 1 and week 3 (p = 0.02). There was no significant increase in fibre intake for those on the HFD. Laxative dose appeared to decrease in the HFS group (38%) and the HFD group (16%) but these changes were not significant when compared to the placebo. This study has confirmed the prevalence of laxative use amongst patients on PD and shown that fibre use can confer improvements in bowel function without affecting biochemistry. © 2014 European Dialysis and Transplant Nurses Association/European Renal Care Association.

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

    LENUS (Irish Health Repository)

    Murphy, Deirdre J

    2012-02-01

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

  16. How to improve walking, balance and social participation following stroke: a comparison of the long term effects of two walking aids--canes and an orthosis TheraTogs--on the recovery of gait following acute stroke. A study protocol for a multi-centre, single blind, randomised control trial

    Directory of Open Access Journals (Sweden)

    Maguire Clare

    2012-03-01

    Full Text Available Abstract Background Annually, some 9000 people in Switzerland suffer a first time stroke. Of these 60% are left with moderate to severe walking disability. Evidence shows that rehabilitation techniques which emphasise activity of the hemiplegic side increase ipsilesional cortical plasticity and improve functional outcomes. Canes are commonly used in gait rehabilitation although they significantly reduce hemiplegic muscle activity. We have shown that an orthosis "TheraTogs" (a corset with elasticated strapping significantly increases hemiplegic muscle activity during gait. The aim of the present study is to investigate the long term effects on the recovery of gait, balance and social participation of gait rehabilitation with TheraTogs compared to gait rehabilitation with a cane following first time acute stroke. Methods/Design Multi-centre, single blind, randomised trial with 120 patients after first stroke. When subjects have reached Functional Ambulation Category 3 they will be randomly allocated into TheraTogs or cane group. TheraTogs will be applied to support hip extensor and abductor musculature according to a standardised procedure. Cane walking held at the level of the radial styloid of the sound wrist. Subjects will walk throughout the day with only the assigned walking aid. Standard therapy treatments and usual care will remain unchanged and documented. The intervention will continue for five weeks or until patients have reached Functional Ambulation category 5. Outcome measures will be assessed the day before begin of intervention, the day after completion, 3 months, 6 months and 2 years. Primary outcome: Timed "up and go" test, secondary outcomes: peak surface EMG of gluteus maximus and gluteus medius, activation patterns of hemiplegic leg musculature, temporo-spatial gait parameters, hemiplegic hip kinematics in the frontal and sagittal planes, dynamic balance, daily activity measured by accelerometry, Stroke Impact Scale

  17. A comparison of the clinical effectiveness and cost of specialised individually delivered parent training for preschool attention-deficit/hyperactivity disorder and a generic, group-based programme: a multi-centre, randomised controlled trial of the New Forest Parenting Programme versus Incredible Years.

    Science.gov (United States)

    Sonuga-Barke, Edmund J S; Barton, Joanne; Daley, David; Hutchings, Judy; Maishman, Tom; Raftery, James; Stanton, Louise; Laver-Bradbury, Cathy; Chorozoglou, Maria; Coghill, David; Little, Louisa; Ruddock, Martin; Radford, Mike; Yao, Guiqing Lily; Lee, Louise; Gould, Lisa; Shipway, Lisa; Markomichali, Pavlina; McGuirk, James; Lowe, Michelle; Perez, Elvira; Lockwood, Joanna; Thompson, Margaret J J

    2017-10-30

    The objective of this study is to compare the efficacy and cost of specialised individually delivered parent training (PT) for preschool children with attention-deficit/hyperactivity disorder (ADHD) against generic group-based PT and treatment as usual (TAU). This is a multi-centre three-arm, parallel group randomised controlled trial conducted in National Health Service Trusts. The participants included in this study were preschool children (33-54 months) fulfilling ADHD research diagnostic criteria. New Forest Parenting Programme (NFPP)-12-week individual, home-delivered ADHD PT programme; Incredible Years (IY)-12-week group-based, PT programme initially designed for children with behaviour problems were the interventions. Primary outcome-Parent ratings of child's ADHD symptoms (Swanson, Nolan & Pelham Questionnaire-SNAP-IV). Secondary outcomes-teacher ratings (SNAP-IV) and direct observations of ADHD symptoms and parent/teacher ratings of conduct problems. NFPP, IY and TAU outcomes were measured at baseline (T1) and post treatment (T2). NFPP and IY outcomes only were measured 6 months post treatment (T3). Researchers, but not therapists or parents, were blind to treatment allocation. Analysis employed mixed effect regression models (multiple imputations). Intervention and other costs were estimated using standardized approaches. NFPP and IY did not differ on parent-rated SNAP-IV, ADHD combined symptoms [mean difference - 0.009 95% CI (- 0.191, 0.173), p = 0.921] or any other measure. Small, non-significant, benefits of NFPP over TAU were seen for parent-rated SNAP-IV, ADHD combined symptoms [- 0.189 95% CI (- 0.380, 0.003), p = 0.053]. NFPP significantly reduced parent-rated conduct problems compared to TAU across scales (p values IY over TAU were seen for parent-rated SNAP, ADHD symptoms [- 0.16 95% CI (- 0.37, 0.04), p = 0.121] or parent-rated conduct problems (p > 0.05). The cost per family of providing NFPP in the trial was significantly

  18. 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

  19. 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

  20. 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.

  1. Clinical effectiveness and cost-effectiveness of collaborative care for depression in UK primary care (CADET): a cluster randomised controlled trial.

    Science.gov (United States)

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

    2016-02-01

    Collaborative care is effective for depression management in the USA. There is little UK evidence on its clinical effectiveness and cost-effectiveness. To determine the clinical effectiveness and cost-effectiveness of collaborative care compared with usual care in the management of patients with moderate to severe depression. Cluster randomised controlled trial. UK primary care practices (n = 51) in three UK primary care districts. A total of 581 adults aged ≥ 18 years in general practice with a current International Classification of Diseases, Tenth Edition depressive episode, excluding acutely suicidal people, those with psychosis, bipolar disorder or low mood associated with bereavement, those whose primary presentation was substance abuse and those receiving psychological treatment. Collaborative care: 14 weeks of 6-12 telephone contacts by care managers; mental health specialist supervision, including depression education, medication management, behavioural activation, relapse prevention and primary care liaison. Usual care was general practitioner standard practice. Blinded researchers collected depression [Patient Health Questionnaire-9 (PHQ-9)], anxiety (General Anxiety Disorder-7) and quality of life (European Quality of Life-5 Dimensions three-level version), Short Form questionnaire-36 items) outcomes at 4, 12 and 36 months, satisfaction (Client Satisfaction Questionnaire-8) outcomes at 4 months and treatment and service use costs at 12 months. In total, 276 and 305 participants were randomised to collaborative care and usual care respectively. Collaborative care participants had a mean depression score that was 1.33 PHQ-9 points lower [n = 230; 95% confidence interval (CI) 0.35 to 2.31; p = 0.009] than that of participants in usual care at 4 months and 1.36 PHQ-9 points lower (n = 275; 95% CI 0.07 to 2.64; p = 0.04) at 12 months after adjustment for baseline depression (effect size 0.28, 95% CI 0.01 to 0.52; odds ratio for

  2. 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.

  3. 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...

  4. Multiple myeloma in Nigeria: a multi-centre epidemiological and ...

    African Journals Online (AJOL)

    Multiple myeloma in Nigeria: a multi-centre epidemiological and biomedical study. Nkiruka Nnonyelum Odunukwe, Jude Anazoeze Madu, Obigeli Eunice Nnodu, Titilola Stella Akingbola, Inyama Marcus Asuquo, Modupe Taiwo Balogun, Olufunto Olufela Kalejaiye, John Chinawaeze Aneke, Joseph Aondowase Orkuma, ...

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

  6. 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....

  7. 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...

  8. 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.

  9. 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

  10. 33 CFR 40.1 - Program for appointing cadets.

    Science.gov (United States)

    2010-07-01

    ... previous academic performance, reported College Entrance Examination Board or American College Testing scores, and the findings of a Cadet Candidate Evaluation Board, consisting of Coast Guard officers...

  11. COMPARATIVE ANALYSIS OF HANDBALL CADETS AND YOUNGER CADETS IN THE MOTOR AND THE SPECIFIC-MOTOR SKILLS

    Directory of Open Access Journals (Sweden)

    Aldijana Muratović

    2014-06-01

    Full Text Available Studies that deal with the problem of comparing two or more groups of handball players of different ages, are not so frequent. A number of Croatian authors contributed to these studies In a way that they have analyzed the differences between handball players at defferent levels of competition. In this study, a survey was conducted in order to determine whether there are differences between handball cadets and junior cadets in the motor and the specific motor skills. The sample in this study consisted of 30 handball players split in this way : the cadets (15, aged 16-17 years old and younger cadets (15 aged 13-14 years. There were 12 tests ( of measuring instruments for estimating general motor abilities and 4 tests for estimating specific-motor skills. Basic statistical parameters were calculated for all the results in the variables. Statistically significant difference between the arithmetic means of cadets and junior cadets was determined by t-test for small independent samples. The data obtained from the testing of differences between group of handball cadets and junior cadets showed that the handball cadets had significantly better results in the four variables (long jump in here, throwing a handball ball from the gray straddle the ground, throwing a medicine ball from lying on back and the accuracy of jump shot from 9 m, while the younger cadets achieved significantly better results in the two variables (side steps and slalom in the area between 6-9 m. Since the results showed that handball cadets had better results (in a number of variables than younger cadets , this study was consistent with the previous studies attempted to analyze the differences between handball players of different ages.

  12. 32 CFR 903.8 - Cadet candidate disenrollment.

    Science.gov (United States)

    2010-07-01

    ... 32 National Defense 6 2010-07-01 2010-07-01 false Cadet candidate disenrollment. 903.8 Section 903.8 National Defense Department of Defense (Continued) DEPARTMENT OF THE AIR FORCE MILITARY TRAINING AND SCHOOLS AIR FORCE ACADEMY PREPARATORY SCHOOL § 903.8 Cadet candidate disenrollment. (a) In...

  13. 32 CFR 903.9 - Cadet records and reassignment forms.

    Science.gov (United States)

    2010-07-01

    ... 32 National Defense 6 2010-07-01 2010-07-01 false Cadet records and reassignment forms. 903.9 Section 903.9 National Defense Department of Defense (Continued) DEPARTMENT OF THE AIR FORCE MILITARY TRAINING AND SCHOOLS AIR FORCE ACADEMY PREPARATORY SCHOOL § 903.9 Cadet records and reassignment forms. (a...

  14. 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.

  15. USMA Foreign Cadet Program -- A Case Study

    Science.gov (United States)

    1981-05-04

    Philippines 58 Ecuador 7 Thailand 10 El Salvador 5 Switzerland 1 Guatemala 5 Uruguay 3 Guyana 3 Venezuela 6 Honduras 4 Vietnam I Jamaica 3 Total 167 _7...result of the USMA entrance examinations. Clearly, the Philippines is providing the USMA with the cr~me de la cr~me. THE FIRST FOREIGN CADET FROM THE...1980), son of Sanchez (USMA 1954). Janairo (USMA 1930), now a US citizen, had two sons graduate--(USMA 1954) and (USMA 1964). Flor Cruz (USMA 1942

  16. 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

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

    NARCIS (Netherlands)

    van Esch, Thamar E. M.; Kollmeier, Birger; Vormann, Matthias; Lyzenga, Johannes; Houtgast, Tammo; Hällgren, Mathias; Larsby, Birgitta; Athalye, Sheetal P.; Lutman, Mark E.; Dreschler, Wouter A.

    2013-01-01

    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 disability

  18. Recommendations of the VAC2VAC workshop on the design of multi-centre validation studies.

    NARCIS (Netherlands)

    Halder, Marlies; Depraetere, Hilde; Delannois, Frédérique; Akkermans, Arnoud; Behr-Gross, Marie-Emmanuelle; Bruysters, Martijn; Dierick, Jean-François; Jungbäck, Carmen; Kross, Imke; Metz, Bernard; Pennings, Jeroen; Rigsby, Peter; Riou, Patrice; Balks, Elisabeth; Dobly, Alexandre; Leroy, Odile; Stirling, Catrina

    2018-01-01

    Within the Innovative Medicines Initiative 2 (IMI 2) project VAC2VAC (Vaccine batch to vaccine batch comparison by consistency testing), a workshop has been organised to discuss ways of improving the design of multi-centre validation studies and use the data generated for product-specific validation

  19. 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...

  20. 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).

  1. 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…

  2. Occupational Issues and Expectations of Turkish Deck Cadets

    Directory of Open Access Journals (Sweden)

    Serdar Yġldġz

    2016-09-01

    Full Text Available Seafaring is one of the world's most difficult professions. Seafarers have to face with many negative factors while they are at sea. These negative factors, makes the seafaring profession difficult to be preferred. Fatigue, stress, heavy weather conditions and lack of communication are some of these factors that affect seafarer’s occupational continuity and also make contribution to occurrence of marine accidents. Cadet is one of the seafarers who will be a navigation officer and captain in the near future. That’s why cadets have a significant role in maritime industry. Theoretical and practical training of cadets is very important. Purpose of this study was to examine deck cadets’ training conditions and difficulties they have to face with during their training period. In order to identify these difficulties, render their lives during trainings easier, and establish their expectations, questionnaire conducted with 618 deck cadets. Interviews were carried out with 3 trainers and 10 maritime companies that have substantial shares in Turkey’s maritime trade. As a result of this study identified factors that increase fatigue mostly, reduction measures have been exposed and have tried to offer solutions. This study is an advisory to improve the occupational continuity of cadets in the profession.

  3. 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.

  4. DIFFERENCES BETWEEN CADET AND YOUNGER CADET HANDBALL PLAYERS IN SPECIFIC MOTOR ABILITIES

    Directory of Open Access Journals (Sweden)

    Dinko Vuleta

    2012-09-01

    Full Text Available The differences were analyzed between 12 cadet and 12 younger cadet handball players in indicators of specific motor abilities. Central and dispersive parameters were computed of the variables obtained in the testing procedures. The acceptable significance level was set at p≤.05. The results of MANOVA showed significant statistical differences (Wilks´ Lambda=.459; p<.01 between the two analyzed groups of handball players. The results of t-test for independent samples of variables assessing specific agility and specific power of arms confirmed statistically significant differences between the groups in all the variables: quickness between goal posts and 4 m line 4 m (KIWI, sitting handball throw (RADAR4, 6-m-line basic stance handball throw (RADAR6, 9-m-line basic ground shot after the three-step approach (RADAROU and 9-m-line jump shot from dribbling (RADAR-SŠ. The obtained results are in accordance with the biological factors of maturation and with the selective approach to the training program design and implementation of training programmes aimed at the development of explosive power of the throwing type in younger age categories of handball players.

  5. Ethical issues: the multi-centre low-risk ethics/governance review process and AMOSS.

    Science.gov (United States)

    Vaughan, Geraldine; Pollock, Wendy; Peek, Michael J; Knight, Marian; Ellwood, David; Homer, Caroline S; Pulver, Lisa Jackson; McLintock, Claire; Ho, Maria T; Sullivan, Elizabeth A

    2012-04-01

    The Australasian Maternity Outcomes Surveillance System (AMOSS) conducts surveillance and research of rare and serious conditions in pregnancy. This multi-centre population health study is considered low risk with minimal ethical impact. To describe the ethics/governance review pathway undertaken by AMOSS. Prospective, descriptive study during 2009-2011 of the governance/ethical review processes required to gain approval for Australian and New Zealand (ANZ) maternity units with more than 50 births per year (n = 303) to participate in AMOSS. Review processes ranged from a single application for 24 NZ sites, a single application for eligible hospitals in two Australian states, full Health Research Ethics Committee (HREC) applications for individual hospitals, through simple letters of support. As of September 2011, 46 full/expedited ethics applications, 131 site governance applications and 136 letters of support requests were made over 33 months, involving an estimated 3261 hours by AMOSS staff/investigators, and an associated resource burden by participating sites, to obtain approval to receive nonidentifiable data from 291 hospitals. The AMOSS research system provides an important resource to enhance knowledge of conditions that cause rare and serious maternal morbidity. Yet the highly variable ethical approval processes required to implement this study have been excessively repetitive and burdensome. This process jeopardises timely, efficient research project implementation, without corresponding benefits to research participants. The resource burden to establish research governance for AMOSS confirms the urgent need for the Harmonisation of Multi-centre Ethical Review (HoMER) to further streamline ethics/governance review processes for multi-centre research. © 2011 The Authors. Australian and New Zealand Journal of Obstetrics and Gynaecology © 2011 The Royal Australian and New Zealand College of Obstetricians and Gynaecologists.

  6. 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.

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

    Science.gov (United States)

    Gómez-Cabello, Alba; Vicente-Rodríguez, Germán; Albers, Ulrike; Mata, Esmeralda; Rodriguez-Marroyo, Jose A; Olivares, Pedro R; Gusi, Narcis; Villa, Gerardo; Aznar, Susana; Gonzalez-Gross, Marcela; Casajús, Jose A; Ara, Ignacio

    2012-01-01

    The elderly EXERNET multi-centre study aims to collect normative anthropometric data for old functionally independent adults living in Spain. 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. 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. 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%. 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.

  8. Harmonization Process and Reliability Assessment of Anthropometric Measurements in the Elderly EXERNET Multi-Centre Study

    Science.gov (United States)

    Gómez-Cabello, Alba; Vicente-Rodríguez, Germán; Albers, Ulrike; Mata, Esmeralda; Rodriguez-Marroyo, Jose A.; Olivares, Pedro R.; Gusi, Narcis; Villa, Gerardo; Aznar, Susana; Gonzalez-Gross, Marcela; Casajús, Jose A.; Ara, Ignacio

    2012-01-01

    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. PMID:22860013

  9. 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.

  10. 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

    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...... fetal head-to-cervix contact (1.83, 1.31-2.56). The use of epidural analgesia (5.65, 4.33-7.38) was also associated with dystocia. CONCLUSION: Vaginal examinations at admission provide useful information on risk indicators for dystocia. The strongest risk indicator was use of epidural analgesia...

  11. 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.

  12. Pneumonia Outbreak Caused by Chlamydophila pneumoniae Among US Air Force Academy Cadets, Colorado, USA

    Science.gov (United States)

    2015-06-01

    2014 Bacteria or virus No. (%) positive Cadets with pneumonia , n = 15 Cadets without pneumonia , n = 53 Chlamydophila pneumonia 11 (73) 19 (36...Article 3. DATES COVERED (From – To) Sep 2013 – May 2014 4. TITLE AND SUBTITLE Pneumonia Outbreak Caused by Chlamydophila pneumoniae among US Air Force...October 2013–May 2014, there were 102 cases of pneumonia diagnosed in US Air Force Academy cadets. A total of 73% of tested nasal washes contained

  13. 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...

  14. 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

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

    Science.gov (United States)

    van Esch, Thamar E M; Kollmeier, Birger; Vormann, Matthias; Lyzenga, Johannes; Houtgast, Tammo; Hällgren, Mathias; Larsby, Birgitta; Athalye, Sheetal P; Lutman, Mark E; Dreschler, Wouter A

    2013-05-01

    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 disability and handicap, and cognition. Clinical applicability and comparability across different centres are investigated. Headphone tests were conducted in five centres divided over four countries. Effects of test-retest, ear, and centre were investigated. Results for normally-hearing (NH) and hearing-impaired (HI) listeners are presented. Thirty NH listeners aged 19-39 years, and 72 HI listeners aged 22-91 years with a broad range of hearing losses were included. Test-retest reliability was generally good and there were very few right/left ear effects. Results of all tests were comparable across centres for NH listeners after baseline correction to account for necessary differences between test materials. For HI listeners, results were comparable across centres for the language-independent tests. The auditory profile forms a clinical test battery that is applicable in four different languages. Even after baseline correction, differences between test materials have to be taken into account when interpreting results of language-dependent tests in HI listeners.

  16. 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.

  17. 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.

  18. 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...

  19. 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 < 0.001]. There were no significant differences in hospital length of stay or pain VAS scores between the two groups. An incisional hernia developed within 1 year in six patients in the SPC group and in three in the MPC group (P = 0.331). Patients were more satisfied with aesthetic results after SPC, whereas surgeons rated the aesthetic results higher after MPC. No difference in quality of life scores, as measured by the gastrointestinal quality of life index at 60 days after surgery, was observed between the two groups. In selected patients undergoing cholecystectomy for benign gallbladder disease, SPC is non-inferior to MPC in terms of safety but it entails a longer operative time. Possible concerns about a higher risk of incisional hernia following SPC do not appear to be justified. Patient satisfaction with aesthetic results was greater after SPC than after MPC.

  20. Immune responsiveness and risk of illness in U.S. Air Force Academy cadets during basic cadet training

    Science.gov (United States)

    Lee, David J.; Meehan, Richard T.; Robinson, Christine; Mabry, Thomas R.; Smith, Morey L.

    1992-01-01

    It has been proposed, but not confirmed, that environmental stressors alter immune function and increase the risk of viral infection among healthy individuals. This hypothesis was evaluated by examining the relationship among stress, immune function, and illness in 96 first-year U.S. Air Force Academy cadets during orientation and four weeks later during the stressful environment of basic cadet training (BCT). Perceived stress and well-being levels of cadets were assessed via questionnaire. Immune responsiveness was analyzed by PHA-stimulated thymidine uptake in mononuclear leucocytes and by serologic evidence of reactivation of the Epstein-Barr virus (EBV). Results showed significant declines in in vitro PHA-induced lymphocyte transformation (-35 percent)and subjective well-being (-19 percent) from orientation to BCT with corresponding, significant increases in perceived stress (+32 percent). Despite significantly altered in vitro immune responsiveness, there was no serologic evidence of EBV reactivation nor was there an association between these measures and risk of illness as determined by medical chart review and self-reported symptoms.

  1. 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…

  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. 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.

  4. 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

  5. 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.

  6. 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.

  7. 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.

  8. 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

  9. Quantification of FDG PET studies using standardised uptake values in multi-centre trials: effects of image reconstruction, resolution and ROI definition parameters

    NARCIS (Netherlands)

    Westerterp, Marinke; Pruim, Jan; Oyen, Wim; Hoekstra, Otto; Paans, Anne; Visser, Eric; van Lanschot, Jan; Sloof, Gerrit; Boellaard, Ronald

    2007-01-01

    PURPOSE: Standardised uptake values (SUVs) depend on acquisition, reconstruction and region of interest (ROI) parameters. SUV quantification in multi-centre trials therefore requires standardisation of acquisition and analysis protocols. However, standardisation is difficult owing to the use of

  10. Quantification of FDG PET studies using standardised uptake values in multi-centre trials: effects of image reconstruction, resolution and ROI definition parameters.

    NARCIS (Netherlands)

    Westerterp, M.; Pruim, J.; Oyen, W.J.G.; Hoekstra, O.; Paans, A.; Visser, E.P.; Lanschot, J.J. van; Sloof, G.; Boellaard, R.

    2007-01-01

    PURPOSE: Standardised uptake values (SUVs) depend on acquisition, reconstruction and region of interest (ROI) parameters. SUV quantification in multi-centre trials therefore requires standardisation of acquisition and analysis protocols. However, standardisation is difficult owing to the use of

  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. Clinical efficacy and safety of IV ferric carboxymaltose (FCM) treatment of RLS: a multi-centred, placebo-controlled preliminary clinical trial.

    Science.gov (United States)

    Allen, Richard P; Adler, Charles H; Du, Wei; Butcher, Angelia; Bregman, David B; Earley, Christopher J

    2011-10-01

    Intravenous (IV) iron has been used as a treatment to reduce Restless Legs Syndrome (RLS) symptoms, but two double-blinded trials of a frequently prescribed IV iron formulation, iron sucrose, failed to show lasting efficacy. This study evaluates efficacy and safety of a new IV iron formulation (ferric carboxymaltose, FCM) with molecular properties that may make iron more available for uptake to the brain than iron sucrose does. In this 28-day, multi-centre, randomised, placebo-controlled trial 46 RLS patients were discontinued from all RLS treatment. Twenty-four received 500 mg FCM in two doses 5 days apart and 22 received a matching placebo. At day 28, those on placebo were given a single 1000 mg IV FCM and those not responding to initial treatment were given a third dose of 500 mg FCM. Patients were followed up for 24 weeks or until needing added RLS treatment. FCM significantly improved primary and secondary outcomes compared to placebo: International Restless Legs Syndrome study group severity scale (IRLS) average (SD) decrease of 8.9 (8.52) versus 4.0 (6.11), p=0.040; Clinical Global Inventory of Change (CGI-1) very much or much improved 48.3% versus 14.3%, p=0.004. Quality of life was also significantly improved. Of the 24 with initial iron treatment 45% responded and 29% remitted (IRLS ≤ 10) at day 28, and 25% continued free of other RLS medications at 24 weeks after treatment. The single 1000 mg dose on day 28 produced the same degree of treatment response as the divided dose, but the added 500 mg dose for those not responding to the initial treatment showed little benefit. There were no significant adverse events. IV FCM provided a safe and effective treatment for RLS that lasted for at least 24 weeks for some patients. Larger studies are needed to confirm these results. Copyright © 2011 Elsevier B.V. All rights reserved.

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

    Directory of Open Access Journals (Sweden)

    Benítez Mència

    2008-05-01

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

  14. 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.

  15. 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.

  16. 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...

  17. 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.)

  18. Determinants of Stress Fracture and Bone Mass in Elite Military Cadets

    National Research Council Canada - National Science Library

    Cosman, Felicia

    2002-01-01

    The aim of this 4-year prospective cohort study of 891 cadets at the United States Military Academy at West Point was to examine the determinants of stress fractures and the acquisition of peak bone...

  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...they attended certain ChalleNGe programs [1]. That is, even after controlling for cadets’ gender , age, and initial abilities (both cognitive and...main goals are for the cadets, how he would characterize the average cadet on arrival at ChalleNGe (in terms of academics, socioeconomics, and self

  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. Longitudinal study of sleep patterns of United States Military Academy cadets.

    Science.gov (United States)

    Miller, Nita Lewis; Shattuck, Lawrence G; Matsangas, Panagiotis

    2010-12-01

    The study provided an opportunity to observe sleep patterns in a college-age population attending the United States Military Academy. This 4-year longitudinal study investigated sleep patterns of cadets. A stratified sample of 80 cadets had sleep patterns monitored using actigraphy for 8 months: one month in both fall and spring academic semesters over a 4-year period. Data were collected at the United States Military Academy, West Point, NY. Participants were members of the class of 2007 (n˜1300) ranging in age from 17 to 22 when entering USMA. A sample of the class (n=80) wore wrist activity monitors and completed activity logs for one month in fall and spring academic semesters for the 4-year period. On average over the 4 years, cadets sleptsleep debt. Cadets slept more during fall than spring semesters. Male and female cadet sleep patterns varied dramatically, with males consistently receiving less sleep than females (˜21 m for nighttime sleep and ˜23 m for daily sleep). Cadet sleep at USMA is related to academic year, semester, season, sex, school day or weekend, and day of the week. These students suffer from chronic sleep debt. Restrictions imposed by the military academy limit the generalizability of the findings to other college age populations.

  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. 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.

  4. ROTC Cadets in Summer Training Worry about Campus Protests Aimed at the Pentagon's Policy Banning Homosexual Recruits.

    Science.gov (United States)

    Dodge, Susan

    1990-01-01

    Some protesters contend that a Defense Department policy barring homosexuals from becoming commissioned military officers contradicts campus regulations against discrimination. The controversy concerns ROTC cadets, whose scholarships may be in jeopardy if the corps were banned from their campus. Cadets also find the summer training builds…

  5. Relating functional changes during hand movement to clinical parameters in patients with multiple sclerosis in a multi-centre fMRI study

    NARCIS (Netherlands)

    Wegner, C.; Filippi, M.; Korteweg, T.; Beckmann, C.; Ciccarelli, O.; De Stefano, N.; Enzinger, C.; Fazekas, F.; Agosta, F.; Gass, A.; Hirsch, J.; Johansen-Berg, H.; Kappos, L.; Barkhof, F.; Polman, C.H.; Mancini, L.; Manfredonia, F.; Marino, S.; Miller, D. H.; Montalban, X.; Palace, J.; Rocca, M.; Ropele, S.; Rovira, A.; Smith, S.; Thompson, A.; Thornton, J.; Yousry, T.; Matthews, P.M.

    2008-01-01

    We performed a prospective multi-centre study using functional magnetic resonance imaging (fMRI) to better characterize the relationships between clinical expression and brain function in patients with multiple sclerosis (MS) at eight European sites (56 MS patients and 60 age-matched, healthy

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

    NARCIS (Netherlands)

    Muller, U.C.; Asherson, P.; Banaschewski, T.; Buitelaar, J.K.; Ebstein, R.P.; Eisenberg, J.; Gill, M.; Manor, I.; Miranda, A.; Oades, R.D.; Roeyers, H.; Rothenberger, A.; Sergeant, J.A.; Sonuga-Barke, E.J.S.; Thompson, M.; Faraone, S.V.; Steinhausen, H.C.

    2011-01-01

    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

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

    Directory of Open Access Journals (Sweden)

    Michael Brach

    2013-12-01

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

  8. 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.

  9. Diferencias fisiológicas entre futbolistas de categoría cadete y juvenil

    OpenAIRE

    Quintela Eguiluz, Kerman

    2014-01-01

    Los objetivos de este estudio fueron analizar las diferencias en las características antropométricas, resistencia aeróbica, temperatura corporal y percepción subjetiva del esfuerzo en futbolistas de distintas categorías (cadete y juvenil), y examinar la relación existente entre las distintas variables analizadas. Para ello participaron 37 jóvenes futbolistas, 20 de ellos cadetes (15,12 ± 0,69 años) y 17 juveniles (16,94 ± 0,89 años). A los futbolistas se les midió la talla y la masa corporal...

  10. KidsBrainIT: A New Multi-centre, Multi-disciplinary, Multi-national Paediatric Brain Monitoring Collaboration.

    Science.gov (United States)

    Lo, T; Piper, I; Depreitere, B; Meyfroidt, G; Poca, M; Sahuquillo, J; Durduran, T; Enblad, P; Nilsson, P; Ragauskas, A; Kiening, K; Morris, K; Agbeko, R; Levin, R; Weitz, J; Park, C; Davis, P

    2018-01-01

    Validated optimal cerebral perfusion pressure (CPP) treatment thresholds in children do not exist. To improve the intensive care unit (ICU) management of the paediatric traumatic brain injury (TBI) population, we are forming a new paediatric multi-centre collaboration to recruit standardised ICU data for running and reporting upon models for assessing autoregulation and optimal CCP (CPPopt). We are adapting the adult BrainIT group's approach to develop a new Paediatric Brain Monitoring and Information Technology Group (KidsBrainIT), which will include a repository to store prospectively collected high-resolution physiological, clinical, and outcome data. In the first phase of this project there are 7 UK Paediatric Intensive Care Units, 1 Spanish, 1 Belgium, and 1 Romanian Centre interested in participating. In subsequent phases, we plan to open recruitment to other centres both within Europe, US and abroad. We are collaborating with the Leuven Group and plan to use their LAx (low-frequency autoregulation index), DATACAR (dynamic adaptive target of active cerebral autoregulation), CPPopt and visualisation methodologies. We also plan to use the continuous diffuse optical monitoring and tomography technology developed in Barcelona as an acute surrogate end-point for optimising brain perfusion. This technology allows non-invasive continuous monitoring of deep tissue perfusion and oxygenation in adults but its clinical application in infants and children with TBI has not been studied previously. We report on the current status of setting up this new collaboration and also on pilot analyses in two centres which are the basis of our rationale for the need for a prospective validation study of CPPopt in children. Specifically, we demonstrated that CPPopt varied with time for each patient during their paediatric intensive care unit (PICU) stay, and the median overall CPPopt levels for children aged 2-6 years, 7-11 years and 12-16 years were 68.83, 68.09, and 72.17 mm

  11. Does Cataract Surgery Alleviate Poverty? Evidence from a Multi-Centre Intervention Study Conducted in Kenya, the Philippines and Bangladesh

    Science.gov (United States)

    Kuper, Hannah; Polack, Sarah; Mathenge, Wanjiku; Eusebio, Cristina; Wadud, Zakia; Rashid, Mamunur; Foster, Allen

    2010-01-01

    Background Poverty and blindness are believed to be intimately linked, but empirical data supporting this purported relationship are sparse. The objective of this study is to assess whether there is a reduction in poverty after cataract surgery among visually impaired cases. Methodology/Principal Findings A multi-centre intervention study was conducted in three countries (Kenya, Philippines, Bangladesh). Poverty data (household per capita expenditure – PCE, asset ownership and self-rated wealth) were collected from cases aged ≥50 years who were visually impaired due to cataract (visual acuityassets and self-rated wealth. By follow-up PCE had increased significantly among operated cases in each of the three settings to the level of controls (Kenya: $30 versus £36 p = 0.49, Bangladesh: $23 vs $23 p = 0.20, Philippines: $45 vs $36 p = 0.68). There were smaller increases in self-rated wealth and no changes in assets. Changes in PCE were apparent in different socio-demographic and ocular groups. The largest PCE increases were apparent among the cases that were poorest at baseline. Conclusions/Significance This study showed that cataract surgery can contribute to poverty alleviation, particularly among the most vulnerable members of society. This study highlights the need for increased provision of cataract surgery to poor people and shows that a focus on blindness may help to alleviate poverty and achieve the Millennium Development Goals. PMID:21085697

  12. 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)

  13. 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…

  14. 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...

  15. Virginia Tech Corps of Cadets plan for annual march to complete freshmen training year

    OpenAIRE

    Cox, Carrie

    2009-01-01

    To commemorate the end of their freshman training, the class of 2012 of the Virginia Tech Corps of Cadets will complete the annual Caldwell March from Caldwell Fields to the Upper Quad of Virginia Tech's main campus in Blacksburg, Va., on Saturday, April 4.

  16. 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.

  17. 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…

  18. 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.

  19. Cognitive and Noncognitive Improvements Among Cadets at the Washington Youth Academy (WYA)

    Science.gov (United States)

    2014-12-01

    dichotomous: cadets either complete ChalleNGe or they do not. We use a logistic (logit) regression model. Since we are working with a relatively small...Robert Shuford. 2008. Variation in Participants and Policies Across ChalleNGe Programs. CNA Corporation. CRM D0016643.A2/Final. [10] Rosen, Jeffrey

  20. Association of Injury History and Incident Injury in Cadet Basic Military Training

    Science.gov (United States)

    Kucera, Kristen L.; Marshall, Stephen W.; Wolf, Susanne H.; Padua, Darin A.; Cameron, Kenneth L.; Beutler, Anthony I.

    2016-01-01

    Purpose To determine the association between injury history at enrollment and incident lower extremity (LE) injury during cadet basic training among first-year military cadets. Methods Medically treated LE injuries during cadet basic training documented in the Defense Medical Surveillance System (DMSS) were ascertained in a prospective cohort study of three large U.S. military academies from 2005–2008. Both acute injuries (ICD-9 codes in the 800–900s, including fracture, dislocations, sprains/strains) and injury-related musculoskeletal injuries (ICD-9 codes in the 700s, including inflammation and pain, joint derangement, stress fracture, sprain/strain/rupture, and dislocation) were included. Risk ratios (RR) and 95% confidence intervals (CI) were computed using multivariate log-binomial models stratified by gender. Results During basic training there were 1,438 medically treated acute and 1,719 musculoskeletal-related LE injuries in the 9,811 cadets. The most frequent LE injuries were sprains/strains (73.6% of acute) and inflammation and pain (89.6% of musculoskeletal-related). The overall risk of incident LE injury was 23.2% [95%CI: 22.3%, 24.0%]. Cadets with a previous history of LE injury were at increased risk for incident LE injury. This association was identical in males (RR=1.74 [1.55, 1.94]) and females (RR=1.74 [1.52, 1.99]). In site-specific analyses, strong associations between injury history and incident injury were observed for hip, knee ligament, stress fracture, and ankle sprain. Injury risk was greater (p<0.01) for females (39.1%) compared to males (18.0%). The elevated injury risk in females (RR=2.19 [2.04, 2.36]) was independent of injury history (adjusted RR=2.09 [1.95, 2.24]). Conclusion Injury history upon entry to the military is associated with incidence of LE injuries sustained during cadet basic training. Prevention programs targeted at modifiable factors in cadets with a prior history of LE injury should be considered. PMID:26765627

  1. 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

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

    Science.gov (United States)

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

    2016-05-01

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

  3. Outcomes following combined intramedullary nail and plate fixation for complex tibia fractures: A multi-centre study.

    Science.gov (United States)

    Yoon, Richard S; Bible, Jesse; Marcus, Matthew S; Donegan, Derek J; Bergmann, Karl A; Siebler, Justin C; Mir, Hassan R; Liporace, Frank A

    2015-01-01

    Concomitant plate fixation as an adjunct to intramedullary nailing (IMN) of proximal third tibia fractures is a proven technique. Benefits include its role as a minimally invasive reduction aid, allowing for minimal soft tissue disruption. Expanding its indications as adjunct fixation to IMN throughout the tibia, we aimed to study outcomes in a multi-centre initiative. From May 1999 to March 2010, a total of 1302 operatively treated tibial fractures (including plateau and pilon fractures) with complete medical records were identified for review. Of these, 376 cases were treated via IMN, of which 30 cases were treated via combined IMN and plating, meeting inclusion criteria. Primary outcome was union rates, time to union, and complication rates. Secondary outcomes included mean alignment from the immediate postoperative period to the time of final follow-up. Twenty-seven out of 30 patients were available for follow-up. Twenty-five (93%) achieved bony union; the remaining two patients, sustained Type IIIA and B injuries respectively, went onto non-union secondary to deep infection and required multiple re-operations before achieving ultimate union. Mean time at final follow-up was 20 ± 10 months, 96% were ambulatory at full weight bearing status with no malunions. No significant changes in alignment in either the coronal or sagittal planes were noted at time of final follow-up. Combined IMN and plate fixation is a reliable tool not only in the treatment of fractures of the proximal tibia, but also for those fractures in the diaphysis and segmental fractures with proximal and/or distal metadiaphyseal extension with consistent ability to maintain high union rates and maintained alignment. However, longer-term follow-up and prospective trials will be necessary before coming to a definitive conclusion. Copyright © 2015 Elsevier Ltd. All rights reserved.

  4. Recommended dairy product intake modulates circulating fatty acid profile in healthy adults: a multi-centre cross-over study.

    Science.gov (United States)

    Abdullah, Mohammad M H; Cyr, Audrey; Lépine, Marie-Claude; Labonté, Marie-Ève; Couture, Patrick; Jones, Peter J H; Lamarche, Benoît

    2015-02-14

    Dairy products are rich sources of an array of fatty acids (FA) that have been shown individually and in certain clusters to exert varying effects on cardiovascular health, for which the circulating lipid profile is a powerful biomarker. Whether the profile of these FA is reflected in blood upon short terms of intake, possibly contributing to the lipid-related health impacts of dairy products, remains to be fully established. The objectives of the present study were to assess a recommended dairy product consumption in relation to circulating FA and lipid profiles, and to evaluate certain FA in dairy fat as potential biomarkers of intake. In a free-living, multi-centre, cross-over design, 124 healthy individuals consumed 3 servings/d of commercial dairy (DAIRY; 1% fat milk, 1·5% fat yogurt and 34% fat cheese) or energy-equivalent control (CONTROL; fruit and vegetable juice, cashews and a cookie) products for 4 weeks each, separated by a 4-week washout period. Plasma FA and serum lipid profiles were assessed by standard methods at the end of each dietary phase. After 4 weeks of intake, plasma levels of FA pentadecanoic acid (15 : 0) and heptadecanoic acid (17 : 0) were higher (0·26 v. 0·22% and 0·42 v. 0·39% of the total identified FA, respectively) after the DAIRY phase than after the CONTROL phase (Pcholesterol levels after the DAIRY phase compared with the CONTROL phase (+0·08 mmol/l; P= 0·04). In conclusion, intake of 3 servings/d of conventional dairy products may modify certain circulating FA and lipid profiles within 4 weeks, where 15 : 0 and 17 : 0 may be potential short-term biomarkers of intake.

  5. [Fingolimod: effectiveness and safety in routine clinical practice. An observational, retrospective, multi-centre study in Galicia].

    Science.gov (United States)

    Pato-Pato, A; Midaglia, L; Costa-Arpin, E; Rodriguez-Regal, A; Puy-Nunez, A; Rodriguez-Rodriguez, M; Lopez-Real, A; Llaneza-Gonzalez, M A; Garcia-Estevez, D A; Moreno-Carretero, M J; Escriche-Jaime, D; Aguado-Valcarcel, M L; Munoz, D; Prieto, J M; Lorenzo-Gonzalez, J R; Amigo-Jorrin, M C

    2016-09-05

    The effectiveness and safety of fingolimod in patients with relapsing-remitting multiple sclerosis (RRMS) have been proven in clinical trials. Yet, due to their limitations, it is important to know how it behaves under everyday clinical practice conditions. Hence, the aim of this study is to evaluate the effectiveness and safety of fingolimod after 12 months' usage in clinical practice in Galicia. We conducted a retrospective, multi-centre study (n = 8) of patients with RRMS who were treated with one or more doses of fingolimod, 0.5 mg/day. Effectiveness was assessed -annualised relapse rate (ARR), changes in the score on the Expanded Disability Status Scale (EDSS), percentage of patients free from relapses, free from progression of disability and free from activity in resonance- for the total number of patients and according to previous treatment. Safety was assessed based on the percentage of patients who withdrew and presented adverse side effects. After 12 months' use, fingolimod reduced the ARR by 87% (1.7 to 0.23; p < 0.0001) and, consequently, 81% of patients were free from relapses. The score was reduced by 9%. In all, 91% of patients were free from progression of disability and 72% were free from resonance activity. No signs of disease activity were found in 43% of the patients. Most of the benefits of fingolimod differed depending on previous treatment. About a third of the patients reported adverse side effects, but only 2% of them withdrew for this reason. In clinical practice, most of the results on the effectiveness of the clinical trials conducted with fingolimod were observed during the first 12 months of treatment. A better safety profile was observed than that reported in the clinical trials.

  6. Does cataract surgery alleviate poverty? Evidence from a multi-centre intervention study conducted in Kenya, the Philippines and Bangladesh.

    Directory of Open Access Journals (Sweden)

    Hannah Kuper

    Full Text Available BACKGROUND: Poverty and blindness are believed to be intimately linked, but empirical data supporting this purported relationship are sparse. The objective of this study is to assess whether there is a reduction in poverty after cataract surgery among visually impaired cases. METHODOLOGY/PRINCIPAL FINDINGS: A multi-centre intervention study was conducted in three countries (Kenya, Philippines, Bangladesh. Poverty data (household per capita expenditure--PCE, asset ownership and self-rated wealth were collected from cases aged ≥50 years who were visually impaired due to cataract (visual acuity<6/24 in the better eye and age-sex matched controls with normal vision. Cases were offered free/subsidised cataract surgery. Approximately one year later participants were re-interviewed about poverty. 466 cases and 436 controls were examined at both baseline and follow-up (Follow up rate: 78% for cases, 81% for controls, of which 263 cases had undergone cataract surgery ("operated cases". At baseline, operated cases were poorer compared to controls in terms of PCE (Kenya: $22 versus £35 p = 0.02, Bangladesh: $16 vs $24 p = 0.004, Philippines: $24 vs 32 p = 0.0007, assets and self-rated wealth. By follow-up PCE had increased significantly among operated cases in each of the three settings to the level of controls (Kenya: $30 versus £36 p = 0.49, Bangladesh: $23 vs $23 p = 0.20, Philippines: $45 vs $36 p = 0.68. There were smaller increases in self-rated wealth and no changes in assets. Changes in PCE were apparent in different socio-demographic and ocular groups. The largest PCE increases were apparent among the cases that were poorest at baseline. CONCLUSIONS/SIGNIFICANCE: This study showed that cataract surgery can contribute to poverty alleviation, particularly among the most vulnerable members of society. This study highlights the need for increased provision of cataract surgery to poor people and shows that a focus on blindness may help to alleviate

  7. Protocol of a randomised delayed-start double-blind placebo-controlled multi-centre trial for Levodopa in EArly Parkinson's disease : the LEAP-study

    NARCIS (Netherlands)

    Verschuur, Constant V. M.; Suwijn, S. R.; Post, B.; Dijkgraaf, M.; Bloem, B. R.; van Hilten, J. J.; van Laar, T.; Tissingh, G.; Deuschl, G.; Lang, A. E.; de Haan, R. J.; de Bie, R. M. A.

    2015-01-01

    Background: The aim of this study is to investigate if early treatment with levodopa has a beneficial disease modifying effect on Parkinson's disease (PD) symptoms and functional health, improves the ability to (maintain) work, and reduces the use of (informal) care, caregiver burden, and costs.

  8. Protocol of a randomised delayed-start double-blind placebo-controlled multi-centre trial for Levodopa in EArly Parkinson's disease: the LEAP-study

    NARCIS (Netherlands)

    Verschuur, Constant V. M.; Suwijn, S. R.; Post, B.; Dijkgraaf, M.; Bloem, B. R.; van Hilten, J. J.; van Laar, T.; Tissingh, G.; Deuschl, G.; Lang, A. E.; de Haan, R. J.; de Bie, R. M. A.

    2015-01-01

    The aim of this study is to investigate if early treatment with levodopa has a beneficial disease modifying effect on Parkinson's disease (PD) symptoms and functional health, improves the ability to (maintain) work, and reduces the use of (informal) care, caregiver burden, and costs. Additionally,

  9. Efficacy and tolerability of myrtol standardized in acute bronchitis. A multi-centre, randomised, double-blind, placebo-controlled parallel group clinical trial vs. cefuroxime and ambroxol.

    Science.gov (United States)

    Matthys, H; de Mey, C; Carls, C; Ryś, A; Geib, A; Wittig, T

    2000-08-01

    Myrtol standardized (Gelomyrtol forte) is a phytotherapeutic extract (distillate) consisting mainly of three monoterpenes: (+)alpha-pinene, d-limonene and 1,8-cineole. This study describes and compares the efficacy, safety and tolerability of a 2-week treatment with myrtol stand. (4 x 300 mg, day 1-14), cefuroxime (CAS 55268-75-2) (2 x 250 mg daily for day 1-6), ambroxol (CAS 18683-91-5) (3 x 30 mg for day 1-3, 2 x 30 mg for days 4-14) and matched placebo in acute bronchitis. 676 male and female outpatients, aged > or = 18 years, with acute bronchitis of recent onset (within last 5 days), with an FEV1 > 75% of the normal EGKS-value and without evidence or suspicion of chronic pulmonary disease or any further confounding illness were included in the study. Patients were randomly assigned to a 2-week treatment course with either myrtol stand. (N = 170), cefuroxime (N = 171), ambroxol (N = 163) or placebo (N = 172) in a double-blind, placebo-matched, parallel-group fashion. Evaluations were at baseline (visit 1), after 1 and 2 weeks of treatment (visits 2 and 3) and at 2 weeks after conclusion of the treatments (visit 4). Responder- and non-responder rates (primary), signs (abnormal auscultation), symptoms (daily diary data on nightly cough, coughing fits during the day, sputum consistence and general well-being; visit data on bronchial hyperreactivity and absence/presence of associated symptoms), FEV1, overall efficacy, absence of relapse, safety and tolerability (adverse events, laboratory screens, vital signs and physical examination). Criteria were evaluated for the intention-to-treat data-set (ITT) and the 'efficacy evaluable' sample (EAP), i.e. excluding patients with missing values (incl. discontinued non-responders and drop-outs for other reasons) at the time of assessment. The signs and symptoms of acute bronchitis regressed readily in all treatment groups, but regression was slower and less complete in the patients treated with placebo. In patients treated with placebo, the acute bronchitis was considered to have deteriorated to such an extent that discontinuation was indicated ('non-responder') in 36 patients (ITT: 20.9%, 95% CI: 15.1 to 27.8% and EAP: 21.3%, CI: 15.4 to 28.3%) after 1 week (visit 2) and in 19 further patients (ITT: 11.0%, CI: 6.8 to 16.7%; EAP: 14.8%, CI: 9.2 to 22.2%) after 1 further week (visit 3). In contrast, in the group of patients treated with myrtol stand. the non-responder rates at visits 2 and 3 were only 5.3% (ITT, CI: 2.4 to 9.8%; EAP: 5.4%, CI: 2.5 to 10.0%) and 1.2% (ITT, CI: 0.1 to 4.2%; EAP: 1.3%, CI: 0.2 to 4.7%); the responder rates at visit 2 were statistically significantly higher (p < 0.001) for myrtol stand. (ITT: 92.9%, CI: 88.0 to 96.3) compared to placebo (ITT: 77.3%, CI: 70.3 to 83.4), and similar to those for cefuroxime (ITT: 92.4%, CI: 87.4 to 95.9) and ambroxol (ITT: 89.6%, CI: 83.8 to 93.8%). The superiority of the active treatments vs. placebo with little difference among the treatments was confirmed for all further criteria of evaluation. There was no evidence of bronchoconstriction or relapse in any treatment group for the patients continuing treatment (i.e. for those who were not discontinued because of non-response). The treatments were safe and comparably well tolerated. Compared to placebo, treatment with myrtol stand. was well tolerated but evidently superior in terms of efficacy, resulting in a more rapid and more complete recovery; although well comparable with the other active treatments, myrtol stand. tended to be superior to cefuroxime and ambroxol for several ancillary criteria. Myrtol stand. is a well-evidenced alternative to antibiotics for acute bronchitis without specified infective agent, without the risk to promote the development of bacterial resistance.

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

    NARCIS (Netherlands)

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

    2010-01-01

    A multicenter prospective randomized clinical trial was undertaken to investigate the effectiveness of the Australian Medical Sheepskin (AMS) in the prevention of sacral pressure ulcers in somatic nursing home patients. Patients were randomized at admission and were then followed daily for 30 days.

  11. 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.

  12. Calibration test of PET scanners in a multi-centre clinical trial on breast cancer therapy monitoring using 18F-FLT.

    Directory of Open Access Journals (Sweden)

    Francis Bouchet

    Full Text Available A multi-centre trial using PET requires the analysis of images acquired on different systems We designed a multi-centre trial to estimate the value of 18F-FLT-PET to predict response to neoadjuvant chemotherapy in patients with newly diagnosed breast cancer. A calibration check of each PET-CT and of its peripheral devices was performed to evaluate the reliability of the results.11 centres were investigated. Dose calibrators were assessed by repeated measurements of a 68Ge certified source. The differences between the clocks associated with the dose calibrators and inherent to the PET systems were registered. The calibration of PET-CT was assessed with an homogeneous cylindrical phantom by comparing the activities per unit of volume calculated from the dose calibrator measurements with that measured on 15 Regions of Interest (ROIs drawn on 15 consecutive slices of reconstructed filtered back-projection (FBP images. Both repeatability of activity concentration based upon the 15 ROIs (ANOVA-test and its accuracy were evaluated.There was no significant difference for dose calibrator measurements (median of difference -0.04%; min = -4.65%; max = +5.63%. Mismatches between the clocks were less than 2 min in all sites and thus did not require any correction, regarding the half life of 18F. For all the PET systems, ANOVA revealed no significant difference between the activity concentrations estimated from the 15 ROIs (median of difference -0.69%; min = -9.97%; max = +9.60%.No major difference between the 11 centres with respect to calibration and cross-calibration was observed. The reliability of our 18F-FLT multi-centre clinical trial was therefore confirmed from the physical point of view. This type of procedure may be useful for any clinical trial involving different PET systems.

  13. Combinatorial detection of autoreactive CD8+T cells with HLA-A2 multimers: a multi-centre study by the Immunology of Diabetes Society T Cell Workshop.

    Science.gov (United States)

    James, Eddie A; Abreu, Joana R F; McGinty, John W; Odegard, Jared M; Fillié, Yvonne E; Hocter, Claire N; Culina, Slobodan; Ladell, Kristin; Price, David A; Alkanani, Aimon; Rihanek, Marynette; Fitzgerald-Miller, Lisa; Skowera, Ania; Speake, Cate; Gottlieb, Peter; Davidson, Howard W; Wong, F Susan; Roep, Bart; Mallone, Roberto

    2018-03-01

    Validated biomarkers are needed to monitor the effects of immune intervention in individuals with type 1 diabetes. Despite their importance, few options exist for monitoring antigen-specific T cells. Previous reports described a combinatorial approach that enables the simultaneous detection and quantification of multiple islet-specific CD8 + T cell populations. Here, we set out to evaluate the performance of a combinatorial HLA-A2 multimer assay in a multi-centre setting. The combinatorial HLA-A2 multimer assay was applied in five participating centres using centralised reagents and blinded replicate samples. In preliminary experiments, samples from healthy donors were analysed using recall antigen multimers. In subsequent experiments, samples from healthy donors and individuals with type 1 diabetes were analysed using beta cell antigen and recall antigen multimers. The combinatorial assay was successfully implemented in each participating centre, with CVs between replicate samples that indicated good reproducibility for viral epitopes (mean %CV = 33.8). For beta cell epitopes, the assay was very effective in a single-centre setting (mean %CV = 18.4), but showed sixfold greater variability across multi-centre replicates (mean %CV = 119). In general, beta cell antigen-specific CD8 + T cells were detected more commonly in individuals with type 1 diabetes than in healthy donors. Furthermore, CD8 + T cells recognising HLA-A2-restricted insulin and glutamate decarboxylase epitopes were found to occur at higher frequencies in individuals with type 1 diabetes than in healthy donors. Our results suggest that, although combinatorial multimer assays are challenging, they can be implemented in multiple laboratories, providing relevant T cell frequency measurements. Assay reproducibility was notably higher in the single-centre setting, suggesting that biomarker analysis of clinical trial samples would be most successful when assays are performed in a single laboratory

  14. TRAINABILITY OF BODY COMPOSITION, AEROBIC POWER AND MUSCULAR ENDURANCE OF CADET WRESTLERS

    Directory of Open Access Journals (Sweden)

    Mirzaei Bahman

    2016-10-01

    Full Text Available Purpose: The purpose of the present study was to investigate the trainability of body composition, aerobic power and muscular endurance of cadet wrestlers. Material: Fifteen cadet wrestlers (age: 15.20±0.94 years participated in this study. Methods: The testing was conducted twice, before and after four-week training period. The physiological parameters included aerobic power, muscular endurance and body composition. Results: A significant decrease in the body fat was observed following the training (p0.05. In general, although a lot of factors including skill, mental, genetic and other fitness factors render some influences on a wrestler's success, improvement of physical fitness plays an important role in championship. Based on results of the present study more time is needed to improve muscular and cardiovascular endurance, therefore wrestling coaches and trainers are recommended to pay special attention to these factors. Conclusion: Our results indicated that wrestlers experienced significant changes in their body fat percentage during four-week training period. Cadet wrestlers’ aerobic power, muscular endurance and body composition are trainable, although these improvements may be less than what has been observed in junior and senior wrestlers.

  15. 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...

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

    Directory of Open Access Journals (Sweden)

    Marić Lela

    2013-01-01

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

  17. [Renal insufficiency and clinical outcomes in patients with acute coronary syndrome undergoing percutaneous coronary intervention: a multi-centre study].

    Science.gov (United States)

    Huo, Yong; Ho, Wa

    2007-12-18

    To investigate the association of renal insufficiency and clinical outcomes in patients with acute coronary syndrome(ACS). The study was a multi-centre register study including 3,589 ACS patients coming from 39 centers across China who had received percutaneous coronary intervention(PCI) prior to 1st February, 2007. Estimated glomerular filtration rate (eGFR) was calculated for all patients using the 4-variable MDRD equation with the serum creatinine obtained before angiography. The association between renal insufficiency and clinical outcomes and the presence of in-hospital death and bleeding was studied by Fisher's exact test. Multi-variable analysis on the risk factors of in-hospital bleeding was done by logistic regression test. The mean age of the study population was (61.74+/-11.37) years (ranging from 23 years to 92 years)and 76.5% (2,746/3,589) of the population was male. Only 90 patients (2.51%) were known to have chronic kidney disease at the time of admission and 144 patients(4.01%) had serum creatinine levels above 133 micromol/L. However, after the evaluation of renal status by the MDRD equation, 2,250 patients (63.1%)showed a reduction in eGFR of less than 90 mL/min, of whom, 472 (13.1%) even reached the level of moderate renal insufficiency (eGFRchronic total occlusion lesions(CTO) and eight (0.22%) needed shift to coronary artery bypass grafting (CABG) after angiography. Both the presence of CTO lesions and CABG were proved to be associated with decrease of renal function through Fisher's exact test (P= 0.005 8 and 0.041, respectively). The in-hospital mortality rate was 0.47%(17/3 589) which was associated with the degree of renal insufficiency (P=0.001 3). A total of 75 patients(2.09%) of in-hospital bleeding were recorded with 26 patients(0.72%) diagnosed as major bleeding events. 92% (69/75) of the bleeding events occurred after PCI. Bleeding was found to be associated with the degree of renal insufficiency in every type of antithrombotic

  18. 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.

  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)

    2017-06-01

    AWARD NUMBER: W81XWH-15-1-0042 TITLE: Psychobiological Assessment & Enhancement of Team Cohesion and Psychological Resilience in ROTC Cadets...NUMBER Psychobiological Assessment & Enhancement of Team Cohesion and Psychological Resilience in ROTC Cadets Using a Virtual- Reality Team Cohesion...cohesion remain unknown. The current project proposed a series of experiments that will: 1) Identify the psychological , behavioral, physiological, and

  20. 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...

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

    Directory of Open Access Journals (Sweden)

    Francisco Heitor Rosa

    2014-09-01

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

  2. A 2-Month Linear Periodized Resistance Exercise Training Improved Musculoskeletal Fitness and Specific Conditioning of Navy Cadets.

    Science.gov (United States)

    Vantarakis, Antonios; Chatzinikolaou, Athanasios; Avloniti, Alexandra; Vezos, Nikolaos; Douroudos, Ioannis I; Draganidis, Dimitrios; Jamurtas, Athanasios Z; Kambas, Antonis; Kalligeros, Stamatios; Fatouros, Ioannis G

    2017-05-01

    Vantarakis, A, Chatzinikolaou, A, Avloniti, A, Vezos, N, Douroudos, II, Draganidis, D, Jamurtas, AΖ, Kambas, A, Kalligeros, S, and Fatouros, IG. A 2-month linear periodized resistance exercise training improved musculoskeletal fitness and specific conditioning of navy cadets. J Strength Cond Res 31(5): 1362-1370, 2017-Major objectives of army and navy training are the development of readiness, performance, and injury prevention. Numerous studies have examined the effect of specific strength training (ST) programs on performance of Special Forces and military personnel. Although navy personnel have to address on-board conditions that require the development of strength, agility, speed, and task-specific endurance, there is no information regarding the effects of ST on navy-specific performance. Therefore, the purpose of this study was to investigate the effect of an 8-week ST on performance of navy cadets. Thirty-one cadets of the Hellenic Naval Academy volunteered to participate and were randomly assigned in 2 groups. Cadets in the Experimental Group participated in a linear periodized ST program in addition to their daily training schedule. Cadets in the control group participated only in pre- and post-measurements. Anthropometrics, maximal oxygen consumption, oxygen consumption during a Navy Obstacle Course (NOC), maximum strength in bench press and squat exercises, hand grip strength, repetitions in push-ups and abdominal test, time to complete a 30-m sprint, and time to complete NOC were measured before and after the intervention. A 2-way repeated-measures analysis of variance showed that ST induced favorable changes in bench press and squat 1 repetition maximum, push-ups, abdominal crunches, time to complete 30-m distance, and time to complete the NOC. These results indicate that an additional ST may induce positive alterations on readiness and performance of navy cadets. The study has the approval of university's institutional review board and ethical

  3. Motivación, autoconcepto personal y bienestar psicológico en Cadetes de la Escuela Militar de Chorrillos

    OpenAIRE

    Mariano Estrada Terrones, Miguel Ángel

    2016-01-01

    La investigación realizada se planteó como objetivo determinar la relación entre la motivación, el autoconcepto y el bienestar psicológico en cadetes de la Escuela Militar de Chorrillos. La población de estudio estuvo conformada por por los cadetes del primero al tercer año de estudios de la Escuela Militar de Chorrillos, matriculados en el semestre académico 2015-I. Los instrumentos utilizados fueron el Cuestionario de Metas Académicas (C.M.A.) elaborado en función de la teoría de Dweck, por...

  4. 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

    2018-03-13

    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

  5. 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

  6. 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

  7. [Evaluation of gynecologic morbidity in female cadets of military universities of St. Petersburg].

    Science.gov (United States)

    Artiukhova, N S; Shmidt, A A; Abashin, V G

    2012-08-01

    In-depth medical examination carried out a comprehensive survey of the dynamic female cadets of higher military educational institutions of the city of St. Petersburg in order to analyze the health of the troops of the Russian Federation Ministry of Defense personnel in the learning process, their level of gynecological diseases, as a possible consequence of influence of combat training. Following the study, shape, volume and frequency of activities to assess the health of women students, as well as a set of measures for the prevention of gynecological morbidity and dispensary of the contingent were developed.

  8. Prevalence and Clinical Correlation of Superficial Fungal Foot Infection in Thai Naval Rating Cadets.

    Science.gov (United States)

    Ongsri, Punyawee; Bunyaratavej, Sumanas; Leeyaphan, Charussri; Pattanaprichakul, Penvadee; Ongmahutmongkol, Pattachee; Komoltri, Chulaluk; Kulthanan, Kanokvalai

    2018-02-13

    Superficial fungal foot infection is one of the most important dermatological diseases currently affecting military personnel. Many Thai naval rating cadets are found to suffer from superficial fungal foot infections and their sequels. To investigate prevalence, potent risk factors, responding pathogens and clinical correlation of superficial fungal foot infection in Thai naval rating cadets training in Naval rating school, Sattahip, Thailand. This cross-sectional study was performed in August 2015. Validated structured questionnaire was used regarding information about behaviors and clinical symptoms. Quality of life was assessed by Dermatology Quality of Life Index (DLQI) questionnaire and clinical presentation demonstrated by Athlete's foot severity score (AFSS). Laboratory investigations including direct microscopic examination and fungal culture were performed and recorded. All of the participants were informed and asked for their consent. A total of 788 Thai naval rating cadets with a mean age of 19 yr were enrolled. There were 406 (51.5%) participants suspected of fungal skin infection from questionnaire screening. After clinical examination, 303 participants (38.5%) were found to have foot lesions (AFSS ≥1). Superficial fungal foot infection was diagnosed with microscopic examination and fungal culture in 57 participants, giving a point prevalence of 7.2%. Tinea pedis was diagnosed in 54 participants with the leading causative organism being Trichophyton mentagrophytes (52.8%). Other 3 participants were diagnosed as cutaneous candidiasis. Wearing combat shoes more than 8 h was found to be a predisposing factor (p = 0.029), taking a shower less than two times a day (p = 0.008), and wearing sandals during shower (p = 0.055) was found to be protective against infection. Most fungal feet infection cases noticed their feet abnormalities (p < 0.001) including scales (p < 0.001), vesicles (p = 0.003) and maceration at interdigital web spaces (p < 0.001). Mean

  9. Clinical tolerability of perioperative tenoxicam in 1001 patients--a prospective, controlled, double-blind, multi-centre study.

    Science.gov (United States)

    Merry, Alan F; Webster, Craig S; Holland, Robin L; Middleton, Neil G; Schug, Stephan A; James, Margaret; McGrath, Ken A

    2004-10-01

    We investigated adverse events (AEs) associated with perioperative tenoxicam in a double-blind, prospective, randomised study. Patients undergoing surgery, screened for contraindications to non-steroidal anti-inflammatory drug, received tenoxicam (n=750) on 2843 days or placebo (n=251) on 988 days, in courses of 1-12 days. There was no increase in the overall incidence of side effects with tenoxicam (33 vs 38% with placebo: P=0.15), or in major side effects (3.9 vs 2.0% with placebo: P=0.11). Of major side effects possibly or probably related to tenoxicam (2.1 vs 1.2% with placebo: P=0.26), all but one involved post-operative surgical site bleeding. However, in the subgroup of patients undergoing otorhinolaryngology surgery, surgical site bleeding occurred in 18 of 171 (10.5%) patients on tenoxicam and one of 57 (1.8%) on placebo (P=0.026); of these, nine in the tenoxicam group and 0 in the placebo were classified as major (P=0.07). One patient on tenoxicam experienced endoscopically proven duodenal ulceration with malaena. In conclusion, perioperative tenoxicam is well tolerated in comparison with placebo and the incidence of drug-related major AEs (other than post-operative bleeding) is no greater than 1 in 150 in low risk patients, but in patients undergoing otorhinolaryngological surgery there may be an increased risk of post-operative bleeding.

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

    DEFF Research Database (Denmark)

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

    2011-01-01

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

  11. Compliance with clothing regulations and traffic flow in the operating room: a multi-centre study of staff discipline during surgical procedures.

    Science.gov (United States)

    Loison, G; Troughton, R; Raymond, F; Lepelletier, D; Lucet, J-C; Avril, C; Birgand, G

    2017-07-01

    This multi-centre study assessed operating room (OR) staff compliance with clothing regulations and traffic flow during surgical procedures. Of 1615 surgical attires audited, 56% respected the eight clothing measures. Lack of compliance was mainly due to inappropriate wearing of jewellery (26%) and head coverage (25%). In 212 procedures observed, a median of five people [interquartile range (IQR) 4-6] were present at the time of incision. The median frequency of entries to/exits from the OR was 10.6/h (IQR 6-29) (range 0-93). Reasons for entries to/exits from the OR were mainly to obtain materials required in the OR (N=364, 44.5%). ORs with low compliance with clothing regulations tended to have higher traffic flows, although the difference was not significant (P=0.12). Copyright © 2017 The Healthcare Infection Society. Published by Elsevier Ltd. All rights reserved.

  12. 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

  13. Effectiveness of nutritional supplementation on sarcopenia and recovery in hip fracture patients. A multi-centre randomized trial.

    Science.gov (United States)

    Malafarina, Vincenzo; Uriz-Otano, Francisco; Malafarina, Concetta; Martinez, J Alfredo; Zulet, M Angeles

    2017-07-01

    Functional deterioration and reduced mobility in elderly patients with a hip fracture are associated with a loss of both muscle mass and function (sarcopenia). The aim of this study was to assess whether oral nutritional supplementation (ONS) improves muscle mass and nutritional markers (BMI, proteins) in elderly patients with hip fracture. Patients aged 65 years and over with hip fractures admitted to either of two rehabilitation facilities were included. Patients with diabetes, with Barthel index scores patients to the intervention group (IG) or the control group (CG). Those in the IG received a standard diet plus ONS in the form of two bottles a day of β-hydroxy-β-methylbutyrate (HMB), while those in the CG received a standard diet only. The intervention was not blinded. In order to assess changes in body mass index (BMI), anthropometric parameters were recorded at both admission and discharge. Patients' functional situation was evaluated using the Barthel index (BI) and the Functional Ambulation Categories (FAC) score. Muscle mass was assessed using bioelectrical impedance analysis, which allowed us to calculate appendicular lean mass (aLM). The outcome variable was the difference between aLM upon discharge, minus aLM upon admission (Δ-aLM). Of the 107 randomised patients (IG n55, CG n52), 49 finished the study in the IG and 43 in the CG. BMI and aLM were stable in IG patients, whilst these parametres decreased in the CG. A significant difference was observed between the two groups (pelderly patients with hip fractures. Orally administered nutritional supplements can help to prevent the onset of sarcopenic obesity. www.clinicaltrials.gov identifier: NCT01404195, registered 22 July 2011, HYPERPROT-GER Study. Copyright © 2017 Elsevier B.V. All rights reserved.

  14. 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.

  15. 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.

  16. 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.

  17. Generación y dibujo de escaleras con el programa CADET

    Directory of Open Access Journals (Sweden)

    Recuero, Alfonso

    1987-04-01

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

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

  18. Influence of Formal Academic Leadership Programs on Undergraduates' Leadership Mindset: An Assessment of a Corps of Cadets Program

    Science.gov (United States)

    Dunn, Allison L.; Ho, Sarah P.; Odom, Summer F.; Perdue, Emily R.

    2016-01-01

    Students enrolled in a Corps of Cadets program at Texas A&M University [N = 336] were surveyed to examine their leadership mindsets and whether their participation in a formal academic leadership program simultaneously influenced their hierarchical and systemic-thinking preferences. No significant differences were found between students…

  19. 32 CFR 903.7 - Reassignment of cadet candidates who graduate from the preparatory school with an appointment to...

    Science.gov (United States)

    2010-07-01

    ... 32 National Defense 6 2010-07-01 2010-07-01 false Reassignment of cadet candidates who graduate from the preparatory school with an appointment to USAFA. 903.7 Section 903.7 National Defense Department of Defense (Continued) DEPARTMENT OF THE AIR FORCE MILITARY TRAINING AND SCHOOLS AIR FORCE ACADEMY...

  20. 32 CFR 903.6 - Reassignment of Air Force members to become cadet candidates at the preparatory school.

    Science.gov (United States)

    2010-07-01

    ... 32 National Defense 6 2010-07-01 2010-07-01 false Reassignment of Air Force members to become cadet candidates at the preparatory school. 903.6 Section 903.6 National Defense Department of Defense (Continued) DEPARTMENT OF THE AIR FORCE MILITARY TRAINING AND SCHOOLS AIR FORCE ACADEMY PREPARATORY SCHOOL...

  1. 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,…

  2. Dietary Supplement Use, Perceptions, and Associated Lifestyle Behaviors in Undergraduate College Students, Student-Athletes, and ROTC Cadets

    Science.gov (United States)

    Valentine, Arthur A.; Schumacher, Julie Raeder; Murphy, Jan; Ma, Yoon Jin

    2018-01-01

    Objective: To identify the prevalence of dietary supplement (DS) use, perceptions of DS efficacy, and lifestyle behaviors of DS users and non-users. Participants: Undergraduate students, student-athletes, and ROTC cadets at a Midwestern University between September 2014 and January 2015. Methods: A cross-sectional online survey was administered.…

  3. 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…

  4. [Optimization of the system of medical service of students of Cadet Schools of the Ministry of Defense of the Russian Federation].

    Science.gov (United States)

    Toporkov, M T; Mikheev, A V; Tsiteladze, A A

    2012-06-01

    One of the factors of the successful military career guidance Cadet schools students is preserving and promoting their health. Medical support of children and adolescents aged 10-17 years should include the full range of medical and preventive measures defined for this group. The state of providing outpatient care for pupils at the Cadet School in St. Petersburg was studied. These results show that full medical care in accordance with the standards can be based only on children's health clinics. It is important that the organization of medical support pupils cadet schools should be cooperate with civilian health care.

  5. Harmonisation of multi-centre real-time reverse-transcribed PCR results of a candidate prognostic marker in breast cancer: an EU-FP6 supported study of members of the EORTC - PathoBiology Group.

    NARCIS (Netherlands)

    Span, P.N.; Sieuwerts, A.M.; Heuvel, J.J.T.M.; Spyratos, F.; Duffy, M.J.; Eppenberger-Castori, S.; Vacher, S.; O'Brien, K.; McKiernan, E.; Pierce, A.; Vuaroqueaux, V.; Foekens, J.A.; Sweep, C.G.J.; Martens, J.W.

    2009-01-01

    AIM: Assessment of intra- and inter-laboratory variation in multi-centre real-time reverse-transcribed PCR (qRT-PCR)-based mRNA quantification of a prognostic marker in breast cancer using external quality assurance (EQA). METHODS: A questionnaire on the methodologies used and EQA calibrators were

  6. 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 (prisk for injury.

  7. 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

  8. Quantification of FDG PET studies using standardised uptake values in multi-centre trials: effects of image reconstruction, resolution and ROI definition parameters.

    Science.gov (United States)

    Westerterp, Marinke; Pruim, Jan; Oyen, Wim; Hoekstra, Otto; Paans, Anne; Visser, Eric; van Lanschot, Jan; Sloof, Gerrit; Boellaard, Ronald

    2007-03-01

    Standardised uptake values (SUVs) depend on acquisition, reconstruction and region of interest (ROI) parameters. SUV quantification in multi-centre trials therefore requires standardisation of acquisition and analysis protocols. However, standardisation is difficult owing to the use of different scanners, image reconstruction and data analysis software. In this study we evaluated whether SUVs, obtained at three different institutes, may be directly compared after calibration and correction for inter-institute differences. First, an anthropomorphic thorax phantom containing variously sized spheres and activities, simulating tumours, was scanned and processed in each institute to evaluate differences in scanner calibration. Secondly, effects of image reconstruction and ROI method on recovery coefficients were studied. Next, SUVs were derived for tumours in 23 subjects. Of these 23 patients, four and ten were scanned in two institutes on an HR+ PET scanner and nine were scanned in one institute on an ECAT EXACT PET scanner. All phantom and clinical data were reconstructed using iterative reconstruction with various iterations, with both measured (MAC) and segmented attenuation correction (SAC) and at various image resolutions. Activity concentrations (AC) or SUVs were derived using various ROI isocontours. Phantom data revealed differences in SUV quantification of up to 30%. After application-specific calibration, recovery coefficients obtained in each institute were equal to within 15%. Varying the ROI isocontour value resulted in a predictable change in SUV (or AC) for both phantom and clinical data. Variation of image resolution resulted in a predictable change in SUV quantification for large spheres/tumours (>5 cc) only. For smaller tumours (<2 cc), differences of up to 40% were found between high (7 mm) and low (10 mm) resolution images. Similar differences occurred when data were reconstructed with a small number of iterations. Finally, no significant

  9. 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

  10. 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

  11. Prevention of heel pressure ulcers among older patients--from ambulance care to hospital discharge: A multi-centre randomized controlled trial.

    Science.gov (United States)

    Bååth, Carina; Engström, Maria; Gunningberg, Lena; Muntlin Athlin, Åsa

    2016-05-01

    The aim was to investigate the effect of an early intervention, a heel suspension device boot, on the incidence of heel pressure ulcers among older patients (aged 70+). Pressure ulcers are a global healthcare issue; furthermore, the heel is an exposed location. Research indicates that preventive nursing interventions starting during the ambulance care and used across the acute care delivery chain are seldom used. A multi-centre randomized control study design was used. Five ambulance stations, two emergency departments and 16 wards at two Swedish hospitals participated. Altogether, 183 patients were transferred by ambulance to the emergency department and were thereafter admitted to one of the participating wards. Significantly fewer patients in the intervention group (n=15 of 103; 14.6%) than the control group (n=24 of 80; 30%) developed heel pressure ulcers during their hospital stay (p=0.017). Pressure ulcer prevention should start early in the acute care delivery chain to increase patient safety. Copyright © 2015 Elsevier Inc. All rights reserved.

  12. 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.

  13. Three-in-one protocol reduces mortality of patients with haemodynamically unstable pelvic fractures-a five year multi-centred review in Hong Kong.

    Science.gov (United States)

    Cheng, Mina; Lee, Kin-Yan; Chang, Annice-M L; Ho, Hiu-Fai; Chan, Lily-P S; Lee, Kin-Bong; Kwok, Philip-C H; Lee, Alexander-C W; Wong, Kevin-Y K; Kam, Chak-Wah; Leung, Gilberto-K K; Wong, John-K S; Cheung, Nai-Kwong; Yeung, Janice-H H; Tang, Ning; Choi, Shing-Hing; Lau, Tak-Wing; Wong, Heidi-H T; Leung, Ming

    2018-02-27

    The mortality rate in patients with haemodynamically unstable pelvic fractures is as high as 40-60%. Despite the new advances in trauma care which are in phase in trauma centres in Hong Kong, the management of haemodynamically unstable pelvic fracture is still heterogeneous. The aim of this study is to review the results of management of haemodynamically unstable pelvic fracture patients in Hong Kong over a five year period. This is a retrospective multi-centred cohort study of patients with haemodynamic and mechanically unstable pelvic fractures from 1 January 2010 to 31 December 2014. The primary outcome investigated is mortality of patients (including overall, 30-day, 7-day and 24-hour mortalities). Implementation of three-in-one pelvic damage control protocol was identified to be a significant independent predictive factor for overall, 30-day, seven-day and 24-hour mortalities. The overall in-hospital and 30-day mortality rates for patients managed with three-in-one protocol was 12.5%, while it was 11% for seven day mortality and 6% for 24 hour mortality. There were no significant differences in demographic characteristics, physiological measurements, types of pelvic fracture, severity and mechanism of injury between patients managed with or without three-in-one protocol. Implementation of the multidisciplinary three-in-one pelvic damage control protocol reduces mortality and therefore should be highly recommended. The results are convincing as it has eliminated the limitations of our previous single-centred trial.

  14. 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

  15. Relating functional changes during hand movement to clinical parameters in patients with multiple sclerosis in a multi-centre fMRI study.

    Science.gov (United States)

    Wegner, C; Filippi, M; Korteweg, T; Beckmann, C; Ciccarelli, O; De Stefano, N; Enzinger, C; Fazekas, F; Agosta, F; Gass, A; Hirsch, J; Johansen-Berg, H; Kappos, L; Barkhof, F; Polman, C; Mancini, L; Manfredonia, F; Marino, S; Miller, D H; Montalban, X; Palace, J; Rocca, M; Ropele, S; Rovira, A; Smith, S; Thompson, A; Thornton, J; Yousry, T; Matthews, P M

    2008-02-01

    We performed a prospective multi-centre study using functional magnetic resonance imaging (fMRI) to better characterize the relationships between clinical expression and brain function in patients with multiple sclerosis (MS) at eight European sites (56 MS patients and 60 age-matched, healthy controls). Patients showed greater task-related activation bilaterally in brain regions including the pre- and post-central, inferior and superior frontal, cingulate and superior temporal gyri and insula (P < 0.05, all statistics corrected for multiple comparisons). Both patients and healthy controls showed greater brain activation with increasing age in the ipsilateral pre-central and inferior frontal gyri (P < 0.05). Patients, but not controls, showed greater brain activation in the anterior cingulate gyrus and the bilateral ventral striatum (P < 0.05) with less hand dexterity. An interaction between functional activation changes in MS and age was found. This large fMRI study over a broadly selected MS patient population confirms that movement for patients demands significantly greater cognitive 'resource allocation' and suggests age-related differences in brain responses to the disease. These observations add to evidence that brain functional responses (including potentially adaptive brain plasticity) contribute to modulation of clinical expression of MS pathology and demonstrate the feasibility of a multi-site functional MRI study of MS.

  16. Prefecture-wide multi-centre radiation dose survey as a useful tool for CT dose optimisation: report of Gunma radiation dose study.

    Science.gov (United States)

    Fukushima, Yasuhiro; Taketomi-Takahashi, Ayako; Nakajima, Takahito; Tsushima, Yoshito

    2015-12-01

    The aim of this study was to verify the usefulness for the dose optimisation of setting a diagnostic reference level (DRL) based on the results of a prefecture-wide multi-centre radiation dose survey and providing data feedback. All hospitals/clinics in the authors' prefecture with computed tomography (CT) scanners were requested to report data. The first survey was done in July 2011, and the results of dose-length products (DLPs) for each CT scanner were fed back to all hospitals/clinics, with DRL set from all the data. One year later, a second survey was done in the same manner. The medians of DLP in the upper abdomen, whole body and coronary CT in 2012 were significantly smaller than those of the 2011 survey. The interquartile ranges of DLP in the head, chest, pelvis and coronary CT were also smaller in 2012. Radiation dose survey with data feedback may be helpful for CT dose optimisation. © The Author 2014. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  17. Gadobutrol-enhanced moving-table magnetic resonance angiography in patients with peripheral vascular disease: a prospective, multi-centre blinded comparison with digital subtraction angiography

    Energy Technology Data Exchange (ETDEWEB)

    Hentsch, Annette [Schering AG, Berlin (Germany); Aschauer, Manuela A.; Ebner, Franz [Department of Magnetic Resonance, University of Graz, Graz (Austria); Balzer, Joern O.; Davis, Kirsten [Department of Diagnostic and Interventional Radiology, University of Frankfurt/Main, Frankfurt/Main (Germany); Brossmann, Joachim; Schaefer, Fritz K.W. [Department of Diagnostic Radiology, University of Kiel, Kiel (Germany); Busch, Hans P. [Krankenhaus der Barmherzigen Brueder, Trier (Germany); Douek, Philippe [Department of Diagnostic Radiology, University of Lyon (France); Engelshoven, Jos M.A. van; Leiner, Tim [Department of Radiology, Cardiovascular Research Institute, University of Maastricht, Maastricht (Netherlands); Gregor, Michaela; Reimer, Peter [Department of Radiology, Staedtisches Klinikum, Karlsruhe (Germany); Kersting, Christian [Department of Diagnostic Radiology, University of Muenster, Muenster (Germany); Knuesel, Patrick R. [Institute of Diagnostic Radiology, University Hospital Zurich, MRI Center, Zurich (Switzerland); Leen, Edward [Department of X-ray, Glasgow Royal Infirmary, Glasgow (United Kingdom); Loewe, Christian; Thurnher, Siegfried A. [Section of Angiography and Interventional Radiology, Department of Radiology' ' University of Vienna, Vienna (Austria); McPherson, Simon [Department of Radiology, University of Leeds, Leeds (United Kingdom); Taupitz, Matthias [Department of Radiology, Humboldt University of Berlin (Charite), Berlin (Germany); Tombach, Bernd; Wegener, Robin; Weishaupt, Dominik; Meaney, James F.M.

    2003-09-01

    The purpose of this study was to compare moving-table three-dimensional contrast-enhanced magnetic resonance angiography (CE MRA), using 1.0-mol gadobutrol, with intra-arterial digital subtraction angiography (i.a. DSA) for evaluation of pelvic and peripheral arteries in patients with peripheral arterial occlusive disease. A total of 203 patients were examined in a prospective, multi-centre study at 1.0/1.5 T. Ten vessel segments of one leg were evaluated on-site and by three independent blinded reviewers off-site. One hundred eighty-two patients were evaluable in blinded reading. For pelvis and thigh, there was statistically significant diagnostic agreement between CE MRA and i.a. DSA on-site (94%) and off-site (86-88%). Overall, for detection of clinically significant stenoses, 93% sensitivity and 90% specificity were achieved in on-site evaluation, with 71-76 and 87-93% off-site; for detection of occlusion, sensitivity and specificity on-site were 91 and 97%, with 75-82 and 94-98% off-site. Evaluation was more sensitive on-site than off-site for detection of stenoses and occlusion, whereas specificity was similar. The CE MRA with 1.0-mol gadobutrol gave results comparable to those of i.a. DSA for the larger arteries of pelvis and thigh. Results for calf arteries were compromised by spatial resolution and technical limitations. (orig.)

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

    Directory of Open Access Journals (Sweden)

    Yuri Sergienko

    2016-09-01

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

  19. 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.

  20. A Marketing Study on the Recruitment and Retention of Black-American and Women Cadets. Part I. Qualitative Research Summaries.

    Science.gov (United States)

    1982-05-15

    retention in terms of the attitudes Blacks must have to persist in the environment. He commented, "Blacks who make it through... .understand racism . They are... stigma attached to it because of the "macho image" that pervaded the atmosphere, so that was out", commxnented one graduate. Another felt that the OB-GYN...together and plan social znd cultural events. The Counseling Center was felt to be good. However, few cadets had used the center because of the stigma

  1. Comparision of overweight and obesity in medical cadets before and after 6 months studying at Phramongkutklao College.

    Science.gov (United States)

    Suwan, Kijja; Hatthachote, Panadda; Panichkul, Suthee; Phromphetcharat, Varee

    2012-05-01

    To evaluate prevalence of overweight and obesity in second-year medical cadets and to determine risk behaviors before and after 6 months studying at Phramongkutklao College of Medicine (PCM). MATERIAL AMD METHOD: Data on self-report behavioral questionnaires was collected from 92 medical cadets before and after 6 months studying at PCM in 2008. Body weight, height, waist circumference, blood pressure and body fat were measured according to standard protocols. Overall, prevalence of overweight and obese medical cadets before studying at PCM was 16.30% and 15.22% according to BMI and 27.17% and 15.22% by percent body fat. After 6 months of study, overall mean of body fat and systolic blood pressure were significantly reduced. For males, the mean of weight, BMI and waist circumference were reduced significantly. In contrast, the mean of body weight and BMI of females were significantly increased. The prevalence of overweight in total participants determined by body fat was significantly reduced from 27.17% to 15.22%. Determination by BMI, obesity was significantly reduced from 34.29% to 14.29% only in males. Behaviors that were found to be significantly increased (p watching TV or using a computer, and duration of sleep was also determined. The present study indicated that overweight, obesity, waist circumference and body fat of medical cadets were decreased after study at PCM which is possibly due to increasing exercise. Nevertheless, behavioral risks for obesity were also increasing, therefore, it might result in increased the prevalence of obesity in the future.

  2. 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.

  3. 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.

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

    Science.gov (United States)

    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

    2017-06-01

    Percutaneous 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. Between 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. Of 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. PIHP with Melphalan proved to be a relatively safe, minimal-invasive and repeatable treatment for patients with non-resectable hepatic metastases of uveal melanoma.

  5. 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.

  6. 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.

  7. Governance approval for multisite, non-interventional research: what can Harmonisation of Multi-Centre Ethical Review learn from the New South Wales experience?

    Science.gov (United States)

    Vajdic, C M; Meagher, N S; Hicks, S C; Faedo, M; Ward, R L; Pearson, S-A

    2012-02-01

    In 2007, New South Wales Health mandated the separation of ethical and scientific review from research governance at all New South Wales public health sites based on their distinction in the National Health and Medical Research Council National Statement. This separation allowed for single-site ethical review of multicentre studies. To investigate the time taken for governance approval of multicentre studies through the site-specific approval (SSA) process. A retrospective audit of the SSA process for five non-interventional studies proposed by a university cancer research unit. The median total governance approval time for all submissions (n= 28) was 12 weeks (range 2.5-64); median time from starting the SSA to submission was 8 weeks (range 1-48) and median time for governance approval was 5 weeks (range 0.3-40). Approval times were shorter for public compared to private institutions. Reasons for delays in finalising submissions for approval were the absence of institutional governance officers, lack of clarity regarding signatories, the need to identify a principal investigator employed by the institution, and lack of recognition of ethical approval by private institutions. The need to develop legal agreements between the university and hospital was the main reason for lengthy delays in obtaining approval. The advantages of a harmonised single ethical review process were undermined by the coexistence of a fragmented, complex and lengthy governance approval process. This experience has implications for the success of the national Harmonisation of Multi-Centre Ethical Review (HoMER) model. A harmonised and fully supported national approach to research governance should be developed contemporaneously with HoMER. © 2011 The Authors. Internal Medicine Journal © 2011 Royal Australasian College of Physicians.

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

    Energy Technology Data Exchange (ETDEWEB)

    Evans, A.J. [Breast Institute, Nottingham City Hospital, Nottingham (United Kingdom)]. E-mail: andrew.evans@nuh.nhs.uk; Kutt, E. [Avon Breast Cancer Screening Unit, Central Health Clinic, Tower Hill, Bristol, Avon (United Kingdom); Record, C. [Breast Screening Service, Stoke Mandeville Hospital, Aylesbury (United Kingdom); Waller, M. [Cancer Screening Evaluation Unit, Institute of Cancer Research, London (United Kingdom); Bobrow, L. [Histopathology, Addenbrookes Hospital, Cambridge (United Kingdom); Moss, S. [Cancer Screening Evaluation Unit, Institute of Cancer Research, London (United Kingdom)

    2007-04-15

    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.

  9. 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

  10. 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

  11. Determinants of self-monitoring of blood glucose in patients with Type 1 diabetes: a multi-centre study in Brazil.

    Science.gov (United States)

    Gomes, M B; Tannus, L R M; Cobas, R A; Matheus, A S M; Dualib, P; Zucatti, A T; Cani, C; Guedes, A D; Santos, F M; Sepulveda, J; Tolentino, M; Façanha, M C; Faria, A C R A; Lavigne, S; Montenegro, A P; Rodacki, M; de Fatima Guedes, M; Szundy, R; Cordeiro, M M; Santos, P T S; Negrato, C A

    2013-10-01

    The aim of this study was to determine the relationship between the daily frequency of self-monitoring of blood glucose and glycaemic control, demographic and socio-economic status in patients with Type 1 diabetes under routine clinical care in Brazil. This was a cross-sectional, multi-centre study conducted between December 2008 and December 2010 in 28 public clinics in 20 Brazilian cities. The data were obtained from 3176 patients, aged 22 ± 11.8 years, of whom 56.3% were female and 57.4% were Caucasian. The mean time since diabetes diagnosis was 11.7 ± 8.1 years. The prevalence of self-monitoring of blood glucose was 88.5%. There was a significant increase in self-monitoring frequency associated with female gender, lower ages, more intensive diabetes management and higher socio-economic status. A correlation between HbA(1c) levels and the daily frequency of self-monitoring was observed (r(s) = -0.13; P = 0.001). The mean HbA1c levels were related to the daily frequency of self-monitoring (P self-monitoring more than four times daily (9.2, 11.2, 10.2,15.2 and 15% for one, two, three, four, five or more self-monitoring tests daily, respectively; P self-monitoring tests daily, with more frequent testing reported by females, younger patients, those on intensive insulin regimens and of higher socio-economic status. No additional benefit was found in patients who performed self-monitoring more than four times daily. The diabetes care team must improve patients' education regarding self-monitoring of blood glucose and its benefits. © 2013 The Authors. Diabetic Medicine © 2013 Diabetes UK.

  12. 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.

  13. 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

  14. 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 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 FFM, it appears to be

  15. RePHILL: protocol for a randomised controlled trial of pre-hospital blood product resuscitation for trauma.

    Science.gov (United States)

    Smith, I M; Crombie, N; Bishop, J R; McLaughlin, A; Naumann, D N; Herbert, M; Hancox, J M; Slinn, G; Ives, N; Grant, M; Perkins, G D; Doughty, H; Midwinter, M J

    2017-11-28

    To describe the 'Resuscitation with Pre-HospItaL bLood products' trial (RePHILL) - a multi-centre randomised controlled trial of pre-hospital blood product (PHBP) administration vs standard care for traumatic haemorrhage. PHBP are increasingly used for pre-hospital trauma resuscitation despite a lack of robust evidence demonstrating superiority over crystalloids. Provision of PHBP carries additional logistical and regulatory implications, and requires a sustainable supply of universal blood components. RePHILL is a multi-centre, two-arm, parallel group, open-label, phase III randomised controlled trial currently underway in the UK. Patients attended by a pre-hospital emergency medical team, with traumatic injury and hypotension (systolic blood pressure pre-hospital time, coagulation indices, in-hospital transfusion requirements and morbidity. Pilot study recruitment began in December 2016. Approval to proceed to the main trial was received in June 2017. Recruitment is expected to continue until 2020. RePHILL will provide high-quality evidence regarding the efficacy and safety of PHBP resuscitation for trauma. © 2017 British Blood Transfusion Society.

  16. 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.

  17. 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

  18. 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.

  19. 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

  20. 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

  1. 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

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

    Science.gov (United States)

    Kissling, Esther; Valenciano, Marta; Cohen, Jean Marie; Oroszi, Beatrix; Barret, Anne-Sophie; Rizzo, Caterina; Stefanoff, Pawel; Nunes, Baltazar; Pitigoi, Daniela; Larrauri, Amparo; Daviaud, Isabelle; Horvath, Judit Krisztina; O'Donnell, Joan; Seyler, Thomas; Paradowska-Stankiewicz, Iwona Anna; Pechirra, Pedro; Ivanciuc, Alina Elena; Jiménez-Jorge, Silvia; Savulescu, Camelia; Ciancio, Bruno Christian; Moren, Alain

    2011-01-01

    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. 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. 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. 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.

  3. 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

  4. 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)

    2009-01-01

    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 support (at the end

  5. 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.

  6. Estimating glomerular filtration rate by serum creatinine or/and cystatin C equations: An analysis of multi-centre Chinese subjects.

    Science.gov (United States)

    Ye, Xiaoshuang; Liu, Xun; Song, Dan; Zhang, Xiaoxuan; Zhu, Bei; Wei, Lu; Pei, Xiaohua; Wu, Jianqing; Lou, Tanqi; Zhao, Weihong

    2016-05-01

    Various equations based on serum creatinine or/and cystatin C, required further validation in a Chinese population. We compared the performance of six Chinese equations (Mascr, Peiscr, Macys, Fengcys, Mascr-cys and Fengscr-cys) with the CKD-EPI equations in multi-centre Chinese subjects and evaluated their applicability in clinical practice. A total of 1522 adult patients from four different hospitals of China were enrolled in the study. (99m) Tc-DTPA renal dynamic imaging was used as the reference GFR (rGFR), and serum creatinine and cystatin C were measured by standardized assays. An optimal score system was implemented in the study. The average rGFR of recruited subjects was 67.30±28.89 mL/min per 1.73m(2) . All estimated GFR (eGFR) correlated well with rGFR. In accordance with Bland-Altman analysis, the Fengscr-cys equations achieved optimal overall performance (score 14 vs 0-6), with least bias (median difference, -0.57 mL/min per 1.73m(2) ; median absolute difference, 8.83 mL/min per 1.73m(2) ), best precision (17.99 mL/min per 1.73m(2) ), highest accuracy (percentage of eGFR within 15%, 30% and 50% of the rGFR (P15 , P30 and P50 ; 49.7%, 78.7% and 91.8%, respectively); root-mean-square-error (RMSE, 16.28)). The Fengcys equation, a typical cystatin C based equation, was another well-behaved formula with an impressive performance. The Ma equations performed much poorer than the CKD-EPI equations. Consistent results can be observed in the GFR- /age- and sex-specific subgroups, while none equation yielded ideal accuracy in GFR<60 mL/min per 1.73 m(2) subgroup. The Fengscr-cys equation appeared to achieve the best performance for GFR estimation in overall Chinese adult patients. However, further research is warranted to improve the accuracy of available equations in GFR less than 60 mL/min per 1.73 m(2) individuals. © 2015 Asian Pacific Society of Nephrology.

  7. 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 smoked at least one daily cigarette (> 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.

  8. Quality of out-of-hospital palliative emergency care depends on the expertise of the emergency medical team--a prospective multi-centre analysis.

    Science.gov (United States)

    Wiese, Christoph H R; Bartels, Utz E; Marczynska, Karolina; Ruppert, David; Graf, Bernhard M; Hanekop, Gerd G

    2009-12-01

    The number of palliative care patients who live at home and have non-curable life-threatening diseases is increasing. This is largely a result of modern palliative care techniques (e.g. specialised out-of-hospital palliative medical care services), changes in healthcare policy and the availability of home care services. Accordingly, pre-hospital emergency physicians today are more likely to be involved in out-of-hospital emergency treatment of palliative care patients with advanced disease. In a prospective multi-centre study, we analysed all palliative emergency care calls during a 24-month period across four emergency services in Germany. Participating pre-hospital emergency physicians were rated according to their expertise in emergency and palliative care as follows--group 1: pre-hospital emergency physicians with high experience in emergency and palliative medical care, group 2: pre-hospital emergency physicians with high experience in emergency medical care but less experience in palliative medical care and group 3: pre-hospital emergency physicians with low experience in palliative and emergency medical care. During the period of interest, the centres received 361 emergency calls requiring a response to palliative care patients (2.8% of all 12,996 emergency calls). Ten percent of all patients were treated by group 1; 42% were treated by group 2 and 47% were treated by group 3. There was a statistically significant difference in the treatment of palliative care patients (e.g. transfer to hospital, symptom control, end-of-life decision) as a result of the level of expertise of the investigated pre-hospital emergency physicians (pmedical treatment of palliative care patients depends on the expertise in palliative medical care of the pre-hospital emergency physicians who respond to the call. In our investigation, best out-of-hospital palliative medical care was given by pre-hospital emergency physicians who had significant expertise in palliative and emergency

  9. 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.

  10. 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

  11. THE EFFECTS OF PROGRAMMED TRAINING ON FLEXIBILITY CHANGE OF CADET AGE FOOTBALL PLAYERS IN PERIOD OF 6 WEEKS

    Directory of Open Access Journals (Sweden)

    Jovan Gardašević

    2013-07-01

    Full Text Available The research was made on sample of 120 football players of cadet age, members of 4 football clubs from Niksic. The aim of research was to identify level of quantitive changes of variables for assessing the flexibility under the influence of football training. The training program included a 44 unit trainers during the summer period time of 6 weeks. Based on the results of t-test for dependent samples large, conclusion is that the training program produced statistically significant positive quantitative changes in all variables, for assessing the flexibility in this sample of player.

  12. 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

  13. 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.

  14. 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

  15. The risk of amenorrhoea after adjuvant chemotherapy for early stage breast cancer is related to inter-individual variations in chemotherapy-induced leukocyte nadir in young patients: data from the randomised SBG 2000-1 study

    DEFF Research Database (Denmark)

    Rosendahl, M.; Ahlgren, J.; Andersen, J.

    2009-01-01

    STUDY AIM: Amenorrhoea is a common side-effect to chemotherapy of premenopausal women. We examine the association between chemotherapy-induced leucopaenia and the development of amenorrhoea in premenopausal women with breast cancer. MATERIALS AND METHODS: In a multi-centre, randomised, controlled...... study, 1016 premenopausal women received seven series of FEC (F: fluorouracil, E: epirubicin and C: cyclophosphamide) for early stage breast cancer. In the first series, all patients received standard dose (F: 600 mg/m(2), E: 60 mg/m(2) and C: 600 mg/m(2)). Patients with leukocyte nadir 1.0-1.9 x 10...

  16. 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

    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...... weeks after randomisation. The primary outcome is change in the positive symptom score of the Positive and Negative Syndrome Scale. The recruitment period is 2010-2014. DISCUSSION: Antipsychotics are currently the only available pharmacologic treatments for psychotic disorders. However, information...... 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...

  17. 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

  18. 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.

  19. 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.

  20. A multi-centre, non-inferiority, randomised controlled trial to compare a cervical pessary with a cervical cerclage in the prevention of preterm delivery in women with short cervical length and a history of preterm birth - PC study

    NARCIS (Netherlands)

    Koullali, Bouchra; van Kempen, Liselotte E. M.; van Zijl, Maud D.; Naaktgeboren, Christiana A.; Schuit, Ewoud; Bekedam, Dick J.; Franssen, Maureen T. M.; Bijvank, Sebastiaan W. A. Nij; Sueters, Marieke; van Baal, Marchien; de Boer, Marjon A.; Hooker, Angelo B.; Hermsen, Brenda B. J.; Toolenaar, Toon A. A. M.; Zwart, Joost J.; van der Ham, David P.; van der Made, Flip W.; Prefumo, Federico; de Tejada, Begona Martinez; Papatsonis, Dimitri N. M.; Huisjes, Anjoke J. M.; Scheepers, Liesbeth H. C. J.; van Hoorn, Marion E.; Hasaart, Tom H. M.; Schuitemaker, Nico W. E.; Vollebregt, Karlijn C.; Mueller, Moira A.; Evers, Inge M.; Post, Marinka S.; de Boer, Karin; Visser, Henricus; van Charante, Nico A. Mensing; Langenveld, Josje; Steemers, Nicole Y. C.; Mol, Ben W. J.; Oudijk, Martijn A.; Pajkrt, Eva

    2017-01-01

    Background: Preterm birth is in quantity and in severity the most important contributor of perinatal morbidity and mortality both in well- and low-resource countries. Cervical pessary and cervical cerclage are both considered as preventive treatments in women at risk for preterm birth. We aim to

  1. 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.

  2. 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.

  3. 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.

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

    Directory of Open Access Journals (Sweden)

    E. V. Khrabrova

    2014-10-01

    Full Text Available The article covers the formation of ecological culture of military high school cadets in the process of the museum’s research activities. The author defines the main mechanism of ecological culture formation, being characteristic of military high school cadets, and believes that the development of the cadets’ ecological culture, while they are engaged in the research process, will be effective, provided an innovative research context has been set up within the educational activities scope of the high school’s museum. For this purpose, the author suggests both considering the formation of ecological culture of military high school cadets in the process of the museum’s research activities and revealing certain links between the following components: socio-cultural environment and the museum’s one, the cadets’ research activities and the setting up of the ecological display at the museum, which comprises the contents of the museum teaching science. The author considers this model to be efficient for the purposes of the formation of the cadets’ ecological culture within the museum educational environment, as it has been proved efficient at a civil high school.

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

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    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

  6. 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

  7. 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

  8. 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.

  9. 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.

  10. TOPPITS: Trial Of Proton Pump Inhibitors in Throat Symptoms. Study protocol for a randomised controlled trial.

    Science.gov (United States)

    Watson, Gillian; O'Hara, James; Carding, Paul; Lecouturier, Jan; Stocken, Deborah; Fouweather, Tony; Wilson, Janet

    2016-04-01

    Persistent throat symptoms and Extra Oesophageal Reflux (EOR) are among the commonest reasons for attendance at a secondary care throat or voice clinic. There is a growing trend to treat throat symptom patients with proton pump inhibitors (PPIs) to suppress stomach acid, but most controlled studies fail to demonstrate a significant benefit of PPI over placebo. In addition, patient views on PPI use vary widely. A UK multi-centre, randomised, controlled trial for adults with persistent throat symptoms to compare the effectiveness of treatment with the proton pump inhibitor (PPI) lansoprazole versus placebo. The trial includes a six-month internal pilot, during which three sites will recruit 30 participants in total, to assess the practicality of the trial and assess the study procedures and willingness of the patient population to participate. If the pilot is successful, three additional sites will be opened to recruitment, and a further 302 participants recruited across the six main trial sites. Further trial sites may be opened, as necessary. The main trial will continue for a further 18 months. Participants will be followed up for 12 months from randomisation, throughout which both primary and secondary outcome data will be collected. The primary outcome is change in Reflux Symptom Index (RSI) score, the 'area standard' for this type of assessment, after 16 weeks (four months) of treatment. Secondary outcomes are RSI changes at 12 months after randomisation, Quality of Life assessment at four and 12 months, laryngeal mucosal changes, assessments of compliance and side effects, and patient-reported satisfaction. TOPPITS is designed to evaluate the relative effectiveness of treatment with a proton pump inhibitor versus placebo in patients with persistent throat symptoms. This will provide valuable information to clinicians and GPs regarding the treatment and management of care for these patients, on changes in symptoms, and in Quality of Life, over time. ISRCTN

  11. [The fate of graduates of the Medical Cadet Officers School, the first nine graduating classes (1922-2001): based on the archives of Dr Roman Jakubski].

    Science.gov (United States)

    Morawski, T

    2001-01-01

    In 1922 a Military Medical School was set up in Warsaw. Following several reorganisations from 1928 it was known as the Medical Cadet Officers' School. This academy trained physicians, pharmacists and dentists for the needs of the Armed Forces. Professional studies were conducted at the Medical or Pharmacy Faculty of Warsaw University. By 1939, 17 incoming classes had been admitted, amounting to 903 students all told. Diplomas and officer's ranks were awarded to 462 graduates. Another 99 senior students were made officers on the eve of the war. The school ceased to exist the moment World War Two broke out. The subject of this article is the fate of graduates of the Medical Cadet Officers School (admitted from 1922 to 1930) who completed their studies in the first nine graduating classes, spent the war in Poland or returned home after the war. It is based on an analysis of archival materials gathered by the late Dr Roman Jakubski in London, who died in 2000. In 1998, he donated his collections to the Main Medical Library in Warsaw. Many graduates of the Medical Cadet Officers School survived the war, and about 26% of them perished. Many of the latter were murdered by Stalin's NKVD (security police) in Katyn and Kharkov, whilst the remainder died at the hands of the Germans while fighting on all the fronts of World War Two. The overwhelming majority of graduates of the school's first nine graduating classes proved through their often complicated biographies that their Alma Mata had played an important role in their lives. It produced many well-trained and at times superbly skilled military physicians. Some of them went on to become outstanding specialists in various fields of medicine and pharmacy. Most of them courageously defended their homeland during the Second War World, providing to be distinguished officers ready to risk their lives when the situation waranted.

  12. Comprehensive biomechanical characterization of feet in USMA cadets: Comparison across race, gender, arch flexibility, and foot types.

    Science.gov (United States)

    Song, Jinsup; Choe, Kersti; Neary, Michael; Zifchock, Rebecca A; Cameron, Kenneth L; Trepa, Michael; Hannan, Marian T; Hillstrom, Howard

    2018-02-01

    Lower extremity musculoskeletal injuries are common, complex, and costly problems. Literature supports associations between static foot structure and dynamic foot function, as well as between overuse injury and demographic characteristics. Previous studies failed to provide a comprehensive biomechanical foot characteristics of at-risk military personnel. In this study, foot structure, function, and arch height flexibility (AHF) were objectively measured in 1090 incoming cadets (16.3% female, mean age of 18.5years and BMI of 24.5kg/m 2 ) of the United States Military Academy at the start of their training. A Generalized Linear Model with an identity link function was used to examine the effects of race, gender, foot types, and AHF while accounting for potential dependence in bilateral data. Planus and flexible feet independently demonstrated over-pronation, as measured by reduced Center of Pressure Excursion Index (CPEI). When comparing across race, Black participants showed a significantly lower arch height index (AHI), a larger malleolar valgus index (MVI), and a higher prevalence of pes planus (91.7% versus 73.3% overall). However, Asian participants with flexible arches, rather than Black with low arch, displayed over-pronation in gait. Females showed no significant difference in standing AHI and MVI but demonstrated a significantly greater AHF and a reduced CPEI than male participants. This was the first large scale investigation that comprehensively characterized biomechanical foot in a cohort of young at-risk individuals with lower limb musculoskeletal injuries. Long-term goal is to examine the relationship between these biomechanical features and injuries, ultimately to develop effective preventive measures. Copyright © 2017 Elsevier B.V. All rights reserved.

  13. 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

  14. 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 2.0 vs. NH: 0.7%) did not reach 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.

  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. 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.

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

    Science.gov (United States)

    Truby, Helen; Hiscutt, Rebecca; Herriot, Anne M; Stanley, Manana; Delooy, Anne; Fox, Kenneth R; Baic, Susan; Robson, Paula J; Macdonald, Ian; Taylor, Moira A; Ware, Robert; Logan, Catherine; Livingstone, Mbe

    2008-09-02

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

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

    Directory of Open Access Journals (Sweden)

    Macdonald Ian

    2008-09-01

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

  19. 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. 

  20. 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.

  1. The CADET Project Modification of the University of Oklahoma Mainframe to Apple Landsat Program for Canadian Computer Compatible Landsat Tapes. A Supplementary Report to the Innovative Project Fund, Alberta Advanced Education, October 16, 1984.

    Science.gov (United States)

    Kirman, Joseph M.

    The CADET Project Modification computer analysis, and both hard copy map-like images and computer tapes are available to the public. A mainframe computer program that permits an Apple microcomputer user to select a particular 40 by 40 pixel sub-scene from a Landsat computer compatible tape and download it to Apple computer diskette via telephone…

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

    Directory of Open Access Journals (Sweden)

    Wallis Matthew G

    2011-01-01

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

  3. 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

  4. A minimum protocol for randomised homeopathic drug proving as basis for further research.

    Science.gov (United States)

    Jansen, Jean Pierre; Jong, Mats; Hildingsson, Ingegerd; Jong, Miek C

    2014-01-01

    In order to further improve the methodology and quality of data collection in homeopathic drug provings (HDP), there is a need for a minimum standardised HDP protocol. The objective of the present study was to test the feasibility of this type of protocol. The study protocol embraced a multi-centre, randomised, double-blind, placebo-controlled trial with 2 parallel groups. It was approved by an ethics review committee. During the pre-approval phase, discordances between the regulatory and homeopathic requirements for the protocol were checked and solutions found. The study medication was Potentilla anserina. 6 participants received verum and 4 placebo. The resulting symptom list will be published elsewhere. The procedure was accepted by all participants. Three important issues were addressed: the requirement to keep all participants blinded; the adverse events reporting to regulatory authorities; and the necessity of a placebo control group. Other issues that need further investigations were identified, e.g. sample size, observation period and dosage regimen. A minimum protocol of a HDP is feasible. All important design elements of HDP could be solved in discussions with the respective regulatory authorities, and participating homeopaths accepted the procedure. © 2014 S. Karger GmbH, Freiburg.

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

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    Nuttall Jacqueline

    2011-02-01

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

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

    Directory of Open Access Journals (Sweden)

    Adriana Inocenti Miasso

    2009-02-01

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

  7. The effect of an education programme (MEDIAS 2 BSC) of non-intensive insulin treatment regimens for people with Type 2 diabetes: a randomized, multi-centre trial.

    Science.gov (United States)

    Hermanns, N; Ehrmann, D; Schall, S; Maier, B; Haak, T; Kulzer, B

    2017-08-01

    A self-management oriented education programme (MEDIAS 2 BSC) for people with Type 2 diabetes who are on a non-intensive insulin treatment regimen was developed. In a randomized, multi-centre trial, the effect of MEDIAS 2 BSC was compared with an established education programme that acted as a control group. The primary outcome was the impact of MEDIAS 2 BSC on glycaemic control. Secondary outcomes included the incidence of severe hypoglycaemia, hypoglycaemia unawareness, diabetes-related distress, diabetes knowledge, quality of life and self-care behaviour. In total, 182 participants were randomized to the control group or MEDIAS 2 BSC [median age 64.0 (interquartile range 58.0-68.5) vs. 63.5 (57.0-70.0) years; HbA 1c 62.8 ± 12.7 mmol/mol vs. 63.7 ± 14.0 mmol/mol; 7.9% ± 1.2% vs. 8.0% ± 1.3%]. After a 6-month follow-up, there was a mean decrease in HbA 1c of 3.5 mmol/mol (0.32%) in the control group and 6.7 mmol/mol (0.61%) in MEDIAS 2 BSC. After adjusting for baseline differences and study centre, the mean difference between the groups was -3.3 mmol/mol [95% confidence interval (CI) -0.54 to -5.90 mmol/mol] [-0.30% (95% CI -0.05 to -0.54)] in favour of MEDIAS 2 BSC (P = 0.018). There were no increases in severe hypoglycaemia or hypoglycaemia unawareness. The education programmes had no significant effects on psychosocial outcome variables. MEDIAS 2 BSC was more effective in lowering HbA 1c than the control condition. MEDIAS 2 BSC is a safe educational tool that improves glycaemic control without increasing the risk for hypoglycaemia. (Clinical Trials Registry No; NCT 02748239). © 2017 Diabetes UK.

  8. Improving family communication after a new genetic diagnosis: a randomised controlled trial of a genetic counselling intervention.

    Science.gov (United States)

    Hodgson, Jan M; Metcalfe, Sylvia A; Aitken, Maryanne; Donath, Susan M; Gaff, Clara L; Winship, Ingrid M; Delatycki, Martin B; Skene, Loane L C; McClaren, Belinda J; Paul, Jean L; Halliday, Jane L

    2014-03-14

    Genetic information given to an individual newly diagnosed with a genetic condition is likely to have important health implications for other family members. The task of communicating with these relatives commonly falls to the newly diagnosed person. Talking to relatives about genetic information can be challenging and is influenced by many factors including family dynamics. Research shows that many relatives remain unaware of relevant genetic information and the possible impact on their own health. This study aims to evaluate whether a specific genetic counselling intervention for people newly diagnosed with a genetic condition, implemented over the telephone on a number of occasions, could increase the number of at-risk relatives who make contact with genetics services after a new genetic diagnosis within a family. This is a prospective, multi-centre randomised controlled trial being conducted at genetics clinics at five public hospitals in Victoria, Australia. A complex genetic counselling intervention has been developed specifically for this trial. Probands (the first person in a family to present with a diagnosis of a genetic condition) are being recruited and randomised into one of two arms - the telephone genetic counselling intervention arm and the control arm receiving usual care. The number of at-risk relatives for each proband will be estimated from a family pedigree collected at the time of diagnosis. The primary outcome will be measured by comparing the proportion of at-risk relatives in each arm of the trial who make subsequent contact with genetics services. This study, the first randomised controlled trial of a complex genetic counselling intervention to enhance family communication, will provide evidence about how best to assist probands to communicate important new genetic information to their at-risk relatives. This will inform genetic counselling practice in the context of future genomic testing. Australia and New Zealand Clinical Trials

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

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    O'Donovan Michael

    2008-05-01

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

  10. Evaluation of the management excellency program: the Perception of the Military of the Permanent Corp of the Preparatory School of Cadets of the Brazilian Army

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    Rogerio da Silva Nunes

    2010-09-01

    Full Text Available This paper discusses the implementation of the Management Excellence Program of the Brazilian Army (PEG-EB in the Preparatory School Army Cadets (EsPCEx identify the importance of the program and show the perception of this permanent implantation in the body of officers and men. The military presented their perceptions on the program and its implementation across the seven quality criteria Quality Program of the Federal Government (PQGF. We administered a survey instrument with 53 assertions, referring to the criteria adopted by the PEG-EB, the 175 soldiers belong to the complementary Officer (QCO and Technical Services Temporary (STT of EsPCEx with a Likert scale, graded zero to four. The results were tabulated with multivariate analysis, performed using a statistical package(SPSS and shows the participants' perception of the quality program for each of the criteria adopted by the PEG-EB.

  11. 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.

  12. Association between arterial elasticity, C-reactive protein and maximal oxygen consumption in well-trained cadets during three days extreme physical load: a pilot study

    International Nuclear Information System (INIS)

    Kampus, Priit; Kals, Jaak; Zilmer, Kersti; Zilmer, Mihkel; Unt, Eve; Eha, Jaan; Teesalu, Rein; Normak, Aivo

    2008-01-01

    Regular aerobic training has beneficial effects on inflammatory pathways and on arterial elasticity, which are both important cardiovascular risk factors. The aim of the present study was to evaluate the effect of extreme physical load on arterial elasticity and inflammatory markers in well-trained healthy men who participated in a high-ranking combat course. Seven well-trained male cadets were examined during an international military combat course of 3.5 days duration. Small (C2) and large (C1) artery elasticity was assessed using diastolic pulse wave analysis. Inflammatory markers and arterial elasticity measurement were performed before and after the competition. The extreme prolonged physical load caused individually different responses in arterial elasticity, C-reactive protein (CRP) and creatine kinase in individual cadets. Maximal oxygen consumption (VO 2 max kg −1 ) correlated significantly with the change (Δ-difference between baseline and 24 h recovery period) of creatine kinase (r = −0.78; p = 0.04) and ΔC2 (r = 0.78; p = 0.04) and ΔC1 (r = 0.82; p = 0.02). In multivariate analysis (R 2 = 0.89, p = 0.01) the ΔC2 correlated strongly with VO 2 max kg −1 (p = 0.005) and with the ΔCRP (p = 0.03), whereas the ΔC1 correlated only with VO 2 max kg −1 and did not correlate significantly with the ΔCRP. Changes in small arterial elasticity induced by extreme physical load were significantly related to VO 2 max kg −1 and ΔCRP, whereas the change of large artery elasticity was only associated with VO 2 max kg −1 . Our preliminary results indicate that acute exercise-induced inflammation may affect small artery elasticity. However, further, more extensive studies are needed in this area

  13. 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

  14. 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

  15. 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

  16. Abdominal massage for neurogenic bowel dysfunction in people with multiple sclerosis (AMBER - Abdominal Massage for Bowel Dysfunction Effectiveness Research): study protocol for a randomised controlled trial.

    Science.gov (United States)

    McClurg, Doreen; Goodman, Kirsteen; Hagen, Suzanne; Harris, Fional; Treweek, Sean; Emmanuel, Anton; Norton, Christine; Coggrave, Maureen; Doran, Selina; Norrie, John; Donnan, Peter; Mason, Helen; Manoukian, Sarkis

    2017-03-29

    Multiple sclerosis (MS) is a life-long condition primarily affecting younger adults. Neurogenic bowel dysfunction (NBD) occurs in 50-80% of these patients and is the term used to describe constipation and faecal incontinence, which often co-exist. Data from a pilot study suggested feasibility of using abdominal massage for the relief of constipation, but the effectiveness remains uncertain. This is a multi-centred patient randomised superiority trial comparing an experimental strategy of once daily abdominal massage for 6 weeks against a control strategy of no massage in people with MS who have stated that their constipation is bothersome. The primary outcome is the Neurogenic Bowel Dysfunction Score at 24 weeks. Both groups will receive optimised advice plus the MS Society booklet on bowel management in MS, and will continue to receive usual care. Participants and their clinicians will not be blinded to the allocated intervention. Outcome measures are primarily self-reported and submitted anonymously. Central trial staff who will manage and analyse the trial data will be unaware of participant allocations. Analysis will follow intention-to-treat principles. This pragmatic randomised controlled trial will demonstrate if abdominal massage is an effective, cost-effective and viable addition to the treatment of NBD in people with MS. ClinicalTrials.gov, ISRCTN85007023 . Registered on 10 June 2014.

  17. GA101 (obinutuzumab) monocLonal Antibody as Consolidation Therapy In CLL (GALACTIC) trial: study protocol for a phase II/III randomised controlled trial.

    Science.gov (United States)

    Oughton, Jamie B; Collett, Laura; Howard, Dena R; Hockaday, Anna; Munir, Talha; McMahon, Kathryn; McParland, Lucy; Dimbleby, Claire; Phillips, David; Rawstron, Andy C; Hillmen, Peter

    2017-07-26

    Chronic lymphocytic leukaemia (CLL) is the most common adult leukaemia. Achieving minimal residual disease (MRD) negativity in CLL is an independent predictor of survival even with a variety of different treatment approaches and regardless of the line of therapy. GA101 (obinutuzumab) monocLonal Antibody as Consolidation Therapy In CLL (GALACTIC) is a seamless phase II/III, multi-centre, randomised, controlled, open, parallel-group trial for patients with CLL who have recently responded to chemotherapy. Participants will be randomised to receive either obinutuzumab (GA-101) consolidation or no treatment (as is standard). The phase II trial will assess safety and short-term efficacy in order to advise on continuation to a phase III trial. The primary objective for phase III is to assess the effect of consolidation therapy on progression-free survival (PFS). One hundred eighty-eight participants are planned to be recruited from forty research centres in the United Kingdom. There is evidence that achieving MRD eradication with alemtuzumab consolidation is associated with improvements in survival and time to progression. This trial will assess whether obinutuzumab is safe in a consolidation setting and effective at eradicating MRD and improving PFS. ISRCTN, 64035629 . Registered on 12 January 2015. EudraCT, 2014-000880-42 . Registered on 12 November 2014.

  18. The TRACTISS Protocol: a randomised double blind placebo controlled clinical TRial of Anti-B-Cell Therapy In patients with primary Sjögren’s Syndrome

    Science.gov (United States)

    2014-01-01

    Background Primary Sjögren’s Syndrome (PSS) mainly affects women (9:1 female:male ratio) and is one of the commonest autoimmune diseases with a prevalence of 0.1 – 0.6% of adult women. For patients with PSS there is currently no effective therapy that can alter the progression of the disease. The aim of the TRACTISS study is to establish whether in patients with PSS, treatment with rituximab improves clinical outcomes. Methods/design TRACTISS is a UK multi-centre, double-blind, randomised, controlled, parallel group trial of 110 patients with PSS. Patients will be randomised on a 1:1 basis to receive two courses of either rituximab or placebo infusion in addition to standard therapy, and will be followed up for up to 48 weeks. The primary objective is to assess the extent to which rituximab improves symptoms of fatigue and oral dryness. Secondary outcomes include ocular dryness, salivary flow rates, lacrimal flow, patient quality of life, measures of disease damage and disease activity, serological and peripheral blood biomarkers, and glandular histology and composition. Discussion The TRACTISS trial will provide direct evidence as to whether rituximab in patients with PSS leads to an improvement in patient symptoms and a reduction in disease damage and activity. Trial registration UKCRN Portfolio ID: 9809 ISRCTN65360827. PMID:24438039

  19. 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.

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

    Directory of Open Access Journals (Sweden)

    Sharpe Michael

    2009-09-01

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

  1. 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

  2. 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,

  3. 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.

  4. Brief Intervention in Type 1 diabetes – Education for Self-efficacy (BITES: Protocol for a randomised control trial to assess biophysical and psychological effectiveness

    Directory of Open Access Journals (Sweden)

    Dromgoole Paul

    2007-09-01

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

  5. 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

    2009-01-01

    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 Ashworth

  6. '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

  7. 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

  8. 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

  9. Visuo-spatial path learning, stress, and cortisol secretion following military cadets' first parachute jump: the effect of increasing task complexity.

    Science.gov (United States)

    Taverniers, John; Smeets, Tom; Lo Bue, Salvatore; Syroit, Jef; Van Ruysseveldt, Joris; Pattyn, Nathalie; von Grumbkow, Jasper

    2011-09-01

    The present field experiment examined how multi-trial visuo-spatial learning and memory performance are impacted by excessive arousal, instigated by a potentially life-threatening event (i.e., a first parachute jump). Throughout a parachute training activity, subjective and neuroendocrine (i.e., cortisol) stress levels were assessed of 61 male military cadets who were randomly assigned to a control (n = 30) or a jump stress condition (n = 31). Post-stress learning and memory capacity was assessed with a 10-trial path-learning task that permitted emergence of learning curves. Pre-activity cortisol concentrations indicated a significant neuroendocrine anticipatory stress response in the stress group. Following parachuting, subjective stress levels and salivary cortisol reactivity differed significantly between groups. Visuo-spatial path-learning performance was impaired significantly after jump stress exposure, relative to the control group. Moreover, examination of the learning curves showed similar learning and memory performance at onset of the trials, with curves bifurcating as the task became more complex. These findings are in accordance with leading theories that acknowledge a moderating effect of task complexity. In sum, the present study extends knowledge concerning anticipatory stress effects, endogenously instigated cortisol reactivity, and the influence of extreme arousal on visuo-spatial path learning.

  10. Impact of a short course in pharmacotherapy for undergraduate medical students: an international randomised controlled study.

    Science.gov (United States)

    de Vries, T P; Henning, R H; Hogerzeil, H V; Bapna, J S; Bero, L; Kafle, K K; Mabadeje, A f; Santoso, B; Smith, A J

    1995-12-02

    Irrational prescribing is a habit which is difficult to cure. However, prevention is possible and for this reason the WHO Action Programme on Essential Drugs aims to improve the teaching of pharmacotherapy to medical students. The impact of a short problem-based training course in pharmacotherapy, using a WHO manual on the principles of rational prescribing, was measured in an international multi-centre randomised controlled study of 219 undergraduate medical students in Groningen (Netherlands), Kathmandu (Nepal), Lagos (Nigeria), Newcastle (Australia), New Delhi (India), San Francisco (USA), and Yogyakarta (Japan). The manual and the course presented the students, who were about to enter the clinical phase of their studies, with a normative model for pharmacotherapeutic reasoning in which they were taught to generate a "standard" pharmacotherapeutic approach to common disorders, resulting in a set of first-choice drugs called P(ersonal)-drugs. The students were then taught how to apply this set of P-drugs to specific patient problems on the symptomatic treatment of pain, using a six-step problem-solving routine. The impact of the course was measured by tests before training, immediately after, and six months later. After the course, students from the study group performed significantly better than controls in all patient problems presented (p students not only remembered how to solve old problems, but they could also apply their skills to new problems. Both retention and transfer effect were maintained at least six months after the training session in all seven medical schools. In view of the impossibility of teaching students all basic knowledge on the thousands of drugs available, this approach seems to be an efficient way of teaching rational prescribing. However, the method should be accompanied by a change in teaching methods away from the habit of transferring knowledge about the drugs towards problem-based teaching of therapeutic reasoning.

  11. A randomised controlled trial of roller versus centrifugal cardiopulmonary bypass pumps in patients undergoing pulmonary endarterectomy.

    Science.gov (United States)

    Mlejnsky, F; Klein, A A; Lindner, J; Maruna, P; Kvasnicka, J; Kvasnicka, T; Zima, T; Pecha, O; Lips, M; Rulisek, J; Porizka, M; Kopecky, P; Kunstyr, J

    2015-10-01

    There is some controversy as to whether there is a benefit from the use of a centrifugal pump compared with a roller pump during cardiopulmonary bypass to facilitate cardiac surgery. We compared the two pumps, with the primary aim of determining any difference in the effects on inflammation after pulmonary endarterectomy surgery which required prolonged cardiopulmonary bypass and deep hypothermic circulatory arrest. Between September 2010 and July 2013, 58 elective patients undergoing pulmonary endarterectomy were included in this prospective, randomised, controlled study; 30 patients were randomly allocated to the control group, which used a roller pump, and 28 patients to the treatment group, which used a centrifugal pump. Interleukin-6, procalcitonin, C-reactive protein, thromboelastographic parameters, P-selectin, international normalised ratio, activated prothrombin time, free haemoglobin, haematocrit, red blood cell count, white blood cell count, platelet count and protein S100β were recorded during and after the procedure. We also recorded the length of intensive care unit stay, blood loss and transfusion, neurological outcomes and respiratory and renal failure. There was a significant difference in the primary outcome measure: Interleukin-6 was significantly higher in the roller pump group (587 ± 38 ng · l(-1) vs. 327 ± 37 ng · l(-1); ppump group 48 hours following surgery (0.79 (0.08-25.25) ng · ml(-1) vs. 0.36 (0.02-5.83) ng · ml(-1); pcentrifugal pump during prolonged cardiopulmonary bypass and deep hypothermic circulatory arrest is associated with a reduced inflammatory response compared to the standard roller pump. Larger multi-centre trials in this area of practice are required. © The Author(s) 2014.

  12. 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

  13. 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

  14. 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

    Science.gov (United States)

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

    2009-01-01

    Background A recent Dutch mono-centre randomised controlled trial has shown that occupational therapy improves daily functioning in dementia. The aim of this present study is to compare the effects of the Dutch community occupational therapy programme with a community occupational therapy 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's sense of competence, caregiver

  15. Balance Right in Multiple Sclerosis (BRiMS): a guided self-management programme to reduce falls and improve quality of life, balance and mobility in people with secondary progressive multiple sclerosis: a protocol for a feasibility randomised controlled trial.

    Science.gov (United States)

    Gunn, H; Andrade, J; Paul, L; Miller, L; Creanor, S; Green, C; Marsden, J; Ewings, P; Berrow, M; Vickery, J; Barton, A; Marshall, B; Zajicek, J; Freeman, J A

    2018-01-01

    Impaired mobility is a cardinal feature of multiple sclerosis (MS) and is rated by people with MS as their highest priority. By the secondary progressive phase, balance, mobility and physical activity levels are significantly compromised; an estimated 70% of people with secondary progressive MS fall regularly. Our ongoing research has systematically developed 'Balance Right in MS' (BRiMS), an innovative, manualised 13-week guided self-management programme tailored to the needs of people with MS, designed to improve safe mobility and minimise falls. Our eventual aim is to assess the clinical and cost effectiveness of BRiMS in people with secondary progressive MS by undertaking an appropriately statistically powered, multi-centre, assessor-blinded definitive, randomised controlled trial. This feasibility study will assess the acceptability of the intervention and test the achievability of running such a definitive trial. This is a pragmatic multi-centre feasibility randomised controlled trial with blinded outcome assessment. Sixty ambulant people with secondary progressive MS who self-report two or more falls in the previous 6 months will be randomly allocated (1:1) to either the BRiMS programme plus usual care or to usual care alone. All participants will be assessed at baseline and followed up at 15 weeks and 27 weeks post-randomisation. The outcomes of this feasibility trial include:Feasibility outcomes, including trial recruitment, retention and completionAssessment of the proposed outcome measures for the anticipated definitive trial (including measures of walking, quality of life, falls, balance and activity level)Measures of adherence to the BRiMS programmeData to inform the economic evaluation in a future trialProcess evaluation (assessment of treatment fidelity and qualitative evaluation of participant and treating therapist experience). The BRiMS intervention aims to address a key concern for MS service users and providers. However, there are several

  16. Determinación de la prevalencia de somnolencia diurna excesiva y su relación con la calidad de sueño, en Cadetes de la Escuela Superior Militar Eloy Alfaro en el mes de Junio del 2014

    OpenAIRE

    De La Vega Granizo, Ivonne Soraya

    2015-01-01

    El objetivo del presente estudio es determinar la prevalencia y gravedad de somnolencia diurna excesiva y su relación con la calidad de sueño en el personal de cadetes de la Escuela Superior Militar Eloy Alfaro, mediante un estudio cuantitativo, de tipo transversal con técnica de encuesta, aplicando la Escala de somnolencia de Epworth; Índice de Calidad de Sueño de Pittsburg; Test de Audit; Cuestionario sobre antecedentes socio demográficos y hábitos y estilo de vida. Los cadetes evaluado...

  17. 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.

  18. 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

    2017-06-20

    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.

  19. 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

  20. Does one size really fit all? The effectiveness of a non-diagnosis-specific integrated mental health care program in Germany in a prospective, parallel-group controlled multi-centre trial.

    Science.gov (United States)

    Mueller-Stierlin, Annabel Sandra; Helmbrecht, Marina Julia; Herder, Katrin; Prinz, Stefanie; Rosenfeld, Nadine; Walendzik, Julia; Holzmann, Marco; Dinc, Uemmueguelsuem; Schützwohl, Matthias; Becker, Thomas; Kilian, Reinhold

    2017-08-01

    The Network for Mental Health (NWpG-IC) is an integrated mental health care program implemented in 2009 by cooperation between health insurance companies and community mental health providers in Germany. Meanwhile about 10,000 patients have been enrolled. This is the first study evaluating the effectiveness of the program in comparison to standard mental health care in Germany. In a parallel-group controlled trial over 18 months conducted in five regions across Germany, a total of 260 patients enrolled in NWpG-IC and 251 patients in standard mental health care (TAU) were recruited between August 2013 and November 2014. The NWpG-IC patients had access to special services such as community-based multi-professional teams, case management, crisis intervention and family-oriented psychoeducation in addition to standard mental health care. The primary outcome empowerment (EPAS) and the secondary outcomes quality of life (WHO-QoL-BREF), satisfaction with psychiatric treatment (CSQ-8), psychosocial and clinical impairment (HoNOS) and information about mental health service needs (CAN) were measured four times at 6-month intervals. Linear mixed-effect regression models were used to estimate the main effects and interaction effects of treatment, time and primary diagnosis. Due to the non-randomised group assignment, propensity score adjustment was used to control the selection bias. NWpG-IC and TAU groups did not differ with respect to most primary and secondary outcomes in our participating patients who showed a broad spectrum of psychiatric diagnoses and illness severities. However, a significant improvement in terms of patients' satisfaction with psychiatric care and their perception of treatment participation in favour of the NWpG-IC group was found. Providing integrated mental health care for unspecific mentally ill target groups increases treatment participation and service satisfaction but seems not suitable to enhance the overall outcomes of mental health care in

  1. 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

  2. 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

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

    Directory of Open Access Journals (Sweden)

    Cornette Luc

    2007-08-01

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

  4. Management of hypotension in preterm infants (The HIP Trial): a randomised controlled trial of hypotension management in extremely low gestational age newborns.

    Science.gov (United States)

    Dempsey, E M; Barrington, K J; Marlow, N; O'Donnell, C P; Miletin, J; Naulaers, G; Cheung, P-Y; Corcoran, D; Pons, G; Stranak, Z; Van Laere, D

    2014-01-01

    Extremely preterm babies (delivered at hypotension and treated with inotropic and pressor drugs in the immediate postnatal period. Dopamine is the most commonly used first-line drug. Babies who are treated for hypotension more frequently sustain brain injury, have long-term disability or die compared to those who are not. Despite the widespread use of drugs to treat hypotension in such infants, evidence for efficacy is lacking, and the effect of these agents on long-term outcomes is unknown. In extremely preterm babies, restricting the use of dopamine when mean blood pressure (BP) values fall below a nominal threshold and using clinical criteria to determine escalation of support ('restricted' approach) will result in improved neonatal and longer-term developmental outcomes. RESEARCH PLAN: In an international multi-centre randomised trial, 830 infants born at <28 weeks of gestation, and within 72 h of birth, will be allocated to 1 of 2 alternative treatment options (dopamine vs. restricted approach) to determine the better strategy for the management of BP, using a conventional threshold to commence treatment. The first co-primary outcome of survival without brain injury will be determined at 36 weeks' postmenstrual age and the second co-primary outcome (survival without neurodevelopmental disability) will be assessed at 2 years of age, corrected for prematurity. It is essential that appropriately designed trials be performed to define the most appropriate management strategies for managing low BP in extremely preterm babies.

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

    Directory of Open Access Journals (Sweden)

    Tietze Anna

    2008-06-01

    Full Text Available Abstract Background Infants born at extreme prematurity are at high risk of developmental disability. A major risk factor for disability is having a low level of thyroid hormone described as hypothyroxinaemia, which is recognised to be a frequent phenomenon in these infants. Derangements of critical thyroid function during the sensitive window in prematurity when early development occurs, may have a range of long term effects for brain development. Further research in preterm infants using neuroimaging techniques will increase our understanding of the specificity of the effects of hypothyroxinaemia on the developing foetal brain. This is an explanatory double blinded randomised controlled trial which is aimed to assess the effect of thyroid hormone supplementation on brain size, key brain structures, extent of myelination, white matter integrity and vessel morphology, somatic growth and the hypothalamic-pituitary-adrenal axis. Methods The study is a multi-centred double blinded randomised controlled trial of thyroid hormone supplementation in babies born below 28 weeks' gestation. All infants will receive either levothyroxine or placebo until 32 weeks corrected gestational age. The primary outcomes will be width of the sub-arachnoid space measured using cranial ultrasound and head circumference at 36 weeks corrected gestational age. The secondary outcomes will be thyroid hormone concentrations, the hypothalamic pituitary axis status and auxological data between birth and expected date of delivery; thyroid gland volume, brain size, volumes of key brain structures, extent of myelination and brain vessel morphology at expected date of delivery and markers of morbidity which include duration of mechanical ventilation and/or oxygen requirement and chronic lung disease. Trial registration Current Controlled Trials ISRCTN89493983

  6. 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

  7. Panax ginseng C.A Meyer root extract for moderate Chronic Obstructive Pulmonary Disease (COPD: study protocol for a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Story David

    2011-06-01

    Full Text Available Abstract Background Chronic obstructive pulmonary disease (COPD impairs quality of life and leads to premature mortality. COPD sufferers experience progressive deterioration of lung function and decreased ability to undertake day-to-day activities. Ginseng has been used for thousands of years in Chinese medicine for respiratory symptoms. Several controlled clinical trials using ginseng for COPD have shown promising clinical effect, however these studies were generally small and with some potential bias, prompting the need for rigorously designed studies. Aim The objective of this study is to evaluate the therapeutic value and safety profile of a standardised root extract of Panax ginseng C.A Meyer (ginseng for symptomatic relief, with a focus on quality of life (QoL improvements in individuals with moderate (Stage II COPD FEV1/FVC 1 50% - 80% predicted. Methods This paper describes the design of a randomised, multi-centre, double-blind, placebo controlled, two-armed parallel clinical trial. Two trial sites in Melbourne Australia will proportionately randomise a total of 168 participants to receive either ginseng capsule (100 mg or matching placebo twice daily for 24 weeks. The primary outcomes will be based on three validated QoL questionnaires, St Georges Respiratory Questionnaire (SGRQ, Short Form Health Survey (SF-36 and the COPD Assessment Test (CAT. Secondary outcomes are based on lung function testing, relief medication usage and exacerbation frequency and severity. Safety endpoints include blood tests and adverse event reporting. Intention-to-treat will be applied to all data analyses. Discussion Findings from this study may lead to new therapeutic development for chronic respiratory diseases, particularly COPD. This protocol may also guide other investigators to develop quality herbal medicine clinical trials in the future. Trial registration Australia and New Zealand Clinical Trials Register (ANZCTR: ACTRN12610000768099

  8. 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.

    Science.gov (United States)

    Adams, Jo; Bridle, Chris; Dosanjh, Sukhdeep; Heine, Peter; Lamb, Sarah E; Lord, Joanne; McConkey, Christopher; Nichols, Vivien; Toye, Francine; Underwood, Martin R; Williams, Mark A; Williamson, Esther M

    2012-11-24

    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. 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. 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.

  9. 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.

  10. 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.

  11. 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.

  12. Standing with electrical stimulation and splinting is no better than standing alone for management of ankle plantarflexion contractures in people with traumatic brain injury: a randomised trial

    Directory of Open Access Journals (Sweden)

    Joan Leung

    2014-12-01

    Full Text Available Question: Is a combination of standing, electrical stimulation and splinting more effective than standing alone for the management of ankle contractures after severe brain injury? Design: A multi-centre randomised trial with concealed allocation, assessor blinding and intention-to-treat analysis. Participants: Thirty-six adults with severe traumatic brain injury and ankle plantarflexion contractures. Intervention: All participants underwent a 6-week program. The experimental group received tilt table standing, electrical stimulation and ankle splinting. The control group received tilt table standing alone. Outcome measures: The primary outcome was passive ankle dorsiflexion with a 12 Nm torque. Secondary outcomes included: passive dorsiflexion with lower torques (3, 5, 7 and 9 Nm; spasticity; the walking item of the Functional Independence Measure; walking speed; global perceived effect of treatment; and perceived treatment credibility. Outcome measures were taken at baseline (Week 0, end of intervention (Week 6, and follow-up (Week 10. Results: The mean between-group differences (95% CI for passive ankle dorsiflexion at Week 6 and Week 10 were –3 degrees (–8 to 2 and –1 degrees (–6 to 4, respectively, in favour of the control group. There was a small mean reduction of 1 point in spasticity at Week 6 (95% CI 0.1 to 1.8 in favour of the experimental group, but this effect disappeared at Week 10. There were no differences for other secondary outcome measures except the physiotherapists’ perceived treatment credibility. Conclusion: Tilt table standing with electrical stimulation and splinting is not better than tilt table standing alone for the management of ankle contractures after severe brain injury. Trial registration: ACTRN12608000637347. [Leung J, Harvey LA, Moseley AM, Whiteside B, Simpson M, Stroud K (2014 Standing with electrical stimulation and splinting is no better than standing alone for management of ankle plantarflexion

  13. 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

  14. 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

  15. Safety of zoledronic acid and incidence of osteonecrosis of the jaw (ONJ) during adjuvant therapy in a randomised phase III trial (AZURE: BIG 01-04) for women with stage II/III breast cancer.

    Science.gov (United States)

    Coleman, R; Woodward, E; Brown, J; Cameron, D; Bell, R; Dodwell, D; Keane, M; Gil, M; Davies, C; Burkinshaw, R; Houston, S J; Grieve, R J; Barrett-Lee, P J; Thorpe, H

    2011-06-01

    The AZURE trial is an ongoing phase III, academic, multi-centre, randomised trial designed to evaluate the role of zoledronic acid (ZOL) in the adjuvant therapy of women with stage II/III breast cancer. Here, we report the safety and tolerability profile of ZOL in this setting. Eligible patients received (neo)adjuvant chemotherapy and/or endocrine therapy and were randomised to receive neither additional treatment nor intravenous ZOL 4 mg. ZOL was administered after each chemotherapy cycle to exploit potential sequence-dependent synergy. ZOL was continued for 60 months post-randomisation (six doses in the first 6 months, eight doses in the following 24 months and five doses in the final 30 months). Serious (SAE) and non-serious adverse event (AE) data generated during the first 36 months on study were analysed for the safety population. 3,360 patients were recruited to the AZURE trial. The safety population comprised 3,340 patients (ZOL 1,665; control 1,675). The addition of ZOL to standard treatment did not significantly impact on chemotherapy delivery. SAE were similar in both treatment arms. No significant safety differences were seen apart from the occurrence of osteonecrosis of the jaw (ONJ) in the ZOL group (11 confirmed cases; 0.7%; 95% confidence interval 0.3-1.1%). ZOL in the adjuvant setting is well tolerated, and can be safely administered in addition to adjuvant therapy including chemotherapy. The adverse events were consistent with the known safety profile of ZOL, with a low incidence of ONJ.

  16. 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

  17. 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

  18. 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

  19. 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

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

    Science.gov (United States)

    McMurran, Mary; Crawford, Mike J; Reilly, Joseph G; McCrone, Paul; Moran, Paul; Williams, Hywel; Adams, Clive E; Duggan, Conor; Delport, Juan; Whitham, Diane; Day, Florence

    2011-08-24

    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 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 by the SFQ. A reduction (i.e., an

  1. 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

  2. Mammographic screening: evidence from randomised controlled trials

    NARCIS (Netherlands)

    H.J. de Koning (Harry)

    2003-01-01

    textabstractBACKGROUND: All randomised breast cancer screening trials have shown a reduction in breast cancer mortality in the 'invited for mammography' screening arm compared with the 'control arm' for women aged 50 years and older at randomisation (overall 25%). However,

  3. 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.

  4. 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

  5. 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

  6. 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.

  7. 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

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

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    McDowell Jenny

    2010-02-01

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

  9. Costs and consequences of treatment for mild gestational diabetes mellitus – evaluation from the ACHOIS randomised trial

    Directory of Open Access Journals (Sweden)

    Willson Kristyn J

    2007-10-01

    Full Text Available Abstract Background Recommended best practice is that economic evaluation of health care interventions should be integral with randomised clinical trials. We performed a cost-consequence analysis of treating women with mild gestational diabetes mellitus by dietary advice, blood glucose monitoring and insulin therapy as needed compared with routine pregnancy care, using patient-level data from a multi-centre randomised clinical trial. Methods Women with a singleton pregnancy who had mild gestational diabetes diagnosed by an oral glucose-tolerance test between 24 and 34 weeks' gestation and their infants were included. Clinical outcomes and outpatient costs derived from all women and infants in the trial. Inpatient costs derived from women and infants attending the hospital contributing the largest number of enrolments (26.1%, and charges to women and their families derived from a subsample of participants from that hospital (in 2002 Australian dollars. Occasions of service and health outcomes were adjusted for maternal age, ethnicity and parity. Analysis of variance was used with bootstrapping to confirm results. Primary clinical outcomes were serious perinatal complications; admission to neonatal nursery; jaundice requiring phototherapy; induction of labour and caesarean delivery. Economic outcome measures were outpatient and inpatient costs, and charges to women and their families. Results For every 100 women with a singleton pregnancy and positive oral glucose tolerance test who were offered treatment for mild gestational diabetes mellitus in addition to routine obstetric care, $53,985 additional direct costs were incurred at the obstetric hospital, $6,521 additional charges were incurred by women and their families, 9.7 additional women experienced induction of labour, and 8.6 more babies were admitted to a neonatal nursery. However, 2.2 fewer babies experienced serious perinatal complication and 1.0 fewer babies experienced perinatal death

  10. Efficacy of a telephone outcall program to reduce caregiver burden among caregivers of cancer patients [PROTECT]: a randomised controlled trial.

    Science.gov (United States)

    Heckel, Leila; Fennell, Kate M; Reynolds, John; Boltong, Anna; Botti, Mari; Osborne, Richard H; Mihalopoulos, Cathrine; Chirgwin, Jacquie; Williams, Melinda; Gaskin, Cadeyrn J; Ashley, David M; Livingston, Patricia M

    2018-01-08

    Informal caregivers provide extended support to people with cancer but they receive little support from the health care system to assist them in their caring role. The aim of this single-blind, multi-centre, randomised controlled trial was to test the efficacy of a telephone outcall program to reduce caregiver burden and unmet needs, and improve psychological well-being among cancer caregivers, as well as evaluating the potential impact on patient outcomes. Cancer patient/caregiver dyads (N = 216) were randomised to a telephone outcall program (n = 108) or attention control group (n = 108). The primary outcome was self-reported caregiver burden. Secondary endpoints included depressive symptoms, unmet needs, self-esteem, self-empowerment, and health literacy. Data were collected at baseline and at both 1 and 6 months post-intervention. An intention to treat analysis was performed. The intervention had no effect on the primary outcome (caregiver burden), but reduced the number of caregiver unmet needs (intervention group baseline, mean = 2.66, 95% confidence interval (CI) [1.91-3.54]; intervention group 1 month post intervention, mean = 0.85, 95%CI [0.42-1.44]; control group baseline, mean = 1.30 95%CI [0.80-1.94], control group 1 month post intervention, mean = 1.02 95%CI [0.52-1.69]; p = 0.023). For caregivers at risk for depression, the intervention had a significant effect on caregivers' confidence in having sufficient information to manage their health (p = 0.040). No effects were found for patients' depressive symptoms, unmet needs, self-empowerment, and other health literacy domains. While caregiver burden was not reduced, the outcall program was effective in reducing unmet needs in caregivers. Provision of cancer information and support via a telephone service may represent a feasible approach to reducing unmet needs among cancer caregiver populations. ACTRN12613000731796 ; prospectively registered on 02/07/2013.

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

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    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

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

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    Russell Stuart J

    2012-02-01

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

  13. 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

  14. 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.

  15. 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

  16. The Women's wellness after cancer program: a multisite, single-blinded, randomised controlled trial protocol.

    Science.gov (United States)

    Anderson, Debra; Seib, Charrlotte; Tjondronegoro, Dian; Turner, Jane; Monterosso, Leanne; McGuire, Amanda; Porter-Steele, Janine; Song, Wei; Yates, Patsy; King, Neil; Young, Leonie; White, Kate; Lee, Kathryn; Hall, Sonj; Krishnasamy, Mei; Wells, Kathy; Balaam, Sarah; McCarthy, Alexandra L

    2017-02-03

    Despite advances in cancer diagnosis and treatment have significantly improved survival rates, patients post-treatment-related health needs are often not adequately addressed by current health services. The aim of the Women's Wellness after Cancer Program (WWACP), which is a digitised multimodal lifestyle intervention, is to enhance health-related quality of life in women previously treated for blood, breast and gynaecological cancers. A single-blinded, multi-centre randomized controlled trial recruited a total of 351 women within 24 months of completion of chemotherapy (primary or adjuvant) and/or radiotherapy. Women were randomly assigned to either usual care or intervention using computer-generated permuted-block randomisation. The intervention comprises an evidence-based interactive iBook and journal, web interface, and virtual health consultations by an experienced cancer nurse trained in the delivery of the WWACP. The 12 week intervention focuses on evidence-based health education and health promotion after a cancer diagnosis. Components are drawn from the American Cancer Research Institute and the World Cancer Research Fund Guidelines (2010), incorporating promotion of physical activity, good diet, smoking cessation, reduction of alcohol intake, plus strategies for sleep and stress management. The program is based on Bandura's social cognitive theoretical framework. The primary outcome is health-related quality of life, as measured by the Functional Assessment of Cancer Therapy-General (FACT-G). Secondary outcomes are menopausal symptoms as assessed by Greene Climacteric Scale; physical activity elicited with the Physical Activity Questionnaire Short Form (IPAQ-SF); sleep measured by the Pittsburgh Sleep Quality Index; habitual dietary intake monitored with the Food Frequency Questionnaire (FFQ); alcohol intake and tobacco use measured by the Australian Health Survey and anthropometric measures including height, weight and waist-to-hip ratio. All

  17. 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

  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. 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.

  20. 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.

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

    NARCIS (Netherlands)

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

    2008-01-01

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

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

    NARCIS (Netherlands)

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

    2008-01-01

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

  3. 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

    Purpose: To assess the impact of a variety of methodological parameters on the association between six drug classes and five key adverse events in multiple databases. Methods: The selection of Drug-Adverse Event pairs was based on public health impact, regulatory relevance, and the possibility to...

  4. Brotizolam and chronic insomnia: a multi-centre study.

    Science.gov (United States)

    Fritz-Osner, A; Arias-Ortiz, J L; Dorantes, J F; Rabago-Sánchez, J; Rodríguez-Tenorio, A; Sánchez-Martinez, J

    1983-01-01

    A double-blind, crossover study was carried out on the acceptability of three doses of brotizolam (0.125, 0.25 and 0.5 mg) in chronic insomniacs aged between 21 and 75 years (33 men: 42 women). Patients reported a shorter time to fall asleep and less nocturnal awakenings. Improvement in sleep was evident during the first week of the study when each patient received 0.25 mg. There were no dose-related side-effects, and on withdrawal from the medication there was no evidence of disturbed sleep which would have suggested a rebound effect.

  5. Prescription errors in psychiatry - a multi-centre study.

    Science.gov (United States)

    Stubbs, Jean; Haw, Camilla; Taylor, David

    2006-07-01

    Medication errors are an important cause of patient morbidity and mortality, of which there have been few reports in psychiatry, especially in the UK. Our aim was to examine the nature, frequency and potential severity of prescribing errors in UK mental health units in a prospective, 1 week survey of errors detected by pharmacy staff in nine NHS trusts. Pharmacists checked 22036 prescription items. In total, 523 errors meeting the study definition were detected (2.4% of prescription items checked). Prescription writing errors (77.4%) were most common, while decision-making errors accounted for 22.6% of errors. In 280 (53.5%) cases the prescribed drug had been administered before the error was detected. Most errors were of doubtful or minor importance but 22 (4.3%) were deemed likely to result in serious adverse effects or death. The error detection rate varied fourfold between trusts. Prescribing errors are fairly common in psychiatry. A small proportion of errors have the potential for serious harm. Pharmacy staff have an important role to play in their management.

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

    Science.gov (United States)

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

    2006-08-01

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

  7. 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

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

    Directory of Open Access Journals (Sweden)

    van Weelden Huib

    2006-08-01

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

  9. 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

  10. 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

  11. 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.

  12. 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

  13. 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.

  14. 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

  15. Adjuvant therapy with high dose vitamin D following primary treatment of melanoma at high risk of recurrence: a placebo controlled randomised phase II trial (ANZMTG 02.09 Mel-D).

    Science.gov (United States)

    Saw, Robyn P M; Armstrong, Bruce K; Mason, Rebecca S; Morton, Rachael L; Shannon, Kerwin F; Spillane, Andrew J; Stretch, Jonathan R; Thompson, John F

    2014-10-24

    Patients with primary cutaneous melanomas that are ulcerated and >2 mm in thickness, >4 mm in thickness and those with nodal micrometastases at diagnosis, have few options for adjuvant treatment. Recent studies have suggested a role for vitamin D to delay melanoma recurrence and improve overall prognosis. This is a pilot placebo-controlled randomised phase II trial to assess the feasibility, safety and toxicity of an oral loading dose of Vitamin D (500,000 IU) followed by an oral dose of 50,000 IU of Vitamin D monthly for 2 years in patients who have been treated for cutaneous melanoma by wide excision of the primary. Patients aged 18-79 years who have completed primary surgical treatment and have Stage IIb, IIc, IIIa (N1a, N2a) or IIIb (N1a, N2a) disease are eligible for randomisation 2:1 to active treatment or placebo. The primary endpoints are sufficiency of dose, adherence to study medication and safety of the drug. The secondary endpoints are participation and progression free survival. The study has been approved by the Ethics Review Committee (RPAH Zone) of the Sydney Local Health District, protocol number X09-0138. Effective, non-toxic adjuvant therapy for high risk primary melanoma is not currently available. Favorable outcomes of this phase II study will form the basis for a multi-centre phase III study to assess whether the addition of oral high-dose vitamin D therapy in patients who have completed primary treatment for melanoma and are at high risk of recurrence will: 1. prolong time to recurrence within 5 years 2. improve overall survival at 5 years and 3. be both safe and tolerable. 62 patients have been randomised since the study commenced in December 2010. Target accrual for the study has been met with 75 patients randomised between December 2010 and August 2014.The Mel-D trial is conducted by the Australia and New Zealand Melanoma Trials Group (ANZMTG 02.09) TRIAL REGISTRATION: Australia and New Zealand Clinical Trials Registry (ANZCTR) ACTRN

  16. 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

  17. 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

  18. 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

  19. 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 (ppatients with experiences of safety incidents in training has an ideological appeal 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.

  20. 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.

  1. The effectiveness of critical time intervention for abused women and homeless people leaving Dutch shelters: study protocol of two randomised controlled trials

    Science.gov (United States)

    2013-01-01

    Background One of the main priorities of Dutch organisations providing shelter services is to develop evidence-based interventions in the care for abused women and homeless people. To date, most of these organisations have not used specific intervention models and the interventions which have been implemented rarely have an empirical and theoretical foundation. The present studies aim to examine the effectiveness of critical time intervention (CTI) for abused women and homeless people. Methods In two multi-centre randomised controlled trials we investigate whether CTI, a time-limited (nine month) outreach intervention, is more effective than care-as-usual for abused women and homeless people making the transition from shelter facilities to supported or independent housing. Participants were recruited in 19 women’s shelter facilities and 22 homeless shelter facilities across The Netherlands and randomly allocated to the intervention group (CTI) or the control group (care-as-usual). They were interviewed four times in nine months: once before leaving the shelter, and then at three, six and nine months after leaving the shelter. Quality of life (primary outcome for abused women) and recurrent loss of housing (primary outcome for homeless people) as well as secondary outcomes (e.g. care needs, self-esteem, loneliness, social support, substance use, psychological distress and service use) were assessed during the interviews. In addition, the model integrity of CTI was investigated during the data collection period. Discussion Based on international research CTI is expected to be an appropriate intervention for clients making the transition from institutional to community living. If CTI proves to be effective for abused women and homeless people, shelter services could include this case management model in their professional standards and improve the (quality of) services for clients. Trial registration NTR3463 and NTR3425 PMID:25927562

  2. The effectiveness of critical time intervention for abused women and homeless people leaving Dutch shelters: study protocol of two randomised controlled trials.

    Science.gov (United States)

    Lako, Danielle A M; de Vet, Renée; Beijersbergen, Mariëlle D; Herman, Daniel B; van Hemert, Albert M; Wolf, Judith R L M

    2013-06-06

    One of the main priorities of Dutch organisations providing shelter services is to develop evidence-based interventions in the care for abused women and homeless people. To date, most of these organisations have not used specific intervention models and the interventions which have been implemented rarely have an empirical and theoretical foundation. The present studies aim to examine the effectiveness of critical time intervention (CTI) for abused women and homeless people. In two multi-centre randomised controlled trials we investigate whether CTI, a time-limited (nine month) outreach intervention, is more effective than care-as-usual for abused women and homeless people making the transition from shelter facilities to supported or independent housing. Participants were recruited in 19 women's shelter facilities and 22 homeless shelter facilities across The Netherlands and randomly allocated to the intervention group (CTI) or the control group (care-as-usual). They were interviewed four times in nine months: once before leaving the shelter, and then at three, six and nine months after leaving the shelter. Quality of life (primary outcome for abused women) and recurrent loss of housing (primary outcome for homeless people) as well as secondary outcomes (e.g. care needs, self-esteem, loneliness, social support, substance use, psychological distress and service use) were assessed during the interviews. In addition, the model integrity of CTI was investigated during the data collection period. Based on international research CTI is expected to be an appropriate intervention for clients making the transition from institutional to community living. If CTI proves to be effective for abused women and homeless people, shelter services could include this case management model in their professional standards and improve the (quality of) services for clients. NTR3463 and NTR3425.

  3. 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

  4. Assignment Procedure Biases in Randomised Policy Experiments

    DEFF Research Database (Denmark)

    Aldashev, Gani; Kirchsteiger, Georg; Sebald, Alexander

    2017-01-01

    's propensity to act reciprocally. When people are motivated by reciprocity, the choice of assignment procedure influences the RCTs’ findings. We show that even credible and explicit randomisation procedures do not guarantee an unbiased prediction of the impact of policy interventions; however, they minimise......Randomised controlled trials (RCT) have gained ground as the dominant tool for studying policy interventions in many fields of applied economics. We analyse theoretically encouragement and resentful demoralisation in RCTs and show that these might be rooted in the same behavioural trait – people...... any bias relative to other less transparent assignment procedures....

  5. Acute pancreatitis: recent advances through randomised trials

    NARCIS (Netherlands)

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

    2017-01-01

    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

  6. 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.

  7. Is the randomised controlled trial the best?

    African Journals Online (AJOL)

    process that show no benefit are acknowledged and then ignored. Randomisation in RCTs can be tampered with; patients may not simply be allocated into treatment or nontreatment by opening a sealed letter or allocation of a randomly generated computer number as they randomly walk in, but may be allocated into ...

  8. 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

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

    Directory of Open Access Journals (Sweden)

    Christiane Dolecek

    2008-05-01

    Full Text Available Drug resistant typhoid fever is a major clinical problem globally. Many of the first line antibiotics, including the older generation fluoroquinolones, ciprofloxacin and ofloxacin, are failing.We performed a randomised controlled trial to compare the efficacy and safety of gatifloxacin (10 mg/kg/day versus azithromycin (20 mg/kg/day as a once daily oral dose for 7 days for the treatment of uncomplicated typhoid fever in children and adults in Vietnam.An open-label multi-centre randomised trial with pre-specified per protocol analysis and intention to treat analysis was conducted. The primary outcome was fever clearance time, the secondary outcome was overall treatment failure (clinical or microbiological failure, development of typhoid fever-related complications, relapse or faecal carriage of S. typhi.We enrolled 358 children and adults with suspected typhoid fever. There was no death in the study. 287 patients had blood culture confirmed typhoid fever, 145 patients received gatifloxacin and 142 patients received azithromycin. The median FCT was 106 hours in both treatment arms (95% Confidence Interval [CI]; 94-118 hours for gatifloxacin versus 88-112 hours for azithromycin, (logrank test p = 0.984, HR [95% CI] = 1.0 [0.80-1.26]. Overall treatment failure occurred in 13/145 (9% patients in the gatifloxacin group and 13/140 (9.3% patients in the azithromycin group, (logrank test p = 0.854, HR [95% CI] = 0.93 [0.43-2.0]. 96% (254/263 of the Salmonella enterica serovar Typhi isolates were resistant to nalidixic acid and 58% (153/263 were multidrug resistant.Both antibiotics showed an excellent efficacy and safety profile. Both gatifloxacin and azithromycin can be recommended for the treatment of typhoid fever particularly in regions with high rates of multidrug and nalidixic acid resistance. The cost of a 7-day treatment course of gatifloxacin is approximately one third of the cost of azithromycin in Vietnam.Controlled-Trials.com ISRCTN67946944.

  10. 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

  11. 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

  12. Study protocol for a randomised pragmatic trial comparing the clinical and cost effectiveness of lithium and quetiapine augmentation in treatment resistant depression (the LQD study).

    Science.gov (United States)

    Marwood, L; Taylor, R; Goldsmith, K; Romeo, R; Holland, R; Pickles, A; Hutchinson, J; Dietch, D; Cipriani, A; Nair, R; Attenburrow, M-J; Young, A H; Geddes, J; McAllister-Williams, R H; Cleare, A J

    2017-06-26

    Approximately 30-50% of patients with major depressive disorder can be classed as treatment resistant, widely defined as a failure to respond to two or more adequate trials of antidepressants in the current episode. Treatment resistant depression is associated with a poorer prognosis and higher mortality rates. One treatment option is to augment an existing antidepressant with a second agent. Lithium and the atypical antipsychotic quetiapine are two such add-on therapies and are currently recommended as first line options for treatment resistant depression. However, whilst neither treatment has been established as superior to the other in short-term studies, they have yet to be compared head-to-head in longer term studies, or with a superiority design in this patient group. The Lithium versus Quetiapine in Depression (LQD) study is a parallel group, multi-centre, pragmatic, open-label, patient randomised clinical trial designed to address this gap in knowledge. The study will compare the clinical and cost effectiveness of the decision to prescribe lithium or quetiapine add-on therapy to antidepressant medication for patients with treatment resistant depression. Patients will be randomised 1:1 and followed up over 12 months, with the hypothesis being that quetiapine will be superior to lithium. The primary outcomes will be: (1) time to all-cause treatment discontinuation over one year, and (2) self-rated depression symptoms rated weekly for one year via the Quick Inventory of Depressive Symptomatology. Other outcomes will include between group differences in response and remission rates, quality of life, social functioning, cost-effectiveness and the frequency of serious adverse events and side effects. The trial aims to help shape the treatment pathway for patients with treatment resistant depression, by determining whether the decision to prescribe quetiapine is superior to lithium. Strengths of the study include its pragmatic superiority design, broad inclusion

  13. Randomised controlled trial of a 12 week yoga intervention on negative affective states, cardiovascular and cognitive function in post-cardiac rehabilitation patients.

    Science.gov (United States)

    Yeung, Alan; Kiat, Hosen; Denniss, A Robert; Cheema, Birinder S; Bensoussan, Alan; Machliss, Bianca; Colagiuri, Ben; Chang, Dennis

    2014-10-24

    Negative affective states such as anxiety, depression and stress are significant risk factors for cardiovascular disease, particularly in cardiac and post-cardiac rehabilitation populations.Yoga is a balanced practice of physical exercise, breathing control and meditation that can reduce psychosocial symptoms as well as improve cardiovascular and cognitive function. It has the potential to positively affect multiple disease pathways and may prove to be a practical adjunct to cardiac rehabilitation in further reducing cardiac risk factors as well as improving self-efficacy and post-cardiac rehabilitation adherence to healthy lifestyle behaviours. This is a parallel arm, multi-centre, randomised controlled trial that will assess the outcomes of post- phase 2 cardiac rehabilitation patients assigned to a yoga intervention in comparison to a no-treatment wait-list control group. Participants randomised to the yoga group will engage in a 12 week yoga program comprising of two group based sessions and one self-administered home session each week. Group based sessions will be led by an experienced yoga instructor. This will involve teaching beginner students a hatha yoga sequence that incorporates asana (poses and postures), pranayama (breathing control) and meditation. The primary outcomes of this study are negative affective states of anxiety, depression and stress assessed using the Depression Anxiety Stress Scale. Secondary outcomes include measures of quality of life, and cardiovascular and cognitive function. The cardiovascular outcomes will include blood pressure, heart rate, heart rate variability, pulse wave velocity, carotid intima media thickness measurements, lipid/glucose profiles and C-reactive protein assays. Assessments will be conducted prior to (week 0), mid-way through (week 6) and following the intervention period (week 12) as well as at a four week follow-up (week 16). This study will determine the effect of yoga practice on negative affective states

  14. Epirubicin dose and sequential hormonal therapy-Mature results of the HMFEC randomised phase III trial in premenopausal patients with node positive early breast cancer.

    Science.gov (United States)

    Coombes, R C; Kilburn, L S; Tubiana-Mathieu, N; Olmos, T; Van Bochove, A; Perez-Lopez, F R; Palmieri, C; Stebbing, J; Bliss, J M

    2016-06-01

    The hormonal manipulation 5-Fluoro-uracil Epirubicin Cyclophosphamide (HMFEC) trial was developed at a time of uncertainty around the dose intensity of chemotherapy given to premenopausal patients with node positive breast cancer and to the benefits of tailored endocrine therapy in such patients. HMFEC was a multi-centre, phase III, open label, randomised controlled trial with a 2 × 2 factorial design. Eligible patients were premenopausal with node positive early breast cancer; significant cardiac disease or uncontrolled hypertension was exclusion criterion. Patients were allocated to receive either eight cycles of FE50C or FE75C (given 3 weekly) with or without hormone manipulation (HM; tamoxifen or luteinising hormone releasing hormone (LHRH) agonists according to residual hormone levels at the end of chemotherapy) irrespective of ER status. The primary end-point was disease free survival (DFS). Principal analyses were by intention to treat (ITT); however, to reflect contemporary practice, subgroup analyses according to ER status were also conducted. The mature follow-up now available from this modest sized trial enables presentation of definitive results. Between 1992 and 2000 a total of 785 patients were randomised into the HMFEC trial (203 FE50C-HM, 191 FE50C+HM, 198 FE75C-HM, 193 FE75C+HM). At a median follow-up of 7.4 years, 245 DFS events have been reported (92 ER-, 153 ER+/unknown). The effects on DFS were not statistically significantly different according to epirubicin dose (hazard ratio [HR] = 0.82, 95% confidence interval [CI] 0.63-1.06; p = 0.13 FE75C versus FE50C); however, FE75C appeared to induce more alopecia and neutropenia. No statistically significant evidence was observed to support an improvement in DFS in patients allocated HM either overall (HR = 0.88, 95% CI 0.68-1.13; p = 0.32) or in patients with ER+/unknown disease (HR = 0.85, 95% CI 0.62-1.17; p = 0.32) although effect sizes are consistent with worthwhile clinical

  15. 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

  16. Induction of labour versus expectant monitoring for gestational hypertension or mild pre-eclampsia between 34 and 37 weeks' gestation (HYPITAT-II: a multicentre, open-label randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Sporken Jan M J

    2011-07-01

    Full Text Available Abstract Background Gestational hypertension (GH and pre-eclampsia (PE can result in severe complications such as eclampsia, placental abruption, syndrome of Hemolysis, Elevated Liver enzymes and Low Platelets (HELLP and ultimately even neonatal or maternal death. We recently showed that in women with GH or mild PE at term induction of labour reduces both high risk situations for mothers as well as the caesarean section rate. In view of this knowledge, one can raise the question whether women with severe hypertension, pre-eclampsia or deterioration chronic hypertension between 34 and 37 weeks of gestation should be delivered or monitored expectantly. Induction of labour might prevent maternal complications. However, induction of labour in late pre-term pregnancy might increase neonatal morbidity and mortality compared with delivery at term. Methods/Design Pregnant women with severe gestational hypertension, mild pre-eclampsia or deteriorating chronic hypertension at a gestational age between 34+0 and 36+6 weeks will be asked to participate in a multi-centre randomised controlled trial. Women will be randomised to either induction of labour or expectant monitoring. In the expectant monitoring arm, women will be induced only when the maternal or fetal condition detoriates or at 37+0 weeks of gestation. The primary outcome measure is a composite endpoint of maternal mortality, severe maternal complications (eclampsia, HELLP syndrome, pulmonary oedema and thromboembolic disease and progression to severe pre-eclampsia. Secondary outcomes measures are respiratory distress syndrome (RDS, neonatal morbidity and mortality, caesarean section and vaginal instrumental delivery rates, maternal quality of life and costs. Analysis will be intention to treat. The power calculation is based on an expectant reduction of the maternal composite endpoint from 5% to 1% for an expected increase in neonatal RDS from 1% at 37 weeks to 10% at 34 weeks. This implies that

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

    Directory of Open Access Journals (Sweden)

    Wilson Edward CF

    2010-05-01

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

  18. 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.

  19. 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.

  20. 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

  1. 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

    2013-12-03

    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. 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. 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. 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. 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 Chi(2) and I(2) statistics. For main trials that hosted retention trials, we extracted data on disease area, intervention, population, healthcare setting, sequence generation and allocation concealment. We identified 38 eligible retention trials. Included trials evaluated six broad types of strategies to improve retention. These were incentives, communication strategies, new questionnaire format, participant case

  2. Observer bias in randomised clinical trials with binary outcomes

    DEFF Research Database (Denmark)

    Hróbjartsson, Asbjørn; Thomsen, Ann Sofia Skou; Emanuelsson, Frida

    2012-01-01

    To evaluate the impact of non-blinded outcome assessment on estimated treatment effects in randomised clinical trials with binary outcomes.......To evaluate the impact of non-blinded outcome assessment on estimated treatment effects in randomised clinical trials with binary outcomes....

  3. a randomised trial comparing Foley catheter plus titrated oral ...

    African Journals Online (AJOL)

    Labour induction at term - a randomised trial comparing. Foley catheter plus titrated oral misoprostol solution, titrated oral misoprostol solution alone, and dinoprostone. Baron B Matonhodze, G Justus Hofmeyr, Jonathan Levin. Objectives. To compare three methods of labour induction. Design. Randomised controlled trial.

  4. 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

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

    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

  6. 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

  7. 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

  8. Análisis de la eficacia del portero de fútbol cadete (14 a 16 años [Analysis of the Effectiveness of Under-16 Football Goalkeepers

    Directory of Open Access Journals (Sweden)

    Daniel Lapresa Ajamil

    2018-01-01

    Full Text Available En comparación con el interés que despierta el análisis del juego de fútbol, hasta fechas muy recientes ha sido poco habitual la presencia de trabajos científicos centrados en el desempeño específico del portero y, en menor medida, del portero de fútbol base. Este trabajo utiliza metodología observacional para analizar la eficacia del comportamiento técnico-táctico del portero de fútbol de categoría cadete (14-16 años, concretamente de equipos participantes en un torneo disputado por equipos filiales de 1ª división. Se ha diseñado un instrumento de observación ad hoc, que se ha introducido en el software Lince, registrándose las secuencias en las que interviene el portero. Tras realizarse una primera aproximación al estudio de las acciones técnicas efectuadas y de la consecuencia obtenida, mediante un análisis de búsqueda de relación asociativa entre variables categóricas, se ha procedido a la detección de patrones temporales ocultos, a través del software Theme, que han permitido tipificar acciones técnico-tácticas defensivas y ofensivas, eficaces e ineficaces. Las conclusiones obtenidas permiten elevar recomendaciones prácticas para el diseño de tareas concretas de entrenamiento tanto para acciones técnicas defensivas –blocaje en colocación y salida, y acciones de juego aéreo y estiradas– como para acciones técnicas ofensivas –inicio o continuación de la fase ofensiva mediante saque a balón parado, saque con el balón en movimiento y control más pase–.

  9. [Mendelian randomisation - a genetic approach to an epidemiological method].

    Science.gov (United States)

    Stensrud, Mats Julius

    2016-06-01

    BACKGROUND Genetic information is becoming more easily available, and rapid progress is being made in developing methods of illuminating issues of interest. Mendelian randomisation makes it possible to study causes of disease using observational data. The name refers to the random distribution of gene variants in meiosis. The methodology makes use of genes that influence a risk factor for a disease, without influencing the disease itself. In this review article I explain the principles behind Mendelian randomisation and present the areas of application for this methodology.MATERIAL AND METHOD Methodology articles describing Mendelian randomisation were reviewed. The articles were found through a search in PubMed with the combination «mendelian randomization» OR «mendelian randomisation», and a search in McMaster Plus with the combination «mendelian randomization». A total of 15 methodology articles were read in full text. Methodology articles were supplemented by clinical studies found in the PubMed search.RESULTS In contrast to traditional observational studies, Mendelian randomisation studies are not affected by two important sources of error: conventional confounding variables and reverse causation. Mendelian randomisation is therefore a promising tool for studying causality. Mendelian randomisation studies have already provided valuable knowledge on the risk factors for a wide range of diseases. It is nevertheless important to be aware of the limitations of the methodology. As a result of the rapid developments in genetics research, Mendelian randomisation will probably be widely used in future years.INTERPRETATION If Mendelian randomisation studies are conducted correctly, they may help to reveal both modifiable and non-modifiable causes of disease.

  10. The NOURISHED randomised controlled trial comparing mentalisation-based treatment for eating disorders (MBT-ED) with specialist supportive clinical management (SSCM-ED) for patients with eating disorders and symptoms of borderline personality disorder.

    Science.gov (United States)

    Robinson, Paul; Hellier, Jennifer; Barrett, Barbara; Barzdaitiene, Daiva; Bateman, Anthony; Bogaardt, Alexandra; Clare, Ajay; Somers, Nadia; O'Callaghan, Aine; Goldsmith, Kimberley; Kern, Nikola; Schmidt, Ulrike; Morando, Sara; Ouellet-Courtois, Catherine; Roberts, Alice; Skårderud, Finn; Fonagy, Peter

    2016-11-17

    In this multi-centre randomized controlled trial (RCT) we compared modified mentalisation-based treatment (MBT-ED) to specialist supportive clinical management (SSCM-ED) in patients with eating disorders (EDs) and borderline personality disorder symptoms (BPD). This group of patients presents complex challenges to clinical services, and a treatment which addresses their multiple problems has the potential to improve outcome. MBT has been shown to be effective in improving outcome in patients with BPD, but its use has not been reported in ED. Sixty-eight eligible participants were randomised to MBT-ED or SSCM-ED. The primary outcome measure was the global score on the Eating Disorder Examination. Secondary outcomes included measures of BPD symptoms (the Zanarini Rating Scale for Borderline Personality Disorder), general psychiatric state, quality of life and service utilisation. Participants were assessed at baseline and at 6, 12 and 18 months after randomisation. Analysis was performed using linear mixed models. Only 15 participants (22 %) completed the 18 month follow-up. Early drop-out occurred significantly more in the SSCM-ED group. Drop-out did not vary with treatment model later in therapy and was sometimes attributed to participants moving away. There was higher drop--out amongst smokers and those with higher neuroticism scores. 47.1 % of participants in the MBT-ED arm and 37.1 % in the SSCM-ED arm attended at least 50 % of therapy sessions offered. Amongst those remaining in the trial, at 12 and 18 months MBT-ED was associated with a greater reduction in Shape Concern and Weight Concern in the Eating Disorder Examination compared to SSCM-ED. At 6, 12 and 18 months there was a decline of ED and BPD symptoms in both groups combined. Ten participants were reported as having had adverse events during the trial, mostly self-harm, and there was one death, attributed as 'unexplained' by the coroner. The high drop-out rate made interpretation of the results

  11. The effectiveness and cost-effectiveness of telephone triage of patients requesting same day consultations in general practice: study protocol for a cluster randomised controlled trial comparing nurse-led and GP-led management systems (ESTEEM)

    Science.gov (United States)

    2013-01-01

    Background Recent years have seen an increase in primary care workload, especially following the introduction of a new General Medical Services contract in 2004. Telephone triage and telephone consultation with patients seeking health care represent initiatives aimed at improving access to care. Some evidence suggests that such approaches may be feasible but conclusions regarding GP workload, cost, and patients’ experience of care, safety, and health status are equivocal. The ESTEEM trial aims to assess the clinical- and cost-effectiveness of nurse-led computer-supported telephone triage and GP-led telephone triage, compared to usual care, for patients requesting same-day consultations in general practice. Methods/design ESTEEM is a pragmatic, multi-centre cluster randomised clinical trial with patients randomised at practice level to usual care, computer decision-supported nurse triage, or GP-led triage. Following triage of 350–550 patients per practice we anticipate estimating and comparing total primary care workload (volume and time), the economic cost to the NHS, and patient experience of care, safety, and health status in the 4-week period following the index same-day consultation request across the three trial conditions. We will recruit all patients seeking a non-emergency same-day appointment in primary care. Patients aged 12.0–15.9 years and temporary residents will be excluded from the study. The primary outcome is the number of healthcare contacts taking place in the 4-week period following (and including) the index same-day consultation request. A range of secondary outcomes will be examined including patient flow, primary care NHS resource use, patients’ experience of care, safety, and health status. The estimated sample size required is 3,751 patients (11,253 total) in each of the three trial conditions, to detect a mean difference of 0.36 consultations per patient in the four week follow-up period between either intervention group and usual

  12. 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

  13. 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

  14. 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

  15. 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

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

    NARCIS (Netherlands)

    Custers, Inge M.; Flierman, Paul A.; Maas, Pettie; Cox, Tessa; van Dessel, Thierry J. H. M.; Gerards, Mariette H.; Mochtar, Monique H.; Janssen, Catharina A. H.; van der Veen, Fulco; Mol, Ben Willem J.

    2009-01-01

    Objective To evaluate the effectiveness of 15 minutes of immobilisation versus immediate mobilisation after intrauterine insemination. Design Randomised controlled trial. Setting One academic teaching hospital and six non-academic teaching hospitals. Participants Women having intrauterine

  17. Randomised control trial on immediate post-operative outcomes on ...

    African Journals Online (AJOL)

    Randomised control trial on immediate post-operative outcomes on patients done either closure or non-closure of peritoneum at caesarean delivery at the Kenyatta national hospital. M Mutua, JG Wanyoike, N Kihara, JB Oyieke ...

  18. 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

  19. Alcohol intake and cardiovascular risk factors: A Mendelian randomisation study

    OpenAIRE

    Cho, Yoonsu; Shin, So-Youn; Won, Sungho; Relton, Caroline L; Davey Smith, George; Shin, Min-Jeong

    2015-01-01

    Mendelian randomisation studies from Asia suggest detrimental influences of alcohol on cardiovascular risk factors, but such associations are observed mainly in men. The absence of associations of genetic variants (e.g. rs671 in ALDH2) with such risk factors in women - who drank little in these populations - provides evidence that the observations are not due to genetic pleiotropy. Here, we present a Mendelian randomisation study in a South Korean population (3,365 men and 3,787 women) that 1...

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

    OpenAIRE

    Walker, Dilys; Gutierrez, Juan Pablo; Torres, Pilar; Bertozzi, Stefano M

    2006-01-01

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

  1. 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

  2. Pressure relieving support surfaces: a randomised evaluation.

    Science.gov (United States)

    Nixon, J; Nelson, E A; Cranny, G; Iglesias, C P; Hawkins, K; Cullum, N A; Phillips, A; Spilsbury, K; Torgerson, D J; Mason, S

    2006-07-01

    To determine differences between alternating pressure overlays and alternating pressure replacement mattresses with respect to the development of new pressure ulcers, healing of existing pressure ulcers, patient acceptability and cost-effectiveness of the different pressure-relieving surfaces. Also to investigate the specific additional impact of pressure ulcers on patients' well-being. A multicentre, randomised, controlled, open, fixed sample, parallel-group trial with equal randomisation was undertaken. The trial used remote, concealed allocation and intention-to-treat (ITT) analysis. The main trial design was supplemented with a qualitative study involving a purposive sample of 20-30 patients who developed pressure ulcers, to assess the impact of the pressure ulcers on their well-being. In addition, a focus group interview was carried out with clinical research nurses, who participated in the PRESSURE (Pressure RElieving Support SUrfaces: a Randomised Evaluation) Trial, to explore the experiences of their role and observations of pressure area care. The study took place in 11 hospital-based research centres within six NHS trusts in England. Acute and elective patients aged 55 years or older and admitted to vascular, orthopaedic, medical or care of the elderly wards in the previous 24 hours were investigated. Patients were randomised to either an alternating pressure overlay or an alternating pressure mattress replacement, with mattress specifications clearly defined to enable the inclusion of centres using products from different manufacturers, and to exclude hybrid mattress systems (which either combine foam or constant low pressure with alternating pressure in one mattress, or can be used as either an overlay or a replacement mattress). Development of a new pressure ulcer (grade pressures ulcers, patient acceptability and cost-effectiveness. In total, 6155 patients were assessed for eligibility to the trial and 1972 were randomised: 990 to the alternating

  3. Mendelian randomisation in cardiovascular research: an introduction for clinicians.

    Science.gov (United States)

    Bennett, Derrick A; Holmes, Michael V

    2017-09-01

    Understanding the causal role of biomarkers in cardiovascular and other diseases is crucial in order to find effective approaches (including pharmacological therapies) for disease treatment and prevention. Classical observational studies provide naïve estimates of the likely role of biomarkers in disease development; however, such studies are prone to bias. This has direct relevance for drug development as if drug targets track to non-causal biomarkers, this can lead to expensive failure of these drugs in phase III randomised controlled trials. In an effort to provide a more reliable indication of the likely causal role of a biomarker in the development of disease, Mendelian randomisation studies are increasingly used, and this is facilitated by the availability of large-scale genetic data. We conducted a narrative review in order to provide a description of the utility of Mendelian randomisation for clinicians engaged in cardiovascular research. We describe the rationale and provide a basic description of the methods and potential limitations of Mendelian randomisation. We give examples from the literature where Mendelian randomisation has provided pivotal information for drug discovery including predicting efficacy, informing on target-mediated adverse effects and providing potential new evidence for drug repurposing. The variety of the examples presented illustrates the importance of Mendelian randomisation in order to prioritise drug targets for cardiovascular research. © 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.

  4. El componente de internacionalización del programa de Maestría en Gestión Logística de la Escuela Naval de Cadetes “Almirante Padilla” y su impacto en el sector marítimo y portuario de Cartagena

    OpenAIRE

    Claudia Margarita Ahumada Klelers; Martha Peña Pertuz

    2017-01-01

    Resumen Al determinar el componente de internacionaliza­ción que el programa de Maestría de Gestión Lo­gística de la Escuela Naval de Cadetes “Almirante Padilla”, debe cumplir para lograr un impacto sig­nificativo de sus egresados en el sector marítimo y portuario de Cartagena, se establece el proceso nece­sario para demarcar estándares e indicadores que de­ben ser parte de este programa, fundamentado en la búsqueda de un proceso de acreditación institucio­nal. Aquí, se destaca el desarrol...

  5. 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

  6. 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 trial if asked, there was little difference in response following the campaign ['yes' 31.3% (28.4, 34.1) prior; 30.4% (27.6, 33.2) following; difference =-0.9%; 95% CI for difference -4.8, 3.1%; P= 0.92]. CONCLUSIONS It is possible to raise public

  7. 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...

  8. A randomised comparison of cognitive behavioural therapy

    Directory of Open Access Journals (Sweden)

    Carlijn de Roos

    2011-04-01

    Full Text Available Background : Building on previous research with disaster-exposed children and adolescents, a randomised clinical trial was performed in the treatment of trauma-related symptoms. In the current study two active treatments were compared among children in a broad age range and from a wide diversity of ethnic populations. Objective : The primary aim was to compare the effectiveness and efficiency of Cognitive Behavioural Therapy (CBT and Eye Movement Desensitisation and Reprocessing (EMDR. Design : Children (n=52, aged 4–18 were randomly allocated to either CBT (n=26 or EMDR (n=26 in a disaster mental health after-care setting after an explosion of a fireworks factory. All children received up to four individual treatment sessions over a 4–8 week period along with up to four sessions of parent guidance. Blind assessment took place pre- and post-treatment and at 3 months follow-up on a variety of parent-rated and self-report measures of post-traumatic stress disorder symptomatology, depression, anxiety, and behaviour problems. Analyses of variance (general linear model repeated measures were conducted on the intention-to-treat sample and the completers. Results : Both treatment approaches produced significant reductions on all measures and results were maintained at follow-up. Treatment gains of EMDR were reached in fewer sessions. Conclusion : Standardised CBT and EMDR interventions can significantly improve functioning of disaster-exposed children.For the abstract in other languages, please see Supplementary files under Reading Tools online

  9. Mechanisms and direction of allocation bias in randomised clinical trials

    DEFF Research Database (Denmark)

    Paludan-Müller, Asger; Teindl Laursen, David Ruben; Hróbjartsson, A.

    2016-01-01

    Background: Selective allocation of patients into the compared groups of a randomised trial may cause allocation bias, but the mechanisms behind the bias and its directionality are incompletely understood. We therefore analysed the mechanisms and directionality of allocation bias in randomised...... the mechanisms of allocation bias and hypothesised which main factors predicts its direction. Results: Three empirical studies addressed motives/methods for deciphering allocation sequences. Main motives included ensuring best care for patients and ensuring best outcome for the trial. Main methods included...... various manipulations with randomisation envelopes. Out of 57 methods publications 11 (19 %) mentioned explicitly that allocation bias can go in either direction. We hypothesised that the direction of allocation bias is mainly decided by the interaction between the patient allocators’ motives...

  10. CONSORT 2010 statement: extension to randomised pilot and feasibility trials.

    Science.gov (United States)

    Eldridge, Sandra M; Chan, Claire L; Campbell, Michael J; Bond, Christine M; Hopewell, Sally; Thabane, Lehana; Lancaster, Gillian A

    2016-01-01

    The Consolidated Standards of Reporting Trials (CONSORT) statement is a guideline designed to improve the transparency and quality of the reporting of randomised controlled trials (RCTs). In this article we present an extension to that statement for randomised pilot and feasibility trials conducted in advance of a future definitive RCT. The checklist applies to any randomised study in which a future definitive RCT, or part of it, is conducted on a smaller scale, regardless of its design (eg, cluster, factorial, crossover) or the terms used by authors to describe the study (eg, pilot, feasibility, trial, study). The extension does not directly apply to internal pilot studies built into the design of a main trial, non-randomised pilot and feasibility studies, or phase II studies, but these studies all have some similarities to randomised pilot and feasibility studies and so many of the principles might also apply. The development of the extension was motivated by the growing number of studies described as feasibility or pilot studies and by research that has identified weaknesses in their reporting and conduct. We followed recommended good practice to develop the extension, including carrying out a Delphi survey, holding a consensus meeting and research team meetings, and piloting the checklist. The aims and objectives of pilot and feasibility randomised studies differ from those of other randomised trials. Consequently, although much of the information to be reported in these trials is similar to those in randomised controlled trials (RCTs) assessing effectiveness and efficacy, there are some key differences in the type of information and in the appropriate interpretation of standard CONSORT reporting items. We have retained some of the original CONSORT statement items, but most have been adapted, some removed, and new items added. The new items cover how participants were identified and consent obtained; if applicable, the prespecified criteria used to judge

  11. The SafeBoosC Phase II Randomised Clinical Trial

    DEFF Research Database (Denmark)

    Pellicer, Adelina; Greisen, Gorm; Benders, Manon

    2013-01-01

    . The treatment guideline is presented to assist neonatologists in making decisions in relation to cerebral oximetry readings in preterm infants within the SafeBoosC phase II randomised clinical trial. The evidence grades were relatively low and the guideline cannot be recommended outside a research setting......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...

  12. Reported challenges in nurse-led randomised controlled trials

    DEFF Research Database (Denmark)

    Wang Vedelø, Tina; Lomborg, Kirsten

    2011-01-01

    , nursing research, nursing, research, challenges, barriers, nurse's role, nurse attitude, attitude of health personnel. Findings: The literature on reported challenges and barriers between 1999 and 2009 showed that the most often experienced problems were (i) sufficient patient recruitment, (ii...... 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.......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...

  13. A randomised trial comparing laparoscopy with laparotomy in the ...

    African Journals Online (AJOL)

    A randomised trial comparing laparoscopy with laparotomy in the management of women with ruptured ectopic pregnancy. ... South African Medical Journal ... Ruptured ectopic pregnancy (REP) is a common gynaecological emergency in resource-poor settings, where laparotomy is the standard treatment despite ...

  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. Authenticity of instruction and student performance: a prospective randomised trial.

    NARCIS (Netherlands)

    Rochelle, J.S. La; Durning, S.J.; Pangaro, L.N.; Artino, A.R.; Vleuten, C.P.M. van der; Schuwirth, L.

    2011-01-01

    OBJECTIVES: This study aimed to investigate the relationship between the authenticity of instructional formats and outcome measures within a pre-clerkship clinical reasoning course. METHODS: We conducted a randomised, prospective, crossover study with Year 2 medical students taking a pre-clerkship

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

    NARCIS (Netherlands)

    Mourits, M. P.; van Kempen-Harteveld, M. L.; García, M. B.; Koppeschaar, H. P.; Tick, L.; Terwee, C. B.

    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

  18. 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

  19. Randomised trials in the South African Medical Journal, 1948- 1997 ...

    African Journals Online (AJOL)

    Objective. To describe randomised controlled trials (RCTs) published in the South African Medical Journal (SAMJ) over a 50-year period from 1948 to 1997 with regard to number, topic and quality. Methods. We hand searched all issues of the SAMJ published during the study period to identify all published RCTs. Outcome ...

  20. The maturation of randomised controlled trials in mental health

    African Journals Online (AJOL)

    Adele

    2004-05-20

    May 20, 2004 ... work for Mental Health.7 It is based upon a foundation of supporting ... 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 ... The question of consent may be a particular difficulty in men- tal health trials ...

  1. Outcomes in a Randomised Controlled Trial of Mathematics Tutoring

    Science.gov (United States)

    Topping, K. J.; Miller, D.; Murray, P.; Henderson, S.; Fortuna, C.; Conlin, N.

    2011-01-01

    Background: Large-scale randomised controlled trials (RCT) are relatively rare in education. The present study was an attempt to scale up previous small peer tutoring projects, while investing only modestly in continuing professional development for teachers. Purpose: A two-year RCT of peer tutoring in mathematics was undertaken in one local…

  2. Education and coronary heart disease : Mendelian randomisation study

    NARCIS (Netherlands)

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

    2017-01-01

    Objective To determine whether educational attainment is a causal risk factor in the development of coronary heart disease. Design Mendelian randomisation study, using genetic data as proxies for education to minimise confounding. Setting The main analysis used genetic data from two large consortia

  3. 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/

  4. 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

  5. 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.

    Science.gov (United States)

    Garnett, Sarah P; Baur, Louise A; Noakes, Manny; Steinbeck, Katharine; Woodhead, Helen J; Burrell, Susie; Chisholm, Kerryn; Broderick, Carolyn R; Parker, Robert; De, Sukanya; Shrinivasan, Shubha; Hopley, Lori; Hendrie, Gilly; Ambler, Geoffrey R; Kohn, Michael R; Cowell, Chris T

    2010-09-25

    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. 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. Clinical insulin resistance and prediabetes in the paediatric population are rapidly emerging clinical problems with serious health outcomes. With appropriate management these conditions are potentially reversible or at

  6. 26 Protocol for the upcoming study: patient input monitoring of pain in the emergency room: novel electronic log (PIMPERNEL): a randomised controlled trial of an electronic pain score display in adults in the emergency department.

    Science.gov (United States)

    Thornton, Hilary; Coats, Timothy

    2017-12-01

    Patient surveys and research have shown that Emergency Department attendees do not receive adequate analgesia. Pain monitoring has not been automated and usually involves a member of staff asking the patient to rate their score with no continuous record, often no specific place to record it and no automated alarm system for scores outside accepted parameters. Few patients have regular monitoring of their pain and our own preliminary research showed that over one week only 58% of patients with moderate to severe pain had a second or subsequent score recorded. A small pain monitoring display has been developed at the University of Leicester and acts as an electronic version of the 11 point numerical rating scale. Data are transmitted to a tablet through a wireless connexion. PIMPERNEL (Patient Input Monitoring of Pain in the Emergency Room: Novel Electronic Log) is a feasibility study testing this for the first time. The primary objective is to determine the feasibility of studying the effect of an electronic pain monitoring display on the pain experienced by emergency care patients. Secondary objectives include determining whether patients use the display, whether pain ratings correlate with routine records, how pain changes over time, whether patients use the display for reasons other than pain, which potential stratification factors may be useful for a subsequent multi-centre study and whether analgesia prescription changes. We will also obtain patient and staff feedback. Adults, initial pain score 5 or more, likely to be staying for at least 2 hours, able to consent and understand English. We aim to recruit 200 patients (100 per arm) from the emergency department at Leicester Royal Infirmary. All patients will use the display. This is a parallel group, two arm superiority trial with a 1:1 allocation ratio. Patients will be randomised to have their pain score on display (intervention) or hidden (control). Blinding is not possible. The display beeps every 15

  7. 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

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

    DEFF Research Database (Denmark)

    Kristensen, Kristian

    2010-01-01

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

  9. Aspirin for Venous Ulcers: Randomised Trial (AVURT): study protocol for a randomised controlled trial.

    Science.gov (United States)

    Tilbrook, Helen; Forsythe, Rachael O; Rolfe, Debbie; Clark, Laura; Bland, Martin; Buckley, Hannah; Chetter, Ian; Cook, Liz; Dumville, Jo; Gabe, Rhian; Harding, Keith; Layton, Alison; Lindsay, Ellie; McDaid, Catriona; Moffatt, Christine; Phillips, Ceri; Stansby, Gerard; Vowden, Peter; Williams, Laurie; Torgerson, David; Hinchliffe, Robert J

    2015-11-10

    Venous leg ulcers (VLUs) are the commonest cause of leg ulceration, affecting 1 in 100 adults. There is a significant health burden associated with VLUs - it is estimated that the cost of treatment for 1 ulcer is up to £1300 per year in the NHS. The mainstay of treatment is with graduated compression bandaging; however, treatment is often prolonged and up to one quarter of venous leg ulcers do not heal despite standard care. Two previous trials have suggested that low-dose aspirin, as an adjunct to standard care, may hasten healing, but these trials were small and of poor quality. Aspirin is an inexpensive, widely used medication but its safety and efficacy in the treatment of VLUs remains to be established. AVURT is a phase II randomised double blind, parallel-group, placebo-controlled efficacy trial. The primary objective is to examine whether aspirin, in addition to standard care, is effective in patients with chronic VLUs (i.e. over 6 weeks in duration or a history of VLU). Secondary objectives include feasibility and safety of aspirin in this population. A target of 100 participants, identified from community leg ulcer clinics and hospital clinics, will be randomised to receive either 300 mg of aspirin once daily or placebo. All participants will receive standard care with compression therapy. The primary outcome will be time to healing of the reference ulcer. Follow-up will occur for a maximum of 27 weeks. The primary analysis will use a Cox proportional hazards model to compare time to healing using the principles of intention-to-treat. Secondary outcomes will include ulcer size, pain evaluation, compliance and adverse events. The AVURT trial will investigate the efficacy and safety of aspirin as a treatment for VLU and will inform on the feasibility of proceeding to a larger phase III study. This study will address the paucity of information currently available regarding aspirin therapy to treat VLU. The study is registered on a public database with

  10. Specific barriers to the conduct of randomised clinical trials on medical devices

    DEFF Research Database (Denmark)

    Neugebauer, Edmund A M; Rath, Ana; Antoine, Sunya-Lee

    2017-01-01

    that the classical evidence hierarchy cannot be applied for medical devices, as randomised clinical trials are impossible to perform. This article aims to identify the barriers for randomised clinical trials on medical devices. METHODS: Systematic literature searches without meta-analysis and internal European...... of scientific advice, regulations and transparency. CONCLUSIONS: The present review offers potential solutions to break down the barriers identified, and argues for applying the randomised clinical trial design when assessing the benefits and harms of medical devices....

  11. Observer bias in randomised clinical trials with binary outcomes

    DEFF Research Database (Denmark)

    Hróbjartsson, Asbjørn; Thomsen, Ann Sofia Skou; Emanuelsson, Frida

    2012-01-01

    with inverse variance random effects meta-analysis and explored reasons for variation in ratios of odds ratios with meta-regression. We also analysed rates of agreement between blinded and non-blinded assessors and calculated the number of patients needed to be reclassified to neutralise any bias. DATA SOURCES......: PubMed, Embase, PsycINFO, CINAHL, Cochrane Central Register of Controlled Trials, HighWire Press, and Google Scholar. ELIGIBILITY CRITERIA FOR SELECTING STUDIES: Randomised clinical trials with blinded and non-blinded assessment of the same binary outcome. RESULTS: We included 21 trials in the main...... patients per trial (1-7%). CONCLUSIONS: On average, non-blinded assessors of subjective binary outcomes generated substantially biased effect estimates in randomised clinical trials, exaggerating odds ratios by 36%. This bias was compatible with a high rate of agreement between blinded and non...

  12. A protocol for a systematic review of non-randomised evaluations of strategies to increase participant retention to randomised controlled trials.

    Science.gov (United States)

    El Feky, Adel; Gillies, Katie; Gardner, Heidi; Fraser, Cynthia; Treweek, Shaun

    2018-02-20

    Randomised control trials are regarded as the gold standard for evaluating the effectiveness and efficacy of healthcare interventions with thousands of trials published every year. Despite significant investment in infrastructure, a staggering number of clinical trials continue to face challenges with retention. Dropouts could lead to negative consequences-from lengthy delays to missing data that can undermine the results and integrity of the trial. Summarising evidence from non-randomised evaluations of retention strategies could provide complementary information to randomised evaluations that could guide trialists to the most effective ways of increasing retention of participants in clinical trials. The following electronic databases will be searched for relevant studies: EMBASE, MEDLINE, the Cochrane Controlled Trials Register, and Cochrane Methodology Register and the search will be limited to English-published studies during the last 10 years to increase relevance to current trials. Non-randomised studies (observational studies) including a comparison of two or more strategies to increase participant retention in randomised trials or comparing one or more strategies with no strategy will be included. The primary outcome will be the proportion of participants remained at the primary analysis as determined in each retention study. This review aims to gather and evaluate evidence on the effect of retention strategies examined in non-randomised studies. It is imperative to collect evidence from obseravational studies to infer whether or not these studies could be considered a practical way to complement or even replace a broadly favourable randomised design. If we find that non-randomised studies to be included in this review are of high quality with adequate control of biases, we will recommend to trialists and others not to rely exclusively on randomised studies and to give meticulous attention to the plentiful evidence that can be obtained from non-randomised

  13. Can unequal be more fair? Ethics, subject allocation, and randomised clinical trials.

    Science.gov (United States)

    Avins, A L

    1998-12-01

    Randomised clinical trials provide the most valid means of establishing the efficacy of clinical therapeutics. Ethical standards dictate that patients and clinicians should not consent to randomisation unless there is uncertainty about whether any of the treatment options is superior to the others ("equipoise"). However, true equipoise is rarely present; most randomised trials, therefore, present challenging ethical dilemmas. Minimising the tension between science and ethics is an obligation of investigators and clinicians. This article briefly reviews several techniques for addressing this issue and suggests that unbalanced randomisation, a technique rarely employed in current clinical trial practice, may be useful for enhancing the ethical design of human experimentation.

  14. Telemedicine in dermatology: a randomised controlled trial.

    Science.gov (United States)

    Bowns, I R; Collins, K; Walters, S J; McDonagh, A J G

    2006-11-01

    To compare the clinical equivalence, patient and clinician opinion of store-and-forward (SF) teledermatology with conventional face-to-face consultation in setting a management plan for new, adult outpatient referrals. To assess the equivalence of digital photography and dermoscopy with conventional face-to-face consultation in the management of suspected cases of malignant melanoma or squamous cell carcinoma. For the SF teledermatology aspect of the study, a prospective randomised controlled trial was carried out. Eight general practices and a hospital dermatology department in Sheffield, England. For the SF teledermatology part of the study, adults (aged 16 years and over) requiring a new (not seen by a hospital dermatologist within the past year) consultant opinion. For the digital photography element of the study, adults (aged 16 years and over) requiring a consultant opinion due to suspicion of malignant melanoma or squamous cell carcinoma. Patients in the telemedicine intervention group were referred to the consultant, and managed as far as possible using one or more digital still images and a structured, electronic referral and reply. The control group was managed by conventional hospital outpatient consultation. Patients referred to the 2-week wait clinic were invited to have a series of digital photographs, with and without dermoscopy, immediately before their face-to-face consultation. A second consultant viewed these and outlined a diagnosis and management plan which was compared with the actual management. Both were compared with the definitive diagnosis (either the final clinical or histological diagnosis, where undertaken). The concordance between the consultant who had managed the case and an independent consultant who gave a second face-to-face opinion. A total of 208 patients were recruited. There was also a greater loss of control cases (26%) than intervention cases (17%). A statistically significant difference in ages between the two groups

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

    Science.gov (United States)

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

    2016-09-10

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

  16. Randomised trial of sidecar crib use on breastfeeding duration (NECOT).

    Science.gov (United States)

    Ball, Helen L; Ward-Platt, Martin P; Howel, Denise; Russell, Charlotte

    2011-07-01

    To determine whether the use of sidecar cribs on the postnatal ward affects breastfeeding duration. A randomised non-blinded parallel trial comparing sidecar cribs with standalone cots. Postnatal wards of the Royal Victoria Infirmary, Newcastle upon Tyne. 1204 pregnant women intending to breastfeed were recruited at 20 weeks' gestation and randomised at 34 weeks to use either a sidecar crib attached to their bed (n=601) or a standalone cot adjacent to their bed (n=603). Duration of any, and exclusive, breastfeeding up to 26 weeks obtained by telephone follow-up. 334 mothers were withdrawn or lost to follow-up from the trial; infant feeding data were therefore obtained for 870 mothers (433 intervention; 437 controls). Using an intention-to-treat Cox regression analysis, no significant difference was found between the two groups for duration of any breastfeeding (sidecar crib vs cot, hazard ratio (HR) 0.96, 95% CI 0.79 to 1.18), or exclusive breastfeeding (HR 0.99, 95% CI 0.85 to 1.16) adjusting for maternal age, education, previous breastfeeding and delivery type. Bed sharing was not significantly more common in mothers randomised to sidecar cribs (67% vs 64%, adjusted difference 2.8%, 95% CI -3.5% to 9.0%). There were no adverse events. The use of sidecar cribs for mothers and infants did not improve the duration of any or exclusive breastfeeding, or frequency of bed sharing at home.

  17. Mechanisms and direction of allocation bias in randomised clinical trials.

    Science.gov (United States)

    Paludan-Müller, Asger; Teindl Laursen, David Ruben; Hróbjartsson, Asbjørn

    2016-10-07

    Selective allocation of patients into the compared groups of a randomised trial may cause allocation bias, but the mechanisms behind the bias and its directionality are incompletely understood. We therefore analysed the mechanisms and directionality of allocation bias in randomised clinical trials. Two systematic reviews and a theoretical analysis. We conducted one systematic review of empirical studies of motives/methods for deciphering patient allocation sequences; and another review of methods publications commenting on allocation bias. We theoretically analysed the mechanisms of allocation bias and hypothesised which main factors predicts its direction. Three empirical studies addressed motives/methods for deciphering allocation sequences. Main motives included ensuring best care for patients and ensuring best outcome for the trial. Main methods included various manipulations with randomisation envelopes. Out of 57 methods publications 11 (19 %) mentioned explicitly that allocation bias can go in either direction. We hypothesised that the direction of allocation bias is mainly decided by the interaction between the patient allocators' motives and treatment preference. Inadequate allocation concealment may exaggerate treatment effects in some trials while underestimate effects in others. Our hypothesis provides a theoretical overview of the main factors responsible for the direction of allocation bias.

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

    DEFF Research Database (Denmark)

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

    2013-01-01

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

  19. [Multi-centre clinical assessment of the Russian language version of the Diagnostic Interview for Psychoses].

    Science.gov (United States)

    Smirnova, D A; Petrova, N N; Pavlichenko, A V; Martynikhin, I A; Dorofeikova, M V; Eremkin, V I; Izmailova, O V; Osadshiy, Yu Yu; Romanov, D V; Ubeikon, D A; Fedotov, I A; Sheifer, M S; Shustov, A D; Yashikhina, A A; Clark, M; Badcock, J; Watterreus, A; Morgan, V; Jablensky, A

    2018-01-01

    The Diagnostic Interview for Psychoses (DIP) was developed to enhance the quality of diagnostic assessment of psychotic disorders. The aim of the study was the adaptation of the Russian language version and evaluation of its validity and reliability. Ninety-eight patients with psychotic disorders (89 video recordings) were assessed by 12 interviewers using the Russian version of DIP at 7 clinical sites (in 6 cities of the Russian Federation). DIP ratings on 32 cases of a randomized case sample were made by 9 interviewers and the inter-rater reliability was compared with the researchers' DIP ratings. Overall pairwise agreement and Cohen's kappa were calculated. Diagnostic validity was evaluated on the basis of comparing the researchers' ratings using the Russian version of DIP with the 'gold standard' ratings of the same 62 clinical cases from the Western Australia Family Study Schizophrenia (WAFSS). The mean duration of the interview was 47±21 minutes. The Kappa statistic demonstrated a significant or almost perfect level of agreement on the majority of DIP items (84.54%) and a significant agreement for the ICD-10 diagnoses generated by the DIP computer diagnostic algorithm (κ=0.68; 95% CI 0.53,0.93). The level of agreement on the researchers' diagnoses was considerably lower (κ=0.31; 95% CI 0.06,0.56). The agreement on affective and positive psychotic symptoms was significantly higher than agreement on negative symptoms (F(2,44)=20.72, pRussian language version of DIP was confirmed by 73% (45/62) of the Russian DIP diagnoses matching the original WAFSS diagnoses. Among the mismatched diagnoses were 80 cases with a diagnosis of F20 Schizophrenia in the medical documentation compared to the researchers' F20 diagnoses in only 68 patients and in 62 of the DIP computerized diagnostic outputs. The reported level of subjective difficulties experienced when using the DIP was low to moderate. The results of the study confirm the validity and reliability of the Russian version of the DIP for evaluating psychotic disorders. DIP can be recommended for use in education and training, clinical practice and research as an important diagnostic resource.

  20. Age in antiretroviral therapy programmes in South Africa: a multi-centre observational cohort study

    Science.gov (United States)

    Cornell, Morna; Johnson, Leigh F; Schomaker, Michael; Tanser, Frank; Maskew, Mhairi; Wood, Robin; Prozesky, Hans; Giddy, Janet; Stinson, Kathryn; Egger, Matthias; Boulle, Andrew; Myer, Landon

    2015-01-01

    Background As access to antiretroviral therapy (ART) expands, increasing numbers of older patients will start treatment and require specialised long-term care. However the impact of age in ART programs in resource-constrained settings is poorly understood. South Africa has the second largest population of older (≥50 years) people in sub-Saharan Africa. The HIV epidemic is also ageing rapidly and the country has one of the highest HIV population prevalences worldwide. This study explored the effect of age on mortality on ART in South Africa and whether this effect was mediated by baseline immunologic status. Methods IeDEA-SA is a regional collaboration which combines routine observational data from large ART programmes across Southern Africa. This study was a retrospective cohort analysis of adults starting ART from 2004-2013 in six large South African cohorts: two primary care clinics, three hospitals and a large rural cohort. The primary outcome was mortality; secondary outcomes were loss to follow-up (LTF), immunologic and virologic responses. Patients' vital status was ascertained through linkage to the National Population Register. Inverse probability weighting was used to correct mortality for LTF. Mortality was estimated using Cox's proportional hazards and competing risks regression. The interaction between baseline CD4+ cell count and age was tested. Immunologic responses were graphed by age and duration on ART. Findings 83 566 patients were followed for 174 640 patient-years. Patients were predominantly female, especially in the younger age groups: 81% (18 819/23 258) of patients 16-29 years and 66% (12 812/19 372) of those aged 30-34. Mortality increased with age in a dose response, mediated by baseline immunologic status. Patients with CD4 counts <50 cells/μL were a particularly high risk group, comprising 14% of all older patients starting ART. The percentage of older patients enrolling increased with successive calendar years from 6% (290/4 999) in 2004 to 10% (35/9 657) in 2012/13, comprising 9% of total enrolment (7 295/83 566). By analysis closure, 14% of all patients still alive and in care were ≥50 years old. Interpretation Health services need re-orientation towards diagnosing and starting ART in older individuals. Policies are needed for long-term care of older people with HIV. Funding Supported by NIH (NIAID), USAID & South African Centre for Epidemiological Modelling & Analysis. PMID:26423550

  1. Adherence to MRI protocol consensus guidelines in multiple sclerosis: an Australian multi-centre study

    International Nuclear Information System (INIS)

    Curley, Michael; Josey, Lawrence; Lucas, Robyn; Dear, Keith; Taylor, Bruce V.; Coulthard, Alan; Ausimmune Investigator Group

    2012-01-01

    Multiple sclerosis (MS) is a debilitating disease that causes significant morbidity within a young demographic. Diagnostic guidelines for MS have evolved, and imaging has played an increasingly important role in diagnosis over the last two decades. For imaging to contribute to diagnosis in a meaningful way, it must be reproducible. Consensus guidelines for MRI in MS exist to define correct sequence type and imaging technique, but it is not clear to what extent they are followed. This study reviewed MRI studies performed on Australian individuals presenting with a first clinical diagnosis of central nervous system demyelination (FCD) for adherence to published guidelines and discussed practical implementation of MS guidelines in light of recent updates. The Ausimmune study was a prospective case control study of Australian participants presenting with FCD from 2003 to 2006. Baseline cranial and spinal cord MRI studies of 226 case participants from four separate Australian regions were reviewed. MRI sequences were classified according to anatomical location, slice plane, tissue weighting and use of gadolinium-containing contrast media. Results were compared with the 2003 Consortium of Multiple Sclerosis Centres MRI protocol for the diagnosis of MS. The composition of core cranial MRI sequences performed varied across the 226 scans. Of the studies, 91% included sagittal fluid attenuated inversion recovery (FLAIR) sequences. Cranial axial T2-weighted, axial FLAIR and axial proton density-weighted sequences were performed in 88%, 60% and 16% (respectively) of scans. Only 25% of the studies included a T1-weighted contrast-enhanced sequence. Concordance with the guidelines in all sequences was very low (2). Only a small number of MRI investigations performed included all of the sequences stipulated by consensus guidelines. This is likely due to poor awareness in the imaging community of the guidelines and the rationale behind certain sequences. Radiologists with a sub-speciality interest in neuroradiology should take ownership of this issue and ensure that recommended imaging guidelines are followed.

  2. Medicine administration errors in patients with dysphagia in secondary care: a multi-centre observational study.

    Science.gov (United States)

    Kelly, Jennifer; Wright, David; Wood, John

    2011-12-01

    The aim of this study was to describe the interventions used by nurses when administering oral medicines to patients with and without dysphagia, to quantify the appropriateness of these interventions and the medicine administration error rate. The administration of medicines to patients with dysphagia is complex and potentially more error prone because of the need to match the medication's formulation to the swallowing ability of the patient. Data was collected on the preparation and administration of oral medicines to patients with and without dysphagia, including those with enteral feeding tubes, using undisguised direct observation of 65 nurse-led medicine administration rounds on stroke and care-of-the-elderly wards at four acute general hospitals in East of England between 1 March and 30 June 2008. Of the 2129 medicine administrations observed, 817 involved an error, and of these 313 involved patients with dysphagia. Excluding time errors, the normalized frequency of medicine administration errors for patients with dysphagia was 21.1% compared with 5.9% for patients without. Using a mixed effects model and excluding time errors, there is a higher risk of errors for patients with dysphagia (excluding patients with enteral tubes) compared with those without (P < 0.001) and a further increase in risk of error for patients with enteral tubes compared with dysphagic patients without tubes (P < 0.001). The increased medicine administration error rate in patients with dysphagia requires healthcare professionals to take extra care when prescribing, dispensing and administering medicines to this group. © 2011 The Authors. Journal of Advanced Nursing © 2011 Blackwell Publishing Ltd.

  3. A multi-centre evaluation of oral cancer in Southern and Western ...

    African Journals Online (AJOL)

    abp

    2017-09-22

    Sep 22, 2017 ... Abstract. Introduction: Oral cancer is a leading cause of cancer deaths among African populations. Lack of standard cancer .... hypopharynx, nasopharynx, larynx, other pharynx and hematological system were .... increase in frequency of OSCC with age is likely due to increase in. DNA damage with age [29, ...

  4. Harmonizing national growth references for multi-centre surveys, drug monitoring and international postmarketing surveillance.

    Science.gov (United States)

    Hermanussen, M; Assmann, C; Wöhling, H; Zabransky, M

    2012-01-01

    National European growth references differ. We aimed to convert (harmonize) currently used charts into a single unified interchangeable LMS format for each European nation. Nine currently used national European growth references from Belgium (2009), France (1979), Poland (2001), Sweden (2002), Switzerland (1989), the UK (1990), Italy (2006) and Germany (1979 and 1997) were harmonized and compared with the international WHO child growth standards and WHO growth reference data for 5-19 years. European growth charts can be harmonized. The approach appears useful as height, and body mass index (BMI) is inappropriately represented by WHO references. European height references exhibit warping when plotted against the WHO reference. The French appears too short, the other Europeans too tall. Also, the BMI is not appropriately represented by the WHO references. Harmonizing references is a novel, convenient and cost-effective approach for converting historic and/or incomplete local or national growth reference charts into a unified interchangeable LMS format. Harmonizing facilitates producing growth references 'on demand', for limited regional purposes, for ethnically, socio-economically or politically defined minorities, but also for matching geographically different groups of children and adolescents for international growth and registry studies. © 2011 The Author(s)/Acta Paediatrica © 2011 Foundation Acta Paediatrica.

  5. Understanding resident ratings of teaching in the workplace: a multi-centre study

    NARCIS (Netherlands)

    Fluit, C.R.M.G.; Feskens, R.; Bolhuis, S.; Grol, R.; Wensing, M.; Laan, R.

    2015-01-01

    Providing clinical teachers with feedback about their teaching skills is a powerful tool to improve teaching. Evaluations are mostly based on questionnaires completed by residents. We investigated to what extent characteristics of residents, clinical teachers, and the clinical environment influenced

  6. Understanding resident ratings of teaching in the workplace: a multi-centre study.

    Science.gov (United States)

    Fluit, Cornelia R M G; Feskens, Remco; Bolhuis, Sanneke; Grol, Richard; Wensing, Michel; Laan, Roland

    2015-08-01

    Providing clinical teachers with feedback about their teaching skills is a powerful tool to improve teaching. Evaluations are mostly based on questionnaires completed by residents. We investigated to what extent characteristics of residents, clinical teachers, and the clinical environment influenced these evaluations, and the relation between residents' scores and their teachers' self-scores. The evaluation and feedback for effective clinical teaching questionnaire (EFFECT) was used to (self)assess clinical teachers from 12 disciplines (15 departments, four hospitals). Items were scored on a five-point Likert scale. Main outcome measures were residents' mean overall scores (MOSs), specific scale scores (MSSs), and clinical teachers' self-evaluation scores. Multilevel regression analysis was used to identify predictors. Residents' scores and self-evaluations were compared. Residents filled in 1,013 questionnaires, evaluating 230 clinical teachers. We received 160 self-evaluations. 'Planning Teaching' and 'Personal Support' (4.52, SD .61 and 4.53, SD .59) were rated highest, 'Feedback Content' (CanMEDS related) (4.12, SD .71) was rated lowest. Teachers in affiliated hospitals showed highest MOS and MSS. Medical specialty did not influence MOS. Female clinical teachers were rated higher for most MSS, achieving statistical significance. Residents in year 1-2 were most positive about their teachers. Residents' gender did not affect the mean scores, except for role modeling. At group level, self-evaluations and residents' ratings correlated highly (Kendall's τ 0.859). Resident evaluations of clinical teachers are influenced by teacher's gender, year of residency training, type of hospital, and to a lesser extent teachers' gender. Clinical teachers and residents agree on strong and weak points of clinical teaching.

  7. Incredible Years parent training support for foster carers in Wales: a multi-centre feasibility study.

    Science.gov (United States)

    Bywater, T; Hutchings, J; Linck, P; Whitaker, C; Daley, D; Yeo, S T; Edwards, R T

    2011-03-01

    the incidence of conduct disorder in young children is 10% in the general population and 37% among fostered children. Up to 40% of untreated children diagnosed with conduct disorder develop problems later in life including drug misuse, criminal and violent behaviour. There are more than 80,000 looked after children in the UK, with 5000 in Wales. Challenging child behaviour is the main reason for placement breakdown and has huge cost implications as challenging children cost up to 10 times more in service use than children without conduct disorder. The Incredible Years (IY) evidence-based parenting programme is an effective, low cost solution in improving child behaviour and social competence in 'conventional' families and thus has the potential to support foster carers in managing difficult behaviours. Our main aims were to establish: • The feasibility of delivery and the effectiveness of the IY parenting programme in supporting carers in managing difficult behaviour in looked after children. • Service use costs for foster carers and looked after child. This was a 12-month trial platform study with 46 foster carers in three authorities in Wales. Carers were allocated 2:1 intervention to waiting-list control. Validated measures were used to assess 'parenting' competency, carers' depression levels, child behaviour and service use. Measures were administered at baseline and 6-month follow-up. Intervention carers received the programme between baseline and follow-up. Analyses showed a significant reduction in child problem behaviour and improvement in carers' depression levels for intervention families at follow-up, compared with control. Unexpectedly, there was a significant improvement in control carers' self-reported 'parenting' strategies. Special education was the greatest service cost for looked after children. Initial foster carer training could incorporate the IY programme to support carers in establishing positive relationships and managing difficult child behaviour. Programme participation may lead to reduced service use and improved placement stability. © 2010 Blackwell Publishing Ltd.

  8. 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 par