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Sample records for multicentre prospective study

  1. Necrotizing soft tissue infections - a multicentre, prospective observational study (INFECT)

    DEFF Research Database (Denmark)

    Madsen, M. B.; Skrede, S.; Bruun, T.

    2018-01-01

    these to patient-important outcomes. With this protocol and statistical analysis plan we describe the methods used to obtain data and the details of the planned analyses. Methods: The INFECT study is a multicentre, prospective observational cohort study. Patients with NSTIs are enrolled in five Scandinavian......Background: The INFECT project aims to advance our understanding of the pathophysiological mechanisms in necrotizing soft tissue infections (NSTIs). The INFECT observational study is part of the INFECT project with the aim of studying the clinical profile of patients with NSTIs and correlating...

  2. MANAGEMENT AND OUTCOMES FROM APPENDECTOMY: AN INTERNATIONAL, PROSPECTIVE, MULTICENTRE STUDY.

    Science.gov (United States)

    Camilleri-Brennan, J; Drake, T; Spence, R; Bhangu, A; Harrison, E

    2017-09-01

    To identify variation in surgical management and outcomes of appendicitis across low, middle and high Human Development Index (HDI) country groups. Multi-centre, international prospective cohort study of consecutive patients undergoing emergency appendectomy over a 6-month period. Follow-up lasted 30 days. Primary outcome measure was overall complication rate. 4546 patients from 52 countries underwent appendectomy (2499 high, 1540 middle and 507 low HDI groups). Complications were more frequent in low-HDI (OR 3.81, 95% CI 2.78 to 5.19, p accounting for case-mix, laparoscopy was still associated with fewer complications (OR 0.55, 95% CI 0.42 to 0.71, pintroduction of laparoscopy that if overcome, could result in significantly improved outcomes for patients in low-resource environments, with potential for wider health-system benefits.

  3. Multicentre prospective cohort study of body mass index and postoperative complications following gastrointestinal surgery

    OpenAIRE

    Drake, T. M.; Nepogodiev, D.; Chapman, S. J.; Glasbey, J. C.; Khatri, C.; Kong, C. Y.; Claireaux, H. A.; Bath, M. F.; Mohan, M.; McNamee, L.; Kelly, M.; Mitchell, H.; Fitzgerald, J. E.; Harrison, E. M.; Bhangu, A.

    2016-01-01

    BackgroundThere is currently conflicting evidence surrounding the effects of obesity on postoperative outcomes. Previous studies have found obesity to be associated with adverse events, but others have found no association. The aim of this study was to determine whether increasing body mass index (BMI) is an independent risk factor for development of major postoperative complications.MethodsThis was a multicentre prospective cohort study across the UK and Republic of Ireland. Consecutive pati...

  4. Job stress, absenteeism and coronary heart disease European cooperative study (the JACE study): Design of a multicentre prospective study

    NARCIS (Netherlands)

    Houtman, I.; Kornitzer, M.; Smet, P. de; Koyuncu, R.; Backer, G. de; Pelfrene, E.; Romon, M.; Boulenguez, C.; Ferrario, M.; Origgi, G.; Sans, S.; Perez, I.; Wilhelmsen, L.; Rosengren, A.; Isacsson, S.-O.; Östergren, P.-O.

    1999-01-01

    Background: The motives, objectives and design of a multicentre prospective study on job stress, absenteeism and coronary heart disease in Europe (the JACE study) is presented in this paper. Some specific gaps in the reviewed literature are explicitly tapped into by the JACE study. Its objectives

  5. Benchmarking of surgical complications in gynaecological oncology: prospective multicentre study.

    Science.gov (United States)

    Burnell, M; Iyer, R; Gentry-Maharaj, A; Nordin, A; Liston, R; Manchanda, R; Das, N; Gornall, R; Beardmore-Gray, A; Hillaby, K; Leeson, S; Linder, A; Lopes, A; Meechan, D; Mould, T; Nevin, J; Olaitan, A; Rufford, B; Shanbhag, S; Thackeray, A; Wood, N; Reynolds, K; Ryan, A; Menon, U

    2016-12-01

    To explore the impact of risk-adjustment on surgical complication rates (CRs) for benchmarking gynaecological oncology centres. Prospective cohort study. Ten UK accredited gynaecological oncology centres. Women undergoing major surgery on a gynaecological oncology operating list. Patient co-morbidity, surgical procedures and intra-operative (IntraOp) complications were recorded contemporaneously by surgeons for 2948 major surgical procedures. Postoperative (PostOp) complications were collected from hospitals and patients. Risk-prediction models for IntraOp and PostOp complications were created using penalised (lasso) logistic regression using over 30 potential patient/surgical risk factors. Observed and risk-adjusted IntraOp and PostOp CRs for individual hospitals were calculated. Benchmarking using colour-coded funnel plots and observed-to-expected ratios was undertaken. Overall, IntraOp CR was 4.7% (95% CI 4.0-5.6) and PostOp CR was 25.7% (95% CI 23.7-28.2). The observed CRs for all hospitals were under the upper 95% control limit for both IntraOp and PostOp funnel plots. Risk-adjustment and use of observed-to-expected ratio resulted in one hospital moving to the >95-98% CI (red) band for IntraOp CRs. Use of only hospital-reported data for PostOp CRs would have resulted in one hospital being unfairly allocated to the red band. There was little concordance between IntraOp and PostOp CRs. The funnel plots and overall IntraOp (≈5%) and PostOp (≈26%) CRs could be used for benchmarking gynaecological oncology centres. Hospital benchmarking using risk-adjusted CRs allows fairer institutional comparison. IntraOp and PostOp CRs are best assessed separately. As hospital under-reporting is common for postoperative complications, use of patient-reported outcomes is important. Risk-adjusted benchmarking of surgical complications for ten UK gynaecological oncology centres allows fairer comparison. © 2016 Royal College of Obstetricians and Gynaecologists.

  6. Necrotizing soft tissue infections - a multicentre, prospective observational study (INFECT)

    NARCIS (Netherlands)

    Madsen, M.B.; Skrede, S.; Bruun, T.; Arnell, P.; Rosén, A.; Nekludov, M.; Karlsson, Y.; Bergey, F.; Saccenti, E.; Martins dos Santos, V.A.P.; Perner, A.; Norrby-Teglund, A.; Hyldegaard, O.

    2018-01-01

    Background: The INFECT project aims to advance our understanding of the pathophysiological mechanisms in necrotizing soft tissue infections (NSTIs). The INFECT observational study is part of the INFECT project with the aim of studying the clinical profile of patients with NSTIs and correlating

  7. Prospective, Controlled, Multicentre Study of Loperimide in Pregnancy

    Directory of Open Access Journals (Sweden)

    A Einarson

    2000-01-01

    Full Text Available BACKGROUND: Loperamide is a synthetic piperidine derivative used for the treatment of both acute and chronic diarrhea. Little is known about its safety and risk in pregnancy. Human data are limited to one surveillance study of Michigan Medicaid patients, with 108 women exposed in the first trimester. In this study there were six major birth defects, three of which were cardiovascular anomalies.

  8. Effects of combined exercise training and electromyostimulation treatments in chronic heart failure: A prospective multicentre study.

    Science.gov (United States)

    Iliou, Marie C; Vergès-Patois, Bénédicte; Pavy, Bruno; Charles-Nelson, Anais; Monpère, Catherine; Richard, Rudy; Verdier, Jean C

    2017-08-01

    Background Exercise training as part of a comprehensive cardiac rehabilitation is recommended for patients with cardiac heart failure. It is a valuable method for the improvement of exercise tolerance. Some studies reported a similar improvement with quadricipital electrical myostimulation, but the effect of combined exercise training and electrical myostimulation in cardiac heart failure has not been yet evaluated in a large prospective multicentre study. Purpose The aim of this study was to determine whether the addition of low frequency electrical myostimulation to exercise training may improve exercise capacity and/or muscular strength in cardiac heart failure patients. Methods Ninety-one patients were included (mean age: 58 ± 9 years; New York Heart Association II/III: 52/48%, left ventricular ejection fraction: 30 ± 7%) in a prospective French study. The patients were randomised into two groups: 41 patients in exercise training and 50 in exercise training + electrical myostimulation. All patients underwent 20 exercise training sessions. In addition, in the exercise training + electrical myostimulation group, patients underwent 20 low frequency (10 Hz) quadricipital electrical myostimulation sessions. Each patient underwent a cardiopulmonary exercise test, a six-minute walk test, a muscular function evaluation and a quality of life questionnaire, before and at the end of the study. Results A significant improvement of exercise capacity (Δ peak oxygen uptake+15% in exercise training group and +14% in exercise training + electrical myostimulation group) and of quality of life was observed in both groups without statistically significant differences between the two groups. Mean creatine kinase level increased in the exercise training group whereas it remained stable in the combined group. Conclusions This prospective multicentre study shows that electrical myostimulation on top of exercise training does not demonstrate any significant

  9. Rationale and design of the BUDAPEST-CRT Upgrade Study: a prospective, randomized, multicentre clinical trial.

    Science.gov (United States)

    Merkely, Bela; Kosztin, Annamaria; Roka, Attila; Geller, Laszlo; Zima, Endre; Kovacs, Attila; Boros, Andras Mihaly; Klein, Helmut; Wranicz, Jerzy K; Hindricks, Gerhard; Clemens, Marcell; Duray, Gabor Z; Moss, Arthur J; Goldenberg, Ilan; Kutyifa, Valentina

    2017-09-01

    There is lack of conclusive evidence from randomized clinical trials on the efficacy and safety of upgrade to cardiac resynchronization therapy (CRT) in patients with implanted pacemakers (PM) or defibrillators (ICD) with reduced left ventricular ejection fraction (LVEF) and chronic heart failure (HF). The BUDAPEST-CRT Upgrade Study was designed to compare the efficacy and safety of CRT upgrade from conventional PM or ICD therapy in patients with intermittent or permanent right ventricular (RV) septal/apical pacing, reduced LVEF, and symptomatic HF. The BUDAPEST-CRT study is a prospective, randomized, multicentre, investigator-sponsored clinical trial. A total of 360 subjects will be enrolled with LVEF ≤ 35%, NYHA functional classes II-IVa, paced QRS ≥ 150 ms, and a RV pacing ≥ 20%. Patients will be followed for 12 months. Randomization is performed in a 3:2 ratio (CRT-D vs. ICD). The primary composite endpoint is all-cause mortality, a first HF event, or less than 15% reduction in left ventricular (LV) end-systolic volume at 12 months. Secondary endpoints are all-cause mortality, all-cause mortality or HF event, and LV volume reduction at 12 months. Tertiary endpoints include changes in quality of life, NYHA functional class, 6 min walk test, natriuretic peptides, and safety outcomes. The results of our prospective, randomized, multicentre clinical trial will provide important information on the role of cardiac resynchronization therapy with defibrillator (CRT-D) upgrade in patients with symptomatic HF, reduced LVEF, and wide-paced QRS with intermittent or permanent RV pacing. NCT02270840. © The Author 2016. Published by Oxford University Press on behalf of the European Society of Cardiology.

  10. A comparison of functional outcome in patients sustaining major trauma: a multicentre, prospective, international study.

    Directory of Open Access Journals (Sweden)

    Timothy H Rainer

    Full Text Available OBJECTIVES: To compare 6 month and 12 month health status and functional outcomes between regional major trauma registries in Hong Kong and Victoria, Australia. SUMMARY BACKGROUND DATA: Multicentres from trauma registries in Hong Kong and the Victorian State Trauma Registry (VSTR. METHODS: Multicentre, prospective cohort study. Major trauma patients and aged ≥18 years were included. The main outcome measures were Extended Glasgow Outcome Scale (GOSE functional outcome and risk-adjusted Short-Form 12 (SF-12 health status at 6 and 12 months after injury. RESULTS: 261 cases from Hong Kong and 1955 cases from VSTR were included. Adjusting for age, sex, ISS, comorbid status, injury mechanism and GCS group, the odds of a better functional outcome for Hong Kong patients relative to Victorian patients at six months was 0.88 (95% CI: 0.66, 1.17, and at 12 months was 0.83 (95% CI: 0.60, 1.12. Adjusting for age, gender, ISS, GCS, injury mechanism and comorbid status, Hong Kong patients demonstrated comparable mean PCS-12 scores at 6-months (adjusted mean difference: 1.2, 95% CI: -1.2, 3.6 and 12-months (adjusted mean difference: -0.4, 95% CI: -3.2, 2.4 compared to Victorian patients. Keeping age, gender, ISS, GCS, injury mechanism and comorbid status, there was no difference in the MCS-12 scores of Hong Kong patients compared to Victorian patients at 6-months (adjusted mean difference: 0.4, 95% CI: -2.1, 2.8 or 12-months (adjusted mean difference: 1.8, 95% CI: -0.8, 4.5. CONCLUSION: The unadjusted analyses showed better outcomes for Victorian cases compared to Hong Kong but after adjusting for key confounders, there was no difference in 6-month or 12-month functional outcomes between the jurisdictions.

  11. A Comparison of Functional Outcome in Patients Sustaining Major Trauma: A Multicentre, Prospective, International Study

    Science.gov (United States)

    Rainer, Timothy H.; Yeung, Hiu Hung; Gabbe, Belinda J.; Yuen, Kai Y.; Ho, Hiu F.; Kam, Chak W.; Chang, Annice; Poon, Wai S.; Cameron, Peter A.; Graham, Colin A.

    2014-01-01

    Objectives To compare 6 month and 12 month health status and functional outcomes between regional major trauma registries in Hong Kong and Victoria, Australia. Summary Background Data Multicentres from trauma registries in Hong Kong and the Victorian State Trauma Registry (VSTR). Methods Multicentre, prospective cohort study. Major trauma patients and aged ≥18 years were included. The main outcome measures were Extended Glasgow Outcome Scale (GOSE) functional outcome and risk-adjusted Short-Form 12 (SF-12) health status at 6 and 12 months after injury. Results 261 cases from Hong Kong and 1955 cases from VSTR were included. Adjusting for age, sex, ISS, comorbid status, injury mechanism and GCS group, the odds of a better functional outcome for Hong Kong patients relative to Victorian patients at six months was 0.88 (95% CI: 0.66, 1.17), and at 12 months was 0.83 (95% CI: 0.60, 1.12). Adjusting for age, gender, ISS, GCS, injury mechanism and comorbid status, Hong Kong patients demonstrated comparable mean PCS-12 scores at 6-months (adjusted mean difference: 1.2, 95% CI: −1.2, 3.6) and 12-months (adjusted mean difference: −0.4, 95% CI: −3.2, 2.4) compared to Victorian patients. Keeping age, gender, ISS, GCS, injury mechanism and comorbid status, there was no difference in the MCS-12 scores of Hong Kong patients compared to Victorian patients at 6-months (adjusted mean difference: 0.4, 95% CI: −2.1, 2.8) or 12-months (adjusted mean difference: 1.8, 95% CI: −0.8, 4.5). Conclusion The unadjusted analyses showed better outcomes for Victorian cases compared to Hong Kong but after adjusting for key confounders, there was no difference in 6-month or 12-month functional outcomes between the jurisdictions. PMID:25157522

  12. PIpelle Prospective ENDOmetrial carcinoma (PIPENDO) study, pre-operative recognition of high risk endometrial carcinoma: a multicentre prospective cohort study

    International Nuclear Information System (INIS)

    Visser, Nicole C. M.; Bulten, Johan; Wurff, Anneke A. M. van der; Boss, Erik A.; Bronkhorst, Carolien M.; Feijen, Harrie W. H.; Haartsen, Joke E.; Herk, Hilde A. D. M. van; Kievit, Ineke M. de; Klinkhamer, Paul J. J. M.; Pijlman, Brenda M.; Snijders, Marc P. M. L.; Vandenput, Ingrid; Vos, M. Caroline; Wit, Peter E. J. de; Poll-Franse, Lonneke V. van de; Massuger, Leon F.A.G.; Pijnenborg, Johanna M. A.

    2015-01-01

    Endometrial carcinoma is the most common gynaecologic malignancy in industrialised countries and the incidence is still rising. Primary treatment is based on preoperative risk classification and consists in most cases of hysterectomy with bilateral salpingo-oophorectomy. In patients with serous and clear cell histology a complete surgical staging is mandatory. However, in routine clinical practice final histology regularly does not correspond with the preoperative histological diagnosis. This results in both over and under treatment. The aim of this multicentre, prospective cohort study is to select a panel of prognostic biomarkers to improve preoperative diagnosis of endometrial carcinoma in order to identify those patients that need extended surgery and/or additional treatment. Additionally, we will determine whether incorporation of cervical cytology and comorbidity could improve this preoperative risk classification. All patients treated for endometrial carcinoma in the participating hospitals from September 2011 till December 2013 are included. Patient characteristics, as well as comorbidity are registered. Patients without preoperative histology, history of hysterectomy and/or endometrial carcinoma or no surgical treatment including hysterectomy are excluded. The preoperative histology and final pathology will be reviewed and compared by expert pathologists. Additional immunohistochemical analysis of IMP3, p53, ER, PR, MLH1, PTEN, beta-catenin, p16, Ki-67, stathmin, ARID1A and L1CAM will be performed. Preoperative histology will be compared with the final pathology results. Follow-up will be at least 24 months to determine risk factors for recurrence and outcome. This study is designed to improve surgical treatment of endometrial carcinoma patients. A total of 432 endometrial carcinoma patients were enrolled between 2011 and 2013. Follow-up will be completed in 2015. Preoperative histology will be evaluated systematically and background endometrium will be

  13. Managing acute alcohol withdrawal with Homoeopathy: A prospective, observational, multicentre exploratory study

    Directory of Open Access Journals (Sweden)

    Debadatta Nayak

    2014-01-01

    Full Text Available Background: Alcohol dependence is a common social problem which may be associated with other risk factors and co-morbidities. Abrupt cessation of alcohol intake may provoke an acute alcohol withdrawal phase with varying degrees of signs and symptoms. In conventional medical system, specific pharmacological interventions are used for management of Acute Alcohol Withdrawal (AAW. There exists a need to explore safe and holistic treatment of AAW. The present work reports the results of a prospective, observational, exploratory, multicentre trial (2008-2011 to assess the role of Homoeopathy in AAW. Materials and Methods: Individualised Homoeopathy was given to 112 patients reporting with AAW. The clinical assessment was done for 05 days using Clinical Institute Withdrawal Assessment Scale of Alcohol-Revised (CIWA-Ar. Post-withdrawal phase, quality of life of patients was assessed at end of 01 st , 03 rd and 06 th month using World Health Organisation quality of life (WHOQOL- BREF. Results and Analysis: There was a significant decrease in CIWA-Ar mean scores and increase in quality of life score (P < 0.001. The most common remedies used were Arsenicum album, Lycopodium clavatum, Belladonna, Nux vomica and Pulsatilla. Conclusion: The results of current observational pilot study suggest the promising use of Homoeopathy in the management of acute alcohol withdrawal. Further studies with large sample size and rigorous design are warranted.

  14. Prospective Multicentre Study on the Epidemiology and Current Therapeutic Management of Severe Bronchiolitis in Spain

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    Jose C. Flores-González

    2017-01-01

    Full Text Available Objective. To determine the epidemiology and therapeutic management of patients with severe acute bronchiolitis (AB admitted to paediatric intensive care units (PICUs in Spain. Design. Descriptive, prospective, multicentre study. Setting. Sixteen Spanish PICUs. Patients. Patients with severe AB who required admission to any of the participating PICUs over 1 year. Interventions. Both epidemiological variables and medical treatment received were recorded. Results. A total of 262 patients were recruited; 143 were male (54.6%, with median age of 1 month (0–23. Median stay in the PICU was 7 days (1–46. Sixty patients (23% received no nebuliser treatment, while the rest received a combination of inhalation therapies. One-quarter of patients (24.8% received corticosteroids and 56.5% antibiotic therapy. High-flow oxygen therapy was used in 14.3% and noninvasive ventilation (NIV was used in 75.6%. Endotracheal intubation was required in 24.4% of patients. Younger age, antibiotic therapy, and invasive mechanical ventilation (IMV were risk factors that significantly increased the stay in the PICU. Conclusions. Spanish PICUs continue to routinely use nebulised bronchodilator treatment and corticosteroid therapy. Despite NIV being widely used in this condition, intubation was required in one-quarter of cases. Younger age, antibiotic therapy, and IMV were associated with a longer stay in the PICU.

  15. Prospective multicentre cohort study of heparin-induced thrombocytopenia in acute ischaemic stroke patients

    Science.gov (United States)

    Kawano, Hiroyuki; Yamamoto, Haruko; Miyata, Shigeki; Izumi, Manabu; Hirano, Teruyuki; Toratani, Naomi; Kakutani, Isami; Sheppard, Jo-Ann I; Warkentin, Theodore E; Kada, Akiko; Sato, Shoichiro; Okamoto, Sadahisa; Nagatsuka, Kazuyuki; Naritomi, Hiroaki; Toyoda, Kazunori; Uchino, Makoto; Minematsu, Kazuo

    2011-01-01

    Acute ischaemic stroke patients sometimes receive heparin for treatment and/or prophylaxis of thromboembolic complications. This study was designed to elucidate the incidence and clinical features of heparin-induced thrombocytopenia (HIT) in acute stroke patients treated with heparin. We conducted a prospective multicentre cohort study of 267 patients who were admitted to three stroke centres within 7 d after stroke onset. We examined clinical data until discharge and collected blood samples on days 1 and 14 of hospitalization to test anti-platelet factor 4/heparin antibodies (anti-PF4/H Abs) using an enzyme-linked immunosorbent assay (ELISA); platelet-activating antibodies were identified by serotonin-release assay (SRA). Patients with a 4Ts score ≥4 points, positive-ELISA, and positive-SRA were diagnosed as definite HIT. Heparin was administered to 172 patients (64·4%: heparin group). Anti-PF4/H Abs were detected by ELISA in 22 cases (12·8%) in the heparin group. Seven patients had 4Ts ≥ 4 points. Among them, three patients (1·7% overall) were also positive by both ELISA and SRA. National Institutes of Health Stroke Scale score on admission was high (range, 16–23) and in-hospital mortality was very high (66·7%) in definite HIT patients. In this study, the incidence of definite HIT in acute ischaemic stroke patients treated with heparin was 1·7% (95% confidence interval: 0·4–5·0). The clinical severity and outcome of definite HIT were unfavourable. PMID:21671895

  16. Preoperative predictive model for acute kidney injury after elective cardiac surgery: a prospective multicentre cohort study.

    Science.gov (United States)

    Callejas, Raquel; Panadero, Alfredo; Vives, Marc; Duque, Paula; Echarri, Gemma; Monedero, Pablo

    2018-05-11

    Predictive models of CS-AKI include emergency surgery and patients with haemodynamic instability. Our objective was to evaluate the performance of validated predictive models (Thakar and Demirjian) in elective cardiac surgery and to propose a better score in the case of poor performance. A prospective, multicentre, observational study was designed. Data were collected from 942 patients undergoing cardiac surgery, after excluding emergency surgery and patients with an intraaortic balloon pump. The main outcome measure was CS-AKI defined by the composite of requiring dialysis or doubling baseline creatinine values. Both models showed poor discrimination in elective surgery (Thakar's model, AUROC = 0.57, 95% CI = 0.50-0.64 and Demirjian's model, AUROC= 0.64, 95% CI = 0.58-0.71). We generated a new model whose significant independent predictors were: anaemia, age, hypertension, obesity, congestive heart failure, previous cardiac surgery and type of surgery. It classifies patients with scores 0-3 as low risk ( 8 as high risk (>30%) of developing CS-AKI with a statistically significant correlation (p <0.001). Our model reflects acceptable discriminatory ability (AUC = 0.72, 95% CI = 0.66-0.78) which is significantly better than Thakar and Demirjian's models (p<0.01). We developed a new simple predictive model of CS-AKI in elective surgery based on available preoperative information. Our new model is easy to calculate and can be an effective tool for communicating risk to patients and guiding decision-making in the perioperative period. The study requires external validation.

  17. Laparoscopic excision of deep rectovaginal endometriosis in BSGE endometriosis centres: a multicentre prospective cohort study

    Science.gov (United States)

    Byrne, Dominic; Curnow, Tamara; Smith, Paul; Cutner, Alfred; Saridogan, Ertan; Clark, T Justin

    2018-01-01

    Objective To estimate the effectiveness and safety of laparoscopic surgical excision of rectovaginal endometriosis. Design A multicentre, prospective cohort study. Setting 51 hospitals accredited as specialist endometriosis centres. Participants 5162 women of reproductive age with rectovaginal endometriosis of which 4721 women had planned laparoscopic excision. Interventions Laparoscopic surgical excision of rectovaginal endometriosis requiring dissection of the pararectal space. Main outcome measures Standardised symptom questionnaires enquiring about chronic pelvic pain, bladder and bowel symptoms, analgesia use and quality of life (EuroQol) completed prior to surgery and at 6, 12 and 24 months postoperatively. Serious perioperative and postoperative complications including major haemorrhage, infection and visceral injury were recorded. Results At 6 months postsurgery, there were significant reductions in premenstrual, menstrual and non-cyclical pelvic pain, deep dyspareunia, dyschezia, low back pain and bladder pain. In addition, there were significant reductions in voiding difficulty, bowel frequency, urgency, incomplete emptying, constipation and passing blood. These reductions were maintained at 2 years, with the exception of voiding difficulty. Global quality of life significantly improved from a median pretreatment score of 55/100 to 80/100 at 6 months. There was a significant improvement in quality of life in all measured domains and in quality-adjusted life years. These improvements were sustained at 2 years. All analgesia use was reduced and, in particular, opiate use fell from 28.1% prior to surgery to 16.1% at 6 months. The overall incidence of complications was 6.8% (321/4721). Gastrointestinal complications (enterotomy, anastomotic leak or fistula) occurred in 52 (1.1%) operations and of the urinary tract (ureteric/bladder injury or leak) in 49 (1.0%) procedures. Conclusion Laparoscopic surgical excision of rectovaginal endometriosis

  18. Clinical and echocardiographic assessment of the Medtronic Advantage aortic valve prosthesis: the Scandinavian multicentre, prospective study

    DEFF Research Database (Denmark)

    Haaverstad, Rune; Vitale, Nicola; Karevold, Asbjørn

    2006-01-01

    OBJECTIVE: The aim of this report is the prospective, multicentre evaluation of clinical results and haemodynamic performance of the Medtronic Advantage aortic valve prosthesis. METHODS: From April 2001 to June 2003, 166 patients (male:female 125:41; mean (SD) age 61.8 (11.8) years) received...... an aortic advantage valve prosthesis. Complete cumulative follow-up was 242.7 patient-years (maximum 3.2; mean 1.6 years). Postoperatively, patients underwent early (within 30 days) and 1 year transthoracic echocardiography. RESULTS: 30 day mortality was 2.4% (n = 4). Kaplan-Meier estimates of freedom from...... echocardiography. CONCLUSIONS: Haemodynamic performance and early clinical results of Medtronic advantage in the aortic position were satisfactory and comparable with those of other bileaflet valves in current clinical use....

  19. Utility of CSF biomarkers in psychiatric disorders: a national multicentre prospective study.

    Science.gov (United States)

    Paquet, Claire; Magnin, Eloi; Wallon, David; Troussière, Anne-Cécile; Dumurgier, Julien; Jager, Alain; Bellivier, Frank; Bouaziz-Amar, Elodie; Blanc, Frédéric; Beaufils, Emilie; Miguet-Alfonsi, Carole; Quillard, Muriel; Schraen, Susanna; Pasquier, Florence; Hannequin, Didier; Robert, Philippe; Hugon, Jacques; Mouton-Liger, François

    2016-06-13

    Affective and psychotic disorders are mental or behavioural patterns resulting in an inability to cope with life's ordinary demands and routines. These conditions can be a prodromal event of Alzheimer's disease (AD). The prevalence of underlying AD lesions in psychiatric diseases is unknown, and it would be helpful to determine them in patients. AD cerebrospinal fluid (CSF) biomarkers (amyloid β, tau and phosphorylated tau) have high diagnostic accuracy, both for AD with dementia and to predict incipient AD (mild cognitive impairment due to AD), and they are sometimes used to discriminate psychiatric diseases from AD. Our objective in the present study was to evaluate the clinical utility of CSF biomarkers in a group of patients with psychiatric disease as the main diagnosis. In a multicentre prospective study, clinicians filled out an anonymous questionnaire about all of their patients who had undergone CSF biomarker evaluation. Before and after CSF biomarker results were obtained, clinicians provided a diagnosis with their level of confidence and information about the treatment. We included patients with a psychiatric disorder as the initial diagnosis. In a second part of the study conducted retrospectively in a followed subgroup, clinicians detailed the psychiatric history and we classified patients into three categories: (1) psychiatric symptoms associated with AD, (2) dual diagnosis and (3) cognitive decline not linked to a neurodegenerative disorder. Of 957 patients, 69 had an initial diagnosis of a psychiatric disorder. Among these 69 patients, 14 (20.2 %) had a CSF AD profile, 5 (7.2 %) presented with an intermediate CSF profile and 50 (72.4 %) had a non-AD CSF profile. Ultimately, 13 (18.8 %) patients were diagnosed with AD. We show that in the AD group psychiatric symptoms occurred later and the delay between the first psychiatric symptoms and the cognitive decline was shorter. This study revealed that about 20 % of patients with a primary

  20. Chronic pancreatitis: Multicentre prospective data collection and analysis by the Hungarian Pancreatic Study Group.

    Directory of Open Access Journals (Sweden)

    Ákos Szücs

    Full Text Available Chronic pancreatitis is an inflammatory disease associated with structural and functional damage to the pancreas, causing pain, maldigestion and weight loss and thus worsening the quality of life.Our aim was to find correlations from a multicentre database representing the epidemiological traits, diagnosis and treatment of the disease in Hungary. The Hungarian Pancreatic Study Group collected data prospectively from 2012 to 2014 on patients suffering from chronic pancreatitis. Statistical analysis was performed on different questions.Data on 229 patients (74% male and 26% female were uploaded from 14 centres. Daily alcohol consumption was present in the aetiology of 56% of the patients. 66% of the patients were previously treated for acute exacerbation. One third of the patients had had previous endoscopic or surgical interventions. Pain was present in 69% of the cases, endocrine insufficiency in 33%, diarrhoea in 13% and weight loss in 39%. Diagnosis was confirmed with US (80%, CT scan (52%, MRI-MRCP (6%, ERCP (39%, and EUS (7,4%. A functional test was carried out in 5% of the patients. In 31% of the cases, an endoscopic intervention was performed with the need for re-intervention in 5%. Further elective surgical intervention was necessitated in 44% of endoscopies. 20% of the registered patients were primarily treated with surgery. The biliary complication rate for surgery was significantly smaller (2% than endoscopy (27%; however, pancreatic complications were higher in the patients treated with surgery. Patients who smoked regularly needed significantly more surgical intervention following endoscopy (66.7% vs. 26.9%, p = 0.002 than non-smokers, and the ratio of surgical intervention alone was also significantly higher (27.3% vs. 10.8%, p = 0.004. The ratio of surgery in patients who smoked and drank was significantly higher (30.09% vs. 12.5%, p = 0.012 than in abstinent and non-smoking patients, similarly to the need for further surgical

  1. Chronic pancreatitis: Multicentre prospective data collection and analysis by the Hungarian Pancreatic Study Group.

    Science.gov (United States)

    Szücs, Ákos; Marjai, Tamás; Szentesi, Andrea; Farkas, Nelli; Párniczky, Andrea; Nagy, György; Kui, Balázs; Takács, Tamás; Czakó, László; Szepes, Zoltán; Németh, Balázs Csaba; Vincze, Áron; Pár, Gabriella; Szabó, Imre; Sarlós, Patrícia; Illés, Anita; Gódi, Szilárd; Izbéki, Ferenc; Gervain, Judit; Halász, Adrienn; Farkas, Gyula; Leindler, László; Kelemen, Dezső; Papp, Róbert; Szmola, Richárd; Varga, Márta; Hamvas, József; Novák, János; Bod, Barnabás; Sahin-Tóth, Miklós; Hegyi, Péter

    2017-01-01

    Chronic pancreatitis is an inflammatory disease associated with structural and functional damage to the pancreas, causing pain, maldigestion and weight loss and thus worsening the quality of life. Our aim was to find correlations from a multicentre database representing the epidemiological traits, diagnosis and treatment of the disease in Hungary. The Hungarian Pancreatic Study Group collected data prospectively from 2012 to 2014 on patients suffering from chronic pancreatitis. Statistical analysis was performed on different questions. Data on 229 patients (74% male and 26% female) were uploaded from 14 centres. Daily alcohol consumption was present in the aetiology of 56% of the patients. 66% of the patients were previously treated for acute exacerbation. One third of the patients had had previous endoscopic or surgical interventions. Pain was present in 69% of the cases, endocrine insufficiency in 33%, diarrhoea in 13% and weight loss in 39%. Diagnosis was confirmed with US (80%), CT scan (52%), MRI-MRCP (6%), ERCP (39%), and EUS (7,4%). A functional test was carried out in 5% of the patients. In 31% of the cases, an endoscopic intervention was performed with the need for re-intervention in 5%. Further elective surgical intervention was necessitated in 44% of endoscopies. 20% of the registered patients were primarily treated with surgery. The biliary complication rate for surgery was significantly smaller (2%) than endoscopy (27%); however, pancreatic complications were higher in the patients treated with surgery. Patients who smoked regularly needed significantly more surgical intervention following endoscopy (66.7% vs. 26.9%, p = 0.002) than non-smokers, and the ratio of surgical intervention alone was also significantly higher (27.3% vs. 10.8%, p = 0.004). The ratio of surgery in patients who smoked and drank was significantly higher (30.09% vs. 12.5%, p = 0.012) than in abstinent and non-smoking patients, similarly to the need for further surgical

  2. Comparison of risk scoring systems for patients presenting with upper gastrointestinal bleeding: international multicentre prospective study.

    Science.gov (United States)

    Stanley, Adrian J; Laine, Loren; Dalton, Harry R; Ngu, Jing H; Schultz, Michael; Abazi, Roseta; Zakko, Liam; Thornton, Susan; Wilkinson, Kelly; Khor, Cristopher J L; Murray, Iain A; Laursen, Stig B

    2017-01-04

     To compare the predictive accuracy and clinical utility of five risk scoring systems in the assessment of patients with upper gastrointestinal bleeding.  International multicentre prospective study.  Six large hospitals in Europe, North America, Asia, and Oceania.  3012 consecutive patients presenting over 12 months with upper gastrointestinal bleeding.  Comparison of pre-endoscopy scores (admission Rockall, AIMS65, and Glasgow Blatchford) and post-endoscopy scores (full Rockall and PNED) for their ability to predict predefined clinical endpoints: a composite endpoint (transfusion, endoscopic treatment, interventional radiology, surgery, or 30 day mortality), endoscopic treatment, 30 day mortality, rebleeding, and length of hospital stay. Optimum score thresholds to identify low risk and high risk patients were determined.  The Glasgow Blatchford score was best (area under the receiver operating characteristic curve (AUROC) 0.86) at predicting intervention or death compared with the full Rockall score (0.70), PNED score (0.69), admission Rockall score (0.66, and AIMS65 score (0.68) (all P<0.001). A Glasgow Blatchford score of ≤1 was the optimum threshold to predict survival without intervention (sensitivity 98.6%, specificity 34.6%). The Glasgow Blatchford score was better at predicting endoscopic treatment (AUROC 0.75) than the AIMS65 (0.62) and admission Rockall scores (0.61) (both P<0.001). A Glasgow Blatchford score of ≥7 was the optimum threshold to predict endoscopic treatment (sensitivity 80%, specificity 57%). The PNED (AUROC 0.77) and AIMS65 scores (0.77) were best at predicting mortality, with both superior to admission Rockall score (0.72) and Glasgow Blatchford score (0.64; P<0.001). Score thresholds of ≥4 for PNED, ≥2 for AIMS65, ≥4 for admission Rockall, and ≥5 for full Rockall were optimal at predicting death, with sensitivities of 65.8-78.6% and specificities of 65.0-65.3%. No score was helpful at predicting rebleeding or length

  3. Diet and Pre-eclampsia: A Prospective Multicentre Case-Control Study in Ethiopia.

    Science.gov (United States)

    Endeshaw, Mulualem; Abebe, Fantu; Bedimo, Melkamu; Asart, Anemaw

    2015-06-01

    Pre-eclampsia is one of the most commonly encountered hypertensive disorders of pregnancy that accounts for 20-80% of maternal mortality in developing countries, including Ethiopia. For many years, diet has been suggested to play a role in pre-eclampsia. However, the hypotheses have been diverse with inconsistent results across studies, and this has not been studied in Ethiopia. The objective of this study was to determine the effect of dietary habits on the incidence of pre-eclampsia in Bahir Dar, Ethiopia A prospective multicentre unmatched case-control study was conducted among 453 (151 cases and 302 controls) pregnant women attending antepartum or intrapartum care in public health facilities of Bahir Dar City from June to September 2014. The interviewer conducted a face-to-face interview, measured the mid-upper arm circumference (MUAC) and collected the mid-pregnancy haemoglobin level from clinical notes using a standardized and pretested questionnaire. Epi Info 3.5.3 was used for data entry and cleaning, while IBM SPSS Statistics 20 was used for data analysis. Backward stepwise unconditional logistic regression analysis was employed to determine the strength of association of predictive variables with the outcome variable and to control for the effect of confounding variables. A P-value ≤0.05 was considered statistically significant. For every 1-cm increase of MUAC, there was an increase in the incidence rate of pre-eclampsia by a factor of 1.35 (adjusted odds ratio (AOR)=1.35, 95% confidence interval (CI): 1.21, 1.51). A higher incidence of pre-eclampsia was found in women who reported to have consumed coffee daily during pregnancy (AOR=1.78, 95% CI: 1.20, 3.05). Similarly, for women who had anaemia during the first trimester, the incidence of pre-eclampsia was 2.5 times higher than their counterparts (AOR=2.47, 95% CI: 1.12, 7.61). This study also revealed consumption of fruit or vegetables at least three times a week during pregnancy to be protective

  4. Pregnancy outcomes in Lebanese women with multiple sclerosis (the LeMS study): a prospective multicentre study.

    Science.gov (United States)

    Fares, Jawad; Nassar, Anwar H; Gebeily, Souheil; Kobeissy, Firas; Fares, Youssef

    2016-05-13

    The Lebanese Multiple Sclerosis (LeMS) study aims to assess the influence of pregnancy and delivery on the clinical course of multiple sclerosis (MS) in Lebanese women. This prospective multicentre study took place in three MS referral university medical centres in Lebanon. Included were 29 women over 18 years who had been diagnosed with MS according to the McDonald criteria, and became pregnant between 1995 and 2015. Participating women should have stopped treatment 3 months before conception and become pregnant after the onset of MS. Women were followed up from 1 year preconceptionally and for 4 years postpartum. The annualised relapse rates per participant during each 3-month period during pregnancy and each year postpartum were compared with the relapse rate during the year before pregnancy using the paired two-tailed t test. p Values women with MS does not seem to increase the risk of complications. No relapses were observed during pregnancy and in the first year postpartum; however, relapses rebounded in the second year postpartum, and over the long term, returned to the levels that preceded pregnancy. 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/

  5. Hepatitis E virus infection and acute non-traumatic neurological injury: A prospective multicentre study

    NARCIS (Netherlands)

    Dalton, H.R.; Eijk, J.J.J. van; Cintas, P.; Madden, R.G.; Jones, C.; Webb, G.W.; Norton, B.; Pique, J.; Lutgens, S.; Devooght-Johnson, N.; Woolson, K.; Baker, J.; Saunders, M.; Househam, L.; Griffiths, J.; Abravanel, F.; Izopet, J.; Kamar, N.; Alfen, N. van; Engelen, B.G.M. van; Hunter, J.G.; Eijk, A.A. van der; Bendall, R.P.; McLean, B.N.; Jacobs, B.C.

    2017-01-01

    BACKGROUND & AIMS: Hepatitis E virus (HEV) has been associated with a number of neurological syndromes, but causality has not yet been established. The aim of this study was to explore the relationship between HEV and neurological illness by prospective HEV testing of patients presenting with acute

  6. Homeopathy in chronic sinusitis: a prospective multi-centric observational study.

    Science.gov (United States)

    Nayak, Chaturbhuja; Singh, Vikram; Singh, V P; Oberai, Praveen; Roja, Varanasi; Shitanshu, Shashi Shekhar; Sinha, M N; Deewan, Deepti; Lakhera, B C; Ramteke, Sunil; Kaushik, Subhash; Sarkar, Sarabjit; Mandal, N R; Mohanan, P G; Singh, J R; Biswas, Sabyasachi; Mathew, Georgekutty

    2012-04-01

    The primary objective was to ascertain the therapeutic usefulness of homeopathic medicine in the management of chronic sinusitis (CS). Multicentre observational study at Institutes and Units of the Central Council for Research in Homoeopathy, India. Symptoms were assessed using the chronic sinusitis assessment score (CSAS). 17 pre-defined homeopathic medicines were shortlisted for prescription on the basis of repertorisation for the pathological symptoms of CS. Regimes and adjustment of regimes in the event of a change of symptoms were pre-defined. The follow-up period was for 6 months. Statistical analysis was done using SPSS version 16. 628 patients suffering from CS confirmed on X-ray were enrolled from eight Institutes and Units of the Central Council for Research in Homoeopathy. All 550 patients with at least one follow-up assessment were analyzed. There was a statistically significant reduction in CSAS (P = 0.0001, Friedman test) after 3 and 6 months of treatment. Radiological appearances also improved. A total of 13 out of 17 pre-defined medicines were prescribed in 550 patients, Sil. (55.2% of 210), Calc. (62.5% of 98), Lyc. (69% of 55), Phos. (66.7% of 45) and Kali iod. (65% of 40) were found to be most useful having marked improvement. 4/17 medicines were never prescribed. No complications were observed during treatment. Homeopathic treatment may be effective for CS patients. Controlled trials are required for further validation. Copyright © 2012 Elsevier Ltd. All rights reserved.

  7. Characteristics of acute treatment costs of traumatic brain injury in Eastern China--a multi-centre prospective observational study.

    Science.gov (United States)

    Yuan, Qiang; Liu, Hua; Wu, Xing; Sun, Yirui; Yao, Haijun; Zhou, Liangfu; Hu, Jin

    2012-12-01

    This study investigated acute treatment costs and related factors for traumatic brain injuries (TBI) in eastern China based on a prospective multicentre study. Data were prospectively collected from 80 hospitals in eastern China by standardized structured questionnaires during 2004. Included patients were admitted to hospitals via an emergency service with a diagnosis of TBI. The total acute hospitalization treatment costs derived from unsubsidized total hospital billings were used as the main outcome measure. Univariate and multivariable regression models were used to examine factors associated with each outcome. In total, 13,007 TBI cases were identified from 80 hospitals in eastern China. The median cost per hospitalization was $879 US (range, $72-45,894). The median cost per day was $79 (interquartile range, $49-126). The hospitalization costs varied based on the cause of TBI, with a median of $1017 for traffic accidents, $816 for falls, $490 for blows to the head, and $712 for falls. The hospitalization costs also varied by injury type with a mean of $918 for TBI associated with other injuries and $831 for isolated TBI. Using multiple regression analyses, lower admission Glasgow Coma score, longer hospital stay (LOS), male sex, transient patient status, traffic accident, injury occurring on a construction site, treatment at a tertiary hospital, neurosurgical intensive care unit (NICU) or ICU stay, associated polytrauma, and those who needed a neurosurgical operation had significantly higher total acute hospitalization costs than those of other groups. Good recovery and self-paying patients had lower total costs. A double LOS was associated with a 1.61 (95% confidence interval, 1.59-1.62) times higher hospital cost. Our results have potential implications for health-care resource planning during TBI treatment. Measures to prevent traffic accidents and reduce the LOS may help to reduce acute hospitalization costs. Crown Copyright © 2012. Published by Elsevier

  8. RECIST response and variation of circulating tumour cells in phase 1 trials: A prospective multicentric study.

    Science.gov (United States)

    Massard, Christophe; Borget, Isabelle; Farace, Françoise; Aspeslagh, Sandrine; Le Deley, Marie-Cécile; Le Tourneau, Christophe; Bidard, François-Clement; Pierga, Jean-Yves; Dieras, Veronique; Hofman, Paul; Spano, Jean-Philippe; Ferte, Charles; Lacroix, Ludovic; Soria, Jean-Charles

    2017-09-01

    Circulating tumour cell (CTC) counting could be a new biomarker for better evaluation of tumour response to molecules tested in phase I trials. Consenting patients with advanced metastatic cancer referred to various phase I units were enrolled prospectively in this study. CTCs from 7.5 ml of whole blood drawn at baseline and after starting experimental therapy were counted using the CellSearch system, and tumour response was assessed using RECIST 1.1 criteria at baseline and 2 months after treatment initiation. Between March 2010 and May 2013, a total of 326 patients were enrolled, among whom 214 were evaluable (49% male, median age = 56; main cancer types: lung [28], colon [53], ovarian [18], breast [28]). At baseline, we detected ≥1 CTC/7.5 ml in 113/214 patients (53%), and at day 30, we observed ≥1 CTC/7.5 ml in 103/214 patients (48%). Two months after treatment initiation, 11 (5%) of the 214 patients were classified as having a partial response, with no CTCs in 9 of them or a decrease in the CTC count after therapy. In contrast, among the 104 patients (49%) classified as having progressive disease, 38 patients had a higher CTC count. The remaining 99 patients (49%), 33 of whom (33%) had a lower CTC count, were classified as having stable disease. The sensitivity and specificity of CTC variation for predicting progressive disease were 41% (32-51%) and 80% (73-88%) respectively. An early CTC change following therapy does not correlate with RECIST response in patients with advanced cancer enrolled in phase I trials. Copyright © 2017 Elsevier Ltd. All rights reserved.

  9. Concurrent chemoradiotherapy in locoregionally advanced nasopharyngeal carcinoma: Treatment outcomes of a prospective, multicentric clinical study

    International Nuclear Information System (INIS)

    Wu, Fang; Wang, Rensheng; Lu, Heming; Wei, Bo; Feng, Guosheng; Li, Guisheng; Liu, Meilian; Yan, Haolin; Zhu, Jinxian; Zhang, Yong; Hu, Kai

    2014-01-01

    Background and purpose: To evaluate long-term outcome in locoregionally advanced nasopharyngeal carcinoma (NPC) treated with intensity-modulated radiation therapy (IMRT) and concurrent chemotherapy. Material and methods: Between January 2006 and August 2008, 249 patients with stage III–IVb NPC were treated by IMRT plus concurrent chemotherapy in this multicenter prospective study. Results: With a mean follow-up of 54.1 months, the 5-year actuarial rates of overall survival (OS), local recurrence-free survival (LRFS), regional recurrence-free survival (RRFS), and distant metastasis-free survival (DMFS) were 78.4%, 86.8%, 88.4%, 78.0%, respectively. There were 29 local recurrences, 25 regional recurrences and 52 distant metastases, respectively. Distant metastasis is the main cause of treatment failure. N-stage was an independent prognostic factor for LRFS, RRFS, DMFS and OS. Acute toxicity ⩾grade III mainly consisted of mucositis (34.9%), neutropenia (11.2%), xerostomia (5.6%), and dermatitis (5.2%). The main documented late toxicity was xerostomia, and the severity of xerostomia decreased over time. At 24 months after treatment, 13.2% of patients had grade 2 xerostomia, and none had grade 3 or 4 xerostomia. Conclusions: IMRT with concurrent cisplatin chemotherapy resulted in encouraging rates of local and distant control and overall survival with acceptable rates of acute and limited rates of late toxicity in patients with locoregionally advanced NPC. Distant metastasis remained the main cause of failure. More effective systemic therapy should be explored for patients with advanced N-stage

  10. Objective and subjective outcomes of strabismus surgery in Graves' orbitopathy: a prospective multicentre study

    NARCIS (Netherlands)

    Jellema, Hinke Marijke; Saeed, Peerooz; Mombaerts, Ilse; Dolman, Peter J.; Garrity, Jim; Kazim, Mike; Dhrami-Gavazi, Elona; Lyons, Christopher; Nieuwkerk, Pythia; Mourits, Maarten P.

    2017-01-01

    To assess the change and interrelationship of the field of binocular single vision (BSV) and the quality of life (QoL), tested with two different tools, after one or two strabismus surgeries in patients with Graves' orbitopathy (GO). Prospectively, consecutive patients with GO who were scheduled for

  11. A multicentre prospective study of Guillain-Barré syndrome in Japan: a focus on the incidence of subtypes.

    Science.gov (United States)

    Mitsui, Yoshiyuki; Kusunoki, Susumu; Arimura, Kimiyoshi; Kaji, Ryuji; Kanda, Takashi; Kuwabara, Satoshi; Sonoo, Masahiro; Takada, Kazuo

    2015-01-01

    Guillain-Barré Syndrome (GBS) is classified into the two major subtypes; acute inflammatory demyelinating polyneuropathy (AIDP) and acute motor axonal neuropathy (AMAN). Previous studies have suggested that AIDP is predominant and AMAN is rare in Western countries, whereas AMAN is not always uncommon in East Asia. We aimed to clarify the incidence of the subtypes of GBS in Japan. We performed a prospective multicentre survey over 3 years (2007-2010). Clinical and electrophysiological findings were collected from 184 patients with GBS in 23 tertiary neurology institutes. Anti-ganglioside antibodies were measured by ELISA. We also surveyed the incidence of Fisher syndrome (FS). By electrodiagnostic criteria of Ho et al, patients were classified as having AIDP (40%), or AMAN (22%), or unclassified (38%). Anti-GM1 IgG antibodies were found for 47% of AMAN patients, and 18% of AIDP patients (p<0.001). There were no specific regional trends of the electrodiagnosis and anti-GM1 positivity. During the same study period, 79 patients with FS were identified; the percentage of FS cases out of all cases (FS/(GBS+FS)) was 26%. The frequency of GBS patients with the electrodiagnosis of AMAN by single nerve conduction studies is approximately 20% in Japan, and the AMAN pattern is closely associated with anti-GM1 antibodies. The incidence of FS appears to be much higher in Japan than in Western countries. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  12. Itopride in the treatment of functional dyspepsia in Chinese patients: a prospective, multicentre, post-marketing observational study.

    Science.gov (United States)

    Sun, Jing; Yuan, Yao-Zong; Holtmann, Gerald

    2011-12-01

    Prokinetic agents are commonly used in the symptomatic treatment of functional dyspepsia (FD). Safety or efficacy issues associated with the use of available prokinetics, such as metoclopramide, domperidone, cisapride and mosapride, mean there is a need for an effective and well tolerated prokinetic agent. Itopride is a novel prokinetic agent with a dual mode of action, good safety profile and documented efficacy in placebo-controlled trials. The objective of this study was to assess the effectiveness and safety of itopride in the management of FD. This was a prospective, multicentre, post-marketing observational study carried out in private outpatient clinics throughout China. The study included patients with symptomatic FD aged ≥18 years. Patients were prescribed itopride 50 mg three times daily before meals for 4 weeks, after which there was a 2-week follow-up period during which they did not take itopride. Effectiveness and tolerability data obtained from patients who completed 4 weeks of therapy were analysed. The treatment response rate after 4 weeks was measured by patient global assessment; scores at the end of treatment were compared with baseline scores. Response rate based on symptom scoring was also measured after 4 weeks, with an effective treatment being defined as a symptom improvement of ≥50%. In total, 587 patients with FD were enrolled. The mean ± SD difference in the total symptom score before and after the 4-week treatment period was -5.62 ± 3.27, corresponding to a 69.23 ± 26.53% reduction from baseline (p Itopride was an effective and well tolerated drug in the management of FD in this patient population.

  13. External validation of prognostic models to predict risk of gestational diabetes mellitus in one Dutch cohort: prospective multicentre cohort study.

    Science.gov (United States)

    Lamain-de Ruiter, Marije; Kwee, Anneke; Naaktgeboren, Christiana A; de Groot, Inge; Evers, Inge M; Groenendaal, Floris; Hering, Yolanda R; Huisjes, Anjoke J M; Kirpestein, Cornel; Monincx, Wilma M; Siljee, Jacqueline E; Van 't Zelfde, Annewil; van Oirschot, Charlotte M; Vankan-Buitelaar, Simone A; Vonk, Mariska A A W; Wiegers, Therese A; Zwart, Joost J; Franx, Arie; Moons, Karel G M; Koster, Maria P H

    2016-08-30

     To perform an external validation and direct comparison of published prognostic models for early prediction of the risk of gestational diabetes mellitus, including predictors applicable in the first trimester of pregnancy.  External validation of all published prognostic models in large scale, prospective, multicentre cohort study.  31 independent midwifery practices and six hospitals in the Netherlands.  Women recruited in their first trimester (diabetes mellitus of any type were excluded.  Discrimination of the prognostic models was assessed by the C statistic, and calibration assessed by calibration plots.  3723 women were included for analysis, of whom 181 (4.9%) developed gestational diabetes mellitus in pregnancy. 12 prognostic models for the disorder could be validated in the cohort. C statistics ranged from 0.67 to 0.78. Calibration plots showed that eight of the 12 models were well calibrated. The four models with the highest C statistics included almost all of the following predictors: maternal age, maternal body mass index, history of gestational diabetes mellitus, ethnicity, and family history of diabetes. Prognostic models had a similar performance in a subgroup of nulliparous women only. Decision curve analysis showed that the use of these four models always had a positive net benefit.  In this external validation study, most of the published prognostic models for gestational diabetes mellitus show acceptable discrimination and calibration. The four models with the highest discriminative abilities in this study cohort, which also perform well in a subgroup of nulliparous women, are easy models to apply in clinical practice and therefore deserve further evaluation regarding their clinical impact. 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.

  14. Help-seeking and antibiotic prescribing for acute cough in a Chinese primary care population: a prospective multicentre observational study.

    Science.gov (United States)

    Wong, Carmen Ka Man; Liu, Zhaomin; Butler, Chris C; Wong, Samuel Yeung Shan; Fung, Alice; Chan, Dicken; Yip, Benjamin Hon Kei; Kung, Kenny

    2016-01-21

    Acute cough is a common reason to prescribe antibiotics in primary care. This study aimed to explore help-seeking and antibiotic prescribing for acute cough in Chinese primary care population. This is a prospective multicentre observational study that included adults presenting with acute cough. Clinicians recorded patients' presenting symptoms, examination findings and medication prescription. Patients completed symptom diaries for up to 28 days by charting their symptom severity and recovery. Adjusted binary logistic regression models identified factors independently associated with antibiotic prescription. Primary care clinicians (n=19) recruited 455 patients. A total of 321 patients (70.5%) returned their completed symptom diaries. Concern about illness severity (41.6%) and obtaining a prescription for symptomatic medications (45.9%), rather than obtaining a prescription for antibiotics, were the main reasons for consulting. Antibiotics were prescribed for 6.8% (n=31) of patients, of which amoxicillin was the most common antimicrobial prescribed (61.3%), as it was associated with clinicians' perception of benefit from antibiotic treatment (odds ratio (OR): 25.9, 95% confidence interval (CI): 6.7-101.1), patients' expectation for antibiotics (OR: 5.1, 95% CI: 1.7-11.6), anticipation (OR: 5.1, 95% CI: 1.6-15.0) and request for antibiotics (OR 15.7, 95% CI: 5.0-49.4), as well as the severity of respiratory symptoms (cough, sputum, short of breath and wheeze OR: 2.7-3.7, all Pantibiotic prescription rates between private primary care clinicians and public primary care clinicians (17.4 vs 1.6%, P=0.00). Symptomatic medication was prescribed in 98.0% of patients. Mean recovery was 9 days for cough and 10 days for all symptoms, which was not significantly associated with antibiotic treatment. Although overall antibiotic-prescribing rates were low, there was a higher rate of antibiotic prescribing among private primary care clinicians, which warrants further

  15. Biopsy transcriptome expression profiling to identify kidney transplants at risk of chronic injury: a multicentre, prospective study

    Science.gov (United States)

    O’Connell, Philip J; Zhang, Weijia; Menon, Madhav C; Yi, Zhengzi; Schröppel, Bernd; Gallon, Lorenzo; Luan, Yi; Rosales, Ivy A; Ge, Yongchao; Losic, Bojan; Xi, Caixia; Woytovich, Christopher; Keung, Karen L; Wei, Chengguo; Greene, Ilana; Overbey, Jessica; Bagiella, Emilia; Najafian, Nader; Samaniego, Milagros; Djamali, Arjang; Alexander, Stephen I; Nankivell, Brian J; Chapman, Jeremy R; Smith, Rex Neal; Colvin, Robert; Murphy, Barbara

    2016-01-01

    Summary Background Chronic injury in kidney transplants remains a major cause of allograft loss. The aim of this study was to identify a gene set capable of predicting renal allografts at risk of progressive injury due to fibrosis. Methods This Genomics of Chronic Allograft Rejection (GoCAR) study is a prospective, multicentre study. We prospectively collected biopsies from renal allograft recipients (n=204) with stable renal function 3 months after transplantation. We used microarray analysis to investigate gene expression in 159 of these tissue samples. We aimed to identify genes that correlated with the Chronic Allograft Damage Index (CADI) score at 12 months, but not fibrosis at the time of the biopsy. We applied a penalised regression model in combination with permutation-based approach to derive an optimal gene set to predict allograft fibrosis. The GoCAR study is registered with ClinicalTrials.gov, number NCT00611702. Findings We identified a set of 13 genes that was independently predictive for the development of fibrosis at 1 year (ie, CADI-12 ≥2). The gene set had high predictive capacity (area under the curve [AUC] 0·967), which was superior to that of baseline clinical variables (AUC 0·706) and clinical and pathological variables (AUC 0·806). Furthermore routine pathological variables were unable to identify which histologically normal allografts would progress to fibrosis (AUC 0·754), whereas the predictive gene set accurately discriminated between transplants at high and low risk of progression (AUC 0·916). The 13 genes also accurately predicted early allograft loss (AUC 0·842 at 2 years and 0·844 at 3 years). We validated the predictive value of this gene set in an independent cohort from the GoCAR study (n=45, AUC 0·866) and two independent, publically available expression datasets (n=282, AUC 0·831 and n=24, AUC 0·972). Interpretation Our results suggest that this set of 13 genes could be used to identify kidney transplant recipients at

  16. The impact of virus infections on pneumonia mortality is complex in adults: a prospective multicentre observational study.

    Science.gov (United States)

    Katsurada, Naoko; Suzuki, Motoi; Aoshima, Masahiro; Yaegashi, Makito; Ishifuji, Tomoko; Asoh, Norichika; Hamashige, Naohisa; Abe, Masahiko; Ariyoshi, Koya; Morimoto, Konosuke

    2017-12-06

    Various viruses are known to be associated with pneumonia. However, the impact of viral infections on adult pneumonia mortality remains unclear. This study aimed to clarify the effect of virus infection on pneumonia mortality among adults stratified by virus type and patient comorbidities. This multicentre prospective study enrolled pneumonia patients aged ≥15 years from September 2011 to August 2014. Sputum samples were tested by in-house multiplex polymerase chain reaction assays to identify 13 respiratory viruses. Viral infection status and its effect on in-hospital mortality were examined by age group and comorbidity status. A total of 2617 patients were enrolled in the study and 77.8% was aged ≥65 years. 574 (21.9%) did not have comorbidities, 790 (30.2%) had chronic respiratory disease, and 1253 (47.9%) had other comorbidities. Viruses were detected in 605 (23.1%) patients. Human rhinovirus (9.8%) was the most frequently identified virus, followed by influenza A (3.9%) and respiratory syncytial virus (3.9%). Respiratory syncytial virus was more frequently identified in patients with chronic respiratory disease (4.7%) than those with other comorbidities (4.2%) and without comorbidities (2.1%) (p = 0.037). The frequencies of other viruses were almost identical between the three groups. Virus detection overall was not associated with increased mortality (adjusted risk ratio (ARR) 0.76, 95% CI 0.53-1.09). However, influenza virus A and B were associated with three-fold higher mortality in patients with chronic respiratory disease but not with other comorbidities (ARR 3.38, 95% CI 1.54-7.42). Intriguingly, paramyxoviruses were associated with dramatically lower mortality in patients with other comorbidities (ARR 0.10, 95% CI 0.01-0.70) but not with chronic respiratory disease. These effects were not affected by age group. The impact of virus infections on pneumonia mortality varies by virus type and comorbidity status in adults.

  17. Absence of low back pain to demarcate an episode: A prospective multicentre study in primary care

    DEFF Research Database (Denmark)

    Eklund, Erik A; Jensen, Irene; Lohela-Karlsson, Malin

    2016-01-01

    Background: It has been proposed that an episode of low back pain (LBP) be defined as: "a period of pain in the lower back lasting for more than 24 h preceded and followed by a period of at least 1 month without LBP". Previous studies have tested the definition in the general population and in se......Background: It has been proposed that an episode of low back pain (LBP) be defined as: "a period of pain in the lower back lasting for more than 24 h preceded and followed by a period of at least 1 month without LBP". Previous studies have tested the definition in the general population...

  18. Assessment of quality of life and functional outcome in patients sustaining moderate and major trauma: a multicentre, prospective cohort study.

    Science.gov (United States)

    Rainer, T H; Yeung, J H H; Cheung, S K C; Yuen, Y K Y; Poon, W S; Ho, H F; Kam, C W; Cattermole, G N; Chang, A; So, F L; Graham, C A

    2014-05-01

    Trauma care systems aim to reduce both death and disability, yet there is little data on post-trauma health status and functional outcome. To evaluate baseline, discharge, six month and 12 month post-trauma quality of life, functional outcome and predictors of quality of life in Hong Kong. Multicentre, prospective cohort study using data from the trauma registries of three regional trauma centres in Hong Kong. Trauma patients with an ISS≥9 and aged≥18 years were included. The main outcome measures were the physical component summary (PCS) score and mental component summary (MCS) scores of the Short-Form 36 (SF36) for health status, and the extended Glasgow Outcome Scale (GOSE) for functional outcome. Between 1 January 2010 and 31 September 2010, 400 patients (mean age 53.3 years; range 18-106; 69.5% male) were recruited to the study. There were no statistically significant differences in baseline characteristics between responders (N=177) and surviving non-responders (N=163). However, there were significant differences between these groups and the group of patients who died (N=60). Only 16/400 (4%) cases reported a GOSE≥7. 62/400 (15.5%) responders reached the HK population norm for PCS. 125/400 (31%) responders reached the HK population norm for MCS. If non-responders had similar outcomes to responders, then the percentages for GOSE≥7 would rise from 4% to 8%, for PCS from 15.5% to 30%, and for MCS from 31% to 60%. Univariate analysis showed that 12-month poor quality of life was significantly associated with age>65 years (OR 4.77), male gender (OR 0.44), pre-injury health problems (OR 2.30), admission to ICU (OR 2.15), ISS score 26-40 (OR 3.72), baseline PCS (OR 0.89), one-month PCS (OR 0.89), one-month MCS (OR 0.97), 6-month PCS (OR 0.76) and 6-month MCS (OR 0.97). For patients sustaining moderate or major trauma in Hong Kong at 12 months after injury<1 in 10 patients had an excellent recovery, ≤3 in 10 reached a physical health status score

  19. Colonoscopic full-thickness resection using an over-the-scope device: a prospective multicentre study in various indications.

    Science.gov (United States)

    Schmidt, Arthur; Beyna, Torsten; Schumacher, Brigitte; Meining, Alexander; Richter-Schrag, Hans-Juergen; Messmann, Helmut; Neuhaus, Horst; Albers, David; Birk, Michael; Thimme, Robert; Probst, Andreas; Faehndrich, Martin; Frieling, Thomas; Goetz, Martin; Riecken, Bettina; Caca, Karel

    2017-08-10

    Endoscopic full-thickness resection (EFTR) is a novel treatment of colorectal lesions not amenable to conventional endoscopic resection. The aim of this prospective multicentre study was to assess the efficacy and safety of the full-thickness resection device. 181 patients were recruited in 9 centres with the indication of difficult adenomas (non-lifting and/or at difficult locations), early cancers and subepithelial tumours (SET). Primary endpoint was complete en bloc and R0 resection. EFTR was technically successful in 89.5%, R0 resection rate was 76.9%. In 127 patients with difficult adenomas and benign histology, R0 resection rate was 77.7%. In 14 cases, lesions harboured unsuspected cancer, another 15 lesions were primarily known as cancers. Of these 29 cases, R0 resection was achieved in 72.4%; 8 further cases had deep submucosal infiltration >1000 µm. Therefore, curative resection could only be achieved in 13/29 (44.8%). In the subgroup with SET (n=23), R0 resection rate was 87.0%. In general, R0 resection rate was higher with lesions ≤2 cm vs >2 cm (81.2% vs 58.1%, p=0.0038). Adverse event rate was 9.9% with a 2.2% rate of emergency surgery. Three-month follow-up was available from 154 cases and recurrent/residual tumour was evident in 15.3%. EFTR has a reasonable technical efficacy especially in lesions ≤2 cm with acceptable complication rates. Curative resection rate for early cancers was too low to recommend its primary use in this indication. Further comparative studies have to show the clinical value and long-term outcome of EFTR in benign colorectal lesions. NCT02362126; Results. © 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.

  20. Coerced hospital admission and symptom change--a prospective observational multi-centre study.

    Directory of Open Access Journals (Sweden)

    Thomas W Kallert

    Full Text Available INTRODUCTION: Coerced admission to psychiatric hospitals, defined by legal status or patient's subjective experience, is common. Evidence on clinical outcomes however is limited. This study aimed to assess symptom change over a three month period following coerced admission and identify patient characteristics associated with outcomes. METHOD: At study sites in 11 European countries consecutive legally involuntary patients and patients with a legally voluntary admission who however felt coerced, were recruited and assessed by independent researchers within the first week after admission. Symptoms were assessed on the Brief Psychiatric Rating Scale. Patients were re-assessed after one and three months. RESULTS: The total sample consisted of 2326 legally coerced patients and 764 patients with a legally voluntary admission who felt coerced. Symptom levels significantly improved over time. In a multivariable analysis, higher baseline symptoms, being unemployed, living alone, repeated hospitalisation, being legally a voluntary patient but feeling coerced, and being initially less satisfied with treatment were all associated with less symptom improvement after one month and, other than initial treatment satisfaction, also after three months. The diagnostic group was not linked with outcomes. DISCUSSION: On average patients show significant but limited symptom improvements after coerced hospital admission, possibly reflecting the severity of the underlying illnesses. Social factors, but not the psychiatric diagnosis, appear important predictors of outcomes. Legally voluntary patients who feel coerced may have a poorer prognosis than legally involuntary patients and deserve attention in research and clinical practice.

  1. Nurses' knowledge and attitudes regarding major immobility complications among bedridden patients: A prospective multicentre study.

    Science.gov (United States)

    Li, Zhen; Zhou, Xinmei; Cao, Jing; Li, Zheng; Wan, Xia; Li, Jiaqian; Jiao, Jing; Liu, Ge; Liu, Ying; Li, Fangfang; Song, Baoyun; Jin, Jingfen; Liu, Yilan; Wen, Xianxiu; Cheng, Shouzhen; Wu, Xinjuan

    2018-05-01

    To gain insight into nurses' knowledge and attitudes regarding major immobility complications (pressure ulcers, pneumonia, deep vein thrombosis and urinary tract infections) and explore the correlation of nurses' knowledge and attitudes with the incidence of these complications. Immobility complications have adverse consequences, and effective management requires appropriate knowledge, attitudes and skills. Evidence about nurses' knowledge and attitudes regarding immobility complications is lacking. Cross-sectional study. A total of 3,903 nurses and 21,333 bedridden patients from 25 hospitals in China were surveyed. Nurses' knowledge and attitudes regarding major immobility complications were assessed using researcher-developed questionnaires. The content validity, reliability and internal consistency of the questionnaires were validated through expert review and a pilot study. The incidence of major immobility complications among bedridden patients from selected wards was surveyed by trained investigators. Correlations between knowledge, attitudes and the incidence of major immobility complications were evaluated with multilevel regression models. Mean knowledge scores were 64.07% for pressure ulcers, 72.92% for deep vein thrombosis, 76.54% for pneumonia and 83.30% for urinary tract infections. Mean attitude scores for these complications were 86.25%, 84.31%, 85.00% and 84.53%, respectively. Knowledge and attitude scores were significantly higher among nurses with older age, longer employment duration, higher education level, previous training experience and those working in tertiary hospitals or critical care units. Nurses' knowledge about pressure ulcers was negatively related to the incidence of pressure ulcers, and attitude towards pneumonia was negatively correlated with the incidence of pneumonia. Clinical nurses have relatively positive attitudes but inadequate knowledge regarding major immobility complications. Improved knowledge and attitudes regarding

  2. Detection of residual disease after neoadjuvant chemoradiotherapy for oesophageal cancer (preSANO): a prospective multicentre, diagnostic cohort study.

    Science.gov (United States)

    Noordman, Bo Jan; Spaander, Manon C W; Valkema, Roelf; Wijnhoven, Bas P L; van Berge Henegouwen, Mark I; Shapiro, Joël; Biermann, Katharina; van der Gaast, Ate; van Hillegersberg, Richard; Hulshof, Maarten C C M; Krishnadath, Kausilia K; Lagarde, Sjoerd M; Nieuwenhuijzen, Grard A P; Oostenbrug, Liekele E; Siersema, Peter D; Schoon, Erik J; Sosef, Meindert N; Steyerberg, Ewout W; van Lanschot, J Jan B

    2018-05-31

    After neoadjuvant chemoradiotherapy for oesophageal cancer, roughly half of the patients with squamous cell carcinoma and a quarter of those with adenocarcinoma have a pathological complete response of the primary tumour before surgery. Thus, the necessity of standard oesophagectomy after neoadjuvant chemoradiotherapy should be reconsidered for patients who respond sufficiently to neoadjuvant treatment. In this study, we aimed to establish the accuracy of detection of residual disease after neoadjuvant chemoradiotherapy with different diagnostic approaches, and the optimal combination of diagnostic techniques for clinical response evaluations. The preSANO trial was a prospective, multicentre, diagnostic cohort study at six centres in the Netherlands. Eligible patients were aged 18 years or older, had histologically proven, resectable, squamous cell carcinoma or adenocarcinoma of the oesophagus or oesophagogastric junction, and were eligible for potential curative therapy with neoadjuvant chemoradiotherapy (five weekly cycles of carboplatin [area under the curve 2 mg/mL per min] plus paclitaxel [50 mg/m 2 of body-surface area] combined with 41·4 Gy radiotherapy in 23 fractions) followed by oesophagectomy. 4-6 weeks after completion of neoadjuvant chemoradiotherapy, patients had oesophagogastroduodenoscopy with biopsies and endoscopic ultrasonography with measurement of maximum tumour thickness. Patients with histologically proven locoregional residual disease or no-pass during endoscopy and without distant metastases underwent immediate surgical resection. In the remaining patients a second clinical response evaluation was done (PET-CT, oesophagogastroduodenoscopy with biopsies, endoscopic ultrasonography with measurement of maximum tumour thickness, and fine-needle aspiration of suspicious lymph nodes), followed by surgery 12-14 weeks after completion of neoadjuvant chemoradiotherapy. The primary endpoint was the correlation between clinical response during

  3. Xpert MTB/RIF Ultra for detection of Mycobacterium tuberculosis and rifampicin resistance: a prospective multicentre diagnostic accuracy study.

    Science.gov (United States)

    Dorman, Susan E; Schumacher, Samuel G; Alland, David; Nabeta, Pamela; Armstrong, Derek T; King, Bonnie; Hall, Sandra L; Chakravorty, Soumitesh; Cirillo, Daniela M; Tukvadze, Nestani; Bablishvili, Nino; Stevens, Wendy; Scott, Lesley; Rodrigues, Camilla; Kazi, Mubin I; Joloba, Moses; Nakiyingi, Lydia; Nicol, Mark P; Ghebrekristos, Yonas; Anyango, Irene; Murithi, Wilfred; Dietze, Reynaldo; Lyrio Peres, Renata; Skrahina, Alena; Auchynka, Vera; Chopra, Kamal Kishore; Hanif, Mahmud; Liu, Xin; Yuan, Xing; Boehme, Catharina C; Ellner, Jerrold J; Denkinger, Claudia M

    2018-01-01

    The Xpert MTB/RIF assay is an automated molecular test that has improved the detection of tuberculosis and rifampicin resistance, but its sensitivity is inadequate in patients with paucibacillary disease or HIV. Xpert MTB/RIF Ultra (Xpert Ultra) was developed to overcome this limitation. We compared the diagnostic performance of Xpert Ultra with that of Xpert for detection of tuberculosis and rifampicin resistance. In this prospective, multicentre, diagnostic accuracy study, we recruited adults with pulmonary tuberculosis symptoms presenting at primary health-care centres and hospitals in eight countries (South Africa, Uganda, Kenya, India, China, Georgia, Belarus, and Brazil). Participants were allocated to the case detection group if no drugs had been taken for tuberculosis in the past 6 months or to the multidrug-resistance risk group if drugs for tuberculosis had been taken in the past 6 months, but drug resistance was suspected. Demographic information, medical history, chest imaging results, and HIV test results were recorded at enrolment, and each participant gave at least three sputum specimen on 2 separate days. Xpert and Xpert Ultra diagnostic performance in the same sputum specimen was compared with culture tests and drug susceptibility testing as reference standards. The primary objectives were to estimate and compare the sensitivity of Xpert Ultra test with that of Xpert for detection of smear-negative tuberculosis and rifampicin resistance and to estimate and compare Xpert Ultra and Xpert specificities for detection of rifampicin resistance. Study participants in the case detection group were included in all analyses, whereas participants in the multidrug-resistance risk group were only included in analyses of rifampicin-resistance detection. Between Feb 18, and Dec 24, 2016, we enrolled 2368 participants for sputum sampling. 248 participants were excluded from the analysis, and 1753 participants were distributed to the case detection group (n=1439

  4. Does osteoporosis increase complication risk in surgical fracture treatment? A protocol combining new endpoints for two prospective multicentre open cohort studies

    Directory of Open Access Journals (Sweden)

    Marent Marta

    2010-11-01

    Full Text Available Abstract Background With an ever-increasing elderly population, orthopaedic surgeons are faced with treating a high number of fragility fractures. Biomechanical tests have demonstrated the potential role of osteoporosis in the increased risk of fracture fixation complications, yet this has not been sufficiently proven in clinical practice. Based on this knowledge, two clinical studies were designed to investigate the influence of local bone quality on the occurrence of complications in elderly patients with distal radius and proximal humerus fractures treated by open reduction and internal fixation. Methods/Design The studies were planned using a prospective multicentre open cohort design and included patients between 50 and 90 years of age. Distal radius and proximal humerus fractures were treated with locking compression 2.4 mm and proximal humerus internal locking plates, respectively. Follow-up examinations were planned for 6 weeks, 3 and 12 months as well as a telephone interview at 6 months. The primary outcome focuses on the occurrence of at least one local bone quality related complication. Local bone quality is determined by measuring bone mineral density and bone mineral content at the contralateral radius. Primary complications are categorised according to predefined factors directly related to the bone/fracture or the implant/surgical technique. Secondary outcomes include the documentation of soft tissue/wound or general/systemic complications, clinical assessment of range of motion, and patient-rated evaluations of upper limb function and quality of life using both objective and subjective measures. Discussion The prospective multicentre open cohort studies will determine the value of local bone quality as measured by bone mineral density and content, and compare the quality of local bone of patients who experience a complication (cases following surgery with that of patients who do not (controls. These measurements are novel and

  5. Protocol for a multicentre, prospective, population-based cohort study of variation in practice of cholecystectomy and surgical outcomes (The CholeS study).

    Science.gov (United States)

    Vohra, Ravinder S; Spreadborough, Philip; Johnstone, Marianne; Marriott, Paul; Bhangu, Aneel; Alderson, Derek; Morton, Dion G; Griffiths, Ewen A

    2015-01-12

    Cholecystectomy is one of the most common general surgical operations performed. Despite level one evidence supporting the role of cholecystectomy in the management of specific gallbladder diseases, practice varies between surgeons and hospitals. It is unknown whether these variations account for the differences in surgical outcomes seen in population-level retrospective data sets. This study aims to investigate surgical outcomes following acute, elective and delayed cholecystectomies in a multicentre, contemporary, prospective, population-based cohort. UK and Irish hospitals performing cholecystectomies will be recruited utilising trainee-led research collaboratives. Two months of consecutive, adult patient data will be included. The primary outcome measure of all-cause 30-day readmission rate will be used in this study. Thirty-day complication rates, bile leak rate, common bile duct injury, conversion to open surgery, duration of surgery and length of stay will be measured as secondary outcomes. Prospective data on over 8000 procedures is anticipated. Individual hospitals will be surveyed to determine local policies and service provision. Variations in outcomes will be investigated using regression modelling to adjust for confounders. Research ethics approval is not required for this study and has been confirmed by the online National Research Ethics Service (NRES) decision tool. This novel study will investigate how hospital-level surgical provision can affect patient outcomes, using a cross-sectional methodology. The results are essential to inform commissioning groups and implement changes within the National Health Service (NHS). Dissemination of the study protocol is primarily through the trainee-led research collaboratives and the Association of Upper Gastrointestinal Surgeons (AUGIS). Individual centres will have access to their own results and the collective results of the study will be published in peer-reviewed journals and presented at relevant

  6. Can Clinical and Surgical Parameters Be Combined to Predict How Long It Will Take a Tibia Fracture to Heal? A Prospective Multicentre Observational Study: The FRACTING Study

    Directory of Open Access Journals (Sweden)

    Leo Massari

    2018-01-01

    Full Text Available Background. Healing of tibia fractures occurs over a wide time range of months, with a number of risk factors contributing to prolonged healing. In this prospective, multicentre, observational study, we investigated the capability of FRACTING (tibia FRACTure prediction healING days score, calculated soon after tibia fracture treatment, to predict healing time. Methods. The study included 363 patients. Information on patient health, fracture morphology, and surgical treatment adopted were combined to calculate the FRACTING score. Fractures were considered healed when the patient was able to fully weight-bear without pain. Results. 319 fractures (88% healed within 12 months from treatment. Forty-four fractures healed after 12 months or underwent a second surgery. FRACTING score positively correlated with days to healing: r=0.63 (p<0.0001. Average score value was 7.3 ± 2.5; ROC analysis showed strong reliability of the score in separating patients healing before versus after 6 months: AUC = 0.823. Conclusions. This study shows that the FRACTING score can be employed both to predict months needed for fracture healing and to identify immediately after treatment patients at risk of prolonged healing. In patients with high score values, new pharmacological and nonpharmacological treatments to enhance osteogenesis could be tested selectively, which may finally result in reduced disability time and health cost savings.

  7. Safety of gadobutrol in over 23,000 patients: the GARDIAN study, a global multicentre, prospective, non-interventional study

    Energy Technology Data Exchange (ETDEWEB)

    Prince, Martin R. [Weill Cornell Medical College, Department of Radiology, New York, NY (United States); Columbia College of Physicians and Surgeons, Department of Radiology, New York, NY (United States); Lee, Hae Giu [Seoul St. Mary' s Hospital, The Catholic University of Korea, College of Medicine, Department of Radiology, Seoul (Korea, Republic of); Lee, Chang-Hee [Korea University Guro Hospital, Department of Radiology, Seoul (Korea, Republic of); Youn, Sung Won [Catholic University of Daegu Medical Center, Department of Radiology, Daegu (Korea, Republic of); Lee, In Ho [Chungnam National University Hospital, Chungnam National University School of Medicine, Department of Radiology, Daejeon (Korea, Republic of); Yoon, Woong [Chonnam National University Hospital, Department of Radiology, Gwangju (Korea, Republic of); Yang, Benqiang [General Hospital of Shenyang Military Region, Department of Radiology, Shenyang (China); Wang, Haiping [Tangshan Worker' s Hospital, Department of Radiology, Tangshan (China); Wang, Jin [Third Affiliated Hospital of Sun Yat-Sen University, Department of Radiology, Guangzhou (China); Shih, Tiffany Ting-fang [National Taiwan University, Medical College and Hospital, Department of Radiology and Medical Imaging, Taipei (China); Huang, Guo-Shu [National Defense Medical Center, Department of Radiology, Tri-Service General Hospital, Taipei (China); Lirng, Jiing-Feng [Taipei Veterans General Hospital, Department of Radiology, Taipei (China); Palkowitsch, Petra [Medical and Clinical Affairs Radiology, Bayer Pharmaceutical Division, Berlin (Germany); Collaboration: on behalf of the GARDIAN study group

    2017-01-15

    To investigate the safety and tolerability of gadobutrol at the recommended dose in patients requiring contrast-enhanced magnetic resonance imaging/angiography (MRI/MRA) in the routine setting. GARDIAN prospectively enrolled 23,708 patients undergoing routine gadobutrol-enhanced MRI/MRA for approved indications at 272 study centres in Europe, Asia, North America, and Africa and monitored for adverse events. Median gadobutrol dose was 0.11 mmol/kg body weight. The overall incidence of adverse drug reactions (ADRs) was 0.7 % (n = 170 patients), with similar incidences in patients with renal impairment or cardiac disease, from different geographic regions and in different gadobutrol dose groups. Patients at risk for contrast media reaction had an ADR incidence of 2.5 %. Five patients (0.02 %) experienced serious adverse events, four were drug-related. One patient experienced a fatal anaphylactoid shock, assessed to be related to injection of gadobutrol. The contrast quality of gadobutrol-enhanced images was rated by treating physicians as good or excellent in 97 % cases, with similar ratings in all patient subgroups and indications. The GARDIAN study shows that gadobutrol at the recommended dose is well tolerated across a large, diverse patient population. (orig.)

  8. Safety of gadobutrol in over 23,000 patients: the GARDIAN study, a global multicentre, prospective, non-interventional study

    International Nuclear Information System (INIS)

    Prince, Martin R.; Lee, Hae Giu; Lee, Chang-Hee; Youn, Sung Won; Lee, In Ho; Yoon, Woong; Yang, Benqiang; Wang, Haiping; Wang, Jin; Shih, Tiffany Ting-fang; Huang, Guo-Shu; Lirng, Jiing-Feng; Palkowitsch, Petra

    2017-01-01

    To investigate the safety and tolerability of gadobutrol at the recommended dose in patients requiring contrast-enhanced magnetic resonance imaging/angiography (MRI/MRA) in the routine setting. GARDIAN prospectively enrolled 23,708 patients undergoing routine gadobutrol-enhanced MRI/MRA for approved indications at 272 study centres in Europe, Asia, North America, and Africa and monitored for adverse events. Median gadobutrol dose was 0.11 mmol/kg body weight. The overall incidence of adverse drug reactions (ADRs) was 0.7 % (n = 170 patients), with similar incidences in patients with renal impairment or cardiac disease, from different geographic regions and in different gadobutrol dose groups. Patients at risk for contrast media reaction had an ADR incidence of 2.5 %. Five patients (0.02 %) experienced serious adverse events, four were drug-related. One patient experienced a fatal anaphylactoid shock, assessed to be related to injection of gadobutrol. The contrast quality of gadobutrol-enhanced images was rated by treating physicians as good or excellent in 97 % cases, with similar ratings in all patient subgroups and indications. The GARDIAN study shows that gadobutrol at the recommended dose is well tolerated across a large, diverse patient population. (orig.)

  9. First clinical evaluation of a new single-use flexible ureteroscope (LithoVue™): a European prospective multicentric feasibility study

    NARCIS (Netherlands)

    Doizi, Steeve; Kamphuis, Guido; Giusti, Guido; Andreassen, Kim Hovgaard; Knoll, Thomas; Osther, Palle Jörn; Scoffone, Cesare; Pérez-Fentes, Daniel; Proietti, Silvia; Wiseman, Oliver; de la Rosette, Jean; Traxer, Olivier

    2017-01-01

    We evaluated a new digital single-use flexible ureteroscope, LithoVue™ with respect to deflection, image quality and maneuverability. A prospective cohort study was conducted in eight tertiary reference centers in Europe in December 2015 and January 2016. All consecutive patients included underwent

  10. Quality of life before and after TVT, a prospective multicentre cohort study, results from the Netherlands TVT database

    NARCIS (Netherlands)

    Koops, SES; Bisseling, TM; Heintz, APM; Vervest, HAM

    Objective To asses the long term outcome of tension-free vaginal tape procedure in women with isolated stress urinary incontinence (SUI). Design Prospective cohort study. Setting Twenty-eight teaching hospitals and 13 local hospitals, with 54 gynaecologists and urologists performing the surgery.

  11. Protocol for a multicentre, multistage, prospective study in China using system-based approaches for consistent improvement in surgical safety.

    Science.gov (United States)

    Yu, Xiaochu; Jiang, Jingmei; Liu, Changwei; Shen, Keng; Wang, Zixing; Han, Wei; Liu, Xingrong; Lin, Guole; Zhang, Ye; Zhang, Ying; Ma, Yufen; Bo, Haixin; Zhao, Yupei

    2017-06-15

    Surgical safety has emerged as a crucial global health issue in the past two decades. Although several safety-enhancing tools are available, the pace of large-scale improvement remains slow, especially in developing countries such as China. The present project (Modern Surgery and Anesthesia Safety Management System Construction and Promotion) aims to develop and validate system-based integrated approaches for reducing perioperative deaths and complications using a multicentre, multistage design. The project involves collection of clinical and outcome information for 1 20 000 surgical inpatients at four regionally representative academic/teaching general hospitals in China during three sequential stages: preparation and development, effectiveness validation and improvement of implementation for promotion. These big data will provide the evidence base for the formulation, validation and improvement processes of a system-based stratified safety intervention package covering the entire surgical pathway. Attention will be directed to managing inherent patient risks and regulating medical safety behaviour. Information technology will facilitate data collection and intervention implementation, provide supervision mechanisms and guarantee transfer of key patient safety messages between departments and personnel. Changes in rates of deaths, surgical complications during hospitalisation, length of stay, system adoption and implementation rates will be analysed to evaluate effectiveness and efficiency. This study was approved by the institutional review boards of Peking Union Medical College Hospital, First Hospital of China Medical University, Qinghai Provincial People's Hospital, Xiangya Hospital Central South University and the Institute of Basic Medical Sciences, Chinese Academy of Medical Sciences. Study findings will be disseminated via peer-reviewed journals, conference presentations and patent papers. © Article author(s) (or their employer(s) unless otherwise

  12. Clinical Outcome after the Use of a New Craniocaudal Expandable Implant for Vertebral Compression Fracture Treatment: One Year Results from a Prospective Multicentric Study

    Directory of Open Access Journals (Sweden)

    David Noriega

    2015-01-01

    Full Text Available The purpose of this prospective multicentric observational study was to confirm the safety and clinical performance of a craniocaudal expandable implant used in combination with high viscosity PMMA bone cement for the treatment of vertebral compression fractures. Thirty-nine VCFs in 32 patients were treated using the SpineJack minimally invasive surgery protocol. Outcome was determined by using the Visual Analogue Scale for measuring pain, the Oswestry Disability Index for scoring functional capacity, and the self-reporting European Quality of Life scores for the quality of life. Safety was evaluated by reporting all adverse events. The occurrence of cement leakages was assessed by either radiographs or CT scan or both. Statistically significant improvements were found regarding pain, function, and quality of life. The global pain score reduction at 1 year was 80.9% compared to the preoperative situation and the result of the Oswestry Disability Index showed a decrease from 65.0% at baseline to 10.5% at 12 months postoperatively. The cement leakage rate was 30.8%. No device- or surgery-related complications were found. This observational study demonstrates promising and persistent results consisting of immediate and sustained pain relief and durable clinical improvement after the procedure and throughout the 1-year follow-up period.

  13. Clinical outcome after the use of a new craniocaudal expandable implant for vertebral compression fracture treatment: one year results from a prospective multicentric study.

    Science.gov (United States)

    Noriega, David; Krüger, Antonio; Ardura, Francisco; Hansen-Algenstaedt, Nils; Hassel, Frank; Barreau, Xavier; Beyerlein, Jörg

    2015-01-01

    The purpose of this prospective multicentric observational study was to confirm the safety and clinical performance of a craniocaudal expandable implant used in combination with high viscosity PMMA bone cement for the treatment of vertebral compression fractures. Thirty-nine VCFs in 32 patients were treated using the SpineJack minimally invasive surgery protocol. Outcome was determined by using the Visual Analogue Scale for measuring pain, the Oswestry Disability Index for scoring functional capacity, and the self-reporting European Quality of Life scores for the quality of life. Safety was evaluated by reporting all adverse events. The occurrence of cement leakages was assessed by either radiographs or CT scan or both. Statistically significant improvements were found regarding pain, function, and quality of life. The global pain score reduction at 1 year was 80.9% compared to the preoperative situation and the result of the Oswestry Disability Index showed a decrease from 65.0% at baseline to 10.5% at 12 months postoperatively. The cement leakage rate was 30.8%. No device- or surgery-related complications were found. This observational study demonstrates promising and persistent results consisting of immediate and sustained pain relief and durable clinical improvement after the procedure and throughout the 1-year follow-up period.

  14. Prospective, Multi-Centre, Single-Arm Study of Mechanical Thrombectomy using Solitaire FR in Acute Ischemic Stroke-STAR

    Science.gov (United States)

    Pereira, Vitor M; Gralla, Jan; Davalos, Antoni; Bonafé, Alain; Castaño, Carlos; Chapot, Rene; Liebeskind, David S; Nogueira, Raul G; Arnold, Marcel; Sztajzel, Roman; Liebig, Thomas; Goyal, Mayank; Besselmann, Michael; Moreno, Alfredo; Schroth, Gerhard

    2013-01-01

    Background and Purpose Mechanical thrombectomy using stent retriever devices have been advocated to increase revascularization in intracranial vessel occlusion. We present the results of a large prospective study on the use of the Solitaire FR in patients with acute ischemic stroke. Methods STAR was an international, multicenter, prospective, single-arm study of Solitaire FR thrombectomy in patients with large vessel anterior circulation strokes treated within 8 hours of symptom onset. Strict criteria for site selection were applied. The primary endpoint was the revascularization rate (3TICI 2b) of the occluded vessel as determined by an independent core lab. The secondary endpoint was the rate of good functional outcome (defined as 90-day modified Rankin scale (mRS) 0–2). Results A total of 202 patients were enrolled across 14 comprehensive stroke centers in Europe, Canada and Australia. The median age was 72 years, 60% were female patients. The median National Institute of Health Stroke Scale (NIHSS) was 17. Most proximal intracranial occlusion was the internal carotid artery in 18%, the middle cerebral artery in 82%. Successful revascularization was achieved in 79.2% of patients. Device and/or procedure related severe adverse events were found in 7.4%. Favorable neurological outcome was found in 57.9%. The mortality rate was 6.9%. Any intracranial hemorrhagic transformation was found in 18.8% of patients, 1.5% were symptomatic. Conclusions In this single arm study, treatment with the Solitaire™ FR device in intracranial anterior circulation occlusions results in high rates of revascularization, low risk of clinically relevant procedural complications, and good clinical outcomes in combination with low mortality at 90 days. Clinical Trial Registration This study is registered with ClinicalTrials.gov, number NCT01327989. PMID:23908066

  15. Phenotypic ASCO Characterisation of Young Patients with Ischemic Stroke in the Prospective Multicentre Observational sifap1 Study.

    Science.gov (United States)

    Wolf, Marc E; Grittner, Ulrike; Böttcher, Tobias; Norrving, Bo; Rolfs, Arndt; Hennerici, Michael G

    2015-01-01

    The prospective, multinational European 'Stroke in Young Fabry Patients' (sifap1) study collected 4,467 patients with acute ischemic cerebrovascular events aged 18-55 years. Initially, aetiologic subtyping was performed using the TOAST classification; however, recently the phenotypic ASCO classification was presented and might be more useful to identify stroke aetiologies in young patients with a wide set of different causes. ASCO is a classification system divided in four etiologic categories (Atherosclerosis, Small vessel disease (SVD), Cardiac embolism, Other cause) with different grades of severity (1-3) and aims to characterise patients in a more comprehensive way. We determined the ASCO score for each patient, according to prospectively collected data using the study protocol. The distribution of aetiologies was analysed with regard to concomitant causes, cryptogenic stroke and different age groups. A potentially causal aetiology (grade 1) was detected in 29.3% of 4,467 patients. Merging grades 1 and 2, a suspected aetiology was found in 54.1%. In 8.6% of patients concomitant aetiologies were identified. Most common causes were cervical arterial dissection and persistent foramen ovale, but there was also a high prevalence of large artery atherosclerosis and SVD especially in older patients of this collective. About 50% of patients had more than one finding with a lower grade of evidence (grade 3). In 14% final classification of strictly cryptogenic stroke was made. This is the largest study to date, using the ASCO characterisation of ischemic stroke aetiologies. ASCO classification provides first evidence that many young patients presenting with acute stroke have concomitant stroke aetiologies associated with a substantial atherosclerosis risk profile. ASCO could be integrated in clinical routine and registry data banks, as well as large clinical trials to improve stroke documentation. © 2015 S. Karger AG, Basel.

  16. Patient-controlled hospital admission for patients with severe mental disorders: study protocol for a nationwide prospective multicentre study.

    Science.gov (United States)

    Thomsen, Christoffer Torgaard; Benros, Michael Eriksen; Hastrup, Lene Halling; Andersen, Per Kragh; Giacco, Domenico; Nordentoft, Merete

    2016-09-28

    Patient-controlled hospital admission for individuals with severe mental disorders is a novel approach in mental healthcare. Patients can admit themselves to a hospital unit for a short stay without being assessed by a psychiatrist or contacting the emergency department. Previous studies assessing the outcomes of patient-controlled hospital admission found trends towards reduction in the use of coercive measures and length of hospital stay; however, these studies have methodological shortcomings and small sample sizes. Larger studies are needed to estimate the effect of patient-controlled hospital admission on the use of coercion and of healthcare services. We aim to recruit at least 315 patients who are offered a contract for patient-controlled hospital admissions in eight different hospitals in Denmark. Patients will be followed-up for at least 1 year to compare the use of coercive measures and of healthcare services, the use of medications and suicidal behaviour. Descriptive statistics will be used to investigate hospitalisations, global assessment of functioning (GAF) and patient satisfaction with treatment. To minimise selection bias, we will match individuals using patient-controlled hospital admission and controls with a 1:5 ratio via a propensity score based on the following factors: sex, age group, primary diagnosis, substance abuse as secondary diagnosis, coercion, number of psychiatric bed days, psychiatric history, urbanity and suicidal behaviour. Additionally, a historical control study will be undertaken in which patients serve as their own control group prior to index date. The study has been approved by The Danish Health and Medicines Authority (j.nr.: 3-3013-934/1/) and by The Danish Data Protection Agency (j.nr.: 2012-58-0004). The study was categorised as a register study by The Danish Health Research Ethics Committee and therefore no further approval was needed (j.nr.: H-2-2014-FSP70). Findings will be disseminated through scientific

  17. FDG PET during radiochemotherapy is predictive of outcome at 1 year in non-small-cell lung cancer patients: a prospective multicentre study (RTEP2)

    International Nuclear Information System (INIS)

    Vera, Pierre; Edet-Sanson, Agathe; Modzelewski, Romain; Mezzani-Saillard, Sandrine; Thureau, Sebastien; Dubray, Bernard; Menard, Jean-Francois; Meyer, Marc-Etienne; Jalali, Khadija; Bardet, Stephane; Lerouge, Delphine; Houzard, Claire; Mornex, Francoise; Olivier, Pierre; Faure, Guillaume; Rousseau, Caroline; Mahe, Marc-Andre; Gomez, Philippe; Brenot-Rossi, Isabelle; Salem, Naji

    2014-01-01

    To assess prospectively the prognostic value of FDG PET/CT during curative-intent radiotherapy (RT) with or without concomitant chemotherapy in patients with non-small-cell lung cancer (NSCLC). Patients with histological proof of invasive localized NSCLC and evaluable tumour, and who were candidates for curative-intent radiochemotherapy (RCT) or RT were preincluded after providing written informed consent. Definitive inclusion was conditional upon significant FDG uptake before RT (PET 1 ). All included patients had a FDG PET/CT scan during RT (PET 2 , mean dose 43 Gy) and were evaluated by FDG PET/CT at 3 months and 1 year after RT. The main endpoint was death (from whatever cause) or tumour progression at 1 year. Of 77 patients preincluded, 52 were evaluable. Among the evaluable patients, 77 % received RT with induction chemotherapy and 73 % RT with concomitant chemotherapy. At 1 year, 40 patients (77 %) had died or had tumour progression. No statistically significant association was found between stage (IIIB vs. other), histology (squamous cell carcinoma vs. other), induction or concomitant chemotherapy, and death/tumour progression at 1 year. The SUV max in the PET 2 scan was the single variable predictive of death or tumour progression at 1 year (odds ratio 1.97, 95 % CI 1.25 - 3.09, p = 0.003) in multivariate analysis. The area under the receiver operating characteristic curve was 0.85 (95 % CI 0.73 - 0.94, p -4 ). A SUV max value of 5.3 in the PET 2 scan yielded a sensitivity of 70 % and a specificity of 92 % for predicting tumour progression or death at 1 year. This prospective multicentre study demonstrated the prognostic value in terms of disease-free survival of SUV max assessed during the 5th week of curative-intent RT or RCT in NSCLC patients (NCT01261598; RTEP2 study). (orig.)

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

    Science.gov (United States)

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

    2014-11-01

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

  19. Impact of harmful use of alcohol on the sedation of critical patients on mechanical ventilation: A multicentre prospective, observational study in 8 Spanish intensive care units.

    Science.gov (United States)

    Sandiumenge, A; Torrado, H; Muñoz, T; Alonso, M Á; Jiménez, M J; Alonso, J; Pardo, C; Chamorro, C

    2016-05-01

    To evaluate the impact of a history of harmful use of alcohol (HUA) on sedoanalgesia practices and outcomes in patients on mechanical ventilation (MV). A prospective, observational multicentre study was made of all adults consecutively admitted during 30 days to 8 Spanish ICUs. Patients on MV >24h were followed-up on until discharge from the ICU or death. Data on HUA, smoking, the use of illegal (IP) and medically prescribed psychotropics (MPP), sedoanalgesia practices and their related complications (sedative failure [SF] and sedative withdrawal [SW]), as well as outcome, were prospectively recorded. A total of 23.4% (119/509) of the admitted patients received MV >24h; 68.9% were males; age 57.0 (17.9) years; APACHE II score 18.8 (7.2); with a medical cause of admission in 53.9%. Half of them consumed at least one psychotropic agent (smoking 27.7%, HUA 25.2%; MPP 9.2%; and IP 7.6%). HUA patients more frequently required PS (86.7% vs. 64%; p2 sedatives (56.7% vs. 28.1%; p<0.02). HUA was associated to an eightfold (p<0.001) and fourfold (p<0.02) increase in SF and SW, respectively. In turn, the duration of MV and the stay in the ICU was increased by 151h (p<0.02) and 4.4 days (p<0.02), respectively, when compared with the non-HUA group. No differences were found in terms of mortality. HUA may be associated to a higher risk of SF and WS, and can prolong MV and the duration of stay in the ICU in critical patients. Early identification could allow the implementation of specific sedation strategies aimed at preventing these complications. Copyright © 2015 Elsevier España, S.L.U. and SEMICYUC. All rights reserved.

  20. Inflammatory Bowel Disease Phenotype as Risk Factor for Cancer in a Prospective Multicentre Nested Case-Control IG-IBD Study.

    Science.gov (United States)

    Biancone, Livia; Armuzzi, Alessandro; Scribano, Maria Lia; D'Inca, Renata; Castiglione, Fabiana; Papi, Claudio; Angelucci, Erika; Daperno, Marco; Mocciaro, Filippo; Riegler, Gabriele; Fries, Walter; Meucci, Gianmichele; Alvisi, Patrizia; Spina, Luisa; Ardizzone, Sandro; Petruzziello, Carmelina; Ruffa, Alessandra; Kohn, Anna; Vecchi, Maurizio; Guidi, Luisa; Di Mitri, Roberto; Renna, Sara; Emma, Calabrese; Rogai, Francesca; Rossi, Alessandra; Orlando, Ambrogio; Pallone, Francesco

    2016-08-01

    Cancer risk in inflammatory bowel disease [IBD] is still debated. In a prospective, multicentre, nested case-control study, we aimed to characterise incident cases of cancer in IBD. The role of immunomodulators vs clinical characteristics of IBD as risk factors for cancer was also investigated. From January 2012 to December 2014, each IBD patient with incident cancer was matched with two IBD patients without cancer for: IBD type, gender, and age. Risk factors were assessed by multivariate regression analysis. IBD patients considered numbered 44619: 21953 Crohn's disease [CD], 22666 ulcerative colitis [UC]. Cancer occurred in 174 patients: 99 CD [CD-K], 75 UC [UC-K]. Controls included 198 CD [CD-C], 150 UC [UC-C]. Cancer incidence in IBD was 3.9/1000, higher in CD (4.5/1000 [99/21,953]) than in UC (3.3/1000 [75/22,666]; p = 0.042). Cancers involved: digestive system [36.8%], skin [13.2%], urinary tract [12.1%], lung [8.6%], breast [8%], genital tract [6.9%], thyroid [4.6%], lymphoma [3.5%], others [6.3%]. In CD, penetrating behaviour and combined thiopurines and tumour necrosis factor alpha [TNFα] antagonists were risk factors for cancer overall: odds ratio [OR] (95% confidence interval [CI] 2.33 [1.01-5.47]); 1.97 [1.1-3.5]; and for extracolonic cancers 3.9 [1.56-10.1]; 2.15 [1.17-4.1], respectively. In UC, risk factors were pancolitis and disease-related surgery for cancer overall (OR: 2.52 [1.26-5.1]; 5.09 [1.73-17.1]); disease-related surgery for colorectal cancer [CRC] (OR 3.6 [1.0-12]); and extensive and left-sided vs distal UC for extracolonic cancers (OR: 2.55 [1.15-5.9]; 2.6 [1.04-6.6]), respectively. In a multicentre study, penetrating CD and extensive UC were risk factors for cancer overall. Cancer incidence was higher in CD than in UC. Copyright © 2016 European Crohn’s and Colitis Organisation (ECCO). Published by Oxford University Press. All rights reserved. For permissions, please email: journals.permissions@oup.com.

  1. Morbidity and mortality in a large series of surgical patients with pulmonary metastases of colorectal carcinoma: a prospective multicentre Spanish study (GECMP-CCR-SEPAR).

    Science.gov (United States)

    Rodríguez-Fuster, Alberto; Belda-Sanchis, José; Aguiló, Rafael; Embun, Raul; Mojal, Sergio; Call, Sergi; Molins, Laureano; Rivas de Andrés, Juan José

    2014-04-01

    Little information is available on postoperative morbidity and mortality after pulmonary metastasectomy. We describe the postoperative morbidity and mortality in a large multicentre series of patients after a first surgical procedure for pulmonary metastases of colorectal carcinoma (CRC) and identify the pre- and intraoperative variables influencing the clinical outcome. A prospective, observational and multicentre study was conducted. Data were collected from March 2008 to February 2010. Patients were grouped into Groups A and B according to the presence or absence of postoperative complications. Variables in both groups were compared by univariate and multivariate analyses. P-values of <0.05 were considered statistically significant. A total of 532 patients (64.5% males) from 32 hospitals were included. The mean (SD) ages of both study groups were similar [68 (10) vs 67 (10) years, P = NS). A total of 1050 lung resections were performed (90% segmentectomies or wedge, n = 946 and 10% lobectomies or greater, n = 104). Group A included 83 (15.6%) patients who developed a total of 100 complications. These included persistent air leaks in 18, atelectasis in 13, pneumonia in 13, paralytic ileum in 12, arrhythmia in 9, acute respiratory distress syndrome in 4 and miscellanea in 31. Reoperation was performed in 5 (0.9%) patients due to persistent air leaks in 4 and lung ischaemia in 1. The mortality rate was 0.4% (n = 2). Causes of death were sepsis in 1 patient and ventricular fibrillation in 1. In the multivariate analysis, lobectomy or greater lung resection [odds ration (OR) 1.9, 95% confidence interval (95% CI) 1.04-3.3, P = 0.03], respiratory co-morbidity (OR 2.3, 95% CI 1.1-4.6, P = 0.01) and cardiovascular co-morbidity (OR 2, 95% CI 1-3.8, P = 0.02) were independent risk factors for postoperative morbidity. Video-assisted surgery vs thoracotomy showed a protective effect (OR 0.3, 95% CI 0.1-0.8, P = 0.01). The first episode of lung surgery for pulmonary

  2. Cohort profile of BIOMArCS: the BIOMarker study to identify the Acute risk of a Coronary Syndrome-a prospective multicentre biomarker study conducted in the Netherlands.

    Science.gov (United States)

    Oemrawsingh, Rohit M; Akkerhuis, K Martijn; Umans, Victor A; Kietselaer, Bas; Schotborgh, Carl; Ronner, Eelko; Lenderink, Timo; Liem, Anho; Haitsma, David; van der Harst, Pim; Asselbergs, Folkert W; Maas, Arthur; Oude Ophuis, Anton J; Ilmer, Ben; Dijkgraaf, Rene; de Winter, Robbert-Jan; The, S Hong Kie; Wardeh, Alexander J; Hermans, Walter; Cramer, Etienne; van Schaik, Ron H; Hoefer, Imo E; Doevendans, Pieter A; Simoons, Maarten L; Boersma, Eric

    2016-12-23

    Progression of stable coronary artery disease (CAD) towards acute coronary syndrome (ACS) is a dynamic and heterogeneous process with many intertwined constituents, in which a plaque destabilising sequence could lead to ACS within short time frames. Current CAD risk assessment models, however, are not designed to identify increased vulnerability for the occurrence of coronary events within a precise, short time frame at the individual patient level. The BIOMarker study to identify the Acute risk of a Coronary Syndrome (BIOMArCS) was designed to evaluate whether repeated measurements of multiple biomarkers can predict such 'vulnerable periods'. BIOMArCS is a multicentre, prospective, observational study of 844 patients presenting with ACS, either with or without ST-elevation and at least one additional cardiovascular risk factor. We hypothesised that patterns of circulating biomarkers that reflect the various pathophysiological components of CAD, such as distorted lipid metabolism, vascular inflammation, endothelial dysfunction, increased thrombogenicity and ischaemia, diverge in the days to weeks before a coronary event. Divergent biomarker patterns, identified by serial biomarker measurements during 1-year follow-up might then indicate 'vulnerable periods' during which patients with CAD are at high short-term risk of developing an ACS. Venepuncture was performed every fortnight during the first half-year and monthly thereafter. As prespecified, patient enrolment was terminated after the primary end point of cardiovascular death or hospital admission for non-fatal ACS had occurred in 50 patients. A case-cohort design will explore differences in temporal patterns of circulating biomarkers prior to the repeat ACS. Follow-up and event adjudication have been completed. Prespecified biomarker analyses are currently being performed and dissemination through peer-reviewed publications and conference presentations is expected from the third quarter of 2016. Should

  3. Blood transfusion in patients having caesarean section: a prospective multicentre observational study of practice in three Pakistan hospitals.

    Science.gov (United States)

    Ismail, S; Siddiqui, S; Shafiq, F; Ishaq, M; Khan, S

    2014-08-01

    Increasing awareness of the risks of blood transfusion has prompted examination of red cell transfusion practice in obstetrics. A six-month prospective observational study was performed to examine blood transfusion practices in patients undergoing caesarean delivery at three hospitals in Pakistan. In the three hospitals (two private, one public) 3438 caesarean deliveries were performed in the study period. Data were collected on patient demographics, indications for transfusion, ordering physicians, consent, associations with obstetric factors, estimated allowable blood loss, calculated blood loss, pre- and post-transfusion haemoglobin and discharge haemoglobin. A total number of 397 (11.5%) patients who underwent caesarean section received a blood transfusion. The highest transfusion rate of 16% was recorded in the public tertiary care hospital compared to 5% in the two private hospitals. Emergency caesarean delivery and multiparity were associated with blood transfusion (Ptransfusion in 98% of cases. In 343 (86%) patients, blood transfusion was given even when the haemoglobin was >7g/dL. The method for documenting the indication or consent for transfusion was not found in any of the three hospitals. Blood transfusion was prescribed more readily in the public hospital. Identification of a transfusion trigger and the development of institutional guidelines to reduce unnecessary transfusion are required. Copyright © 2014 Elsevier Ltd. All rights reserved.

  4. Morbidity and mortality in the antiphospholipid syndrome during a 10-year period: a multicentre prospective study of 1000 patients.

    Science.gov (United States)

    Cervera, R; Serrano, R; Pons-Estel, G J; Ceberio-Hualde, L; Shoenfeld, Y; de Ramón, E; Buonaiuto, V; Jacobsen, S; Zeher, M M; Tarr, T; Tincani, A; Taglietti, M; Theodossiades, G; Nomikou, E; Galeazzi, M; Bellisai, F; Meroni, P L; Derksen, R H W M; de Groot, P G D; Baleva, M; Mosca, M; Bombardieri, S; Houssiau, F; Gris, J-C; Quéré, I; Hachulla, E; Vasconcelos, C; Fernández-Nebro, A; Haro, M; Amoura, Z; Miyara, M; Tektonidou, M; Espinosa, G; Bertolaccini, M L; Khamashta, M A

    2015-06-01

    To assess the prevalence of the main causes of morbi-mortality in the antiphospholipid syndrome (APS) during a 10-year-follow-up period and to compare the frequency of early manifestations with those that appeared later. In 1999, we started an observational study of 1000 APS patients from 13 European countries. All had medical histories documented when entered into the study and were followed prospectively during the ensuing 10 years. 53.1% of the patients had primary APS, 36.2% had APS associated with systemic lupus erythematosus and 10.7% APS associated with other diseases. Thrombotic events appeared in 166 (16.6%) patients during the first 5-year period and in 115 (14.4%) during the second 5-year period. The most common events were strokes, transient ischaemic attacks, deep vein thromboses and pulmonary embolism. 127 (15.5%) women became pregnant (188 pregnancies) and 72.9% of pregnancies succeeded in having one or more live births. The most common obstetric complication was early pregnancy loss (16.5% of the pregnancies). Intrauterine growth restriction (26.3% of the total live births) and prematurity (48.2%) were the most frequent fetal morbidities. 93 (9.3%) patients died and the most frequent causes of death were severe thrombosis (36.5%) and infections (26.9%). Nine (0.9%) cases of catastrophic APS occurred and 5 (55.6%) of them died. The survival probability at 10 years was 90.7%. Patients with APS still develop significant morbidity and mortality despite current treatment. It is imperative to increase the efforts in determining optimal prognostic markers and therapeutic measures to prevent these complications. 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.

  5. A prospective, observational, open-label, multicentre study to investigate the daily treatment practice of ranibizumab in patients with neovascular age-related macular degeneration.

    Science.gov (United States)

    van Asten, Freekje; Evers-Birkenkamp, Kim U; van Lith-Verhoeven, Janneke J C; de Jong-Hesse, Yvonne; Hoppenreijs, Vincent P T; Hommersom, Richard F; Scholten, Agnes M; Hoyng, Carel B; Klaver, Johannes H J

    2015-03-01

    The HELIOS (Health Economics with Lucentis in Observational Settings) study was designed on request of the Dutch Health Authority for an observational study to assess the effectiveness and safety of ranibizumab for neovascular age-related macular degeneration (wet AMD) in daily practice. The HELIOS study was a 2-year prospective, observational, open-label, multicentre study involving 14 sites. Patients with wet AMD were enrolled and observed for a period of 24 months. The data were collected at baseline and at the visits closest around the time-points 3, 6, 12, 18 and 24 months after inclusion. Treatment with ranibizumab resulted in prevention of vision loss. The mean ETDRS score increased from 45.1 letters at baseline to 48.5 letters at 24 months. This was achieved with a mean of 7.8 injections over 24 months. Stabilization of visual acuity was also reflected by the scores on the quality of life EQ-5D questionnaire, which did not significantly change over the study period. The more subjective EQ-VAS questionnaire showed an overall improvement. The VFQ-25 questionnaire was also mostly stable over time. After 24 months, 32.2% of the patients gained ≥1 letter and 17.1% gained >15 letters. Patients completing the loading phase were better responders, as demonstrated by increased long-term visual acuity. In addition, ranibizumab was well tolerated and had a safety profile commonly seen in routine clinical practice. This study demonstrates that also in daily practice ranibizumab was effective in preventing vision loss over a period of 24 months. No new safety findings were identified. © 2014 Acta Ophthalmologica Scandinavica Foundation. Published by John Wiley & Sons Ltd.

  6. Effects of periodontal treatment on carotid intima-media thickness in patients with lifestyle-related diseases: Japanese prospective multicentre observational study.

    Science.gov (United States)

    Kudo, Chieko; Shin, Wee Soo; Sasaki, Nobuhiro; Harai, Kazuo; Kato, Kai; Seino, Hiroaki; Goke, Eiji; Fujino, Takemasa; Kuribayashi, Nobuichi; Pearce, Youko Onuki; Taira, Masato; Matsushima, Ryoji; Minabe, Masato; Takashiba, Shogo

    2018-01-12

    Atherosclerosis, a chronic inflammatory disease in arterial blood vessels, is one of the major causes of death in worldwide. Meanwhile, periodontal disease is a chronic inflammatory disease caused by infection with periodontal pathogens such as P. gingivalis (Porphyromonas gingivalis). Several studies have reported association between periodontal infection and atherosclerosis, but direct investigation about the effects of periodontal treatment on atherosclerosis has not been reported. We have planned Japanese local clinics to determine the relationship between periodontal disease and atherosclerosis under collaborative with medical and dental care. A prospective, multicentre, observational study was conducted including 38 medical patients with lifestyle-related diseases in the stable period under consultation at participating medical clinics and 92 periodontal patients not undergoing medical treatment but who were consulting at participating dental clinics. Systemic and periodontal examinations were performed before and after periodontal treatment. At baseline, LDL-C (low-density lipoprotein cholesterol) levels and percentage (%) of mobile teeth were positively related to plasma IgG (immunoglobulin) antibody titer against P. gingivalis with multivariate analysis. Corresponding to improvements in periodontal clinical parameters after treatment, right and left max IMT (maximum intima-media thickness) levels were decreased significantly after treatment (SPT-S: start of supportive periodontal therapy, SPT-1y: at 1 year under SPT, and SPT-3y: at 3 years under SPT). The present study has clarified our previous univariate analysis results, wherein P. gingivalis infection was positively associated with progression of atherosclerosis. Thus, routine screening using plasma IgG antibody titer against P. gingivalis and periodontal treatment under collaborative with medical and dental care may prevent cardiovascular accidents caused by atherosclerosis.

  7. Validation of SAPS3 admission score and its customization for use in Korean intensive care unit patients: a prospective multicentre study.

    Science.gov (United States)

    Lim, So Yeon; Koh, Shin Ok; Jeon, Kyeongman; Na, Sungwon; Lim, Chae-Man; Choi, Won-Il; Lee, Young-Joo; Kim, Seok Chan; Chon, Gyu Rak; Kim, Je Hyeong; Kim, Jae Yeol; Lim, Jaemin; Rhee, Chin Kook; Park, Sunghoon; Kim, Ho Cheol; Lee, Jin Hwa; Lee, Ji Hyun; Park, Jisook; Koh, Younsuck; Suh, Gee Young

    2013-08-01

    To externally validate the simplified acute physiology score 3 (SAPS3) and to customize it for use in Korean intensive care unit (ICU) patients. This is a prospective multicentre cohort study involving 22 ICUs from 15 centres throughout Korea. The study population comprised patients who were consecutively admitted to participating ICUs from 1 July 2010 to 31 January 2011. A total of 4617 patients were enrolled. ICU mortality was 14.3%, and hospital mortality was 20.6%. The patients were randomly assigned into one of two cohorts: a development (n = 2309) or validation (n = 2308) cohort. In the development cohort, the general SAPS3 had good discrimination (area under the receiver operating characteristics curve = 0.829), but poor calibration (Hosmer-Lemeshow goodness-of-fit test H = 123.06, P Customization was achieved by altering the logit of the original SAPS3 equation. The new equation for Korean ICU patients was validated in the validation cohort, and demonstrated both good discrimination (area under the receiver operating characteristics curve = 0.835) and good calibration (H = 4.61, P = 0.799, C = 5.67, P = 0.684). General and regional Australasia SAPS3 admission scores showed poor calibration for use in Korean ICU patients, but the prognostic power of the SAPS3 was significantly improved by customization. Prediction models should be customized before being used to predict mortality in different regions of the world. © 2013 The Authors. Respirology © 2013 Asian Pacific Society of Respirology.

  8. 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.

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

    Science.gov (United States)

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

    2017-11-01

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

  10. Use of XenX™, the latest ureteric occlusion device with guide wire utility: results from a prospective multicentric comparative study.

    Science.gov (United States)

    Sanguedolce, Francesco; Montanari, Emanuele; Alvarez-Maestro, Mario; Macchione, Nicola; Hruby, Stephan; Papatsoris, Athanasios; Kallidonis, Panagiotis; Villa, Luca; Honeck, Patrick; Traxer, Olivier; Greco, Francesco

    2016-11-01

    This is a prospective multicentric comparative study evaluating the performance of XenX-a new dual-purpose device for the prevention of stone fragments migration during ureteroscopic lithotripsy (URS). Between March 2014 and January 2015, 41 patients undertaking URS + XenX were matched with 41 patients undergoing standard URS. Patients included had unilateral ureteric stone(s) of 0.5-1.5 cm in maximum size. Demographics, complication rates and surgical outcomes were recorded for comparison. A Likert-like 5-grade scoring system was used for surgeons' evaluation of XenX properties. Cost analysis was performed by comparing weighted mean costs of the relevant procedures. Patients' characteristics between the two groups were comparable. Lasering time was longer for XenX group (13.59 vs. 5.17 min; p = 0.0001) whilst use of basket and need of JJ stent insertion was more frequent in control group (19.5 vs. 97.6 %; p = 0.0001 and 22 vs. 35 %; p = 0.001, respectively). Intra-operative SFR was significantly higher for XenX group (100 vs. 85.4 %; p = 0.0001), but not at 4-week follow-up, after ancillary procedures were needed in 17.1 % of the control group. Surgeons' evaluations for XenX were suboptimal for "Ease of Basketing" (2/5) and "Advancement of double J stent" (3/5). The use of XenX increased costs of procedures, but spared the costs associated to ancillary procedures and stent removals. XenX confirmed to be a safe and effective device especially for the treatment of upper ureteric tract stones; moreover, XenX may reduce the risk for the need of auxiliary procedures and for the insertion of a JJ stent.

  11. Food and Drug Administration criteria for the diagnosis of drug-induced valvular heart disease in patients previously exposed to benfluorex: a prospective multicentre study.

    Science.gov (United States)

    Maréchaux, Sylvestre; Rusinaru, Dan; Jobic, Yannick; Ederhy, Stéphane; Donal, Erwan; Réant, Patricia; Arnalsteen, Elise; Boulanger, Jacques; Garban, Thierry; Ennezat, Pierre-Vladimir; Jeu, Antoine; Szymanski, Catherine; Tribouilloy, Christophe

    2015-02-01

    The Food and Drug Administration (FDA) criteria for diagnosis of drug-induced valvular heart disease (DIVHD) are only based on the observation of aortic regurgitation ≥ mild and/or mitral regurgitation ≥ moderate. We sought to evaluate the diagnostic value of FDA criteria in a cohort of control patients and in a cohort of patients exposed to a drug (benfluorex) known to induce VHD. This prospective, multicentre study included 376 diabetic control patients not exposed to valvulopathic drugs and 1000 subjects previously exposed to benfluorex. Diagnosis of mitral or aortic DIVHD was based on a combined functional and morphological echocardiographic analysis of cardiac valves. Patients were classified according to the FDA criteria [mitral or aortic-FDA(+) and mitral or aortic-FDA(-)]. Among the 376 control patients, 2 were wrongly classified as mitral-FDA(+) and 17 as aortic-FDA(+) (0.53 and 4.5% of false positives, respectively). Of those exposed to benfluorex, 48 of 58 with a diagnosis of mitral DIVHD (83%) were classified as mitral-FDA(-), and 901 of the 910 patients (99%) without a diagnosis of the mitral DIVHD group were classified as mitral-FDA(-). All 40 patients with a diagnosis of aortic DIVHD were classified as aortic-FDA(+), and 105 of the 910 patients without a diagnosis of aortic DIVHD (12%) were classified aortic-FDA(+). Older age and lower BMI were independent predictors of disagreement between FDA criteria and the diagnosis of DIVHD in patients exposed to benfluorex (both P ≤ 0.001). FDA criteria solely based on the Doppler detection of cardiac valve regurgitation underestimate for the mitral valve and overestimate for the aortic valve the frequency of DIVHD. Therefore, the diagnosis of DIVHD must be based on a combined echocardiographic and Doppler morphological and functional analysis of cardiac valves. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2014. For permissions please email: journals.permissions@oup.com.

  12. Coexistence of IgM antihepatitis A virus and IgM antihepatitis E virus in acute viral hepatitis: a prospective, multicentre study in Korea.

    Science.gov (United States)

    Jang, J-H; Jung, Y M; Kim, J S; Lee, S H; Kim, J-W; Hwang, S G; Rim, K S; Park, S J; Park, Y M; Kang, S-K; Lee, H S; Yun, H; Kim, J-H; Jeong, S-H

    2011-10-01

    This study investigated the clinical, serological and molecular characteristics of coexistence of both immunoglobulin M (IgM) antihepatitis A virus (HAV) and IgM antihepatitis E virus (HEV) in acute viral hepatitis using a prospective, multicentre design. Among a total of 771 symptomatic cases with acute viral hepatitis enrolled in a Korean city from September 2006 to August 2008, coexistence of IgM anti-HAV and IgM anti-HEV was found in 43 patients (A+E group; 6%), while the existence of IgM anti-HAV alone was found in 595 patients (A group; 77%) and that of IgM anti-HEV alone in 14 patients (E group; 2%). Clinical data analysis and measurement of IgM and IgG anti-HEV were performed using two different commercial kits, and HAV RNA and HEV RNA were detected in available serum or stool samples. The clinical features of the A+E group were similar to those of the A group. HAV RNA detection rates in the A+E and A group were similar, while HEV RNA was detected only in the stool samples of the E group, not in the A+E group. Comparative testing of anti-HEV using two different ELISA kits showed markedly discordant results for IgM anti-HEV positivity and consistently low positivity for IgG anti-HEV in the A+E group. Coexistence of IgM anti-HEV measured by the Genelabs ELISA kit in the setting of hepatitis A appears to yield false-positive results in nonendemic areas of HEV infection. Diagnosis of hepatitis E using IgM anti-HEV should be made with caution. © 2011 Blackwell Publishing Ltd.

  13. Metabolic syndrome is associated with advanced prostate cancer in patients treated with radical retropubic prostatectomy: results from a multicentre prospective study

    International Nuclear Information System (INIS)

    De Nunzio, Cosimo; Simone, Giuseppe; Brassetti, Aldo; Mastroianni, Riccardo; Collura, Devis; Muto, Giovanni; Gallucci, Michele; Tubaro, Andrea

    2016-01-01

    Prostate cancer (PCa) is the most common non-skin cancer in USA and the second leading cause of cancer death in Western Countries. Despite the high mortality associated with PCa, the only established risk factors are age, race and family history. A possible association between metabolic syndrome (MetS) and PCa was firstly described in 2004 and several subsequent studies in biopsy cohorts have shown conflicting results. Aim of our multicentre prospective study was to investigate the association between MetS and PCa in men undergoing radical prostatectomy (RP). From January 2012 to June 2015, 349 consecutive men undergoing RP for PCa at three centres in Italy were enrolled into a prospective database. Body Mass Index (BMI) as well as waist circumference was measured before RP. Blood samples were also collected and tested for total PSA, fasting glucose, triglycerides and HDLs. Blood pressure was also recorded. We evaluated the association between MetS, defined according to Adult Treatment Panel III, PCa stage (advanced stage defined as pT ≥ 3 or N1) and grade (high grade defined as Gleason Score ≥ 4 + 3) using logistic regression analyses. Median age and preoperative PSA levels were 66 years (IQR: 61-69) and 7 ng/ml (IQR: 5-10), respectively. Median BMI was 26.12 kg/m 2 (IQR 24-29) with 56 (16 %) obese (BMI ≥ 30 kg/m 2 ) patients and 87 (25 %) patients with MetS. At pathological evaluation, advanced PCa and high-grade disease were present in 126 (36 %) and 145 (41.5 %) patients, respectively. MetS was significantly associated with advanced PCa (45/87, 51 % vs 81/262, 31 %; p = 0.008) and high-grade disease (47/87, 54 % vs 98/262, 37 %; p = 0.001). On multivariable analysis, MetS was an independent predictor of pathological stage ≥ pT3a or N1 (OR: 2.227; CI: 1.273-3.893; p = 0.005) and Gleason score ≥ 4 + 3 (OR: 2.007, CI: 1.175-3.428; p = 0.011). We firstly demonstrated in a European radical retropubic prostatectomy cohort study that MetS is associated with

  14. Multiple-source current steering in subthalamic nucleus deep brain stimulation for Parkinson's disease (the VANTAGE study): a non-randomised, prospective, multicentre, open-label study.

    Science.gov (United States)

    Timmermann, Lars; Jain, Roshini; Chen, Lilly; Maarouf, Mohamed; Barbe, Michael T; Allert, Niels; Brücke, Thomas; Kaiser, Iris; Beirer, Sebastian; Sejio, Fernando; Suarez, Esther; Lozano, Beatriz; Haegelen, Claire; Vérin, Marc; Porta, Mauro; Servello, Domenico; Gill, Steven; Whone, Alan; Van Dyck, Nic; Alesch, Francois

    2015-07-01

    High-frequency deep brain stimulation (DBS) with a single electrical source is effective for motor symptom relief in patients with Parkinson's disease. We postulated that a multiple-source, constant-current device that permits well defined distribution of current would lead to motor improvement in patients with Parkinson's disease. We did a prospective, multicentre, non-randomised, open-label intervention study of an implantable DBS device (the VANTAGE study) at six specialist DBS centres at universities in six European countries. Patients were judged eligible if they were aged 21-75 years, had been diagnosed with bilateral idiopathic Parkinson's disease with motor symptoms for more than 5 years, had a Hoehn and Yahr score of 2 or greater, and had a Unified Parkinson's disease rating scale part III (UPDRS III) score in the medication-off state of more than 30, which improved by 33% or more after a levodopa challenge. Participants underwent bilateral implantation in the subthalamic nucleus of a multiple-source, constant-current, eight-contact, rechargeable DBS system, and were assessed 12, 26, and 52 weeks after implantation. The primary endpoint was the mean change in UPDRS III scores (assessed by site investigators who were aware of the treatment assignment) from baseline (medication-off state) to 26 weeks after first lead implantation (stimulation-on, medication-off state). This study is registered with ClinicalTrials.gov, number NCT01221948. Of 53 patients enrolled in the study, 40 received a bilateral implant in the subthalamic nucleus and their data contributed to the primary endpoint analysis. Improvement was noted in the UPDRS III motor score 6 months after first lead implantation (mean 13·5 [SD 6·8], 95% CI 11·3-15·7) compared with baseline (37·4 [8·9], 34·5-40·2), with a mean difference of 23·8 (SD 10·6; 95% CI 20·3-27·3; p<0·0001). One patient died of pneumonia 24 weeks after implantation, which was judged to be unrelated to the procedure

  15. Influence of social support on cognitive change and mortality in old age: results from the prospective multicentre cohort study AgeCoDe

    Science.gov (United States)

    2012-01-01

    Background Social support has been suggested to positively influence cognition and mortality in old age. However, this suggestion has been questioned due to inconsistent operationalisations of social support among studies and the small number of longitudinal studies available. This study aims to investigate the influence of perceived social support, understood as the emotional component of social support, on cognition and mortality in old age as part of a prospective longitudinal multicentre study in Germany. Methods A national subsample of 2,367 primary care patients was assessed twice over an observation period of 18 months regarding the influence of social support on cognitive function and mortality. Perceived social support was assessed using the 14-item version of the FSozU, which is a standardised and validated questionnaire of social support. Cognition was tested by the neuropsychological test battery of the Structured Interview for the Diagnosis of Dementia (SIDAM). The influence of perceived support on cognitive change was analysed by multivariate ANCOVA; mortality was analysed by multivariate logistic and cox regression. Results Sample cognitive change (N = 1,869): Mean age was 82.4 years (SD 3.3) at the beginning of the observation period, 65.9% were female, mean cognition was 49 (SD 4.4) in the SIDAM. Over the observation period cognitive function declined in 47.2% by a mean of 3.4 points. Sample mortality (N = 2,367): Mean age was 82.5 years (SD 3.4), 65.7% were female and 185 patients died during the observation period. Perceived social support showed no longitudinal association with cognitive change (F = 2.235; p = 0.135) and mortality (p = 0.332; CI 0.829-1.743). Conclusions Perceived social support did not influence cognition and mortality over an 18 months observation period. However, previous studies using different operationalisations of social support and longer observation periods indicate that such an influence may exist. This influence is

  16. An international multi-centre prospective study on the efficacy of an intraarticular polyacrylamide hydrogel in horses with osteoarthritis

    DEFF Research Database (Denmark)

    Tnibar, Aziz; Schougaard, Hans; Camitz, Linus

    2015-01-01

    Background: Polyacrylamide hydrogel (PAAG) was evaluated recently to treat osteoarthritis (OA) in horses with highly encouraging results; however no long term field-study was done to explore its clinical efficacy and lasting effect. The objective of this study was to evaluate the efficacy of PAAG...

  17. Airway management by physician-staffed Helicopter Emergency Medical Services - a prospective, multicentre, observational study of 2,327 patients.

    Science.gov (United States)

    Sunde, Geir Arne; Heltne, Jon-Kenneth; Lockey, David; Burns, Brian; Sandberg, Mårten; Fredriksen, Knut; Hufthammer, Karl Ove; Soti, Akos; Lyon, Richard; Jäntti, Helena; Kämäräinen, Antti; Reid, Bjørn Ole; Silfvast, Tom; Harm, Falko; Sollid, Stephen J M

    2015-08-07

    Despite numerous studies on prehospital airway management, results are difficult to compare due to inconsistent or heterogeneous data. The objective of this study was to assess advanced airway management from international physician-staffed helicopter emergency medical services. We collected airway data from 21 helicopter emergency medical services in Australia, England, Finland, Hungary, Norway and Switzerland over a 12-month period. A uniform Utstein-style airway template was used for collecting data. The participating services attended 14,703 patients on primary missions during the study period, and 2,327 (16 %) required advanced prehospital airway interventions. Of these, tracheal intubation was attempted in 92 % of the cases. The rest were managed with supraglottic airway devices (5 %), bag-valve-mask ventilation (2 %) or continuous positive airway pressure (0.2 %). Intubation failure rates were 14.5 % (first-attempt) and 1.2 % (overall). Cardiac arrest patients showed significantly higher first-attempt intubation failure rates (odds ratio: 2.0; 95 % CI: 1.5-2.6; p < 0.001) compared to non-cardiac arrest patients. Complications were recorded in 13 %, with recognised oesophageal intubation being the most frequent (25 % of all patients with complications). For non-cardiac arrest patients, important risk predictors for first-attempt failure were patient age (a non-linear association) and administration of sedatives (reduced failure risk). The patient's sex, provider's intubation experience, trauma type (patient category), indication for airway intervention and use of neuromuscular blocking agents were not risk factors for first-attempt intubation failure. Advanced airway management in physician-staffed prehospital services was performed frequently, with high intubation success rates and low complication rates overall. However, cardiac arrest patients showed significantly higher first-attempt failure rates compared to non-cardiac arrest patients. All

  18. Protocol for validation of the 4AT, a rapid screening tool for delirium: a multicentre prospective diagnostic test accuracy study.

    Science.gov (United States)

    Shenkin, Susan D; Fox, Christopher; Godfrey, Mary; Siddiqi, Najma; Goodacre, Steve; Young, John; Anand, Atul; Gray, Alasdair; Smith, Joel; Ryan, Tracy; Hanley, Janet; MacRaild, Allan; Steven, Jill; Black, Polly L; Boyd, Julia; Weir, Christopher J; MacLullich, Alasdair Mj

    2018-02-10

    Delirium is a severe neuropsychiatric syndrome of rapid onset, commonly precipitated by acute illness. It is common in older people in the emergency department (ED) and acute hospital, but greatly under-recognised in these and other settings. Delirium and other forms of cognitive impairment, particularly dementia, commonly coexist. There is a need for a rapid delirium screening tool that can be administered by a range of professional-level healthcare staff to patients with sensory or functional impairments in a busy clinical environment, which also incorporates general cognitive assessment. We developed the 4 'A's Test (4AT) for this purpose. This study's primary objective is to validate the 4AT against a reference standard. Secondary objectives include (1) comparing the 4AT with another widely used test (the Confusion Assessment Method (CAM)); (2) determining if the 4AT is sensitive to general cognitive impairment; (3) assessing if 4AT scores predict outcomes, including (4) a health economic analysis. 900 patients aged 70 or over in EDs or acute general medical wards will be recruited in three sites (Edinburgh, Bradford and Sheffield) over 18 months. Each patient will undergo a reference standard delirium assessment and will be randomised to assessment with either the 4AT or the CAM. At 12 weeks, outcomes (length of stay, institutionalisation and mortality) and resource utilisation will be collected by a questionnaire and via the electronic patient record. Ethical approval was granted in Scotland and England. The study involves administering tests commonly used in clinical practice. The main ethical issues are the essential recruitment of people without capacity. Dissemination is planned via publication in high impact journals, presentation at conferences, social media and the website www.the4AT.com. ISRCTN53388093; Pre-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial

  19. Validation of the German version of the Kujala score in patients with patellofemoral instability: a prospective multi-centre study.

    Science.gov (United States)

    Dammerer, D; Liebensteiner, M C; Kujala, U M; Emmanuel, K; Kopf, S; Dirisamer, F; Giesinger, J M

    2018-04-01

    The Kujala score is the most frequently used questionnaire for patellofemoral disorders like pain, instability or osteoarthritis. Unfortunately, we are not aware of a validated German version of the Kujala score. The aim of our study was the translation and linguistic validation of the Kujala score in German-speaking patients with patella instability and the assessment of its measurement characteristics. The German Kujala score was developed in several steps of translation. In addition to healthy controls, the Kujala German was assessed in consecutive patients undergoing reconstruction of the medial patellofemoral ligament for recurrent patellar dislocations. Pre-op, 6 and 12 months postop the patients completed the Kujala German score, the KOOS, the Lysholm score, a VAS Pain, and the SF-12v2 scores. In addition, there was a Kujala German Score retest preop after a 1-week interval. We found high reliability in terms of internal consistency for the Kujala score (Cronbach's alpha = 0.87). Convergent validity with the KOOS (symptom r = 0.65, pain r = 0.78, ADL r = 0.74, sports/recreation r = 0.84, quality of life r = 0.70), the Lysholm score (r = 0.88) and the SF-12 physical component summary score (r = 0.79) and VAS pain (r = - 0.71) was also very high. Discriminant validity in terms of correlation with the SF-12 mental component summary Score was satisfactory (r = 0.14). In conclusion, the German version of the Kujala score proved to be a reliable and valid instrument in the setting of a typical patellofemoral disease treated with a standard patellofemoral procedure.

  20. Soft tissues stability of cad-cam and stock abutments in anterior regions: 2-year prospective multicentric cohort study.

    Science.gov (United States)

    Lops, Diego; Bressan, Eriberto; Parpaiola, Andrea; Sbricoli, Luca; Cecchinato, Denis; Romeo, Eugenio

    2015-12-01

    Aim of this study was to verify if the type of implant abutment manufacturing, stock or cad-cam, could influence the maintenance of stable gingival margins around single restorations in anterior areas. After 16 weeks of healing, implants (Osseospeed, Astra Tech Dental Implant) were positioned. Depending on the different fixture inclination and the thickness of buccal peri-implant soft tissue, abutment selection resulted in four groups: Group 1 (patients with zirconia ZirDesign(®) stock abutments), Group 2 (titanium stock TiDesign(®) abutments), Group 3 (zirconia cad-cam abutments), and Group 4 (titanium cad-cam abutments). The following parameters were assessed: buccal gingival margin modification (BGM). The modification of the implant gingival margin was followed at 1 and 2 years of follow-up. A computerized analysis was performed for measurements. Differences between soft tissue margin at baseline and after 2 years measured the gingival margin recession. A general linear model was used to evaluate each group in relation to gingival recession after two years. Tukey's post hoc test was used to compare the mean REC indexes of each group of abutments. Seventy-two healthy patients (39 males and 33 females; mean age of 46 years) scheduled for single gap rehabilitation in anterior areas were enrolled. A 100% of implant survival rate was observed after 24 months of function. One failure occurred due to fracture of a Zirconia cad-cam abutment. Moreover, two abutment screw unscrewing were observed. Both for zirconia and titanium stock abutments (Group 1 and 2), the mean recession of implant buccal soft tissue was of 0.3 mm (SD of 0.3 and 0.4 mm, respectively). Soft tissue mean recession of zirconia and titanium cad-cam abutments (Group 3 and 4) was of 0.1 and -0.3 mm, respectively (SD of 0.3 and 0.4 mm, respectively). REC values of cad-cam titanium abutments (Group 4) were significantly lower than that of Group 1 (-0.57 mm), Group 2 (-0.61 mm), and Group 3 (-0.40 mm

  1. The predictive value of treatment response using FDG PET performed on day 21 of chemoradiotherapy in patients with oesophageal squamous cell carcinoma. A prospective, multicentre study (RTEP3)

    International Nuclear Information System (INIS)

    Palie, Odre; Vera, Pierre; Michel, Pierre; Di Fiore, Frederic; Menard, Jean-Francois; Rousseau, Caroline; Bridji, Boumediene; Rio, Emmanuel; Benyoucef, Ahmed; Meyer, Marc-Etienne; Jalali, Khadija; Bardet, Stephane; M'Vondo, Che Mabubu; Olivier, Pierre; Faure, Guillaume; Itti, Emmanuel; Diana, Christian; Houzard, Claire; Mornex, Francoise

    2013-01-01

    therefore TLG 40 1 and TLG p 1 , but not the SUV values, were significantly lower in patients with CR at 3 months. SUVmax 1 , TV p 1 and TLG p 1 were significantly lower in patients with CR at 1 year. With respect to the predictive value of PET 2 , only TV 40 2 and TV p 2 values, and therefore TLG 40 2 and TLG p 2 , but not the SUV values, were significantly lower in patients with CR at 3 months. None of the PET 2 parameters had significant value in predicting patient outcome at 1 year. The changes in SUVmax, TV 40 , TV p , TLG 40 and TLG p between PET 1 and PET 2 had no relationship to patient outcome at 3 months or 1 year. This prospective, multicentre study performed in a selected population of patients with oesophageal squamous cell cancer demonstrates that the parameters derived from baseline PET 1 are good predictors of response to CRT. Specifically, a high TV and TLG are associated with a poor response to CRT at 3 months and 1 year, and a high SUVmax is associated with a poor response to CRT at 1 year. FDG PET performed during CRT on day 21 appears to have less clinical relevance. However, patients with a large functional TV on day 21 of CRT have a poor clinical outcome (ClinicalTrials.gov NCT 00934505). (orig.)

  2. Quality control within the multicentre perfusion CT study of primary colorectal cancer (PROSPeCT): results of an iodine density phantom study

    Energy Technology Data Exchange (ETDEWEB)

    Lewis, Maria; Honey, Ian [Trust, Medical Physics Department, Guy' s and St. Thomas' NHS Foundation, London (United Kingdom); Goh, Vicky [King' s College London, St Thomas' Hospital, Division of Imaging Sciences and Biomedical Engineering, London (United Kingdom); Beggs, Shaun [Bradford Teaching Hospitals NHS Foundation Trust, Radiation Physics Services, Bradford (United Kingdom); Bridges, Andrew; Wayte, Sarah [Radiology Physics University Hospitals Coventry and Warwickshire NHS Trust, Coventry (United Kingdom); Clewer, Philip [Medical Physics Department, University Hospital Southampton NHS Foundation Trust, Southampton (United Kingdom); Davis, Anne [Portsmouth Hospitals NHS Trust, Medical Physics Department, Portsmouth (United Kingdom); Foy, Trevelyan [Royal Cornwall Hospital NHS Trust, Medical Physics Department, Truro (United Kingdom); Fuller, Karen [Sheffield Teaching Hospitals NHS Foundation Trust, Medical Physics Department, Sheffield (United Kingdom); George, Jennifer [University Hospital of North Staffordshire NHS Trust, Medical Physics Department, Stoke-on-Trent (United Kingdom); Higginson, Antony [Portsmouth Hospitals NHS Trust, Department of Radiology, Portsmouth (United Kingdom); Iball, Gareth [Leeds Teaching Hospitals NHS Trust, Department of Medical Physics and Engineering, Leeds (United Kingdom); Mutch, Steve [Oxford University Hospitals NHS Trust, Radiation Physics and Protection Department, Oxford (United Kingdom); Neil, Shellagh; Sutton, David [NHS Tayside, Medical Physics Department, Dundee, Scotland (United Kingdom); Rivett, Cat [Plymouth Hospitals NHS Trust, Clinical and Radiation Physics, Plymouth (United Kingdom); Slater, Andrew [Oxford University Hospitals NHS Trust, Department of Radiology, Oxford (United Kingdom); Weir, Nick [Queen' s Medical Research Institute, Clinical Research Imaging Centre, Edinburgh, Scotland (United Kingdom); Collaboration: on behalf of the PROSPeCT Investigators

    2014-09-15

    To assess the cross-centre consistency of iodine enhancement, contrast-to-noise ratio and radiation dose in a multicentre perfusion CT trial of colorectal cancer. A cylindrical water phantom containing different iodine inserts was examined on seven CT models in 13 hospitals. The relationship between CT number (Hounsfield units, HU) and iodine concentration (milligrams per millilitre) was established and contrast-to-noise ratios (CNRs) calculated. Radiation doses (CTDI{sub vol}, DLP) were compared across all sites. There was a linear relationship between CT number and iodine density. Iodine enhancement varied by a factor of at most 1.10, and image noise by at most 1.5 across the study sites. At an iodine concentration of 1 mg ml{sup -1} and 100 kV, CNRs ranged from 3.6 to 4.8 in the 220-mm phantom and from 1.4 to 1.9 in the 300-mm phantom. Doses varied by a factor of at most 2.4, but remained within study dose constraints. Iterative reconstruction algorithms did not alter iodine enhancement but resulted in reduced image noise by a factor of at most 2.2, allowing a potential dose decrease of at most 80 % compared to filtered back projection (FBP). Quality control of CT performance across centres indicates that CNR values remain relatively consistent across all sites, giving acceptable image quality within the agreed dose constraints. (orig.)

  3. Quality control within the multicentre perfusion CT study of primary colorectal cancer (PROSPeCT): results of an iodine density phantom study

    International Nuclear Information System (INIS)

    Lewis, Maria; Honey, Ian; Goh, Vicky; Beggs, Shaun; Bridges, Andrew; Wayte, Sarah; Clewer, Philip; Davis, Anne; Foy, Trevelyan; Fuller, Karen; George, Jennifer; Higginson, Antony; Iball, Gareth; Mutch, Steve; Neil, Shellagh; Sutton, David; Rivett, Cat; Slater, Andrew; Weir, Nick

    2014-01-01

    To assess the cross-centre consistency of iodine enhancement, contrast-to-noise ratio and radiation dose in a multicentre perfusion CT trial of colorectal cancer. A cylindrical water phantom containing different iodine inserts was examined on seven CT models in 13 hospitals. The relationship between CT number (Hounsfield units, HU) and iodine concentration (milligrams per millilitre) was established and contrast-to-noise ratios (CNRs) calculated. Radiation doses (CTDI vol , DLP) were compared across all sites. There was a linear relationship between CT number and iodine density. Iodine enhancement varied by a factor of at most 1.10, and image noise by at most 1.5 across the study sites. At an iodine concentration of 1 mg ml -1 and 100 kV, CNRs ranged from 3.6 to 4.8 in the 220-mm phantom and from 1.4 to 1.9 in the 300-mm phantom. Doses varied by a factor of at most 2.4, but remained within study dose constraints. Iterative reconstruction algorithms did not alter iodine enhancement but resulted in reduced image noise by a factor of at most 2.2, allowing a potential dose decrease of at most 80 % compared to filtered back projection (FBP). Quality control of CT performance across centres indicates that CNR values remain relatively consistent across all sites, giving acceptable image quality within the agreed dose constraints. (orig.)

  4. Effectiveness and tolerability of fixed-dose combination enalapril plus nitrendipine in hypertensive patients: results of the 3-month observational, post-marketing, multicentre, prospective CENIT study.

    Science.gov (United States)

    Sierra, Alejandro de la; Roca-Cusachs, Alejandro; Redón, Josep; Marín, Rafael; Luque, Manuel; Figuera, Mariano de la; Garcia-Garcia, Margarida; Falkon, Liliana

    2009-01-01

    Monotherapy with any class of antihypertensive drug effectively controls blood pressure (BP) in only about 50% of patients. Consequently, the majority of patients with hypertension require combined therapy with two or more medications. This study aimed to evaluate the effectiveness (systolic BP [SBP]/diastolic BP [DBP] control) and tolerability of the fixed-dose combination enalapril/nitrendipine 10 mg/20 mg administered as a single daily dose in hypertensive patients. This was a post-authorization, multicentre, prospective, observational study conducted in primary care with a 3-month follow-up. Patients throughout Spain with uncontrolled hypertension (> or =140/90 mmHg for patients without diabetes mellitus, or > or =130/85 mmHg for patients with diabetes) on monotherapy or with any combination other than enalapril + nitrendipine, or who were unable to tolerate their previous antihypertensive therapy, were recruited. Change from previous to study treatment was according to usual clinical practice. BP was measured once after 5 minutes of rest in the sitting position. Therapeutic response was defined as follows: 'controlled' meant controlled BP ( or =20 mmHg and in DBP of > or =10 mmHg. The main laboratory test parameters were documented at baseline and after 3 months. Patients aged >65 years, with diabetes, with isolated systolic hypertension (ISH; SBP > or =140 mmHg for patients without diabetes, SBP > or =130 mmHg for patients with diabetes) and who were obese (body mass index [BMI] > or =30 kg/m2) were analysed separately. Of 6537 patients included, 5010 and 6354 patients were assessed in effectiveness and tolerability analyses, respectively. In the tolerability analysis population, there were 3023 men (47.6%) and 3321 women (52.4%). The mean (+/- SD) age of the tolerability analysis group was 62.8 (+/- 10.7) years. A total of 71.1% of the patients presented at least one clinical cardiovascular risk factor other than hypertension, with the most frequent being

  5. Clinical Performance and Safety of 108 SpineJack Implantations: 1-Year Results of a Prospective Multicentre Single-Arm Registry Study

    Directory of Open Access Journals (Sweden)

    David Noriega

    2015-01-01

    Full Text Available This prospective, consecutive, multicentre observational registry aimed to confirm the safety and clinical performance of the SpineJack system for the treatment of vertebral compression fractures (VCF of traumatic origin. We enrolled 103 patients (median age: 61.6 years with 108 VCF due to trauma, or traumatic VCF with associated osteoporosis. Primary outcome was back pain intensity (VAS. Secondary outcomes were Oswestry Disability Index (ODI, EuroQol-VAS, and analgesic consumption. 48 hours after surgery, a median relative decrease in pain intensity of 81.5% was observed associated with a significant reduction in analgesic intake. Improvements in disability (91.3% decrease in ODI score and in quality of life (increase 21.1% of EQ-VAS score were obtained 3 months after surgery. All results were maintained at 12 months. A reduction in the kyphotic angulation was observed postoperatively (-5.4±6.3°; p<0.001, remained at 12 months (-4.4±6.0°, p=0.002. No adverse events were implant-related and none required device removal. Three patients (2.9% experienced procedure-related complications. The overall adjacent fracture rate up to 1 year after surgery was 2.9%. The SpineJack procedure is an effective, low-risk procedure for patients with traumatic VCF allowing a fast and sustained improvement in quality of life over 1 year after surgery.

  6. The predictive value of treatment response using FDG PET performed on day 21 of chemoradiotherapy in patients with oesophageal squamous cell carcinoma. A prospective, multicentre study (RTEP3)

    Energy Technology Data Exchange (ETDEWEB)

    Palie, Odre; Vera, Pierre [Henri Becquerel Cancer Center and Rouen University Hospital, and QuantIF - LITIS (EA 4108), University of Rouen, Department of Nuclear Medicine, Faculty of Medicine, Rouen (France); Michel, Pierre; Di Fiore, Frederic [Rouen University Hospital and University of Rouen, Digestive Oncology Unit, Hepatogastroenterology Department, Rouen (France); Menard, Jean-Francois [Rouen University Hospital and University of Rouen, Department of Biostatistic, Rouen (France); Rousseau, Caroline; Bridji, Boumediene [Department of Nuclear Medicine, Renee Gauducheau Cancer Center, Nantes (France); Rio, Emmanuel [Department of Radiotherapy, Renee Gauducheau Cancer Center, Nantes (France); Benyoucef, Ahmed [Department of Radiotherapy, Henri Becquerel Cancer Center, Rouen (France); Meyer, Marc-Etienne [Amiens University Hospital, Department of Nuclear Medicine, Amiens (France); Jalali, Khadija [Amiens University Hospital, Department of Radiotherapy, Amiens (France); Bardet, Stephane [Department of Nuclear Medicine, Francois Baclesse Cancer Center, Caen (France); M' Vondo, Che Mabubu [Department of radiotherapy, Francois Baclesse Cancer Center, Caen (France); Olivier, Pierre [Brabois University Hospital, Department of Nuclear Medicine, Nancy (France); Faure, Guillaume [Department of Radiotherapy, Centre prive de Radiotherapie de Metz, Metz (France); Itti, Emmanuel [Henri Mondor University Hospital, Department of Nuclear Medicine, Creteil (France); Diana, Christian [Henri Mondor University Hospital, Department of Radiotherapy, Creteil (France); Houzard, Claire [Department of Nuclear Medicine, Hospices Civils de Lyon, Lyon (France); Mornex, Francoise [Department of Radiotherapy, Hospices Civils de Lyon, Lyon (France)

    2013-09-15

    as TV{sub p} (p = 0.02); TV{sub 40} did not decrease significantly. With respect to the predictive value of PET{sub 1}, only TV{sub 40} {sub 1} and TV{sub p} {sub 1} values, and therefore TLG{sub 40} {sub 1} and TLG{sub p} {sub 1}, but not the SUV values, were significantly lower in patients with CR at 3 months. SUVmax{sub 1}, TV{sub p} {sub 1} and TLG{sub p} {sub 1} were significantly lower in patients with CR at 1 year. With respect to the predictive value of PET{sub 2}, only TV{sub 40} {sub 2} and TV{sub p} {sub 2} values, and therefore TLG{sub 40} {sub 2} and TLG{sub p} {sub 2}, but not the SUV values, were significantly lower in patients with CR at 3 months. None of the PET{sub 2} parameters had significant value in predicting patient outcome at 1 year. The changes in SUVmax, TV{sub 40}, TV{sub p}, TLG{sub 40} and TLG{sub p} between PET{sub 1} and PET{sub 2} had no relationship to patient outcome at 3 months or 1 year. This prospective, multicentre study performed in a selected population of patients with oesophageal squamous cell cancer demonstrates that the parameters derived from baseline PET{sub 1} are good predictors of response to CRT. Specifically, a high TV and TLG are associated with a poor response to CRT at 3 months and 1 year, and a high SUVmax is associated with a poor response to CRT at 1 year. FDG PET performed during CRT on day 21 appears to have less clinical relevance. However, patients with a large functional TV on day 21 of CRT have a poor clinical outcome (ClinicalTrials.gov NCT 00934505). (orig.)

  7. 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.

  8. The prognosis of incurable cachectic cancer patients on home parenteral nutrition: a multi-centre observational study with prospective follow-up of 414 patients

    NARCIS (Netherlands)

    Bozzetti, F.; Santarpia, L.; Pironi, L.; Thul, P.; Klek, S.; Gavazzi, C.; Tinivella, M.; Joly, F.; Jonkers, C.; Baxter, J.; Gramlich, L.; Chicharro, L.; Staun, M.; van Gossum, A.; Lo Vullo, S.; Mariani, L.

    2014-01-01

    The role of home parenteral nutrition (HPN) in incurable cachectic cancer patients unable to eat is extremely controversial. The aim of this study is to analyse which factors can influence the outcome. We studied prospectively 414 incurable cachectic (sub)obstructed cancer patients receiving HPN and

  9. Efficacy and safety of renal denervation for Chinese patients with resistant hypertension using a microirrigated catheter: study design and protocol for a prospective multicentre randomised controlled trial.

    Science.gov (United States)

    Liu, Zongjun; Shen, Li; Huang, Weijian; Zhao, Xianxian; Fang, Weiyi; Wang, Changqian; Yin, Zhaofang; Wang, Jianan; Fu, Guosheng; Liu, Xuebo; Jiang, Jianjun; Zhang, Zhihui; Li, Jingbo; Lu, Yingmin; Ge, Junbo

    2017-09-01

    Available data show that approximately 8%-18% of patients with primary hypertension will develop resistant hypertension. In recent years, catheter-based renal denervation (RDN) has emerged as a potential treatment option for resistant hypertension. A number of observational studies and randomised controlled trials among non-Chinese patients have demonstrated its potential safety and efficacy. This is a multicentre, randomised, open-label, parallel-group, active controlled trial that will investigate the efficacy and safety of a 5F saline-irrigated radiofrequency ablation (RFA) used for RDN in the treatment of Chinese patients with resistant hypertension. A total of 254 patients who have failed pharmacological therapy will be enrolled. Eligible subjects will be randomised in a 1:1 ratio to undergo RDN using the RFA plus antihypertensive medication or to receive treatment with antihypertensive medication alone. The primary outcome measure is the change in 24 hours average ambulatory systolic blood pressure from baseline to 3 months, comparing the RDN-plus-medication group with the medication-alone group. Important secondary endpoints include the change in office blood pressure from baseline to 6 months after randomisation. Safety endpoints such as changes in renal function will also be evaluated. The full analysis set, according to the intent-to-treat principle, will be established as the primary analysis population. All participants will provide informed consent; the study protocol has been approved by the Independent Ethics Committee for each site. This study is designed to investigate the efficacy and safety of RDN using a 5F saline microirrigated RFA. Findings will be shared with participating hospitals, policymakers and the academic community to promote the clinical management of resistant hypertension in China. ClinicalTrials.gov ID: NCT02900729; pre-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017

  10. Progress towards non-invasive diagnosis and follow-up of celiac disease in children : a prospective multicentre study to the usefulness of plasma I-FABP

    NARCIS (Netherlands)

    Adriaanse, Marlou P. M.; Mubarak, A; Riedl, R G; Ten Kate, F J W; Damoiseaux, J G M C; Buurman, Wim A.; Houwen, R H J; Vreugdenhil, A C E

    2017-01-01

    This prospective study investigates whether measurement of plasma intestinal-fatty acid binding protein (I-FABP), a sensitive marker for small intestinal epithelial damage, improves non-invasive diagnosing of celiac disease (CD), and whether I-FABP levels are useful to evaluate mucosal healing in

  11. The role of gestational diabetes, pre-pregnancy body mass index and gestational weight gain on the risk of newborn macrosomia: results from a prospective multicentre study

    OpenAIRE

    Alberico, Salvatore; Montico, Marcella; Barresi, Valentina; Monasta, Lorenzo; Businelli, Caterina; Soini, Valentina; Erenbourg, Anna; Ronfani, Luca; Maso, Gianpaolo

    2014-01-01

    Background It is crucial to identify in large population samples the most important determinants of excessive fetal growth. The aim of the study was to evaluate the independent role of pre-pregnancy body mass index (BMI), gestational weight gain and gestational diabetes on the risk of macrosomia. Methods A prospective study collected data on mode of delivery and maternal/neonatal outcomes in eleven Hospitals in Italy. Multiple pregnancies and preterm deliveries were excluded. The sample inclu...

  12. Impact of CAre-related Regret Upon Sleep (ICARUS) cohort study: protocol of a 3-year multicentre, international, prospective cohort study of novice healthcare professionals.

    Science.gov (United States)

    Cheval, Boris; Cullati, Stéphane; Pihl-Thingvad, Jesper; Mongin, Denis; Von Arx, Martina; Chopard, Pierre; Courvoisier, Delphine S

    2018-03-27

    Healthcare professionals are particularly at risk of developing numerous physical and psychological health problems. The experiences of emotional burden associated with providing healthcare, notably care-related regret, have been associated with these health problems, but only using cross-sectional data so far. Evidence of a causal impact of regret has not been assessed. The Impact of CAre-related Regret Upon Sleep (ICARUS) study is the first prospective and international cohort study established to examine how newly practising healthcare professionals adapt to their challenging job by assessing the impact of care-related regret on sleep and job quitting. The ICARUS cohort study will include newly practising healthcare professionals working in acute care hospitals and clinics recruited between May 2017 and November 2019. Data collection, which will begin as soon as the participant starts working with patients, will consist of a 1-year weekly assessment using a secure web survey. Follow-up data will be collected at 6, 12, 18 and 24 months after the end of the first year. We will collect detailed information on the experience of care-related regret (ie, highest regret intensity, accumulation of regrets and coping strategies related to regrets), sleep problems and job quitting. Moreover, quality of life, health status and burnout will be assessed during the follow-up. Several confounders factors, including sociodemographic characteristics, personality, night shifts and work environment characteristics, will be assessed. The study was approved by the Ethics Committee of Geneva Canton, Switzerland (CCER2016-02041), the Ethics Committee of London South Bank University (HSCSEP/17/06) and the University Research Ethics Committee of Bedfordshire (UREC106). Other study centres deemed local ethical approval unnecessary since the main ethics committee (Geneva) had already accepted the project. Results will be published in relevant scientific journals and be disseminated in

  13. [Multicentre, prospective cohort study, to validate the Italian version of the Braden Q scale for the risk of the pressure sores in newborns and up to 8 years old children].

    Science.gov (United States)

    Chiari, Paolo; Poli, Marco; Magli, Claudia; Bascelli, Emanuele; Rocchi, Roberto; Bolognini, Silvia; Tartari, Piero; Armuzzi, Roberta; Rossi, Gianna; Peghetti, Angela; Biavati, Catia; Fontana, Mirella; Gazineo, Domenica; Cordella, Simona; Tiozzo, Emanuela; Ciliento, Gaetano; Carta, Giovanna; Taddia, Patrizia

    2012-01-01

    Multicenter prospective cohort study, to validate the Italian version of the Braden Q scale for the risk of pressure sores in newborns and up to 8 years old children. Children admitted to Intensive care Units (ICU), oncology and neurology/neurosurgery wards are at risk of developing pressure sores. To validate the Italian version of the Braden Q scale for the assessment of the risk of developing pressure sores in children. Children from 21 days to 8 years, admitted to intensive and sub intensive units were recruited. Premature babies, children admitted with a pressure sore and with a story of congenital cardiomiopathy were excluded. In this cohort, multicentre and with repeated measurements study, the first assessment was performed after 24 hours from hospital admission, using the Braden Q Scale (Suddaby's version). The pressure sores were assessed with the Skin assessment Tool and staged according to the National Pressure Ulcer Advisory Panel. RESULTS. On the 157 children 524 observation were conducted. The incidence of pressure sores was 17.2%. Only the analysis on specific subgroups of patients showed a good diagnostic accuracy: 71.4% on children 3-8 years; 85.6% in sub intensive wards. The Braden Q scale may be reliably used and shows a good diagnostic accuracy in children 3-8 years of age admitted to sub-intensive, neurology, oncology and heamatology wards.

  14. Cohort profile: maternal lifestyle and diet in relation to pregnancy, postpartum and infant health outcomes in Vietnam: A multicentre prospective cohort study.

    Science.gov (United States)

    Nguyen, Cong Luat; Nguyen, Phung Thi Hoang; Chu, Tan Khac; Ha, Anh Vo Van; Pham, Ngoc Minh; Duong, Dat Van; Do, Dung Van; Tang, Hong Kim; Binns, Colin W; Lee, Andy H

    2017-09-05

    To determine modifiable maternal risk factors for adverse pregnancy, postpartum maternal and child health outcomes in Vietnam. This prospective cohort study included pregnant women seeking prenatal care at six hospitals in three large cities in Vietnam. After enrolment, eligible participants who gave their consent to participate in the study were interviewed at 24-28 weeks' gestation. Glucose testing was conducted and blood pressure was measured during this period. Each participant will be assessed prospectively during their postnatal visits at delivery, 1, 3, 6, 12, 18 and 24 months, and will be followed up for 5 years. Of 2248 eligible pregnant women, 2030 were recruited (participation rate 90.3%) between August 2015 and July 2016. All participants completed the baseline assessment. Their mean (SD) age was 27.6 (5.3) years. The mean pre-pregnancy body mass index (BMI) was 20.2 (SD 2.6) kg/m 2 , with nearly two-thirds of participants having a normal pre-pregnancy BMI (18.5 to pregnancy BMI pregnancy BMI ≥23.0 kg/m 2 ) accounted for 12.8%. No pregnant women reported smoking during their pregnancy while 13.4% of them had continued drinking. 22.8% of participants had hyperglycaemia. Their mean systolic blood pressure was 105.6 (SD 8.2) mm Hg, and diastolic blood pressure was 67.4 (SD 7.5) mm Hg. The relationships of maternal lifestyle and nutritional status with the health outcomes of pregnancy, postpartum maternity and infants will be analysed. Meanwhile, participants will be closely tracked to minimise loss to follow-up. © 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.

  15. Does the age of acute care physicians impact their (1) crisis management performance and (2) learning after simulation-based education? A protocol for a multicentre prospective cohort study in Toronto and Ottawa, Canada.

    Science.gov (United States)

    Alam, Fahad; LeBlanc, Vicki R; Baxter, Alan; Tarshis, Jordan; Piquette, Dominique; Gu, Yuqi; Filipkowska, Caroline; Krywenky, Ashley; Kester-Greene, Nicole; Cardinal, Pierre; Au, Shelly; Lam, Sandy; Boet, Sylvain; Clinical Trials Group, Perioperative Anesthesia

    2018-04-21

    The proportion of older acute care physicians (ACPs) has been steadily increasing. Ageing is associated with physiological changes and prospective research investigating how such age-related physiological changes affect clinical performance, including crisis resource management (CRM) skills, is lacking. There is a gap in the literature on whether physician's age influences baseline CRM performance and also learning from simulation. We aim to investigate whether ageing is associated with baseline CRM skills of ACPs (emergency, critical care and anaesthesia) using simulated crisis scenarios and to assess whether ageing influences learning from simulation-based education. This is a prospective cohort multicentre study recruiting ACPs from the Universities of Toronto and Ottawa, Canada. Each participant will manage an advanced cardiovascular life support crisis-simulated scenario (pretest) and then be debriefed on their CRM skills. They will then manage another simulated crisis scenario (immediate post-test). Three months after, participants will return to manage a third simulated crisis scenario (retention post-test). The relationship between biological age and chronological age will be assessed by measuring the participants CRM skills and their ability to learn from high-fidelity simulation. This protocol was approved by Sunnybrook Health Sciences Centre Research Ethics Board (REB Number 140-2015) and the Ottawa Health Science Network Research Ethics Board (#20150173-01H). The results will be disseminated in a peer-reviewed journal and at scientific meetings. NCT02683447; Pre-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  16. Role of the internet as an information resource before anaesthesia consultation: A French prospective multicentre survey.

    Science.gov (United States)

    Nucci, Bastian; Claret, Pierre-Geraud; Leclerc, Gilles; Chaumeron, Arnaud; Grillo, Philippe; Buleon, Clément; Leprince, Vincent; Raux, Mathieu; Minville, Vincent; Futier, Emmanuel; Lefrant, Jean-Yves; Cuvillon, Philippe

    2017-12-01

    Use of the internet as an information search tool has increased dramatically. Our study assessed preoperative use of the internet by patients to search for information regarding anaesthesia, surgery, pain or outcomes. The aim of this study was to test whether patients used the internet prior to surgery and what kinds of information they looked for (anaesthetic technique, pain, adverse events, outcomes and surgery). Correlation between patient age and information sought about surgery from the internet was also explored. A prospective multicentre observational study. In total, 14 French private and public institutions from May 2015 to January 2016. In total, 3161 adult patients scheduled for elective surgery under regional or general anaesthesia. An anonymous questionnaire was presented to adult patients scheduled for elective surgery under regional or general anaesthesia for completion before the first meeting with the anaesthesiologist. The investigator at each centre completed specific items that the patient could not complete. We defined the primary endpoint as the number of patients who searched for information about their anaesthesia or surgery on the internet by the time of the their preanaesthetic consultation. Of the 3234 questionnaires distributed, responses were received from 3161 patients. Within this respondent sample, 1304 (45%) were professionally active and 1664 (59%) used the internet at least once per day. Among 3098 (98%) patients who answered the question concerning the primary endpoint, 1506 (48%) had searched the internet for information about their health. In total, 784 (25%) used the internet to find information about their surgery and 113 (3.5%) looked for specific information about anaesthesia. Of the 3161, 52% reported difficulty searching for appropriate information about anaesthesia on the internet. 'Daily use of the web' [odds ratio (OR) 2.0; (95% CI: 1.65 to 2.55) P internet was not widely used by patients scheduled for elective

  17. Multicentre, prospective, randomised, open-label, blinded end point trial of the efficacy of allopurinol therapy in improving cardiovascular outcomes in patients with ischaemic heart disease: protocol of the ALL-HEART study.

    Science.gov (United States)

    Mackenzie, Isla S; Ford, Ian; Walker, Andrew; Hawkey, Chris; Begg, Alan; Avery, Anthony; Taggar, Jaspal; Wei, Li; Struthers, Allan D; MacDonald, Thomas M

    2016-09-08

    Ischaemic heart disease (IHD) is one of the most common causes of death in the UK and treatment of patients with IHD costs the National Health System (NHS) billions of pounds each year. Allopurinol is a xanthine oxidase inhibitor used to prevent gout that also has several positive effects on the cardiovascular system. The ALL-HEART study aims to determine whether allopurinol improves cardiovascular outcomes in patients with IHD. The ALL-HEART study is a multicentre, controlled, prospective, randomised, open-label blinded end point (PROBE) trial of allopurinol (up to 600 mg daily) versus no treatment in a 1:1 ratio, added to usual care, in 5215 patients aged 60 years and over with IHD. Patients are followed up by electronic record linkage and annual questionnaires for an average of 4 years. The primary outcome is the composite of non-fatal myocardial infarction, non-fatal stroke or cardiovascular death. Secondary outcomes include all-cause mortality, quality of life and cost-effectiveness of allopurinol. The study will end when 631 adjudicated primary outcomes have occurred. The study is powered at 80% to detect a 20% reduction in the primary end point for the intervention. Patient recruitment to the ALL-HEART study started in February 2014. The study received ethical approval from the East of Scotland Research Ethics Service (EoSRES) REC 2 (13/ES/0104). The study is event-driven and results are expected after 2019. Results will be reported in peer-reviewed journals and at scientific meetings. Results will also be disseminated to guideline committees, NHS organisations and patient groups. 32017426, pre-results. 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/

  18. The role of gestational diabetes, pre-pregnancy body mass index and gestational weight gain on the risk of newborn macrosomia: results from a prospective multicentre study.

    Science.gov (United States)

    Alberico, Salvatore; Montico, Marcella; Barresi, Valentina; Monasta, Lorenzo; Businelli, Caterina; Soini, Valentina; Erenbourg, Anna; Ronfani, Luca; Maso, Gianpaolo

    2014-01-15

    It is crucial to identify in large population samples the most important determinants of excessive fetal growth. The aim of the study was to evaluate the independent role of pre-pregnancy body mass index (BMI), gestational weight gain and gestational diabetes on the risk of macrosomia. A prospective study collected data on mode of delivery and maternal/neonatal outcomes in eleven Hospitals in Italy. Multiple pregnancies and preterm deliveries were excluded. The sample included 14109 women with complete records. Associations between exposure variables and newborn macrosomia were analyzed using Pearson's chi squared test. Multiple logistic regression models were built to assess the independent association between potential predictors and macrosomia. Maternal obesity (adjusted OR 1.7, 95% CI 1.4-2.2), excessive gestational weight gain (adjusted OR 1.9, 95% CI 1.6-2.2) and diabetes (adjusted OR 2.1, 95% CI 1.5-3.0 for gestational; adjusted OR 3.0, 95% CI 1.2-7.6 for pre-gestational) resulted to be independent predictors of macrosomia, when adjusted for other recognized risk factors. Since no significant interaction was found between pre-gestational BMI and gestational weight gain, excessive weight gain should be considered an independent risk factor for macrosomia. In the sub-group of women affected by gestational or pre-gestational diabetes, pre-gestational BMI was not significantly associated to macrosomia, while excessive pregnancy weight gain, maternal height and gestational age at delivery were significantly associated. In this sub-population, pregnancy weight gain less than recommended was not significantly associated to a reduction in macrosomia. Our findings indicate that maternal obesity, gestational weight gain excess and diabetes should be considered as independent risk factors for newborn macrosomia. To adequately evaluate the clinical evolution of pregnancy all three variables need to be carefully assessed and monitored.

  19. Risk factors for anastomotic leak and postoperative morbidity and mortality after elective right colectomy for cancer: results from a prospective, multicentric study of 1102 patients.

    Science.gov (United States)

    Frasson, Matteo; Granero-Castro, Pablo; Ramos Rodríguez, José Luis; Flor-Lorente, Blas; Braithwaite, Mariela; Martí Martínez, Eva; Álvarez Pérez, Jose Antonio; Codina Cazador, Antonio; Espí, Alejandro; Garcia-Granero, Eduardo

    2016-01-01

    Studies focused on postoperative outcome after oncologic right colectomy are lacking. The main objective was to determine pre-/intraoperative risk factors for anastomotic leak after elective right colon resection for cancer. Secondary objectives were to determine risk factors for postoperative morbidity and mortality. Fifty-two hospitals participated in this prospective, observational study (September 2011-September 2012), including 1102 patients that underwent elective right colectomy. Forty-two pre-/intraoperative variables, related to patient, tumor, surgical procedure, and hospital, were analyzed as potential independent risk factors for anastomotic leak and postoperative morbidity and mortality. Anastomotic leak was diagnosed in 93 patients (8.4 %), and 72 (6.5 %) of them needed radiological or surgical intervention. Morbidity, mortality, and wound infection rates were 29.0, 2.6, and 13.4 %, respectively. Preoperative serum protein concentration was the only independent risk factor for anastomotic leak (p leaks, stapled technique (p = 0.03, OR 2.1) and preoperative serum protein concentration (p = 0.004, OR 0.6 g/dL) were identified as the only two independent risk factors. Age and preoperative serum albumin concentration resulted to be risk factors for postoperative mortality. Male gender, pulmonary or hepatic disease, and open surgical approach were identified as risk factors for postoperative morbidity, while male gender, obesity, intraoperative complication, and end-to-end anastomosis were risk factors for wound infection. Preoperative nutritional status and the stapled anastomotic technique were the only independent risk factors for clinically relevant anastomotic leak after elective right colectomy for cancer. Age and preoperative nutritional status determined the mortality risk, while laparoscopic approach reduced postoperative morbidity.

  20. Predicting Outcome and Therapy Response in mCRC Patients Using an Indirect Method for CTCs Detection by a Multigene Expression Panel: A Multicentric Prospective Validation Study

    Directory of Open Access Journals (Sweden)

    Yolanda Vidal Insua

    2017-06-01

    Full Text Available Colorectal cancer (CRC is one of the major causes of cancer-related deaths. Early detection of tumor relapse is crucial for determining the most appropriate therapeutic management. In clinical practice, computed tomography (CT is routinely used, but small tumor changes are difficult to visualize, and reliable blood-based prognostic and monitoring biomarkers are urgently needed. The aim of this study was to prospectively validate a gene expression panel (composed of GAPDH, VIL1, CLU, TIMP1, TLN1, LOXL3 and ZEB2 for detecting circulating tumor cells (CTCs as prognostic and predictive tool in blood samples from 94 metastatic CRC (mCRC patients. Patients with higher gene panel expression before treatment had a reduced progression-free survival (PFS and overall-survival (OS rates compared with patients with low expression (p = 0.003 and p ≤ 0.001, respectively. Patients with increased expression of CTCs markers during treatment presented PFS and OS times of 8.95 and 11.74 months, respectively, compared with 14.41 and 24.7 for patients presenting decreased expression (PFS; p = 0.020; OS; p ≤ 0.001. Patients classified as non-responders by CTCs with treatment, but classified as responders by CT scan, showed significantly shorter survival times (PFS: 8.53 vs. 11.70; OS: 10.37 vs. 24.13; months. In conclusion, our CTCs detection panel demonstrated efficacy for early treatment response assessment in mCRC patients, and with increased reliability compared to CT scan.

  1. Do depression and anxiety reduce the likelihood of remission in rheumatoid arthritis and psoriatic arthritis? Data from the prospective multicentre NOR-DMARD study.

    Science.gov (United States)

    Michelsen, Brigitte; Kristianslund, Eirik Klami; Sexton, Joseph; Hammer, Hilde Berner; Fagerli, Karen Minde; Lie, Elisabeth; Wierød, Ada; Kalstad, Synøve; Rødevand, Erik; Krøll, Frode; Haugeberg, Glenn; Kvien, Tore K

    2017-11-01

    To investigate the predictive value of baseline depression/anxiety on the likelihood of achieving joint remission in rheumatoid arthritis (RA) and psoriatic arthritis (PsA) as well as the associations between baseline depression/anxiety and the components of the remission criteria at follow-up. We included 1326 patients with RA and 728 patients with PsA from the prospective observational NOR-DMARD study starting first-time tumour necrosis factor inhibitors or methotrexate. The predictive value of depression/anxiety on remission was explored in prespecified logistic regression models and the associations between baseline depression/anxiety and the components of the remission criteria in prespecified multiple linear regression models. Baseline depression/anxiety according to EuroQoL-5D-3L, Short Form-36 (SF-36) Mental Health subscale ≤56 and SF-36 Mental Component Summary ≤38 negatively predicted 28-joint Disease Activity Score anxiety was associated with increased patient's and evaluator's global assessment, tender joint count and joint pain in RA at follow-up, but not with swollen joint count and acute phase reactants. Depression and anxiety may reduce likelihood of joint remission based on composite scores in RA and PsA and should be taken into account in individual patients when making a shared decision on a treatment target. © 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.

  2. Diversity of Clostridium difficile PCR ribotypes in Europe: results from the European, multicentre, prospective, biannual, point-prevalence study of Clostridium difficile infection in hospitalised patients with diarrhoea (EUCLID), 2012 and 2013.

    Science.gov (United States)

    Davies, Kerrie A; Ashwin, Helen; Longshaw, Christopher M; Burns, David A; Davis, Georgina L; Wilcox, Mark H

    2016-07-21

    Clostridium difficile infection (CDI) is the major cause of infective diarrhoea in healthcare environments. As part of the European, multicentre, prospective, biannual, point-prevalence study of Clostridium difficile infection in hospitalised patients with diarrhoea (EUCLID), the largest C. difficile epidemiological study of its type, PCR ribotype distribution of C. difficile isolates in Europe was investigated. PCR ribotyping was performed on 1,196 C. difficile isolates from diarrhoeal samples sent to the European coordinating laboratory in 2012-13 and 2013 (from two sampling days) by 482 participating hospitals from 19 European countries. A total of 125 ribotypes were identified, of which ribotypes 027 (19%, n =222), 001/072 (11%, n = 134) and 014/020 (10%, n = 119) were the most prevalent. Distinct regional patterns of ribotype distribution were noted. Of 596 isolates from patients with toxin-positive stools (CDI cases), ribotype 027 accounted for 22% (32/144) of infections in cases aged from 18 to less than 65 years, but the prevalence decreased in those aged ≥ 65 years (14% (59/412)) and further decreased in those aged ≥ 81 years (9% (18/195)). The prevalence of ribotype 027 and 176, but not other epidemic strains, was inversely proportional to overall ribotype diversity (R(2) = 0.717). This study highlights an increased diversity of C. difficile ribotypes across Europe compared with previous studies, with considerable intercountry variation in ribotype distribution. Continuous surveillance programmes are necessary to monitor the changing epidemiology of C. difficile. This article is copyright of The Authors, 2016.

  3. Sensitivity and Specificity of a Prototype Rapid Diagnostic Test for the Detection of Trypanosoma brucei gambiense Infection: A Multi-centric Prospective Study.

    Science.gov (United States)

    Bisser, Sylvie; Lumbala, Crispin; Nguertoum, Etienne; Kande, Victor; Flevaud, Laurence; Vatunga, Gedeao; Boelaert, Marleen; Büscher, Philippe; Josenando, Theophile; Bessell, Paul R; Biéler, Sylvain; Ndung'u, Joseph M

    2016-04-01

    A major challenge in the control of human African trypanosomiasis (HAT) is lack of reliable diagnostic tests that are rapid and easy to use in remote areas where the disease occurs. In Trypanosoma brucei gambiense HAT, the Card Agglutination Test for Trypanosomiasis (CATT) has been the reference screening test since 1978, usually on whole blood, but also in a 1/8 dilution (CATT 1/8) to enhance specificity. However, the CATT is not available in a single format, requires a cold chain for storage, and uses equipment that requires electricity. A solution to these challenges has been provided by rapid diagnostic tests (RDT), which have recently become available. A prototype immunochromatographic test, the SD BIOLINE HAT, based on two native trypanosomal antigens (VSG LiTat 1.3 and VSG LiTat 1.5) has been developed. We carried out a non-inferiority study comparing this prototype to the CATT 1/8 in field settings. The prototype SD BIOLINE HAT, the CATT Whole Blood and CATT 1/8 were systematically applied on fresh blood samples obtained from 14,818 subjects, who were prospectively enrolled through active and passive screening in clinical studies in three endemic countries of central Africa: Angola, the Democratic Republic of the Congo and the Central African Republic. One hundred and forty nine HAT cases were confirmed by parasitology. The sensitivity and specificity of the prototype SD BIOLINE HAT was 89.26% (95% confidence interval (CI) = 83.27-93.28) and 94.58% (95% CI = 94.20-94.94) respectively. The sensitivity and specificity of the CATT on whole blood were 93.96% (95% CI = 88.92-96.79) and 95.91% (95% CI = 95.58-96.22), and of the CATT 1/8 were 89.26% (95% CI = 83.27-93.28) and 98.88% (95% CI = 98.70-99.04) respectively. After further optimization, the prototype SD BIOLINE HAT could become an alternative to current screening methods in primary healthcare settings in remote, resource-limited regions where HAT typically occurs.

  4. Reduced-intensity conditioning and HLA-matched haemopoietic stem-cell transplantation in patients with chronic granulomatous disease: a prospective multicentre study.

    Science.gov (United States)

    Güngör, Tayfun; Teira, Pierre; Slatter, Mary; Stussi, Georg; Stepensky, Polina; Moshous, Despina; Vermont, Clementien; Ahmad, Imran; Shaw, Peter J; Telles da Cunha, José Marcos; Schlegel, Paul G; Hough, Rachel; Fasth, Anders; Kentouche, Karim; Gruhn, Bernd; Fernandes, Juliana F; Lachance, Silvy; Bredius, Robbert; Resnick, Igor B; Belohradsky, Bernd H; Gennery, Andrew; Fischer, Alain; Gaspar, H Bobby; Schanz, Urs; Seger, Reinhard; Rentsch, Katharina; Veys, Paul; Haddad, Elie; Albert, Michael H; Hassan, Moustapha

    2014-02-01

    In chronic granulomatous disease allogeneic haemopoietic stem-cell transplantation (HSCT) in adolescents and young adults and patients with high-risk disease is complicated by graft-failure, graft-versus-host disease (GVHD), and transplant-related mortality. We examined the effect of a reduced-intensity conditioning regimen designed to enhance myeloid engraftment and reduce organ toxicity in these patients. This prospective study was done at 16 centres in ten countries worldwide. Patients aged 0-40 years with chronic granulomatous disease were assessed and enrolled at the discretion of individual centres. Reduced-intensity conditioning consisted of high-dose fludarabine (30 mg/m(2) [infants HLA-matched related-donors or HLA-9/10 or HLA-10/10 matched unrelated-donors were infused. The primary endpoints were overall survival and event-free survival (EFS), probabilities of overall survival and EFS at 2 years, incidence of acute and chronic GVHD, achievement of at least 90% myeloid donor chimerism, and incidence of graft failure after at least 6 months of follow-up. 56 patients (median age 12·7 years; IQR 6·8-17·3) with chronic granulomatous disease were enrolled from June 15, 2003, to Dec 15, 2012. 42 patients (75%) had high-risk features (ie, intractable infections and autoinflammation), 25 (45%) were adolescents and young adults (age 14-39 years). 21 HLA-matched related-donor and 35 HLA-matched unrelated-donor transplants were done. Median time to engraftment was 19 days (IQR 16-22) for neutrophils and 21 days (IQR 16-25) for platelets. At median follow-up of 21 months (IQR 13-35) overall survival was 93% (52 of 56) and EFS was 89% (50 of 56). The 2-year probability of overall survival was 96% (95% CI 86·46-99·09) and of EFS was 91% (79·78-96·17). Graft-failure occurred in 5% (three of 56) of patients. The cumulative incidence of acute GVHD of grade III-IV was 4% (two of 56) and of chronic graft-versus-host disease was 7% (four of 56). Stable (≥90%) myeloid

  5. A comparison of the temporary placement of 3 different self-expanding stents for the treatment of refractory benign esophageal strictures: a prospective multicentre study

    Directory of Open Access Journals (Sweden)

    Canena Jorge Manuel

    2012-06-01

    Full Text Available Abstract Background Refractory benign esophageal strictures (RBESs have been treated with the temporary placement of different self-expanding stents with conflicting results. We compared the clinical effectiveness of 3 types of stents: self-expanding plastic stents (SEPSs, biodegradable stents, and fully covered self-expanding metal stents (FCSEMSs, for the treatment of RBES. Methods This study prospectively evaluated 3 groups of 30 consecutive patients with RBESs who underwent temporary placement of either SEPSs (12 weeks, n = 10, biodegradable stents (n = 10 or FCSEMSs (12 weeks, n = 10. Data were collected to analyze the technical success and clinical outcome of the stents as evaluated by recurrent dysphagia, complications and reinterventions. Results Stent implantation was technically successful in all patients. Migration occurred in 11 patients: 6 (60% in the SEPS group, 2 (20% in the biodegradable group and 3 (30% in the FCSEMS group (P = 0.16. A total of 8/30 patients (26.6% were dysphagia-free after the end of follow-up: 1 (10% in the SEPS group, 3 (30% in the biodegradable group and 4 (40% in the FCSEMS group (P = 0.27. More reinterventions were required in the SEPS group (n = 24 than in the biodegradable group (n = 13 or the FCSEMS group (n = 13 (P = 0.24. Multivariate analysis showed that stricture length was significantly associated with higher recurrence rates after temporary stent placement (HR = 1.37; 95% CI = 1.08-1.75; P = 0.011. Conclusions Temporary placement of a biodegradable stent or of a FCSEMS in patients with RBES may lead to long-term relief of dysphagia in 30 and 40% of patients, respectively. The use of SEPSs seems least preferable, as they are associated with frequent stent migration, more reinterventions and few cases of long-term improvement. Additionally, longer strictures were associated with a higher risk of recurrence.

  6. The social and economic burden of stroke survivors in Italy: a prospective, incidence-based, multi-centre cost of illness study

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    Fattore Giovanni

    2012-11-01

    Full Text Available Abstract Background The aim of this study was to estimate the one-year societal costs due to a stroke event in Italy and to investigate variables associated with costs in different phases following hospital admission. Methods The patients were enrolled in 44 hospitals across the country and data on socio-demographic, clinical variables and resource consumption were prospectively surveyed for 411 stroke survivors at admission, discharge and 3, 6 and 12 months post the event. We adopted a micro-costing procedure to identify cost generating components and the attribution of appropriate unit costs for three cost categories: direct healthcare, direct non-healthcare (including informal care costs and productivity losses. The relation between costs of stroke management and socio-demographic and clinical characteristics as well as disability levels was evaluated in a series of bivariate analyses using non parametric tests (Mann Whitney and Kruskal-Wallis. Multiple linear regression analyses were performed to determine predictors of costs incurred by stroke patients during the acute phase and follow-up of 1 year. Results On average, one-year healthcare and societal costs amounted to €11,747 and € 19,953 per stroke survivor, respectively. The major cost component of societal costs was informal care accounting for € 6,656 (33.4% of total, followed by the initial hospitalisation, (€ 5,573; 27.9% of total, rehabilitation during follow up (€ 4,112; 20.6 %, readmissions (€ 439 and specialist and general practioner visits (€ 326. Mean drug costs per patient over the follow-up period was about € 50 per month. Costs associated to the provision of paid and informal care followed different pattern and were persistent over time (ranging from € 639 to € 597 per month in the first and the second part of the year, respectively. Clinical variables (presence of diabetes mellitus and hemorrhagic stroke were significant predictors of total healthcare

  7. Prospective, Multicentre, Nationwide Clinical Data from 600 Cases of Acute Pancreatitis.

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    Andrea Párniczky

    Full Text Available The aim of this study was to analyse the clinical characteristics of acute pancreatitis (AP in a prospectively collected, large, multicentre cohort and to validate the major recommendations in the IAP/APA evidence-based guidelines for the management of AP.Eighty-six different clinical parameters were collected using an electronic clinical research form designed by the Hungarian Pancreatic Study Group.600 adult patients diagnosed with AP were prospectively enrolled from 17 Hungarian centres over a two-year period from 1 January 2013.With respect to aetiology, biliary and alcoholic pancreatitis represented the two most common forms of AP. The prevalence of biliary AP was higher in women, whereas alcoholic AP was more common in men. Hyperlipidaemia was a risk factor for severity, lack of serum enzyme elevation posed a risk for severe AP, and lack of abdominal pain at admission demonstrated a risk for mortality. Abdominal tenderness developed in all the patients with severe AP, while lack of abdominal tenderness was a favourable sign for mortality. Importantly, lung injury at admission was associated with mortality. With regard to laboratory parameters, white blood cell count and CRP were the two most sensitive indicators for severe AP. The most common local complication was peripancreatic fluid, whereas the most common distant organ failure in severe AP was lung injury. Deviation from the recommendations in the IAP/APA evidence-based guidelines on fluid replacement, enteral nutrition and timing of interventions increased severity and mortality.Analysis of a large, nationwide, prospective cohort of AP cases allowed for the identification of important determinants of severity and mortality. Evidence-based guidelines should be observed rigorously to improve outcomes in AP.

  8. Multicentre prospective evaluation of implant-assisted mandibular removable partial dentures: surgical and prosthodontic outcomes.

    Science.gov (United States)

    Payne, Alan G T; Tawse-Smith, Andrew; Wismeijer, Daniel; De Silva, Rohana K; Ma, Sunyoung

    2017-01-01

    To determine implant survival and prosthodontic maintenance of implant-assisted mandibular removable partial dentures in a multicentre prospective study up to 10 years. Forty-eight participants with mandibular distal extension partial dentures were selected. A control group of 12 New Zealand participants had new conventional mandibular partial dentures made. Three test groups of 36 participants in New Zealand (n = 12), the Netherlands (n = 12) and Colombia (n = 12) had bilateral distal implants placed. Surgical and prosthodontic outcomes were documented with only healing caps placed (Stage 1) and with an attachment system (Stage 2). No implants failed after 3 years. Four late implant failures in three participants occurred in New Zealand (two unilateral implant failures after 5 and 8 years and two bilateral implant failures in the same participant after 6 and 10 years); two unilateral late implant failures occurred in the Netherlands and no late failures in Colombia. Implant survival rate was 92% by 10 years. Resonance frequency measurements were taken at surgery implant stability quotient (ISQ) 62.44 ± 7.46; range 40 - 79), baseline (ISQ 63.22 ± 6.17; range 50 - 74) and after 3 years (ISQ 66.38 ± 6.77; range 55 - 83). In New Zealand and Colombia, measured crestal bone levels were 2.03 ± 0.71 mm and 2.20 ± 0.81 mm, respectively, at baseline and 3 years. For Stage I, principal prosthodontic maintenance issues were loose healing caps among 10 New Zealand participants, four Colombian participants and one Netherlands participant. For Stage 2, matrix activation and overdenture puncture fractures resulted in 41 events (25 participants) in New Zealand over 10 years, whilst over 3 years, there were 14 events in nine Colombian participants and six events in five Netherlands participants. This clinical multicentre research complements previous case reports, case series, retrospective and prospective studies on the notion of implant

  9. Multicentre prospective evaluation of implant-assisted mandibular bilateral distal extension removable partial dentures: patient satisfaction.

    Science.gov (United States)

    Wismeijer, Daniel; Tawse-Smith, Andrew; Payne, Alan G T

    2013-01-01

    To compare the levels of patient satisfaction with either conventional mandibular bilateral distal extension partial dentures or those assisted by bilateral distal implants. Forty-eight participants who were dissatisfied with their existing conventional mandibular distal extension dentures opposing complete maxillary dentures were selected for a multicentre prospective study in New Zealand, Colombia and the Netherlands. A control group of 12 participants in New Zealand received conventional mandibular partial dentures. Three test groups involving 36 participants in New Zealand (12), Colombia (12) and the Netherlands (12) received bilateral distal implants in the second molar regions. After conventional loading, the test group participants initially had healing caps placed on the distal implants providing support only, followed after approximately 6 months by ball abutments (retentive anchors) for support and retention. Patient outcomes were determined with questionnaires completed at specific stages of the study for up to 3 years. Visual analogue scale, Likert and oral health impact questionnaires before and after treatment indicated improved results. There were significantly improved parameters of overall satisfaction, stability, chewing and appearance after 3 years (P removable partial dentures are a preferable treatment option for patients with complaints about their conventional distal extension partial dentures. © 2011 John Wiley & Sons A/S.

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

    Science.gov (United States)

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

    2018-05-03

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

  11. Haptic-based neurorehabilitation in poststroke patients: a feasibility prospective multicentre trial for robotics hand rehabilitation.

    Science.gov (United States)

    Turolla, Andrea; Daud Albasini, Omar A; Oboe, Roberto; Agostini, Michela; Tonin, Paolo; Paolucci, Stefano; Sandrini, Giorgio; Venneri, Annalena; Piron, Lamberto

    2013-01-01

    Background. Haptic robots allow the exploitation of known motor learning mechanisms, representing a valuable option for motor treatment after stroke. The aim of this feasibility multicentre study was to test the clinical efficacy of a haptic prototype, for the recovery of hand function after stroke. Methods. A prospective pilot clinical trial was planned on 15 consecutive patients enrolled in 3 rehabilitation centre in Italy. All the framework features of the haptic robot (e.g., control loop, external communication, and graphic rendering for virtual reality) were implemented into a real-time MATLAB/Simulink environment, controlling a five-bar linkage able to provide forces up to 20 [N] at the end effector, used for finger and hand rehabilitation therapies. Clinical (i.e., Fugl-Meyer upper extremity scale; nine hold pegboard test) and kinematics (i.e., time; velocity; jerk metric; normalized jerk of standard movements) outcomes were assessed before and after treatment to detect changes in patients' motor performance. Reorganization of cortical activation was detected in one patient by fMRI. Results and Conclusions. All patients showed significant improvements in both clinical and kinematic outcomes. Additionally, fMRI results suggest that the proposed approach may promote a better cortical activation in the brain.

  12. Haptic-Based Neurorehabilitation in Poststroke Patients: A Feasibility Prospective Multicentre Trial for Robotics Hand Rehabilitation

    Directory of Open Access Journals (Sweden)

    Andrea Turolla

    2013-01-01

    Full Text Available Background. Haptic robots allow the exploitation of known motorlearning mechanisms, representing a valuable option for motor treatment after stroke. The aim of this feasibility multicentre study was to test the clinical efficacy of a haptic prototype, for the recovery of hand function after stroke. Methods. A prospective pilot clinical trial was planned on 15 consecutive patients enrolled in 3 rehabilitation centre in Italy. All the framework features of the haptic robot (e.g., control loop, external communication, and graphic rendering for virtual reality were implemented into a real-time MATLAB/Simulink environment, controlling a five-bar linkage able to provide forces up to 20 [N] at the end effector, used for finger and hand rehabilitation therapies. Clinical (i.e., Fugl-Meyer upper extremity scale; nine hold pegboard test and kinematics (i.e., time; velocity; jerk metric; normalized jerk of standard movements outcomes were assessed before and after treatment to detect changes in patients' motor performance. Reorganization of cortical activation was detected in one patient by fMRI. Results and Conclusions. All patients showed significant improvements in both clinical and kinematic outcomes. Additionally, fMRI results suggest that the proposed approach may promote a better cortical activation in the brain.

  13. Response of vascular pigment epithelium detachment due to age-related macular degeneration to monthly treatment with ranibizumab: the prospective, multicentre RECOVER study.

    Science.gov (United States)

    Clemens, Christoph R; Wolf, Armin; Alten, Florian; Milojcic, Carolin; Heiduschka, Peter; Eter, Nicole

    2017-11-01

    To assess the effects of monthly intravitreal ranibizumab injections in patients with vascularized pigment epithelium detachment (vPED) secondary to age-related macular degeneration (AMD). A total of 40 patients were prospectively observed and treated monthly with 0.5 mg ranibizumab injections (ClinicalTrials.gov Ident. NCT00976222). Inclusion criterion was a treatment-naïve vPED lesion with a minimum height of ≥200 μm. Best-corrected visual acuity (BCVA) and spectral-domain optical coherence tomography (SD-OCT) were evaluated at all visits. Fluorescein angiography and indocyanine green angiography were performed at baseline and quarterly. Lesions were differentiated between serous vascular PED (svPED, group A, 29 patients) and fibrovascular PED (fPED, group B, 11 patients). Primary outcome was the effectivity of continuous monthly treatment during a 12-month period as measured in change in BCVA. Secondary outcomes were change in PED height and PED greatest linear diameter (GLD). Further secondary outcomes were the presence of subretinal fluid and prognostic markers of an impending retinal pigment epithelium (RPE) tear: PED lesion height and diameter, ratio of choroidal neovascularization (CNV) size to PED size, hyperreflective lines in near-infrared images, microrips and subretinal cleft. Mean BCVA was 56.9 ± 11.5 letters (A: 55.4 ± 10.8; B: 59.1 ± 13.4) at baseline and 55.1 ± 15.9 (A: 53.7 ± 17.0; B: 58.9 ± 12.7) at 12-month follow-up. Excluding the RPE tear patients, the svPED group showed an increase in BCVA from 56.1 ± 10.3 at baseline to 62.4 ± 10.2 at 12-month follow-up (p = 0.048). Best-corrected visual acuity in patient who developed a RPE tear was 55.8 ± 12.5 at baseline and 37.1 ± 14.9 at 12-month follow-up. The mean change in PED height was -242.1 μm ± 285.5 (A: -427.3 μm ± 299.7; B: -51.6 μm ± 99.5). The mean decrease in PED GLD was -471.8 μm ± 727.6 (A: -738.9 μm ± 788.2; B: -10.4

  14. A Multi-centric, Double-blind, Placebo-controlled, Randomized, Prospective Study to Evaluate the Efficacy and Safety of Carica papaya Leaf Extract, as Empirical Therapy for Thrombocytopenia associated with Dengue Fever.

    Science.gov (United States)

    Kasture, Prabhu Nagnathappa; Nagabhushan, K H; Kumar, Arun

    2016-06-01

    Dengue is a rapidly expanding global health problem. Approximately 2.5 billion people live in dengue-risk regions with about 100 million new cases each year worldwide. The cumulative dengue diseases burden has attained an unprecedented proportion in recent times with sharp increase in the size of human population at risk. The management of dengue virus infection is essentially supportive and symptomatic and no specific treatment is available for increasing the fallen platelets, which have a significant role in causing the mortality of dengue patient.This study was conducted to evaluate the platelet increasing efficacy of Carica papaya leaf extract (CPLE) in patients with dengue fever (DF). The administration of Carica papaya leaf extract should significantly increase the platelet count in cases of thrombocytopenia associated with dengue, preventing the patient to go in DHF or DSS conditions. A Multi-centric, Double blind, Placebo controlled, Randomized, prospective study was conducted in 300 patients across 5 centres', to evaluate the Efficacy and Safety of Carica Papaya Leaf Extract, as empirical therapy for thrombocytopenia associated with dengue fever. The subjects were randomized into two groups, as control and intervention group. Both the groups were managed by the standard management guidelines for dengue except steroid administration. In addition to this, the intervention group received CPLE tablet three times daily for five days. All of them were followed daily with platelet monitoring. This study has been registered in the clinical trial registry-India (CTRI Registration number: CTRI/2015/05/005806). The results indicate that CPLE had significant increase(p< 0.01) in the platelet count over the therapy duration, in dengue fever patients, confirming CPLE accelerates the increase in platelet count compared to the control group. There were few adverse events related to GI disturbance like nausea and vomiting which were similar in both groups. Thus this study

  15. A prospective, observational, open-label, multicentre study to investigate the daily treatment practice of ranibizumab in patients with neovascular age-related macular degeneration

    NARCIS (Netherlands)

    Asten, F. van; Evers-Birkenkamp, K.U.; Lith-Verhoeven, J.J. van; Jong-Hesse, Y. de; Hoppenreijs, V.P.T.; Hommersom, R.F.; Scholten, A.M.; Hoyng, C.B.; Klaver, J.H.

    2015-01-01

    PURPOSE: The HELIOS (Health Economics with Lucentis in Observational Settings) study was designed on request of the Dutch Health Authority for an observational study to assess the effectiveness and safety of ranibizumab for neovascular age-related macular degeneration (wet AMD) in daily practice.

  16. A prospective, observational, open-label, multicentre study to investigate the daily treatment practice of ranibizumab in patients with neovascular age-related macular degeneration

    NARCIS (Netherlands)

    van Asten, Freekje; Evers-Birkenkamp, Kim U.; van Lith-Verhoeven, Janneke J. C.; de Jong-Hesse, Yvonne; Hoppenreijs, Vincent P. T.; Hommersom, Richard F.; Scholten, Agnes M.; Hoyng, Carel B.; Klaver, Johannes H. J.; Klaver, J. H. J.; Hoyng, C. B.; Raijmakers, A. J.; van Lith-Verhoeven, J. J. C.; Rulo, A. H. F.; Verbraak, F. D.; Schlingemann, R. O.; Hommersom, C. F.; de Jong-Hesse, Y.; Bosch-Driessen, E. H.; Smeets, M. H.; Gonçalves, A.; Klomp, H. J.; Hoppenreijs, V. P. T.; Dito, J. J.

    2015-01-01

    The HELIOS (Health Economics with Lucentis in Observational Settings) study was designed on request of the Dutch Health Authority for an observational study to assess the effectiveness and safety of ranibizumab for neovascular age-related macular degeneration (wet AMD) in daily practice. The HELIOS

  17. Physical activity, body mass index and bone mineral density-associations in a prospective population-based cohort of women and men: the Canadian Multicentre Osteoporosis Study (CaMos).

    Science.gov (United States)

    Langsetmo, L; Hitchcock, C L; Kingwell, E J; Davison, K S; Berger, C; Forsmo, S; Zhou, W; Kreiger, N; Prior, J C

    2012-01-01

    Physical activity (PA) is an important modifiable risk factor for both bone mineral density (BMD) and body mass index (BMI). However, BMI is itself strongly predictive of BMD. Our aim was to determine the association between PA and BMD, with consideration of BMI as a potential mediating factor. The Canadian Multicentre Osteoporosis Study (CaMos) is a population-based prospective cohort study of Canadian women and men. PA was determined from interviewer-administered questionnaires at baseline and Year 5 and summarized as daily energy expenditure in total metabolic equivalents of the task multiplied by minutes/day (MET*m/d). Height, weight, and total hip and lumbar spine BMD were measured at baseline and Year 5. General linear models assessed relationships between PA and BMD, both cross-sectionally (baseline PA with baseline BMD) and longitudinally (average PA and change in PA with change in BMD). BMI was considered as a mediating factor. Potential confounders included age, center, education, caffeine intake, alcohol exposure, smoking history, history of weight-cycling, age at menarche, past use of oral contraceptives, history of >3 months missed menstruation, menopausal status, and antiresorptive use, as relevant. The study included 2855 men and 6442 women. PA was inversely associated with BMI at baseline, and an increase in PA between baseline and Year 5 was associated with a decrease in BMI, with 0.41 (95% CI: 0.22, 0.60) kg/m(2) loss per 1000 MET*m/d increase (in men) and 0.40 (95% CI: 0.23, 0.57) kg/m(2) loss per 1000 MET*m/d increase (in women). BMI was strongly associated with BMD, both cross-sectionally and longitudinally. However, increased PA was associated with a small increase in total hip BMD, 0.004 (95% CI: 0.000-0.008) g/cm(2) per 1000 MET*m/d (in men) and 0.003 (95% CI: 0.000-0.007) g/cm(2) per 1000 MET*m/d (in women). Average PA was associated with an increase in lumbar spine BMD in women, but not in men; it was not associated with change in total

  18. Physical Activity, Body Mass Index and Bone Mineral Density— Associations in a Prospective Population-based Cohort of Women and Men: The Canadian Multicentre Osteoporosis Study (CaMos)

    Science.gov (United States)

    Langsetmo, L; Hitchcock, CL; Kingwell, EJ; Davison, KS; Berger, C; Forsmo, S.; Zhou, W; Kreiger, N; Prior, JC

    2013-01-01

    Background Physical activity (PA) is an important modifiable risk factor for both bone mineral density (BMD) and body mass index (BMI). However, BMI is itself strongly predictive of BMD. Our aim was to determine the association between PA and BMD, with consideration of BMI as a potential mediating factor. Methods The Canadian Multicentre Osteoporosis Study (CaMos) is a population-based prospective cohort study of Canadian women and men. PA was determined from interviewer-administered questionnaires at baseline and Year 5 and summarized as daily energy expenditure in total metabolic equivalents of the task multiplied by minutes/day (MET*m/d). Height, weight, and total hip and lumbar spine BMD were measured at baseline and Year 5. General linear models assessed relationships between PA and BMD, both cross-sectionally (baseline PA with baseline BMD) and longitudinally (average PA and change in PA with change in BMD). BMI was considered as a mediating factor. Potential confounders included age, center, education, caffeine intake, alcohol exposure, smoking history, history of weight-cycling, age at menarche, past use of oral contraceptives, history of >3 months missed menstruation, menopausal status, and antiresorptive use, as relevant. Results The study included 2855 men and 6442 women. PA was inversely associated with BMI at baseline, and an increase in PA between baseline and Year 5 was associated with a decrease in BMI, with 0.41 (95% CI: 0.22, 0.60) kg/m2 loss per 1000 MET*m/d increase (in men) and 0.40 (95% CI: 0.23, 0.57) kg/m2 loss per 1000 MET*m/d increase (in women). BMI was strongly associated with BMD, both cross-sectionally and longitudinally. However, increased PA was associated with a small increase in total hip BMD, 0.004 (95% CI: 0.000–0.008) g/cm2 per 1000 MET*m/d (in men) and 0.003 (95% CI: 0.000–0.007) g/cm2 per 1000 MET*m/d (in women). Average PA was associated with an increase in lumbar spine BMD in women, but not in men; it was not associated

  19. Validation of a clinical screening instrument for tumour predisposition syndromes in patients with childhood cancer (TuPS) : Protocol for a prospective, observational, multicentre study

    NARCIS (Netherlands)

    Postema, Floor A M; Hopman, Saskia M J; De Borgie, Corianne A J M; Hammond, Peter; Hennekam, Raoul C.; Merks, Johannes H M; Aalfs, Cora M.; Anninga, Jakob K.; Berger, Lieke P V; Bleeker, Fonnet E.; De Bont, Eveline S J M; Dommering, Charlotte J.; Van Eijkelenburg, Natasha K A; Van Den Heuvel-Eibrink, Marry M.; Jongmans, Marjolijn C J; Kors, Wijnanda A.; Letteboer, Tom G W; Loeffen, Jan L C M; Olderode-Berends, Maran J W; Wagner, Anja

    2017-01-01

    Introduction: Recognising a tumour predisposition syndrome (TPS) in patients with childhood cancer is of significant clinical relevance, as it affects treatment, prognosis and facilitates genetic counselling. Previous studies revealed that only half of the known TPSs are recognised during standard

  20. Diagnostic yield and accuracy of CT angiography, MR angiography, and digital subtraction angiography for detection of macrovascular causes of intracerebral haemorrhage: Prospective, multicentre cohort study

    NARCIS (Netherlands)

    C.J.J. Van Asch (Charlotte J.J.); B.K. Velthuis (Birgitta K.); G.J.E. Rinkel (Gabriël J.E.); A. Algra (Ale); G.A.P. de Kort (G. A P); T.D. Witkamp (Theo); J.C.M. De Ridder (Johanna C.M.); K.M. Van Nieuwenhuizen (Koen M.); F.-E. De Leeuw (Frank-Erik); W.J. Schonewille (Wouter); P.L.M. de Kort (Paul); D.W.J. Dippel (Diederik); T.W.M. Raaymakers (Theodora W.M.); J. Hofmeijer; M.J.H. Wermer (Marieke); H. Kerkhoff (Henk); K. Jellema (Korné); I.M. Bronner (Irene M.); M.J.M. Remmers (Michel ); H.P. Bienfait (Henri); R.J.G.M. Witjes (Ron J.G.M.); J.P. Greving (Jacoba); C.J.M. Klijn (Catharina J.M.); H.F. de Leeuw (Frank); H.B. Boogaarts; E.J. van Dijk (Ewoud); W.J. Schonewille; W.M.J. Pellikaan; C. Puppels-De Waard; P.L.M. De Kort; J.P. Peluso; J. van Tuijl (Jordie); J. Hofmeijer; F.B.M. Joosten (Frank); D.W.J. Dippel (Diederik); L. Khajeh (Ladbon); T.W.M. Raaijmakers; M.J. Wermer; M.A.A. van Walderveen (Marianne); H. Kerkhoff; E. Zock; K. Jellema (Korné); G.J. Lycklama à Nijeholt (Geert); I.M. Bronner; M.J.M. Remmers; R.J.G.M. Witjes; H.P. Bienfait; K.E. Droogh-Greve; R. Donders (Rogier); V.I.H. Kwa; T.H.C.M.L. Schreuder (Tobien H. C. M. L.); C.L. Franke (Cees); J.S. Straver; C. Jansen; S.L.M. Bakker (Stef); C.C. Pleiter (C.); M.C. Visser; C.J.J. Van Asch; B.K. Velthuis (Birgitta); G.J.E. Rinkel (Gabriel); K.M. Van Nieuwenhuizen; C.J.M. Klijn (Catharina J.M.)

    2015-01-01

    textabstractStudy question What are the diagnostic yield and accuracy of early computed tomography (CT) angiography followed by magnetic resonance imaging/angiography (MRI/MRA) and digital subtraction angiography (DSA) in patients with non-traumatic intracerebral haemorrhage? Methods This

  1. Stabilisation of sagittal split advancement osteotomies with miniplates: a prospective, multicentre study with two-year follow-up. Part I. Clinical parameters.

    NARCIS (Netherlands)

    Borstlap, W.A.; Stoelinga, P.J.W.; Hoppenreijs, T.J.M.; Hof, M.A. van 't

    2004-01-01

    The principal aim of this study was to assess the postoperative stability of bilateral sagittal split osteotomies (BSSO) using two miniplates. Part I reports on the clinical results including treatment characteristics, nerve functions, TMJ function, occlusional relapse and patient satisfaction. This

  2. [Multicentric prospective randomized study evaluating the interest of intravaginal electro-stimulation at home for urinary incontinence after prior perineal reeducation. Interim analysis].

    Science.gov (United States)

    Lopès, P; Levy-Toledano, R; Chiarelli, P; Rimbault, F; Marès, P

    2014-03-01

    Perineal reeducation of stress urinary incontinence is beneficial in 80% of cases. However, patients have to perform self-retraining exercises of the perineal muscles at home, in order to maintain the benefit of the physiotherapy. The aim of this study is to assess the benefit of GYNEFFIK(®), a perineal electro-stimulator, during this home-care phase. Women with stress urinary incontinence (UI) or with mixed UI (composed predominantly of stress UI) that responded to physiotherapy were included in this study in two parallel groups. The groups followed a self-reeducation program, with or without GYNEFFIK(®) electro-stimulation sessions. The comparison of the two groups was based on the rate of women for whom the benefit of the initial perineal reeducation was maintained (defined as non-worsening ICIQ and Ditrovie scales' score). According to the protocol, an interim analysis was performed on 95 patients (i.e. almost half of the expected sample size) who had had at least one evaluation under treatment, among which 44 patients had finished the study. The therapeutic benefit of the initial perineal reeducation was maintained in 87.8% of the GYNEFFIK(®) patient group, while it was maintained in 52.2% (P=0.0001) in the usual care group (i.e. who did not use electro-stimulation). Likewise, patient had a more favorable subjective impression when using GYNEFFIK(®) (83.7% versus 60.0% in the usual care group) as they felt that they improved during the study. In the GYNEFFIK(®) group, no increase in symptoms was reported, whereas almost one out of five patients in the usual care group felt that their condition had worsened. Copyright © 2014. Published by Elsevier SAS.

  3. Evaluation of the geriatric co-management for patients with fragility fractures of the proximal femur (Geriatric Fracture Centre (GFC) concept): protocol for a prospective multicentre cohort study.

    Science.gov (United States)

    Joeris, Alexander; Hurtado-Chong, Anahí; Hess, Denise; Kalampoki, Vasiliki; Blauth, Michael

    2017-07-12

    Treatment of fractures in the elderly population is a clinical challenge due partly to the presence of comorbidities. In a Geriatric Fracture Centre (GFC), patients are co-managed by a geriatrician in an attempt to improve clinical outcomes and reduce morbidity and mortality. Until now the beneficial effect of orthogeriatric co-management has not been definitively proven. The primary objective of this study is to determine the effect of GFC on predefined major adverse events related to a hip fracture compared to usual care centres (UCC). The secondary objectives include assessments in quality of life, patient-reported outcomes and cost-effectiveness. Two hundred and sixty-six elderly patients diagnosedwith hip fracture and planned to be treated with osteosynthesis or endoprosthesis in either a GFC or UCC study site will be recruited, 133 per type of centre. All procedures and management will be done according to the site's standard of care. Study-related visits will be performed at the following time points: preoperative, intraoperative, discharge from the orthopaedic/trauma department, discharge to definite residential status, 12 weeks and 12 months postsurgery. Data collected include demographics, residential status, adverse events, patient-reported outcomes, fall history, costs and resources related to treatment. The risk of major adverse events at 12 months will be calculated for each centre type; patient-reported outcomes will be analysed by mixed effects regression models to estimate differences in mean scores between baseline and follow-ups whereas cost-effectiveness will be assessed using the incremental cost-effectiveness ratio. Ethics approval for this study was granted from the local Ethics Committees or Institutional Review Board from each of the participating sites prior to patient enrolment. The results of this study will be published in peer-reviewed journals and presented at different conferences. ClinicalTrials.gov: NCT02297581; pre-results.

  4. Rituximab plus chemotherapy as first-line treatment in Chinese patients with diffuse large B-cell lymphoma in routine practice: a prospective, multicentre, non-interventional study

    International Nuclear Information System (INIS)

    Wu, Jianqiu; Song, Yongping; Su, Liping; Xu, Li; Chen, Tingchao

    2016-01-01

    The efficacy and safety of rituximab-based chemotherapy (R-chemo), the standard regimen for patients with diffuse large B-cell lymphoma (DLBCL), which is more common in Asia than in Western countries, are well confirmed in randomized controlled trials (RCTs). However, the safety and effectiveness of R-chemo in patients who are largely excluded from RCTs have not been well characterized. This real-world study investigated the safety and effectiveness of R-chemo as first-line treatment in Chinese patients with DLBCL. Treatment-naive DLBCL patients who were CD20 positive and eligible to receive R-chemo were enrolled with no specific exclusion criteria. Data collected at baseline included age, gender, disease stage, international prognostic index (IPI), B symptoms, extranodal involvement, performance status, and medical history. In the present study, data on safety, treatment effectiveness, and HBV infection management were collected 120 days after the last R-chemo administration. Overall, R-chemo was well tolerated. The safety profile of R-chemo in patients with a history of heart or liver disease was well described without any additional unexpected safety concerns. The overall response rate (ORR) in the Chinese patients from this study was 94.2 % (complete response [CR], 55.0 %; CR unconfirmed [CRu] 18.2 %; and partial response [PR], 20.9 %). Compared to patients with no history of disease, the CR and PR rates of patients with a history of heart or liver disease were lower and higher, respectively; this tendency could be in part explained by treatment interruptions in patients with heart or liver diseases. HBsAg positivity and a maximum tumor diameter of ≥7.5 cm negatively correlated with CR + CRu, whereas age and HBsAg positivity negatively correlated with CR. This study further validated the safety and effectiveness of R-chemo in Chinese patients with DLBCL. Patients with a history of heart or liver disease may further benefit from R-chemo if preventive measures

  5. Ligation of the intersphincteric fistula tract (LIFT): a minimally invasive procedure for complex anal fistula: two-year results of a prospective multicentric study.

    Science.gov (United States)

    Sileri, Pierpaolo; Giarratano, Gabriella; Franceschilli, Luana; Limura, Elsa; Perrone, Federico; Stazi, Alessandro; Toscana, Claudio; Gaspari, Achille Lucio

    2014-10-01

    The surgical management of anal fistulas is still a matter of discussion and no clear recommendations exist. The present study analyses the results of the ligation of the intersphincteric fistula tract (LIFT) technique in treating complex anal fistulas, in particular healing, fecal continence, and recurrence. Between October 2010 and February 2012, a total of 26 consecutive patients underwent LIFT. All patients had a primary complex anal fistula and preoperatively all underwent clinical examination, proctoscopy, transanal ultrasonography/magnetic resonance imaging, and were treated with the LIFT procedure. For the purpose of this study, fistulas were classified as complex if any of the following conditions were present: tract crossing more than 30% of the external sphincter, anterior fistula in a woman, recurrent fistula, or preexisting incontinence. Patient's postoperative complications, healing time, recurrence rate, and postoperative continence were recorded during follow-up. The minimum follow-up was 16 months. Five patients required delayed LIFT after previous seton. There were no surgical complications. Primary healing was achieved in 19 patients (73%). Seven patients (27%) had recurrence presenting between 4 and 8 weeks postoperatively and required further surgical treatment. Two of them (29%) had previous insertion of a seton. No patients reported any incontinence postoperatively and we did not observe postoperative continence worsening. In our experience, LIFT appears easy to perform, is safe with no surgical complication, has no risk of incontinence, and has a low recurrence rate. These results suggest that LIFT as a minimally invasive technique should be routinely considered for patients affected by complex anal fistula. © The Author(s) 2013.

  6. A prospective multicentric international study on the surgical outcomes and patients' satisfaction rates of the 'sliding' technique for end-stage Peyronie's disease with severe shortening of the penis and erectile dysfunction.

    Science.gov (United States)

    Rolle, Luigi; Falcone, Marco; Ceruti, Carlo; Timpano, Massimiliano; Sedigh, Omid; Ralph, David J; Kuehhas, Franklin; Oderda, Marco; Preto, Mirko; Sibona, Mattia; Gillo, Arianna; Garaffa, Giulio; Gontero, Paolo; Frea, Bruno

    2016-05-01

    To report the results from a prospective multicentric study of patients with Peyronie's disease (PD) treated with the 'sliding' technique (ST). From June 2010 to January 2014, 28 consecutive patients affected by stable PD with severe penile shortening and end-stage erectile dysfunction (ED) were enrolled in three European PD tertiary referral centres. The validated International Index of Erectile Function (IIEF) questionnaire, the Sexual Encounter Profile (SEP) Questions 2 and 3, and the Peyronie's disease questionnaire (PDQ) were completed preoperatively by all patients. At the follow-up visits (at 3, 6 and 12 months), the IIEF, the SEP Questions 2 and 3, the PDQ, and the Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) were completed. The outcome analysis was focused on penile length restoration, and intra- and postoperative complications classified according the Clavien-Dindo Classification. The mean (range) follow-up was 37 (9-60) months. A malleable penile prosthesis (PP) was implanted in seven patients, while an inflatable three-pieces PP was placed in the remainder. In the case of inflatable PP implantation, porcine small intestinal submucosa and acellular porcine dermal matrix were used to cover the tunical defects. While in patients undergoing malleable PP implantation, collagen-fibrin sponge was used. The mean operative time was 145 min in the inflatable PP group and 115 min in the malleable PP group. There were no intraoperative complications. Postoperative complications included profuse bleeding requiring a blood transfusion in one patient (3.5%) on anticoagulation therapy for a mechanical heart valve (Grade II) and PP infection requiring the removal of the device (7%) (Grade III). There were no late recurrences of the shaft deformation. The postoperative functional data showed a progressive improvement in the score of all questionnaires, peaking at 12 months postoperatively. The mean (range) penile lengthening was 3.2 (2.5-4) cm and no

  7. A prospective multi-centre study of the value of FDG-PET as part of a structured diagnostic protocol in patients with fever of unknown origin

    International Nuclear Information System (INIS)

    Bleeker-Rovers, Chantal P.; Vos, Fidel J.; Meer, Jos W.M. van der; Mudde, Aart H.; Dofferhoff, Anton S.M.; Geus-Oei, Lioe-Fee de; Rijnders, Anton J.; Krabbe, Paul F.M.; Corstens, Frans H.M.; Oyen, Wim J.G.

    2007-01-01

    Since 18 F-fluorodeoxyglucose (FDG) accumulates in neoplastic cells and in activated inflammatory cells, positron emission tomography (PET) with FDG could be valuable in diagnosing patients with fever of unknown origin (FUO). The aim of this study was to validate the use of FDG-PET as part of a structured diagnostic protocol in the general patient population with FUO. From December 2003 to July 2005, 70 patients with FUO were recruited from one university hospital (n=38) and five community hospitals (n=32). A structured diagnostic protocol including FDG-PET was used. A dedicated, full-ring PET scanner was used for data acquisition. FDG-PET scans were interpreted by two staff members of the department of nuclear medicine without further clinical information. The final clinical diagnosis was used for comparison with the FDG-PET results. Of all scans, 33% were clinically helpful. The contribution of FDG-PET to the final diagnosis did not differ significantly between patients diagnosed in the university hospital and patients diagnosed in the community hospitals. FDG-PET contributed significantly more often to the final diagnosis in patients with continuous fever than in patients with periodic fever. FDG-PET was not helpful in any of the patients with normal erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP). FDG-PET is a valuable imaging technique as part of a diagnostic protocol in the general patient population with FUO and a raised ESR or CRP. (orig.)

  8. Health-related quality of life in relapsing remitting multiple sclerosis patients during treatment with glatiramer acetate: a prospective, observational, international, multi-centre study

    Directory of Open Access Journals (Sweden)

    Fredrikson Sten

    2010-11-01

    Full Text Available Abstract Background Glatiramer acetate (GA and interferon-beta (INFb are first-line disease modifying drugs for relapsing remitting multiple sclerosis (RRMS. Treatment with INFb is associated with a significant increase in health-related quality of life (HR-QoL in the first 12 months. It is not known whether HR-QoL increases during treatment with GA. Methods 197 RRMS patients, 106 without and 91 with prior immunomodulation/immunosuppression, were studied for HR-QoL (Leeds Multiple Sclerosis-QoL [LMS-QoL] scale, score range 0 - 32, fatigue (Fatigue Impact Scale [FIS] and depressed mood (Beck Depression Inventory-Short Form [BDI-SF] at baseline and 6 and 12 months after start of GA treatment. Results At 6 and 12 months mean LMS-QoL scores were significantly increased in the treatment-naive patient group (p Conclusions In RRMS patients without prior immunomodulation/immunosuppression treatment with GA was associated with an increase in HR-QoL in the first 6 months, that was sustained at 12 months. In 4 out of 10 patients HR-QoL improved. Increase in HR-QoL was associated with decrease in fatigue.

  9. Clinical profile and predictors of mortality of severe pandemic (H1N1 2009 virus infection needing intensive care: A multi-centre prospective study from South India

    Directory of Open Access Journals (Sweden)

    Kartik Ramakrishna

    2012-01-01

    Full Text Available Background: This multi-center study from India details the profile and outcomes of patients admitted to the intensive care unit (ICU with pandemic Influenza A (H1N1 2009 virus [P(H1N12009v] infection. Materials and Methods: Over 4 months, adult patients diagnosed to have P(H1N12009v infection by real-time RT-PCR of respiratory specimens and requiring ICU admission were followed up until death or hospital discharge. Sequential organ failure assessment (SOFA scores were calculated daily. Results: Of the 1902 patients screened, 464 (24.4% tested positive for P(H1N12009v; 106 (22.8% patients aged 35±11.9 (mean±SD years required ICU admission 5.8±2.7 days after onset of illness. Common symptoms were fever (96.2%, cough (88.7%, and breathlessness (85.9%. The admission APACHE-II and SOFA scores were 14.4±6.5 and 5.5±3.1, respectively. Ninety-six (90.6% patients required ventilation for 10.1±7.5 days. Of these, 34/96 (35.4% were non-invasively ventilated; 16/34 were weaned successfully whilst 18/34 required intubation. Sixteen patients (15.1% needed dialysis. The duration of hospitalization was 14.0±8.0 days. Hospital mortality was 49%. Mortality in pregnant/puerperal women was 52.6% (10/19. Patients requiring invasive ventilation at admission had a higher mortality than those managed with non-invasive ventilation and those not requiring ventilation (44/62 vs. 8/44, P<0.001. Need for dialysis was independently associated with mortality (P=0.019. Although admission APACHE-II and SOFA scores were significantly (P<0.02 higher in non-survivors compared with survivors on univariate analysis, individually, neither were predictive on multivariate analysis. Conclusions: In our setting, a high mortality was observed in patients admitted to ICU with severe P(H1N12009v infection. The need for invasive ventilation and dialysis were associated with a poor outcome.

  10. Influence of abutment material on peri-implant soft tissues in anterior areas with thin gingival biotype: a multicentric prospective study.

    Science.gov (United States)

    Lops, Diego; Stellini, Edoardo; Sbricoli, Luca; Cea, Niccolò; Romeo, Eugenio; Bressan, Eriberto

    2017-10-01

    The aim of the present clinical trial was to analyze, through spectrophotometric digital technology, the influence of the abutment material on the color of the peri-implant soft tissue in patients with thin gingival biotype. Thirty-seven patients received an endosseous dental implant in the anterior maxilla. At time of each definitive prosthesis delivery, an all-ceramic crown has been tried on gold, titanium and zirconia abutment. Peri-implant soft-tissue color has been measured through a spectrophotometer after the insertion of each single abutment. Also facial peri-implant soft-tissue thickness was measured at the level of the implant neck through a caliper. A specific software has been utilized to identify a standardized tissue area and to collect the data before the statistical analysis in Lab* color space. ΔE parameters of the selected abutments were tested for correlation with mucosal thickness. Pearson correlation test was used. Only 15 patients met the study inclusion criteria on peri-implant soft-tissue thickness. Peri-implant soft-tissue color was different from that around natural teeth, no matter which type of restorative material was selected. Measurements regarding all the abutments were above the critical threshold of ΔE 8.74 for intraoral color distinction by the naked eye. The ΔE mean values of gold and zirconium abutments were similar (11.43 and 11.37, respectively) and significantly lower (P = 0.03 and P = 0.04, respectively) than the titanium abutment (13.55). In patients with a facial soft-tissue thickness ≤2 mm, the ΔE mean value of gold and zirconia abutments was significantly lower than that of titanium abutments (P = 0.03 and P = 0.04, respectively) and much more close to the reference threshold of 8.74. For peri-implant soft tissue of ≤2 mm, gold or zirconia abutments could be selected in anterior areas treatment. Moreover, the thickness of the peri-implant soft tissue seemed to be a crucial factor in the abutment impact

  11. 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

  12. A prospective multi-centric open clinical trial of homeopathy in diabetic distal symmetric polyneuropathy.

    Science.gov (United States)

    Nayak, Chaturbhuja; Oberai, Praveen; Varanasi, Roja; Baig, Hafeezullah; Ch, Raveender; Reddy, G R C; Devi, Pratima; S, Bhubaneshwari; Singh, Vikram; Singh, V P; Singh, Hari; Shitanshu, Shashi Shekhar

    2013-04-01

    To evaluate homeopathic treatment in the management of diabetic distal symmetric polyneuropathy. A prospective multi-centric clinical observational study was carried out from October 2005 to September 2009 by Central Council for Research in Homeopathy (CCRH) (India) at its five institutes/units. Patients suffering from diabetes mellitus (DM) and presenting with symptoms of diabetic polyneuropathy (DPN) were screened, investigated and were enrolled in the study after fulfilling the inclusion and exclusion criteria. Patients were evaluated by the diabetic distal symmetric polyneuropathy symptom score (DDSPSS) developed by the Council. A total of 15 homeopathic medicines were identified after repertorizing the nosological symptoms and signs of the disease. The appropriate constitutional medicine was selected and prescribed in 30, 200 and 1 M potency on an individualized basis. Patients were followed up regularly for 12 months. Out of 336 patients (167 males and 169 females) enrolled in the study, 247 patients (123 males and 124 females) were analyzed. All patients who attended at least three follow-up appointments and baseline curve conduction studies were included in the analysis.). A statistically significant improvement in DDSPSS total score (p = 0.0001) was found at 12 months from baseline. Most objective measures did not show significant improvement. Lycopodium clavatum (n = 132), Phosphorus (n = 27) and Sulphur (n = 26) were the medicines most frequently prescribed. Adverse event of hypoglycaemia was observed in one patient only. This study suggests homeopathic medicines may be effective in managing the symptoms of DPN patients. Further studies should be controlled and include the quality of life (QOL) assessment. Copyright © 2013 The Faculty of Homeopathy. Published by Elsevier Ltd. All rights reserved.

  13. Effects of surgery on ischaemic mitral regurgitation: a prospective multicentre registry (SIMRAM registry)

    DEFF Research Database (Denmark)

    Lancellotti, P.; Donal, E.; Cosyns, B.

    2008-01-01

    at rest. Exercise echocardiography may help identify a subset of patients at higher risk of cardiovascular events by revealing the dynamic component of IMR. METHODS: A large prospective, multicentre, non-randomized registry is designed to evaluate the effects of surgery on IMR at rest and on its dynamic......AIMS: Functional ischaemic mitral regurgitation (IMR) is common in patients with ischaemic left ventricular dysfunction undergoing coronary artery bypass surgery. Although the presence of IMR negatively affects prognosis, the additional benefit of valve repair is debated, particularly with mild IMR...... component at exercise (z). SIMRAM will enrol approximately 550 patients with IMR in up to 17 centres with clinical and exercise follow-up for 1 year. Three sets of outcomes will be prospectively assessed and several hypotheses will be tested including determinants of adverse outcome and progressive left...

  14. A prospective, parallel group, open-labeled, comparative, multi-centric, active controlled study to evaluate the safety, tolerability and benefits of fixed dose combination of acarbose and metformin versus metformin alone in type 2 diabetes.

    Science.gov (United States)

    Jayaram, S; Hariharan, R S; Madhavan, R; Periyandavar, I; Samra, S S

    2010-11-01

    The present study was a prospective, parallel group, open-labeled, comparative, multicentric, active controlled study to evaluate the safety, tolerability and benefits of fixed dose combination of acarbose and metformin versus metformin alone in type 2 diabetic patients. A total of 229 patients with type 2 diabetes were enrolled at 5 medical centers across India. They received either acarbose (50 mg) + metformin (500 mg) bid/tid (n=115) or metformin monotherapy (500 mg) bid/ tid (n=114) for 12 weeks. Primary objective was to evaluate safety and tolerability based on the adverse events reported. Secondary objective was efficacy assessment based on changes in fasting, post prandial blood glucose and HbA1c values. In the acarbose + metformin group 10 patients reported 14 adverse events while in metformin group 9 patients reported 10 adverse events. No patient reported any serious adverse event or was withdraw from study because of adverse events. In the acarbose plus metformin group fasting blood glucose (FBG) decreased from a baseline of 158.85 +/- 18.14 mg/dl to 113.55 +/- 19.38 mg/dl (p fasting blood glucose decreased from a baseline of 158.31 +/- 26.53 mg/dl to 130.55 +/- 28.31 mg/dl (p < 0.0001) (decrease of 27.76 +/- 22.91 mg/dl) at 12 weeks. In the acarbose plus metformin group postprandial blood glucose (PPBG) decreased from a baseline of 264.65 +/- 34.03 mg/dl to 173.22 +/- 31.40 mg/dl (p < 0.0001) (decrease of 91.43 +/- 28.65 mg/dl) at 12 weeks, while in the metformin group PPBG decreased from a baseline of 253.56 +/- 36.28 mg/dl to 205.36 +/- 39.49 mg/dl (p < 0.0001) (decrease of 48.20 +/- 32.72 mg/dl) at 12 weeks. In the acarbose plus metformin group glycosylated haemoglobin (HbA1c) decreased from a baseline of 9.47 +/- 0.69% to 7.71 +/- 0.85% (p < 0.0001) (% decrease of 1.76 +/- 1.11) at 12 weeks, while in the metformin group HbAlc decreased from a baseline of 9.32 +/- 0.65% to 8.26 +/- 0.68% (p < 0.0001) (% decrease of 1.06 +/- 0.66) at 12 weeks. The

  15. Cardiac mucosa at the gastro-oesophageal junction: indicator of gastro-oesophageal reflux disease? Data from a prospective central European multicentre study on histological and endoscopic diagnosis of oesophagitis (histoGERD trial).

    Science.gov (United States)

    Langner, Cord; Schneider, Nora I; Plieschnegger, Wolfgang; Schmack, Bertram; Bordel, Hartmut; Höfler, Bernd; Eherer, Andreas J; Wolf, Eva-Maria; Rehak, Peter; Vieth, Michael

    2014-07-01

    The origin and significance of cardiac mucosa at the gastro-oesophageal junction are controversial. In the prospective Central European multicentre histoGERD trial, we aimed to assess the prevalence of cardiac mucosa, characterized by the presence of glands composed of mucous cells without parietal cells, and to relate its presence to features related to gastro-oesophageal reflux disease (GORD). One thousand and seventy-one individuals (576 females and 495 males; median age 53 years) were available for analysis. Overall, in biopsy specimens systematically taken from above and below the gastro-oesophageal junction, cardiac mucosa was observed in 713 (66.6%) individuals. Its presence was associated with patients' symptoms and/or complaints (P = 0.0025), histological changes of the squamous epithelium (P gastro-oesophageal junction. Its association with reflux symptoms, histological changes indicating GORD and the endoscopic diagnosis of oesophagitis suggests that injury and repair related to GORD contribute to its development and/or expansion. © 2014 John Wiley & Sons Ltd.

  16. A Multicentre Study of Thromboprophylaxis in Pregnancy

    LENUS (Irish Health Repository)

    Crowley, MP

    2017-05-01

    Venous thromboembolism (VTE) is a leading cause of maternal mortality. The risk increases with increasing maternal age, mode of delivery and medical co-morbidities. Thromboprophylaxis with low molecular weight heparin (LMWH) has been shown to be both safe and efficacious. The aim of this study was to prospectively investigate the incidence of maternal risk factors in pregnant women admitted to hospital, to calculate their VTE risk status and to investigate if they were receiving appropriate thromboprophylaxis. All patients admitted to the participating hospitals on the day of investigation were assessed for risk of VTE on the basis of hospital chart review. Five Hundred and forty women were recruited from 16 hospitals. Almost 32% (31.7%) were receiving thromboprophylaxis with LMWH. Just under 80% of patients were on the correct thromboprophylaxis strategy as defined by the RCOG guideline but 49% were under-dosed. The odds of receiving appropriate thromboprophylaxis were significantly increased if the woman was >35 years 0or with parity>3.

  17. Iohexol in investigations of the spinal canal. Multicentre study

    International Nuclear Information System (INIS)

    Bories, J.

    1988-01-01

    The author presents the results of a multicentric study of Iohexol in investigation of the spinal canal undertaken at the request of Winthrop Laboratories in 32 Radiological departments. The study involved 329 adults of both sexes. It confirmed the excellent quality of results obtained with this preparation in the literature and its excellent tolerance. On the basis of these results Iohexol may be considered to be definitely one of the best currently available preparations for investigation of the spinal canal [fr

  18. A randomised, double-blind, multicentre, parallel-group, prospective study comparing the pharmacokinetics, safety, and efficacy of CT-P13 and innovator infliximab in patients with ankylosing spondylitis: the PLANETAS study.

    Science.gov (United States)

    Park, Won; Hrycaj, Pawel; Jeka, Slawomir; Kovalenko, Volodymyr; Lysenko, Grygorii; Miranda, Pedro; Mikazane, Helena; Gutierrez-Ureña, Sergio; Lim, MieJin; Lee, Yeon-Ah; Lee, Sang Joon; Kim, HoUng; Yoo, Dae Hyun; Braun, Jürgen

    2013-10-01

    To compare the pharmacokinetics (PK), safety and efficacy of innovator infliximab (INX) and CT-P13, a biosimilar to INX, in patients with active ankylosing spondylitis (AS). Phase 1 randomised, double-blind, multicentre, multinational, parallel-group study. Patients were randomised to receive 5 mg/kg of CT-P13 (n=125) or INX (n=125). Primary endpoints were area under the concentration-time curve (AUC) at steady state and observed maximum steady state serum concentration (Cmax,ss) between weeks 22 and 30. Additional PK, efficacy endpoints, including 20% and 40% improvement response according to Assessment in Ankylosing Spondylitis International Working Group criteria (ASAS20 and ASAS40), and safety outcomes were also assessed. Geometric mean AUC was 32 765.8 μgh/ml for CT-P13 and 31 359.3 μgh/ml for INX. Geometric mean Cmax,ss was 147.0 μg/ml for CT-P13 and 144.8 μg/ml for INX. The ratio of geometric means was 104.5% (90% CI 94% to 116%) for AUC and 101.5% (90% CI 95% to 109%) for Cmax,ss. ASAS20 and ASAS40 responses at week 30 were 70.5% and 51.8% for CT-P13 and 72.4% and 47.4% for INX, respectively. In the CT-P13 and INX groups more than one adverse event occurred in 64.8% and 63.9% of patients, infusion reactions occurred in 3.9% and 4.9%, active tuberculosis occurred in 1.6% and 0.8%, and 27.4% and 22.5% of patients tested positive for anti-drug antibodies, respectively. The PK profiles of CT-P13 and INX were equivalent in patients with active AS. CT-P13 was well tolerated, with an efficacy and safety profile comparable to that of INX up to week 30.

  19. Feasibility and cost efficiency of a diagnostic guideline for chronic polyneuropathy : a prospective implementation study

    NARCIS (Netherlands)

    Vrancken, A.F.J.E.; Kalmijn, S.; Buskens, E.; Franssen, H.; Wokke, J.H.J.; Notermans, N.C.

    2006-01-01

    Background: Extensive investigations are often performed to reveal the cause of chronic polyneuropathy. It is not known whether a restrictive diagnostic guideline improves cost efficiency without loss of diagnostic reliability. Methods: In a prospective multicentre study, a comparison was made

  20. Early invasive versus non-invasive treatment in patients with non-ST-elevation acute coronary syndrome (FRISC-II): 15 year follow-up of a prospective, randomised, multicentre study.

    Science.gov (United States)

    Wallentin, Lars; Lindhagen, Lars; Ärnström, Elisabet; Husted, Steen; Janzon, Magnus; Johnsen, Søren Paaske; Kontny, Frederic; Kempf, Tibor; Levin, Lars-Åke; Lindahl, Bertil; Stridsberg, Mats; Ståhle, Elisabeth; Venge, Per; Wollert, Kai C; Swahn, Eva; Lagerqvist, Bo

    2016-10-15

    The FRISC-II trial was the first randomised trial to show a reduction in death or myocardial infarction with an early invasive versus a non-invasive treatment strategy in patients with non-ST-elevation acute coronary syndrome. Here we provide a remaining lifetime perspective on the effects on all cardiovascular events during 15 years' follow-up. The FRISC-II prospective, randomised, multicentre trial was done at 58 Scandinavian centres in Sweden, Denmark, and Norway. Between June 17, 1996, and Aug 28, 1998, we randomly assigned (1:1) 2457 patients with non-ST-elevation acute coronary syndrome to an early invasive treatment strategy, aiming for revascularisation within 7 days, or a non-invasive strategy, with invasive procedures at recurrent symptoms or severe exercise-induced ischaemia. Plasma for biomarker analyses was obtained at randomisation. For long-term outcomes, we linked data with national health-care registers. The primary endpoint was a composite of death or myocardial infarction. Outcomes were compared as the average postponement of the next event, including recurrent events, calculated as the area between mean cumulative count-of-events curves. Analyses were done by intention to treat. At a minimum of 15 years' follow-up on Dec 31, 2014, data for survival status and death were available for 2421 (99%) of the initially recruited 2457 patients, and for other events after 2 years for 2182 (89%) patients. During follow-up, the invasive strategy postponed death or next myocardial infarction by a mean of 549 days (95% CI 204-888; p=0·0020) compared with the non-invasive strategy. This effect was larger in non-smokers (mean gain 809 days, 95% CI 402-1175; p interaction =0·0182), patients with elevated troponin T (778 days, 357-1165; p interaction =0·0241), and patients with high concentrations of growth differentiation factor-15 (1356 days, 507-1650; p interaction =0·0210). The difference was mainly driven by postponement of new myocardial infarction

  1. Clinical performance of the Prostate Health Index (PHI) for the prediction of prostate cancer in obese men: data from the PROMEtheuS project, a multicentre European prospective study.

    Science.gov (United States)

    Abrate, Alberto; Lazzeri, Massimo; Lughezzani, Giovanni; Buffi, Nicolòmaria; Bini, Vittorio; Haese, Alexander; de la Taille, Alexandre; McNicholas, Thomas; Redorta, Joan Palou; Gadda, Giulio M; Lista, Giuliana; Kinzikeeva, Ella; Fossati, Nicola; Larcher, Alessandro; Dell'Oglio, Paolo; Mistretta, Francesco; Freschi, Massimo; Guazzoni, Giorgio

    2015-04-01

    To test serum prostate-specific antigen (PSA) isoform [-2]proPSA (p2PSA), p2PSA/free PSA (%p2PSA) and Prostate Health Index (PHI) accuracy in predicting prostate cancer in obese men and to test whether PHI is more accurate than PSA in predicting prostate cancer in obese patients. The analysis consisted of a nested case-control study from the pro-PSA Multicentric European Study (PROMEtheuS) project. The study is registered at http://www.controlled-trials.com/ISRCTN04707454. The primary outcome was to test sensitivity, specificity and accuracy (clinical validity) of serum p2PSA, %p2PSA and PHI, in determining prostate cancer at prostate biopsy in obese men [body mass index (BMI) ≥30 kg/m(2) ], compared with total PSA (tPSA), free PSA (fPSA) and fPSA/tPSA ratio (%fPSA). The number of avoidable prostate biopsies (clinical utility) was also assessed. Multivariable logistic regression models were complemented by predictive accuracy analysis and decision-curve analysis. Of the 965 patients, 383 (39.7%) were normal weight (BMI PHI were significantly higher, and %fPSA significantly lower in patients with prostate cancer (P PHI significantly increased accuracy of the base multivariable model by 8.8% (P = 0.007). At a PHI threshold of 35.7, 46 (32.4%) biopsies could have been avoided. In obese patients, PHI is significantly more accurate than current tests in predicting prostate cancer. © 2014 The Authors. BJU International © 2014 BJU International.

  2. Prospective evaluation of the International Neuroblastoma Staging System (INSS) and the International Neuroblastoma Response Criteria (INRC) in a multicentre setting.

    Science.gov (United States)

    Castel, V; García-Miguel, P; Cañete, A; Melero, C; Navajas, A; Ruíz-Jiménez, J I; Navarro, S; Badal, M D

    1999-04-01

    The aim of this study was to classify prospectively a series of neuroblastoma tumours according to the International Neuroblastoma Staging System (INSS) and the International Neuroblastoma Response Criteria (INRC) and to evaluate the difficulties and pitfalls involved in a multicentre setting. Each hospital provided their data for central review. The surgical procedures and their complications were reported. Kaplan-Meier estimates of survival and event-free survival were calculated according to stage and response to therapy. From June 1992 to December 1996, 194 patients were included in the study, with a mean age of 2 years. Initial studies were performed according to INSS recommendations without major problems. INSS stage was correctly applied to all patients except for 9 (95%). Post-operative complications were observed in 15 patients (8.3%). Response to therapy (INRC) was studied in 63 stage 4 patients, 11 of whom were not classified correctly (17%). Differences in survival according to stage (INSS) and group of response to therapy (INRC) were statistically significant (P INSS was easy to use and separated different prognostic groups. Surgical complications and mortality did not increase in this series because of using the INSS. The feasibility of INRC was evaluated in a small series of stage 4 patients and the designation of response was problematic in a relatively high proportion of cases. The prognostic value of the different responses was highly significant, but less informative than had been hoped for.

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

    Directory of Open Access Journals (Sweden)

    Montgomery Ken

    2008-01-01

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

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

    Science.gov (United States)

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

    2008-01-07

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

  5. The South African Surgical Outcomes Study: A 7-day prospective ...

    African Journals Online (AJOL)

    To investigate the perioperative mortality and need for critical care admission in patients undergoing inpatient non-cardiac surgery in SA. Methods. A 7-day national, multicentre, prospective, observational cohort study of all patients ≥16 years of age undergoing inpatient noncardiac surgery between 19 and 26 May 2014 at ...

  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. Scintimammography with technetium-99m methoxyisobutylisonitrile: results of a prospective European multicentre trial

    Energy Technology Data Exchange (ETDEWEB)

    Palmedo, H.; Biersack, H.J. [Bonn Univ. (Germany). Dept. of Nucl. Med.; Lastoria, S. [Department of Nuclear Medicine, National Cancer Institute of Naples (Italy); Maublant, J. [Department of Nuclear Medicine, Centre Jean Perrin in Clermont Ferrand (France); Prats, E. [Department of Nuclear Medicine, University Hospital of Zaragoza (Spain); Stegner, H.E. [Department of Gynecology, University of Hamburg (Germany); Bourgeois, P. [Department of Nuclear Medicine, Hospital St. Pierre in Bruxelles (Belgium); Hustinx, R. [Department of Nuclear Medicine, University Hospital in Liege (Belgium); Hilson, A.J.W. [Department of Nuclear Medicine, NHS Trust Hospital in London (United Kingdom); Bischof-Delaloye, A. [Department of Nuclear Medicine, University of Lausanne (Switzerland)

    1998-04-01

    The aim of the trial was to determine the diagnostic accuracy of scintimmammography with technetium-99m methoxyisobutylisonitrile ({sup 99m}Tc-MIBI) in the detection of primary breast cancer and to verify its clinical usefulness. A total of 246 patients with a suspicious breast mass or positive mammogram were included in this prospective European multicentre trial. At 5 min and 60 min (optional) p.i. two lateral prone images were acquired for 10 min each; 30 min p.i. one anterior image was acquired for 10 min. There were 253 lesions (195 palpable and 58 non-palpable), in respect of which histology revealed 165 cancers and 88 benign lesions. Institutional and blinded read results were correlated to core laboratory histopathology results obtained during excisional biopsy. Diagnostic accuracy for the detection of breast cancer was calculated per lesion. The overall sensitivity and specificity of blinded read scintimammography were 71% and 69%, respectively. For palpable lesions, the sensitivity of blinded read and institutional read scintimammography was 83% and 91%, respectively. Sensitivity was not dependent on the density of the breast tissue. Invasive ductal and invasive lobular cancers showed similar sensitivity. The sensitivity and specificity of mammography were 91% and 42%, respectively, and did not depend on the tumour size. In 60% of false-negative mammograms, {sup 99m}Tc-MIBI was able to diagnose malignancy (true-positive). High-quality imaging with {sup 99m}Tc-MIBI has a high diagnostic accuracy for the detection of primary breast cancer. Used as a complementary method, scintimammography with {sup 99m}Tc-MIBI can help to diagnose breast cancer at an earlier stage in patients with dense breasts. (orig.) With 6 figs., 12 tabs., 55 refs.

  8. Early salpingectomy (TUbectomy) with delayed oophorectomy to improve quality of life as alternative for risk-reducing salpingo-oophorectomy in BRCA1/2 mutation carriers (TUBA study): a prospective non-randomised multicentre study

    International Nuclear Information System (INIS)

    Harmsen, Marline G.; Arts-de Jong, Marieke; Hoogerbrugge, Nicoline; Maas, Angela H. E. M.; Prins, Judith B.; Bulten, Johan; Teerenstra, Steven; Adang, Eddy M. M.; Piek, Jurgen M. J.; Doorn, Helena C van; Beurden, Marc van; Mourits, Marian J. E.; Zweemer, Ronald P.; Gaarenstroom, Katja N.; Slangen, Brigitte F. M.; Vos, M. Caroline; Lonkhuijzen, Luc R. C. W. van; Massuger, Leon F. A. G.; Hermens, Rosella P. M. G.; Hullu, Joanne A. de

    2015-01-01

    Risk-reducing salpingo-oophorectomy (RRSO) around the age of 40 is currently recommended to BRCA1/2 mutation carriers. This procedure decreases the elevated ovarian cancer risk by 80–96 % but it initiates premature menopause as well. The latter is associated with short-term and long-term morbidity, potentially affecting quality of life (QoL). Based on recent insights into the Fallopian tube as possible site of origin of serous ovarian carcinomas, an alternative preventive strategy has been put forward: early risk-reducing salpingectomy (RRS) and delayed oophorectomy (RRO). However, efficacy and safety of this alternative strategy have to be investigated. A multicentre non-randomised trial in 11 Dutch centres for hereditary cancer will be conducted. Eligible patients are premenopausal BRCA1/2 mutation carriers after completing childbearing without (a history of) ovarian carcinoma. Participants choose between standard RRSO at age 35–40 (BRCA1) or 40–45 (BRCA2) and the alternative strategy (RRS upon completion of childbearing and RRO at age 40–45 (BRCA1) or 45–50 (BRCA2)). Women who opt for RRS but do not want to postpone RRO beyond the currently recommended age are included as well. Primary outcome measure is menopause-related QoL. Secondary outcome measures are ovarian/breast cancer incidence, surgery-related morbidity, histopathology, cardiovascular risk factors and diseases, and cost-effectiveness. Mixed model data analysis will be performed. The exact role of the Fallopian tube in ovarian carcinogenesis is still unclear. It is not expected that further fundamental research will elucidate this role in the near future. Therefore, this clinical trial is essential to investigate RRS with delayed RRO as alternative risk-reducing strategy in order to improve QoL. ClinicalTrials.gov: NCT02321228

  9. Cerebral sinus venous thromboses in children with acute lymphoblastic leukaemia - a multicentre study from the Nordic Society of Paediatric Haematology and Oncology

    DEFF Research Database (Denmark)

    Ranta, Susanna; Tuckuviene, Ruta; Mäkipernaa, Anne

    2014-01-01

    We present a prospective multicentre cohort of 20 children with acute lymphoblastic leukaemia (ALL) and cerebral sinus venous thrombosis (CSVT). The study covers a period of 5 years and comprises 1038 children treated according to the Nordic Society of Paediatric Haematology and Oncology (NOPHO...

  10. Multicentre study with activity meters launched by PTB

    International Nuclear Information System (INIS)

    Rodloff, G.

    1992-01-01

    The German Pharmacopeia tolerates for most radionuclides deviations of up to 10% from the actual activity value. The evaluation of a multicentre study launched by the PTB (Federal Physicotechnical Institute) during the period between 1982 and 1987 revealed, however, that not all producers paid attention to these tolerance limits. Occasional values were reported to differ by more than 50% or even a factor of 2 from the PTB value. In order that those deviations are kept to a minimum it is necessary for both manufacturers and users to meet the requirements of the DIN 6852 industrial standard. Activity determinations for 99 Tc m eluates must additionally be carried out in accordance with the recommendations contained in DIN 6854. (orig./DG) [de

  11. 18F-FDG PET/CT in the characterization and surgical decision concerning adrenal masses: a prospective multicentre evaluation

    International Nuclear Information System (INIS)

    Ansquer, Catherine; Scigliano, Sonia; Mirallie, Eric; Taieb, David; Brunaud, Laurent; Sebag, Frederic; Leux, Christophe; Drui, Delphine; Dupas, Benoit; Renaudin, Karine; Kraeber-Bodere, Francoise

    2010-01-01

    This prospective multicentre study assesses the usefulness of FDG PET/CT in characterizing and making the therapeutic decision concerning adrenal tumours that are suspicious or indeterminate in nature after conventional examinations (CE). Seventy-eight patients (37 men, 41 women, 81 adrenal lesions) underwent FDG PET/CT after CE including CT scan, biological tests and optionally 131 I-metaiodobenzylguanidine (MIBG) and/or 131 I-norcholesterol scans. FDG adrenal uptake exceeding that of the liver was considered positive. PET results were not decisive. Surgery was discussed when at least one of the following criteria was found during CE: size >3 cm, spontaneous attenuation value >10 HU, heterogeneous aspect, abnormal MIBG or norcholesterol scan or hormonal hypersecretion. Following the gold standard (histology analysis or ≥9 months follow-up), 49 lesions potentially qualified for surgery (malignant = 27, benign secreting = 22) and 32 benign non-secreting lesions did not. PET was negative in 97% of non-surgical lesions and positive in 73% of potentially surgical ones which included all the malignant lesions, except 3 renal cell metastases, and 12 of 22 benign secreting lesions. The negative predictive value for malignancy was 93% (41/44) and positive predictive value for detecting surgical lesions was 97% (36/37). A high FDG uptake (maximum standardized uptake value ≥ 10) was highly predictive of malignancy. Adrenal FDG uptake is a good indicator of malignancy and/or of secreting lesions and should lead one to discuss surgery. If there is no prior history of poorly FDG-avid cancer, the absence of FDG uptake should avoid unnecessary removal of benign adrenal lesions. (orig.)

  12. Perinatal complications in patients with unisutural craniosynostosis: An international multicentre retrospective cohort study

    NARCIS (Netherlands)

    Cornelissen, Martijn J.; Softeland, Madiha; Apon, Inge; Ladfors, Lars; Mathijssen, Irene M. J.; Cohen-Overbeek, Titia E.; Bonsel, Gouke J.; Kolby, Lars

    2017-01-01

    Purpose Craniosynostosis may lead to hampered fetal head molding and birth complications. To study the interaction between single suture craniosynostosis and delivery complications, an international, multicentre, retrospective cohort study was performed. Materials and methods All infants born

  13. Assessment of early-stage optic nerve invasion in retinoblastoma using high-resolution 1.5 Tesla MRI with surface coils: a multicentre, prospective accuracy study with histopathological correlation

    Energy Technology Data Exchange (ETDEWEB)

    Brisse, Herve J. [Institut Curie, Department of Radiology, Paris (France); Institut CURIE, Imaging Department, Paris (France); Graaf, Pim de; Rodjan, Firazia; Jong, Marcus C. de; Castelijns, Jonas A. [VU University Medical Center, Department of Radiology, Amsterdam (Netherlands); Galluzzi, Paolo [Neuroimaging and Neurointerventional Unit (NINT) Azienda Ospedaliera e Universitaria Senese, Siena (Italy); Cosker, Kristel; Savignoni, Alexia [Institut Curie, Department of Biostatistics, Paris (France); Maeder, Philippe [Centre Hospitalier Universitaire Vaudois (CHUV) and University of Lausanne, Department of Radiology, Lausanne (Switzerland); Goericke, Sophia [University Hospital Essen, Institute of Diagnostic and Interventional Radiology and Neuroradiology, Essen (Germany); Aerts, Isabelle [Institut Curie, Department of Pediatric Oncology, Paris (France); Desjardins, Laurence [Institut Curie, Department of Ophthalmology, Paris (France); Moll, Annette C. [VU University Medical Center, Department of Ophthalmology, Amsterdam (Netherlands); Hadjistilianou, Theodora [Azienda Ospedaliera Universitaria Senese, Department of Ophthalmology, Siena (Italy); Toti, Paolo [University of Siena, Department of Medical Biotechnologies, Pathology Unit, Siena (Italy); Valk, Paul van der [VU University Medical Center, Department of Pathology, Amsterdam (Netherlands); Sastre-Garau, Xavier [Institut Curie, Department of Biopathology, Paris (France); Collaboration: European Retinoblastoma Imaging Collaboration (ERIC)

    2015-05-01

    To assess the accuracy of high-resolution (HR) magnetic resonance imaging (MRI) in diagnosing early-stage optic nerve (ON) invasion in a retinoblastoma cohort. This IRB-approved, prospective multicenter study included 95 patients (55 boys, 40 girls; mean age, 29 months). 1.5-T MRI was performed using surface coils before enucleation, including spin-echo unenhanced and contrast-enhanced (CE) T1-weighted sequences (slice thickness, 2 mm; pixel size <0.3 x 0.3 mm{sup 2}). Images were read by five neuroradiologists blinded to histopathologic findings. ROC curves were constructed with AUC assessment using a bootstrap method. Histopathology identified 41 eyes without ON invasion and 25 with prelaminar, 18 with intralaminar and 12 with postlaminar invasion. All but one were postoperatively classified as stage I by the International Retinoblastoma Staging System. The accuracy of CE-T1 sequences in identifying ON invasion was limited (AUC = 0.64; 95 % CI, 0.55 - 0.72) and not confirmed for postlaminar invasion diagnosis (AUC = 0.64; 95 % CI, 0.47 - 0.82); high specificities (range, 0.64 - 1) and negative predictive values (range, 0.81 - 0.97) were confirmed. HR-MRI with surface coils is recommended to appropriately select retinoblastoma patients eligible for primary enucleation without the risk of IRSS stage II but cannot substitute for pathology in differentiating the first degrees of ON invasion. (orig.)

  14. Italian multicentre study on intrathecal fluorescein for craniosinusal fistulae.

    Science.gov (United States)

    Felisati, G; Bianchi, A; Lozza, P; Portaleone, S

    2008-08-01

    derives from frequent reports of complications, often related to the intrathecal administration; such complications are, however, always due to an incorrect dosage. In order to perform correct monitoring of any complication related to the use of intrathecal fluorescein and to investigate in a strictly scientific fashion, the legal problem related to the off label use (intrathecal administration) of an authorised substance, the Authors coordinated an Italian multicentre study aimed at establishig the tolerability of the lumbar intrathecal administration of fluorescein. Aim of the study was to review the literature focusing on CSF leaks, to set up to date diagnostic and therapeutic indications of fluorescein and to report the preliminary results of the Italian multicentre study.

  15. A Prospective Multicentre Study to Evaluate the Efficacy and Tolerability of Osmotic Release Oral System (Oros® Hydromorphone in Opioid-Naive Cancer Patients: Results of the Korean South West Oncology Group Study

    Directory of Open Access Journals (Sweden)

    Eun-Kee Song

    2015-01-01

    Full Text Available BACKGROUND: Osmotic release oral system (OROS® hydromorphone is a potent, long-acting opioid analgesic, effective and safe for controlling cancer pain in patients who have received other strong opioids. To date, few studies have examined the efficacy of hydromorphone for pain relief in opioid-naive cancer patients.

  16. Captopril radionuclide test in renovascular hypertension: a European multicentre study

    International Nuclear Information System (INIS)

    Fommei, E.; Ghione, S.; Hilson, A.J.W.; Mezzasalma, L.; Oei, H.Y.; Piepsz, A.; Volterrani, D.

    1993-01-01

    The efficacy of renal scintigraphy with technetium-99m DTPA before and after captopril was evaluated in a multicentre study. All 380 hypertensive patients in the study underwent renal arteriography; 125 had renal arterial stenosis ≥70%, and 54 had a technically successful intervention to correct the stenosis. The post-captopril study had a sensitivity of 93% and a specificity of 100% for predicting blood pressure response to intervention, if renal function was normal and a combination of quantitative parameters was applied. In the entire population renal artery stenosis ≥70% was detected with a sensitivity of 83% and a specificity of 93% if renal function was normal. In patients with abnormal renal function the performance of the test was worse, owing to a lower specificity which could be increased by using only time parameters. The performance of the test was optimal when the post-captopril findings were examined; no improvement was achieved by evaluation of the changes induced by captopril from the baseline. The test can thus be simplified by performing only a post-captopril study for routine use: a negative test would exclude a curable form of renovascular hypertension in right angle 80% and a positive test would predict it in right angle 90% of the patients selected for suspicion of the disease. Usefulness of the scintigraphic test for monitoring the clinical results of intervention is suggested by correlating post-intervention outcome with pre- and post-intervention scintigraphic results. (orig./MG)

  17. Understanding barriers and outcomes of unspecified (non-directed altruistic) kidney donation from both professional's and patient's perspectives: research protocol for a national multicentre mixed-methods prospective cohort study.

    Science.gov (United States)

    Gare, Rebecca; Gogalniceanu, Petrut; Maple, Hannah; Burnapp, Lisa; Clarke, Alexis; Williams, Lynsey; Norton, Sam; Chilcot, Joseph; Gibbs, Paul; Mitchell, Annie; McCrone, Paul; Draper, Heather; Mamode, Nizam

    2017-09-21

    Living donation accounts for over one-third of all kidney transplants taking place in the UK. 1 The concept of anonymously donating a kidney to a stranger (non-directed altruistic or unspecified kidney donation (UKD)) remains uncomfortable for some clinicians, principally due to concerns about the motivations and long-term physical and psychological outcomes in this donor group. The research programme aims to provide a comprehensive assessment of the unspecified donor programme in the UK. It aims to identify reasons for variations in practice across centres, explore outcomes for donors and ascertain barriers and facilitators to UKD, as well as assess the economic implications of unspecified donation. The research programme will adopt a mixed-methods approach to assessing UKD nationally using focus groups, interviews and questionnaires. Two study populations will be investigated. The first will include transplant professionals involved in unspecified kidney donation. The second will include a 5-year prospective cohort of individuals who present to any of the 23 UK transplant centres as a potential unspecified living kidney donor. Physical and psychological outcomes will be followed up to 1 year following donation or withdrawal from the donation process. A matched sample of specified donors (those donating to someone they know) will be recruited as a control group. Further qualitative work consisting of interviews will be performed on a purposive sample of unspecified donors from both groups (those who do and do not donate). The findings will be reported to NHS Blood and Transplant and the British Transplant Society with a view to developing national guidelines and a protocol for the management of those presenting for unspecified donation. ISRCTN23895878, Pre-results. © 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.

  18. Quality control and data-handling in multicentre studies: the case of the Multicentre Project for Tuberculosis Research

    Directory of Open Access Journals (Sweden)

    Caloto Teresa

    2001-12-01

    Full Text Available Abstract Background The Multicentre Project for Tuberculosis Research (MPTR was a clinical-epidemiological study on tuberculosis carried out in Spain from 1996 to 1998. In total, 96 centres scattered all over the country participated in the project, 19935 "possible cases" of tuberculosis were examined and 10053 finally included. Data-handling and quality control procedures implemented in the MPTR are described. Methods The study was divided in three phases: 1 preliminary phase, 2 field work 3 final phase. Quality control procedures during the three phases are described. Results: Preliminary phase: a organisation of the research team; b design of epidemiological tools; training of researchers. Field work: a data collection; b data computerisation; c data transmission; d data cleaning; e quality control audits; f confidentiality. Final phase: a final data cleaning; b final analysis. Conclusion The undertaking of a multicentre project implies the need to work with a heterogeneous research team and yet at the same time attain a common goal by following a homogeneous methodology. This demands an additional effort on quality control.

  19. ECSPECT prospective multicentre registry for single-port laparoscopic colorectal procedures

    DEFF Research Database (Denmark)

    Weiss, Helmut; Zorron, R; Vestweber, K-H

    2017-01-01

    BACKGROUND: The international multicentre registry ECSPECT (European Consensus of Single Port Expertise in Colorectal Treatment) was established to evaluate the general feasibility and safety of single-port colorectal surgery with regard to preoperative risk assessment. METHODS: Consecutive...... patients undergoing single-port colorectal surgery were enrolled from 11 European centres between March 2010 and March 2014. Data were analysed to assess patient-, technique- and procedure-dependent parameters. A validated sex-adjusted risk chart was developed for prediction of single-port colorectal...

  20. Preoperative chemosensitivity testing as Predictor of Treatment benefit in Adjuvant stage III colon cancer (PePiTA): Protocol of a prospective BGDO (Belgian Group for Digestive Oncology) multicentric study

    International Nuclear Information System (INIS)

    Hendlisz, Alain; Maetens, Marion; Borbath, Ivan; Dresse, Damien; Houbiers, Ghislain; Fried, Michael; Awada, Ahmad; Piccart, Martine; Laethem, Jean-Luc Van; Flamen, Patrick; Golfinopoulos, Vassilis; Deleporte, Amelie; Paesmans, Marianne; Mansy, Hazem El; Garcia, Camilo; Peeters, Marc; Annemans, Lieven; Vandeputte, Caroline

    2013-01-01

    Surgery is a curative treatment for patients with locally advanced colon cancer, but recurrences are frequent for those with stage III disease. FOLFOX adjuvant chemotherapy has been shown to improve recurrence-free survival and overall survival by more than 20% and is nowadays considered a standard of care. However, the vast majority of patients will not benefit from receiving cytotoxic drugs because they have either already been cured by surgery or because their tumor cells are resistant to the chemotherapy, for which predictive factors are still not available. Identifying which patients are unlikely to respond to adjuvant chemotherapy from among those who are eligible for such treatment would be a major step towards treatment personalization. It would spare such patients from unnecessary toxicities and would improve the allocation of societal healthcare resources. PePiTA is a prospective, multicenter, non-randomised trial built on the hypothesis that preoperative chemosensitivity testing using FDG-PET/CT before and after one course of FOLFOX can identify the patients who are unlikely to benefit from 6 months of adjuvant FOLFOX treatment for stage III colon cancer. The study’s primary objective is to examine the ability of PET/CT-assessed tumor FDG uptake after one course of preoperative chemotherapy to predict the outcome of adjuvant therapy, as measured by 3-year disease-free survival. Secondary objectives are to examine the predictive value of changes in PET/CT-assessed tumor FDG uptake on overall survival, to define the best cut-off value of FDG uptake for predicting treatment outcome, and to analyse the cost-effectiveness of such preoperative chemo-sensitivity testing. At study planning, exploratory translational research objectives were 1) to assess the predictive value of circulating tumor cells for disease-free survival, 2) to examine the predictive value of single nucleotide polymorphisms for disease-free survival with respect to genes related either to

  1. Hydroxyethyl starch 130/0.42/6:1 for perioperative plasma volume replacement in 1130 children: results of an European prospective multicenter observational postauthorization safety study (PASS)

    NARCIS (Netherlands)

    Sümpelmann, Robert; Kretz, Franz-Josef; Luntzer, Robert; de Leeuw, Thomas G.; Mixa, Vladimir; Gäbler, Ralf; Eich, Christoph; Hollmann, Markus W.; Osthaus, Wilhelm A.

    2012-01-01

    Introduction: Third-generation hydroxyethyl starch (HES) is now approved also for the use in children, but safety studies including large numbers of pediatric patients are still missing. Therefore, we performed an European multicentric prospective observational postauthorization safety study (PASS)

  2. A Prospective Observational Study

    African Journals Online (AJOL)

    Methods: This was a prospective, questionnaire-based observational study. Printed questionnaires were distributed to the visitors of medical, surgical and neurosurgical ICU patients to determine awareness of basic infection control practices among visitors to an ICU. All the ICU staff, including nurses, doctors, consultant ...

  3. Functional independence and health-related functional status following spinal cord injury : a prospective study of the association with physical capacity

    NARCIS (Netherlands)

    Haisma, Janneke A.; Post, Marcel W.; van der Woude, Lucas H.; Stam, Henk J.; Bergen, Michael P.; Sluis, Tebbe A.; van den Berg-Emons, Hendrika J.; Bussmann, Johannes B.

    2008-01-01

    Objective: To determine changes in functional independence following spinal cord injury and to evaluate the association between functional independence and physical capacity. Design: Multi-centre prospective cohort study. Subjects: Patients with spinal cord injury admitted for initial

  4. [The PreFord Study. A prospective cohort study to evaluate the risk of a cardiovascular event (overall-collective) as well as a prospective, randomized, controlled, multicentre clinical intervention study (high-risk-collective) on primary prevention of cardiovascular diseases in the Ford Motor Company employees in Germany].

    Science.gov (United States)

    Gysan, D B; Latsch, J; Bjarnason-Wehrens, B; Albus, C; Falkowski, G; Herold, G; Mey, E; Heinzler, R; Montiel, G; Schneider, C A; Stützer, H; Türk, S; Weisbrod, M; Predel, H G

    2004-02-01

    The PreFord Study is a multicenter prospective cohort study to evaluate guideline based risk management on primary prevention of cardiovascular diseases. Furthermore a randomised controlled trial (RCT) will be designed to analyse the effect of a special intervention program. 40,000 employees of the Ford Motor Company, Visteon Company and Deutz Company in Germany will be included, monitored for ten years and the following primary endpoints will be investigated: 1. evaluation and comparison of established and newly developed risk-scores, 2. the relative impact of single and combined cardiovascular risk factors on cardiovascular diseases, 3. the influence of a novel occupationally integrated ambulant rehabilitation program in combination with a guideline oriented optimal drug therapy within a high risk group on the primary endpoint: risk reduction by, 4. the influence of this intervention on secondary endpoints: death, myocardial infarction and stroke, combined appearance of angina pectoris and hospitalisation, occurrence of cerebral circulatory disorder and hospitalisation, occurrence of peripheral occlusive arterial disease and hospitalisation and single cardiovascular risk factors and cost-benefit-analysis. Beginning with an cross sectional study there will be a systemic screening of cardiovascular risk profiles, of anthropometric data and different lifestyle-factors. Based on these data participants will be differentiated into three risk-groups according to the risk score of the European Society of Cardiology (risk of a lethal primary acute cardiovascular event: I 1- or = 5%). In the following longitudinal study different strategies will be applied: Group I: low risk ( 1.5% per year or >15% within the next 10 years) will be randomised into two interventional groups. The first one, the intervention-group "PreFord" will perform an occupational integrated rehabilitation program (2,5-3 hours twice a week, for 15 weeks according to the BAR guidelines) with a following

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

    Science.gov (United States)

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

    2008-01-01

    Background In nulliparous women dystocia is the most common obstetric problem and its etiology is largely unknown. The frequency of augmentation and cesarean delivery related to dystocia is high although it is not clear if a slow progress justifies the interventions. Studies of risk factors for dystocia often do not provide diagnostic criteria for the diagnosis. The aim of the present study was to identify obstetric and clinical risk indicators of dystocia defined by strict and explicit criteria. Methods A multi-centre population based cohort study with prospectively collected data from 2810 nulliparous women in term spontaneous labour with a singleton infant in cephalic presentation. Data were collected by self-administered questionnaires and clinical data-records. Logistic regression analyses were used to estimate adjusted Odds Ratios (OR) and 95% confidence intervals (CI) are given. Results The following characteristics, present at admission to hospital, were associated with dystocia during labour (OR, 95% CI): dilatation of cervix dystocia. Conclusion Vaginal examinations at admission provide useful information on risk indicators for dystocia. The strongest risk indicator was use of epidural analgesia and if part of that is causal, it is of concern. PMID:18837972

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

    Directory of Open Access Journals (Sweden)

    Ottesen Bent

    2008-10-01

    Full Text Available Abstract Background In nulliparous women dystocia is the most common obstetric problem and its etiology is largely unknown. The frequency of augmentation and cesarean delivery related to dystocia is high although it is not clear if a slow progress justifies the interventions. Studies of risk factors for dystocia often do not provide diagnostic criteria for the diagnosis. The aim of the present study was to identify obstetric and clinical risk indicators of dystocia defined by strict and explicit criteria. Methods A multi-centre population based cohort study with prospectively collected data from 2810 nulliparous women in term spontaneous labour with a singleton infant in cephalic presentation. Data were collected by self-administered questionnaires and clinical data-records. Logistic regression analyses were used to estimate adjusted Odds Ratios (OR and 95% confidence intervals (CI are given. Results The following characteristics, present at admission to hospital, were associated with dystocia during labour (OR, 95% CI: dilatation of cervix Conclusion Vaginal examinations at admission provide useful information on risk indicators for dystocia. The strongest risk indicator was use of epidural analgesia and if part of that is causal, it is of concern.

  7. Use of metformin before and during assisted reproductive technology in non-obese young infertile women with polycystic ovary syndrome: a prospective, randomized, double-blind, multi-centre study

    DEFF Research Database (Denmark)

    Kjøtrød, S B; Carlsen, S M; Rasmussen, P E

    2011-01-01

    To study the effect of metformin before and during assisted reproductive technology (ART) on the clinical pregnancy rate (CPR) in non-obese women with polycystic ovary syndrome (PCOS).......To study the effect of metformin before and during assisted reproductive technology (ART) on the clinical pregnancy rate (CPR) in non-obese women with polycystic ovary syndrome (PCOS)....

  8. Patch: platelet transfusion in cerebral haemorrhage: study protocol for a multicentre, randomised, controlled trial

    Directory of Open Access Journals (Sweden)

    Dijkgraaf Marcel G

    2010-03-01

    Full Text Available Abstract Background Patients suffering from intracerebral haemorrhage have a poor prognosis, especially if they are using antiplatelet therapy. Currently, no effective acute treatment option for intracerebral haemorrhage exists. Limiting the early growth of intracerebral haemorrhage volume which continues the first hours after admission seems a promising strategy. Because intracerebral haemorrhage patients who are on antiplatelet therapy have been shown to be particularly at risk of early haematoma growth, platelet transfusion may have a beneficial effect. Methods/Design The primary objective is to investigate whether platelet transfusion improves outcome in intracerebral haemorrhage patients who are on antiplatelet treatment. The PATCH study is a prospective, randomised, multi-centre study with open treatment and blind endpoint evaluation. Patients will be randomised to receive platelet transfusion within six hours or standard care. The primary endpoint is functional health after three months. The main secondary endpoints are safety of platelet transfusion and the occurrence of haematoma growth. To detect an absolute poor outcome reduction of 20%, a total of 190 patients will be included. Discussion To our knowledge this is the first randomised controlled trial of platelet transfusion for an acute haemorrhagic disease. Trial registration The Netherlands National Trial Register (NTR1303

  9. Prospective randomized double-blind multicentre phase II study comparing gemcitabine and cisplatin plus sorafenib chemotherapy with gemcitabine and cisplatin plus placebo in locally advanced and/or metastasized urothelial cancer: SUSE (AUO-AB 31/05).

    Science.gov (United States)

    Krege, Susanne; Rexer, Heidrun; vom Dorp, Frank; de Geeter, Patrick; Klotz, Theodor; Retz, Margitte; Heidenreich, Axel; Kühn, Michael; Kamradt, Joern; Feyerabend, Susan; Wülfing, Christian; Zastrow, Stefan; Albers, Peter; Hakenberg, Oliver; Roigas, Jan; Fenner, Martin; Heinzer, Hans; Schrader, Mark

    2014-03-01

    To evaluate the efficacy and safety of gemcitabine and cisplatin in combination with sorafenib, a tyrosine-kinase inhibitor, compared with chemotherapy alone as first-line treatment in advanced urothelial cancer. The study was a randomized phase II trial. Its primary aim was to show an improvement in progression-free survival (PFS) of 4.5 months by adding sorafenib to conventional chemotherapy. Secondary objectives were objective response rate (ORR), overall survival (OS) and toxicity. The patients included in the trial had histologically confirmed locally advanced and/or metastatic urothelial cancer of the bladder or upper urinary tract. Chemotherapy with gemcitabine (1250 mg/qm on days 1 and 8) and cisplatin (70 mg/qm on day 1) repeated every 21 days, was administered to all patients in a double-blind randomization of additional sorafenib (400 mg twice daily) vs placebo (two tablets twice daily) on days 3-21. Treatment continued until progression or unacceptable toxicity, the maximum number of cycles was limited to eight. The response assessment was repeated after every two cycles. Between October 2006 and October 2010, 98 of 132 planned patients were recruited. Nine patients were ineligible. The final analysis included 40 patients in the sorafenib and 49 patients in the placebo arm. There were no significant differences between the two arms concerning ORR (sorafenib: complete response [CR] 12.5%, partial response [PR] 40%; placebo: CR 12%, PR 35%), median PFS (sorafenib: 6.3 months, placebo: 6.1 months) or OS (sorafenib: 11.3 months, placebo: 10.6 months). Toxicity was moderately higher in the sorafenib arm. Diarrrhoea occurred significantly more often in the sorafenib arm and hand-foot syndrome occurred only in the sorafenib arm. The study was closed prematurely because of slow recruitment. Although the addition of sorafenib to standard chemotherapy showed acceptable toxicity, the trial failed to show a 4.5 months improvement in PFS. © 2013 The Authors

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

    DEFF Research Database (Denmark)

    Harding, Keith; Gottrup, Finn; Jawień, Arkadiusz

    2011-01-01

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

  11. 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.

  12. Multicentre European study of thalamic stimulation for parkinsonian tremor: a 6 year follow-up

    NARCIS (Netherlands)

    Hariz, M. I.; Krack, P.; Alesch, F.; Augustinsson, L.-E.; Bosch, A.; Ekberg, R.; Johansson, F.; Johnels, B.; Meyerson, B. A.; N'Guyen, J.-P.; Pinter, M.; Pollak, P.; von Raison, F.; Rehncrona, S.; Speelman, J. D.; Sydow, O.; Benabid, A.-L.

    2008-01-01

    To evaluate the results of ventral intermediate (Vim) thalamic deep brain stimulation (DBS) in patients with tremor predominant Parkinson's disease (PD) at 6 years post surgery. This was a prolonged follow-up study of 38 patients from eight centres who participated in a multicentre study, the 1 year

  13. Multicentre Double-Blind Placebo-Controlled Food Challenge Study in Children Sensitised to Cashew Nut

    NARCIS (Netherlands)

    van der Valk, Johanna P. M.; van Wijk, Roy Gerth; Dubois, Anthony E. J.; de Groot, Hans; Reitsma, Marit; Vlieg-Boerstra, Berber; Savelkoul, Huub F. J.; Wichers, Harry J.; de Jong, Nicolette W.

    2016-01-01

    Background Few studies with a limited number of patients have provided indications that cashew-allergic patients may experience severe allergic reactions to minimal amounts of cashew nut. The objectives of this multicentre study were to assess the clinical relevance of cashew nut sensitisation, to

  14. The vascularised fibular graft for limb salvage after bone tumour surgery A MULTICENTRE STUDY

    NARCIS (Netherlands)

    Hilven, P. H.; Bayliss, L.; Cosker, T.; Dijkstra, P. D. S.; Jutte, P. C.; Lahoda, L. U.; Schaap, G. R.; Bramer, J. A. M.; van Drunen, G. K.; Strackee, S. D.; van Vooren, J.; Gibbons, M.; Giele, H.; van de Sande, M. A. J.

    2015-01-01

    Vascularised fibular grafts (VFGs) are a valuable surgical technique in limb salvage after resection of a tumour. The primary objective of this multicentre study was to assess the risk factors for failure and complications for using a VFG after resection of a tumour. The study involved 74

  15. Multicentre European study of thalamic stimulation in parkinsonian and essential tremor

    NARCIS (Netherlands)

    Limousin, P.; Speelman, J. D.; Gielen, F.; Janssens, M.

    1999-01-01

    Thalamic stimulation has been proposed to treat disabling tremor. The aims of this multicentre study were to evaluate the efficacy and the morbidity of thalamic stimulation in a large number of patients with parkinsonian or essential tremor. One hundred and eleven patients were included in the study

  16. Daily variations in air pollution and respiratory health in a multicentre study: the PEACE project.

    NARCIS (Netherlands)

    Roemer, W.; Hoek, G.; Brunekreef, B.; Haluszka, J.; Kalandidi, A.; Pekkanen, J.

    1998-01-01

    The Pollution Effects on Asthmatic Children in Europe (PEACE) study is a multicentre study of the acute effects of particles with a 50% cut-off aerodynamic diameter of 10 μm (PM10), black smoke (BS), sulphur dioxide (SO2) and nitrogen dioxide (NO2) on the respiratory health of children with chronic

  17. Feasibility and cost efficiency of a diagnostic guideline for chronic polyneuropathy: a prospective implementation study

    NARCIS (Netherlands)

    Vrancken, A. F. J. E.; Kalmijn, S.; Buskens, E.; Franssen, H.; Vermeulen, M.; Wokke, J. H. J.; Notermans, N. C.

    2006-01-01

    Extensive investigations are often performed to reveal the cause of chronic polyneuropathy. It is not known whether a restrictive diagnostic guideline improves cost efficiency without loss of diagnostic reliability. In a prospective multicentre study, a comparison was made between the workup in

  18. Loss to follow-up in an international, multicentre observational study

    DEFF Research Database (Denmark)

    Mocroft, A; Kirk, O; Aldins, P

    2008-01-01

    OBJECTIVE: The aim of this work was to assess loss to follow-up (LTFU) in EuroSIDA, an international multicentre observational cohort study. METHODS: LTFU was defined as no follow-up visit, CD4 cell count measurement or viral load measurement after 1 January 2006. Poisson regression was used...

  19. Violent women : A multicentre study into gender differences in forensic psychiatric patients

    NARCIS (Netherlands)

    de Vogel, Vivienne; Stam, Jeantine; Bouman, Yvonne H. A.; Ter Horst, P.R.M.; Lancel, Marike

    2016-01-01

    To gain insight into the relatively small, but increasing group of women in forensic psychiatry, a retrospective multicentre study was started gathering information from the files of 275 female patients of four Dutch forensic psychiatric hospitals on characteristics and violence risk factors.

  20. The effectiveness of 2-implant overdentures: a pragmatic international multicentre study

    NARCIS (Netherlands)

    Rashid, F.; Awad, M.A.; Thomason, J.M.; Piovano, A.; Spielberg, G.P.; Scilingo, E.; Mojon, P.; Müller, F.; Spielberg, M.; Heydecke, G.; Stoker, G.; Wismeijer, D.; Allen, F.; Feine, J.S.

    2011-01-01

    The purpose of this multicentre observational study was to determine patient satisfaction with either conventional dentures or mandibular 2-implant overdentures in a 'real world' setting. Two hundred and three edentulous patients (mean age 68·8 ± 10·4 years) were recruited at eight centres located

  1. Salmeterol versus slow-release theophylline combined with ketotifen in nocturnal asthma: a multicentre trial. French Multicentre Study Group.

    Science.gov (United States)

    Muir, J F; Bertin, L; Georges, D

    1992-11-01

    We wished to assess the efficacy of inhaled salmeterol (SML; 50 micrograms b.i.d.) compared to a combination of slow-release theophylline and ketotifen p.o. (TK; T 300 mg+K 1 mg b.i.d.) for the treatment of nocturnal asthma. Ninety six patients with nocturnal asthma, (forced expiratory volume in one second (FEV1) 60-90% of predicted value, reversibility > or = 15%, at least two nocturnal awakenings per week) were eligible for a multicentre, double-blind, double-dummy cross-over study (14-day run-in, two successive 28-day treatment periods). Efficacy was assessed as success/failure, success being defined as the complete disappearance of nocturnal symptoms/awakening during the last week of each treatment period. There was a statistically significant difference between SML and TK for this criterion: 46% and 39% success with SML during periods I (first 28-day period) and II (following the cross-over), compared to only 15% and 26% with TK, respectively (p < 0.01). SML was also significantly better for the other criteria (lung function, rescue salbutamol intake during day and night). Side-effects were five times less frequent in SML-treated patients (p < 0.004). Efficacy and tolerance of SML were obviously far better than those of TK in patients with nocturnal asthma.

  2. Exploring venlafaxine pharmacokinetic variability with a phenotyping approach, a multicentric french-swiss study (MARVEL study).

    Science.gov (United States)

    Lloret-Linares, Célia; Daali, Youssef; Chevret, Sylvie; Nieto, Isabelle; Molière, Fanny; Courtet, Philippe; Galtier, Florence; Richieri, Raphaëlle-Marie; Morange, Sophie; Llorca, Pierre-Michel; El-Hage, Wissam; Desmidt, Thomas; Haesebaert, Frédéric; Vignaud, Philippe; Holtzmann, Jerôme; Cracowski, Jean-Luc; Leboyer, Marion; Yrondi, Antoine; Calvas, Fabienne; Yon, Liova; Le Corvoisier, Philippe; Doumy, Olivier; Heron, Kyle; Montange, Damien; Davani, Siamak; Déglon, Julien; Besson, Marie; Desmeules, Jules; Haffen, Emmanuel; Bellivier, Frank

    2017-11-07

    It is well known that the standard doses of a given drug may not have equivalent effects in all patients. To date, the management of depression remains mainly empirical and often poorly evaluated. The development of a personalized medicine in psychiatry may reduce treatment failure, intolerance or resistance, and hence the burden and costs of mood depressive disorders. The Geneva Cocktail Phenotypic approach presents several advantages including the "in vivo" measure of different cytochromes and transporter P-gp activities, their simultaneous determination in a single test, avoiding the influence of variability over time on phenotyping results, the administration of low dose substrates, a limited sampling strategy with an analytical method developed on DBS analysis. The goal of this project is to explore the relationship between the activity of drug-metabolizing enzymes (DME), assessed by a phenotypic approach, and the concentrations of Venlafaxine (VLX) + O-demethyl-venlafaxine (ODV), the efficacy and tolerance of VLX. This study is a multicentre prospective non-randomized open trial. Eligible patients present a major depressive episode, MADRS over or equal to 20, treatment with VLX regardless of the dose during at least 4 weeks. The Phenotype Visit includes VLX and ODV concentration measurement. Following the oral absorption of low doses of omeprazole, midazolam, dextromethorphan, and fexofenadine, drug metabolizing enzymes activity is assessed by specific metabolite/probe concentration ratios from a sample taken 2 h after cocktail administration for CYP2C19, CYP3A4, CYP2D6; and by the determination of the limited area under the curve from the capillary blood samples taken 2-3 and 6 h after cocktail administration for CYP2C19 and P-gp. Two follow-up visits will take place between 25 and 40 days and 50-70 days after inclusion. They include assessment of efficacy, tolerance and observance. Eleven french centres are involved in recruitment, expected to be

  3. Lymphoscintigraphy and SPECT/CT in multicentric and multifocal breast cancer: does each tumour have a separate drainage pattern? Results of a Dutch multicentre study (MULTISENT)

    Energy Technology Data Exchange (ETDEWEB)

    Brouwer, O.R. [Antoni van Leeuwenhoek Hospital, Department of Nuclear Medicine, Netherlands Cancer Institute, Amsterdam (Netherlands); Antoni van Leeuwenhoekhospital, Amsterdam (Netherlands); Vermeeren, L.; Valdes Olmos, R.A. [Antoni van Leeuwenhoek Hospital, Department of Nuclear Medicine, Netherlands Cancer Institute, Amsterdam (Netherlands); Ploeg, I.M.C. van der; Rutgers, E.J.T.; Oldenburg, H.S.A. [Antoni van Leeuwenhoek Hospital, Department of Surgery, Netherlands Cancer Institute, Amsterdam (Netherlands); Loo, C.E. [Antoni van Leeuwenhoek Hospital, Department of Radiology, Netherlands Cancer Institute, Amsterdam (Netherlands); Pereira-Bouda, L.M.; Smit, F. [Rijnland Hospital, Department of Nuclear Medicine, Leiderdorp (Netherlands); Neijenhuis, P. [Rijnland Hospital, Department of Surgery, Leiderdorp (Netherlands); Vrouenraets, B.C. [Sint Lucas Andreas Hospital, Department of Surgery, Amsterdam (Netherlands); Sivro-Prndelj, F. [Sint Lucas Andreas Hospital, Department of Nuclear Medicine, Amsterdam (Netherlands); Jap-a-Joe, S.M.; Borgstein, P.J. [Onze Lieve Vrouwe Gasthuis, Department of Nuclear Medicine, Amsterdam (Netherlands)

    2012-07-15

    To investigate whether lymphoscintigraphy and SPECT/CT after intralesional injection of radiopharmaceutical into each tumour separately in patients with multiple malignancies in one breast yields additional sentinel nodes compared to intralesional injection of the largest tumour only. Patients were included prospectively at four centres in The Netherlands. Lymphatic flow was studied using planar lymphoscintigraphy and SPECT/CT until 4 h after administration of {sup 99m}Tc-nanocolloid in the largest tumour. Subsequently, the smaller tumour(s) was injected intratumorally followed by the same imaging sequence. Sentinel nodes were intraoperatively localized using a gamma ray detection probe and vital blue dye. Included in the study were 50 patients. Additional lymphatic drainage was depicted after the second and/or third injection in 32 patients (64 %). Comparison of planar images and SPECT/CT images after consecutive injections enabled visualization of the number and location of additional sentinel nodes (32 axillary, 11 internal mammary chain, 2 intramammary, and 1 interpectoral. A sentinel node contained metastases in 17 patients (34 %)). In five patients with a tumour-positive node in the axilla that was visualized after the first injection, an additional involved axillary node was found after the second injection. In two patients, isolated tumour cells were found in sentinel nodes that were only visualized after the second injection, whilst the sentinel nodes identified after the first injection were tumour-negative. Lymphoscintigraphy and SPECT/CT after consecutive intratumoral injections of tracer enable lymphatic mapping of each tumour separately in patients with multiple malignancies within one breast. The high incidence of additional sentinel nodes draining from tumours other than the largest one suggests that separate tumour-related tracer injections may be a more accurate approach to mapping and sampling of sentinel nodes in patients with multicentric or

  4. Lymphoscintigraphy and SPECT/CT in multicentric and multifocal breast cancer: does each tumour have a separate drainage pattern? Results of a Dutch multicentre study (MULTISENT).

    Science.gov (United States)

    Brouwer, O R; Vermeeren, L; van der Ploeg, I M C; Valdés Olmos, R A; Loo, C E; Pereira-Bouda, L M; Smit, F; Neijenhuis, P; Vrouenraets, B C; Sivro-Prndelj, F; Jap-a-Joe, S M; Borgstein, P J; Rutgers, E J Th; Oldenburg, H S A

    2012-07-01

    To investigate whether lymphoscintigraphy and SPECT/CT after intralesional injection of radiopharmaceutical into each tumour separately in patients with multiple malignancies in one breast yields additional sentinel nodes compared to intralesional injection of the largest tumour only. Patients were included prospectively at four centres in The Netherlands. Lymphatic flow was studied using planar lymphoscintigraphy and SPECT/CT until 4 h after administration of (99m)Tc-nanocolloid in the largest tumour. Subsequently, the smaller tumour(s) was injected intratumorally followed by the same imaging sequence. Sentinel nodes were intraoperatively localized using a gamma ray detection probe and vital blue dye. Included in the study were 50 patients. Additional lymphatic drainage was depicted after the second and/or third injection in 32 patients (64%). Comparison of planar images and SPECT/CT images after consecutive injections enabled visualization of the number and location of additional sentinel nodes (32 axillary, 11 internal mammary chain, 2 intramammary, and 1 interpectoral. A sentinel node contained metastases in 17 patients (34%). In five patients with a tumour-positive node in the axilla that was visualized after the first injection, an additional involved axillary node was found after the second injection. In two patients, isolated tumour cells were found in sentinel nodes that were only visualized after the second injection, whilst the sentinel nodes identified after the first injection were tumour-negative. Lymphoscintigraphy and SPECT/CT after consecutive intratumoral injections of tracer enable lymphatic mapping of each tumour separately in patients with multiple malignancies within one breast. The high incidence of additional sentinel nodes draining from tumours other than the largest one suggests that separate tumour-related tracer injections may be a more accurate approach to mapping and sampling of sentinel nodes in patients with multicentric or

  5. Erysipelas of the leg (cellulitis in sub-Saharan Africa: A multicentric study of 562 cases

    Directory of Open Access Journals (Sweden)

    Bayaki Saka

    2017-01-01

    Full Text Available Introduction: Erysipelas of the leg is a common and serious infection. We carried out this study aiming at describing the epidemiological and clinical characteristics, and assessing the risks factors associated with the local complications of erysipelas of the leg in sub-Saharan Africa. Methods: This was a prospective multicentric study carried out in the dermatology units of Hospitals located in seven sub-Saharan African countries during a period of 12 months. Patients aged 15 and above with a first episode of erysipelas of the leg were recruited. Results: In this study, 562 patients were recruited, having a mean age of 43.7±16.9 years and a sex-ratio (M/F of 0.67. Patients infected on one leg were 562 while those infected with two were 27. Bullous forms of the disease were observed in 95 patients, while purpuric forms were observed in 167 patients. The existence of a point of entry (485 cases, obesity (230, lymph edema (130 and the use of bleaching agents (97 were the mains risk factors. Complications during the course of the infection such as necrotizing fasciitis (34 cases and abscesses (63 cases were observed. They were due to the use of antibiotics and non-steroidal anti-inflammatory treatments, and the use of cataplasm. Conclusion: This study reveals that existence of a point of entry, obesity and lymph edema, and the use of bleaching agents were the mains risk factors influencing the local complications of erysipelas of the leg. Necrotizing fasciitis and abscesses were influenced by the use of antibiotics and non-steroidal anti-inflammatory treatments, and the use of cataplasm.

  6. Factors associated with survival of epiploic foramen entrapment colic: a multicentre, international study.

    Science.gov (United States)

    Archer, D C; Pinchbeck, G L; Proudman, C J

    2011-08-01

    Epiploic foramen entrapment (EFE) has been associated with reduced post operative survival compared to other types of colic but specific factors associated with reduced long-term survival of these cases have not been evaluated in a large number of horses using survival analysis. To describe post operative survival of EFE cases and to identify factors associated with long-term survival. A prospective, multicentre, international study was conducted using clinical data and long-term follow-up information for 126 horses diagnosed with EFE during exploratory laparotomy at 15 clinics in the UK, Ireland and USA. Descriptive data were generated and survival analysis performed to identify factors associated with reduced post operative survival. For the EFE cohort that recovered following anaesthesia, survival to hospital discharge was 78.5%. Survival to 1 and 2 years post operatively was 50.6 and 34.3%, respectively. The median survival time of EFE cases undergoing surgery was 397 days. Increased packed cell volume (PCV) and increased length of small intestine (SI) resected were significantly associated with increased likelihood of mortality when multivariable analysis of pre- and intraoperative variables were analysed. When all pre-, intra- and post operative variables were analysed separately, only horses that developed post operative ileus (POI) were shown to be at increased likelihood of mortality. Increased PCV, increased length of SI resected and POI are all associated with increased likelihood of mortality of EFE cases. This emphasises the importance of early diagnosis and treatment and the need for improved strategies in the management of POI in order to reduce post operative mortality in these cases. The present study provides evidence-based information to clinicians and owners of horses undergoing surgery for EFE about long-term survival. These results are applicable to university and large private clinics over a wide geographical area. © 2011 EVJ Ltd.

  7. Strategies to diagnose ovarian cancer: new evidence from phase 3 of the multicentre international IOTA study.

    Science.gov (United States)

    Testa, A; Kaijser, J; Wynants, L; Fischerova, D; Van Holsbeke, C; Franchi, D; Savelli, L; Epstein, E; Czekierdowski, A; Guerriero, S; Fruscio, R; Leone, F P G; Vergote, I; Bourne, T; Valentin, L; Van Calster, B; Timmerman, D

    2014-08-12

    To compare different ultrasound-based international ovarian tumour analysis (IOTA) strategies and risk of malignancy index (RMI) for ovarian cancer diagnosis using a meta-analysis approach of centre-specific data from IOTA3. This prospective multicentre diagnostic accuracy study included 2403 patients with 1423 benign and 980 malignant adnexal masses from 2009 until 2012. All patients underwent standardised transvaginal ultrasonography. Test performance of RMI, subjective assessment (SA) of ultrasound findings, two IOTA risk models (LR1 and LR2), and strategies involving combinations of IOTA simple rules (SRs), simple descriptors (SDs) and LR2 with and without SA was estimated using a meta-analysis approach. Reference standard was histology after surgery. The areas under the receiver operator characteristic curves of LR1, LR2, SA and RMI were 0.930 (0.917-0.942), 0.918 (0.905-0.930), 0.914 (0.886-0.936) and 0.875 (0.853-0.894). Diagnostic one-step and two-step strategies using LR1, LR2, SR and SD achieved summary estimates for sensitivity 90-96%, specificity 74-79% and diagnostic odds ratio (DOR) 32.8-50.5. Adding SA when IOTA methods yielded equivocal results improved performance (DOR 57.6-75.7). Risk of Malignancy Index had sensitivity 67%, specificity 91% and DOR 17.5. This study shows all IOTA strategies had excellent diagnostic performance in comparison with RMI. The IOTA strategy chosen may be determined by clinical preference.

  8. PET-PANC: multicentre prospective diagnostic accuracy and health economic analysis study of the impact of combined modality 18fluorine-2-fluoro-2-deoxy-d-glucose positron emission tomography with computed tomography scanning in the diagnosis and management of pancreatic cancer.

    Science.gov (United States)

    Ghaneh, Paula; Hanson, Robert; Titman, Andrew; Lancaster, Gill; Plumpton, Catrin; Lloyd-Williams, Huw; Yeo, Seow Tien; Edwards, Rhiannon Tudor; Johnson, Colin; Abu Hilal, Mohammed; Higginson, Antony P; Armstrong, Tom; Smith, Andrew; Scarsbrook, Andrew; McKay, Colin; Carter, Ross; Sutcliffe, Robert P; Bramhall, Simon; Kocher, Hemant M; Cunningham, David; Pereira, Stephen P; Davidson, Brian; Chang, David; Khan, Saboor; Zealley, Ian; Sarker, Debashis; Al Sarireh, Bilal; Charnley, Richard; Lobo, Dileep; Nicolson, Marianne; Halloran, Christopher; Raraty, Michael; Sutton, Robert; Vinjamuri, Sobhan; Evans, Jonathan; Campbell, Fiona; Deeks, Jon; Sanghera, Bal; Wong, Wai-Lup; Neoptolemos, John P

    2018-02-01

    Pancreatic cancer diagnosis and staging can be difficult in 10-20% of patients. Positron emission tomography (PET)/computed tomography (CT) adds precise anatomical localisation to functional data. The use of PET/CT may add further value to the diagnosis and staging of pancreatic cancer. To determine the incremental diagnostic accuracy and impact of PET/CT in addition to standard diagnostic work-up in patients with suspected pancreatic cancer. A multicentre prospective diagnostic accuracy and clinical value study of PET/CT in suspected pancreatic malignancy. Patients with suspected pancreatic malignancy. All patients to undergo PET/CT following standard diagnostic work-up. The primary outcome was the incremental diagnostic value of PET/CT in addition to standard diagnostic work-up with multidetector computed tomography (MDCT). Secondary outcomes were (1) changes in patients' diagnosis, staging and management as a result of PET/CT; (2) changes in the costs and effectiveness of patient management as a result of PET/CT; (3) the incremental diagnostic value of PET/CT in chronic pancreatitis; (4) the identification of groups of patients who would benefit most from PET/CT; and (5) the incremental diagnostic value of PET/CT in other pancreatic tumours. Between 2011 and 2013, 589 patients with suspected pancreatic cancer underwent MDCT and PET/CT, with 550 patients having complete data and in-range PET/CT. Sensitivity and specificity for the diagnosis of pancreatic cancer were 88.5% and 70.6%, respectively, for MDCT and 92.7% and 75.8%, respectively, for PET/CT. The maximum standardised uptake value (SUV max. ) for a pancreatic cancer diagnosis was 7.5. PET/CT demonstrated a significant improvement in relative sensitivity ( p  = 0.01) and specificity ( p  = 0.023) compared with MDCT. Incremental likelihood ratios demonstrated that PET/CT significantly improved diagnostic accuracy in all scenarios ( p  diagnostic benefit in the diagnosis of pancreatic cancer and

  9. Prevalence and predictors of alcohol use during pregnancy: findings from international multicentre cohort studies.

    Science.gov (United States)

    O'Keeffe, Linda M; Kearney, Patricia M; McCarthy, Fergus P; Khashan, Ali S; Greene, Richard A; North, Robyn A; Poston, Lucilla; McCowan, Lesley M E; Baker, Philip N; Dekker, Gus A; Walker, James J; Taylor, Rennae; Kenny, Louise C

    2015-07-06

    To compare the prevalence and predictors of alcohol use in multiple cohorts. Cross-cohort comparison of retrospective and prospective studies. Population-based studies in Ireland, the UK, Australia and New Zealand. 17,244 women of predominantly Caucasian origin from two Irish retrospective studies (Growing up in Ireland (GUI) and Pregnancy Risk Assessment Monitoring System Ireland (PRAMS Ireland)), and one multicentre prospective international cohort, Screening for Pregnancy Endpoints (SCOPE) study. Prevalence of alcohol use pre-pregnancy and during pregnancy across cohorts. Sociodemographic factors associated with alcohol consumption in each cohort. Alcohol consumption during pregnancy in Ireland ranged from 20% in GUI to 80% in SCOPE, and from 40% to 80% in Australia, New Zealand and the UK. Levels of exposure also varied substantially among drinkers in each cohort ranging from 70% consuming more than 1-2 units/week in the first trimester in SCOPE Ireland, to 46% and 15% in the retrospective studies. Smoking during pregnancy was the most consistent predictor of gestational alcohol use in all three cohorts, and smokers were 17% more likely to drink during pregnancy in SCOPE, relative risk (RR)=1.17 (95% CI 1.12 to 1.22), 50% more likely to drink during pregnancy in GUI, RR=1.50 (95% CI 1.36 to 1.65), and 42% more likely to drink in PRAMS, RR=1.42 (95% CI 1.18 to 1.70). Our data suggest that alcohol use during pregnancy is prevalent and socially pervasive in the UK, Ireland, New Zealand and Australia. New policy and interventions are required to reduce alcohol prevalence both prior to and during pregnancy. Further research on biological markers and conventions for measuring alcohol use in pregnancy is required to improve the validity and reliability of prevalence estimates. 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.

  10. [Multicentre study of infection incidence in knee prosthesis].

    Science.gov (United States)

    Jaén, F; Sanz-Gallardo, M I; Arrazola, M P; García de Codes, A; de Juanes, A; Resines, C

    2012-01-01

    To determine the incidence of surgical site infection in knee prosthesis surgical procedure for a follow-up period of one year in twelve hospitals in Madrid region. A prospective study was carried out from January to December 2009 using a national surveillance system called Indicadores Clínicos de Mejora Continua de Calidad. Primary and revision knee joint replacements in patients operated on in the previous year were included. Criteria used to define surgical site infection and patient risk index categories were those established by the Centers for Disease Control and Prevention and National Nosocomial Infections Surveillance. The incidence rates were worked out crude and adjusted by hazard ratio. 2,088 knee prosthesis procedures were analyzed. The overall incidence of surgical site infection was 2.1%. Sixty-five percent of the infections were organ/space. Sixty percent of the infections were identified in the early postoperative period. Of all surgical site infections, 41.9% were microbiologically confirmed. Antibiotic prophylaxis was implemented correctly in 63.3% of the cases. The most important cause of inappropriate prophylaxis was an unsuitable duration in 85.7% of the cases. The presurgical preparation was carried out correctly in 50.3% of surgical operations. The incidence of knee arthroplasty infection was twice as high as in the National Healthcare Safety Network and similar to national rates. In this study, the incidence of infection was within the range of infection rates in other published European studies. Surveillance and control strategies of health care for associated infections allow us to assess trends and the impact of preventive measures. Copyright © 2011 SECOT. Published by Elsevier Espana. All rights reserved.

  11. Mygale lasiodora: A multicentric observational homoeopathic clinical verification study

    Directory of Open Access Journals (Sweden)

    Raj K Manchanda

    2015-01-01

    Conclusions: Total 34 available symptoms were verified, and 47 new symptoms were identified. Cautious interpretation is necessary. Further replication on larger sample and estimation of likelihood ratio, in general, practice settings in prospective Bayesian approach is necessary before inclusion of the symptoms in homoeopathic literature.

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

    Science.gov (United States)

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

    2008-08-01

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

  13. Questing for circadian dependence in ST-segment-elevation acute myocardial infarction: A multicentric and multiethnic study

    KAUST Repository

    Ammirati, Enrico

    2013-05-09

    Rationale: Four monocentric studies reported that circadian rhythms can affect left ventricular infarct size after ST-segment-elevation acute myocardial infarction (STEMI). Objective: To further validate the circadian dependence of infarct size after STEMI in a multicentric and multiethnic population. Methods and Results: We analyzed a prospective cohort of subjects with first STEMI from the First Acute Myocardial Infarction study that enrolled 1099 patients (ischemic time <6 hours) in Italy, Scotland, and China. We confirmed a circadian variation of STEMI incidence with an increased morning incidence (from 6:00 am till noon). We investigated the presence of circadian dependence of infarct size plotting the peak creatine kinase against time onset of ischemia. In addition, we studied the patients from the 3 countries separately, including 624 Italians; all patients were treated with percutaneous coronary intervention. We adopted several levels of analysis with different inclusion criteria consistent with previous studies. In all the analyses, we did not find a clear-cut circadian dependence of infarct size after STEMI. Conclusions: Although the circadian dependence of infarct size supported by previous studies poses an intriguing hypothesis, we were unable to converge toward their conclusions in a multicentric and multiethnic setting. Parameters that vary as a function of latitude could potentially obscure the circadian variations observed in monocentric studies. We believe that, to assess whether circadian rhythms can affect the infarct size, future study design should not only include larger samples but also aim to untangle the molecular time-dynamic mechanisms underlying such a relation. © 2013 American Heart Association, Inc.

  14. Prophylactic mesh placement to prevent parastomal hernia, early results of a prospective multicentre randomized trial

    NARCIS (Netherlands)

    Brandsma, H.T.; Hansson, B.M.; Aufenacker, T.J.; Geldere, D. van; Lammeren, F.M. van; Mahabier, C.; Steenvoorde, P.; Reilingh, T.S. de Vries; Wiezer, R.J.; Wilt, J.H.W. de; Bleichrodt, R.P.; Rosman, C.

    2016-01-01

    PURPOSE: Parastomal hernia (PSH) is a common complication after colostomy formation. Recent studies indicate that mesh implantation during formation of a colostomy might prevent a PSH. To determine if placement of a retromuscular mesh at the colostomy site is a feasible, safe and effective procedure

  15. Harmonizing FDG PET quantification while maintaining optimal lesion detection: prospective multicentre validation in 517 oncology patients

    International Nuclear Information System (INIS)

    Quak, Elske; Le Roux, Pierre-Yves; Robin, Philippe; Bourhis, David; Salaun, Pierre-Yves; Hofman, Michael S.; Callahan, Jason; Binns, David; Hicks, Rodney J.; Desmonts, Cedric; Aide, Nicolas

    2015-01-01

    Point-spread function (PSF) or PSF + time-of-flight (TOF) reconstruction may improve lesion detection in oncologic PET, but can alter quantitation resulting in variable standardized uptake values (SUVs) between different PET systems. This study aims to validate a proprietary software tool (EQ.PET) to harmonize SUVs across different PET systems independent of the reconstruction algorithm used. NEMA NU2 phantom data were used to calculate the appropriate filter for each PSF or PSF+TOF reconstruction from three different PET systems, in order to obtain EANM compliant recovery coefficients. PET data from 517 oncology patients were reconstructed with a PSF or PSF+TOF reconstruction for optimal tumour detection and an ordered subset expectation maximization (OSEM3D) reconstruction known to fulfil EANM guidelines. Post-reconstruction, the proprietary filter was applied to the PSF or PSF+TOF data (PSF EQ or PSF+TOF EQ ). SUVs for PSF or PSF+TOF and PSF EQ or PSF+TOF EQ were compared to SUVs for the OSEM3D reconstruction. The impact of potential confounders on the EQ.PET methodology including lesion and patient characteristics was studied, as was the adherence to imaging guidelines. For the 1380 tumour lesions studied, Bland-Altman analysis showed a mean ratio between PSF or PSF+TOF and OSEM3D of 1.46 (95 %CI: 0.86-2.06) and 1.23 (95 %CI: 0.95-1.51) for SUV max and SUV peak , respectively. Application of the proprietary filter improved these ratios to 1.02 (95 %CI: 0.88-1.16) and 1.04 (95 %CI: 0.92-1.17) for SUV max and SUV peak , respectively. The influence of the different confounding factors studied (lesion size, location, radial offset and patient's BMI) was less than 5 %. Adherence to the European Association of Nuclear Medicine (EANM) guidelines for tumour imaging was good. These data indicate that it is not necessary to sacrifice the superior lesion detection and image quality achieved by newer reconstruction techniques in the quest for harmonizing quantitative

  16. The Se.Ko.Ph. study: a European multicentre study on falls in elderly subjects living in residential homes

    Directory of Open Access Journals (Sweden)

    Aladar Bruno Ianes

    2017-05-01

    Full Text Available The aim was to investigate risk factors for falls in elderly people living in residential nursing homes. An observational, prospective, multicentre study was conducted between March 2010 and March 2011 investigating falls in elderly residents living in residential nursing homes (4 Italian¸ 4 French and 5 German nursing homes. A number of risk factors were assessed as well as details of the fall (dynamics, reasons, location and time of occurrence. Differences were observed between the countries related to different nursing practices. Fallers comprised 36.5% of all residents and approximately 40% were injured as a consequence. Six logistic regression models were created to assess which fallrelated variables had the most impact, and showed subjects with faecal incontinence had a lower risk of falling, while subjects afflicted with dementia and visual impairment showed an increased risk of falling. Higher Tinetti scores were found to be related to an increased fall risk. Falls in the elderly occur due to complex interactions between demographic, physical, behavioural and environmental risk factors. Differences between countries in fall rates were seen, probably due to different medical practices, use of aids and restraints, and characteristics of the populations (i.e. the Italian residents tended to be more cognitively impaired and more impaired in balance and gait compared to the French and German residents. There was evidence that subjects with a better clinical status fall more frequently, whereas non-fallers had a worse clinical status and therefore tended to be more bedridden.

  17. Cognition and bimanual performance in children with unilateral cerebral palsy: protocol for a multicentre, cross-sectional study.

    Science.gov (United States)

    Hoare, Brian; Ditchfield, Michael; Thorley, Megan; Wallen, Margaret; Bracken, Jenny; Harvey, Adrienne; Elliott, Catherine; Novak, Iona; Crichton, Ali

    2018-05-08

    Motor outcomes of children with unilateral cerebral palsy are clearly documented and well understood, yet few studies describe the cognitive functioning in this population, and the associations between the two is poorly understood. Using two hands together in daily life involves complex motor and cognitive processes. Impairment in either domain may contribute to difficulties with bimanual performance. Research is yet to derive whether, and how, cognition affects a child's ability to use their two hands to perform bimanual tasks. This study will use a prospective, cross-sectional multi-centre observational design. Children (aged 6-12 years) with unilateral cerebral palsy will be recruited from one of five Australian treatment centres. We will examine associations between cognition, bimanual performance and brain neuropathology (lesion type and severity) in a sample of 131 children. The primary outcomes are: Motor - the Assisting Hand Assessment; Cognitive - Executive Function; and Brain - lesion location on structural MRI. Secondary data collected will include: Motor - Box and Blocks, ABILHAND- Kids, Sword Test; Cognitive - standard neuropsychological measures of intelligence. We will use generalized linear modelling and structural equation modelling techniques to investigate relationships between bimanual performance, executive function and brain lesion location. This large multi-centre study will examine how cognition affects bimanual performance in children with unilateral cerebral palsy. First, it is anticipated that distinct relationships between bimanual performance and cognition (executive function) will be identified. Second, it is anticipated that interrelationships between bimanual performance and cognition will be associated with common underlying neuropathology. Findings have the potential to improve the specificity of existing upper limb interventions by providing more targeted treatments and influence the development of novel methods to improve both

  18. Ex-vivo perfusion of donor hearts for human heart transplantation (PROCEED II): a prospective, open-label, multicentre, randomised non-inferiority trial.

    Science.gov (United States)

    Ardehali, Abbas; Esmailian, Fardad; Deng, Mario; Soltesz, Edward; Hsich, Eileen; Naka, Yoshifumi; Mancini, Donna; Camacho, Margarita; Zucker, Mark; Leprince, Pascal; Padera, Robert; Kobashigawa, Jon

    2015-06-27

    The Organ Care System is the only clinical platform for ex-vivo perfusion of human donor hearts. The system preserves the donor heart in a warm beating state during transport from the donor hospital to the recipient hospital. We aimed to assess the clinical outcomes of the Organ Care System compared with standard cold storage of human donor hearts for transplantation. We did this prospective, open-label, multicentre, randomised non-inferiority trial at ten heart-transplant centres in the USA and Europe. Eligible heart-transplant candidates (aged >18 years) were randomly assigned (1:1) to receive donor hearts preserved with either the Organ Care System or standard cold storage. Participants, investigators, and medical staff were not masked to group assignment. The primary endpoint was 30 day patient and graft survival, with a 10% non-inferiority margin. We did analyses in the intention-to-treat, as-treated, and per-protocol populations. This trial is registered with ClinicalTrials.gov, number NCT00855712. Between June 29, 2010, and Sept 16, 2013, we randomly assigned 130 patients to the Organ Care System group (n=67) or the standard cold storage group (n=63). 30 day patient and graft survival rates were 94% (n=63) in the Organ Care System group and 97% (n=61) in the standard cold storage group (difference 2·8%, one-sided 95% upper confidence bound 8·8; p=0·45). Eight (13%) patients in the Organ Care System group and nine (14%) patients in the standard cold storage group had cardiac-related serious adverse events. Heart transplantation using donor hearts adequately preserved with the Organ Care System or with standard cold storage yield similar short-term clinical outcomes. The metabolic assessment capability of the Organ Care System needs further study. TransMedics. Copyright © 2015 Elsevier Ltd. All rights reserved.

  19. Uptake of breast cancer preventive therapy in the UK: results from a multicentre prospective survey and qualitative interviews.

    Science.gov (United States)

    Hackett, Julia; Thorneloe, Rachael; Side, Lucy; Wolf, Michael; Horne, Rob; Cuzick, Jack; Smith, Samuel G

    2018-04-24

    Uptake of preventive therapy for women at increased breast cancer risk in England is unknown following the introduction of UK clinical guidelines in 2013. Preventive therapy could create socioeconomic inequalities in cancer incidence if it is more readily accepted by particular socio-demographic groups. In this multicentre study, we investigated uptake of tamoxifen and evaluated socio-demographic and clinical factors associated with initiation. We explored women's experiences of treatment decision-making using qualitative interview data. Between September 2015 and December 2016, women (n = 732) attending an appointment at one of 20 centres in England to discuss breast cancer risk were approached to complete a survey containing socio-demographic details and nulliparity. Of the baseline survey respondents (n = 408/732, 55.7% response rate), self-reported uptake of tamoxifen at 3-month follow-up was reported in 258 (63.2%). Sixteen women participated in semi-structured interviews. One in seven (38/258 = 14.7%) women initiated tamoxifen. Women who had children were more likely to report use of tamoxifen than those without children (OR = 5.26; 95%CI: 1.13-24.49, p = 0.035). Interview data suggested that women weigh up risks and benefits of tamoxifen within the context of familial commitments, with exposure to significant other's beliefs and experiences of cancer and medication a basis for their decision. Uptake of tamoxifen is low in clinical practice. There were no socio-demographic differences in uptake, suggesting that the introduction of breast cancer preventive therapy is unlikely to create socioeconomic inequalities in cancer incidence. Women's decision-making was influenced by familial priorities, particularly having children.

  20. Early Lupus Project - A multicentre Italian study on systemic lupus erythematosus of recent onset.

    Science.gov (United States)

    Sebastiani, G D; Prevete, I; Piga, M; Iuliano, A; Bettio, S; Bortoluzzi, A; Coladonato, L; Tani, C; Spinelli, F R; Fineschi, I; Mathieu, A

    2015-10-01

    Systemic lupus erythematosus (SLE) is an autoimmune disease with a high degree of variability at onset that is problematic for a correct and prompt diagnosis. We undertook this project with the purpose of collecting an inception cohort of Italian patients with recent-onset SLE, in order to obtain information on the main clinical and serological characteristics at the beginning of the disease. In this first report we describe the characteristics of this cohort at study entry. All patients with a diagnosis of SLE (1997 ACR criteria) and a disease duration less than 12 months were consecutively enrolled between 1 January 2012 and 31 December 2013 in a multicentre prospective study. Information on clinical and serological characteristics at study entry and then every six months was collected into a specific electronic database. Statistical analysis was performed by means of the Openstat program. Among 122 patients enrolled (103 F) 94.3% were Caucasians. Mean age (SD) of patients at study entry was 37.3 (14.3) years, mean age at disease onset was 34.8 (14.3) years, mean age at diagnosis was 36.9 (14.3) years, and mean disease duration was 2.9 (3.9) months. The frequency of the manifestations included in the 1997 ACR criteria was as follows: ANA 97.5%, immunologic disorders (anti-dsDNA, anti-Sm, antiphospholipid antibodies) 85.2%, arthritis 61.8%, haematologic disorders 55.7%, malar rash 31.1%, photosensitivity 29.5%, serositis 27%, renal disorders 27%, oral/nasal ulcers 11.5%, neurologic disorders 8.2%, and discoid rash 5.7%. The cumulative frequency of mucocutaneous symptoms was 77.8%. At enrolment, autoantibody frequency was: ANA 100%, anti-dsDNA 83.6%, anti-SSA 28%, anticardiolipin 24.5%, anti-nRNP 20.4%, anti-beta2GPI 17.2%, lupus anticoagulant 16.3%, anti-Sm 16%, and anti-SSB 13.1%. In this paper we describe the main clinical and serological characteristics of an Italian inception cohort of patients with recent-onset SLE. At disease onset, mucocutaneous

  1. Primary adrenal insufficiency in adult population: a Portuguese Multicentre Study by the Adrenal Tumours Study Group.

    Science.gov (United States)

    Ferreira, Lia; Silva, João; Garrido, Susana; Bello, Carlos; Oliveira, Diana; Simões, Hélder; Paiva, Isabel; Guimarães, Joana; Ferreira, Marta; Pereira, Teresa; Bettencourt-Silva, Rita; Martins, Ana Filipa; Silva, Tiago; Fernandes, Vera; Pereira, Maria Lopes

    2017-11-01

    Primary adrenal insufficiency (PAI) is a rare but severe and potentially life-threatening condition. No previous studies have characterized Portuguese patients with PAI. To characterize the clinical presentation, diagnostic workup, treatment and follow-up of Portuguese patients with confirmed PAI. This multicentre retrospective study examined PAI patients in 12 Portuguese hospitals. We investigated 278 patients with PAI (55.8% were females), with a mean age of 33.6 ± 19.3 years at diagnosis. The most frequent presenting clinical features were asthenia (60.1%), mucocutaneous hyperpigmentation (55.0%) and weight loss (43.2%); 29.1% of the patients presented with adrenal crisis. Diagnosis was established by high plasma ACTH and low serum cortisol in most patients (43.9%). The most common aetiology of PAI was autoimmune adrenalitis (61.0%). There were 38 idiopathic cases. Autoimmune comorbidities were found in 70% of the patients, the most frequent being autoimmune thyroiditis (60.7%) and type 1 diabetes mellitus (17.3%). Seventy-nine percent were treated with hydrocortisone (mean dose 26.3 ± 8.3 mg/day) mostly in three (57.5%) or two (37.4%) daily doses. The remaining patients were treated with prednisolone (10.1%), dexamethasone (6.2%) and methylprednisolone (0.7%); 66.2% were also on fludrocortisone (median dose of 100 µg/day). Since diagnosis, 33.5% of patients were hospitalized for disease decompensation. In the last appointment, 17.2% of patients had complaints (7.6% asthenia and 6.5% depression) and 9.7% had electrolyte disturbances. This is the first multicentre Portuguese study regarding PAI. The results emphasize the need for standardization in diagnostic tests and etiological investigation and provide a framework for improving treatment. © 2017 The authors.

  2. Time-courses of lung function and respiratory muscle pressure generating capacity after spinal cord injury : a prospective cohort study

    NARCIS (Netherlands)

    Mueller, Gabi; de Groot, Sonja; van der Woude, Lucas; Hopman, Maria T E

    OBJECTIVE: To investigate the time-courses of lung function and respiratory muscle pressure generating capacity after spinal cord injury. DESIGN: Multi-centre, prospective cohort study. SUBJECTS: One hundred and nine subjects with recent, motor complete spinal cord injury. METHODS: Lung function and

  3. Efficacy and Safety of the Biosimilar Infliximab CT-P13 Treatment in Inflammatory Bowel Diseases: A Prospective, Multicentre, Nationwide Cohort.

    Science.gov (United States)

    Gecse, Krisztina B; Lovász, Barbara D; Farkas, Klaudia; Banai, János; Bene, László; Gasztonyi, Beáta; Golovics, Petra Anna; Kristóf, Tünde; Lakatos, László; Csontos, Ágnes Anna; Juhász, Márk; Nagy, Ferenc; Palatka, Károly; Papp, Mária; Patai, Árpád; Lakner, Lilla; Salamon, Ágnes; Szamosi, Tamás; Szepes, Zoltán; Tóth, Gábor T; Vincze, Áron; Szalay, Balázs; Molnár, Tamás; Lakatos, Péter L

    2016-02-01

    Biosimilar infliximab CT-P13 is approved for all indications of the originator product in Europe. Prospective data on its efficacy, safety, and immunogenicity in inflammatory bowel diseases are lacking. A prospective, nationwide, multicentre, observational cohort was designed to examine the efficacy, safety, and immunogenicity of CT-P13 infliximab biosimilar in the induction treatment of Crohn's disease [CD] and ulcerative colitis [UC]. Demographic data were collected and a harmonised monitoring strategy was applied. Early clinical remission, response, and early biochemical response were evaluated at Week 14, steroid-free clinical remission was evaluated at Week 30. Therapeutic drug level was monitored using a conventional enzyme-linked immunosorbent assay. In all, 210 consecutive inflammatory bowel disease [126 CD and 84 UC] patients were included in the present cohort. At Week 14, 81.4% of CD and 77.6% of UC patients showed clinical response and 53.6% of CD and 58.6% of UC patients were in clinical remission. Clinical remission rates at Week 14 were significantly higher in CD and UC patients who were infliximab naïve, compared with those with previous exposure to the originator compound [p < 0.05]. Until Week 30, adverse events were experienced in 17.1% of all patients. Infusion reactions and infectious adverse events occurred in 6.6% and 5.7% of all patients, respectively. This prospective multicentre cohort shows that CT-P13 is safe and effective in the induction of clinical remission and response in both CD and UC. Patients with previous infliximab exposure exhibited decreased response rates and were more likely to develop allergic reactions. Copyright © 2015 European Crohn’s and Colitis Organisation (ECCO). Published by Oxford University Press. All rights reserved. For permissions, please email: journals.permissions@oup.com.

  4. At-Risk Phenotype of Neurofibromatose-1 Patients: A Multicentre Case-Control Study

    Directory of Open Access Journals (Sweden)

    Ferkal Salah

    2011-07-01

    Full Text Available Abstract Objectives To assess associations between subcutaneous neurofibromas (SC-NFs and internal neurofibromas in patients with neurofibromatosis type 1 (NF-1 and to determine whether the association between SC-NFs and peripheral neuropathy was ascribable to internal neurofibromas. Patients and methods Prospective multicentre case-control study. Between 2005 and 2008, 110 NF-1 adults having two or more SC-NFs were individually matched for age, sex and hospital with 110 controls who had no SC-NF. Patients underwent standardized MRI of the spinal cord, nerve roots and sciatic nerves and an electrophysiological study. Analyses used adjusted multinomial logistic regression (ORa to estimate the risk of the presence of internal neurofibromas or peripheral neuropathies associated with patients presented 2 to 9 SC-NFs, at least 10 SC-NFs as compared to patients without any (referential category. Results Cases had a mean age of 41 (± 13 years; 85 (80% had two to nine SC-NFs and 21 (19% at least ten SC-NFs. SC-NFs were more strongly associated with internal neurofibromas in patients with ten or more SC-NFs than in patients with fewer NF-SCs (e.g., sciatic nerve, aOR = 29.1 [8.5 to 100] vs. 4.3 [2.1 to 9.0]. The association with SC-NFs was stronger for diffuse, intradural, and > 3 cm internal neurofibromas than with other internal neurofibromas. Axonal neuropathy with slowed conduction velocities (SCV was more strongly associated with having at least ten SC-NFs (aOR = 29.9, 5.5 to 162.3 than with having fewer SC-NFs (aOR = 4.4, 0.9 to 22.0. Bivariate analyses showed that the association between axonal neuropathy with SCV and sciatic neurofibromas was mediated by the association between SC-NFs and sciatic neurofibromas. Conclusion The at-risk phenotype of NF-1 patients (i.e. NF-1 patients with SC-NFs is ascribable to associations linking SC-NFs to internal neurofibromas at risk for malignant transformation and to axonal neuropathies with slowed

  5. Implementing diffusion-weighted MRI for body imaging in prospective multicentre trials. Current considerations and future perspectives

    Energy Technology Data Exchange (ETDEWEB)

    DeSouza, N.M.; Winfield, J.M.; Weller, A.; Papoutsaki, M.V.; Doran, S.J.; Collins, D.J. [Institute of Cancer Research and Royal Marsden NHS Foundation Trust, CRUK Cancer Imaging Centre, Surrey (United Kingdom); Waterton, J.C.; Jackson, A. [University of Manchester, Manchester Academic Health Sciences Institute, Manchester (United Kingdom); Fournier, L. [Universite Paris Descartes Sorbonne Paris Cite, Assistance Publique-Hopitaux de Paris, Hopital Europeen Georges Pompidou, Radiology Department, Paris (France); Sullivan, D. [Duke Comprehensive Cancer Institute, Durham, NC (United States); Chenevert, T. [University of Michigan Health System, Department of Radiology, Ann Arbor, MI (United States); Boss, M. [National Institute of Standards and Technology (NIST), Applied Physics Division, Boulder, CO (United States); Trattnig, S. [Medical University of Vienna, Department of Biomedical Imaging and Image Guided Therapy, Vienna (Austria); Liu, Y. [European Organisation for Research and Treatment of Cancer, Brussels (Belgium)

    2018-03-15

    For body imaging, diffusion-weighted MRI may be used for tumour detection, staging, prognostic information, assessing response and follow-up. Disease detection and staging involve qualitative, subjective assessment of images, whereas for prognosis, progression or response, quantitative evaluation of the apparent diffusion coefficient (ADC) is required. Validation and qualification of ADC in multicentre trials involves examination of i) technical performance to determine biomarker bias and reproducibility and ii) biological performance to interrogate a specific aspect of biology or to forecast outcome. Unfortunately, the variety of acquisition and analysis methodologies employed at different centres make ADC values non-comparable between them. This invalidates implementation in multicentre trials and limits utility of ADC as a biomarker. This article reviews the factors contributing to ADC variability in terms of data acquisition and analysis. Hardware and software considerations are discussed when implementing standardised protocols across multi-vendor platforms together with methods for quality assurance and quality control. Processes of data collection, archiving, curation, analysis, central reading and handling incidental findings are considered in the conduct of multicentre trials. Data protection and good clinical practice are essential prerequisites. Developing international consensus of procedures is critical to successful validation if ADC is to become a useful biomarker in oncology. (orig.)

  6. A multicentre prospective randomised study of single-incision mini-sling (Ajust®) versus tension-free vaginal tape-obturator (TVT-O™) in the management of female stress urinary incontinence: pain profile and short-term outcomes.

    Science.gov (United States)

    Mostafa, Alyaa; Agur, Wael; Abdel-All, Mohamed; Guerrero, Karen; Lim, Chi; Allam, Mohamed; Yousef, Mohamed; N'Dow, James; Abdel-fattah, Mohamed

    2012-11-01

    To compare the postoperative pain profile, peri-operative details, and short-term patient-reported and objective success rates of single-incision mini-slings (SIMS) versus standard mid-urethral slings (SMUS). In a multicentre prospective randomised trial in six UK centres in the period between October 2009 and October 2010, 137 women were randomised to either adjustable SIMS (Ajust®, C. R. Bard Inc., NJ, USA), performed under local anaesthesia as an opt-out policy (n=69), or SMUS (TVT-O™, Ethicon Inc., Somerville, USA) performed under general anaesthesia (n=68). Randomisation was done through number-allocation software and using telephone randomisation. Postoperative pain profile (primary outcome) was assessed on a ten-point visual analogue scale at fixed time-points. Pre- and post operatively (4-6 months) women completed symptom severity, urgency perception scale (UPS), quality of life and sexual function questionnaires. In addition, women completed a Patient Global Impression of Improvement Questionnaire and underwent a cough stress test at 4-6 months follow up. Sample size calculation was performed and data were analysed using SPSS 18. Descriptive analyses are given and between-group comparisons were performed using chi-square, Fischer exact test and Mann-Whitney test as appropriate. Significance level was set at 5%. Women in the SIMS Ajust® group had a significantly lower postoperative pain profile up to 4 weeks (p=TVT-O™ groups respectively. There was a trend towards higher rates of de novo urgency or worsening of pre-existing urgency in the SIMS Ajust® group (21.7% versus 8.8%) but this did not reach statistical significance (p=0.063). Women in the SIMS Ajust® group had shorter hospital stay (median (IQR) 3.65 (2.49, 4.96)) compared to (4.42 (3.16, 5.56)) the TVT-O™ group 95% CI (-0.026, 1.326), with significantly earlier return to normal activities (p=0.025) and to work (p=0.006). The adjustable single-incision mini-sling (Ajust®) is associated

  7. Multicentre study of Wilm's tumours treated by different therapeutic ...

    African Journals Online (AJOL)

    National Wilm's Tumour Study (NWTS) group and the. International ... improvement in the survival of children with cancer in ... at diagnosis, sex, incidence, presenting symptoms, pre- ... localized in the left kidney in 22 (55%) patients, the right.

  8. Diversity of Pneumocystis jirovecii Across Europe: A Multicentre Observational Study

    Directory of Open Access Journals (Sweden)

    Alexandre Alanio

    2017-08-01

    Our study showed the wide population diversity across Europe, with evidence of local clusters of patients harbouring a given genotype. These data suggest a specific association between genotype and underlying disease, with evidence of a different natural history of PCP in HIV patients and renal transplant recipients.

  9. Colorectal cancer and its association with the metabolic syndrome: a Malaysian multi-centric case-control study.

    Science.gov (United States)

    Ulaganathan, V; Kandiah, M; Zalilah, M S; Faizal, J A; Fijeraid, H; Normayah, K; Gooi, B H; Othman, R

    2012-01-01

    Colorectal cancer (CRC) and the metabolic syndrome (MetS) are both on the rise in Malaysia. A multi-centric case-control study was conducted from December 2009 to January 2011 to determine any relationship between the two. Patients with confirmed CRC based on colonoscopy findings and cancer free controls from five local hospitals were assessed for MetS according to the International Diabetes Federation (IDF) definition. Each index case was matched for age, gender and ethnicity with two controls (140: 280). MetS among cases was highly prevalent (70.7%), especially among women (68.7%). MetS as an entity increased CRC risk by almost three fold independently (OR=2.61, 95%CI=1.53-4.47). In men MetS increased the risk of CRC by two fold (OR=2.01, 95%CI, 1.43-4.56), demonstrating an increasing trend in risk with the number of Mets components observed. This study provides evidence for a positive association between the metabolic syndrome and colorectal cancer. A prospective study on the Malaysian population is a high priority to confirm these findings.

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

    Directory of Open Access Journals (Sweden)

    Alba Gómez-Cabello

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

  11. 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.

  12. Postoperative radiotherapy of uterine sarcoma: A multicentric retrospective study

    International Nuclear Information System (INIS)

    Champetier, C.; Cowen, D.; Hannoun-Levi, J.M.; Resbeut, M.; Azria, D.; Salem, N.; Tessier, E.; Ellis, S.

    2011-01-01

    Purpose. - Surgery is the treatment of choice for localized uterine sarcomas. We conducted a retrospective study to define prognostic factors. Patients and methods. - We studied 111 cases of patients treated by adjuvant radiotherapy for uterine sarcoma in seven French centers. The median decline was 31 months. We conducted a univariate analysis to identify factors correlated with local recurrence. The statistically significant factors were studied in multivariate analysis by Cox model. Results. - The median dose of external beam radiotherapy was 45 Gy. Forty-three percent of patients had vaginal vault brachytherapy and 21 % chemotherapy. Only 6.3 % of patients had complications of acute grade III and 8.1 % of long-term sequelae of radiotherapy. The survival rate at 5 years was 74.6 %. They noted 12.6 % of isolated locoregional recurrences, against 29.7 % for distant recurrences, 80 % were pulmonary. Factors correlated with the risk of locoregional relapse were menopausal status (P = 0.045) and surgical margins suspicious or not healthy (P = 0.0095). The chemotherapy did not improve overall survival or disease free survival but the numbers were low. Conclusion. - The postoperative radiotherapy provides good local control in this disease. Brachytherapy is sometimes done, but it does not improve local control. Chemotherapy is not a standard localized stage but the rate of metastatic recurrence calls for the development of strategies involving systemic treatment with radiotherapy. (authors)

  13. 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.

  14. Young ischemic stroke in Tunisia: a multicentric study.

    Science.gov (United States)

    Kefi, Asma; Larbi, Thara; Abdallah, Meya; Ouni, Amira El; Bougacha, Neil; Bouslama, Kamel; Hamzaoui, Saloua; M'rad, Skander

    2017-04-01

    There is wanting data regarding young ischemic stroke in developing countries, especially in Tunisia. The purpose of this study was to investigate risk factors and etiologies of young ischemic stroke in Tunisian and make a comparison with previous reports. A total of 102 young ischemic stroke patients (15-45 years old) were admitted, between January 1996 and August 2007, to 11 departments of internal medicine in different Tunisian hospitals. The risk factors for stroke were documented and assessed. Diagnosis workup consisted of anamnesis, complete physical examination and extensive laboratory, radiologic, immunologic, neurologic and cardiologic examination. Stroke etiologies were classified according the Trial of ORG 10172 in acute stroke treatment. There were 42 men (41.2%) and 60 women (58.89%) with a mean age at onset of 35.7 years. As regards stroke subtype, large-artery atherosclerosis was diagnosed in 6.9% of cases, cardioembolism in 11.8%, small-vessel occlusion in 8.8%, other determined etiology in 37.3% and undetermined etiology in 35.3%. Concerning the traditional risk factors, smoking (31.4%), hypertension and diabetes mellitus (12.7% for each one) and a family history of stroke (10.8%) were the most common. The mean follow-up period was 30.5 months. In our study, traditional risk factors were not-so-uncommon in young adults with ischemic stroke suggesting that prevention can go through controlling these factors. Stroke of other determined etiology was the most common among our patients, so that a broad and detailed diagnostic workup is crucial to puzzle out the etiology for more and better stroke prevention.

  15. The learning environment and medical student burnout: a multicentre study.

    Science.gov (United States)

    Dyrbye, Liselotte N; Thomas, Matthew R; Harper, William; Massie, F Stanford; Power, David V; Eacker, Anne; Szydlo, Daniel W; Novotny, Paul J; Sloan, Jeff A; Shanafelt, Tait D

    2009-03-01

    Little is known about specific personal and professional factors influencing student distress. The authors conducted a comprehensive assessment of how learning environment, clinical rotation factors, workload, demographics and personal life events relate to student burnout. All medical students (n = 3080) at five medical schools were surveyed in the spring of 2006 using a validated instrument to assess burnout. Students were also asked about the aforementioned factors. A total of 1701 medical students (response rate 55%) completed the survey. Learning climate factors were associated with student burnout on univariate analysis (odds ratio [OR] 1.36-2.07; all P burnout (ORs 1.69 and 1.48, respectively; both P student burnout. Students who experienced a positive personal life event had a lower frequency of burnout (OR 0.70; P burnout than students who did not experience a negative personal life event. On multivariate analysis personal characteristics, learning environment and personal life events were all independently related to student burnout. Although a complex array of personal and professional factors influence student well-being, student satisfaction with specific characteristics of the learning environment appears to be a critical factor. Studies determining how to create a learning environment that cultivates student well-being are needed.

  16. Breast sarcoma surgical management: a five-year multicentric study

    Directory of Open Access Journals (Sweden)

    Răzvan V. Scăunașu

    2016-11-01

    Full Text Available Background. Breast sarcomas are a heterogeneous group of breast neoplasms with a low incidence and a reserved prognosis. No treatment protocol has been yet established, a guideline similar to soft tissue sarcomas is used. Materials and Methods. Our study analyzed all the patients admitted with the diagnosis of malignant breast disease in two specialized centers on a five-year time frame. We compared long term results for the patients who underwent conservative treatment and mastectomy. Results. A total of 76 cases received surgical treatment with curative intent, 24 conservative procedures and 52 mastectomies. Incidence of local recurrence does not appear to be closely related to the type of surgical procedure. There were a number of five local recurrences for patients who received conservative treatment and 7 local recurrences where we used mastectomy. Kaplan-Meier analysis conducted shows no differences statistically significant (sig = 0.459 between the results of conservative treatment and mastectomy. Basically conservative surgery seems to get similar results, provided that R0 resection objective can be met. Conclusions. Treatment options are more limited for breast sarcomas than carcinomas, the role of surgery being more important to therapeutic success. The biological characteristic of the tumor including histological type and sub-type, play an important role in determining the results and the treatment should be tailored and adapted for each case.

  17. Infectious sacroiliitis: a retrospective, multicentre study of 39 adults

    Directory of Open Access Journals (Sweden)

    Hermet Marion

    2012-11-01

    Full Text Available Abstract Background Non-brucellar and non-tuberculous infectious sacroiliitis (ISI is a rare disease, with misleading clinical signs that delay diagnosis. Most observations are based on isolated case reports or small case series. Our aim was to describe the clinical, bacteriological, and radiological characteristics of ISI, as well as the evolution of these arthritis cases under treatment. Methods This retrospective study included all ISI cases diagnosed between 1995 and 2011 in eight French rheumatology departments. ISI was diagnosed if sacroiliitis was confirmed bacteriologically or, in the absence of pathogenic agents, if clinical, biological, and radiological data was compatible with this diagnosis and evolution was favourable under antibiotic therapy. Results Overall, 39 cases of ISI were identified in adults, comprising 23 women and 16 men, with a mean age at diagnosis of 39.7 ± 18.1 years. The left sacroiliac joint (SI was affected in 59% of cases, with five cases occurring during the post-partum period. Lumbogluteal pain was the most common symptom (36/39. Manipulations of the SI joint were performed in seven patients and were always painful. Mean score for pain using the visual analogue score was 7.3/10 at admission, while 16 patients were febrile at diagnosis. No risk factor was found for 30.7% of patients. A diagnosis of ISI was only suspected in five cases at admission. The mean time to diagnosis was long, being 43.3 ± 69.1 days on average. Mean C-reactive protein was 149.7 ± 115.3 mg/l, and leukocytosis (leukocytes ≥ 10 G/l was uncommon (n = 15 (mean level of leukocytes 10.4 ± 3.5 G/l. Radiographs (n = 33 were abnormal in 20 cases, revealing lesions of SI, while an abdominopelvic computed tomography (CT scan (n = 27 was abnormal in 21 cases, suggesting arthritis of the SI joints in 13 cases (48.1% and a psoas abscess in eight. Bone scans (n = 14 showed hyperfixation of the SI in 13 cases

  18. Management of SPN in France. Pathways for definitive diagnosis of solitary pulmonary nodule: a multicentre study in 18 French districts

    International Nuclear Information System (INIS)

    Alzahouri, Kazem; Velten, Michel; Arveux, Patrick; Woronoff-Lemsi, Marie-Christine; Jolly, Damien; Guillemin, Francis

    2008-01-01

    The process of diagnosis and management of solitary pulmonary nodules (SPNs) between 1 and 3 cm is not standardized. This multicentre study investigated how diagnosis of newly discovered SPNs is managed in routine practice. We examined 11,515 radiology reports of patients undergoing chest computed tomography (CT) at all 76 radiology centres in 18 French administrative districts covering 8,220,000 people. Information on diagnostic procedures and treatment administered from discovery to definitive diagnosis of SPN was collected prospectively. We identified 152 cases of newly diagnosed SPNs. Follow-up was complete for 112 patients. The median number of diagnostic tests was 4 and the mean time to diagnosis was 41.4 days. Marked variability was observed in the sequence of diagnostic tests, and 8 diagnostic pathways were identified. Patients' characteristics and radiological features of SPNs influenced the number of tests performed. Referral by specialist, history of smoking and spiculated SPN predicted the performance of at least one invasive procedure (P < 0.01). Definitive diagnosis was a malignant disease in 30 patients (26%). The diagnosis of SPN is a complex process that physicians approach in markedly different ways. Implementing practice guidelines for managing the diagnosis of SPN requires clarification

  19. Single-Port Transumbilical Laparoscopic Appendectomy: A Preliminary Multicentric Comparative Study in 87 Patients with Acute Appendicitis

    Directory of Open Access Journals (Sweden)

    Ramon Vilallonga

    2012-01-01

    Full Text Available Introduction. Laparoscopic appendectomy (LA has been performed in many approaches such as open, laparoscopic and recently Single Port Access (SPAA. In order to elucidate its potential advantages, we compared the two laparoscopic approaches. Methods. 87 patients were included in a multicentric study for suspected appendicitis in order to perform (SPAA appendectomy or laparoscopic appendectomy (LA. All outcomes, including blood loss, operative time, complications, and length of stay and pain were recorded prospectively. Results. There were 46 patients in the SPAA group and 41 in the LAG with a mean operative time of 40,4 minutes in the SPAA group and 35,0 minutes in the LA group. Only one patient was converted to an open approach. We described only 2 complications. Pain was graded 2,8 in the SPAA group and 2,9 in the LA group, according to the AVS after 24 hours. Patients in the SPAA Group were more satisfied (7,5 versus 6,9 (<0.05. Same results were found for the cosmetic result (8,6 versus 7,4 (<0.05. Conclusion. Using the single port approach feasible and safe. The true benefit of the technique should be assessed by new randomised controlled trials.

  20. A Prospective Study

    Directory of Open Access Journals (Sweden)

    Nandeesh BN

    2014-08-01

    Lattice and Avellino's dystrophies among dystrophies and Salzmann's nodular degeneration showed specific stromal deposits making them easily diagnosable at histopathology, whereas the rest showed non-specific stromal changes mandating correlation with clinical findings. Seven regraft corneas showed stromal fibrosis making identification of primary dystrophy impossible. However, transmural vascularization and lymphocytic stromal infiltrate were prominently noted in failed grafts though their numbers were few. Conclusion: This histopathologic study characterizes classic features of macular, Avellino's, lattice corneal dystrophies and Salzmann's degeneration for their microscopic diagnosis, while the rest showed non-specific changes. Stromal edema was prominently noted in degenerations than in dystrophies. Degree of stromal vascularization and type of cellular infiltrate need attention in regrafts. [J Interdiscipl Histopathol 2014; 2(4.000: 197-204

  1. Prophylactic efficacy of lithium administered every second day: a WHO multicentre study

    DEFF Research Database (Denmark)

    Plenge, P; Amin, M; Agarwal, A K

    1999-01-01

    OBJECTIVES: To study the prophylactic efficacy of lithium administered every second day to patients with bipolar disorder or recurrent unipolar depressive disorder. METHODS: The study was carried out as a WHO multicentre study in five different psychiatric clinics: Russia (Moscow), Canada (Montreal......), India (Lucknow), Germany (Munich) and South Korea (Pusan), with the lithium tablets being supplied from Denmark (Copenhagen). Participation in the study was conditional on the patient having been in prophylactic lithium treatment for the preceding 2-year period and having been free of depressive...... of bipolar disorder and five with a diagnosis of recurrent unipolar depressive disorder, participated in the study. The number of patients from each centre ranged from six to 11. The mean lithium dose every second day was 36 mmol lithium, leading to a mean 12-h standard serum lithium concentration during...

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

    DEFF Research Database (Denmark)

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

    2003-01-01

    The paper presents the exposure assessment method and quality control procedure used in an international, multi-centre case-control study within a joint Nordic and Italian cohort. This study was conducted to evaluate whether occupational exposure to carcinogens influenced the predictivity of high...... was higher among the original assessors (the assessor from the same country as the subject) than the average prevalence assessed by the other four in the quality control round. The original assessors classified more job situations as exposed than the others. Several reasons for this are plausible: real...... country-specific differences, differences in information available to the home assessor and the others and misunderstandings or difficulties in translation of information. To ensure the consistency of exposure assessments in international retrospective case-control studies it is important to have a well...

  3. A multicentre study to improve clinical interpretation of proteinase-3 and myeloperoxidase anti-neutrophil cytoplasmic antibodies

    DEFF Research Database (Denmark)

    Bossuyt, Xavier; Rasmussen, Niels; van Paassen, Pieter

    2017-01-01

    Objective: The objective of this multicentre study was to improve the clinical interpretation of PR3- and MPO-ANCAs as an adjunct for the diagnosis of ANCA-associated vasculitis (AAV) by defining thresholds and test result intervals based on predefined specificities and by calculating test result...

  4. 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.

  5. Attachment Styles of Dermatological Patients in Europe: A Multi-centre Study in 13 Countries.

    Science.gov (United States)

    Szabó, Csanád; Altmayer, Anita; Lien, Lars; Poot, Françoise; Gieler, Uwe; Tomas-Aragones, Lucía; Kupfer, Jörg; Jemec, Gregor B E; Misery, Laurent; Linder, M Dennis; Sampogna, Francesca; van Middendorp, Henriët; Halvorsen, Jon Anders; Balieva, Flora; Szepietowski, Jacek C; Romanov, Dmitry; Marron, Servando E; Altunay, Ilknur K; Finlay, Andrew Y; Salek, Sam S; Dalgard, Florence

    2017-07-06

    Attachment styles of dermatological outpatients and satisfaction with their dermatologists were investigated within the framework of a multicentre study conducted in 13 European countries, organized by the European Society for Dermatology and Psychiatry. Attachment style was assessed with the Adult Attachment Scale. Patient satisfaction with the dermatologist was assessed with an 11-degree scale. A total of 3,635 adult outpatients and 1,359 controls participated in the study. Dermatological outpatients were less able to depend on others, were less comfortable with closeness and intimacy, and experienced similar rates of anxiety in relationships as did the controls. Participants who had secure attachment styles reported stressful life events during the last 6 months significantly less often than those who had insecure attachment styles. Patients with secure attachment styles tended to be more satisfied with their dermatologist than did insecure patients. These results suggest that secure attachment of dermatological outpatients may be a protective factor in the management of stress.

  6. Italian multicentre study on microbial environmental contamination in dental clinics: a pilot study.

    Science.gov (United States)

    Pasquarella, Cesira; Veronesi, Licia; Castiglia, Paolo; Liguori, Giorgio; Montagna, Maria Teresa; Napoli, Christian; Rizzetto, Rolando; Torre, Ida; Masia, Maria Dolores; Di Onofrio, Valeria; Colucci, Maria Eugenia; Tinteri, Carola; Tanzi, Marialuisa

    2010-09-01

    The dental practice is associated with a high risk of infections, both for patients and healthcare operators, and the environment may play an important role in the transmission of infectious diseases. A microbiological environmental investigation was carried out in six dental clinics as a pilot study for a larger multicentre study that will be performed by the Italian SItI (Society of Hygiene, Preventive Medicine and Public Health) working group "Hygiene in Dentistry". Microbial contamination of water, air and surfaces was assessed in each clinic during the five working days of the week, before and during treatments. Air and surfaces were also examined at the end of the daily activity. A wide variation was found in microbial environmental contamination, both within the participating clinics and relative to the different sampling times. Microbial water contamination in Dental Unit Water Systems (DUWS) reached values of up to 26x10(4)cfu/mL (colony forming units per millilitre). P. aeruginosa was found in 33% of the sampled DUWS and Legionella spp. in 50%. A significant decrease in the Total Viable Count (TVC) was recorded during the activity. Microbial air contamination showed the highest levels during dental treatments and tended to decrease at the end of the working activity (p<0.05). Microbial buildup on surfaces increased significantly during the working hours. As these findings point out, research on microbial environmental contamination and the related risk factors in dental clinics should be expanded and should also be based on larger collections of data, in order to provide the essential knowledge aimed at targeted preventive interventions. Copyright 2010 Elsevier B.V. All rights reserved.

  7. An international multicentre study on the allergenic activity of air-oxidized R-limonene

    DEFF Research Database (Denmark)

    Bråred Christensson, Johanna; Andersen, Klaus Ejner; Bruze, Magnus

    2013-01-01

    Background. Limonene is a common fragrance terpene that, in its pure form, is not allergenic or is a very weak allergen. However, limonene autoxidizes on air exposure, and the oxidation products can cause contact allergy. Oxidized R-limonene has previously been patch tested in multicentre studies......, giving 2-3% positive patch test reactions in consecutive patients. Objectives. To investigate whether oxidized R-limonene 3.0% in petrolatum, with a stable concentration of the main haptens, limonene hydroperoxides (Lim-OOHs), could be a useful tool for the detection of contact allergy...... in an international setting. Methods. Oxidized R-limonene 3.0% (Lim-OOHs 0.33%) pet. was tested in 2900 consecutive dermatitis patients in Denmark, the United Kingdom, Singapore, Spain, Sweden, and Australia. Results. Overall, 5.2% (range 2.3-12.1%) of the patients showed a positive patch test reaction to oxidized R...

  8. Multicentric cohort study on the long-term efficacy and safety of electronic cigarettes: study design and methodology.

    Science.gov (United States)

    Manzoli, Lamberto; La Vecchia, Carlo; Flacco, Maria Elena; Capasso, Lorenzo; Simonetti, Valentina; Boccia, Stefania; Di Baldassarre, Angela; Villari, Paolo; Mezzetti, Andrea; Cicolini, Giancarlo

    2013-09-24

    While electronic cigarettes are forbidden in several countries, their sales are exploding in many others. Although e-cigarettes have been proposed as long-term substitutes for traditional smoking or as a tool for smoking cessation, very scarce data are available on their efficacy and safety.We describe the protocol of a 5-year multicentric prospective study aimed to evaluate short- and long-term adherence to e-cigarette smoking and the efficacy of e-cigarettes in reducing and/or quitting traditional cigarette smoking. The study will also compare the health effects of electronic vs traditional vs mixed cigarette smoking. From June to December 2013, we will enroll adult smokers of: (EC) e-cigarettes (self-reported inhaling ≥ 50 puffs per week since ≥ 6 months); (TC) traditional cigarettes (≥ 1 per day since ≥ 6 m); (Mixed) both electronic and traditional cigarettes (≥ 1 per day since ≥ 6 m). Eligible subjects will be requested participation through newspaper advertisements and direct contact at the shops. Each subject will have to compile a structured questionnaire at enrolment and after 6, 12, 24, 36 and 60 months. The level of carbon monoxide in expired after breath will be evaluated in all subjects declaring no traditional cigarette smoking in any follow-up phase, using portable carbon monoxide analyzers. The primary outcomes are traditional smoking cessation rates and number of smoked cigarettes. Secondary outcomes include adherence to e-cigarettes, self-reported adverse events, quality of life, and time to hospital admission for one among cardiovascular diseases, chronic obstructive pulmonary diseases, cancer of the lung, esophagus, larynx, oral cavity, bladder, pancreas, kidney, stomach, cervix, and myeloid leukemia. Admissions will be checked using official discharge data of the Abruzzo Region. A minimum of 500 subjects in each group will be enrolled, for a total of 1500 participants. Cox proportional hazards analysis will be used to calculate

  9. Maternal and neonatal consequences of treated and untreated asymptomatic bacteriuria in pregnancy: a prospective cohort study with an embedded randomised controlled trial

    NARCIS (Netherlands)

    Kazemier, Brenda M.; Koningstein, Fiona N.; Schneeberger, Caroline; Ott, Alewijn; Bossuyt, Patrick M.; de Miranda, Esteriek; Vogelvang, Tatjana E.; Verhoeven, Corine J. M.; Langenveld, Josje; Woiski, Mallory; Oudijk, Martijn A.; van der Ven, Jeanine E. M.; Vlegels, Manita T. W.; Kuiper, Petra N.; Feiertag, Nicolette; Pajkrt, Eva; de Groot, Christianne J. M.; Mol, Ben W. J.; Geerlings, Suzanne E.

    2015-01-01

    Existing approaches for the screening and treatment of asymptomatic bacteriuria in pregnancy are based on trials that were done more than 30 years ago. In this study, we reassessed the consequences of treated and untreated asymptomatic bacteriuria in pregnancy. In this multicentre prospective cohort

  10. Discontinuation of tofacitinib after achieving low disease activity in patients with rheumatoid arthritis: a multicentre, observational study.

    Science.gov (United States)

    Kubo, Satoshi; Yamaoka, Kunihiro; Amano, Koichi; Nagano, Shuji; Tohma, Shigeto; Suematsu, Eiichi; Nagasawa, Hayato; Iwata, Kanako; Tanaka, Yoshiya

    2017-08-01

    To determine whether tofacitinib can be discontinued in patients with RA who achieve low disease activity (LDA). RA patients with LDA after tofacitinib treatment in a phase III and long-term extension study were enrolled in this multicentre, non-randomized, open, prospective, observational study. The decision of discontinuation or continuation of tofacitinib was determined based on patient-physician decision making with informed consent. The primary endpoint was the proportion of patients who remained tofacitinib-free at post-treatment week 52. Clinical outcome was compared between those who continued and those who discontinued tofacitinib. The last observation carried forward method was used for patients who could not discontinue tofacitinib before week 52. Of 64 patients, 54 discontinued and 10 continued tofacitinib therapy. At post-treatment week 52, 20 of the 54 patients (37%) of the discontinuation group remained tofacitinib-free without disease flare. Disease activity at post-treatment week 52 was higher in the discontinuation group than the continuation group. Among the discontinuation group, the RF titre at baseline was significantly lower in patients who remained tofacitinib-free than those who did not (40 vs 113 U/ml). In fact, a higher proportion of patients with lower RF remained tofacitinib-free at week 52 compared with those with higher RF at baseline. In patients who could not achieve tofacitinib-free status, re-initiation of tofacitinib or other biologics improved disease activity. It is possible to discontinue tofacitinib without flare in about a third of patients with RA. A low RF predicts maintenance of LDA after discontinuation of tofacitinib. © The Author 2017. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For Permissions, please email: journals.permissions@oup.com

  11. Clinical predictors of rectal lymphogranuloma venereum infection: results from a multicentre case–control study in the UK

    Science.gov (United States)

    Pallawela, S N S; Sullivan, A K; Macdonald, N; French, P; White, J; Dean, G; Smith, A; Winter, A J; Mandalia, S; Alexander, S; Ison, C; Ward, H

    2014-01-01

    Objective Since 2003, over 2000 cases of lymphogranuloma venereum (LGV) have been diagnosed in the UK in men who have sex with men (MSM). Most cases present with proctitis, but there are limited data on how to differentiate clinically between LGV and other pathology. We analysed the clinical presentations of rectal LGV in MSM to identify clinical characteristics predictive of LGV proctitis and produced a clinical prediction model. Design A prospective multicentre case–control study was conducted at six UK hospitals from 2008 to 2010. Cases of rectal LGV were compared with controls with rectal symptoms but without LGV. Methods Data from 98 LGV cases and 81 controls were collected from patients and clinicians using computer-assisted self-interviews and clinical report forms. Univariate and multivariate logistic regression was used to compare symptoms and signs. Clinical prediction models for LGV were compared using receiver operating curves. Results Tenesmus, constipation, anal discharge and weight loss were significantly more common in cases than controls. In multivariate analysis, tenesmus and constipation alone were suggestive of LGV (OR 2.98, 95% CI 0.99 to 8.98 and 2.87, 95% CI 1.01 to 8.15, respectively) and that tenesmus alone or in combination with constipation was a significant predictor of LGV (OR 6.97, 95% CI 2.71 to 17.92). The best clinical prediction was having one or more of tenesmus, constipation and exudate on proctoscopy, with a sensitivity of 77% and specificity of 65%. Conclusions This study indicates that tenesmus alone or in combination with constipation makes a diagnosis of LGV in MSM presenting with rectal symptoms more likely. PMID:24687130

  12. Clinical predictors of rectal lymphogranuloma venereum infection: results from a multicentre case-control study in the U.K.

    Science.gov (United States)

    Pallawela, S N S; Sullivan, A K; Macdonald, N; French, P; White, J; Dean, G; Smith, A; Winter, A J; Mandalia, S; Alexander, S; Ison, C; Ward, H

    2014-06-01

    Since 2003, over 2000 cases of lymphogranuloma venereum (LGV) have been diagnosed in the U.K. in men who have sex with men (MSM). Most cases present with proctitis, but there are limited data on how to differentiate clinically between LGV and other pathology. We analysed the clinical presentations of rectal LGV in MSM to identify clinical characteristics predictive of LGV proctitis and produced a clinical prediction model. A prospective multicentre case-control study was conducted at six U.K. hospitals from 2008 to 2010. Cases of rectal LGV were compared with controls with rectal symptoms but without LGV. Data from 98 LGV cases and 81 controls were collected from patients and clinicians using computer-assisted self-interviews and clinical report forms. Univariate and multivariate logistic regression was used to compare symptoms and signs. Clinical prediction models for LGV were compared using receiver operating curves. Tenesmus, constipation, anal discharge and weight loss were significantly more common in cases than controls. In multivariate analysis, tenesmus and constipation alone were suggestive of LGV (OR 2.98, 95% CI 0.99 to 8.98 and 2.87, 95% CI 1.01 to 8.15, respectively) and that tenesmus alone or in combination with constipation was a significant predictor of LGV (OR 6.97, 95% CI 2.71 to 17.92). The best clinical prediction was having one or more of tenesmus, constipation and exudate on proctoscopy, with a sensitivity of 77% and specificity of 65%. This study indicates that tenesmus alone or in combination with constipation makes a diagnosis of LGV in MSM presenting with rectal symptoms more likely. 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.

  13. Diagnosis of prosthetic joint infection with alpha-defensin using a lateral flow device: a multicentre study.

    Science.gov (United States)

    Berger, P; Van Cauter, M; Driesen, R; Neyt, J; Cornu, O; Bellemans, J

    2017-09-01

    The purpose of this current multicentre study is to analyse the presence of alpha-defensin proteins in synovial fluid using the Synovasure lateral flow device and to determine its diagnostic reliability and accuracy compared with the prosthetic joint infection (PJI) criteria produced by the Musculoskeletal Infection Society (MSIS). A cohort of 121 patients comprising 85 total knee arthroplasties and 36 total hip arthroplasties was prospectively evaluated between May 2015 and June 2016 in three different orthopaedic centres. The tests were performed on patients with a chronically painful prosthesis undergoing a joint aspiration in a diagnostic pathway or during revision surgery. Based on the MSIS criteria, 34 patients (28%) would have had a PJI, and 87 patients had no PJI. Testing with the lateral flow device had a sensitivity of 97.1% (95% confidence intervals (CI) 84.5 to 99.9) and a specificity of 96.6% (95% CI 90.3 to 99.2). The positive predictive value was 91.7% (95% CI 77.7% to 98.3), and the negative predictive value was 98.8% (95% CI 93.6 to 99.9). Receiver operator characteristics analysis demonstrated an area under the curve for the Synovasure test of 0.97 (95% CI 0.93 to 1.00). Our findings suggest that the Synovasure test has an excellent diagnostic performance to confirm or reject the diagnosis of a PJI. The results are promising for the care of the painful or problematic knee and hip joint arthroplasty and the test should be considered as part of the diagnostic toolbox for PJIs. Cite this article: Bone Joint J 2017;99-B:1176-82. ©2017 The British Editorial Society of Bone & Joint Surgery.

  14. Recombinant LH supplementation to recombinant FSH during the final days of controlled ovarian stimulation for in vitro fertilization. A multicentre, prospective, randomized, controlled trial

    DEFF Research Database (Denmark)

    Nyboeandersen, A.; Humaidan, P.; Fried, G.

    2008-01-01

    BACKGROUND: The purpose of this multicentre, multinational trial was to study whether rLH supplementation to recombinant FSH (rFSH) during the late follicular phase increased pregnancy rates. METHODS: After down-regulation with nafarelin, 526 women were randomized on Day 1 of stimulation to use...... either rFSH (Gonal-F) alone (n = 261) or to continue after Day 6 of stimulation with both rFSH (Gonal-F) and rLH (Luveris) (n = 265) from Day 6. The starting dose of rFSH was 150-225 IU/day according to age below or above 35 years. RESULTS: Ongoing pregnancy rate at week 10-12 was 28.7% after rFSH alone...... and 27.2% after rFSH + rLH. This showed no evidence of a difference. Administration of rLH significantly (Prates in patients with low LH levels (

  15. Recombinant LH supplementation to recombinant FSH during the final days of controlled ovarian stimulation for in vitro fertilization. A multicentre, prospective, randomized, controlled trial

    DEFF Research Database (Denmark)

    Nyboeandersen, A; Al Humaidan, Peter Samir Heskjær; Fried, G

    2008-01-01

    BACKGROUND: The purpose of this multicentre, multinational trial was to study whether rLH supplementation to recombinant FSH (rFSH) during the late follicular phase increased pregnancy rates. METHODS: After down-regulation with nafarelin, 526 women were randomized on Day 1 of stimulation to use...... either rFSH (Gonal-F) alone (n = 261) or to continue after Day 6 of stimulation with both rFSH (Gonal-F) and rLH (Luveris) (n = 265) from Day 6. The starting dose of rFSH was 150-225 IU/day according to age below or above 35 years. RESULTS: Ongoing pregnancy rate at week 10-12 was 28.7% after rFSH alone...... and 27.2% after rFSH + rLH. This showed no evidence of a difference. Administration of rLH significantly (PLH. Ongoing pregnancy rates in patients with low LH levels (

  16. Problem-solving ability and repetition of deliberate self-harm: a multicentre study.

    Science.gov (United States)

    McAuliffe, Carmel; Corcoran, Paul; Keeley, Helen S; Arensman, Ella; Bille-Brahe, Unni; De Leo, Diego; Fekete, Sandor; Hawton, Keith; Hjelmeland, Heidi; Kelleher, Margaret; Kerkhof, Ad J F M; Lönnqvist, Jouko; Michel, Konrad; Salander-Renberg, Ellinor; Schmidtke, Armin; Van Heeringen, Kees; Wasserman, Danuta

    2006-01-01

    While recent studies have found problem-solving impairments in individuals who engage in deliberate self-harm (DSH), few studies have examined repeaters and non-repeaters separately. The aim of the present study was to investigate whether specific types of problem-solving are associated with repeated DSH. As part of the WHO/EURO Multicentre Study on Suicidal Behaviour, 836 medically treated DSH patients (59% repeaters) from 12 European regions were interviewed using the European Parasuicide Study Interview Schedule (EPSIS II) approximately 1 year after their index episode. The Utrecht Coping List (UCL) assessed habitual responses to problems. Factor analysis identified five dimensions--Active Handling, Passive-Avoidance, Problem Sharing, Palliative Reactions and Negative Expression. Passive-Avoidance--characterized by a pre-occupation with problems, feeling unable to do anything, worrying about the past and taking a gloomy view of the situation, a greater likelihood of giving in so as to avoid difficult situations, the tendency to resign oneself to the situation, and to try to avoid problems--was the problem-solving dimension most strongly associated with repetition, although this association was attenuated by self-esteem. The outcomes of the study indicate that treatments for DSH patients with repeated episodes should include problem-solving interventions. The observed passivity and avoidance of problems (coupled with low self-esteem) associated with repetition suggests that intensive therapeutic input and follow-up are required for those with repeated DSH.

  17. Prospective outcomes of injury study.

    Science.gov (United States)

    Derrett, S; Langley, J; Hokowhitu, B; Ameratunga, S; Hansen, P; Davie, G; Wyeth, E; Lilley, R

    2009-10-01

    In New Zealand (NZ), 20% of adults report a disability, of which one-third is caused by injury. No prospective epidemiological studies of predictors of disability following all-cause injury among New Zealanders have been undertaken. Internationally, studies have focused on a limited range of predictors or specific injuries. Although these studies provide useful insights, applicability to NZ is limited given the importance of NZ's unique macro-social factors, such as NZ's no-fault accident compensation and rehabilitation scheme, the Accident Compensation Corporation (ACC). (1) To quantitatively determine the injury, rehabilitation, personal, social and economic factors leading to disability outcomes following injury in NZ. (2) To qualitatively explore experiences and perceptions of injury-related outcomes in face-to-face interviews with 15 Māori and 15 other New Zealanders, 6 and 12 months after injury. Four geographical regions within NZ. Prospective cohort study with telephone interviews 1, 4 and 12 months after injury. 2500 people (including 460 Māori), aged 18-64 years, randomly selected from ACC's entitlement claims register (people likely to be off work for at least 1 week or equivalent). Telephone interviews, electronic hospital and ACC injury data. Exposures include demographic, social, economic, work-related, health status, participation and/or environmental factors. Primary: disability (including WHODAS II) and health-related quality of life (including EQ-5D). Secondary: participation (paid and unpaid activities), life satisfaction and costs. Separate regression models will be developed for each of the outcomes. Repeated measures outcomes will be modelled using general estimating equation models and generalised linear mixed models.

  18. Rhenium-188 Lipiodol Therapy of Hepatocellular Carcinoma: Results of a multicentre-multinational study

    International Nuclear Information System (INIS)

    Padhy, A.K.; Bernal, P.; Buscombe, R.J.

    2007-01-01

    Full text: A multi-centre study was sponsored by the IAEA to assess the safety and efficacy of trans-arterial Rhenium-188 HDD Lipiodol in the treatment of inoperable Hepatocellular Carcinoma. The radioconjugate was prepared by using an HDD kit and Lipiodol. Over three years, 185 patients received at least one treatment. The dose administered was based on radiation absorbed dose to critical normal organs, calculated following a ''scout'' dose (approximately 4 mCi) of radioconjugate. The organs at greatest risk for radiation toxicity are the liver, the lung and the bone marrow. An Excel spreadsheet was used to determine maximum tolerated activity, defined as the amount of radioactivity calculated to deliver no more than 12 Gy to lungs, 30 Gy to liver, or 1.5 Gy to bone marrow. A single treatment was given to 134 patients, 42 patients received two doses, 8 received three and one patient received four treatments. The total injected activity including the scout dose during the first treatment ranged from 21 to 364 mCi (average 108 mCi). Patients were followed for at least l2 weeks after therapy. The clinical parameters evaluated included toxicity, response as determined objectively by contrast enhanced computed tomography, palliation of symptoms, overall survival, performance status (Karnofsky), and hepatic function (Child's classification). Liver function tests, serum alpha-fetoprotein (AFP) levels and complete blood counts were done at each follow-up visit. Side effects were minimal and usually presented as loss of appetite, right hypochondrial discomfort and low-grade fever. Liver function tests at 24 and 72 hours showed no significant changes and complete blood counts at 1 week, 4 weeks and 12 weeks showed no changes (no bone marrow suppression). Data on largest tumour diameter after therapy and/or tumour response as evaluated from CT scans are available for 88 patients. Complete disappearance of tumour was recorded in 3 (3%), partial response in 19 (22%), stable

  19. A Japanese cross-sectional multicentre study of biomarkers associated with cardiovascular disease in smokers and non-smokers

    OpenAIRE

    L?dicke, Frank; Magnette, John; Baker, Gizelle; Weitkunat, Rolf

    2015-01-01

    Abstract We performed a cross-sectional, multicentre study in Japan to detect the differences in biomarkers of exposure and cardiovascular biomarkers between smokers and non-smokers. Several clinically relevant cardiovascular biomarkers differed significantly between smokers and non-smokers, including lipid metabolism (high-density lipoprotein cholesterol concentrations ? lower in smokers), inflammation (fibrinogen and white blood cell count ? both higher in smokers), oxidative stress (8-epi-...

  20. Coping strategies for postpartum depression: a multi-centric study of 1626 women.

    Science.gov (United States)

    Gutiérrez-Zotes, Alfonso; Labad, Javier; Martín-Santos, Rocío; García-Esteve, Luisa; Gelabert, Estel; Jover, Manuel; Guillamat, Roser; Mayoral, Fermín; Gornemann, Isolde; Canellas, Francesca; Gratacós, Mónica; Guitart, Montserrat; Roca, Miguel; Costas, Javier; Ivorra, Jose Luis; Navinés, Ricard; de Diego-Otero, Yolanda; Vilella, Elisabet; Sanjuan, Julio

    2016-06-01

    The transition to motherhood is stressful as it requires several important changes in family dynamics, finances, and working life, along with physical and psychological adjustments. This study aimed at determining whether some forms of coping might predict postpartum depressive symptomatology. A total of 1626 pregnant women participated in a multi-centric longitudinal study. Different evaluations were performed 8 and 32 weeks after delivery. Depression was assessed using the Edinburgh Postnatal Depression Scale (EPDS) and the structured Diagnostic Interview for Genetic Studies (DIGS). The brief Coping Orientation for Problem Experiences (COPE) scale was used to measure coping strategies 2-3 days postpartum. Some coping strategies differentiate between women with and without postpartum depression. A logistic regression analysis was used to explore the relationships between the predictors of coping strategies and major depression (according to DSM-IV criteria). In this model, the predictor variables during the first 32 weeks were self-distraction (OR 1.18, 95 % CI 1.04-1.33), substance use (OR 0.58, 95 % CI 0.35-0.97), and self-blame (OR 1.18, 95 % CI 1.04-1.34). In healthy women with no psychiatric history, some passive coping strategies, both cognitive and behavioral, are predictors of depressive symptoms and postpartum depression and help differentiate between patients with and without depression.

  1. EANM/EARL harmonization strategies in PET quantification: from daily practice to multicentre oncological studies

    Energy Technology Data Exchange (ETDEWEB)

    Aide, Nicolas [University Hospital, Nuclear Medicine Department, Caen (France); Caen University, Inserm U1086 ANTICIPE, Caen (France); Lasnon, Charline [Caen University, Inserm U1086 ANTICIPE, Caen (France); Francois Baclesse Cancer Centre, Nuclear Medicine Department, Caen (France); Veit-Haibach, Patrick [University Hospital Zurich, Department of Nuclear Medicine and Department of Diagnostic and Interventional Radiology, Zurich (Switzerland); University Health Network, University of Toronto, Joint Department Medical Imaging, Toronto (Canada); Sera, Terez [University of Szeged, Nuclear Medicine Department, Szeged (Hungary); Sattler, Bernhard [University Hospital of Leipzig, Department of Nuclear Medicine, Leipzig (Germany); Boellaard, Ronald [University of Groningen, University Medical Center Groningen, Department of Nuclear Medicine and Molecular Imaging, Groningen (Netherlands); VU University Medical Center, Department of Radiology and Nuclear Medicine, Amsterdam (Netherlands)

    2017-08-15

    Quantitative positron emission tomography/computed tomography (PET/CT) can be used as diagnostic or prognostic tools (i.e. single measurement) or for therapy monitoring (i.e. longitudinal studies) in multicentre studies. Use of quantitative parameters, such as standardized uptake values (SUVs), metabolic active tumor volumes (MATVs) or total lesion glycolysis (TLG), in a multicenter setting requires that these parameters be comparable among patients and sites, regardless of the PET/CT system used. This review describes the motivations and the methodologies for quantitative PET/CT performance harmonization with emphasis on the EANM Research Ltd. (EARL) Fluorodeoxyglucose (FDG) PET/CT accreditation program, one of the international harmonization programs aiming at using FDG PET as a quantitative imaging biomarker. In addition, future accreditation initiatives will be discussed. The validation of the EARL accreditation program to harmonize SUVs and MATVs is described in a wide range of tumor types, with focus on therapy assessment using either the European Organization for Research and Treatment of Cancer (EORTC) criteria or PET Evaluation Response Criteria in Solid Tumors (PERCIST), as well as liver-based scales such as the Deauville score. Finally, also presented in this paper are the results from a survey across 51 EARL-accredited centers reporting how the program was implemented and its impact on daily routine and in clinical trials, harmonization of new metrics such as MATV and heterogeneity features. (orig.)

  2. Performance of mechanical ventilators at the patient's home: a multicentre quality control study.

    Science.gov (United States)

    Farré, R; Navajas, D; Prats, E; Marti, S; Guell, R; Montserrat, J M; Tebe, C; Escarrabill, J

    2006-05-01

    Quality control procedures vary considerably among the providers of equipment for home mechanical ventilation (HMV). A multicentre quality control survey of HMV was performed at the home of 300 patients included in the HMV programmes of four hospitals in Barcelona. It consisted of three steps: (1) the prescribed ventilation settings, the actual settings in the ventilator control panel, and the actual performance of the ventilator measured at home were compared; (2) the different ventilator alarms were tested; and (3) the effect of differences between the prescribed settings and the actual performance of the ventilator on non-programmed readmissions of the patient was determined. Considerable differences were found between actual, set, and prescribed values of ventilator variables; these differences were similar in volume and pressure preset ventilators. The percentage of patients with a discrepancy between the prescribed and actual measured main ventilator variable (minute ventilation or inspiratory pressure) of more than 20% and 30% was 13% and 4%, respectively. The number of ventilators with built in alarms for power off, disconnection, or obstruction was 225, 280 and 157, respectively. These alarms did not work in two (0.9%), 52 (18.6%) and eight (5.1%) ventilators, respectively. The number of non-programmed hospital readmissions in the year before the study did not correlate with the index of ventilator error. This study illustrates the current limitations of the quality control of HMV and suggests that improvements should be made to ensure adequate ventilator settings and correct ventilator performance and ventilator alarm operation.

  3. Study for every other day administration of vonoprazan in maintenance treatment of erosive GERD: study protocol for a multicentre randomised cross-over study.

    Science.gov (United States)

    Kato, Mototsugu; Ito, Noriko; Demura, Mamiko; Kubo, Kimitoshi; Mabe, Katsuhiro; Harada, Naohiko

    2018-01-01

    The first drug selected for treatment of gastro-oesophageal reflux disease (GERD) and prevention of the recurrence is a proton pump inhibitor (PPI), but recently, a potassium-competitive acid blocker (P-CAB) was put on the market in Japan. Its onset of effect is faster than PPI, and it takes more than 2 days to recover acid secretion after the withdrawal period. Therefore, unlike PPI, the usefulness of every other day administration or discontinuous administration is expected. This study is a prospective, multicentre, open-label, two-period randomised cross-over study to compare the efficacy and safety of PPI every other day administration and P-CAB every other day administration in 120 patients who receive erosive GERD maintenance therapy with PPI. Patients will be randomly allocated to receive 4 weeks P-CAB or PPI followed by 4 weeks cross over, where those on P-CAB will receive PPI and vice versa. The primary endpoint is proportion of asymptomatic patients. Secondary endpoints are suppressive effect of GERD symptoms, proportion of asymptomatic patients at each time point, safety and cost-saving effect of P-CAB every other day administration, compliance with every other day administration, and proportion of asymptomatic patients at the first month of study drug administration. This study was approved by the National Hospital Organization Central Review Board for Clinical Trials (5 December 2017). If P-CAB every other day administration is established as one of GERD maintenance therapies, there is merit in both medical cost reduction and the safety to alleviate elevation in serum gastrin. UMIN000034701.

  4. HPV and cofactors for invasive cervical cancer in Morocco: a multicentre case-control study.

    Science.gov (United States)

    Berraho, Mohamed; Amarti-Riffi, Afaf; El-Mzibri, Mohammed; Bezad, Rachid; Benjaafar, Noureddine; Benideer, Abdelatif; Matar, Noureddine; Qmichou, Zinab; Abda, Naima; Attaleb, Mohammed; Znati, Kaoutar; El Fatemi, Hind; Bendahhou, Karima; Obtel, Majdouline; Filali Adib, Abdelhai; Mathoulin-Pelissier, Simone; Nejjari, Chakib

    2017-06-20

    Limited national information is available in Morocco on the prevalence and distribution of HPV-sub-types of cervical cancer and the role of other risk factors. The aim was to determine the frequency of HPV-sub-types of cervical cancer in Morocco and investigate risk factors for this disease. Between November 2009 and April 2012 a multicentre case-control study was carried out. A total of 144 cases of cervical cancer and 288 age-matched controls were included. Odds-ratios and corresponding confidence-intervals were computed by conditional logistic regression models. Current HPV infection was detected in 92.5% of cases and 13.9% of controls. HPV16 was the most common type for both cases and controls. Very strong associations between HPV-sub-types and cervical cancer were observed: total-HPV (OR = 39), HPV16 (OR = 49), HPV18 (OR = 31), and multiple infections (OR = 13). Education, high parity, sexual intercourse during menstruation, history of sexually transmitted infections, and husband's multiple sexual partners were also significantly associated with cervical cancer in the multivariate analysis. Our results could be used to establish a primary prevention program and to prioritize limited screening to women who have specific characteristics that may put them at an increased risk of cervical cancer.

  5. The effectiveness of 2-implant overdentures - a pragmatic international multicentre study.

    LENUS (Irish Health Repository)

    Rashid, F

    2011-03-01

    The purpose of this multicentre observational study was to determine patient satisfaction with either conventional dentures or mandibular 2-implant overdentures in a \\'real world\\' setting. Two hundred and three edentulous patients (mean age 68·8 ± 10·4 years) were recruited at eight centres located in North America, South America and Europe. The patients were provided with new mandibular conventional dentures or implant overdentures supported by two implants and ball attachments. At baseline and at 6 months post-treatment, they rated their satisfaction with their mandibular prostheses on 100-mm visual analogue scale questionnaires. One hundred and two (50·2%) participants had valid baseline and 6-month satisfaction data. Although both groups reported improvements, the implant overdenture group reported significantly higher ratings of overall satisfaction, comfort, stability, ability to speak and ability to chew. These results suggest that edentulous patients who choose mandibular implant overdentures have significantly greater improvements in satisfaction, despite their relatively higher cost, than those who choose new conventional dentures.

  6. Iatrogenic facial nerve injuries during chronic otitis media surgery: a multicentre retrospective study.

    Science.gov (United States)

    Linder, T; Mulazimoglu, S; El Hadi, T; Darrouzet, V; Ayache, D; Somers, T; Schmerber, S; Vincent, C; Mondain, M; Lescanne, E; Bonnard, D

    2017-06-01

    To give an insight into why, when and where iatrogenic facial nerve (FN) injuries may occur and to explain how to deal with them in an emergency setting. Multicentre retrospective study in eight tertiary referral hospitals over 17 years. Twenty patients with partial or total FN injury during surgery for chronic otitis media (COM) were revised. Indication and type of surgery, experience of the surgeon, intra- and postoperative findings, value of CT scanning, patient management and final FN outcome were recorded. In 12 cases, the nerve was completely transected, but the surgeon was unaware in 11 cases. A minority of cases occurred in academic teaching hospitals. Tympanic segment, second genu and proximal mastoid segments were the sites involved during injury. The FN was not deliberately identified in 18 patients at the time of injury, and nerve monitoring was only applied in one patient. Before revision surgery, CT scanning correctly identified the lesion site in 11 of 12 cases and depicted additional lesions such as damage to the lateral semicircular canal. A greater auricular nerve graft was interposed in 10 cases of total transection and in one partially lesioned nerve: seven of them resulted in an HB III functional outcome. In two of the transected nerves, rerouting and direct end-to-end anastomosis was applied. A simple FN decompression was used in four cases of superficially traumatised nerves. We suggest checklists for preoperative, intraoperative and postoperative management to prevent and treat iatrogenic FN injury during COM surgery. © 2016 John Wiley & Sons Ltd.

  7. [Prospective study in 2 hospitals].

    Science.gov (United States)

    Jiménez-Buñuales, M T; Martínez-Sáenz, M S; González-Diego, P; Vallejo-García, M; Gallardo-Anciano, J; Cestafe-Martínez, A

    2016-06-01

    The purpose of this study is to know the incidence rate of medication reconciliation at admission and discharge in patients of La Rioja and to improve the patient safety on medication reconciliation. An observational prospective study, part of the Joint Action PaSQ, Work Package 5, European Union Network for Patient Safety and Quality of Care. The study has taken into account the definitions of the Institute for Safe Medication Practices. Any unintended discrepancy in medication between chronic treatment and the treatment prescribed in the hospital was considered as a reconciliation error. A total of 750 patients were included, 9 (1.2%) of whom showed at least one discrepancy. The patients had a total of 3,156 mediations registered: 2,313 prescriptions (73.4%) showed no differences, while 821 prescriptions (26%) were intended discrepancies and 21 prescriptions (0.6%) unintended discrepancies were considered by the physician as reconciliation errors. A percentage of 1.2 of the patients, which represents 0.6% of the medicines (one in 166 medications registered) had reconciliation errors during their hospital stay. A proceeding has been implemented by means of the physician doing the medication reconciliation and reviewing it with the help of a medication reconciliation form. The medication reconciliation is a priority strategic objective to improve the safety of patients. Copyright © 2016 SECA. Published by Elsevier Espana. All rights reserved.

  8. Randomized, interventional, prospective, comparative study to ...

    African Journals Online (AJOL)

    Randomized, interventional, prospective, comparative study to evaluate the antihypertensive efficacy and tolerability of ramipril versus telmisartan in stage 1 hypertensive patients with diabetes mellitus.

  9. 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

  10. Immuno-related polymorphisms and cervical cancer risk: The IARC multicentric case-control study.

    Directory of Open Access Journals (Sweden)

    James McKay

    Full Text Available A small proportion of women who are exposed to infection with human-papillomavirus (HPV develop cervical cancer (CC. Genetic factors may affect the risk of progression from HPV infection to cervical precancer and cancer. We used samples from the International Agency for Research on Cancer (IARC multicentric case-control study to evaluate the association of selected genetic variants with CC. Overall, 790 CC cases and 717 controls from Algeria, Morocco, India and Thailand were included. Cervical exfoliated cells were obtained from control women and cervical exfoliated cells or biopsy specimens from cases. HPV-positivity was determined using a general primer GP5+/6+ mediated PCR. Unconditional logistic regression was used to estimate odds ratios (OR and corresponding 95% confidence intervals (CI of host genotypes with CC risk, using the homozygous wild type genotype as the referent category and adjusting by age and study centre. The association of polymorphisms with the risk of high-risk HPV-positivity among controls was also evaluated. A statistically significant association was observed between single nucleotide polymorphism (SNP CHR6 rs2844511 and CC risk: the OR for carriers of the GA or GG genotypes was 0.70 (95% CI: 0.43-1.14 and 0.61 (95% CI: 0.38-0.98, respectively, relative to carriers of AA genotype (p-value for trend 0.03. We also observed associations of borderline significance with the TIPARP rs2665390 polymorphism, which was previously found to be associated with ovarian and breast cancer, and with the EXOC1 rs13117307 polymorphism, which has been linked to cervical cancer in a large study in a Chinese population. We confirmed the association between CC and the rs2844511 polymorphism previously identified in a GWAS study in a Swedish population. The major histocompatibility region of chromosome 6, or perhaps other SNPs in linkage disequilibrium, may be involved in CC onset.

  11. A multicentre cohort study assessing day of week effect and outcome from emergency appendicectomy.

    Science.gov (United States)

    Ferguson, Henry J M; Hall, Nigel J; Bhangu, Aneel

    2014-09-01

    There is evidence to suggest that patients undergoing treatment at weekends may be subject to different care processes and outcomes compared with weekdays. This study aimed to determine whether clinical outcomes from weekend appendicectomy are different from those performed on weekdays. Multicentre cohort study during May-June 2012 from 95 centres (89 within the UK). The primary outcome was the 30-day adverse event rate. Multilevel modelling was used to account for clustering within hospitals while adjusting for case mix to produce adjusted ORs and 95% CIs. When compared with Monday, there were no significant differences for other days of the week considering 30-day adverse events in adjusted models. On Sunday, rates of simple appendicitis were highest, and rates of normal (OR 0.62, 95% CI 0.42 to 0.90) and complex appendicitis (OR 0.65, 95% CI 0.46 to 0.93) lowest. This was accompanied by a 43% lower likelihood in use of laparoscopy on Sunday (OR 0.47, 95% CI 0.32 to 0.69), accompanied by the lowest level of consultant presence for the week. When pooling weekends and weekdays, laparoscopy use remained less likely at the weekend (OR 0.68, 95% CI 0.55 to 0.83), with no significant difference for 30-day adverse event rate (OR 1.01, 95% CI 0.80 to 1.29). This study found that weekend appendicectomy was not associated with increased 30-day adverse events. It cannot rule out smaller increases that may be shown by larger studies. It further illustrated that patients operated on at weekends were subject to different care processes, which may expose them to risk. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  12. Knowledge, attitudes, and smoking behaviours among physicians specializing in public health: a multicentre study.

    Science.gov (United States)

    La Torre, Giuseppe; Saulle, Rosella; Unim, Brigid; Angelillo, Italo Francesco; Baldo, Vincenzo; Bergomi, Margherita; Cacciari, Paolo; Castaldi, Silvana; Del Corno, Giuseppe; Di Stanislao, Francesco; Panà, Augusto; Gregorio, Pasquale; Grillo, Orazio Claudio; Grossi, Paolo; La Rosa, Francesco; Nante, Nicola; Pavia, Maria; Pelissero, Gabriele; Quarto, Michele; Ricciardi, Walter; Romano, Gabriele; Schioppa, Francesco Saverio; Fallico, Roberto; Siliquini, Roberta; Triassi, Maria; Vitale, Francesco; Boccia, Antonio

    2014-01-01

    Healthcare professionals have an important role to play both as advisers-influencing smoking cessation-and as role models. However, many of them continue to smoke. The aims of this study were to examine smoking prevalence, knowledge, attitudes, and behaviours among four cohorts physicians specializing in public health, according to the Global Health Profession Students Survey (GHPSS) approach. A multicentre cross-sectional study was carried out in 24 Italian schools of public health. The survey was conducted between January and April 2012 and it was carried out a census of students in the selected schools for each years of course (from first to fourth year of attendance), therefore among four cohorts of physicians specializing in Public Health (for a total of n. 459 medical doctors). The GHPSS questionnaires were self-administered via a special website which is created ad hoc for the survey. Logistic regression model was used to identify possible associations with tobacco smoking status. Hosmer-Lemeshow test was performed. The level of significance was P ≤ 0.05. A total of 388 answered the questionnaire on the website (85%), of which 81 (20.9%) declared to be smokers, 309 (79.6%) considered health professionals as behavioural models for patients, and 375 (96.6%) affirmed that health professionals have a role in giving advice or information about smoking cessation. Although 388 (89.7%) heard about smoking related issues during undergraduate courses, only 17% received specific smoking cessation training during specialization. The present study highlights the importance of focusing attention on smoking cessation training, given the high prevalence of smokers among physicians specializing in public health, their key role both as advisers and behavioural models, and the limited tobacco training offered in public health schools.

  13. Effects of acupuncture on patients with fibromyalgia: study protocol of a multicentre randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Santos-Rey Koldo

    2011-02-01

    Full Text Available Abstract Background Fibromyalgia is a multidimensional disorder for which treatment as yet remains unsatisfactory. Studies of an acupuncture-based approach, despite its broad acceptance among patients and healthcare staff, have not produced sufficient evidence of its effectiveness in treating this syndrome. The present study aims to evaluate the effectiveness of individualized acupuncture for patients with fibromyalgia, with respect to reducing their pain and level of incapacity, and improving their quality of life. Methods/design Randomized controlled multicentre study, with 156 outpatients, aged over 17 years, diagnosed with fibromyalgia according to American College of Rheumatology criteria, either alone or associated with severe depression, according to the criteria of the Diagnostic and Statistical Manual for Mental Disorders. The participants will be randomly assigned to receive either "True acupuncture" or "Sham acupuncture". They will be evaluated using a specific measurement system, constituted of the Fibromyalgia Impact Questionnaire and the Hamilton rating scale for depression. Also taken into consideration will be the clinical and subjective pain intensity, the patient's family structure and relationships, psychological aspects, quality of life, the duration of previous temporary disability, the consumption of antidepressant, analgesic and anti-inflammatory medication, and the potential effect of factors considered to be predictors of a poor prognosis. All these aspects will be examined by questionnaires and other suitably-validated instruments. The results obtained will be analysed at 10 weeks, and 6 and 12 months from the start of treatment. Discussion This trial will utilize high quality trial methodologies in accordance with CONSORT guidelines. It may provide evidence for the effectiveness of acupuncture as a treatment for fibromyalgia either alone or associated with severe depression. Trial registration ISRCTN trial number

  14. Feasibility of implementing a practice guideline for fall prevention on geriatric wards: a multicentre study.

    Science.gov (United States)

    Milisen, Koen; Coussement, Joke; Arnout, Hanne; Vanlerberghe, Virginie; De Paepe, Leen; Schoevaerdts, Didier; Lambert, Margareta; Van Den Noortgate, Nele; Delbaere, Kim; Boonen, Steven; Dejaeger, Eddy

    2013-04-01

    About 40% of all adverse events in hospital are falls, but only about one in three Belgian hospitals have a fall prevention policy in place. The implementation of a national practice guideline is urgently needed. This multicentre study aimed to determine the feasibility of a previously developed guideline. SETTING, PARTICIPANTS AND METHOD: Seventeen geriatric wards, selected at random out of 40 Belgian hospitals who agreed to take part in the study, evaluated the fall prevention guideline. After the one-month test period, 49 healthcare workers completed a questionnaire on the feasibility of the guideline. At the end of the study, 512 geriatric patients had been assessed using the practice guideline. The average time spent per patient on case finding, multifactorial assessment and initiating a treatment plan was 5.1, 76.1 and 30.6 min, respectively. For most risk assessments and risk modifications, several disciplines considered themselves as being responsible and capable. The majority (more than 69%) of the respondents judged the practice guideline as useful, but only a small majority (62.3%) believed that the guideline could be successfully integrated into their daily practice over a longer period of time. Barriers for implementation included a large time investment (81.1%), lack of communication between the different disciplines (35.8%), lack of motivation of the patient (34.0%), lack of multidisciplinary teamwork (28.3%), and lack of interest from the hospital management (15.4%). Overall, the guideline was found useful, and for each risk factor (except for visual impairment), at least one discipline felt responsible and capable. Towards future implementation of the guideline, following steps should be considered: division of the risk-factor assessment duties and interventions among different healthcare workers; patient education; appointment of a fall prevention coordinator; development of a fall prevention policy with support from the management of the hospital

  15. An Italian multicentre study on adult atopic dermatitis: persistent versus adult-onset disease.

    Science.gov (United States)

    Megna, Matteo; Patruno, Cataldo; Balato, Anna; Rongioletti, Franco; Stingeni, Luca; Balato, Nicola

    2017-08-01

    Atopic dermatitis (AD) is a chronic, recurrent, inflammatory skin disease which predominantly affects children. However, AD may persist until adulthood (persistent AD), or directly start in adults (adult-onset AD). AD often shows a non-flexural rash distribution, and atypical morphologic variants in adults and specific diagnostic criteria are lacking. Moreover, adult AD prevalence as well as detailed data which can characterize persistent vs adult-onset subtype are scant. The aim of this study was to investigate on the main features of adult AD particularly highlighting differences between persistent vs adult-onset form. An Italian multicentre observational study was conducted between April 2015-July 2016 through a study-specific digital database. 253 adult AD patients were enrolled. Familiar history of AD was negative in 81.0%. Erythemato-desquamative pattern was the most frequent clinical presentation (74.3%). Flexural surface of upper limbs was most commonly involved (47.8%), followed by eyelid/periocular area (37.9%), hands (37.2%), and neck (32%). Hypertension (7.1%) and thyroiditis (4.3%) were the most frequent comorbidities. A subgroup analysis between persistent (59.7%) vs adult-onset AD patients (40.3%) showed significant results only regarding AD severity (severe disease was more common in persistent group, p adult-onset disease), and comorbidities (hypertension was more frequent in adult-onset group, p Adult AD showed uncommon features such as significant association with negative AD family history and lacking of association with systemic comorbidities respect to general population. No significant differences among persistent vs adult-onset subgroup were registered except for hypertension, itch intensity, and disease severity.

  16. Knowledge, Attitudes, and Smoking Behaviours among Physicians Specializing in Public Health: A Multicentre Study

    Directory of Open Access Journals (Sweden)

    Giuseppe La Torre

    2014-01-01

    Full Text Available Background. Healthcare professionals have an important role to play both as advisers—influencing smoking cessation—and as role models. However, many of them continue to smoke. The aims of this study were to examine smoking prevalence, knowledge, attitudes, and behaviours among four cohorts physicians specializing in public health, according to the Global Health Profession Students Survey (GHPSS approach. Materials and Methods. A multicentre cross-sectional study was carried out in 24 Italian schools of public health. The survey was conducted between January and April 2012 and it was carried out a census of students in the selected schools for each years of course (from first to fourth year of attendance, therefore among four cohorts of physicians specializing in Public Health (for a total of n. 459 medical doctors. The GHPSS questionnaires were self-administered via a special website which is created ad hoc for the survey. Logistic regression model was used to identify possible associations with tobacco smoking status. Hosmer-Lemeshow test was performed. The level of significance was P≤0.05. Results. A total of 388 answered the questionnaire on the website (85%, of which 81 (20.9% declared to be smokers, 309 (79.6% considered health professionals as behavioural models for patients, and 375 (96.6% affirmed that health professionals have a role in giving advice or information about smoking cessation. Although 388 (89.7% heard about smoking related issues during undergraduate courses, only 17% received specific smoking cessation training during specialization. Conclusions. The present study highlights the importance of focusing attention on smoking cessation training, given the high prevalence of smokers among physicians specializing in public health, their key role both as advisers and behavioural models, and the limited tobacco training offered in public health schools.

  17. Characteristics of patients with rheumatoid arthritis presenting for physiotherapy management: a multicentre study.

    Science.gov (United States)

    Kennedy, Norelee; Keogan, Fiona; Fitzpatrick, Martina; Cussen, Grainne; Wallace, Lorraine

    2007-03-01

    To describe the characteristics of patients with rheumatoid arthritis (RA) attending for physiotherapy management in Ireland. Managers of physiotherapy departments in the 53 hospitals in Ireland were invited to participate in a multi-centre observational study over a 6-month period. Data on patients with RA the day of presentation for physiotherapy management were recorded. These data related to patient demographic details, disease management, aids and appliances, splint and orthoses usage and occupational issues. The Health Assessment Questionnaire was also recorded for each patient. A total of 273 patients from eight physiotherapy departments participated in the survey (n = 199; 73% female). Mean age of the participants was 59.3 (SD 12.5) years with mean disease duration of 13.8 (SD 10.6) years. The majority of the patients were inpatients (n = 170, 62%). Sixty-eight per cent of patients had attended for previous physiotherapy treatment and 98% were under current rheumatologist care. Biologic therapies were prescribed to 11% of patients. Use of splint and foot orthoses was high with 133 patients (49%) wearing splints and 75 (31%) wearing foot orthoses. The majority of patients had moderate (n = 119, 44%) or severe (n = 94, 35%) disability as per Health Assessment Questionnaire (HAQ) score. Mean HAQ score was 1.5, with HAQ scores showing increasing disability with increasing age, disease duration and erythrocyte sedimentation rate (ESR) levels. Patients with RA attending for physiotherapy management present with varied profiles. This study provides valuable information on the characteristics of patients with RA attending for physiotherapy management which will contribute to physiotherapy service planning and delivery and will optimize patient care.

  18. Impulse control disorder in patients with Parkinson's disease under dopamine agonist therapy: a multicentre study.

    Science.gov (United States)

    Garcia-Ruiz, Pedro J; Martinez Castrillo, Juan Carlos; Alonso-Canovas, Araceli; Herranz Barcenas, Antonio; Vela, Lydia; Sanchez Alonso, Pilar; Mata, Marina; Olmedilla Gonzalez, Nuria; Mahillo Fernandez, Ignacio

    2014-08-01

    Impulse control disorders (ICDs) encompass a wide spectrum of abnormal behaviour frequently found in cases of Parkinson's disease (PD) treated with dopamine agonists (DAs). The main aim of this study was to analyse ICD prevalence with different DAs. We carried out a multicentre transversal study to evaluate the presence of ICDs in patients with PD chronically treated (>6 months) with a single non-ergolinic DA (pramipexole, ropinirole, or rotigotine). Clinical assessment of ICD was performed using the Questionnaire for Impulsive-Compulsive Disorders in Parkinson's disease. Thirty-nine per cent of patients (91/233) fulfilled the clinical criteria for ICD. The group of patients with ICD symptoms (ICD+) differed from those without ICD symptoms (ICD-) in younger age and type of DA intake. Oral DA treatment (pramipexole and ropinirole) was associated with higher risk of ICDs compared with transdermal DA (rotigotine): 84/197 (42%) patients treated with oral DA developed ICD, versus 7/36 (19%) patients treated with transdermal DA (Fisher's exact text <0.01). In univariate analysis, a younger age (p<0.01), treatment with rasagiline (p<0.05), and especially treatment with an oral DA (pramipexole or ropinirole) (p<0.01) were significantly associated with ICD. Multivariate analysis confirmed that oral DA remained significantly associated with ICD (p: 0.014, OR: 3.14; 1.26-7.83). ICD was significantly associated with the use of the non-ergolinic oral DA (pramipexole and ropinirole) when compared with transdermal non-ergolinic DA (rotigotine). Since pramipexole, ropinirole and rotigotine are non-ergolinic DAs with very similar pharmacodynamic profiles, it is likely that other factors including route of administration (transdermal vs oral) explain the difference in risk of ICD development. 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.

  19. Analysis of GPR101 and AIP genes mutations in acromegaly: a multicentric study.

    Science.gov (United States)

    Ferraù, Francesco; Romeo, P D; Puglisi, S; Ragonese, M; Torre, M L; Scaroni, C; Occhi, G; De Menis, E; Arnaldi, G; Trimarchi, F; Cannavò, S

    2016-12-01

    This multicentric study aimed to investigate the prevalence of the G protein-coupled receptor 101 (GPR101) p.E308D variant and aryl hydrocarbon receptor interacting protein (AIP) gene mutations in a representative cohort of Italian patients with acromegaly. 215 patients with GH-secreting pituitary adenomas, referred to 4 Italian referral centres for pituitary diseases, have been included. Three cases of gigantism were present. Five cases were classified as FIPA. All the patients have been screened for germline AIP gene mutations and GPR101 gene p.E308D variant. Heterozygous AIP gene variants have been found in 7 patients (3.2 %). Five patients carried an AIP mutation (2.3 %; 4 females): 3 patients harboured the p.R3O4Q mutation, one had the p.R304* mutation and the last one the IVS3+1G>A mutation. The prevalence of AIP mutations was 3.3 % and 2.8 % when considering only the patients diagnosed when they were <30 or <40-year old, respectively. Furthermore, 2.0 % of the patients with a pituitary macroadenoma and 4.2 % of patients resistant to somatostatin analogues treatment were found to harbour an AIP gene mutation. None of the patients was found to carry the GPR101 p.E308D variant. The prevalence of AIP gene mutations among our sporadic and familial acromegaly cases was similar to that one reported in previous studies, but lower when considering only the cases diagnosed before 40 years of age. The GPR101 p.E308D change is unlikely to have a role in somatotroph adenomas tumorigenesis, since none of our sporadic or familial patients tested positive for this variant.

  20. The epidemiology of skin care provided by nurses at home: a multicentre prevalence study.

    Science.gov (United States)

    Kottner, Jan; Boronat, Xavier; Blume-Peytavi, Ulrike; Lahmann, Nils; Suhr, Ralf

    2015-03-01

    The aim of this study was to estimate the frequencies and patterns of skin care and applied skin care products in the home care nursing setting in Germany. Skin care belongs to the core activities of nursing practice. Especially in aged and long-term care settings, clients are vulnerable to various skin conditions. Dry skin is one of the most prevalent problems. Using mild skin cleansers and the regular application of moisturizing leave-on products is recommended. Until today, there are no quantitative empirical data about nursing skin care practice at home in the community. A multicentre cross-sectional study was conducted in July 2012. Home care clients from the German home care nursing setting were randomly selected. Instructed nurse raters performed the data collection using standardized forms. Variables included demographics, skin care needs and skin caring activities. Approximately 60% of home care clients received skin care interventions. The majority were washed and two-thirds received a leave-on product once daily. There was large heterogeneity in cleansing and skin care product use. Most often the product labels were unknown or product types were selected haphazardly. Skin care interventions play a significant role in home care and nurses have a considerable responsibility for skin health. Skin care provided does not meet recent recommendations. The importance of targeted skin cleansing and care might be underestimated. There are a confusing variety of skin care products available and often the labels provide little information regarding the ingredients or guidance about how they affect skin health. © 2014 John Wiley & Sons Ltd.

  1. An Italian multicentre validation study of the coma recovery scale-revised.

    Science.gov (United States)

    Estraneo, A; Moretta, P; De Tanti, A; Gatta, G; Giacino, J T; Trojano, L

    2015-10-01

    Rate of misdiagnosis of disorders of consciousness (DoC) can be reduced by employing validated clinical diagnostic tools, such as the Coma Recovery Scale-Revised (CRS-R). An Italian version of the CRS-R has been recently developed, but its applicability across different clinical settings, and its concurrent validity and diagnostic sensitivity have not been estimated yet. To perform a multicentre validation study of the Italian version of the Coma Recovery Scale-Revised (CRS-R). Analysis of inter-rater reliability, concurrent validity and diagnostic sensitivity of the scale. One Intensive Care Unit, 8 Post-acute rehabilitation centres and 2 Long-term facilities Twenty-seven professionals (physicians, N.=11; psychologists, N.=5; physiotherapists, N.=3; speech therapists, N.=6; nurses, N.=2) from 11 Italian Centres. CRS-R and Disability Rating Scale (DRS) applied to 122 patients with clinical diagnosis of Vegetative State (VS) or Minimally Conscious State (MCS). CRS-R has good-to-excellent inter-rater reliability for all subscales, particularly for the communication subscale. The Italian version of the CRS-R showed a high sensitivity and specificity in detecting MCS with reference to clinical consensus diagnosis. The CRS-R showed good concurrent validity with the Disability Rating Scale, which had very low specificity with reference to clinical consensus diagnosis. The Italian version of the CRS-R is a valid scale for use from the sub-acute to chronic stages of DoC. It can be administered reliably by all members of the rehabilitation team with different specialties, levels of experience and settings. The present study promote use of the Italian version of the CRS-R to improve diagnosis of DoC patients, and plan tailored rehabilitation treatment.

  2. The prevalence and specific characteristics of hospitalised pressure ulcer patients: A multicentre cross-sectional study.

    Science.gov (United States)

    Zhou, Qing; Yu, Ting; Liu, Yuan; Shi, Ruifen; Tian, Suping; Yang, Chaoxia; Gan, Huaxiu; Zhu, Yanying; Liang, Xia; Wang, Ling; Wu, Zhenhua; Huang, Jinping; Hu, Ailing

    2018-02-01

    To ascertain the pressure ulcer prevalence in secondary and tertiary general hospitals in different areas of Guangdong Province in China and explore the possible risk factors that are related to pressure ulcers. Few multicentre studies have been conducted on pressure ulcer prevalence in Chinese hospitals. A cross-sectional study design was used. Data from a total of 25,264 patients were included in the analysis at 25 hospitals in China. The investigators were divided into two groups. The investigators in group 1 examined the patients' skin. When a pressure ulcer was found, a pressure ulcer assessment form was completed. The investigators in group 2 provided guidance to the nurses, who assessed all patients and completed another questionnaire. A multivariate logistic regression analysis was used to analyse the relationship between the possible risk factors and pressure ulcer. The overall prevalence rate of pressure ulcers in the 25 hospitals ranged from 0%-3.49%, with a mean of 1.26%. The most common stage of the pressure ulcers was stage II (41.4%); most common anatomical locations were sacrum (39.5%) and the feet (16.4%). Braden score (p pressure ulcers from the multivariate logistic regression analysis. The overall prevalence rate of pressure ulcers in Chinese hospitals was lower than that reported in previous investigations. Specific characteristics of pressure ulcer patients were as follows: low Braden score, longer expected length of stay, double incontinence, an ICU and a medical ward, hospital location in the Pearl River Delta, a university hospital and an older patient. The survey could make managers know their prevalence level of pressure ulcers and provide priorities for clinical nurses. © 2017 John Wiley & Sons Ltd.

  3. Blunt Cardiac Injury in the Severely Injured - A Retrospective Multicentre Study.

    Directory of Open Access Journals (Sweden)

    Marc Hanschen

    Full Text Available Blunt cardiac injury is a rare trauma entity. Here, we sought to evaluate the relevance and prognostic significance of blunt cardiac injury in severely injured patients.In a retrospective multicentre study, using data collected from 47,580 patients enrolled to TraumaRegister DGU (1993-2009, characteristics of trauma, prehospital / hospital trauma management, and outcome analysis were correlated to the severity of blunt cardiac injury. The severity of cardiac injury was assessed according to the abbreviated injury score (AIS score 1-6, the revised injury severity score (RISC allowed comparison of expected outcome with injury severity-dependent outcome. N = 1.090 had blunt cardiac trauma (AIS 1-6 (2.3% of patients.Predictors of blunt cardiac injury could be identified. Sternal fractures indicate a high risk of the presence of blunt cardiac injury (AIS 0 [control]: 3.0%; AIS 1: 19.3%; AIS 2-6: 19.1%. The overall mortality rate was 13.9%, minor cardiac injury (AIS 1 and severe cardiac injury (AIS 2-6 are associated with higher rates. Severe blunt cardiac injury (AIS 4 and AIS 5-6 is associated with a higher mortality (OR 2.79 and 4.89, respectively as compared to the predicted average mortality (OR 2.49 of the study collective.Multiple injured patients with blunt cardiac trauma are at high risk to be underestimated. Careful evaluation of trauma patients is able to predict the presence of blunt cardiac injury. The severity of blunt cardiac injury needs to be stratified according to the AIS score, as the patients' outcome is dependent on the severity of cardiac injury.

  4. Joys and challenges of relationships in Scotland and New Zealand rural midwifery: A multicentre study.

    Science.gov (United States)

    Crowther, Susan; Deery, Ruth; Daellenbach, Rea; Davies, Lorna; Gilkison, Andrea; Kensington, Mary; Rankin, Jean

    2018-04-21

    Globally there are challenges meeting the recruitment and retention needs for rural midwifery. Rural practice is not usually recognised as important and feelings of marginalisation amongst this workforce are apparent. Relationships are interwoven throughout midwifery and are particularly evident in rural settings. However, how these relationships are developed and sustained in rural areas is unclear. To study the significance of relationships in rural midwifery and provide insights to inform midwifery education. Multi-centre study using online surveys and discussion groups across New Zealand and Scotland. Descriptive and template analysis were used to organise, examine and analyse the qualitative data. Rural midwives highlighted how relationships with health organisations, each other and women and their families were both a joy and a challenge. Social capital was a principal theme. Subthemes were (a) working relationships, (b) respectful communication, (c) partnerships, (d) interface tensions, (e) gift of time facilitates relationships. To meet the challenges of rural practice the importance of relationship needs acknowledging. Relationships are created, built and sustained at a distance with others who have little appreciation of the rural context. Social capital for rural midwives is thus characterised by social trust, community solidarity, shared values and working together for mutual benefit. Rural communities generally exhibit high levels of social capital and this is key to sustainable rural midwifery practice. Midwives, educationalists and researchers need to address the skills required for building social capital in rural midwifery practice. These skills are important in midwifery pre- and post-registration curricula. Copyright © 2018 Australian College of Midwives. All rights reserved.

  5. Mesh, graft, or standard repair for women having primary transvaginal anterior or posterior compartment prolapse surgery: two parallel-group, multicentre, randomised, controlled trials (PROSPECT).

    Science.gov (United States)

    Glazener, Cathryn Ma; Breeman, Suzanne; Elders, Andrew; Hemming, Christine; Cooper, Kevin G; Freeman, Robert M; Smith, Anthony Rb; Reid, Fiona; Hagen, Suzanne; Montgomery, Isobel; Kilonzo, Mary; Boyers, Dwayne; McDonald, Alison; McPherson, Gladys; MacLennan, Graeme; Norrie, John

    2017-01-28

    The use of transvaginal mesh and biological graft material in prolapse surgery is controversial and has led to a number of enquiries into their safety and efficacy. Existing trials of these augmentations are individually too small to be conclusive. We aimed to compare the outcomes of prolapse repair involving either synthetic mesh inlays or biological grafts against standard repair in women. We did two pragmatic, parallel-group, multicentre, randomised controlled trials for our study (PROSPECT [PROlapse Surgery: Pragmatic Evaluation and randomised Controlled Trials]) in 35 centres (a mix of secondary and tertiary referral hospitals) in the UK. We recruited women undergoing primary transvaginal anterior or posterior compartment prolapse surgery by 65 gynaecological surgeons in these centres. We randomly assigned participants by a remote web-based randomisation system to one of the two trials: comparing standard (native tissue) repair alone with standard repair augmented with either synthetic mesh (the mesh trial) or biological graft (the graft trial). We assigned women (1:1:1 or 1:1) within three strata: assigned to one of the three treatment options, comparison of standard repair with mesh, and comparison of standard repair with graft. Participants, ward staff, and outcome assessors were masked to randomisation where possible; masking was obviously not possible for the surgeon. Follow-up was for 2 years after the surgery; the primary outcomes, measured at 1 year and 2 years, were participant-reported prolapse symptoms (i.e. the Pelvic Organ Prolapse Symptom Score [POP-SS]) and condition-specific (ie, prolapse-related) quality-of-life scores, analysed in the modified intention-to-treat population. This trial is registered as an International Standard Randomised Controlled Trial, number ISRCTN60695184. Between Jan 8, 2010, and Aug 30, 2013, we randomly allocated 1352 women to treatment, of whom 1348 were included in the analysis. 865 women were included in the mesh

  6. Aprotinin vs. tranexamic acid in isolated coronary artery bypass surgery: A multicentre observational study.

    Science.gov (United States)

    Deloge, Elsa; Amour, Julien; Provenchère, Sophie; Rozec, Bertrand; Scherrer, Bruno; Ouattara, Alexandre

    2017-05-01

    Aprotinin appears to be more efficacious than lysine analogues to reduce bleeding and transfusion of blood products in high-transfusion-risk cardiac surgical patients. However, in isolated coronary artery bypass graft (CABG) surgery, the results from head-to-head trials remain less conclusive. Our objective was to compare the efficacies and safety of aprotinin and tranexamic acid (TXA) in patients undergoing isolated on-pump CABG. A multicentre before-and-after study pooling individual data from published trials and unpublished data from three other databases. Four tertiary care teaching hospitals (Haut-Lévêque Hospital in Bordeaux, Pitié-Salpêtrière Hospital and Bichat-Claude Bernard Hospital in Paris, and Laennec Hospital in Nantes). We included data of 2496 isolated on-pump CABG surgery patients who received either aprotinin between November 2003 and May 2008 (n = 1267) or TXA between November 2007 and November 2013 (n = 1229). The primary outcome was total blood loss within 24 h after operation. Secondary outcomes were transfusion of blood products, reoperation for bleeding, renal replacement therapy, ICU length of stay and in-hospital mortality. Adjusted mean (SEM) 24-h blood loss after surgery [483 (11) vs. 634 (11) ml, P < 0.0001] and the proportion of patients requiring intraoperative blood product transfusion (32.7 vs. 46.5%, P = 0.01) were lower in aprotinin-treated patients. No difference was observed with regard to reoperations for bleeding, renal replacement therapy and in-hospital mortality. However, patients receiving aprotinin had a significantly shorter adjusted ICU length of stay. In patients undergoing isolated CABG, aprotinin was more effective than TXA in reducing postoperative blood loss, and no safety concerns were identified. The benefits of aprotinin should be considered when evaluating the risk of major blood loss and transfusion in patients scheduled for isolated CABG surgery.

  7. Prevalence of β-thalassemia and other haemoglobinopathies in six cities in India: a multicentre study.

    Science.gov (United States)

    Mohanty, D; Colah, R B; Gorakshakar, A C; Patel, R Z; Master, D C; Mahanta, J; Sharma, S K; Chaudhari, U; Ghosh, M; Das, S; Britt, R P; Singh, S; Ross, C; Jagannathan, L; Kaul, R; Shukla, D K; Muthuswamy, V

    2013-01-01

    The population of India is extremely diverse comprising of more than 3,000 ethnic groups who still follow endogamy. Haemoglobinopathies are the commonest hereditary disorders in India and pose a major health problem. The data on the prevalence of β-thalassemias and other haemoglobinopathies in different caste/ethnic groups of India is scarce. Therefore the present multicentre study was undertaken in six cities of six states of India (Maharashtra, Gujarat, West Bengal, Assam, Karnataka and Punjab) to determine the prevalence of haemoglobinopathies in different caste/ethnic groups using uniform methodology. Fifty-six thousand seven hundred eighty individuals (college students and pregnant women) from different caste/ethnic groups were screened. RBC indices were measured on an automated haematology counter while the percentage of HbA(2), HbF and other abnormal Hb variants were estimated by HPLC on the Variant Hemoglobin Testing System. The overall prevalence of β-thalassemia trait was 2.78 % and varied from 1.48 to 3.64 % in different states, while the prevalence of β-thalassemia trait in 59 ethnic groups varied from 0 to 9.3 %. HbE trait was mainly seen in Dibrugarh in Assam (23.9 %) and Kolkata in West Bengal (3.92 %). In six ethnic groups from Assam, the prevalence of HbE trait varied from 41.1 to 66.7 %. Few subjects with δβ-thalassemia, HPFH, HbS trait, HbD trait, HbE homozygous and HbE β-thalassemia as well as HbS homozygous and HbS-β-thalassemia (India.

  8. A double-blind comparative multicentre study of remoxipride and haloperidol in schizophrenia.

    Science.gov (United States)

    Lindström, L H; Wieselgren, I M; Struwe, G; Kristjansson, E; Akselson, S; Arthur, H; Andersen, T; Lindgren, S; Norman, O; Naimell, L

    1990-01-01

    In a double-blind multicentre study of parallel group design the efficacy and safety of remoxipride and haloperidol were compared in a total of 96 patients with acute episodes of schizophrenic or schizophreniform disorder according to DSM-III. There were 48 patients in each treatment group; 27 men and 21 women in the remoxipride group, 33 men and 15 women in the haloperidol group. The median duration of illness was 7 years in both groups. The mean daily dose was 437 mg for remoxipride and 10.6 mg for haloperidol during the last week of treatment. No statistically significant differences in total BPRS scores were found between remoxipride and haloperidol. The median total BPRS scores at the start of active treatment were 26 in the remoxipride and 27 in the haloperidol group; these were reduced to 16 and 12.5, respectively, at the last rating. According to Clinical Global Impression (CGI), 43% of patients in the remoxipride group and 68% of those in the haloperidol group improved much or very much during treatment. This difference was not statistically significant. Treatment-emergent extrapyramidal side effects such as akathisia, tremor, and rigidity occurred significantly more frequently in the haloperidol group; this group also made more frequent use of anticholinergic drugs. Neither of the trial drugs seriously affected laboratory or cardiovascular variables. It is concluded that remoxipride has an antipsychotic effect in a dose range of 150-600 mg per day comparable to that of haloperidol in doses up to 20 mg per day but with fewer extrapyramidal side effects.

  9. Prognostic indicators in primary plasma cell leukaemia: a multicentre retrospective study of 117 patients.

    Science.gov (United States)

    Jurczyszyn, Artur; Radocha, Jakub; Davila, Julio; Fiala, Mark A; Gozzetti, Alessandro; Grząśko, Norbert; Robak, Paweł; Hus, Iwona; Waszczuk-Gajda, Anna; Guzicka-Kazimierczak, Renata; Atilla, Erden; Mele, Giuseppe; Sawicki, Waldemar; Jayabalan, David S; Charliński, Grzegorz; Szabo, Agoston G; Hajek, Roman; Delforge, Michel; Kopacz, Agnieszka; Fantl, Dorotea; Waage, Anders; Avivi, Irit; Rodzaj, Marek; Leleu, Xavier; Richez, Valentine; Knopińska-Posłuszny, Wanda; Masternak, Anna; Yee, Andrew J; Barchnicka, Agnieszka; Druzd-Sitek, Agnieszka; Guerrero-Garcia, Thomas; Liu, Jieqi; Vesole, David H; Castillo, Jorge J

    2018-03-01

    We report a multicentre retrospective study that analysed clinical characteristics and outcomes in 117 patients with primary plasma cell leukaemia (pPCL) treated at the participating institutions between January 2006 and December 2016. The median age at the time of pPCL diagnosis was 61 years. Ninety-eight patients were treated with novel agents, with an overall response rate of 78%. Fifty-five patients (64%) patients underwent upfront autologous stem cell transplantation (ASCT). The median follow-up time was 50 months (95% confidence interval [CI] 33; 76), with a median overall survival (OS) for the entire group of 23 months (95% CI 15; 34). The median OS time in patients who underwent upfront ASCT was 35 months (95% CI 24·3; 46) as compared to 13 months (95% CI 6·3; 35·8) in patients who did not receive ASCT (P = 0·001). Multivariate analyses identified age ≥60 years, platelet count ≤100 × 10 9 /l and peripheral blood plasma cell count ≥20 × 10 9 /l as independent predictors of worse survival. The median OS in patients with 0, 1 or 2-3 of these risk factors was 46, 27 and 12 months, respectively (P < 0·001). Our findings support the use of novel agents and ASCT as frontline treatment in patients with pPCL. The constructed prognostic score should be independently validated. © 2018 John Wiley & Sons Ltd.

  10. 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.

  11. Neurocutaneous syndrome: A prospective study

    Directory of Open Access Journals (Sweden)

    Radheshyam Purkait

    2011-01-01

    Full Text Available Background: Neurocutaneous syndromes (NCS are a group of genetic disorders that produce a variety of developmental abnormalities of the skin along with an increased risk of neurological complications. Cutaneous manifestations usually appear early in life and progress with time, but neurological features generally present at a later age. There is a paucity of data regarding the evolution of skin lesions and their correlation with the central nervous system involvement in children. Aim: The primary objective was to track the course of skin lesions in various forms of NCS in the pediatric age group. Our secondary aim was to assess whether there was any predictive value of the lesions in relation to the neurological manifestations. Materials and Methods: This prospective longitudinal study was conducted at a tertiary care pediatric dermatology referral clinic of the Institute of Child Health, Kolkata, West Bengal. Children between the age group 0 and 12 years were included in the study on the basis of standard diagnostic criteria for different NCS, during the period from March, 2000 to February, 2004, and each of the enrolled cases were followed up for a duration of six years. Results: The study population comprised of 67 children (35 boys, 32 girls.The mean age of presentation was 33.8±27.8 months (range 10 days to 111 months. The various forms of NCS observed was neurofibromatosis 1(NF1 (n=33, tuberous sclerosis complex (TSC (n=23, Sturge Weber syndrome (n=6, ataxia telangiectasia (n=2, PHACE syndrome (n=1, incontinentia pigmenti (n=1, and hypomelanosis of Ito (n=1. The presentations were varied, ranging from predominantly cutaneous to primarily neurological, depending on the disease entity and age group concerned. There was a significant increase in the number of café au lait macules (CALMs with time (P=0.0002 in NF1, unlike that of hypopigmented macules of TSC (P=0.15. Statistically, no relation was documented between the evolution of skin

  12. Chasing the effects of Pre-analytical Confounders - a Multicentre Study on CSF-AD biomarkers

    Directory of Open Access Journals (Sweden)

    Maria Joao Leitao

    2015-07-01

    Full Text Available Core cerebrospinal fluid (CSF biomarkers-Aβ42, Tau and pTau–have been recently incorporated in the revised criteria for Alzheimer’s disease (AD. However, their widespread clinical application lacks standardization. Pre-analytical sample handling and storage play an important role in the reliable measurement of these biomarkers across laboratories. In this study, we aim to surpass the efforts from previous studies, by employing a multicentre approach to assess the impact of less studied CSF pre-analytical confounders in AD-biomarkers quantification. Four different centres participated in this study and followed the same established protocol. CSF samples were analysed for three biomarkers (Aβ42, Tau and pTau and tested for different spinning conditions (temperature: Room temperature (RT vs. 4oC; speed: 500g vs. 2000g vs. 3000g, storage volume variations (25%, 50% and 75% of tube total volume as well as freezing-thaw cycles (up to 5 cyles. The influence of sample routine parameters, inter-centre variability and relative value of each biomarker (reported as normal/abnormal, was analysed. Centrifugation conditions did not influence biomarkers levels, except for samples with a high CSF total protein content, where either non centrifugation or centrifugation at RT, compared to 4ºC, led to higher Aβ42 levels. Reducing CSF storage volume from 75% to 50% of total tube capacity, decreased Aβ42 concentration (within analytical CV of the assay, whereas no change in Tau or pTau was observed. Moreover, the concentration of Tau and pTau appears to be stable up to 5 freeze-thaw cycles, whereas Aβ42 levels decrease if CSF is freeze-thawed more than 3 times. This systematic study reinforces the need for CSF centrifugation at 4ºC prior to storage and highlights the influence of storage conditions in Aβ42 levels. This study contributes to the establishment of harmonized standard operating procedures that will help reducing inter-lab variability of CSF

  13. 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...

  14. Danazol treatment of benign breast disease: a survey of U.S.A. multi-centre studies.

    Science.gov (United States)

    Brookshaw, J D

    1979-01-01

    514 patients with benign breast disease provided records from multicentre studies in the U.S.A. Results showed that a high proportion responded with either decrease or elimination of symptoms, response usually being apparent 15 to 45 days after commencing treatment. Dosage schedules varied between 50 and 400 mg danazol daily and length of treatment between 15 and 196 days. There was a tendency for patients with more severe symptoms to respond better to the higher dosages, and for the elimination rate for all grades of severity to improve with time. Side effects were not severe, and of the expected type including weight gain, oiliness of skin and hair, and acne.

  15. A multicentre study of 513 Danish patients with systemic lupus erythematosus. II. Disease mortality and clinical factors of prognostic value

    DEFF Research Database (Denmark)

    Jacobsen, S; Petersen, J; Ullman, S

    1998-01-01

    influence on survival related to mortality caused by infections. Diffuse central nervous system disease and myocarditis were related to increased SLE-related mortality, whereas photosensitivity predicted a decreased mortality. Non-fatal infections and thrombotic events predicted a decreased overall survival......In this Danish multicentre study, predictive clinical factors of mortality and survival were calculated for 513 patients with systemic lupus erythematosus (SLE), 122 of whom died within a mean observation period of 8.2 years equalling a mortality rate of 2.9% per year. Survival rates were 97%, 91...

  16. 99mTc-DTPA aerosol for same-day post-perfusion ventilation imaging: Results of a multicentre study

    International Nuclear Information System (INIS)

    Koehn, H.; Koenig, B.; Bachmayr, S.; Markt, B.; Eber, O.; Lind, P.; Galvan, G.; Rettenbacher, L.; Holm, C.; Ogris, E.

    1993-01-01

    A multicentre study was performed in an attempt to evaluate a submicronic technetium-99m diethylene triamine penta-acetic acid aerosol generated by a newly developed delivery system, the aerosol production equipment (APE nebulizer), for same-day post-perfusion ventilation imaging in patients with clinically suspected pulmonary embolism. Quantitative comparison between the DTPA aerosol and krypton gas demonstrated a close correlation with respect to regional pulmonary distribution of activity and peripheral lung penetration (n=14, r=0.94, P 99m Tc-labelled DTPA aerosol is well suited for fast same-day post-perfusion ventilation imaging in patients with clinical suspicion of pulmonary embolism. (orig.)

  17. Optimisation of metabolic criteria in the prognostic assessment in patients with lymphoma. A multicentre study.

    Science.gov (United States)

    Del Puig Cózar-Santiago, M; García-Garzón, J R; Moragas-Freixa, M; Soler-Peter, M; Bassa Massanas, P; Sánchez-Delgado, M; Sanchez-Jurado, R; Aguilar-Barrios, J E; Sanz-Llorens, R; Ferrer-Rebolleda, J

    To compare sensitivity, specificity and predictive value of Deauville score (DS) vs. ΔSUVmax in interim-treatment PET (iPET) and end-treatment PET (ePET), in patients with diffuse large B cell lymphoma (DLBCL), Hodgkin lymphoma (HL), and follicular lymphoma (FL). Retrospective longitudinal multicentre study including 138 patients (46 DLBCL, 46 HL, 46 FL), on whom 3 18 F-FDG PET/CT were performed: baseline, iPET, and ePET. Visual (DS) and semi-quantitative (ΔSUVmax) parameters were determined for iPET and ePET. Predictive value was determined in relation to disease-free interval. Statistical analysis. iPET for DLBCL, HL, and FL: 1) sensitivity of DS: 76.92/83.33/61.53%; specificity: 78.78/85/81.81%; 2) sensitivity of ΔSUVmax: 53.84/83.33/61.53%; specificity: 87.87/87.50/78.78%. ePET for DLBCL, HL and FL: 1) sensitivity of DS: 61.53/83.33/69.23%; specificity: 90.90/85/87.87%; 2) sensitivity of ΔSUVmax: 69.23/83.33/69.23%; specificity: 90.90/87.50/84.84%. Predictive assessment. iPET study: in DLBCL, DS resulted in 10.3% recurrence of negative iPET, and 17.1% in ΔSUVmax at disease-free interval; in HL, both parameters showed a 2.8% recurrence of negative iPET; in FL, DS resulted in 15.6% recurrence of negative iPET, and 16.1% in ΔSUVmax, with no statistical significance. ePET study: in DLBCL, DS resulted in 14.3% recurrence of negative ePET, and 11.8% in ΔSUVmax at disease-free interval; in HL and FL, both methods showed 2.8 and 12.5% recurrence in negative ePET, respectively. DS and ΔSUVmax did not show significant differences in DLBCL, HL and FL. Their predictive value also did not show significant differences in HL and FL. In DLBCL, DS was higher in iPET, and ΔSUVmax in ePET. Copyright © 2017 Elsevier España, S.L.U. y SEMNIM. All rights reserved.

  18. 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

  19. Impact of treatment delay on mortality in ST-segment elevation myocardial infarction (STEMI) patients presenting with and without haemodynamic instability: results from the German prospective, multicentre FITT-STEMI trial.

    Science.gov (United States)

    Scholz, Karl Heinrich; Maier, Sebastian K G; Maier, Lars S; Lengenfelder, Björn; Jacobshagen, Claudius; Jung, Jens; Fleischmann, Claus; Werner, Gerald S; Olbrich, Hans G; Ott, Rainer; Mudra, Harald; Seidl, Karlheinz; Schulze, P Christian; Weiss, Christian; Haimerl, Josef; Friede, Tim; Meyer, Thomas

    2018-04-01

    The aim of this study was to investigate the effect of contact-to-balloon time on mortality in ST-segment elevation myocardial infarction (STEMI) patients with and without haemodynamic instability. Using data from the prospective, multicentre Feedback Intervention and Treatment Times in ST-Elevation Myocardial Infarction (FITT-STEMI) trial, we assessed the prognostic relevance of first medical contact-to-balloon time in n = 12 675 STEMI patients who used emergency medical service transportation and were treated with primary percutaneous coronary intervention (PCI). Patients were stratified by cardiogenic shock (CS) and out-of-hospital cardiac arrest (OHCA). For patients treated within 60 to 180 min from the first medical contact, we found a nearly linear relationship between contact-to-balloon times and mortality in all four STEMI groups. In CS patients with no OHCA, every 10-min treatment delay resulted in 3.31 additional deaths in 100 PCI-treated patients. This treatment delay-related increase in mortality was significantly higher as compared to the two groups of OHCA patients with shock (2.09) and without shock (1.34), as well as to haemodynamically stable patients (0.34, P < 0.0001). In patients with CS, the time elapsing from the first medical contact to primary PCI is a strong predictor of an adverse outcome. This patient group benefitted most from immediate PCI treatment, hence special efforts to shorten contact-to-balloon time should be applied in particular to these high-risk STEMI patients. NCT00794001.

  20. Patient’s satisfaction after 2-piece inflatable penile prosthesis implantation: An Italian multicentric study

    Directory of Open Access Journals (Sweden)

    Giorgio Gentile

    2016-03-01

    Full Text Available Introduction: Penile prosthesis implant represents a valuable solution for pts with severe erectile dysfunction (ED, non-responders to medical management. The aim of our study was to evaluate the satisfaction of patients (pts after 2-pieces inflatable penile prosthesis (IPP. Aim of the study: to evaluate safety, reliability and post-operative patient’s satisfaction after implantation of two-pieces IPP. Materials and Methods: This retrospective multicentric analysis concerns a group of 42 patients undergone 2-pieces IPP implantation from November 2005 to November 2013, in four Centers of proven experience. As a first step, a detailed review of all clinical reports was performed. Secondly, every patient was asked to fill the Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS specifically modified, in order to assess their own satisfaction after surgery and, its impact on patient’s quality of sexual life. Results: 42 pts were evaluated (AMS-Ambicor: 28; Coloplast- Excell: 14; mean age, at time of operation: 60,7 years; mean follow up: 27,6 months; etiology of ED: vascular 23,8%, diabetes 19%, La Peyronie D. 7,1%, consequence of radical prostatectomy 31%, consequence of other pelvic surgery 11,9%, spinal trauma 7%. Mean operative time: 117 ± 58 min, mean postoperative hospital stay 3 ± 1,6 days. Post operative short-term complications: 4 pts (9,5%. Post operative long-term complications: 4 pts (9,5%. Long-term functional results (Questionnaire: 71% of pts (30 reported regular use of the prosthesis, at least 1 time/week, the satisfaction was good in 42% of pts (18, quite good in 33,3% (14, quite bad in 2,4% (1, very bad in 7,1% (3, 6 pts (14,4% didn’t answer. Conclusions: 2 pieces IPP appears to be associated with a low complication rate and good satisfaction of pts especially in the elderly. It also assures satisfactory rates of aesthetics and functional results.

  1. Job satisfaction and turnover intention among Iraqi doctors--a descriptive cross-sectional multicentre study.

    Science.gov (United States)

    Ali Jadoo, Saad Ahmed; Aljunid, Syed Mohamed; Dastan, Ilker; Tawfeeq, Ruqiya Subhi; Mustafa, Mustafa Ali; Ganasegeran, Kurubaran; AlDubai, Sami Abdo Radman

    2015-04-19

    During the last two decades, the Iraqi human resources for health was exposed to an unprecedented turnover of trained and experienced medical professionals. This study aimed to explore prominent factors affecting turnover intentions among Iraqi doctors. A descriptive cross-sectional multicentre study was carried out among 576 doctors across 20 hospitals in Iraq using multistage sampling technique. Participants completed a self-administered questionnaire, which included socio-demographic information, work characteristics, the 10-item Warr-Cook-Wall job satisfaction scale, and one question on turnover intention. Descriptive and bivariate and multiple logistic regression analyses were conducted to identify significant factors affecting turnover intentions. More than one half of Iraqi doctors (55.2%) were actively seeking alternative employment. Factors associated with turnover intentions among doctors were low job satisfaction score (odds ratio (OR) = 0.97; 95% confidence interval (CI): 0.95, 0.99), aged 40 years old or less (OR = 2.9; 95% CI: 1.74, 4.75), being male (OR = 4.2; 95% CI: 2.54, 7.03), being single (OR = 5.0; 95% CI: 2.61, 9.75), being threatened (OR = 3.5; 95% CI: 1.80, 6.69), internally displaced (OR = 3.1; 95% CI: 1.43, 6.57), having a perception of unsafe medical practice (OR = 4.1; 95% CI: 1.86, 9.21), working more than 40 h per week, (OR = 2.3; 95% CI: 1.27, 4.03), disagreement with the way manager handles staff (OR = 2.2; 95% CI: 1.19, 4.03), being non-specialist, (OR = 3.9, 95% CI: 2.08, 7.13), and being employed in the government sector only (OR = 2.0; 95% CI: 1.09, 3.82). The high-turnover intention among Iraqi doctors is significantly associated with working and security conditions. An urgent and effective strategy is required to prevent doctors' exodus.

  2. A teaching intervention in a contouring dummy run improved target volume delineation in locally advanced non-small cell lung cancer. Reducing the interobserver variability in multicentre clinical studies

    International Nuclear Information System (INIS)

    Schimek-Jasch, Tanja; Prokic, Vesna; Doll, Christian; Grosu, Anca-Ligia; Nestle, Ursula; Troost, Esther G.C.; Ruecker, Gerta; Avlar, Melanie; Duncker-Rohr, Viola; Mix, Michael

    2015-01-01

    Interobserver variability in the definition of target volumes (TVs) is a well-known confounding factor in (multicentre) clinical studies employing radiotherapy. Therefore, detailed contouring guidelines are provided in the prospective randomised multicentre PET-Plan (NCT00697333) clinical trial protocol. This trial compares strictly FDG-PET-based TV delineation with conventional TV delineation in patients with locally advanced non-small cell lung cancer (NSCLC). Despite detailed contouring guidelines, their interpretation by different radiation oncologists can vary considerably, leading to undesirable discrepancies in TV delineation. Considering this, as part of the PET-Plan study quality assurance (QA), a contouring dummy run (DR) consisting of two phases was performed to analyse the interobserver variability before and after teaching. In the first phase of the DR (DR1), radiation oncologists from 14 study centres were asked to delineate TVs as defined by the study protocol (gross TV, GTV; and two clinical TVs, CTV-A and CTV-B) in a test patient. A teaching session was held at a study group meeting, including a discussion of the results focussing on discordances in comparison to the per-protocol solution. Subsequently, the second phase of the DR (DR2) was performed in order to evaluate the impact of teaching. Teaching after DR1 resulted in a reduction of absolute TVs in DR2, as well as in better concordance of TVs. The Overall Kappa(κ) indices increased from 0.63 to 0.71 (GTV), 0.60 to 0.65 (CTV-A) and from 0.59 to 0.63 (CTV-B), demonstrating improvements in overall interobserver agreement. Contouring DRs and study group meetings as part of QA in multicentre clinical trials help to identify misinterpretations of per-protocol TV delineation. Teaching the correct interpretation of protocol contouring guidelines leads to a reduction in interobserver variability and to more consistent contouring, which should consequently improve the validity of the overall study

  3. A teaching intervention in a contouring dummy run improved target volume delineation in locally advanced non-small cell lung cancer: Reducing the interobserver variability in multicentre clinical studies.

    Science.gov (United States)

    Schimek-Jasch, Tanja; Troost, Esther G C; Rücker, Gerta; Prokic, Vesna; Avlar, Melanie; Duncker-Rohr, Viola; Mix, Michael; Doll, Christian; Grosu, Anca-Ligia; Nestle, Ursula

    2015-06-01

    Interobserver variability in the definition of target volumes (TVs) is a well-known confounding factor in (multicentre) clinical studies employing radiotherapy. Therefore, detailed contouring guidelines are provided in the prospective randomised multicentre PET-Plan (NCT00697333) clinical trial protocol. This trial compares strictly FDG-PET-based TV delineation with conventional TV delineation in patients with locally advanced non-small cell lung cancer (NSCLC). Despite detailed contouring guidelines, their interpretation by different radiation oncologists can vary considerably, leading to undesirable discrepancies in TV delineation. Considering this, as part of the PET-Plan study quality assurance (QA), a contouring dummy run (DR) consisting of two phases was performed to analyse the interobserver variability before and after teaching. In the first phase of the DR (DR1), radiation oncologists from 14 study centres were asked to delineate TVs as defined by the study protocol (gross TV, GTV; and two clinical TVs, CTV-A and CTV-B) in a test patient. A teaching session was held at a study group meeting, including a discussion of the results focussing on discordances in comparison to the per-protocol solution. Subsequently, the second phase of the DR (DR2) was performed in order to evaluate the impact of teaching. Teaching after DR1 resulted in a reduction of absolute TVs in DR2, as well as in better concordance of TVs. The Overall Kappa(κ) indices increased from 0.63 to 0.71 (GTV), 0.60 to 0.65 (CTV-A) and from 0.59 to 0.63 (CTV-B), demonstrating improvements in overall interobserver agreement. Contouring DRs and study group meetings as part of QA in multicentre clinical trials help to identify misinterpretations of per-protocol TV delineation. Teaching the correct interpretation of protocol contouring guidelines leads to a reduction in interobserver variability and to more consistent contouring, which should consequently improve the validity of the overall study

  4. Puberty in perinatal HIV-1 infection: a multicentre longitudinal study of 212 children.

    Science.gov (United States)

    de Martino, M; Tovo, P A; Galli, L; Gabiano, C; Chiarelli, F; Zappa, M; Gattinara, G C; Bassetti, D; Giacomet, V; Chiappini, E; Duse, M; Garetto, S; Caselli, D

    2001-08-17

    To define age at entry into Tanner stages in children with perinatal HIV-1 infection. Multicentre longitudinal study including 212 perinatally HIV-1-infected children (107 girls and 105 boys) followed-up during puberty (from 8 and 9 years onwards in girls and boys, respectively). Healthy children (843 girls and 821 boys) provided reference percentiles. P2 or B2 stages in girls and P2 or G2 stages in boys defined onset of puberty. The cumulative probability [95% confidence limit (CI)] of entry into each stage at different ages was estimated by the Kaplan-Meier product-limit method; differences were evaluated by log rank test. Relationships were tested using the Spearman's rank correlation coefficient. Ages of girls [years (95%CI)] at P2 [12.9 (12.6-13.2)], P3 [13.4 (13.0-13.8)], P4 [14.6 (14.0-15.2)], B2 [12.7 (12.2-13.2)], B3 [13.3 (12.8-14.0)] and B4 [14.6 (14.0-15.2)] stages were > 97th percentile (> or = 21 month delay) of controls. Ages of boys [years (95%CI)] at P2 [12.6 (12.1-13.1)], P3 [13.9 (13.4-14.4)], P4 [14.9 (14.2-15.6)], G2 [12.1 (11.5-12.7)], G3 [13.6 (13.1-14.1)] and G4 [14.9 (14.1-15.7)] stages were at the 75-97th percentiles (< or = 15 month delay). Age at onset of puberty was not related to clinical and immunological condition, antiretroviral treatment, weigh for height and age at onset of severe disease or immune suppression. Perinatal HIV-1 infection interferes with sexual maturation. The mechanisms by which this occurs should be elucidated and intervention strategies designed. Intervention could save much psychological distress, since associated linear growth failure can exacerbate adolescents' feelings of being different and unwell.

  5. Treatment of Advanced Glaucoma Study: a multicentre randomised controlled trial comparing primary medical treatment with primary trabeculectomy for people with newly diagnosed advanced glaucoma-study protocol.

    Science.gov (United States)

    King, Anthony J; Fernie, Gordon; Azuara-Blanco, Augusto; Burr, Jennifer M; Garway-Heath, Ted; Sparrow, John M; Vale, Luke; Hudson, Jemma; MacLennan, Graeme; McDonald, Alison; Barton, Keith; Norrie, John

    2017-10-26

    Presentation with advanced glaucoma is the major risk factor for lifetime blindness. Effective intervention at diagnosis is expected to minimise risk of further visual loss in this group of patients. To compare clinical and cost-effectiveness of primary medical management compared with primary surgery for people presenting with advanced open-angle glaucoma (OAG). Design : A prospective, pragmatic multicentre randomised controlled trial (RCT). Twenty-seven UK hospital eye services. Four hundred and forty patients presenting with advanced OAG, according to the Hodapp-Parish-Anderson classification of visual field loss. Participants will be randomised to medical treatment or augmented trabeculectomy (1:1 allocation minimised by centre and presence of advanced disease in both eyes). The primary outcome is vision-related quality of life measured by the National Eye Institute-Visual Function Questionnaire-25 at 24 months. Secondary outcomes include generic EQ-5D-5L, Health Utility Index-3 and glaucoma-related health status (Glaucoma Utility Index), patient experience, visual field measured by mean deviation value, logarithm of the mean angle of resolution visual acuity, intraocular pressure, adverse events, standards for driving and eligibility for blind certification. Incremental cost per quality-adjusted life-year (QALY) based on EQ-5D-5L and glaucoma profile instrument will be estimated. The study will report the comparative effectiveness and cost-effectiveness of medical treatment against augmented trabeculectomy in patients presenting with advanced glaucoma in terms of patient-reported health and visual function, clinical outcomes and incremental cost per QALY at 2 years. Treatment of Advanced Glaucoma Study will be the first RCT reporting outcomes from the perspective of those with advanced glaucoma. ISRCTN56878850, Pre-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial

  6. Distribution of causes of maternal mortality during delivery and post-partum: results of an African multicentre hospital-based study.

    Science.gov (United States)

    Thonneau, Patrick F; Matsudai, Tomohiro; Alihonou, Eusèbe; De Souza, Jose; Faye, Ousseynou; Moreau, Jean-Charles; Djanhan, Yao; Welffens-Ekra, Christiane; Goyaux, Nathalie

    2004-06-15

    To assess the maternal mortality ratio in maternity units of reference hospitals in large west African cities, and to describe the distribution of complications and causes of maternal deaths. Prospective descriptive study in twelve reference maternities located in three African countries (Benin, Ivory Coast, Senegal). Data (clinical findings at hospital entry, medical history, complications, type of surgery, vital status of the women at discharge) were collected from obstetrical and surgical files and from admission hospital registers. All cases of maternal deaths were systematically reviewed by African and European staff. Of a total of 10,515 women, 1495 presented a major obstetric complication with dystocia or inappropriate management of the labour phase as the leading cause. Eighty-five maternal deaths were reported, giving a global hospital-based maternal mortality ratio of 800/100,000. Hypertensive disorders were involved in 25/85 cases (29%) and post-partum haemorrhage in 13/85 cases (15%). Relatively few cases (14) of major sepsis were reported, leading to three maternal deaths. The results of this multicentre study confirm the high rates of maternal mortality in maternity units of reference hospitals in large African cities, and in addition to dystocia the contribution of hypertensive disorders and post-partum haemorrhage to maternal deaths.

  7. The prognostic value of pimonidazole and tumour pO2 in human cervix carcinomas after radiation therapy: a prospective international multi-center study

    DEFF Research Database (Denmark)

    Nordsmark, Marianne; Loncaster, Julie; Aquino-Parsons, Christina

    2006-01-01

    BACKGROUND AND PURPOSE: Hypoxia adversely affects treatment outcome in human uterine cervical cancer. Here, we present the results of a prospective international multi-centre study evaluating the prognostic value of pre-treatment tumour oxygen partial pressure (pO(2)) and the hypoxia marker pimon...... pimonidazole (pimo). MATERIALS AND METHODS: One hundred and twenty-seven patients with primary cervix cancer were entered. Pre-treatment tumour pO(2) measurements were obtained, and reported by the median tumour pO(2), the fraction of pO(2) values......BACKGROUND AND PURPOSE: Hypoxia adversely affects treatment outcome in human uterine cervical cancer. Here, we present the results of a prospective international multi-centre study evaluating the prognostic value of pre-treatment tumour oxygen partial pressure (pO(2)) and the hypoxia marker...

  8. 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...

  9. Antiproliferative effects of lanreotide autogel in patients with progressive, well-differentiated neuroendocrine tumours: a Spanish, multicentre, open-label, single arm phase II study

    International Nuclear Information System (INIS)

    Martín-Richard, Marta; Sala, Maria Angeles; Pericay, Carlos; Rivera, Fernando; Sastre, Javier; Segura, Ángel; Quindós, Maria; Maisonobe, Pascal; Massutí, Bartomeu; Pineda, Eva; Alonso, Vicente; Marmol, Maribel; Castellano, Daniel; Fonseca, Emilio; Galán, Antonio; Llanos, Marta

    2013-01-01

    Somatostatin analogues (SSAs) are indicated to relieve carcinoid syndrome but seem to have antiproliferative effects on neuroendocrine tumours (NETs). This is the first prospective study investigating tumour stabilisation with the long-acting SSA lanreotide Autogel in patients with progressive NETs. This was a multicentre, open-label, phase II trial conducted in 17 Spanish specialist centres. Patients with well-differentiated NETs and radiologically confirmed progression within the previous 6 months received lanreotide Autogel, 120 mg every 28 days over ≤92 weeks. The primary endpoint was progression-free survival (PFS). Secondary endpoints were response rate, tumour biomarkers, symptom control, quality of life (QoL), and safety. Radiographic imaging was assessed by a blinded central radiologist. Of 30 patients included in the efficacy and safety analyses, 40% had midgut tumours and 27% pancreatic tumours; 63% of tumours were functioning. Median PFS time was 12.9 (95% CI: 7.9, 16.5) months, and most patients achieved disease stabilisation (89%) or partial response (4%). No deterioration in QoL was observed. Nineteen patients (63%) experienced treatment-related adverse events, most frequently diarrhoea and asthenia; only one treatment-related adverse event (aerophagia) was severe. Lanreotide Autogel provided effective tumour stabilisation and PFS >12 months in patients with progressive NETs ineligible for surgery or chemotherapy, with a safety profile consistent with the pharmacology of the class. ClinicalTrials.gov Identifier http://clinicaltrials.gov/show/NCT00326469; EU Clinical Trial Register EudraCT no 2004-002871-18

  10. Improving the well-being of elderly patients via community pharmacy-based provision of pharmaceutical care - A multicentre study in seven European countries

    NARCIS (Netherlands)

    Bernsten, C; Bjorkman, [No Value; Caramona, M; Crealey, G; Frokjaer, B; Grundberger, E; Gustafsson, T; Henman, M; Herborg, H; Hughes, C; McElnay, J; Magner, M; van Mil, F; Schaeffer, M; Silva, S; Sondergaard, B; Sturgess, [No Value; Tromp, D; Vivero, L; Winterstein, A

    2001-01-01

    Objective: This study aimed to measure the outcomes of a harmonised, structured pharmaceutical care programme provided to elderly patients: (greater than or equal to 65 years of age) by community pharmacists in a multicentre international study performed in 7 European countries. Design and setting:

  11. European Prospective Investigation into Cancer and Nutrition (EPIC) calibration study: rationale, design and population characteristics

    DEFF Research Database (Denmark)

    Slimani, N.; Kaaks, R.; Ferrari, P.

    2002-01-01

    The European Prospective Investigation into Cancer and Nutrition (EPIC), which covers a large cohort of half a million men and women from 23 European centres in 10 Western European countries, was designed to study the relationship between diet and the risk of chronic diseases, particularly cancer......, a calibration approach was developed. This approach involved an additional dietary assessment common across study populations to re-express individual dietary intakes according to the same reference scale. A single 24-hour diet recall was therefore collected, as the EPIC reference calibration method, from...... in a large multi-centre European study. These studies showed that, despite certain inherent methodological and logistic constraints, a study design such as this one works relatively well in practice. The average response in the calibration study was 78.3% and ranged from 46.5% to 92.5%. The calibration...

  12. Emergency IVF for embryo freezing to preserve female fertility: a French multicentre cohort study.

    Science.gov (United States)

    Courbiere, B; Decanter, C; Bringer-Deutsch, S; Rives, N; Mirallié, S; Pech, J C; De Ziegler, D; Carré-Pigeon, F; May-Panloup, P; Sifer, C; Amice, V; Schweitzer, T; Porcu-Buisson, G; Poirot, C

    2013-09-01

    What are the outcomes of French emergency IVF procedures involving embryo freezing for fertility preservation before gonadotoxic treatment? Pregnancy rates after emergency IVF, cryopreservation of embryos, storage, thawing and embryo transfer (embryo transfer), in the specific context of the preservation of female fertility, seem to be similar to those reported for infertile couples undergoing ART. A French retrospective multicentre cohort study initiated by the GRECOT network-the French Study Group for Ovarian and Testicular Cryopreservation. We sent an e-mail survey to the 97 French centres performing the assisted reproduction technique in 2011, asking whether the centre performed emergency IVF and requesting information about the patients' characteristics, indications, IVF cycles and laboratory and follow-up data. The response rate was 53.6% (52/97). Fourteen French centres reported that they performed emergency IVF (56 cycles in total) before gonadotoxic treatment, between 1999 and July 2011, in 52 patients. The patients had a mean age of 28.9 ± 4.3 years, and a median length of relationship of 3 years (1 month-15 years). Emergency IVF was indicated for haematological cancer (42%), brain tumour (23%), sarcoma (3.8%), mesothelioma (n = 1) and bowel cancer (n = 1). Gynaecological problems accounted for 17% of indications. In 7.7% of cases, emergency IVF was performed for autoimmune diseases. Among the 52 patients concerned, 28% (n = 14) had undergone previous courses of chemotherapy before beginning controlled ovarian stimulation (COS). The initiation of gonadotoxic treatment had to be delayed in 34% of the patients (n = 19). In total, 56 cycles were initiated. The mean duration of stimulation was 11.2 ± 2.5 days, with a mean peak estradiol concentration on the day on which ovulation was triggered of 1640 ± 1028 pg/ml. Three cycles were cancelled due to ovarian hyperstimulation syndrome (n = 1), poor response (n = 1) and treatment error (n = 1). A mean of 8

  13. Image acquisition and interpretation criteria for Tc-99m-HMPAO-labelled white blood cell scintigraphy : results of a multicentre study

    NARCIS (Netherlands)

    Erba, Paola A.; Glaudemans, Andor W. J. M.; Veltman, Niels C.; Sollini, Martina; Pacilio, Marta; Galli, Filippo; Dierckx, Rudi A. J. O.; Signore, Alberto

    Purpose There is no consensus yet on the best protocol for planar image acquisition and interpretation of radiolabelled white blood cell (WBC) scintigraphy. This may account for differences in reported diagnostic accuracy amongst different centres. Methods This was a multicentre retrospective study

  14. Comparative activity of tigecycline and tetracycline on Gram-negative and Gram-positive bacteria revealed by a multicentre study in four North European countries

    DEFF Research Database (Denmark)

    Nilsson, Lennart E; Frimodt-Møller, Niels; Vaara, Martti

    2011-01-01

    This study involves a multicentre surveillance of tigecycline and tetracycline activity against Gram-negative and Gram-positive bacteria from primary care centres (PCCs), general hospital wards (GHWs) and intensive care units (ICUs) in Denmark (n = 9), Finland (n = 10), Norway (n = 7) and Sweden (n...

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

    NARCIS (Netherlands)

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

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

  16. 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

  17. Comparison between repaglinide and glipizide in Type 2 diabetes mellitus: a 1-year multicentre study

    DEFF Research Database (Denmark)

    Madsbad, Sten; Kilhovd, B; Lager, I

    2001-01-01

    AIMS: To evaluate the long-term effectiveness and safety of repaglinide, a novel prandial glucose regulator, in comparison with glipizide in the treatment of patients with Type 2 diabetes. METHODS: Diet or tablet-treated patients with Type 2 diabetes (n = 256; age 40-75 years, body mass index (BMI...... with Type 2 diabetes, and is better than glipizide in controlling HbA1c and FBG levels, overall, and in OHA-naive patients.......) 20-35 kg/m2, HbA1c 4.2-12.8%), without signs of severe microvascular or macrovascular complications, were included in this double-blind, multicentre, parallel-group comparative trial. Patients were randomized at a 2:1 ratio to repaglinide, 1-4 mg at mealtimes, or glipizide, 5-15 mg daily. RESULTS...

  18. Uranium project. Geochemistry prospection[Study of Uranium geochemical prospection in Uruguay]; Proyecto Uranio. Prospeccion geoquimica

    Energy Technology Data Exchange (ETDEWEB)

    Lambert, J

    1983-07-01

    Geochemistry studies the distribution of the chemicals elements in the terrestrial crust and its ways to migrate. The terminology used in this report is the following one: 1) Principles of the prospection geochemistry 2) Stages of the prospection geochemistry 3)utility of the prospection geochemistry 4) geochemistry of uranium 5) procedures used within the framework of uranium project 6) Average available 7) Selection of the zones of prospection geochemistry 8) Stages of the prospection, Sample preparation and analisis 9) Presentation of the results.

  19. Radiofrequency-induced thermal therapy: results of a European multicentre study of resistive ablation of incompetent truncal varicose veins.

    Science.gov (United States)

    Braithwaite, B; Hnatek, L; Zierau, U; Camci, M; Akkersdijk, Gjm; Nio, D; Sarlija, M; Ajduk, M; Santoro, P; Roche, E

    2013-02-01

    To investigate the effectiveness of bipolar radiofrequency-induced thermal therapy (RFITT) in a multicentre non-randomized study. Some 672 incompetent saphenous veins (85% great saphenous varicose vein, 15% short saphenous vein) in 462 patients (56.5% CEAP [clinical, aetiological, anatomical and pathological elements] class 3 or worse) were treated in eight European centres. Patients were assessed between 180 and 360 days postoperatively. Occlusion rates were determined by duplex ultrasound and compared with the power used for treatment, pull back rate and experience of the operating surgeon. Complete occlusion rates of 98.4% were achieved when treatments were performed by an experienced operator (more than 20 cases), when the maximum power setting on the RFITT generator was between 18 and 20 W and the applicator was withdrawn at a rate slower than 1.5 second/cm RFITT is efficacious, well tolerated by patients and has a low incidence of procedure-related post-operative complications.

  20. Early marginal ulcer following Roux-en-Y gastric bypass under proton pump inhibitor treatment: prospective multicentric study Úlcera perianastomótica após derivação gástrica em Y-de-Roux mesmo em uso de inibidor de bomba de prótons: estudo prospectivo multicêntrico

    Directory of Open Access Journals (Sweden)

    Arthur Belarmino Garrido Jr.

    2010-06-01

    Full Text Available CONTEXT: Causal factors of gastrojejunal ulcers after Roux-en-Y gastric bypass include peptic acid secretion from the gastric pouch. Esomeprazole is a potent inhibitor of acid secretion. OBJECTIVE: To assess the occurrence of dyspepsia and gastrojejunal ulcers within the first 2 months after Roux-en-Y gastric bypass during the use of esomeprazole. METHODS: One hundred eighteen morbid obese subjects were submitted to Roux-en-Y gastric bypass. Preoperative upper gastrointestinal tract endoscopy was negative for H. pylori. All subjects received esomeprazole for 60 days after surgery. RESULTS: Two weeks after surgery only 13 mild symptoms were reported. After 2 months, 17 also moderate complaints were registered. Endoscopy around the 60th day showed esophagitis in 10 (8.5%, hiatal hernia in 2 (1.7%, foreign body in the anastomotic line in 12 (10.2% and gastrojejunal ulcers was observed in 9 (7.6% subjects, 2 of which had a suture material or metallic staple granuloma in the gastrojejunostomy. Ten subjects took nonsteroidal anti-inflammatory drugs at least once during study, but none of them developed ulcer. None of the subjects with ulcer had dyspeptic symptoms. CONCLUSION: The incidence of ulcer in the gastrojejunal anastomosis within the first 2 months following Rouxen-Y gastric bypass under proton pump inhibitors is considerable. It was not related to the use of non-steroidal anti-inflammatory drugs, highlighting the possibility of ischemia and foreign body as causal factors. The ulcers were asymptomatic, and all post-surgical dyspeptic symptoms were moderate in severity.CONTEXTO: Sintomas dispépticos são comuns após derivação gástrica em Y-de-Roux. Podem decorrer de úlceras de boca anastomótica, cujos possíveis fatores causais incluem a secreção cloridropéptica da bolsa gástrica, isquemia, efeito de corpo estranho dos materiais de sutura e uso de antiinflamatórios não-esteróides. O esomeprazol é um redutor potente da secre

  1. One-year multicentre outcomes of transapical aortic valve implantation using the SAPIEN XT™ valve: the PREVAIL transapical study.

    Science.gov (United States)

    Walther, Thomas; Thielmann, Matthias; Kempfert, Joerg; Schroefel, Holger; Wimmer-Greinecker, Gerhard; Treede, Hendrik; Wahlers, Thorsten; Wendler, Olaf

    2013-05-01

    The study aimed to evaluate 1-year outcomes of the multicentre PREVAIL transapical (TA) study of TA-aortic valve implantation (AVI) in high-risk patients. From September 2009 to August 2010, a total of 150 patients, aged 81.6 ± 5.8 years, 40.7% female, were included at 12 European TA-AVI experienced sites. Patients received 23 (n = 36), 26 (n = 57) and 29 mm (n = 57) second-generation SAPIEN XT™ (Edwards Lifesciences, Irvine, CA, USA) valves. The mean logistic EuroSCORE was 24.3 ± 7.0, and mean Society Thoracic Surgeons score was 7.5 ± 4.4%. Survival was 91.3% at 30 days and 77.9% at 1 year. Subgroup analysis revealed survivals of 91.7/88.9, 86.0/70.2, 96.55/91.2% for patients receiving 23-, 26- and 29-mm valves at 30 days and at 1 year, respectively. Transthoracic echocardiography revealed preserved left ventricular ejection fraction and low gradients. Aortic incompetence was none in 41/48, trace 30/36, mild 22/12 and moderate in 7/4% at discharge and 1 year. Walking distance increased from 221 (postimplant) to 284 m (at 1 year, P = 0.0004). Three patients required reoperation due to increasing aortic incompetence during follow-up. Causes of mortality at 1 year were cardiac (n = 7), stroke (n = 1) and others (n = 5). The European PREVAIL multicentre trial demonstrates good functionality and good outcomes for TA-AVI using the second-generation SAPIEN XT prosthesis and the ASCENDRA-II delivery system. The 29-mm SAPIEN XT valve was successfully introduced and showed excellent results.

  2. Intra- and interobserver analysis in the morphological assessment of early stage embryos during an IVF procedure: a multicentre study

    Directory of Open Access Journals (Sweden)

    Devroe Johanna

    2011-09-01

    Full Text Available Abstract Background Quality control programs are necessary to maintain good clinical practice. Embryo grading has been described as one of the external quality assurance schemes. Although the evaluation of embryos is based on the assessment of morphological characteristics, considerable intra- and inter-observer variability has been described. In this multicentre study, the variability in the embryo evaluation has been evaluated using morphological characteristics on day 1, day 2 and day 3 of embryo development. Methods Five embryologists of four different IVF centers participated in this study. Multilevel images of embryos were presented on a website at different time points to evaluate intra-and inter-observer agreement in the assessment of embryo morphology. The embryos were evaluated on day 1, day 2 and day 3 of their development and each embryologist had to decide if the embryo had to be transferred, cryopreserved or discarded. Results Both intra-observer agreement and inter-observer agreement were good to excellent for the position of the pronuclei on day 1, the number of blastomeres on day 2 and day 3 and the clinical decision (transfer, cryopreservation, discard. For all other characteristics (size of pronuclei, presence of cytoplasomic halo, degree of fragmentation and size of blastomeres the intra- and inter-observer agreement was moderate to very poor. Conclusions Mono- or multicentre quality control on embryo scoring by morphological assessment can easily be performed through the design of a simple website. In the future the website design can be adapted to generate statistical feedback upon scoring and can even include a training module.

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

    Science.gov (United States)

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

    2006-12-21

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

  4. Malnutrition in Hospitalised Older Adults: A Multicentre Observational Study of Prevalence, Associations and Outcomes.

    Science.gov (United States)

    O'Shea, E; Trawley, S; Manning, E; Barrett, A; Browne, V; Timmons, S

    2017-01-01

    Malnutrition is common in older adults and is associated with high costs and adverse outcomes. The prevalence, predictors and outcomes of malnutrition on admission to hospital are not clear for this population. Prospective Cohort Study. Six hospital sites (five public, one private). In total, 606 older adults aged 70+ were included. All elective and acute admissions to any speciality were eligible. Day-case admissions and those moribund on admission were excluded. Socio-demographic and clinical data, including nutritional status (Mini-Nutritional Assessment - short form), was collected within 36 hours of admission. Outcome data was collected prospectively on length of stay, in-hospital mortality and new institutionalisation. The mean age was 79.7; 51% were female; 29% were elective admissions; 67% were admitted to a medical specialty. Nutrition scores were available for 602/606; 37% had a 'normal' status, 45% were 'at-risk', and 18% were 'malnourished'. Malnutrition was more common in females, acute admissions, older patients and those who were widowed/ separated. Dementia, functional dependency, comorbidity and frailty independently predicted a) malnutrition and b) being at-risk of malnutrition, compared to normal status (p Malnutrition was associated with outcomes including an increased length of stay (p < .001), new institutionalisation (p =<0.001) and in-hospital mortality (p < .001). These findings support the prioritisation of nutritional screening in clinical practice and public health policy, for all patients ≥70 on admission to hospital, and in particular for people with dementia, increased functional dependency and/or multi-morbidity, and those who are frail.

  5. Prediction of renal mass aggressiveness using clinical and radiographic features: a global, multicentre prospective study

    NARCIS (Netherlands)

    Golan, Shay; Eggener, Scott; Subotic, Svetozar; Barret, Eric; Cormio, Luigi; Naito, Seiji; Tefekli, Ahmet; Pilar Laguna Pes, M.

    2016-01-01

    To examine the ability of preoperative clinical characteristics to predict histological features of renal masses (RMs). Data from consecutive patients with clinical stage I RMs treated surgically between 2010 and 2011 in the Clinical Research Office of Endourology Society (CROES) Renal Mass Registry

  6. Patient-controlled hospital admission for patients with severe mental disorders: a nationwide prospective multicentre study.

    Science.gov (United States)

    Thomsen, C T; Benros, M E; Maltesen, T; Hastrup, L H; Andersen, P K; Giacco, D; Nordentoft, M

    2018-04-01

    To assess whether implementing patient-controlled admission (PCA) can reduce coercion and improve other clinical outcomes for psychiatric in-patients. During 2013-2016, 422 patients in the PCA group were propensity score matched 1:5 with a control group (n = 2110) that received treatment as usual (TAU). Patients were followed up for at least one year using the intention to treat principle utilising nationwide registers. In a paired design, the outcomes of PCA patients during the year after signing a contract were compared with the year before. No reduction in coercion (risk difference = 0.001; 95% CI: -0.038; 0.040) or self-harming behaviour (risk difference = 0.005; 95% CI: -0.008; 0.018) was observed in the PCA group compared with the TAU group. The PCA group had more in-patient bed days (mean difference = 28.4; 95% CI: 21.3; 35.5) and more medication use (P < 0.0001) than the TAU group. Before and after analyses showed reduction in coercion (P = 0.0001) and in-patient bed days (P = 0.0003). Implementing PCA did not reduce coercion, service use or self-harm behaviour when compared with TAU. Beneficial effects of PCA were observed only in the before and after PCA comparisons. Further research should investigate whether PCA affects other outcomes to better establish its clinical value. © 2018 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  7. [Introduction of capillary glycosylated haemoglobin determination in a Primary Care Health Area: Multicentre study of the evolution of patients with type 2 diabetes mellitus].

    Science.gov (United States)

    Núñez-Sánchez, M Á; Cervantes-Cuesta, M Á; Brocal-Ibañez, P; Salmeron-Arjona, E; León-Martínez, L P; Cerezo-Sanmartin, M

    The aim of this study was to evaluate the efficiency of a joint intervention that included educational components, self-assessment, and information to optimise diabetes control through the introduction of instant capillary glycosylated haemoglobin (HbA1c) determination in Primary Care. A multicentre prospective descriptive study was carried out over 3years in 10Primary Care Centres of the Area VII Murcia East. At the end of the study there were 804 patients with type 2 diabetes (DM2). Patients were divided into 4 groups based on initial values of HbA1c, and if changes in their treatment were needed. HbA1c, body mass index, and blood pressure were monitored. A financial assessment was also performed on the impact of the implementation of a protocol to measure instant capillary RESULTS: A significant reduction was observed in HbA1c values. The initial HbA1c mean value was 7.4±1.4%, which decreased to a final value of 6.9±1.0% (P<.001). At the end of the study, 71.4% of patients included reached diabetic control objectives. In addition, the financial assessment demonstrated that the implementation of this diabetes control system led to a decrease of the 24.7% in spending on glucose strips after the first year of study in Area VII Murcia Health Service. The introduction of capillary HbA1c determination in Primary Care has demonstrated to improve diabetes control and the efficiency of the health personnel. Furthermore, a reduction in the health costs of patients with DM2 was also shown. Copyright © 2016 SECA. Publicado por Elsevier España, S.L.U. All rights reserved.

  8. Comparison of manual and semi-automatic measuring techniques in MSCT scans of patients with lymphoma: a multicentre study

    Energy Technology Data Exchange (ETDEWEB)

    Hoeink, A.J.; Wessling, J.; Schuelke, C.; Kohlhase, N.; Wassenaar, L.; Heindel, W.; Buerke, B. [University Hospital Muenster, Department of Clinical Radiology, Muenster (Germany); Koch, R. [University of Muenster, Institute of Biostatistics and Clinical Research (IBKF), Muenster (Germany); Mesters, R.M. [University Hospital Muenster, Department of Haematology and Oncology, Muenster (Germany); D' Anastasi, M.; Graser, A.; Karpitschka, M. [University Hospital Muenchen (LMU), Institute of Clinical Radiology, Muenchen (Germany); Fabel, M.; Wulff, A. [University Hospital Kiel, Department of Clinical Radiology, Kiel (Germany); Pinto dos Santos, D. [University Hospital Mainz, Department of Diagnostic and Interventional Radiology, Mainz (Germany); Kiessling, A. [University Hospital Marburg, Department of Diagnostic and Interventional Radiology, Marburg (Germany); Dicken, V.; Bornemann, L. [Institute of Medical Imaging Computing, Fraunhofer MeVis, Bremen (Germany)

    2014-11-15

    Multicentre evaluation of the precision of semi-automatic 2D/3D measurements in comparison to manual, linear measurements of lymph nodes regarding their inter-observer variability in multi-slice CT (MSCT) of patients with lymphoma. MSCT data of 63 patients were interpreted before and after chemotherapy by one/tworadiologists in five university hospitals. In 307 lymph nodes, short (SAD)/long (LAD) axis diameter and WHO area were determined manually and semi-automatically. Volume was solely calculated semi-automatically. To determine the precision of the individual parameters, a mean was calculated for every lymph node/parameter. Deviation of the measured parameters from this mean was evaluated separately. Statistical analysis entailed intraclass correlation coefficients (ICC) and Kruskal-Wallis tests. Median relative deviations of semi-automatic parameters were smaller than deviations of manually assessed parameters, e.g. semi-automatic SAD 5.3 vs. manual 6.5 %. Median variations among different study sites were smaller if the measurement was conducted semi-automatically, e. g. manual LAD 5.7/4.2 % vs. semi-automatic 3.4/3.4 %. Semi-automatic volumetry was superior to the other parameters (2.8 %). Semi-automatic determination of different lymph node parameters is (compared to manually assessed parameters) associated with a slightly greater precision and a marginally lower inter-observer variability. These results are with regard to the increasing mobility of patients among different medical centres and in relation to the quality management of multicentre trials of importance. (orig.)

  9. A prospective study of gentamicin ototoxicity

    DEFF Research Database (Denmark)

    Winkel, O; Hansen, M M; Kaaber-Bühler, Søren

    2010-01-01

    of gentamicin did not rule out the possiblity of ototoxicity. These results urge the continuing of prospective studies and indicate that gentamicin should be used only as a link in the primary treatment of severe infection or in cases in which other, less toxic agents have failed....

  10. A prospective study of gentamicin ototoxicity

    DEFF Research Database (Denmark)

    Winkel, O; Hansen, M M; Kaaber-Bühler, Søren

    1978-01-01

    of gentamicin did not rule out the possiblity of ototoxicity. These results urge the continuing of prospective studies and indicate that gentamicin should be used only as a link in the primary treatment of severe infection or in cases in which other, less toxic agents have failed....

  11. Rehabilitation of traumatic brain injury in Italy: a multi-centred study.

    Science.gov (United States)

    Zampolini, M; Zaccaria, B; Tolli, V; Frustaci, A; Franceschini, M

    2012-01-01

    The aims of this study were to analyse TBI rehabilitation in Italy, identifying the main factors conditioning motor and functional recovery and destination upon discharge of traumatic severe acquired brain injury (sABI) patients who had undergone intensive rehabilitative treatment. An observational prospective study of 863 consecutive patients admitted to 52 Rehabilitation Centres from January 2001 to December 2003. The main cause of trauma was road accidents (79.8%), the mean length of stay was 87.31 ± 77.26 days and 40.4% access to rehabilitation facilities after a month. Pressure sore rates fell from 26.1% to 6.6% during the rehabilitation programme. After discharge 615 patients returned home, whilst 212 were admitted to other health facilities. This study highlights some major criticisms of rehabilitation of TBI. The delay of admission and evitable complications such as pressure sores are correlated to a worse outcome. While LOS causes a problem of cost-effectiveness, the rate of home discharge is prevalent and very high compared with other studies.

  12. Treatment influencing down-staging in EORTC Melanoma Group sentinel node histological protocol compared with complete step-sectioning: a national multicentre study.

    Science.gov (United States)

    Riber-Hansen, Rikke; Hastrup, Nina; Clemmensen, Ole; Behrendt, Nille; Klausen, Siri; Ramsing, Mette; Spaun, Eva; Hamilton-Dutoit, Stephen Jacques; Steiniche, Torben

    2012-02-01

    Metastasis size in melanoma sentinel lymph nodes (SLNs) is an emerging prognostic factor. Two European melanoma treatment trials include SLN metastasis diameters as inclusion criteria. Whilst diameter estimates are sensitive to the number of sections examined, the level of this bias is largely unknown. We performed a prospective multicentre study to compare the European Organisation for Research and Treatment of Cancer (EORTC) recommended protocol with a protocol of complete step-sectioning. One hundred and thirty-three consecutive SLNs from seven SLN centres were analysed by five central sections 50μm apart (EORTC Protocol) followed by complete 250μm step-sectioning. Overall, 29 patients (21.8%) were SLN-positive. The EORTC Protocol missed eight of these metastases (28%), one metastasis measuring less than 0.1mm in diameter, seven measuring between 0.1 and 1mm. Complete step-sectioning at 250μm intervals (Extensive Protocol) missed one metastasis (3%) that measured less than 0.1mm. Thirteen treatment courses (34%) performed if inclusion was based on the Combined Protocol would not be performed if assessed by the EORTC Protocol. Thus, 10 patients would be without completion lymph node dissection (EORTC MINITUB study), whilst three patients would not be eligible for anti-CTLA4 trial (EORTC protocol 18071). The corresponding number with the Extensive Protocol would be three; one patient for the MINITUB registration study and two patients for the anti-CTLA4 study. Examining SLNs by close central sectioning alone (EORTC Protocol) misses a substantial number of metastases and underestimates the maximum metastasis diameter, leading to important changes in patient eligibility for various treatment protocols. Copyright © 2011 Elsevier Ltd. All rights reserved.

  13. The diagnostic and therapeutic impact of MRI: an observational multi-centre study

    Energy Technology Data Exchange (ETDEWEB)

    Hollingworth, William; Todd, Christopher J.; Bell, Matthew I.; Arafat, Qais; Girling, Simon; Karia, Kanti R.; Dixon, Adrian K

    2000-11-01

    AIM: To provide information about the diagnostic and therapeutic impact of magnetic resonance imaging (MRI) and to compare the findings across diagnostic groups. MATERIALS AND METHODS: A prospective, observational study of 2017 consecutive referrals for MRI of the head, spine or knee at four imaging centres. Clinicians completed questionnaires before MRI stating initial diagnoses, diagnostic confidence and treatment plans. After imaging, a second questionnaire evaluated clinicians' revised diagnosis and treatment plans in the light of imaging findings. Patients were grouped into nine diagnostic categories for analysis. Comparison between pre- and post-imaging was used to assess the diagnostic and therapeutic impact of MRI. RESULTS: In seven of nine diagnostic groups MRI findings were associated with a diagnostic impact. Diagnoses were revised or discarded following normal MR findings and diagnostic confidence was increased by confirmative MR findings. There was no statistically significant diagnostic impact for suspected pituitary or cerebello-pontine angle lesions. In five of nine diagnostic groups (knee meniscus, knee ligament, multiple sclerosis, lumbar and cervical spine) MRI findings had a clear impact on treatment plans. CONCLUSION: This study demonstrates that in most diagnostic categories, MRI influences diagnosis and treatment. However, experimental studies are needed to prove that these diagnostic and therapeutic impacts lead to improved health. Hollingworth (2000)

  14. The diagnostic and therapeutic impact of MRI: an observational multi-centre study

    International Nuclear Information System (INIS)

    Hollingworth, William; Todd, Christopher J.; Bell, Matthew I.; Arafat, Qais; Girling, Simon; Karia, Kanti R.; Dixon, Adrian K.

    2000-01-01

    AIM: To provide information about the diagnostic and therapeutic impact of magnetic resonance imaging (MRI) and to compare the findings across diagnostic groups. MATERIALS AND METHODS: A prospective, observational study of 2017 consecutive referrals for MRI of the head, spine or knee at four imaging centres. Clinicians completed questionnaires before MRI stating initial diagnoses, diagnostic confidence and treatment plans. After imaging, a second questionnaire evaluated clinicians' revised diagnosis and treatment plans in the light of imaging findings. Patients were grouped into nine diagnostic categories for analysis. Comparison between pre- and post-imaging was used to assess the diagnostic and therapeutic impact of MRI. RESULTS: In seven of nine diagnostic groups MRI findings were associated with a diagnostic impact. Diagnoses were revised or discarded following normal MR findings and diagnostic confidence was increased by confirmative MR findings. There was no statistically significant diagnostic impact for suspected pituitary or cerebello-pontine angle lesions. In five of nine diagnostic groups (knee meniscus, knee ligament, multiple sclerosis, lumbar and cervical spine) MRI findings had a clear impact on treatment plans. CONCLUSION: This study demonstrates that in most diagnostic categories, MRI influences diagnosis and treatment. However, experimental studies are needed to prove that these diagnostic and therapeutic impacts lead to improved health. Hollingworth (2000)

  15. Effects of SofZia-preserved travoprost and benzalkonium chloride-preserved latanoprost on the ocular surface -- a multicentre randomized single-masked study.

    Science.gov (United States)

    Aihara, Makoto; Oshima, Hiromi; Araie, Makoto

    2013-02-01

    To assess the effect of SofZia-preserved travoprost on ocular surface conditions in comparison with benzalkonium chloride (BAK)-preserved latanoprost. A prospective randomized multicentre single-masked comparative study. Patients with open-angle glaucoma or ocular hypertension who had been treated with BAK-preserved latanoprost 0.005% (Xalatan(®) ) monotherapy for at least 3 months. Patients were enrolled at 23 facilities. Patients were randomly divided into the X-X group, continuous use of Xalatan(®) , or the X-T group, switching from Xalatan(®) to SofZia-preserved travoprost 0.004% (TravatanZ(®) ), and followed for 3 months. The superficial punctate keratopathy (SPK), conjunctival epitheliopathy, hyperaemia, tear break-up time (TBUT) and intraocular pressure (IOP) were examined for each patient in a masked manner. Changes in the frequency of keratoconjunctival epitheliopathy were evaluated 3 months after study initiation. Intra- and intergroup comparisons of changes in SPK, conjunctival epitheliopathy, hyperaemia, TBUT and IOP were also carried out. Two hundred twenty patients participated and 215 completed the 3-month study. The frequency of keratoconjunctival epitheliopathy significantly decreased in the X-T group (p = 0.036) and the intergroup difference was also significant (p = 0.001). SPK scores and TBUT were significantly improved in the X-T group (p = 0.034, 0.049), also with significant intergroup differences in the cornea excluding the inferior area and TBUT. There were no significant intergroup differences in changes of the hyperaemia scores and the IOP reduction. Switching to SofZia-preserved travoprost after BAK-preserved latanoprost resulted in a lower incidence of keratoconjunctival epitheliopathy, especially in the cornea, with no clinically relevant changes in hyperaemia and IOP. © 2012 The Authors. Acta Ophthalmologica © 2012 Acta Ophthalmologica Scandinavica Foundation.

  16. Optimisation and validation of a remote monitoring system (Onco-TreC) for home-based management of oral anticancer therapies: an Italian multicentre feasibility study.

    Science.gov (United States)

    Passardi, Alessandro; Rizzo, Mimma; Maines, Francesca; Tondini, Carlo; Zambelli, Alberto; Vespignani, Roberto; Andreis, Daniele; Massa, Ilaria; Dianti, Marco; Forti, Stefano; Piras, Enrico Maria; Eccher, Claudio

    2017-05-29

    Despite the growing number of oral agents available for cancer treatment, their efficacy may be reduced due to the lack of adherence, inappropriate adverse event self-management and arbitrary dose adjustment. The management of anticancer therapies could exponentially benefit from the introduction of mobile health technologies in a highly integrated electronic oncology system. We plan to customise and fine-tune an existing monitoring TreC platform used in different chronic diseases in the oncology setting. This project follows a multistep approach with two major purposes: 1. participatory design techniques driven by Health Literacy and Patient Reported Outcomes principles in order to adapt the system to the oncology setting involving patients and healthcare providers; 2. a prospective training-validation, interventional, non-pharmacological, multicentre study on a series of consecutive patients with cancer (20 and 60 patients in the training and validation steps, respectively) in order to assess system capability, usability and acceptability. The novel Onco-TreC 2.0 is expected to contribute to improving the adherence and safety of cancer care, promoting patient empowerment and patient-doctor communication. Ethical approval was obtained from the Independent Ethics Committees of the participating institutions (CEIIAV protocol Number 2549/2015; reference Number 1315-PU). Informed consent will be obtained from all study participants. Findings will be disseminated through peer-reviewed journals, conferences and event presentations. ClinicalTrials.gov (NCT02921724); (Pre-results). Other study ID Number: IRST100.18. © 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.

  17. The impact of incident fractures on health-related quality of life: 5 years of data from the Canadian Multicentre Osteoporosis Study.

    Science.gov (United States)

    Papaioannou, A; Kennedy, C C; Ioannidis, G; Sawka, A; Hopman, W M; Pickard, L; Brown, J P; Josse, R G; Kaiser, S; Anastassiades, T; Goltzman, D; Papadimitropoulos, M; Tenenhouse, A; Prior, J C; Olszynski, W P; Adachi, J D

    2009-05-01

    Using prospective data from the Canadian Multicentre Osteoporosis Study (CaMos), we compared health utilities index (HUI) scores after 5 years of follow-up among participants (50 years and older) with and without incident clinical fractures. Incident fractures had a negative impact on HUI scores over time. This study examined change in health-related quality of life (HRQL) in those with and without incident clinical fractures as measured by the HUI. The study cohort was 4,820 women and 1,783 men (50 years and older) from the CaMos. The HUI was administered at baseline and year 5. Participants were sub-divided into incident fracture groups (hip, rib, spine, forearm, pelvis, other) and were compared with those without these fractures. The effects of both time and fracture type on HUI scores were examined in multivariable regression analyses. Men and women with hip fractures, compared to those without, had lower HUI measures that ranged from -0.05 to -0.25. Both women and men with spine fractures had significant deficits on the pain attributes (-0.07 to -0.12). In women, self-care (-0.06), mobility and ambulation (-0.05) were also negatively impacted. Women with rib fractures had deficits similar to women with spine fractures, and these effects persisted over time. In men, rib fractures did not significantly affect HUI scores. Pelvic and forearm fractures did not substantially influence HUI scores. The HUI was a sensitive measure of HRQL change over time. These results will inform economic analyses evaluating osteoporosis therapies.

  18. Differential Item Functioning in the SF-36 Physical Functioning and Mental Health Sub-Scales: A Population-Based Investigation in the Canadian Multicentre Osteoporosis Study.

    Science.gov (United States)

    Lix, Lisa M; Wu, Xiuyun; Hopman, Wilma; Mayo, Nancy; Sajobi, Tolulope T; Liu, Juxin; Prior, Jerilynn C; Papaioannou, Alexandra; Josse, Robert G; Towheed, Tanveer E; Davison, K Shawn; Sawatzky, Richard

    2016-01-01

    Self-reported health status measures, like the Short Form 36-item Health Survey (SF-36), can provide rich information about the overall health of a population and its components, such as physical, mental, and social health. However, differential item functioning (DIF), which arises when population sub-groups with the same underlying (i.e., latent) level of health have different measured item response probabilities, may compromise the comparability of these measures. The purpose of this study was to test for DIF on the SF-36 physical functioning (PF) and mental health (MH) sub-scale items in a Canadian population-based sample. Study data were from the prospective Canadian Multicentre Osteoporosis Study (CaMos), which collected baseline data in 1996-1997. DIF was tested using a multiple indicators multiple causes (MIMIC) method. Confirmatory factor analysis defined the latent variable measurement model for the item responses and latent variable regression with demographic and health status covariates (i.e., sex, age group, body weight, self-perceived general health) produced estimates of the magnitude of DIF effects. The CaMos cohort consisted of 9423 respondents; 69.4% were female and 51.7% were less than 65 years. Eight of 10 items on the PF sub-scale and four of five items on the MH sub-scale exhibited DIF. Large DIF effects were observed on PF sub-scale items about vigorous and moderate activities, lifting and carrying groceries, walking one block, and bathing or dressing. On the MH sub-scale items, all DIF effects were small or moderate in size. SF-36 PF and MH sub-scale scores were not comparable across population sub-groups defined by demographic and health status variables due to the effects of DIF, although the magnitude of this bias was not large for most items. We recommend testing and adjusting for DIF to ensure comparability of the SF-36 in population-based investigations.

  19. 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

  20. Local epidemiology and resistance profiles in acute uncomplicated cystitis (AUC) in women: a prospective cohort study in an urban urological ambulatory setting.

    Science.gov (United States)

    Seitz, Michael; Stief, Christian; Waidelich, Raphaela

    2017-10-16

    Acute uncomplicated cystitis (AUC) is a common ailment in the urological setting. Guidelines for urinary tract infections are based on large-scale multi-centre, epidemiological and international studies. The objective of this observational study was to establish whether the results of a multi-centre study on the resistance profile of Escherichia coli (E. coli) in patients with AUC could be directly applied to an urological practice in a major European city or whether there are divergences in the resistance profile. An observational study was applied prospectively to 502 patients with AUC between January 2015 and January 2017). Personal data were anonymised. Exclusion criteria were the patient's age (AUC should therefore only be treated with TRS, CIP and AMC after a susceptibility test has been carried out.

  1. Autonomic symptoms in idiopathic REM behavior disorder: a multicentre case-control study.

    Science.gov (United States)

    Ferini-Strambi, Luigi; Oertel, Wolfgang; Dauvilliers, Yves; Postuma, Ronald B; Marelli, Sara; Iranzo, Alex; Arnulf, Isabelle; Högl, Birgit; Birgit, Högl; Manni, Raffaele; Miyamoto, Tomoyuki; Fantini, Maria-Livia; Puligheddu, Monica; Jennum, Poul; Sonka, Karel; Santamaria, Joan; Zucconi, Marco; Rancoita, Paola M V; Leu-Semenescu, Smeranda; Frauscher, Birgit; Terzaghi, Michele; Miyamoto, Masayuki; Unger, Marcus; Stiasny-Kolster, Karin; Desautels, Alex; Wolfson, Christina; Pelletier, Amélie; Montplaisir, Jacques

    2014-06-01

    Patients with idiopathic REM sleep behavior disorder (iRBD) are at very high risk of developing neurodegenerative synucleinopathies, which are disorders with prominent autonomic dysfunction. Several studies have documented autonomic dysfunction in iRBD, but large-scale assessment of autonomic symptoms has never been systematically performed. Patients with polysomnography-confirmed iRBD (318 cases) and controls (137 healthy volunteers and 181 sleep center controls with sleep diagnoses other than RBD) were recruited from 13 neurological centers in 10 countries from 2008 to 2011. A validated scale to study the disorders of the autonomic nervous system in Parkinson's disease (PD) patients, the SCOPA-AUT, was administered to all the patients and controls. The SCOPA-AUT consists of 25 items assessing the following domains: gastrointestinal, urinary, cardiovascular, thermoregulatory, pupillomotor, and sexual dysfunction. Our results show that compared to control subjects with a similar overall age and sex distribution, patients with iRBD experience significantly more problems with gastrointestinal, urinary, and cardiovascular functioning. The most prominent differences in severity of autonomic symptoms between our iRBD patients and controls emerged in the gastrointestinal domain. Interestingly, it has been reported that an altered gastrointestinal motility can predate the motor phase of PD. The cardiovascular domain SCOPA-AUT score in our study in iRBD patients was intermediate with respect to the scores reported in PD patients by other authors. Our findings underline the importance of collecting data on autonomic symptoms in iRBD. These data may be used in prospective studies for evaluating the risk of developing neurodegenerative disorders.

  2. Fibrinogen concentrate as a treatment for postpartum haemorrhage-induced coagulopathy: A study protocol for a randomised multicentre controlled trial. The fibrinogen in haemorrhage of DELivery (FIDEL) trial.

    Science.gov (United States)

    Ducloy-Bouthors, Anne-Sophie; Mignon, Alexandre; Huissoud, Cyril; Grouin, Jean-Marie; Mercier, Frédéric J

    2016-08-01

    Postpartum haemorrhage (PPH) remains the leading cause for maternal mortality worldwide. Hypofibrinogenaemia has been identified as a major risk factor for progress towards severe PPH. The efficacy of fibrinogen concentrate supplementation in PPH has been shown in various clinical settings but the level of evidence is not sufficient to prove the benefit, evaluate the risks, and determine the value, timing and dose of fibrinogen supplementation in PPH. The FIDEL trial objective is to evaluate the impact of a therapeutic strategy based on the early administration of human fibrinogen concentrate compared to the current practice based on late administration in severe PPH patients requiring second line uterotonics. This is a prospective multicentre, randomised, double-blind, placebo-controlled trial. A total of 412 patients will be randomised if they meet the following criteria: female patients≥18 years old, vaginal delivery, PPH requiring IV administration of prostaglandins (sulprostone) after 20 to 30minutes of oxytocin failure. The participants are assigned to receive either fibrinogen 3g or placebo infusions. The primary endpoint is a composite endpoint defined as the percentage of patients losing at least 4g/dL of Hb, and/or requiring a transfusion of at least 2 units of packed red blood cells, within the 48hours following fibrinogen administration. The purpose of this study is to demonstrate the efficacy and safety of an early fibrinogen concentrate infusion in uncontrolled active PPH. Copyright © 2016 Société française d'anesthésie et de réanimation (Sfar). Published by Elsevier Masson SAS. All rights reserved.

  3. International investigation of breast MRI: results of a multicentre study (11 sites) concerning diagnostic parameters for contrast-enhanced MRI based on 519 histopathologically correlated lesions

    International Nuclear Information System (INIS)

    Heywang-Koebrunner, S.H.; Bick, U.; Bradley, W.G. Jr.; Bone, B.; Casselman, J.; Coulthard, A.; Fischer, U.; Mueller-Schimpfle, M.; Oellinger, H.; Patt, R.; Teubner, J.; Friedrich, M.; Newstead, G.; Holland, R.; Schauer, A.; Sickles, E.A.; Tabar, L.; Waisman, J.; Wernecke, K.D.

    2001-01-01

    A multicentre study was undertaken to provide fundamentals for improved standardization and optimized interpretation guidelines of dynamic contrast-enhanced MRI. Only patients scheduled for biopsy of a clinical or imaging abnormality were included. They underwent standardized dynamic MRI on Siemens 1.0 (163 valid lesions ≥ 5 mm) or 1.5 T (395 valid lesions ≥ 5 mm) using 3D fast low-angle shot (FLASH; 87 s) before and five times after standardized bolus of 0.2 mmol Gd-DTPA/kg. One-Tesla and 1.5 T data were analysed separately using a discriminant analysis. Only histologically correlated lesions entered the statistical evaluation. Histopathology and imaging were correlated in retrospect and in open. The best results were achieved by combining up to five wash-in or wash-out parameters. Different weighting of false-negative vs false-positive calls allowed formulation of a statistically based interpretation scheme yielding optimized rules for the highest possible sensitivity (specificity 30 %), for moderate (50 %) or high (64-71 %) specificity. The sensitivities obtained at the above specificity levels were better at 1.0 T (98, 97, or 96 %) than at 1.5 T (96, 93, 86 %). Using a widely available standardized MR technique definition of statistically founded interpretation rules is possible. Choice of an optimum interpretation rule may vary with the clinical question. Prospective testing remains necessary. Differences of 1.0 and 1.5 T are not statistically significant but may be due to pulse sequences (orig.)

  4. International investigation of breast MRI: results of a multicentre study (11 sites) concerning diagnostic parameters for contrast-enhanced MRI based on 519 histopathologically correlated lesions

    Energy Technology Data Exchange (ETDEWEB)

    Heywang-Koebrunner, S.H. [Dept. of Diagnostic Radiology, Univ. Hospital Halle (Germany); Bick, U. [Dept. of Diagnostic Radiology, Westphalian Wilhelms Univ., Muenster (Germany); Bradley, W.G. Jr. [Memorial Medical Center, Long Beach, CA (United States); Bone, B. [Dept. of Diagnostic Radiology, Huddinge Univ., Stockholm (Sweden); Casselman, J. [Dept. of Diagnostic Radiology, Brugge (Belgium); Coulthard, A. [Dept. of Diagnostic Radiology, Royal Victoria Infirmary, Newcastle (United Kingdom); Fischer, U. [Dept. of Diagnostic Radiology, Georg August University, Goettingen (Germany); Mueller-Schimpfle, M. [Dept. of Diagnostic Radiology, Eberhard Karls University, Tuebingen (Germany); Oellinger, H. [Dept. of Diagnostic Radiology, Rudolph Virchow Univ. Clinic, Berlin (Germany); Patt, R. [Dept. of Diagnostic Radiology, Georgetown Univ., Washington, DC (United States); Teubner, J. [Dept. of Diagnostic Radiology, Mannheim Clinic, Heidelberg Univ. (Germany); Friedrich, M. [Dept. of Diagnostic Radiology, Urban Hospital, Berlin (Germany); Newstead, G. [Faculty Practice Radiology, New York Univ., NY (United States); Holland, R. [Dept. of Pathology, Univ. Hospital Nijmegen (Netherlands); Schauer, A. [Dept. of Pathology, Georg August Univ., Goettingen (Germany); Sickles, E.A. [Dept. of Radiology, University of California, San Francisco (United States); Tabar, L. [Falun Central Hospital, Falun (Sweden); Waisman, J. [Dept. of Pathology, New York University, NY (United States); Wernecke, K.D. [Inst. of Medical Biometrics, University Charite, Berlin (Germany)

    2001-04-01

    A multicentre study was undertaken to provide fundamentals for improved standardization and optimized interpretation guidelines of dynamic contrast-enhanced MRI. Only patients scheduled for biopsy of a clinical or imaging abnormality were included. They underwent standardized dynamic MRI on Siemens 1.0 (163 valid lesions {>=} 5 mm) or 1.5 T (395 valid lesions {>=} 5 mm) using 3D fast low-angle shot (FLASH; 87 s) before and five times after standardized bolus of 0.2 mmol Gd-DTPA/kg. One-Tesla and 1.5 T data were analysed separately using a discriminant analysis. Only histologically correlated lesions entered the statistical evaluation. Histopathology and imaging were correlated in retrospect and in open. The best results were achieved by combining up to five wash-in or wash-out parameters. Different weighting of false-negative vs false-positive calls allowed formulation of a statistically based interpretation scheme yielding optimized rules for the highest possible sensitivity (specificity 30 %), for moderate (50 %) or high (64-71 %) specificity. The sensitivities obtained at the above specificity levels were better at 1.0 T (98, 97, or 96 %) than at 1.5 T (96, 93, 86 %). Using a widely available standardized MR technique definition of statistically founded interpretation rules is possible. Choice of an optimum interpretation rule may vary with the clinical question. Prospective testing remains necessary. Differences of 1.0 and 1.5 T are not statistically significant but may be due to pulse sequences (orig.)

  5. Complications of ERCP: a prospective study

    DEFF Research Database (Denmark)

    Christensen, Merete; Matzen, Peter; Schulze, Svend

    2004-01-01

    included in this prospective study. Complications were assessed at the time of ERCP and by postal/telephone contact at 30-days after the procedure. RESULTS: A total of 1177 ERCPs were included in the analysis, of which 56.2% were therapeutic. The 30-day complication rate was 15.9%; the procedure...... occurred in relation to 5% of the ERCP procedures (3 deaths). Cardiorespiratory complications occurred in 2.3% (2 deaths). Dilated bile duct ( p = 0.0001), placement of stent ( p = 0.001), and use of more than 40 mg of hyoscine-N-butyl bromide ( p ... analysis. Risk of pancreatitis was increased with age under 40 years ( p = 0.0078), placement of stent ( p = 0.031), and a dilated bile duct ( p = 0.036). CONCLUSIONS: This prospective study confirms that the complication rate of ERCP including therapeutic procedures is high. Cardiopulmonary complications...

  6. Tfficacy to efficacy of thyroid/parotid ratio in the diagnosis of hyperthyroidism in different environmental conditions: a multi-centric study

    International Nuclear Information System (INIS)

    Das, B.K.; Pradhan, P.K.; Senthilnathan, M.S.

    2010-01-01

    and different ethnic populations as has been confirmed in this multi-centric prospective study. The morphological information obtained from the scan and the objective TPR value for functional status is sufficient to start definitive therapy on the same day in most cases without waiting for biochemical test results. This is important for patients coming from far off places and from poor socio-economic conditions. Thyroid Scan of a normal patient showing Thyroid to Parotid Ratio (TPR) of 1.30 which is within normal range (left panel bellow). Thyroid Scan of a hyperthyroid patient showing Thyroid to Parotid Ratio (TPR) of 15.26 which is more than six times of the normal value ±2SD (right panel bellow)

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

    Directory of Open Access Journals (Sweden)

    Fayers Peter

    2010-09-01

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

  8. European multi-centre study of the Nucleus Hybrid L24 cochlear implant

    NARCIS (Netherlands)

    Lenarz, T.; James, C.; Cuda, D.; Fitzgerald O'Connor, A.; Frachet, B.; Frijns, J.H.M.; Klenzner, T.; Laszig, R.; Manrique, M.; Marx, M.; Merkus, P.; Mylanus, E.A.M.; Offeciers, E.; Pesch, J.; Ramos-Macias, A.; Robier, A.; Sterkers, O.; Uziel, A.

    2013-01-01

    Objectives: To investigate the preservation of residual hearing in subjects who received the Nucleus Hybrid L24 cochlear implant. To investigate the performance benefits up to one year post-implantation in terms of speech recognition, sound quality, and quality of life. Design: Prospective, with

  9. Prevalence, risk factors and associated adverse pregnancy outcomes of anaemia in Chinese pregnant women: a multicentre retrospective study.

    Science.gov (United States)

    Lin, Li; Wei, Yumei; Zhu, Weiwei; Wang, Chen; Su, Rina; Feng, Hui; Yang, Huixia

    2018-04-23

    Anaemia in pregnant women is a public health problem, especially in developing countries. The aim of this study was to assess the prevalence and related risk factors of anaemia during pregnancy in a large multicentre retrospective study (n = 44,002) and to determine the adverse pregnancy outcomes in women with or without anaemia. The study is a secondary data analysis of a retrospective study named "Gestational diabetes mellitus Prevalence Survey (GPS) study in China". Structured questionnaires were used to collect socio-demographic characteristics, haemoglobin levels and pregnancy outcomes from all the participants. Anaemia in pregnancy is defined as haemoglobin anaemia and associated adverse pregnancy outcomes. The overall prevalence of anaemia was 23.5%. Maternal anaemia was significantly associated with maternal age ≥ 35 years (AOR = 1.386), family per capita monthly incomepregnancy BMI pregnancy outcomes, including GDM, polyhydramnios, preterm birth, low birth weight (anaemia than those without. The results indicated that anaemia continues to be a severe health problem among pregnant women in China. Anaemia is associated with adverse pregnancy outcomes. Pregnant women should receive routine antenatal care and be given selective iron supplementation when appropriate.

  10. Nocturnal emergency department visits, duration of symptoms and risk of hospitalisation among adults with asthma exacerbations: a multicentre observational study.

    Science.gov (United States)

    Yasuda, Hideto; Hagiwara, Yusuke; Watase, Hiroko; Hasegawa, Kohei

    2016-08-12

    We sought to compare the characteristics of patients with asthma presenting to the emergency department (ED) during the night-time with those of patients presenting at other times of the day, and to determine whether the time of ED presentation is associated with the risk of hospitalisation. A multicentre chart review study of 23 EDs across Japan. Patients aged 18-54 years with a history of physician-diagnosed asthma, presented to the ED between January 2009 and December 2011 OUTCOME MEASURES: The outcome of interest was hospitalisation, including admissions to an observation unit, inpatient unit and intensive care unit. Among the 1354 patients (30.1% in the night-time group vs 69.9% in the other time group) included in this study, the median age was 34 years and ∼40% were male. Overall 145 patients (10.7%) were hospitalised. Patients in the night-time group were more likely to have a shorter duration of symptoms (≤3 hours) before ED presentation than those in the other time group (25.9% in night-time vs 13.4% in other times; pdifferences in respiratory rate, initial peak expiratory flow or ED asthma treatment between the two groups (p>0.05). Similarly, the risk of hospitalisation did not differ between the two groups (11.3% in night-time vs 10.5% in other times; p=0.65). In a multivariable model adjusting for potential confounders, the risk of hospitalisation in the night-time group was not statistically different from the other time group (OR, 1.10; 95% CI 0.74 to 1.61; p=0.63). This multicentre study in Japan demonstrated no significant difference in the risk of hospitalisations according to the time of ED presentation. 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/

  11. 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

  12. 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.

  13. 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.

  14. The efficacy of Femal in women with premenstrual syndrome: a randomised, double-blind, parallel-group, placebo-controlled, multicentre study

    DEFF Research Database (Denmark)

    Gerhardsen, G.; Hansen, A.V.; Killi, M.

    2008-01-01

    Introduction: A double-blind, placebo-controlled, randomised, parallel-group, multicentre study was conducted to evaluate the effect of a pollen-based herbal medicinal product, Femal (R) (Sea-Band Ltd, Leicestershire, UK), on premenstrual sleep disturbances (PSD) in women with premenstrual syndrome...... as the main symptom cluster makes this herbal medicinal product a promising addition to the therapeutic arsenal for women with PMS Udgivelsesdato: 2008/6...

  15. 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)

  16. Multicentre structural and functional MRI

    OpenAIRE

    Gountouna, Viktoria-Eleni

    2014-01-01

    Neuroimaging techniques are likely to continue to improve our understanding of the brain in health and disease, but studies tend to be small, based in one imaging centre and of uncertain generalisability. Multicentre imaging studies therefore have great appeal but it is not yet clear under which circumstances data from different scanners can be combined. The successful harmonisation of multiple Magnetic Resonance Imaging (MRI) machines will increase study power, flexibility and...

  17. 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.

  18. Erectile dysfunction and quality of life in men receiving methadone or buprenorphine maintenance treatment. A cross-sectional multicentre study.

    Directory of Open Access Journals (Sweden)

    Fabio Lugoboni

    Full Text Available Erectile dysfunction (ED is common among men on opioid replacement therapy (ORT, but most previous studies exploring its prevalence and determinants yielded contrasting findings. Moreover, the impact of ED on patients' quality of life (QoL has been seldom explored.To explore the prevalence and determinants of ED in men on ORT, and the impact on QoL.In a multicentre cross-sectional study, we recruited 797 consecutive male patients on methadone and buprenorphine treatment, collected data on demographic, clinical, and psychopathological factors, and explored their role as predictors of ED and QoL through univariate and multivariate analysis. ED severity was assessed with a self-assessment questionnaire.Nearly half of patients in our sample were sexually inactive or reported some degree of ED. Some demographic, clinical and psychopathological variables significantly differed according to the presence or absence of ED. Multivariate regression analysis indicated that age, employment, smoke, psychoactive drugs, opioid maintenance dosage, and severity of psychopathological factors significantly influenced the risk and severity of ED. QoL was worse in patients with ED and significantly correlated with ED severity. Age, education, employment, opioid maintenance dosage, ED score, and severity of psychopathology significantly influenced QoL in the multivariate analysis.ED complaints can be explored in male opioid users on ORT through a simple and quick self-assessment tool. ED may have important effects on emotional and social well-being, and may affect outcome.

  19. Preliminary Results of a Multicentre Study of the UBC Rapid Test for Detection of Urinary Bladder Cancer.

    Science.gov (United States)

    Ecke, Thorsten H; Arndt, Christian; Stephan, Carsten; Hallmann, Steffen; Lux, Oliver; Otto, Thomas; Ruttloff, Jürgen; Gerullis, Holger

    2015-05-01

    UBC Rapid is a test detecting fragments of cytokeratins 8 and 18 in urine. These are cytokeratins frequently overexpressed in tumor cells. We present the first results of a multi-centre study using UBC Rapid in patients with bladder cancer and healthy controls. Clinical urine samples from 92 patients with tumors of the urinary bladder (45 low-grade and 47 high-grade tumors) and from 33 healthy controls were used. Urine samples were analyzed by the UBC Rapid point-of-care (POC) system and evaluated both visually and quantitatively using a concile Omega 100 POC reader. For visual evaluation, different thresholds of band intensity for considering a test as positive were applied. Sensitivities and specificities were calculated by contingency analyses. We found that pathological concentrations by UBC Rapid are detectable in urine of patients with bladder cancer. The calculated diagnostic sensitivity of UBC Rapid in urine was 68.1% for high-grade, but only 46.2% for low-grade tumors. The specificity was 90.9%. The area under the curve (AUC) after receiver-operated curve (ROC) analysis was 0.733. Pathological levels of UBC Rapid in urine are higher in patients with bladder cancer in comparison to the control group (pbladder cancer and controls. Further studies with a greater number of patients will show how valuable these results are. Copyright© 2015 International Institute of Anticancer Research (Dr. John G. Delinassios), All rights reserved.

  20. Predictors of subjective quality of life in schizophrenic patients living in the community. A Nordic multicentre study.

    Science.gov (United States)

    Hansson, L; Middelboe, T; Merinder, L; Bjarnason, O; Bengtsson-Tops, A; Nilsson, L; Sandlund, M; Sourander, A; Sørgaard, K W; Vinding, H

    1999-01-01

    As part of a Nordic multi-centre study investigating the life and care situation of community samples of schizophrenic patients the aim of the present part of the study was to examine the relationship between global subjective quality of life and objective life conditions, clinical characteristics including psychopathology and number of needs for care, subjective factors such as satisfaction with different life domains, social network, and self-esteem. A sample of 418 persons with schizophrenia from 10 sites was used. The results of a final multiple regression analysis, explaining 52.3% of the variance, showed that five subjective factors were significantly associated with global subjective quality of life, together with one objective indicator, to have a close friend. No clinical characteristics were associated with global subjective quality of life. The largest part of the variance was explained by satisfaction with health, 36.3% of the variance, and self-esteem, 7.3% of the variance. It is concluded that the actual relationship between objective life conditions and subjectively experienced quality of life still remains unclear. Furthermore, it seems obvious that personality related factors such as self-esteem, mastery and sense of autonomy also play a role in the appraisal of subjective quality of life, which implies that factors like these are important to consider in clinical and social interventions for patients with schizophrenia in order to improve quality of life for these persons.

  1. Epidemiological and clinical characteristics and behaviours of individuals with newly diagnosed HIV infection: a multicentre study in north Italy.

    Science.gov (United States)

    Casari, S; Suligoi, B; Camoni, L; Pavan, A; Macchi, L; Capelli, M; Paraninfo, G; Compostella, S; Castelli, F; Carosi, G; Donato, F

    2012-12-01

    We aimed to investigate socio-demographic, clinical and epidemiological characteristics and behaviours of subjects with new HIV diagnosis. We carried out a multi-centre cross-sectional study comprising 17 infectious diseases units in the Lombardy Region, North Italy. All subjects with a first positive test for HIV infection examined in 2008-09 were interviewed using a structured questionnaire. 472 patients were enrolled (mean age 39.8 years, standard deviation [SD] 11.5), mostly males (78%), and born in Italy (77%). The most common routes of HIV transmission were heterosexual intercourse (49%) and sex among men who have sex with men (MSM) (40%). Never/sometimes use of a condom with occasional partners was associated with male gender, heterosexual transmission route, and with >10 sexual partners in their lifetime. 47% had previous HIV negative tests. Having had more than 2 previous HIV negative tests was associated with younger age, MSM transmission route, CD4+ lymphocyte count >350/microl and self-perception of risk. This study shows that there is a large portion of the adult population, especially heterosexual men aged 45 years and over, who are at high risk of acquiring and transmitting HIV infection and undergoing the HIV diagnostic test late, due to risk behaviours combined with a low perception of being at risk. Compared to people infected by heterosexual contacts, MSM show a greater awareness of being at risk of infection, but this knowledge has a low impact in reducing at-risk behaviours.

  2. Gram-negative prosthetic joint infection: outcome of a debridement, antibiotics and implant retention approach. A large multicentre study.

    Science.gov (United States)

    Rodríguez-Pardo, D; Pigrau, C; Lora-Tamayo, J; Soriano, A; del Toro, M D; Cobo, J; Palomino, J; Euba, G; Riera, M; Sánchez-Somolinos, M; Benito, N; Fernández-Sampedro, M; Sorli, L; Guio, L; Iribarren, J A; Baraia-Etxaburu, J M; Ramos, A; Bahamonde, A; Flores-Sánchez, X; Corona, P S; Ariza, J

    2014-11-01

    We aim to evaluate the epidemiology and outcome of gram-negative prosthetic joint infection (GN-PJI) treated with debridement, antibiotics and implant retention (DAIR), identify factors predictive of failure, and determine the impact of ciprofloxacin use on prognosis. We performed a retrospective, multicentre, observational study of GN-PJI diagnosed from 2003 through to 2010 in 16 Spanish hospitals. We define failure as persistence or reappearance of the inflammatory joint signs during follow-up, leading to unplanned surgery or repeat debridement>30 days from the index surgery related death, or suppressive antimicrobial therapy. Parameters predicting failure were analysed with a Cox regression model. A total of 242 patients (33% men; median age 76 years, interquartile range (IQR) 68-81) with 242 episodes of GN-PJI were studied. The implants included 150 (62%) hip, 85 (35%) knee, five (2%) shoulder and two (1%) elbow prostheses. There were 189 (78%) acute infections. Causative microorganisms were Enterobacteriaceae in 78%, Pseudomonas spp. in 20%, and other gram-negative bacilli in 2%. Overall, 19% of isolates were ciprofloxacin resistant. DAIR was used in 174 (72%) cases, with an overall success rate of 68%, which increased to 79% after a median of 25 months' follow-up in ciprofloxacin-susceptible GN-PJIs treated with ciprofloxacin. Ciprofloxacin treatment exhibited an independent protective effect (adjusted hazard ratio (aHR) 0.23; 95% CI, 0.13-0.40; pInfection © 2014 European Society of Clinical Microbiology and Infectious Diseases.

  3. A multicentre observational study to evaluate a new tool to assess emergency physicians' non-technical skills.

    Science.gov (United States)

    Flowerdew, Lynsey; Gaunt, Arran; Spedding, Jessica; Bhargava, Ajay; Brown, Ruth; Vincent, Charles; Woloshynowych, Maria

    2013-06-01

    To evaluate a new tool to assess emergency physicians' non-technical skills. This was a multicentre observational study using data collected at four emergency departments in England. A proportion of observations used paired observers to obtain data for inter-rater reliability. Data were also collected for test-retest reliability, observability of skills, mean ratings and dispersion of ratings for each skill, as well as a comparison of skill level between hospitals. Qualitative data described the range of non-technical skills exhibited by trainees and identified sources of rater error. 96 assessments of 43 senior trainees were completed. At a scale level, intra-class coefficients were 0.575, 0.532 and 0.419 and using mean scores were 0.824, 0.702 and 0.519. Spearman's ρ for calculating test-retest reliability was 0.70 using mean scores. All skills were observed more than 60% of the time. The skill Maintenance of Standards received the lowest mean rating (4.8 on a nine-point scale) and the highest mean was calculated for Team Building (6.0). Two skills, Supervision & Feedback and Situational Awareness-Gathering Information, had significantly different distributions of ratings across the four hospitals (ptechnical skills, especially in relation to leadership. The framework of skills may be used to identify areas for development in individual trainees, as well as guide other patient safety interventions.

  4. Work productivity and activity impairment in gastroesophageal reflux disease in Korean full-time employees: a multicentre study.

    Science.gov (United States)

    Shin, Woon Geon; Kim, Heung Up; Kim, Sang Gyun; Kim, Gwang Ha; Shim, Ki-Nam; Kim, Jeong Wook; Kim, Jin Il; Kim, Jae Gyu; Kim, Jae J; Yim, Da-Hae; Park, Sue K; Park, Soo-Heon

    2012-04-01

    The costs of gastroesophageal reflux disease have not been assessed in Asia, even though the prevalence of gastroesophageal reflux disease is gradually increasing. We evaluated work presenteeism and absenteeism as indirect costs of gastroesophageal reflux disease in Korea. This was a cross-sectional and multicentre study using patient-reported outcome instruments. A total of 1009 full-time employees who visited the gastrointestinal department for any reason (281 patients with gastroesophageal reflux disease and 728 controls) were included. Main outcomes were presenteeism and absenteeism measured as work productivity loss and monetary cost per week. Absenteeism and presenteeism were significantly higher in the gastroesophageal reflux disease than the control group (1.49% vs. 0.46%, P=0.0010; 34.13% vs. 9.23%, Pgastroesophageal reflux disease than the control group (33.09% vs. 9.02%; Pgastroesophageal reflux disease group compared with the control group. Assuming average hourly wages of $14.12, the weekly burden of gastroesophageal reflux disease reached $165.07 per person. Gastroesophageal reflux disease was associated with substantial work productivity loss, mainly due to presenteeism rather than absenteeism, in Korean full-time employees. Copyright © 2011 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.

  5. Changing prevalence patterns in endoscopic and histological diagnosis of gastritis? Data from a cross-sectional Central European multicentre study.

    Science.gov (United States)

    Wolf, Eva-Maria; Plieschnegger, Wolfgang; Geppert, Michael; Wigginghaus, Bernd; Höss, Gabriele M; Eherer, Andreas; Schneider, Nora I; Hauer, Almuthe; Rehak, Peter; Vieth, Michael; Langner, Cord

    2014-05-01

    Traditionally, Helicobacter infection is considered to be the most common cause of gastritis. In the cross-sectional Central European histoGERD trial, we assessed the prevalence of different types of gastritis, correlating histological and endoscopic diagnoses. A total of 1123 individuals participated in an observational multicentre study. Endoscopists classified individuals as positive or negative for gastritis and rendered the putative cause. Pathologists evaluated biopsy specimens based upon the Updated Sydney System. Histological diagnosis of gastritis was made in 639 (56.9%) participants. In all, 210 (18.7%) individuals were diagnosed with Helicobacter gastritis, 215 (19.1%) with post Helicobacter gastritis, 234 (20.8%) with reactive gastropathy, 26 (2.3%) with autoimmune gastritis, and 6 (0.5%) with focally enhanced gastritis related to Crohn's disease. In 46 out of 639 (7.2%) individuals diagnosed with gastritis, combinations of different histological subtypes were noted the most common being reactive gastropathy and post Helicobacter gastritis. Endoscopic diagnosis of gastritis was made in 534 (47.6%) individuals. Reactive gastropathy was more common than active Helicobacter gastritis, and the majority of cases attributable to Helicobacter infection were no longer ongoing, i.e. post Helicobacter gastritis. Agreement between histological and endoscopic diagnoses was better in reactive gastropathy than in Helicobacter gastritis. Copyright © 2014 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.

  6. Reliability of intra-oral quantitative sensory testing (QST) in patients with atypical odontalgia and healthy controls - a multicentre study.

    Science.gov (United States)

    Baad-Hansen, L; Pigg, M; Yang, G; List, T; Svensson, P; Drangsholt, M

    2015-02-01

    The reliability of comprehensive intra-oral quantitative sensory testing (QST) protocol has not been examined systematically in patients with chronic oro-facial pain. The aim of the present multicentre study was to examine test-retest and interexaminer reliability of intra-oral QST measures in terms of absolute values and z-scores as well as within-session coefficients of variation (CV) values in patients with atypical odontalgia (AO) and healthy pain-free controls. Forty-five patients with AO and 68 healthy controls were subjected to bilateral intra-oral gingival QST and unilateral extratrigeminal QST (thenar) on three occasions (twice on 1 day by two different examiners and once approximately 1 week later by one of the examiners). Intra-class correlation coefficients and kappa values for interexaminer and test-retest reliability were computed. Most of the standardised intra-oral QST measures showed fair to excellent interexaminer (9-12 of 13 measures) and test-retest (7-11 of 13 measures) reliability. Furthermore, no robust differences in reliability measures or within-session variability (CV) were detected between patients with AO and the healthy reference group. These reliability results in chronic orofacial pain patients support earlier suggestions based on data from healthy subjects that intra-oral QST is sufficiently reliable for use as a part of a comprehensive evaluation of patients with somatosensory disturbances or neuropathic pain in the trigeminal region. © 2014 John Wiley & Sons Ltd.

  7. Mathematical geology studies of deposit prospect types

    International Nuclear Information System (INIS)

    Liu Guangping

    1998-08-01

    Exact certainty prospect type of uranium deposit, not only can assure the quality of deposit prospects, but also increase economic benefits. Based on the standard of geological prospect of uranium deposit, the author introduces a method of Fuzzy Synthetical Comment for dividing prospect type of uranium deposit. The practical applications demonstrate that the regression accuracy, discriminated by Zadeh operator, of 15 known deposits is 100%

  8. The Biosulin equivalence in standard therapy (BEST) study − a ...

    African Journals Online (AJOL)

    -label, non-randomised, interventional, observational study in subjects using Biosulin ... Methods. Subjects in this interventional, observational, multicentre, open-label, prospective study were switched from their existing human premix insulin ...

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

    Science.gov (United States)

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

    2015-07-01

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

  10. Protocol of the Australasian Malignant Pleural Effusion (AMPLE) trial: a multicentre randomised study comparing indwelling pleural catheter versus talc pleurodesis

    Science.gov (United States)

    Fysh, Edward T H; Thomas, Rajesh; Read, Catherine A; Lam, Ben C H; Yap, Elaine; Horwood, Fiona C; Lee, Pyng; Piccolo, Francesco; Shrestha, Ranjan; Garske, Luke A; Lam, David C L; Rosenstengel, Andrew; Bint, Michael; Murray, Kevin; Smith, Nicola A; Lee, Y C Gary

    2014-01-01

    Introduction Malignant pleural effusion can complicate most cancers. It causes breathlessness and requires hospitalisation for invasive pleural drainages. Malignant effusions often herald advanced cancers and limited prognosis. Minimising time spent in hospital is of high priority to patients and their families. Various treatment strategies exist for the management of malignant effusions, though there is no consensus governing the best choice. Talc pleurodesis is the conventional management but requires hospitalisation (and substantial healthcare resources), can cause significant side effects, and has a suboptimal success rate. Indwelling pleural catheters (IPCs) allow ambulatory fluid drainage without hospitalisation, and are increasingly employed for management of malignant effusions. Previous studies have only investigated the length of hospital care immediately related to IPC insertion. Whether IPC management reduces time spent in hospital in the patients’ remaining lifespan is unknown. A strategy of malignant effusion management that reduces hospital admission days will allow patients to spend more time outside hospital, reduce costs and save healthcare resources. Methods and analysis The Australasian Malignant Pleural Effusion (AMPLE) trial is a multicentred, randomised trial designed to compare IPC with talc pleurodesis for the management of malignant pleural effusion. This study will randomise 146 adults with malignant pleural effusions (1:1) to IPC management or talc slurry pleurodesis. The primary end point is the total number of days spent in hospital (for any admissions) from treatment procedure to death or end of study follow-up. Secondary end points include hospital days specific to pleural effusion management, adverse events, self-reported symptom and quality-of-life scores. Ethics and dissemination The Sir Charles Gairdner Group Human Research Ethics Committee has approved the study as have the ethics boards of all the participating hospitals. The

  11. Differential Item Functioning in the SF-36 Physical Functioning and Mental Health Sub-Scales: A Population-Based Investigation in the Canadian Multicentre Osteoporosis Study.

    Directory of Open Access Journals (Sweden)

    Lisa M Lix

    Full Text Available Self-reported health status measures, like the Short Form 36-item Health Survey (SF-36, can provide rich information about the overall health of a population and its components, such as physical, mental, and social health. However, differential item functioning (DIF, which arises when population sub-groups with the same underlying (i.e., latent level of health have different measured item response probabilities, may compromise the comparability of these measures. The purpose of this study was to test for DIF on the SF-36 physical functioning (PF and mental health (MH sub-scale items in a Canadian population-based sample.Study data were from the prospective Canadian Multicentre Osteoporosis Study (CaMos, which collected baseline data in 1996-1997. DIF was tested using a multiple indicators multiple causes (MIMIC method. Confirmatory factor analysis defined the latent variable measurement model for the item responses and latent variable regression with demographic and health status covariates (i.e., sex, age group, body weight, self-perceived general health produced estimates of the magnitude of DIF effects.The CaMos cohort consisted of 9423 respondents; 69.4% were female and 51.7% were less than 65 years. Eight of 10 items on the PF sub-scale and four of five items on the MH sub-scale exhibited DIF. Large DIF effects were observed on PF sub-scale items about vigorous and moderate activities, lifting and carrying groceries, walking one block, and bathing or dressing. On the MH sub-scale items, all DIF effects were small or moderate in size.SF-36 PF and MH sub-scale scores were not comparable across population sub-groups defined by demographic and health status variables due to the effects of DIF, although the magnitude of this bias was not large for most items. We recommend testing and adjusting for DIF to ensure comparability of the SF-36 in population-based investigations.

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

    Directory of Open Access Journals (Sweden)

    Dykes Anna-Karin

    2011-02-01

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

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

    Science.gov (United States)

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

    2011-02-21

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

  14. [Cinacalcet in the management of normocalcaemic secondary hyperparathyroidism after kidney transplantation: one-year follow-up multicentre study].

    Science.gov (United States)

    Torregrosa, Josep V; Morales, Enrique; Díaz, Juan M; Crespo, Josep; Bravo, Juan; Gómez, Gonzalo; Gentil, Miguel A; Rodríguez-Benot, Alberto; Rodríguez-García, Minerva; López-Jiménez, Verónica; Gutiérrez-Dalmau, Álex; Jimeno, Luisa; Pérez-Sáez, M José; Romero, Rafael; Gómez-Alamillo, Carlos

    2014-01-01

    The effect of cinacalcet in patients with persistent secondary hyperparathyroidism (SHPT) after kidney transplantation (RT) has mainly been reported in patients with secondary hypercalcaemia. Our objective was to assess the long-term effect of cinacalcet on patients with a RT and normocalcaemic SHPT. A one-year multicentre, observational, retrospective study that included kidney recipients with SHPT (intact parathyroid hormone [iPTH] >120 pg/ml) and calcium levels within the normal range (8.4-10.2 mg/dl). Patients began treatment with cinacalcet in clinical practice. 32 patients with a mean age (standard deviation [SD]) of 54 (11) years, 56% male, were included in the study. Treatment with cinacalcet began a median of 16 months after RT (median dose of 30 mg/day). Levels of iPTH decreased from a median (P25, P75) of 364 (220, 531) pg/ml at the start of the study to 187 (98, 320) after 6 months (48.6% reduction, P=.001) and to 145 (91, 195) after 12 months (60.2% reduction, P=.001), without there being changes in calcium and phosphorus levels (P=.214 and P=.216, respectively). No changes were observed in kidney function or anti-calcineuric drug levels. 3.1% of patients discontinued cinacalcet due to intolerance and 6.2% due to a lack of efficacy. In patients with normocalcaemic SHPT after RT, cinacalcet improves the control of serum PTH values without causing changes to calcaemia, phosphataemia or kidney function. Cinacalcet showed good tolerability.

  15. Risk and protective factors for falls on one level in young children: multicentre case-control study.

    Science.gov (United States)

    Benford, P; Young, B; Coupland, C; Watson, M; Hindmarch, P; Hayes, M; Goodenough, T; Majsak-Newman, G; Kendrick, D

    2015-12-01

    Childhood falls are an important global public health problem, but there is lack of evidence about their prevention. Falls on one level result in considerable morbidity and they are costly to health services. To estimate ORs for falls on one level in children aged 0-4 years for a range of safety behaviours, safety equipment use and home hazards. Multicentre case-control study at hospitals, minor injury units and general practices in and around four UK study centres. Participants included 582 children less than 5 years of age with a medically attended fall injury occurring at home and 2460 controls matched on age, sex, calendar time and study centre. Fall on one level. Cases' most common injuries were bangs on the head (52%), cuts or grazes not needing stitches (29%) or cuts or grazes needing stitches (17%). Comparing cases to community controls in the adjusted analyses, significant findings were observed for only two exposures. Injured children were significantly less likely to live in a household without furniture corner covers (adjusted OR (AOR) 0.72, 95% CI 0.55 to 0.95), or without rugs and carpets firmly fixed to the floor (AOR 0.76, 95% CI 0.59 to 0.98). We did not find any safety practices, use of safety equipment or home hazards associated with a reduced risk of fall on one level. Our findings do not provide evidence to support changes to current injury prevention practice. 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/

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

    Science.gov (United States)

    2011-01-01

    Background Although both labour dystocia and domestic violence during pregnancy are associated with adverse maternal and fetal outcome, evidence in support of a possible association between experiences of domestic violence and labour dystocia is sparse. The aim of this study was to investigate whether self-reported history of violence or experienced violence during pregnancy is associated with increased risk of labour dystocia in nulliparous women at term. Methods A population-based multi-centre cohort study. A self-administrated questionnaire collected at 37 weeks of gestation from nine obstetric departments in Denmark. The total cohort comprised 2652 nulliparous women, among whom 985 (37.1%) met the protocol criteria for dystocia. Results Among the total cohort, 940 (35.4%) women reported experience of violence, and among these, 66 (2.5%) women reported exposure to violence during their first pregnancy. Further, 39.5% (n = 26) of those had never been exposed to violence before. Univariate logistic regression analysis showed no association between history of violence or experienced violence during pregnancy and labour dystocia at term, crude OR 0.91, 95% CI (0.77-1.08), OR 0.90, 95% CI (0.54-1.50), respectively. However, violence exposed women consuming alcoholic beverages during late pregnancy had increased odds of labour dystocia, crude OR 1.45, 95% CI (1.07-1.96). Conclusions Our findings indicate that nulliparous women who have a history of violence or experienced violence during pregnancy do not appear to have a higher risk of labour dystocia at term, according to the definition of labour dystocia in this study. Additional research on this topic would be beneficial, including further evaluation of the criteria for labour dystocia. PMID:21338523

  17. Open Abdomen Therapy with Vacuum and Mesh Mediated Fascial Traction After Aortic Repair: an International Multicentre Study.

    Science.gov (United States)

    Acosta, Stefan; Seternes, Arne; Venermo, Maarit; Vikatmaa, Leena; Sörelius, Karl; Wanhainen, Anders; Svensson, Mats; Djavani, Khatereh; Björck, Martin

    2017-12-01

    Open abdomen therapy may be necessary to prevent or treat abdominal compartment syndrome (ACS). The aim of the study was to analyse the primary delayed fascial closure (PDFC) rate and complications after open abdomen therapy with vacuum and mesh mediated fascial traction (VACM) after aortic repair and to compare outcomes between those treated with open abdomen after primary versus secondary operation. This was a retrospective cohort, multicentre study in Sweden, Finland, and Norway, including consecutive patients treated with open abdomen and VACM after aortic repair at six vascular centres in 2006-2015. The primary endpoint was PDFC rate. Among 191 patients, 155 were men. The median age was 71 years (IQR 66-76). Ruptured abdominal aortic aneurysm (RAAA) occurred in 69.1%. Endovascular/hybrid and open repairs were performed in 49 and 142 patients, respectively. The indications for open abdomen were inability to close the abdomen (62%) at primary operation and ACS (80%) at secondary operation. Duration of open abdomen was 11 days (IQR 7-16) in 157 patients alive at open abdomen termination. The PDFC rate was 91.8%. Open abdomen initiated at primary (N=103), compared with secondary operation (N=88), was associated with less severe initial open abdomen status (p=.006), less intestinal ischaemia (p=.002), shorter duration of open abdomen (p=.007), and less renal replacement therapy (RRT, popen abdomen initiated at primary versus secondary operation. VACM was associated with a high PDFC rate after prolonged open abdomen therapy following aortic repair. Patient outcomes seemed better when open abdomen was initiated at primary, compared with secondary operation but a selection effect is possible. Copyright © 2017 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved.

  18. Right-to-left shunt and subclinical ischemic brain lesions in Chinese migraineurs: a multicentre MRI study.

    Science.gov (United States)

    Jiang, Xiao-Han; Wang, Si-Bo; Tian, Qian; Zhong, Chi; Zhang, Guan-Ling; Li, Ya-Jie; Lin, Pan; You, Yong; Guo, Rong; Cui, Ying-Hua; Xing, Ying-Qi

    2018-02-14

    Migraine is considered as a risk factor for subclinical brain ischemic lesions, and right-to-left shunt (RLS) is more common among migraineurs. This cross-sectional study assessed the association of RLS with the increased prevalence of subclinical ischemic brain lesions in migraineurs. We enrolled 334 migraineurs from a multicentre study from June 2015 to August 2016. Participants were all evaluated using contrast-enhanced transcranial Doppler, magnetic resonance imaging (MRI), and completed a questionnaire covering demographics, the main risk factors of vascular disease, and migraine status. RLS was classified into four grades (Grade 0 = Negative; Grade I = 1 ≤ microbubbles (MBs) ≤ 10; Grade II = MBs > 10 and no curtain; Grade III = curtain). Silent brain ischemic infarctions (SBI) and white matter hyperintensities (WMHs) were evaluated on MRI. We found no significant differences between migraineurs with RLS and migraineurs without RLS in subclinical ischemic brain lesions.SBI and WMHs did not increase with the size of the RLS(p for trend for SBI = 0.066, p for trend for WMHs = 0.543). Furthermore, curtain RLS in migraineurs was a risk factor for the presence of SBI (p = 0.032, OR = 3.47; 95%CI: 1.12-10.76). There was no association between RLS and the presence of WMHs. Overall, RLS is not associated with increased SBI or WMHs in migraineurs. However, when RLS is present as a curtain pattern, it is likely to be a risk factor for SBIs in migraineurs. No. NCT02425696 ; registered on April 21, 2015.

  19. Is lesional stability in vitiligo more important than disease stability for performing surgical interventions? results from a multicentric study

    Directory of Open Access Journals (Sweden)

    Imran Majid

    2016-01-01

    Full Text Available Background: Ensuring stability of the disease process is essential for undertaking surgical intervention in vitiligo. However, there is no consensus regarding the minimum duration of stability or the relative importance of disease and lesional stability in selecting patients for vitiligo grafting. Aim: This multicentric study aims to assess the relative importance of lesional and disease stability on selecting patients for vitiligo grafting. Materials and Methods: One hundred seventy patients were recruited into the study and divided into two groups: Group A with lesional stability of >1 year but overall disease stability of only 6-11 months and Group B with overall disease stability of >1 year. Patients underwent either tissue or cellular vitiligo grafting on the selected lesions and the repigmentation achieved was scored from 0 (no repigmentation to 6 (100% repigmentation. Repigmentation achieved on different sites of the body was compared between the two groups. Adverse effects at both the donor and the recipient sites were also compared. Results: Of the 170 patients who were enrolled, 82 patients were placed in Group A and 88 patients in Group B. Average repigmentation achieved (on scale of 0 to 6 was 3.8 and 4.04 in Group A and Group B, respectively. In Group A, ≥90% repigmentation was achieved in 36.6% (30/82 patients, while 37.5% (33/88 achieved similar results in Group B. Additionally, 47.6% (39/82 and 53.4% (47/88 of cases achieved partial repigmentation in Group A and Group B, respectively. Perigraft halo was the commonest adverse effect observed in both groups. Statistical analysis revealed no significant differences between the two groups with respect to the repigmentation achieved or adverse effects observed. Repigmentation achieved was the best on the face and neck area, while acral areas responded the least. Conclusions: Lesional stability seems to be as relevant as the overall disease stability in selecting patients for

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

    Science.gov (United States)

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

    2011-01-01

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

  1. Effect of personalised citizen assistance for social participation (APIC) on older adults' health and social participation: study protocol for a pragmatic multicentre randomised controlled trial (RCT).

    Science.gov (United States)

    Levasseur, Mélanie; Dubois, Marie-France; Filliatrault, Johanne; Vasiliadis, Helen-Maria; Lacasse-Bédard, Joanie; Tourigny, André; Levert, Marie-Josée; Gabaude, Catherine; Lefebvre, Hélène; Berger, Valérie; Eymard, Chantal

    2018-03-31

    The challenges of global ageing and the growing burden of chronic diseases require innovative interventions acting on health determinants like social participation. Many older adults do not have equitable opportunities to achieve full social participation, and interventions might underempower their personal and environmental resources and only reach a minority. To optimise current practices, the Accompagnement-citoyen Personnalisé d'Intégration Communautaire (APIC), an intervention demonstrated as being feasible and having positive impacts, needs further evaluation. A pragmatic multicentre, prospective, two-armed, randomised controlled trial will evaluate: (1) the short-term and long-term effects of the APIC on older adults' health, social participation, life satisfaction and healthcare services utilisation and (2) its cost-effectiveness. A total of 376 participants restricted in at least one instrumental activity of daily living and living in three large cities in the province of Quebec, Canada, will be randomly assigned to the experimental or control group using a centralised computer-generated random number sequence procedure. The experimental group will receive weekly 3-hour personalised stimulation sessions given by a trained volunteer over the first 12 months. Sessions will encourage empowerment, gradual mobilisation of personal and environmental resources and community integration. The control group will receive the publicly funded universal healthcare services available to all Quebecers. Over 2 years (baseline and 12, 18 and 24 months later), self-administered questionnaires will assess physical and mental health (primary outcome; version 2 of the 36-item Short-Form Health Survey, converted to SF-6D utility scores for quality-adjusted life years), social participation (Social Participation Scale) and life satisfaction (Life Satisfaction Index-Z). Healthcare services utilisation will be recorded and costs of each intervention calculated. The Research

  2. Treatment of Children With Central Nervous System Primitive Neuroectodermal Tumors/Pinealoblastomas in the Prospective Multicentric Trial HIT 2000 Using Hyperfractionated Radiation Therapy Followed by Maintenance Chemotherapy

    Energy Technology Data Exchange (ETDEWEB)

    Gerber, Nicolas U., E-mail: nicolas.gerber@kispi.uzh.ch [Department of Pediatric Oncology, University Children' s Hospital, Zurich (Switzerland); Hoff, Katja von; Resch, Anika [Department of Pediatric Hematology and Oncology, University Medical Center Hamburg-Eppendorf, Hamburg (Germany); Ottensmeier, Holger [Department of Pediatric Oncology, University of Wuerzburg, Wuerzburg (Germany); Kwiecien, Robert; Faldum, Andreas [Institute of Biostatistics and Clinical Research, University of Muenster (Germany); Matuschek, Christiane [Department of Radiation Oncology, Medical Faculty, Heinrich Heine University of Duesseldorf, Duesseldorf (Germany); Hornung, Dagmar [Department of Radiotherapy and Radio-Oncology, University Medical Center Hamburg-Eppendorf, Hamburg (Germany); Bremer, Michael [Institute for Radiation Therapy and Special Oncology, Hannover Medical School, Hannover (Germany); Benesch, Martin [Division of Pediatric Hematology and Oncology, Department of Pediatrics and Adolescent Medicine, Medical University of Graz, Graz (Austria); Pietsch, Torsten [Department of Neuropathology, University of Bonn, Bonn (Germany); Warmuth-Metz, Monika [Department of Neuroradiology, University of Wuerzburg, Wuerzburg (Germany); Kuehl, Joachim [Department of Pediatric Oncology, University of Wuerzburg, Wuerzburg (Germany); Rutkowski, Stefan [Department of Pediatric Hematology and Oncology, University Medical Center Hamburg-Eppendorf, Hamburg (Germany); Kortmann, Rolf D. [Department of Radiation Oncology, University of Leipzig, Leipzig (Germany)

    2014-07-15

    Purpose: The prognosis for children with central nervous system primitive neuroectodermal tumor (CNS-PNET) or pinealoblastoma is still unsatisfactory. Here we report the results of patients between 4 and 21 years of age with nonmetastatic CNS-PNET or pinealoblastoma diagnosed from January 2001 to December 2005 and treated in the prospective GPOH-trial P-HIT 2000-AB4. Methods and Materials: After surgery, children received hyperfractionated radiation therapy (36 Gy to the craniospinal axis, 68 Gy to the tumor region, and 72 Gy to any residual tumor, fractionated at 2 × 1 Gy per day 5 days per week) accompanied by weekly intravenous administration of vincristine and followed by 8 cycles of maintenance chemotherapy (lomustine, cisplatin, and vincristine). Results: Twenty-six patients (15 with CNS-PNET; 11 with pinealoblastoma) were included. Median age at diagnosis was 11.5 years old (range, 4.0-20.7 years). Gross total tumor resection was achieved in 6 and partial resection in 16 patients (indistinct, 4 patients). Median follow-up of the 15 surviving patients was 7.0 years (range, 5.2-10.0 years). The combined response rate to postoperative therapy was 17 of 20 (85%). Eleven of 26 patients (42%; 7 of 15 with CNS-PNET; 4 of 11 with pinealoblastoma) showed tumor progression or relapse at a median time of 1.3 years (range, 0.5-1.9 years). Five-year progression-free and overall survival rates (±standard error [SE]) were each 58% (±10%) for the entire cohort: CNS-PNET was 53% (±13); pinealoblastoma was 64% (±15%; P=.524 and P=.627, respectively). Conclusions: Postoperative hyperfractionated radiation therapy with local dose escalation followed by maintenance chemotherapy was feasible without major acute toxicity. Survival rates are comparable to those of a few other recent studies but superior to those of most other series, including the previous trial, HIT 1991.

  3. The South African Surgical Outcomes Study: a seven-day ...

    African Journals Online (AJOL)

    LR Mathivha, TR Mokoena, S Monokoane, Rui Moreno, David ... Method: A seven-day national, multicentre, prospective, observational cohort study was conducted in 50 government-funded hospitals in South .... Dr George Mukhari Hospital.

  4. Prospective SAH Study in Japan, 2005(Prospective SAH Study)

    OpenAIRE

    塩川, 芳昭; 栗田, 浩樹; 藤井, 清孝; Yoshiaki, SHIOKAWA; Hiroki, KURITA; Kiyotaka, FUJII; 杏林大学脳神経外科; 杏林大学脳神経外科; 北里大学脳神経外科; Department of Neurosurgery, Kyorin University School of Medicine; Department of Neurosurgery, Kyorin University School of Medicine

    2009-01-01

    To clarify current treatment status of ruptured cerebral aneurysms in Japan, a prospective multicenter observational study on the treatment results for aneurysmal subarachnoid hemorrhage was conducted over calendar year 2005 and final 1-year outcomes were collected. Studied centers were selected from among institutes of committee member of Japanese stroke surgery organization or symposium of vasospasm in Japan. A total of 927 patients were enrolled in this study and treatment policies were le...

  5. Long-term outcome of the adjustable transobturator male system (ATOMS): results of a European multicentre study.

    Science.gov (United States)

    Friedl, Alexander; Mühlstädt, Sandra; Zachoval, Roman; Giammò, Alessandro; Kivaranovic, Danijel; Rom, Maximilian; Fornara, Paolo; Brössner, Clemens

    2017-05-01

    To evaluate the long-term effectiveness and safety of the adjustable transobturator male system (ATOMS ® , Agency for Medical Innovations A.M.I., Feldkirch, Austria) in a European-wide multicentre setting. In all, 287 men with stress urinary incontinence (SUI) were treated with the ATOMS device between June 2009 and March 2016. Continence parameters (daily pad test/pad use), urodynamics (maximum urinary flow rate, voiding volume, residual urine), and pain/quality of life (QoL) ratings (visual analogue scale/Leeds Assessment of Neuropathic Symptoms and Signs, International Consultation on Incontinence Questionnaire-Short Form [ICIQ-SF]/Patient Global Impression of Improvement [PGI-I]) were compared preoperatively and after intermediate (12 months) as well as after individual maximum follow-up. Overall success rate, dry rate (ATOMS devices are still functioning; 56 (20%) were removed, the most common reason being local titanium intolerance (41%) and leak/dysfunction (30%). The operating time and continence outcome varied between port generations. In this regard the latest port generation (silicone-covered scrotal port) was superior to its predecessors. Primary implantation (P = 0.002), good physical health (P = 0.001), and no history of radiotherapy (P ATOMS device is safe and shows high treatment efficacy and patient satisfaction in the largest cohort study to date. The latest generation, with its pre-attached silicone-covered scrotal port, is superior to its predecessors. Significantly better results were achieved with primary implantation and in those without a history of radiotherapy. © 2016 The Authors BJU International © 2016 BJU International Published by John Wiley & Sons Ltd.

  6. Multi-centre evaluation of accuracy and reproducibility of planar and SPECT image quantification. An IAEA phantom study

    Energy Technology Data Exchange (ETDEWEB)

    Zimmermann, Brian E. [National Institute of Standards and Technology, Gaithersburg, MD (United States); Grosev, Darko [Univ. Hospital Centre Zagreb (Croatia); Buvat, Irene [Service Hospitalier Frederic Joliot, Paris (France); and others

    2017-08-01

    Accurate quantitation of activity provides the basis for internal dosimetry of targeted radionuclide therapies. This study investigated quantitative imaging capabilities at sites with a variety of experience and equipment and assessed levels of errors in activity quantitation in Single-Photon Emission Computed Tomography (SPECT) and planar imaging. Participants from 9 countries took part in a comparison in which planar, SPECT and SPECT with X ray computed tomography (SPECT-CT) imaging were used to quantify activities of four epoxy-filled cylinders containing {sup 133}Ba, which was chosen as a surrogate for {sup 131}I. The sources, with nominal volumes of 2, 4, 6 and 23 mL, were calibrated for {sup 133}Ba activity by the National Institute of Standards and Technology, but the activity was initially unknown to the participants. Imaging was performed in a cylindrical phantom filled with water. Two trials were carried out in which the participants first estimated the activities using their local standard protocols, and then repeated the measurements using a standardized acquisition and analysis protocol. Finally, processing of the imaging data from the second trial was repeated by a single centre using a fixed protocol. In the first trial, the activities were underestimated by about 15% with planar imaging. SPECT with Chang's first order attenuation correction (Chang-AC) and SPECT-CT overestimated the activity by about 10%. The second trial showed moderate improvements in accuracy and variability. Planar imaging was subject to methodological errors, e.g., in the use of a transmission scan for attenuation correction. The use of Chang-AC was subject to variability from the definition of phantom contours. The project demonstrated the need for training and standardized protocols to achieve good levels of quantitative accuracy and precision in a multicentre setting. Absolute quantification of simple objects with no background was possible with the strictest protocol to

  7. [Yeast urinary tract infections. Multicentre study in 14 hospitals belonging to the Buenos Aires City Mycology Network].

    Science.gov (United States)

    Maldonado, Ivana; Arechavala, Alicia; Guelfand, Liliana; Relloso, Silvia; Garbasz, Claudia

    2016-01-01

    Urinary tract infections are a frequent ailment in patients in intensive care units. Candida and other yeasts cause 5-12% of these infections. The value of the finding of any yeast is controversial, and there is no consensus about which parameters are adequate for differentiating urinary infections from colonization or contamination. To analyse the epidemiological characteristics of patients with funguria, to determine potential cut-off points in cultures (to distinguish an infection from other conditions), to identify the prevalent yeast species, and to determine the value of a second urine sample. A multicentre study was conducted in intensive care units of 14 hospitals in the Buenos Aires City Mycology Network. The first and second samples of urine from every patient were cultured. The presence of white cells and yeasts in direct examination, colony counts, and the identification of the isolated species, were evaluated. Yeasts grew in 12.2% of the samples. There was no statistical correlation between the number of white cells and the fungal colony-forming units. Eighty five percent of the patients had indwelling catheters. Funguria was not prevalent in women or in patients over the age of 65. Candida albicans, followed by Candida tropicalis, were the most frequently isolated yeasts. Candida parapsilosis and Candida glabrata appeared less frequently. The same species were isolated in 70% of second samples, and in 23% of the cases the second culture was negative. It was not possible to determine a useful cut-off point for colony counts to help in the diagnosis of urinary infections. As in other publications, C. albicans, followed by C. tropicalis, were the most prevalent species. Copyright © 2015 Asociación Española de Micología. Published by Elsevier Espana. All rights reserved.

  8. A multicomponent approach to identify predictors of hospital outcomes in older in-patients: a multicentre, observational study.

    Directory of Open Access Journals (Sweden)

    Stefanie L De Buyser

    Full Text Available BACKGROUND: The identification of older patients at risk of poor hospital outcomes (e.g. longer hospital stay, in-hospital mortality, and institutionalisation is important to provide an effective healthcare service. OBJECTIVE: To identify factors related to older patients' clinical, nutritional, functional and socio-demographic profiles at admission to an acute care ward that can predict poor hospital outcomes. DESIGN AND SETTING: The CRiteria to assess appropriate Medication use among Elderly complex patients project was a multicentre, observational study performed in geriatric and internal medicine acute care wards of seven Italian hospitals. SUBJECTS: One thousand one hundred twenty-three consecutively admitted patients aged 65 years or older. METHODS: Hospital outcomes were length of stay, in-hospital mortality, and institutionalisation. RESULTS: Mean age of participants was 81 years, 56% were women. Median length of stay was 10 (7-14 days, 41 patients died during hospital stay and 37 were newly institutionalised. Number of drugs before admission, metastasized cancer, renal failure or dialysis, infection, falls at home during the last year, pain, and walking speed were independent predictors of LoS. Total dependency in activities of daily living and inability to perform grip strength test were independent predictors of in-hospital mortality. Malnutrition and total dependency in activities of daily living were independent predictors of institutionalisation. CONCLUSIONS: Our results confirm that not only diseases, but also multifaceted aspects of ageing such as physical function and malnutrition are strong predictors of hospital outcomes and suggest that these variables should be systematically recorded.

  9. Endodontic flare-ups: a prospective study.

    Science.gov (United States)

    Alves, Vanessa de Oliveira

    2010-11-01

    The objective of this prospective clinical study was to evaluate the incidence of flare-ups (pain and/or swelling requiring endodontic interappointment and emergency treatment) and identify the risk factors associated with their occurrence in patients who received endodontic treatment from June 2006 to June 2007 at the endodontics clinic of the São Paulo Dental Association (APCD), Jardim Paulista branch, São Paulo, Brazil. The incidence of flare-ups was 1.71% out of 408 teeth that had received endodontic therapy. Statistical analysis using the chi-squared test (P flare-up rate and the presence of a periradicular radiolucency. Copyright © 2010 Mosby, Inc. All rights reserved.

  10. Quality of life and educational benefit among orthopedic surgery residents: a prospective, multicentre comparison of the night float and the standard call systems.

    Science.gov (United States)

    Zahrai, Ali; Chahal, Jaskarndip; Stojimirovic, Dan; Schemitsch, Emil H; Yee, Albert; Kraemer, William

    2011-02-01

    Given recent evolving guidelines regarding postcall clinical relief of residents and emphasis on quality of life, novel strategies are required for implementing call schedules. The night float system has been used by some institutions as a strategy to decrease the burden of call on resident quality of life in level-1 trauma centres. The purpose of this study was to determine whether there are differences in quality of life, work-related stressors and educational experience between orthopedic surgery residents in the night float and standard call systems at 2 level-1 trauma centres. We conducted a prospective cohort study at 2 level-1 trauma hospitals comprising a standard call (1 night in 4) group and a night float (5 14-hour shifts [5 pm-7 am] from Monday to Friday) group for each hospital. Over the course of a 6-month rotation, each resident completed 3 weeks of night float. The remainder of the time on the trauma service consists of clinical duties from 6:30 am to 5:30 pm on a daily basis and intermittent coverage of weekend call only. Residents completed the Short Form-36 (SF-36) general quality-of-life questionnaire, as well as questionnaires on stress level and educational experience before the rotation (baseline) and at 2, 4 and 6 months. We performed an analysis of covariance to compare between-group differences using the baseline scores as covariates and Wilcoxon signed-rank tests (nonparametric) to determine if the residents' SF-36 scores were different from the age- and sex-matched Canadian norms. We analyzed predictors of resident quality of life using multivariable mixed models. Seven residents were in the standard call group and 9 in the night float group, for a total of 16 residents (all men, mean age 35.1 yr). Controlling for between-group differences at baseline, residents on the night float rotation had significantly lower role physical, bodily pain, social function and physical component scale scores over the 6-month observation period. Compared

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

    DEFF Research Database (Denmark)

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

    2015-01-01

    injection (n = 372) showed Bemfola yielding similar efficacy and safety profiles to Gonal-f. Women aged 20-38 years of age were randomized 2:1 to receive a single, daily, subcutaneous 150 IU dose of either Bemfola or Gonal-f. This study tested equivalence in the number of retrieved oocytes using a pre......Bemfola (follitropin alfa) (Finox AG, Switzerland), a new recombinant FSH, has a comparable pharmacological profile to that of Gonal-f (Merck Serono, Germany), the current standard for ovarian stimulation. A randomized, multi-centre, Phase 3 study in women undergoing IVF or intracytoplasmic sperm...

  12. Acupuncture and rehabilitation of the painful shoulder: study protocol of an ongoing multicentre randomised controlled clinical trial [ISRCTN28687220

    Directory of Open Access Journals (Sweden)

    Jimenez Carmen

    2005-10-01

    Full Text Available Abstract Background Although the painful shoulder is one of the most common dysfunctions of the locomotor apparatus, and is frequently treated both at primary healthcare centres and by specialists, little evidence has been reported to support or refute the effectiveness of the treatments most commonly applied. According to the bibliography reviewed, physiotherapy, which is the most common action taken to alleviate this problem, has not yet been proven to be effective, because of the small size of sample groups and the lack of methodological rigor in the papers published on the subject. No reviews have been made to assess the effectiveness of acupuncture in treating this complaint, but in recent years controlled randomised studies have been made and these demonstrate an increasing use of acupuncture to treat pathologies of the soft tissues of the shoulder. In this study, we seek to evaluate the effectiveness of physiotherapy applied jointly with acupuncture, compared with physiotherapy applied with a TENS-placebo, in the treatment of painful shoulder caused by subacromial syndrome (rotator cuff tendinitis and subacromial bursitis. Methods/design Randomised controlled multicentre study with blind evaluation by an independent observer and blind, independent analysis. A study will be made of 465 patients referred to the rehabilitation services at participating healthcare centres, belonging to the regional public health systems of Andalusia and Murcia, these patients presenting symptoms of painful shoulder and a diagnosis of subacromial syndrome (rotator cuff tendinitis and subacromial bursitis. The patients will be randomised into two groups: 1 experimental (acupuncture + physiotherapy; 2 control (TENS-placebo + physiotherapy; the administration of rescue medication will also be allowed. The treatment period will have a duration of three weeks. The main result variable will be the change produced on Constant's Shoulder Function Assessment (SFA Scale

  13. The BEST study - a prospective study to compare business class ...

    African Journals Online (AJOL)

    Background. As many as 10% of airline passengers travelling without prophylaxis for long distances may develop a venous thrombosis. There is, however, no evidence that economy class travellers are at increased risk of thrombosis. Objectives. A suitably powered prospective study, based on the incidence of deep-vein ...

  14. Factors associated with early outcomes following standardised therapy in children with ulcerative colitis (PROTECT): a multicentre inception cohort study.

    Science.gov (United States)

    Hyams, Jeffrey S; Davis, Sonia; Mack, David R; Boyle, Brendan; Griffiths, Anne M; LeLeiko, Neal S; Sauer, Cary G; Keljo, David J; Markowitz, James; Baker, Susan S; Rosh, Joel; Baldassano, Robert N; Patel, Ashish; Pfefferkorn, Marian; Otley, Anthony; Heyman, Melvin; Noe, Joshua; Oliva-Hemker, Maria; Rufo, Paul; Strople, Jennifer; Ziring, David; Guthery, Stephen L; Sudel, Boris; Benkov, Keith; Wali, Prateek; Moulton, Dedrick; Evans, Jonathan; Kappelman, Michael D; Marquis, Alison; Sylvester, Francisco A; Collins, Margaret H; Venkateswaran, Suresh; Dubinsky, Marla; Tangpricha, Vin; Spada, Krista L; Britt, Ashley; Saul, Bradley; Gotman, Nathan; Wang, Jessie; Serrano, Jose; Kugathasan, Subra; Walters, Thomas; Denson, Lee A

    2017-12-01

    Previous retrospective studies of paediatric ulcerative colitis have had limited ability to describe disease progression and identify predictors of treatment response. In this study, we aimed to identify characteristics associated with outcomes following standardised therapy after initial diagnosis. The PROTECT multicentre inception cohort study was based at 29 centres in the USA and Canada and included paediatric patients aged 4-17 years who were newly diagnosed with ulcerative colitis. Guided by the Pediatric Ulcerative Colitis Activity Index (PUCAI), patients received initial standardised treatment with mesalazine (PUCAI 10-30) oral corticosteroids (PUCAI 35-60), or intravenous corticosteroids (PUCAI ≥65). The key outcomes for this analysis were week 12 corticosteroid-free remission, defined as PUCAI less than 10 and taking only mesalazine, and treatment escalation during the 12 study weeks to anti-tumour necrosis factor α (TNFα) agents, immunomodulators, or colectomy among those initially treated with intravenous corticosteroids. We identified independent predictors of outcome through multivariable logistic regression using a per-protocol approach. This study is registered with ClinicalTrials.gov, number NCT01536535. Patients were recruited between July 10, 2012, and April 21, 2015. 428 children initiated mesalazine (n=136), oral corticosteroids (n=144), or intravenous corticosteroids (n=148). Initial mean PUCAI was 31·1 (SD 13·3) in children initiating with mesalazine, 50·4 (13·8) in those initiating oral corticosteroids, and 66·9 (13·7) in those initiating intravenous corticosteroids (pmodel due to clinical relevance]), rectal biopsy eosinophil count less than or equal to 32 cells per high power field (4·55, 1·62-12·78; p=0·0040), rectal biopsy surface villiform changes (3·05, 1·09-8·56; p=0·034), and not achieving week 4 remission (30·28, 6·36-144·20; p<0·0001). Our findings provide guidelines to assess the response of children newly

  15. Bruxism in craniocervical dystonia: a prospective study.

    Science.gov (United States)

    Borie, Laetitia; Langbour, Nicolas; Guehl, Dominique; Burbaud, Pierre; Ella, Bruno

    2016-09-01

    Bruxism pathophysiology remains unclear, and its occurrence has been poorly investigated in movement disorders. The aim of this study was to compare the frequency of bruxism in patients with craniocervical dystonia vs. normal controls and to determine its associated clinical features. This is a prospective-control study. A total of 114 dystonic subjects (45 facial dystonia, 69 cervical dystonia) and 182 controls were included. Bruxism was diagnosed using a hetero-questionnaire and a clinical examination performed by trained dentists. Occurrence of bruxism was compared between the different study populations. A binomial logistic regression analysis was used to determine which clinical features influenced bruxism occurrence in each population. The frequency of bruxism was significantly higher in the dystonic group than in normal controls but there was no difference between facial and cervical dystonia. It was also higher in women than in men. Bruxism features were similar between normal controls and dystonic patients except for a higher score of temporomandibular jaw pain in the dystonic group. The higher frequency of bruxism in dystonic patients suggests that bruxism is increased in patients with basal ganglia dysfunction but that its nature does not differ from that seen in bruxers from the normal population.

  16. Ossiculoplasty: A Prospective Study of 80 Cases

    Directory of Open Access Journals (Sweden)

    Shrinivas Shripatrao Chavan

    2014-07-01

    Full Text Available Introduction: The use of ossicular graft material in ossicular chain reconstruction has significantly improved hearing results hearing after tympanoplasty and tympanomastoid surgery for chronic otitis media. Today, otologists have a wide array of tools from which to choose, but may find it difficult to know which middle ear implant works best.   Materials and Methods: A prospective study of 80 patients who underwent ossiculoplasty was performed in the ear, nose, and throat (ENT department at a tertiary health care facility from 2011 to 2013. Patients with chronic suppurative otitis media with an air-bone gap (ABG of >25 dB with ossicular involvement were included in the study. Total ossicular replacement prosthesis (TORP, partial ossicular replacement prosthesis (PORP, and refashioned incus were used. Success was defined as ABG   Results: The majority patients were of middle age with moderate conductive hearing loss. Incus was the most susceptible ossicle. Overall success rate in this study was 80.0% with an average change of 15.76 dB in ABG.   Conclusion:  With continuing advances in our understanding of middle ear mechanics, the results of ossiculoplasty are improving and results can be very rewarding in experienced hands. Severity of preoperative ear discharge, preoperative mastoid cellularity, presence of disease, and surgical procedure proved to be significant prognostic factors. Autograft incus and PORP fared better when the malleus handle was present while TORP gave better results when the malleus handle was eroded.  

  17. Problem solving ability and repetition of deliberate self-harm: a multicentre study.

    NARCIS (Netherlands)

    McAuliffe, C.; Corcoran, P.; Keeley, H.S.; Arensman, E.; Bille Brahe, U.; de Leio, D.; Fekete, S.; Hawton, K.; Hjelmeland, H.; Kelleher, M.; Kerkhof, A.J.F.M.; Lonnqvist, J.; Michel, K.; Salander Renberg, E.; Schmidtke, A.; van Heeringen, K.; Wasserman, D.

    2006-01-01

    Background. While recent studies have found problem-solving impairments in individuals who engage in deliberate self-harm (DSH), few studies have examined repeaters and non-repeaters separately. The aim of the present study was to investigate whether specific types of problem-solving are associated

  18. Injuries in competitive boxing. A prospective study.

    Science.gov (United States)

    Siewe, J; Rudat, J; Zarghooni, K; Sobottke, R; Eysel, P; Herren, C; Knöll, P; Illgner, U; Michael, J

    2015-03-01

    Boxing remains a subject of controversy and is often classified as dangerous. But the discussion is based mostly on retrospective studies. This survey was conducted as a prospective study. From October 2012 to September 2013, 44 competitive boxers were asked to report their injuries once a month. The questionnaire collected general information (training, competition) and recorded the number of bouts fought, injuries and resulting lost days. A total of 192 injuries were recorded, 133 of which resulted in interruption of training or competition. Each boxer sustained 3 injuries per year on average. The injury rate was 12.8 injuries per 1 000 h of training. Boxers fighting more than 3 bouts per year sustain more injuries (p=0.0075). The injury rate does is not a function of age (age≤19 vs. > 19a, p=0.53). Injuries to the head and the upper limbs occur most frequently. The most common injuries are soft tissue lacerations and contusions. Head injuries with neurological symptoms rarely occur (4.2%). Boxing has a high injury rate that is comparable with other contact sports, but most injuries are minor. Injury frequency is not a function of whether the boxer competes in the junior or adult category. Athletes fighting many bouts per year have a greater risk of injury. © Georg Thieme Verlag KG Stuttgart · New York.

  19. Quality of pain treatment after caesarean section : Results of a multicentre cohort study

    NARCIS (Netherlands)

    Marcus, H.; Gerbershagen, H. J.; Peelen, Linda M.; Aduckathil, S.; Kappen, T. H.; Kalkman, C. J.; Meissner, W.; Stamer, U. M.; Peelen, LM

    BackgroundA large cohort study recently reported high pain scores after caesarean section (CS). The aim of this study was to analyse how pain after CS interferes with patients' activities and to identify possible causes of insufficient pain treatment. MethodsWe analysed pain scores, pain-related

  20. A multicentre weight loss study using a low-calorie diet over 8 weeks

    DEFF Research Database (Denmark)

    Papadaki, Angeliki; Linardakis, Manolis; Plada, Maria

    2013-01-01

    The efficacy of low-calorie diets (LCDs) has not been investigated in large-scale studies or among people from different regions, who are perhaps unaccustomed to such methods of losing weight. The aim of the present study was to investigate changes in obesity measures among overweight/obese adults...

  1. Prevalence of adherence to treatment in homebound elderly people in primary health care: a descriptive, cross-sectional, multicentre study.

    Science.gov (United States)

    Cárdenas-Valladolid, Juan; Martín-Madrazo, Carmen; Salinero-Fort, Miguel A; Carrillo de-Santa Pau, Enrique; Abánades-Herranz, Juan C; de Burgos-Lunar, Carmen

    2010-08-01

    Adherence to the therapeutic plan is one of the most important health issues in terms of treatment efficacy, healthcare costs and patient safety. Unfortunately, homebound elderly patients are especially vulnerable to nonadherence because they have higher morbidity rates combined with cognitive and social problems that hinder their correct use of drugs. The level of therapeutic adherence in homebound elderly people has not been adequately studied. To estimate the prevalence of therapeutic adherence, using the Morisky-Green test, in homebound elderly patients taking polypharmacy (defined as use of four or more drugs), and to study the factors associated with adherence. This was a descriptive, cross-sectional, multicentre study. A total of 327 patients were selected by random start systematic sampling from the total number of homebound patients taking four or more drugs in Healthcare Area 4 of the Madrid Autonomous Region, Spain. Through an in-home survey of patients and their caregivers, information was gathered on sociodemographic data, co-morbidities, number of hospital admissions, responsibility for purchasing and preparation of the medication, level of cognitive impairment (Pfeiffer questionnaire), functional dependence in activities of daily living (Katz Index), knowledge of the disease (Batalla test), adherence to treatment (Morisky-Green test), visual and auditory perception, and caregiver burden (Zarit interview). Of the homebound patients, 65.7% (95% CI 60.6, 70.9) had good adherence to treatment. The variables most negatively associated with therapeutic adherence, after adjustment for age, sex, number of drugs, knowledge of the disease, and cognitive function, were a large caregiver burden (odds ratio [OR] 3.09; 95% CI 1.75, 5.48) and impaired hearing (OR 2.00; 95% CI 1.17, 3.40). There was also a trend toward a positive association between nonadherence and patients aged <85 years (OR 1.57; 95% CI 0.93, 2.65) and patients who had nine or more drug

  2. Perception and use of massive open online courses among medical students in a developing country: multicentre cross-sectional study

    Science.gov (United States)

    Aboshady, Omar A; Radwan, Ahmed E; Eltaweel, Asmaa R; Azzam, Ahmed; Aboelnaga, Amr A; Hashem, Heba A; Darwish, Salma Y; Salah, Rehab; Kotb, Omar N; Afifi, Ahmed M; Noaman, Aya M; Salem, Dalal S; Hassouna, Ahmed

    2015-01-01

    Objectives To assess the prevalence of awareness and use of massive open online courses (MOOCs) among medical undergraduates in Egypt as a developing country, as well as identifying the limitations and satisfaction of using these courses. Design A multicentre, cross-sectional study using a web-based, pilot-tested and self-administered questionnaire. Settings Ten out of 19 randomly selected medical schools in Egypt. Participants 2700 undergraduate medical students were randomly selected, with an equal allocation of participants in each university and each study year. Primary and secondary outcome measures Primary outcome measures were the percentages of students who knew about MOOCs, students who enrolled and students who obtained a certificate. Secondary outcome measures included the limitations and satisfaction of using MOOCs through five-point Likert scale questions. Results Of 2527 eligible students, 2106 completed the questionnaire (response rate 83.3%). Of these students, 456 (21.7%) knew the term MOOCs or websites providing these courses. Out of the latter, 136 (29.8%) students had enrolled in at least one course, but only 25 (18.4%) had completed courses earning certificates. Clinical year students showed significantly higher rates of knowledge (p=0.009) and enrolment (p<0.001) than academic year students. The primary reasons for the failure of completion of courses included lack of time (105; 77.2%) and slow Internet speed (73; 53.7%). Regarding the 25 students who completed courses, 21 (84%) were satisfied with the overall experience. However, there was less satisfaction regarding student–instructor (8; 32%) and student–student (5; 20%) interactions. Conclusions About one-fifth of Egyptian medical undergraduates have heard about MOOCs with only about 6.5% actively enrolled in courses. Students who actively participated showed a positive attitude towards the experience, but better time-management skills and faster Internet connection speeds are required

  3. Computers and internet in dental education system of Kerala, South India: A multicentre study

    Directory of Open Access Journals (Sweden)

    Kanakath Harikumar

    2015-01-01

    Full Text Available Computers and internet have exerted a tremendous effect on dental education programs all over the world. A multicenter study was done to assess trends in computer and internet usage among the dental students and faculty members across the South Indian state, Kerala. A total of 347 subjects participated in the study. All participants were highly competent with the use of computers and internet. 72.3% of the study subjects preferred hard copy textbooks to PDF format books. 81.3% of the study subjects thought that internet was a useful adjunct to dental education. 73.8% of the study subjects opined that computers and internet could never be a replacement to conventional classroom teaching. Efforts should be made to provide greater infrastructure with regard to computers and internet such as Wi-Fi, free, unlimited internet access to all students and faculty members.

  4. Collecting core data in severely injured patients using a consensus trauma template: an international multicentre study

    DEFF Research Database (Denmark)

    Ringdal, Kjetil G; Lossius, Hans Morten; Jones, J Mary

    2011-01-01

    ABSTRACT: INTRODUCTION: No worldwide, standardised definitions exist for documenting, reporting, and comparing data from severely injured trauma patients. This study evaluated the feasibility of collecting the data variables of the international consensus-derived Utstein Trauma Template. METHODS:...

  5. Community and Healthcare Providers' Perspectives on Male Circumcision: A Multi-Centric Qualitative Study in India

    OpenAIRE

    Sahay, Seema; Nagarajan, Karikalan; Mehendale, Sanjay; Deb, Sibnath; Gupta, Abhilasha; Bharat, Shalini; Bhatt, Shripad; Kumar, Athokpam Bijesh; Kanthe, Vidisha; Sinha, Anju; Chandhiok, Nomita

    2014-01-01

    Background Although male circumcision (MC) is recommended as an HIV prevention option, the religious, cultural and biomedical dimensions of its feasibility, acceptability and practice in India have not been explored till date. This study explores beliefs, experiences and understanding of the community and healthcare providers (HCPs) about adult MC as an HIV prevention option in India. Methods This qualitative study covered 134 in-depth interviews from Belgaum, Kolkata, Meerut and Mumbai citie...

  6. Urea cycle disorders in Spain: an observational, cross-sectional and multicentric study of 104 cases

    OpenAIRE

    Martín-Hernández, Elena; Aldámiz-Echevarría, Luis; Castejón-Ponce, Esperanza; Pedrón-Giner, Consuelo; Couce, María Luz; Serrano-Nieto, Juliana; Pintos-Morell, Guillem; Bélanger-Quintana, Amaya; Martínez-Pardo, Mercedes; García-Silva, María Teresa; Quijada-Fraile, Pilar; Vitoria-Miñana, Isidro; Dalmau, Jaime; Lama-More, Rosa A; Bueno-Delgado, María Amor

    2014-01-01

    Background Advances in the diagnosis and treatment of urea cycle disorders (UCDs) have led to a higher survival rate. The purpose of this study is to describe the characteristics of patients with urea cycle disorders in Spain. Methods Observational, cross-sectional and multicenter study. Clinical, biochemical and genetic data were collected from patients with UCDs, treated in the metabolic diseases centers in Spain between February 2012 and February 2013, covering the entire Spanish populatio...

  7. The EMBARC European bronchiectasis registry: Protocol for an international observational study

    NARCIS (Netherlands)

    Chalmers, J.D. (James D.); S. Aliberti (Stefano); Polverino, E. (Eva); Vendrell, M. (Montserrat); Crichton, M. (Megan); Loebinger, M. (Michael); Dimakou, K. (Katerina); Clifton, I. (Ian); M. van der Eerden (Menno); G. Rohde (Gernot); Murris-Espin, M. (Marlene); Masefield, S. (Sarah); Gerada, E. (Eleanor); Shteinberg, M. (Michal); F.C. Ringshausen (Felix C.); Haworth, C. (Charles); W.G. Boersma (Wim); Rademacher, J. (Jessica); Hill, A.T. (Adam T.); Aksamit, T. (Timothy); O’Donnell, A. (Anne); Morgan, L. (Lucy); B. Milenkovic (Branislava); Tramma, L. (Leandro); Neves, J. (Joao); Menendez, R. (Rosario); Paggiaro, P. (Perluigi); Botnaru, V. (Victor); Skrgat, S. (Sabina); R. Wilson (Richard); Goeminne, P. (Pieter); De Soyza, A. (Anthony); T. Welte; Torres, A. (Antoni); S. Elborn (Stuart); Blasi, F. (Francesco)

    2016-01-01

    textabstractBronchiectasis is one of the most neglected diseases in respiratory medicine. There are no approved therapies and few large-scale, representative epidemiological studies. The EMBARC (European Multicentre Bronchiectasis Audit and Research Collaboration) registry is a prospective,

  8. Mid-term results of lateral unicondylar mobile bearing knee arthroplasty: a multicentre study of 363 cases.

    Science.gov (United States)

    Walker, T; Zahn, N; Bruckner, T; Streit, M R; Mohr, G; Aldinger, P R; Clarius, M; Gotterbarm, T

    2018-01-01

    The aim of this independent multicentre study was to assess the mid-term results of mobile bearing unicondylar knee arthroplasty (UKA) for isolated lateral osteoarthritis of the knee joint. We retrospectively evaluated 363 consecutive, lateral UKAs (346 patients) performed using the Oxford domed lateral prosthesis undertaken in three high-volume knee arthroplasty centres between 2006 and 2014. Mean age of the patients at surgery was 65 years (36 to 88) with a mean final follow-up of 37 months (12 to 93) RESULTS: A total of 36 (10.5%) patients underwent revision surgery, giving a survival rate of 90.1% at three years (95% confidence intervals (CI) 86.1 to 93.1; number at risk: 155) and 85.0% at five years (95% CI 77.9 to 89.9; number at risk: 43). Dislocation of the mobile bearing occurred in 18 patients (5.6%) at three years (95% CI 1.0 to 16.4; number at risk: 154) and in 20 patients (8.5%) at five years (95% CI 1.0 to 27.0; number at risk: 42). There were no significant differences in the dislocation rate between the participating centres or the surgeons. We were not able to identify an effect of each surgeon's learning curve on the dislocation rate of the mobile bearing. The clinical outcome in patients without revision surgery at final follow-up was good to excellent, with a mean Oxford knee score of 40.3 (95% CI 39.4 to 41.2), a mean Tegner activity score of 3.2 (95% CI 3.1 to 3.3) and a mean University of California, Los Angeles score of 5.7 (95% CI 5.5 to 5.9). Our data, which consists of a high number of patients treated with mobile bearing UKA in the lateral compartment, indicates a high revision rate of 15% at five years with dislocation of the mobile bearing being the main reason for implant failure. Despite the good functional and clinical results and the high patient satisfaction in our study group, we therefore discontinued using mobile-bearing lateral UKA in favour of a fixed-bearing component. Cite this article: Bone Joint J 2018;100-B:42-9. ©2018

  9. Phenylketonuria patients' and their parents' acceptance of the disease: multi-centre study.

    Science.gov (United States)

    Witalis, Ewa; Mikoluc, Bożena; Motkowski, Radoslaw; Szyszko, Justyna; Chrobot, Agnieszka; Didycz, Bozena; Lange, Agata; Mozrzymas, Renata; Milanowski, Andrzej; Nowacka, Maria; Piotrowska-Depta, Mariola; Romanowska, Hanna; Starostecka, Ewa; Wierzba, Jolanta; Skorniewska, Magdalena; Wojcicka-Bartlomiejczyk, Barbara Iwona; Gizewska, Maria

    2016-11-01

    Phenylketonuria (PKU) still poses a therapeutic challenge for patients and medical professionals. The aim of the study was to assess both patients' and their parents' acceptance of the disease. The study included 218 PKU patients and 178 parents of PKU children who were enrolled in the study on the basis of questionnaire data. Regarding attitude towards the disease, our study demonstrated that 63 (28.9 %) PKU patients did not accept the disease. Patients who found accepting the disease difficult, more frequently perceived themselves as inferior/different in comparison with their peers. In total, 36 % of patients did not want their friends to be aware of their condition, while only 18 % of parents believed that their children's peers should not know about their disease. In total, 42 % of parents wanted to talk to other parents of PKU children and only 13 % to a doctor. Only 20 % of patients saw the need to discuss their condition with a doctor. In total, 8 % of children, regardless of age, and 14 % of parents preferred to talk to a psychologist. Our data demonstrated that disease acceptance played an essential role in patients' social integration. The study also indicated the need to overcome communication barriers between patients and their healthy peers and for patients to find the courage to be open about the disease. The importance of support groups for PKU families and the significance of strict cooperation between patients and their families with PKU treatment teams were also revealed.

  10. Low incidence but poor prognosis of complicated coeliac disease: a retrospective multicentre study.

    Science.gov (United States)

    Biagi, Federico; Gobbi, Paolo; Marchese, Alessandra; Borsotti, Edoardo; Zingone, Fabiana; Ciacci, Carolina; Volta, Umberto; Caio, Giacomo; Carroccio, Antonio; Ambrosiano, Giuseppe; Mansueto, Pasquale; Corazza, Gino R

    2014-03-01

    Coeliac disease is a chronic enteropathy characterized by an increased mortality caused by its complications, mainly refractory coeliac disease, small bowel carcinoma and abdominal lymphoma. Aim of the study was to study the epidemiology of complications in patients with coeliac disease. Retrospective multicenter case-control study based on collection of clinical and laboratory data. The incidence of complicated coeliac disease was studied among coeliac patients directly diagnosed in four Italian centres. Patients referred to these centres after a diagnosis of coeliac disease and/or complicated coeliac disease in other hospitals were therefore excluded. Between 1/1999 and 10/2011, 1840 adult coeliac patients were followed up for 7364.3 person-years. Fourteen developed complications. Since five patients died, at the end of the observation period (10/2011), the prevalence of complicated coeliac disease was 9/1835 (1/204, 0.49%, 95% CI 0.2-0.9%). The annual incidence of complicated coeliac disease in the study period was 14/7364 (0.2%, 95% CI 0.1-0.31%). Although complications tend to occur soon after the diagnosis of coeliac disease, Kaplan-Meier curve analysis showed that they can actually occur at any time after the diagnosis of coeliac disease. Complications of coeliac disease in our cohort were quite rare, though characterised by a very high mortality. Copyright © 2013 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.

  11. WHO multicentre study for the development of growth standards from fetal life to childhood

    DEFF Research Database (Denmark)

    Merialdi, Mario; Widmer, Mariana; Gülmezoglu, Ahmet Metin

    2014-01-01

    backgrounds. The study will select pregnant women of high-middle socioeconomic status with no obvious environmental constraints on growth (adequate nutritional status, non-smoking), and normal pregnancy history with no complications likely to affect fetal growth. The study will be conducted in centres from...... ten developing and industrialized countries: Argentina, Brazil, Democratic Republic of Congo, Denmark, Egypt, France, Germany, India, Norway, and Thailand. At each centre, 140 pregnant women will be recruited between 8 + 0 and 12 + 6 weeks of gestation. Subsequently, visits for fetal biometry...

  12. Depression after CABG: a prospective study

    Directory of Open Access Journals (Sweden)

    Joana Kátya Veras Rodrigues Sampaio Nunes

    2013-12-01

    Full Text Available INTRODUCTION: Depression during or shortly after hospitalization elevated two to three times the risk of mortality or nonfatal cardiac events, significantly increasing the morbidity and mortality of these patients. OBJECTIVE: To assess the impact of revascularization on symptoms of depression in patients with coronary artery disease. METHODS: A prospective cohort study of 57 patients of both sexes undergoing coronary artery bypass grafting between June 2010 and June 2011. We used the SF-36 to assess quality of life, and the Beck Depression Inventory to detect depressive symptoms, applied preoperatively and six months. RESULTS: The prevalence of patients aged 60-69 years was 22 patients (38.60%, 39 men (68.42%, 26 described themselves as mixed race (45.61%, 16 literate (28.07 % and 30 married (52.63%. The beck depression inventory score demonstrated increased after revascularization: 15 patients mild (26.32% at time zero to 17 (29.82% after. And with moderate, seven patients (12.28% before and 10 (17.54% after. In the categories of individuals with decreased minimum degree of 32 (56.14% to 28 (49.12%, and severe of three (5.26% for two (3.51% patients. Association was observed between beck depression inventory, gender, age, lifestyle, comorbidities and quality of life. CONCLUSION: There was a high prevalence of elevated beck depression inventory scores, lowest scores of depressive symptoms among men and association between the improvement of quality of life scores and beck depression inventory.

  13. Influence of female bodyweight on IVF outcome: a longitudinal multicentre cohort study of 487 infertile couples

    DEFF Research Database (Denmark)

    Pinborg, A; Gaarslev, C; Hougaard, C O

    2011-01-01

    This study investigated the impact of women's body mass index (BMI) on the outcome after consecutive IVF/intracytoplasmic sperm injection cycles in 487 patients initiating treatment with 5-year follow-up. The total number of cycles was 1417. In total 103 (21.1%) were overweight (BMI 25-29.9 kg...

  14. National pholcodine consumption and prevalence of IgE-sensitization: a multicentre study

    DEFF Research Database (Denmark)

    Johansson, S G O; Florvaag, E; Oman, H

    2010-01-01

    The aim of this study was to test, on a multinational level, the pholcodine (PHO) hypothesis, i.e. that the consumption of PHO-containing cough mixtures could cause higher prevalence of IgE antibodies to PHO, morphine (MOR) and suxamethonium (SUX). As a consequence the risk of anaphylaxis to neur...

  15. How patients would like to improve medical consultations: insights from a multicentre European study.

    NARCIS (Netherlands)

    Mazzi, M.A.; Rimondini, M.; Boerma, W.G.W.; Zimmermann, C.; Bensing, J.M.

    2016-01-01

    Objective: In a previous qualitative study (GULiVer-I), a series of lay-people derived recommendations (‘tips’) was listed for doctor and patient on ‘How to make medical consultation more effective from the patient’s perspective’. This work (GULiVer-II) aims to find evidence whether these tips can

  16. How patients would like to improve medical consultations : Insights from a multicentre European study

    NARCIS (Netherlands)

    Mazzi, Maria Angela; Rimondini, Michela; Boerma, Wienke G W; Zimmermann, Christa; Bensing, Jozien M|info:eu-repo/dai/nl/068519397

    OBJECTIVE: In a previous qualitative study (GULiVer-I), a series of lay-people derived recommendations ('tips') was listed for doctor and patient on 'How to make medical consultation more effective from the patient's perspective'. This work (GULiVer-II) aims to find evidence whether these tips can

  17. EC multicentre study on small area variations in air quality and health (SAVIAH)

    Energy Technology Data Exchange (ETDEWEB)

    Lebret, E [National Inst. of Public Health and Environmental Protection (Netherlands); Elliott, P [London School of Hygiene and Tropical Medicine (United Kingdom); Briggs, D [Huddersfield Univ. (United Kingdom). Inst. of Environmental and Policy Analysis; Gorynski, P [National Inst. of Hygiene, Warsaw (Poland); Kriz, B [National Inst. of Public Health, Prague (Czech Republic)

    1996-12-31

    SAVIAH is an EC-funded methodological study coordinated by Dr. Paul Elliott at the LSHTM (London School of Hygiene and Tropical Medicine). The project aims to apply, test and evaluate new and emerging methodologies in the fields of epidemiology, geography, air pollution modelling and small area health statistics, and to bring the data together in a consistent geographic framework. The study was carried out in the U.K., The Netherlands, Poland and the Czech Republic, using the example of childhood wheeze and outdoor air pollution. Specific aims of the study were, in each centre, (1) to carry out a questionnaire survey among parents of guardians of around 4000 to 5000 children aged between 7 and 11, (2) to carry out a series of air pollution surveys for NO{sub 2} as a proxy for the complex of traffic-related pollutants, and SO{sub 2} (PL), using a dense network of passive samplers, (3) to build up a detailed Geographical Information System (GIS) for each of the study areas; (4) to construct an air pollution `map` based on the NO{sub 2} and SO{sub 2} measurements and a health `map` based on `map smoothing` techniques and (5) to explore methods to examine relationships between health, pollution, socio-economic and other data. (author)

  18. EC multicentre study on small area variations in air quality and health (SAVIAH)

    Energy Technology Data Exchange (ETDEWEB)

    Lebret, E. [National Inst. of Public Health and Environmental Protection (Netherlands); Elliott, P. [London School of Hygiene and Tropical Medicine (United Kingdom); Briggs, D. [Huddersfield Univ. (United Kingdom). Inst. of Environmental and Policy Analysis; Gorynski, P. [National Inst. of Hygiene, Warsaw (Poland); Kriz, B. [National Inst. of Public Health, Prague (Czech Republic)

    1995-12-31

    SAVIAH is an EC-funded methodological study coordinated by Dr. Paul Elliott at the LSHTM (London School of Hygiene and Tropical Medicine). The project aims to apply, test and evaluate new and emerging methodologies in the fields of epidemiology, geography, air pollution modelling and small area health statistics, and to bring the data together in a consistent geographic framework. The study was carried out in the U.K., The Netherlands, Poland and the Czech Republic, using the example of childhood wheeze and outdoor air pollution. Specific aims of the study were, in each centre, (1) to carry out a questionnaire survey among parents of guardians of around 4000 to 5000 children aged between 7 and 11, (2) to carry out a series of air pollution surveys for NO{sub 2} as a proxy for the complex of traffic-related pollutants, and SO{sub 2} (PL), using a dense network of passive samplers, (3) to build up a detailed Geographical Information System (GIS) for each of the study areas; (4) to construct an air pollution `map` based on the NO{sub 2} and SO{sub 2} measurements and a health `map` based on `map smoothing` techniques and (5) to explore methods to examine relationships between health, pollution, socio-economic and other data. (author)

  19. The incidence of venous thromboembolism in patients with overt hyperthyroidism A retrospective multicentre cohort study

    NARCIS (Netherlands)

    Kootte, Ruud S.; Stuijver, Danka J. F.; Dekkers, Olaf M.; van Zaane, Bregje; Fliers, Eric; Cannegieter, Suzanne C.; Gerdes, Victor E. A.

    2012-01-01

    Hyperthyroidism is associated with several changes in the haemostatic system resulting in a hypercoagulable state. It is uncertain at this stage whether this leads to an increased risk of venous thromboembolism (VIE). The aim of this retrospective cohort study was to determine the risk of VTE in all

  20. Effectiveness of family work interventions on schizophrenia: evidence from a multicentre study in Catalonia.

    Science.gov (United States)

    Tomás, Esther Pousa; Hurtado, Gemma; Noguer, Sílvia; Domènech, Cristina; García, Montse; López, Nuria; Negredo, Maríacruz; Penadés, Rafael; Reinares, María; Serrano, Dolors; Dolz, Montse; Gallo, Pedro

    2012-11-01

    Despite their proven efficacy, family work interventions on families of patients with schizophrenia are not being implemented in routine clinical practice in contexts where expressed emotion levels among caregivers are relatively high. This study aimed to explore the effectiveness of a family work intervention in a Mediterranean environment in Catalonia, Spain. Participants were 23 patients and 35 key relatives in five different clinical settings. The family intervention was provided by 10 trained health care professionals during a nine-month period. A six-month follow-up was also conducted. Statistically significant improvements were found in patients' clinical status, global functioning and social functioning levels, as well as in caregivers' burden of care. These results were maintained during follow-up. This is the first study to explore the effectiveness of family intervention in a high-expressed emotion context in Catalonia. The findings add weight to the growing literature supporting these interventions in different cultural settings.

  1. The use of antidepressants in patients with advanced cancer--results from an international multicentre study.

    Science.gov (United States)

    Janberidze, Elene; Hjermstad, Marianne Jensen; Brunelli, Cinzia; Loge, Jon Håvard; Lie, Hanne Cathrine; Kaasa, Stein; Knudsen, Anne Kari

    2014-10-01

    Depression is common in patients with advanced cancer; however, it is not often recognized and therefore not treated. The aims of this study were to examine the prevalence of the use of antidepressants (ADs) in an international cross-sectional study sample and to identify sociodemographic and medical variables associated with their use. The study was conducted in patients with advanced cancer from 17 centres across eight countries. Healthcare professionals registered patient and disease-related characteristics. A dichotomous score (no/yes) was used to assess the use of ADs other than as adjuvant for pain. Self-report questionnaires from patients were used for the assessment of functioning and symptom intensity. Of 1051 patient records with complete data on ADs, 1048 were included (M:540/F:508, mean age 62 years, standard deviation [SD] 12). The majority were inpatients, and 85% had metastatic disease. The prevalence of AD use was 14%. Multivariate logistic regression analyses showed that younger age (odds ratio [OR] 2.46; confidence interval [CI] 1.32-4.55), female gender (OR 1.59; CI 1.09-2.33), current medication for pain (OR 2.68; CI 1.65-4.33) and presence of three or more co-morbidities (OR 4.74; CI 2.27-9.91) were associated with AD use for reasons other than pain. Disease-related variables (diagnoses, stage, Karnofsky Performance Status and survival) were not associated with the use of ADs. Female gender, younger age, analgesic use and multiple co-morbidities were associated with the use of ADs. However, information is still limited on which variables guide physicians in prescribing AD medication. Further longitudinal studies including details on psychiatric and medication history are needed to improve the identification of patients in need of ADs. Copyright © 2014 John Wiley & Sons, Ltd.

  2. Community and Healthcare Providers' Perspectives on Male Circumcision: A Multi-Centric Qualitative Study in India

    Science.gov (United States)

    Sahay, Seema; Nagarajan, Karikalan; Mehendale, Sanjay; Deb, Sibnath; Gupta, Abhilasha; Bharat, Shalini; Bhatt, Shripad; Kumar, Athokpam Bijesh; Kanthe, Vidisha; Sinha, Anju; Chandhiok, Nomita

    2014-01-01

    Background Although male circumcision (MC) is recommended as an HIV prevention option, the religious, cultural and biomedical dimensions of its feasibility, acceptability and practice in India have not been explored till date. This study explores beliefs, experiences and understanding of the community and healthcare providers (HCPs) about adult MC as an HIV prevention option in India. Methods This qualitative study covered 134 in-depth interviews from Belgaum, Kolkata, Meerut and Mumbai cities of India. Of these, 62 respondents were the members of circumcising (CC)/non-circumcising communities (NCC); including medically and traditionally circumcised men, parents of circumcised children, spouses of circumcised men, and religious clerics. Additionally, 58 registered healthcare providers (RHCPs) such as general and pediatric surgeons, pediatricians, skin and venereal disease specialists, general practitioners, and operation theatre nurses were interviewed. Fourteen traditional circumcisers were also interviewed. The data were coded and analyzed in QSR NUD*IST ver. 6.0. The study has not explored the participants' views about neonatal versus adult circumcision. Results Members of CC/NCC, traditional circumcisers and RCHPs expressed sharp religious sensitivities around the issue of MC. Six themes emerged: Male circumcision as the religious rite; Multiple meanings of MC: MC for ‘religious identity/privilege/sacrifice’ or ‘hygiene’; MC inflicts pain and cost; Medical indications outweigh faith; Hesitation exists in accepting ‘foreign’ evidence supporting MC; and communication is the key for acceptance of MCs. Medical indications could make members of NCC accept MC following appropriate counseling. Majority of the RHCPs demanded local in-country evidence. Conclusion HCPs must educate high-risk groups regarding the preventive and therapeutic role of MC. Communities need to discuss and create new social norms about male circumcision for better societal acceptance

  3. Community and healthcare providers' perspectives on male circumcision: a multi-centric qualitative study in India.

    Directory of Open Access Journals (Sweden)

    Seema Sahay

    Full Text Available Although male circumcision (MC is recommended as an HIV prevention option, the religious, cultural and biomedical dimensions of its feasibility, acceptability and practice in India have not been explored till date. This study explores beliefs, experiences and understanding of the community and healthcare providers (HCPs about adult MC as an HIV prevention option in India.This qualitative study covered 134 in-depth interviews from Belgaum, Kolkata, Meerut and Mumbai cities of India. Of these, 62 respondents were the members of circumcising (CC/non-circumcising communities (NCC; including medically and traditionally circumcised men, parents of circumcised children, spouses of circumcised men, and religious clerics. Additionally, 58 registered healthcare providers (RHCPs such as general and pediatric surgeons, pediatricians, skin and venereal disease specialists, general practitioners, and operation theatre nurses were interviewed. Fourteen traditional circumcisers were also interviewed. The data were coded and analyzed in QSR NUD*IST ver. 6.0. The study has not explored the participants' views about neonatal versus adult circumcision.Members of CC/NCC, traditional circumcisers and RCHPs expressed sharp religious sensitivities around the issue of MC. Six themes emerged: Male circumcision as the religious rite; Multiple meanings of MC: MC for 'religious identity/privilege/sacrifice' or 'hygiene'; MC inflicts pain and cost; Medical indications outweigh faith; Hesitation exists in accepting 'foreign' evidence supporting MC; and communication is the key for acceptance of MCs. Medical indications could make members of NCC accept MC following appropriate counseling. Majority of the RHCPs demanded local in-country evidence.HCPs must educate high-risk groups regarding the preventive and therapeutic role of MC. Communities need to discuss and create new social norms about male circumcision for better societal acceptance especially among the NCC. Feasibility

  4. ABO and Rh (D group distribution and gene frequency; the first multicentric study in India

    Directory of Open Access Journals (Sweden)

    Amit Agrawal

    2014-01-01

    Full Text Available Background and Objectives: The study was undertaken with the objective to provide data on the ABO and Rh(D blood group distribution and gene frequency across India. Materials and Methods: A total of 10,000 healthy blood donors donating in blood banks situated in five different geographical regions of the country (North, South, East and Center were included in the study. ABO and Rh (D grouping was performed on all these samples. Data on the frequency of ABO and Rh(D blood groups was reported in simple numbers and percentages. Results: The study showed that O was the most common blood group (37.12% in the country closely followed by B at 32.26%, followed by A at 22.88% while AB was the least prevalent group at 7.74%. 94.61% of the donor population was Rh positive and the rest were Rh negative. Regional variations were observed in the distribution. Using the maximum likelihood method, the frequencies of the I A , I B and I O alleles were calculated and tested according to the Hardy Weinberg law of Equilibrium. The calculated gene frequencies are 0.1653 for I A (p, 0.2254 for I B (q and 0.6093 for I O (r. In Indian Population, O (r records the highest value followed by B (q and A (p; O > B > A. Conclusion: The study provides information about the relative distribution of various alleles in the Indian population both on a pan-India basis as well as region-wise. This vital information may be helpful in planning for future health challenges, particularly planning with regards to blood transfusion services.

  5. Multicentre study of treatment outcomes in Australian adolescents and young adults commencing dialysis.

    Science.gov (United States)

    Krischock, Leah; Kennedy, Sean E; Hayen, Andrew

    2017-12-01

    The aim of the study is to improve the understanding of outcomes and complications of dialysis in adolescents and young adults (AYA) to inform decisions about dialysis modality in this patient population. Registry data on Australian AYA aged 13 to 20 years who commenced dialysis between 1/1/2000 and 31/12/2013 were retrieved from the Australia and New Zealand Dialysis and Transplantation Registry and analyzed to determine associations between demographic characteristics, dialysis modality and outcomes. During the study period 300 AYA commenced dialysis at a median age of 17.2 years (IQR 15.6 to 18.6 years). Haemodialysis (HD) was the initial dialysis modality in 201 patients (67%). No significant differences between AYA receiving HD and peritoneal dialysis (PD) were noted in patient gender, age, race, primary renal disease, treating centre type, remoteness of residential area, lateness of referral or period of study. Mean haemoglobin levels were lower in the HD group (P = 0.005) and significantly fewer HD patients attended school full time compared to patients managed on PD (P = 0.002 first year; P = 0.05 second year). Dialysis modality choice does not appear to be influenced by patient characteristics nor dialysis outcomes. Future research is required to examine the reasons that HD is preferred over PD and to determine the optimal method of dialysis for this age group. © 2016 Asian Pacific Society of Nephrology.

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

    Science.gov (United States)

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

    2016-07-01

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

  7. Outcome of adults with Eisenmenger syndrome treated with drugs specific to pulmonary arterial hypertension: A French multicentre study.

    Science.gov (United States)

    Hascoet, Sebastien; Fournier, Emmanuelle; Jaïs, Xavier; Le Gloan, Lauriane; Dauphin, Claire; Houeijeh, Ali; Godart, Francois; Iriart, Xavier; Richard, Adelaïde; Radojevic, Jelena; Amedro, Pascal; Bosser, Gilles; Souletie, Nathalie; Bernard, Yvette; Moceri, Pamela; Bouvaist, Hélène; Mauran, Pierre; Barre, Elise; Basquin, Adeline; Karsenty, Clement; Bonnet, Damien; Iserin, Laurence; Sitbon, Olivier; Petit, Jérôme; Fadel, Elie; Humbert, Marc; Ladouceur, Magalie

    2017-05-01

    The relationship between pulmonary arterial hypertension-specific drug therapy (PAH-SDT) and mortality in Eisenmenger syndrome (ES) is controversial. To investigate outcomes in patients with ES, and their relationship with PAH-SDT. Retrospective, observational, nationwide, multicentre cohort study. We included 340 patients with ES: genetic syndrome (n=119; 35.3%); pretricuspid defect (n=75; 22.1%). Overall, 276 (81.2%) patients received PAH-SDT: monotherapy (endothelin receptor antagonist [ERA] or phosphodiesterase 5 inhibitor [PDE5I]) 46.7%; dual therapy (ERA+PDE5I) 40.9%; triple therapy (ERA+PDE5I+prostanoid) 9.1%. Median PAH-SDT duration was 5.5 years [3.0-9.1 years]. Events (death, lung or heart-lung transplantation) occurred in 95 (27.9%) patients at a median age of 40.5 years [29.4-47.6]. The cumulative occurrence of events was 16.7% [95% confidence interval 12.8-21.6%] and 46.4% [95% confidence interval 38.2-55.4%] at age 40 and 60 years, respectively. With age at evaluation or time since PAH diagnosis as time scales, cumulative occurrence of events was lower in patients taking one or two PAH-SDTs (P=0.0001 and P=0.004, respectively), with the largest differences in the post-tricuspid defect subgroup (P<0.001 and P<0.02, respectively) versus patients without PAH-SDT. By multivariable Cox analysis, with time since PAH diagnosis as time scale, New York Heart Association/World Health Organization functional class III/IV, lower peripheral arterial oxygen saturation and pretricuspid defect were associated with a higher risk of events (P=0.002, P=0.01 and P=0.04, respectively), and one or two PAH-SDTs with a lower risk of events (P=0.009). Outcomes are poor in ES, but seem better with PAH-SDT. ES with pretricuspid defects has worse outcomes despite the delayed disease onset. Copyright © 2017 Elsevier Masson SAS. All rights reserved.

  8. Cerebrospinal fluid biomarker supported diagnosis of Creutzfeldt–Jakob disease and rapid dementias: a longitudinal multicentre study over 10 years

    Science.gov (United States)

    Sanchez-Juan, Pascual; Gawinecka, Joanna; Green, Alison; Ladogana, Anna; Pocchiari, Maurizio; Sanchez-Valle, Raquel; Mitrova, Eva; Sklaviadis, Theodor; Kulczycki, Jerzy; Slivarichova, Dana; Saiz, Albert; Calero, Miguel; Knight, Richard; Aguzzi, Adriano; Laplanche, Jean-Louis; Peoc’h, Katell; Schelzke, Gabi; Karch, Andre; van Duijn, Cornelia M.; Zerr, Inga

    2012-01-01

    To date, cerebrospinal fluid analysis, particularly protein 14-3-3 testing, presents an important approach in the identification of Creutzfeldt–Jakob disease cases. However, one special point of criticism of 14-3-3 testing is the specificity in the differential diagnosis of rapid dementia. The constant observation of increased cerebrospinal fluid referrals in the national surveillance centres over the last years raises the concern of declining specificity due to higher number of cerebrospinal fluid tests performed in various neurological conditions. Within the framework of a European Community supported longitudinal multicentre study (‘cerebrospinal fluid markers’) we analysed the spectrum of rapid progressive dementia diagnoses, their potential influence on 14-3-3 specificity as well as results of other dementia markers (tau, phosphorylated tau and amyloid-β1–42) and evaluated the specificity of 14-3-3 in Creutzfeldt–Jakob disease diagnosis for the years 1998–2008. A total of 29 022 cerebrospinal fluid samples were analysed for 14-3-3 protein and other cerebrospinal fluid dementia markers in patients with rapid dementia and suspected Creutzfeldt–Jakob disease in the participating centres. In 10 731 patients a definite diagnosis could be obtained. Protein 14-3-3 specificity was analysed for Creutzfeldt–Jakob disease with respect to increasing cerebrospinal fluid tests per year and spectrum of differential diagnosis. Ring trials were performed to ensure the comparability between centres during the reported time period. Protein 14-3-3 test specificity remained high and stable in the diagnosis of Creutzfeldt–Jakob disease during the observed time period across centres (total specificity 92%; when compared with patients with definite diagnoses only: specificity 90%). However, test specificity varied with respect to differential diagnosis. A high 14-3-3 specificity was obtained in differentiation to other neurodegenerative diseases (95–97%) and non

  9. Cerebrospinal fluid biomarker supported diagnosis of Creutzfeldt-Jakob disease and rapid dementias: a longitudinal multicentre study over 10 years.

    Science.gov (United States)

    Stoeck, Katharina; Sanchez-Juan, Pascual; Gawinecka, Joanna; Green, Alison; Ladogana, Anna; Pocchiari, Maurizio; Sanchez-Valle, Raquel; Mitrova, Eva; Sklaviadis, Theodor; Kulczycki, Jerzy; Slivarichova, Dana; Saiz, Albert; Calero, Miguel; Knight, Richard; Aguzzi, Adriano; Laplanche, Jean-Louis; Peoc'h, Katell; Schelzke, Gabi; Karch, Andre; van Duijn, Cornelia M; Zerr, Inga

    2012-10-01

    To date, cerebrospinal fluid analysis, particularly protein 14-3-3 testing, presents an important approach in the identification of Creutzfeldt-Jakob disease cases. However, one special point of criticism of 14-3-3 testing is the specificity in the differential diagnosis of rapid dementia. The constant observation of increased cerebrospinal fluid referrals in the national surveillance centres over the last years raises the concern of declining specificity due to higher number of cerebrospinal fluid tests performed in various neurological conditions. Within the framework of a European Community supported longitudinal multicentre study ('cerebrospinal fluid markers') we analysed the spectrum of rapid progressive dementia diagnoses, their potential influence on 14-3-3 specificity as well as results of other dementia markers (tau, phosphorylated tau and amyloid-β(1-42)) and evaluated the specificity of 14-3-3 in Creutzfeldt-Jakob disease diagnosis for the years 1998-2008. A total of 29 022 cerebrospinal fluid samples were analysed for 14-3-3 protein and other cerebrospinal fluid dementia markers in patients with rapid dementia and suspected Creutzfeldt-Jakob disease in the participating centres. In 10 731 patients a definite diagnosis could be obtained. Protein 14-3-3 specificity was analysed for Creutzfeldt-Jakob disease with respect to increasing cerebrospinal fluid tests per year and spectrum of differential diagnosis. Ring trials were performed to ensure the comparability between centres during the reported time period. Protein 14-3-3 test specificity remained high and stable in the diagnosis of Creutzfeldt-Jakob disease during the observed time period across centres (total specificity 92%; when compared with patients with definite diagnoses only: specificity 90%). However, test specificity varied with respect to differential diagnosis. A high 14-3-3 specificity was obtained in differentiation to other neurodegenerative diseases (95-97%) and non

  10. Socio-demographic and clinical determinants of self-care in adults with type 2 diabetes: a multicentre observational study.

    Science.gov (United States)

    Ausili, Davide; Rossi, Emanuela; Rebora, Paola; Luciani, Michela; Tonoli, Luca; Ballerini, Enrico; Androni, Silvia; Vellone, Ercole; Riegel, Barbara; Di Mauro, Stefania

    2018-04-05

    To describe self-care as defined by the Middle Range Theory of Self-Care of Chronic Illness and to identify clinical and socio-demographic determinants in a T2DM population. A multicentre observational cross-sectional study was conducted involving 540 adults with a confirmed diagnosis of T2DM from six outpatient diabetes services in Italy. Socio-demographic and clinical data were collected from medical records. The Self-Care of Diabetes Inventory (SCODI) was used to measure self-care maintenance, monitoring, management, and confidence dimensions. For each separate scale, scores were standardized 0-100 with higher SCODI scores indicating better self-care; a score ≥ 70 is adequate. Multiple quantile regression models were performed to identify determinants of each self-care dimension. Self-care maintenance (median = 81.3) and self-care confidence (median = 79.5) were adequate in most of the subjects. Self-care monitoring was adequate in only half of the sample (median = 70.6). Self-care management was poor (median = 59.4). Lower self-care maintenance was associated with lower self-care confidence (p self-care monitoring was associated with being male (p self-care confidence (p diabetes for self-care management was associated with being male (p = 0.002), being older (p = 0.005), having a low income (p = 0.030), being employed (p = 0.008), having missed diabetes education in the last year (p = 0.002), and lower self-care confidence (p self-care confidence was associated with having diabetes for self-care maintenance, monitoring, management and confidence include both clinical and socio-demographic variables. Modifiable determinants such as self-care confidence and diabetes self-care management education could be used to tailor interventions to improve diabetes self-care.

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

    Energy Technology Data Exchange (ETDEWEB)

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

    2009-04-15

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

  12. Prospective study on quality of newborn care

    Directory of Open Access Journals (Sweden)

    N Khanam

    2013-12-01

    Full Text Available Background: Quality of services provided by health care provider, the closest health functionary to the community has impact on neonatal mortality. Aims: Study on quality of newborn care in rural areas.  Settings and Design: This is a prospective study in the field practice areas of J.N. Medical College and areas under primary health centre of public health care system in Wardha district.  Methods and Material: Modified quality check list on the basis of PHC MAP module guidelines for assessing the quality of service-module 6-user’s guide was prepared. Face to face interview with 205 (group-A/104 nos + group-B/101 nos mother of newborn was method to collected information in three postnatal visits.  Statistical analysis: Quality (verbal response of each service was quantified as acceptable, average and worst.  Quality of both the groups was compared by calculating P-value after utilizing Z-test.  Results: Over all acceptable quality of medical history was 30.03%, physical examination was 21.73%, preventive service was 91.17% and counseling was 24.83%. Significant difference between two groups were found on history taking for (cry, breathing and body movement of baby, recording weight and counseling regarding exclusive breast feeding for first 6 month of life. Worst quality in this study were observed in history for anything applying to eyes, umbilical cord stump and complication of baby for which appropriate management was taken. Except for weight recording and examination of head and fontanels all other variables under physical examination were not acceptable. Counseling regarding high risk condition of baby was only 13.66%. Conclusion: Existing newborn services except immunization is inadequate and needs to be strengthened especially physical examination and counseling services. 

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

    DEFF Research Database (Denmark)

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

    2008-01-01

    nulliparous women in term spontaneous labour with a singleton infant in cephalic presentation. Data were collected by self-administered questionnaires and clinical data-records. Logistic regression analyses were used to estimate adjusted Odds Ratios (OR) and 95% confidence intervals (CI) are given. RESULTS......BACKGROUND: In nulliparous women dystocia is the most common obstetric problem and its etiology is largely unknown. The frequency of augmentation and cesarean delivery related to dystocia is high although it is not clear if a slow progress justifies the interventions. Studies of risk factors......: The following characteristics, present at admission to hospital, were associated with dystocia during labour (OR, 95% CI): dilatation of cervix

  14. A multicentric observational study to evaluate the role of homoeopathic therapy in vitiligo

    Directory of Open Access Journals (Sweden)

    P S Chakraborty

    2015-01-01

    Results: The changes in the mean VSS at intervals of every 6 months was found to be statistically significant. Homoeopathic treatment was found to be useful in relieving vitiligo in varying degrees in 126 patients, out of which 4 (2.94% cases showed marked improvement, 15 (11.03% cases showed moderate improvement, 77 (56.62% cases showed mild improvement, and 30 patients although improved, fell in the category of not significant improvement group (below 25% improvement. Ten homoeopathic medicines were found useful in the study of which Sulphur (n = 27, Arsenicum album (n = 19, Phosphorus (n = 19, and Lycopodium clavatum (n = 10 were the most commonly indicated and useful medicines.

  15. Review of Van earthquakes form an orthopaedic perspective: a multicentre retrospective study.

    Science.gov (United States)

    Guner, Savas; Guner, Sukriye Ilkay; Isik, Yasemin; Gormeli, Gokay; Kalender, Ali Murat; Turktas, Ugur; Gokalp, Mehmet Ata; Gozen, Abdurrahim; Isik, Mustafa; Ozkan, Sezai; Turkozu, Tulin; Karadas, Sevdegul; Ceylan, Mehmet Fethi; Ediz, Levent; Bulut, Mehmet; Gunes, Yusuf; Gormeli, Ayse; Erturk, Cemil; Eseoglu, Metehan; Dursun, Recep

    2013-01-01

    This is a descriptive analysis, of victims of Turkey's October 23, 2011 and November 21, 2011 Van earthquakes. The goal of this study is investigated the injury profile of the both earthquakes in relation to musculoskeletal trauma. We retrospectively reviewed medical records of 3,965 patients admitted to in seven hospitals. A large share of these injuries were soft tissue injuries, followed by fractures, crush injuries, crush syndromes, nerve injuries, vascular injuries, compartment syndrome and joint dislocations. A total of 73 crush injuries were diagnosed and 31 of them were developed compartment syndrome. The patients with closed undisplaced fractures were treated with casting braces. For closed unstable fractures with good skin and soft-tissue conditions, open reduction and internal fixation was performed. All patients with open fracture had an external fixator applied after adequate debridement. Thirty one of 40 patients with compartment syndrome were treated by fasciotomy. For twelve of them, amputation was necessary. The most common procedure performed was debridement, followed by open reduction and internal fixation and closed reduction-casting, respectively. The results of this study may provide the basis for future development of strategy to optimise attempts at rescue and plan treatment of survivors with musculoskeletal injuries after earthquakes.

  16. [A multicentre comparative study of the ESPrit and the Nucleus 22].

    Science.gov (United States)

    Berger, K; Bagus, H; Michels, H; Roth, J; Voss, B; Klenzner, T

    2006-05-01

    Cochlear implant recipients often report additional difficulty in comprehension of speech in noisy conditions and of softly spoken speech. The aim of this clinical study was to evaluate and compare the performance advantages offered by the ear level ESPrit 3G for experienced Nucleus Mini 22 cochlear implantees. Twenty-eight German-speaking implanted subjects, who had had experience with either the Spectra 22 or the ESPrit 22 for at least 6 months, were evaluated with their current processor and the ESPrit 3G (on microphone, M, and whisper, W, settings) following a 4-week trial. Freiburger monosyllabic words (FMW) were used at soft and conversational levels in quiet conditions and Oldenburger sentences (OLSA) were used in noisy conditions to compare performance. Subjective impressions of sound quality and user aspects were evaluated and combined with data from 31 English-speaking subjects from a parallel study. In comparison to the previously worn processor, statistically significantly superior performance (pESPrit 3G was preferred by 86% of subjects (51/59). The ESPrit 3G for Nucleus 22 users has the potential to further improve speech understanding in quiet conditions at soft intensity levels and also in noisy conditions at conversational levels relative to the currently worn speech processor, the Spectra 22 or the ESPrit 22, for the majority of subjects. Subjectively, together with the improvement in sound quality, the majority of subjects also reported improved ease of use and wearer comfort.

  17. Stigma experienced by patients with severe mental disorders: A nationwide multicentric study from India.

    Science.gov (United States)

    Grover, Sandeep; Avasthi, Ajit; Singh, Aakanksha; Dan, Amitava; Neogi, Rajarshi; Kaur, Darpan; Lakdawala, Bhavesh; Rozatkar, Abhijit R; Nebhinani, Naresh; Patra, Suravi; Sivashankar, Priya; Subramanyam, Alka A; Tripathi, Adarsh; Gania, Ab Majid; Singh, Gurvinder Pal; Behere, Prakash

    2017-11-01

    This study aimed to evaluate the stigma and its correlates among patients with severe mental disorders. Patients with diagnosis of schizophrenia (N = 707), bipolar disorder (N = 344) and recurrent depressive disorder (N = 352) currently in clinical remission from 14 participating centres were assessed on Internalized Stigma of Mental Illness Scale (ISMIS). Patients with diagnosis of schizophrenia experienced higher level of alienation, sterotype endorsement, discrimination experience and total stigma when compared to patients with bipolar disorder and recurrent depressive disorder. Patients with bipolar disorder experienced higher stigma than those with recurrent depressive disorder in the domain of stigma resistance only. Overall compared to affective disorder groups, higher proportion of patients with schizophrenia reported stigma in all the domains of ISMIS. In general in all the 3 diagnostic groups' stigma was associated with shorter duration of illness, shorter duration of treatment and younger age of onset. To conclude, this study suggests that compared to affective disorder, patients with schizophrenia experience higher self stigma. Higher level of stigma is experienced during the early phase of illness. Stigma intervention programs must focus on patients during the initial phase of illness in order to reduce the negative consequences of stigma. Copyright © 2017 Elsevier B.V. All rights reserved.

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

    Science.gov (United States)

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

    2011-11-01

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

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

    Science.gov (United States)

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

    2005-12-01

    Patients with Usher syndrome face a special set of challenges in order to maintain their independence when their sight and hearing worsen. Three different types of Usher (I, II and III) are distinguished by differences in onset, progression and severity of hearing loss, and by the presence or absence of balance problems. In this study 93 Usher patients from seven European countries filled out a questionnaire on maintaining independence (60 patients type I, 25 patients type II, four patients type III and four patients type unknown). Results of Usher type I and II patients are presented. Following the Nordic definition of maintaining independence in deaf-blindness, three domains are investigated: access to information, communication and mobility. Research variables in this study are: age and type of Usher, considered hearing loss- and the number of retinitis pigmentosa-related sight problems. Usher type I patients tend to need more help than Usher type II patients and the amount of help that they need grows when patients get older or when considered hearing loss worsens. No patterns in results were seen for the number of retinitis pigmentosa related sight problems.

  20. Urea cycle disorders in Spain: an observational, cross-sectional and multicentric study of 104 cases.

    Science.gov (United States)

    Martín-Hernández, Elena; Aldámiz-Echevarría, Luis; Castejón-Ponce, Esperanza; Pedrón-Giner, Consuelo; Couce, María Luz; Serrano-Nieto, Juliana; Pintos-Morell, Guillem; Bélanger-Quintana, Amaya; Martínez-Pardo, Mercedes; García-Silva, María Teresa; Quijada-Fraile, Pilar; Vitoria-Miñana, Isidro; Dalmau, Jaime; Lama-More, Rosa A; Bueno-Delgado, María Amor; Del Toro-Riera, Mirella; García-Jiménez, Inmaculada; Sierra-Córcoles, Concepción; Ruiz-Pons, Mónica; Peña-Quintana, Luis J; Vives-Piñera, Inmaculada; Moráis, Ana; Balmaseda-Serrano, Elena; Meavilla, Silvia; Sanjurjo-Crespo, Pablo; Pérez-Cerdá, Celia

    2014-11-30

    Advances in the diagnosis and treatment of urea cycle disorders (UCDs) have led to a higher survival rate. The purpose of this study is to describe the characteristics of patients with urea cycle disorders in Spain. Observational, cross-sectional and multicenter study. Clinical, biochemical and genetic data were collected from patients with UCDs, treated in the metabolic diseases centers in Spain between February 2012 and February 2013, covering the entire Spanish population. Heterozygous mothers of patients with OTC deficiency were only included if they were on treatment due to being symptomatic or having biochemistry abnormalities. 104 patients from 98 families were included. Ornithine transcarbamylase deficiency was the most frequent condition (64.4%) (61.2% female) followed by type 1 citrullinemia (21.1%) and argininosuccinic aciduria (9.6%). Only 13 patients (12.5%) were diagnosed in a pre-symptomatic state. 63% of the cases presented with type intoxication encephalopathy. The median ammonia level at onset was 298 μmol/L (169-615). The genotype of 75 patients is known, with 18 new mutations having been described. During the data collection period four patients died, three of them in the early days of life. The median current age is 9.96 years (5.29-18), with 25 patients over 18 years of age. Anthropometric data, expressed as median and z-score for the Spanish population is shown. 52.5% of the cases present neurological sequelae, which have been linked to the type of disease, neonatal onset, hepatic failure at diagnosis and ammonia values at diagnosis. 93 patients are following a protein restrictive diet, 0.84 g/kg/day (0.67-1.10), 50 are receiving essential amino acid supplements, 0.25 g/kg/day (0.20-0.45), 58 arginine, 156 mg/kg/day (109-305) and 45 citrulline, 150 mg/kg/day (105-199). 65 patients are being treated with drugs: 4 with sodium benzoate, 50 with sodium phenylbutyrate, 10 with both drugs and 1 with carglumic acid. Studies like this make it

  1. Social disadvantages associated with myasthenia gravis and its treatment: a multicentre cross-sectional study.

    Science.gov (United States)

    Nagane, Yuriko; Murai, Hiroyuki; Imai, Tomihiro; Yamamoto, Daisuke; Tsuda, Emiko; Minami, Naoya; Suzuki, Yasushi; Kanai, Tetsuya; Uzawa, Akiyuki; Kawaguchi, Naoki; Masuda, Masayuki; Konno, Shingo; Suzuki, Hidekazu; Aoki, Masashi; Utsugisawa, Kimiaki

    2017-02-23

    To clarify the social disadvantages associated with myasthenia gravis (MG) and examine associations with its disease and treatment. Cross-sectional study. We evaluated 917 consecutive cases of established MG seen at 13 neurological centres in Japan over a short duration. All patients completed a questionnaire on social disadvantages resulting from MG and its treatment and a 15-item MG-specific quality of life scale at study entry. Clinical severity at the worst condition was graded according to the MG Foundation of America classification, and that at the current condition was determined according to the quantitative MG score and MG composite. Maximum dose and duration of dose ≥20 mg/day of oral prednisolone during the disease course were obtained from the patients' medical records. Achievement of the treatment target (minimal manifestation status with prednisolone at ≤5 mg/day) was determined at 1, 2 and 4 years after starting treatment and at study entry. We found that 27.2% of the patients had experienced unemployment, 4.1% had been unwillingly transferred and 35.9% had experienced a decrease in income, 47.1% of whom reported that the decrease was ≥50% of their previous total income. In addition, 49.0% of the patients reported feeling reduced social positivity. Factors promoting social disadvantages were severity of illness, dose and duration of prednisolone, long-term treatment, and a depressive state and change in appearance after treatment with oral steroids. Early achievement of the treatment target was a major inhibiting factor. Patients with MG often experience unemployment, unwilling job transfers and a decrease in income. In addition, many patients report feeling reduced social positivity. To inhibit the social disadvantages associated with MG and its treatment, greater focus needs to be placed on helping patients with MG resume a normal lifestyle as soon as possible by achieving the treatment target. Published by the BMJ Publishing Group

  2. High-risk papillomavirus infection among women living with human Immunodeficiency virus: Brazilian multicentric study.

    Science.gov (United States)

    Miranda, Angelica E; Silveira, Mariangela F; Travassos, Ana G; Tenório, Teresinha; Val, Isabel C C; Lannoy, Leonor; Mattos Junior, Hortensio S; Carvalho, Newton S

    2017-12-01

    Cervical cancer is an important health issue in Latin America. Although HPV infections can have spontaneous clearance, persistence of high-risk (HR) HPV is a risk factor for cervical cancer among women and it is even higher in HIV-infected women. To determine the prevalence of HR-HPV and risk factors among HIV-infected women attending reference services for HIV/AIDS in different regions of Brazil. Cross-sectional study conducted among HIV-infected women attended at referral care centers for HIV/AIDS in nine states of Brazil. Women from 18 to 49 years that accept to participate and were not pregnant at the time of the approach were recruited for the study. The HPV screening was realized using qPCR in closed system, in vitro Diagnostic, COBAS ® -HPV Roche. The cytology results were available by the Bethesda System. A total of 802(89.1%) from the selected women agreed to participate in the study. Median age was 39(Inter quartile range [IQR34-46]) years and median education was 9(IQR6-11) years. General prevalence of HR-HPV was 28.4%(228/802). HPV-16 prevalence rate was 8.1%(65/802), HPV-18 was 3.7%(30/802) and other types of HR-HPV were 23.6% (189/802). Risk factors for HR-HPV infection in the multivariate logistic regression analysis were: age ranging from 18 to 34 years (OR = 1.43[95%CI:1.18-1.75]), illicit drugs use (OR = 1.61[95%CI:1.10-2.42]) and abnormal cervical cytology (OR = 1.56[95%CI:1.34-1.81]). Results showed a prevalence rate of 28.4% of HR-HPV infection in women living with HIV in Brazil. These infections were significantly associated with having less than 35 years old, illicit drug use and abnormal cervical cytology. © 2017 Wiley Periodicals, Inc.

  3. The Diabetes Care Project: an Australian multicentre, cluster randomised controlled trial [