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Sample records for multi-centre individual patient

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

    Science.gov (United States)

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

    2012-05-01

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

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

    Science.gov (United States)

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

    2015-12-17

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

  3. 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.

  4. Multi-Centre Study on Cardiovascular Risk Management on Patients Undergoing AAA Surveillance.

    Science.gov (United States)

    Saratzis, A; Dattani, N; Brown, A; Shalhoub, J; Bosanquet, D; Sidloff, D; Stather, P

    2017-07-01

    The risk of cardiovascular events and death in patients with abdominal aortic aneurysms (AAA) is high. Screening has been introduced to reduce AAA related mortality; however, after AAA diagnosis, cardiovascular modification may be as important to patient outcomes as surveillance. The aim of this study was to assess cardiovascular risk reduction in patients with small AAA. Institutional approval was granted for The Vascular and Endovascular Research Network (VERN) to retrospectively collect data pertaining to cardiovascular risk reduction from four tertiary vascular units in England. Patients with small AAA (January 2013-December 2015) were included. Demographic details, postcode, current medications, and smoking status were recorded using a bespoke electronic database and analysed. In a secondary analysis VERN contacted all AAA screening units in England and Wales to assess their current protocols relating to CV protection. In total, 1053 patients were included (mean age 74 ± 9 years, all men). Of these, 745 patients (70.8%) had been prescribed an antiplatelet agent and 787 (74.7%) a statin. Overall, only 666 patients (63.2%) were prescribed both a statin and antiplatelet. Two hundred and sixty eight patients (32.1%) were current smokers and the proportion of patients who continued to smoke decreased with age. Overall, only 401 patients (48.1%) were prescribed a statin, antiplatelet, and had stopped smoking. In the secondary analysis 38 AAA screening units (84% national coverage) replied. Thirty-one units (82%) suggest changes to the patient's prescription; however, none monitor compliance with these recommendations or assess whether the general practitioner has been made aware of the AAA diagnosis or prescription advice. Many patients with small AAA are not prescribed an antiplatelet/statin, and still smoke cigarettes, and therefore remain at high risk of cardiovascular morbidity and mortality. National guidance to ensure this high risk group of patients is

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

    Directory of Open Access Journals (Sweden)

    Freeman Jennifer

    2012-04-01

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

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

    Science.gov (United States)

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

    2012-04-05

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

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

    Directory of Open Access Journals (Sweden)

    Norrie John

    2010-04-01

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

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

    International Nuclear Information System (INIS)

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

    1996-01-01

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

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

    Science.gov (United States)

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

    2018-01-21

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

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

    Directory of Open Access Journals (Sweden)

    Bateman James

    2012-08-01

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

  12. 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.

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

    Energy Technology Data Exchange (ETDEWEB)

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

    2017-06-15

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

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

    International Nuclear Information System (INIS)

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

    2017-01-01

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

  15. Multi-centre European study of breakthrough cancer pain: pain characteristics and patient perceptions of current and potential management strategies

    DEFF Research Database (Denmark)

    Davies, Andrew; Zeppetella, Giovambattista; Andersen, Steen

    2011-01-01

    This study involved 320 cancer patients from four Northern European countries. Patients with breakthrough pain were questioned about the characteristics of their pain, the current management of their pain, and the acceptability/utility of alternative routes of administration. The median number...... of episodes was 3/day. Forty-four percent patients reported incident-type pain, 39% spontaneous-type pain, and 17% a combination of these pains. The median duration was 60 min, and the median time to peak intensity was 15 min. Three percent patients reported "mild" pain, 37% "moderate" pain, and 60% "severe......" pain. Ninety percent patients stated that the pain interfered with their daily activities. All patients were using opioids as rescue medication (mainly oral morphine/oxycodone), whilst 28% patients were using non-opioids, and 50% patients were using non-pharmacological interventions. Only 55% patients...

  16. Are you better? A multi-centre study of patient-defined recovery from Complex Regional Pain Syndrome

    DEFF Research Database (Denmark)

    Llewellyn, A; McCabe, CS; Hibberd, Y

    2018-01-01

    Background: Complex Regional Pain Syndrome (CRPS) symptoms can significantly differ between patients, fluctuate over time, disappear or persist. This leads to problems in defining recovery and in evaluating the efficacy of therapeutic interventions. Objectives: To define recovery from the patient...

  17. Assessment of coeliac disease prevalence in patients with Down syndrome in Poland - a multi-centre study.

    Science.gov (United States)

    Szaflarska-Popławska, Anna; Soroczyńska-Wrzyszcz, Anetta; Barg, Ewa; Józefczuk, Jan; Korczowski, Bartosz; Grzybowska-Chlebowczyk, Urszula; Więcek, Sabina; Cukrowska, Bożena

    2016-01-01

    The results of studies assessing whether patients with Down syndrome have increased risk of coeliac disease are contradictory. The prevalence of coeliac disease in patients with Down syndrome is estimated at a wide range between 1% to as much as 18.6%. To assess coeliac disease prevalence in patients with Down syndrome in Poland. The study enrolled 301 patients with Down syndrome from six centres in Poland (Wroclaw, Sandomierz, Rzeszow, Grudziadz, Katowice, and Bydgoszcz). We measured the concentration of anti-tissue transglutaminase IgA antibodies and anti-deamidated gliadin peptide IgG antibodies in all patients. Patients with abnormal positive (> 10 U/ml) or inconclusive (7-10 U/ml) result of the serological test were offered endoscopic biopsy of the small intestine in the main centre. In 31 (10.3%) patients increased concentrations of the investigated antibodies were found, including 19 (6.3%) patients with increased tTg-IgA concentration, 27 (8.97%) patients with increased concentration of DGP-IgG, and 15 (4.98%) patients with increased concentration of both types of antibodies. Endoscopic biopsy of the small intestine was planned for all 31 patients with abnormal results of at least one antibody test and for 2 patients with inconclusive results. One of them suffered from previously diagnosed and histologically confirmed coeliac disease. Biopsy was not conducted in 9 patients due to contraindications, lack of their consent, or introduction of a gluten-free diet by the parents before the examination. In a group of 23 patients who underwent endoscopic biopsy of the small intestine, in 15 patients the histopathological picture of the small intestinal mucosa was typical for coeliac disease, 2 patients were diagnosed with lesions of grade 1 according to the classification by Marsh-Oberhuber, 1 patient was diagnosed with focal shortening of villi and hypertrophy of the crypts with no intraepithelial lymphocytosis (remains under gastrological observation), 2 patients

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

    Science.gov (United States)

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

    2012-08-01

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

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

    Science.gov (United States)

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

    2014-10-29

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

  20. Low social interactions in eating disorder patients in childhood and adulthood: a multi-centre European case control study.

    Science.gov (United States)

    Krug, Isabel; Penelo, Eva; Fernandez-Aranda, Fernando; Anderluh, Marija; Bellodi, Laura; Cellini, Elena; di Bernardo, Milena; Granero, Roser; Karwautz, Andreas; Nacmias, Benedetta; Ricca, Valdo; Sorbi, Sandro; Tchanturia, Kate; Wagner, Gudrun; Collier, David; Treasure, Janet

    2013-01-01

    The objective of this article was to examine lifestyle behaviours in eating disorder (ED) patients and healthy controls. A total of 801 ED patients and 727 healthy controls from five European countries completed the questions related to lifestyle behaviours of the Cross-Cultural Questionnaire (CCQ). For children, the ED sample exhibited more solitary activities (rigorously doing homework [psocializing with friends [pgroup and this continued in adulthood. There were minimal differences across ED sub-diagnoses and various cross-cultural differences emerged. Reduced social activities may be an important risk and maintaining factor for ED symptomatology.

  1. 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.

  2. Contact sensitisation in hand eczema patients-relation to subdiagnosis, severity and quality of life: a multi-centre study

    DEFF Research Database (Denmark)

    Agner, Tove; Andersen, Klaus Ejner; Brandao, Francisco M

    2009-01-01

    BACKGROUND: Contact sensitisation has been identified as a factor associated with poor prognosis for patients with hand eczema. OBJECTIVES: To study implications of contact sensitisation with respect to severity, quality of life (QoL) and subdiagnosis of hand eczema. METHODS: The study was perfor......BACKGROUND: Contact sensitisation has been identified as a factor associated with poor prognosis for patients with hand eczema. OBJECTIVES: To study implications of contact sensitisation with respect to severity, quality of life (QoL) and subdiagnosis of hand eczema. METHODS: The study...... eczema and presence of contact sensitisation were independent risk factors for increased severity as measured by Hand Eczema Severity Index. Furthermore, the severity of hand eczema increased by the number of contact sensitisations detected (P = 0.023). High age and personal history of atopic eczema were...... independent risk factors for low QoL, as measured by Dermatology Life Quality Index, and atopic eczema as well as allergic contact dermatitis as subdiagnosis was associated with increased sick leave. CONCLUSION: Diagnostic subgroups were not found to be related to specific allergens. Contact sensitisation...

  3. Contact sensitisation in hand eczema patients-relation to subdiagnosis, severity and quality of life: a multi-centre study

    DEFF Research Database (Denmark)

    Agner, T.; Andersen, K.E.; Brandao, F.M.

    2009-01-01

    Background Contact sensitisation has been identified as a factor associated with poor prognosis for patients with hand eczema. Objectives To study implications of contact sensitisation with respect to severity, quality of life (QoL) and subdiagnosis of hand eczema. Methods The study was performed...... and presence of contact sensitisation were independent risk factors for increased severity as measured by Hand Eczema Severity Index. Furthermore, the severity of hand eczema increased by the number of contact sensitisations detected (P = 0.023). High age and personal history of atopic eczema were independent...... risk factors for low QoL, as measured by Dermatology Life Quality Index, and atopic eczema as well as allergic contact dermatitis as subdiagnosis was associated with increased sick leave. Conclusion Diagnostic subgroups were not found to be related to specific allergens. Contact sensitisation was found...

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

    Science.gov (United States)

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

    2016-10-06

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

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

    Science.gov (United States)

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

    2015-11-06

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

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

    Science.gov (United States)

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

    2013-01-01

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

  7. 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.

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

    Science.gov (United States)

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

    2014-05-01

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

  9. 12 A multi-centre randomised feasibility study evaluating the impact of a prognostic model for management of blunt chest wall trauma patients: stumbl trial.

    Science.gov (United States)

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

    2017-12-01

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

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

    Science.gov (United States)

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

    2018-05-01

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

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

    Science.gov (United States)

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

    2012-07-06

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

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

    Directory of Open Access Journals (Sweden)

    Roberts Jason A

    2012-07-01

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

  13. 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

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

    Directory of Open Access Journals (Sweden)

    Tjitra Emiliana

    2012-06-01

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

  15. Epidemiological, virological and clinical characteristics of HBV infection in 223 HIV co-infected patients: a French multi-centre collaborative study.

    Science.gov (United States)

    Thibault, Vincent; Gaudy-Graffin, Catherine; Colson, Philippe; Gozlan, Joël; Schnepf, Nathalie; Trimoulet, Pascale; Pallier, Coralie; Saune, Karine; Branger, Michel; Coste, Marianne; Thoraval, Francoise Roudot

    2013-03-15

    Chronic hepatitis B (CHB) is a clinical concern in human immunodeficiency virus (HIV)-infected individuals due to substantial prevalence, difficulties to treat, and severe liver disease outcome. A large nationwide cross-sectional multicentre analysis of HIV-HBV co-infected patients was designed to describe and identify parameters associated with virological and clinical outcome of CHB in HIV-infected individuals with detectable HBV viremia. A multicenter collaborative cross-sectional study was launched in 19 French University hospitals distributed through the country. From January to December 2007, HBV load, genotype, clinical and epidemiological characteristics of 223 HBV-HIV co-infected patients with an HBV replication over 1000 IU/mL were investigated. Patients were mostly male (82%, mean age 42 years). Genotype distribution (A 52%; E 23.3%; D 16.1%) was linked to risk factors, geographic origin, and co-infection with other hepatitis viruses. This genotypic pattern highlights divergent contamination event timelines by HIV and HBV viruses. Most patients (74.7%) under antiretroviral treatment were receiving a drug with anti-HBV activity, including 47% receiving TDF. Genotypic lamivudine-resistance detected in 26% of the patients was linked to duration of lamivudine exposure, age, CD4 count and HIV load. Resistance to adefovir (rtA181T/V) was detected in 2.7% of patients. Advanced liver lesions were observed in 54% of cases and were associated with an older age and lower CD4 counts but not with viral load or genotype. Immune escape HBsAg variants were seldom detected. Despite the detection of advanced liver lesions in most patients, few were not receiving anti-HBV drugs and for those treated with the most potent anti-HBV drugs, persistent replication suggested non-optimal adherence. Heterogeneity in HBV strains reflects epidemiological differences that may impact liver disease progression. These findings are strong arguments to further optimize clinical management

  16. Symptomatic Patients without Epidemiological Indicators of HIV Have a High Risk of Missed Diagnosis: A Multi-Centre Cross Sectional Study.

    Science.gov (United States)

    Brännström, Johanna; Svedhem, Veronica; Marrone, Gaetano; Andersson, Örjan; Azimi, Farshad; Blaxhult, Anders; Sönnerborg, Anders

    2016-01-01

    One quarter of HIV-1 positive individuals in Sweden present for care with HIV or AIDS associated conditions without an HIV test (missed presentations) and 16% report neglect of such symptoms. The objective of this study was to identify risk factors for these missed opportunities of HIV-1 diagnosis. A national study, recruiting 409 newly diagnosed HIV-1 infected adults over a 2.5-year period, was performed. Logistic regression models tested the relationship between missed presentation and patient's neglect versus socio-demographic and behavioural risk factors. Additionally the initiator of the HIV test was assessed. The odds for a missed presentation was lower for migrants (from East Europe, Asia, and Pacific (East): OR 0.4 (0.2-0.8); Sub-Saharan Africa (SSA): 0.3 (0.2-0.6); other: 0.5 (0.2-1.0)), compared to patients born in Sweden, just as symptoms neglected by the patient (East (0.3 (0.1-1.0); SSA (0.4 (0.2-0.8)). The latter was also lower for men who have sex with men (0.5 (0.2-1.0)), compared to patients infected heterosexually. Patients infected in the East, with present/previous substance use or a previous negative HIV test were more likely to take the initiative to test on their own, whereas those >50 years and with a previously missed presentation had significantly reduced odds, pepidemiological indicators of HIV are more likely to have a history of missed presentations, to neglect symptoms and are less prone to take an initiative to test for HIV themselves. It is important to further implement testing to include all patients with symptoms and conditions indicative of HIV.

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

    Science.gov (United States)

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

    2011-04-01

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

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

    International Nuclear Information System (INIS)

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

    2009-01-01

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

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

    Science.gov (United States)

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

    2013-08-01

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

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

    Directory of Open Access Journals (Sweden)

    Nauta Maaike H

    2012-04-01

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

  1. 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.

  2. 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.

  3. 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.)

  4. Evaluation of iopentol (Imagopaque trademark 350) in CT enhancement. A multi-centre monitoring trial assessing adverse events and diagnostic information - results from 1823 patients in France

    International Nuclear Information System (INIS)

    Oxaal, M.; Lambrechts, M.; Bunouf, P.; Menuet, J.F.

    1997-01-01

    Objectives: To evaluate the safety and efficacy of iopentol 350 mg I/ml (Imagopaque trademark /Ivepaque trademark , Nycomed Imaging As, Oslo, Norway), a monomeric non-ionic contrast medium for computed tomography, in a large population. To identify predictive factors for patient safety. Materials and methods: One thousand eight hundred and twenty-three (1,823) patients form 48 centres in France were included during a 5-month period. Safety was evaluated by registering adverse events (AEs) reported by the patients, and data were analysed using a multiple factor model. Results: Only 2.6% of the patients experienced AEs other than discomfort. There were no serious AEs. Overall, AEs were more frequent in patients under 50 years of age, in women, and in patients who received contrast medium as a single bolus. Contrast enhancement was considered adequate or better in 98.9% of the patients. A large variation in discomfort (local warmth/chill or pain) frequency was seen between centres, ranging from 0% to 81%. This result implies that factors other than the CM influence the incidence of discomfort. Conclusions: This first study in a large population shows that iopentol 350 mg I/ml is well tolerated and provides CT images of excellent, good or adequate quality in the vast majority of patients. Age, sex and injection procedure were shown to be independent predictors in the AE survey. (orig.)

  5. A multi-centre cohort study evaluating the role of inflammatory markers in patient’s presenting with acute ureteric colic (MIMIC

    Directory of Open Access Journals (Sweden)

    T.T. Shah

    Full Text Available Background: Spontaneous Stone Passage (SSP rates in acute ureteric colic range from 47 to 75%. There is conflicting evidence on the role of raised inflammatory markers in acute ureteric colic. The use of an easily applicable biomarker that could predict SSP or need for intervention would improve the management of obstructing ureteric stones. Thus, there is a need to determine in an appropriately powered study, in patients who are initially managed conservatively, which factors at the time of acute admission can predict subsequent patient outcome such as SSP and the need for intervention. Particularly, establishing whether levels of white cell count (WBC at presentation are associated with likelihood of SSP or intervention may guide clinicians on the management of these patients’ stones. Design: Multi-center cohort study disseminated via the UK British Urology Researchers in Surgical Training (BURST and Australian Young Urology Researchers Organisation (YURO. Primary research question: What is the association between WBC and SSP in patients discharged from emergency department after initial conservative management? Patient population: Patients who have presented with acute renal colic with CT KUB evidence of a solitary ureteric stone. A minimum sample size of 720 patients across 15 centres will be needed. Hypothesis: A raised WBC is associated with decreased odds of spontaneous stone passage. Primary outcome: The occurrence of SSP within six months of presentation with acute ureteric colic (YES/NO. SSP was defined as absence of need for intervention to assist stone passage. Statistical analysis plan: A multivariable logistic regression model will be constructed, where the outcome of interest is SSP using data from patients who do not undergo intervention at presentation. A random effect will be used to account for clustering of patients within hospitals/institutions. The model will include adjustments for gender, age as control variables

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

    Science.gov (United States)

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

    2012-07-20

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

  7. Early home-based group education to support informed decision-making among patients with end-stage renal disease: a multi-centre randomized controlled trial.

    Science.gov (United States)

    Massey, Emma K; Gregoor, Peter J H Smak; Nette, Robert W; van den Dorpel, Marinus A; van Kooij, Anthony; Zietse, Robert; Zuidema, Willij C; Timman, Reinier; Busschbach, Jan J; Weimar, Willem

    2016-05-01

    The aim was to test the effectiveness of early home-based group education on knowledge and communication about renal replacement therapy (RRT). We conducted a randomized controlled trial using a cross-over design among 80 end-stage renal disease (ESRD) patients. Between T0 and T1 (weeks 1-4) Group 1 received the intervention and Group 2 received standard care. Between T1 and T2 (weeks 5-8) Group 1 received standard care and Group 2 received the intervention. The intervention was a group education session on RRT options held in the patient's home given by social workers. Patients invited members from their social network to attend. Self-report questionnaires were used at T0, T1 and T2 to measure patients' knowledge and communication, and concepts from the Theory of Planned Behaviour such as attitude. Comparable questionnaires were completed pre-post intervention by 229 attendees. Primary RRT was registered up to 2 years post-intervention. Multilevel linear modelling was used to analyse patient data and paired t-tests for attendee data. Statistically significant increases in the primary targets knowledge and communication were found among patients and attendees after receiving the intervention. The intervention also had a significant effect in increasing positive attitude toward living donation and haemodialysis. Of the 80 participants, 49 underwent RRT during follow-up. Of these, 34 underwent a living donor kidney transplant, of which 22 were pre-emptive. Early home-based group education supports informed decision-making regarding primary RRT for ESRD patients and their social networks and may remove barriers to pre-emptive transplantation. © The Author 2015. Published by Oxford University Press on behalf of ERA-EDTA. All rights reserved.

  8. AB0 blood groups and rhesus factor expression as prognostic parameters in patients with epithelial ovarian cancer - a retrospective multi-centre study.

    Science.gov (United States)

    Seebacher, Veronika; Polterauer, Stephan; Reinthaller, Alexander; Koelbl, Heinz; Achleitner, Regina; Berger, Astrid; Concin, Nicole

    2018-04-19

    AB0 blood groups and Rhesus factor expression have been associated with carcinogenesis, response to treatment and tumor progression in several malignancies. The aim of the present study was to test the hypothesis that AB0 blood groups and Rhesus factor expression are associated with clinical outcome in patients with epithelial ovarian cancer (EOC). AB0 blood groups and Rhesus factor expression were evaluated in a retrospective multicenter study including 518 patients with EOC. Their association with patients' survival was assessed using univariate and multivariable analyses. Neither AB0 blood groups nor Rhesus factor expression were associated with clinico-pathological parameters, recurrence-free, cancer-specific, or overall survival. In a subgroup of patients with high-grade serous adenocarcinoma, however, blood groups B and AB were associated with a better 5-year cancer-specific survival rate compared to blood groups A and 0 (60.3 ± 8.6% vs. 43.8 ± 3.6%, p = 0.04). Yet, this was not significant in multivariable analysis. AB0 blood groups and Rhesus factor expression are both neither associated with features of biologically aggressive disease nor clinical outcome in patients with EOC. Further investigation of the role of the blood group B antigen on cancer-specific survival in the subgroup of high-grade serous should be considered.

  9. Patients' attitudes to medical and psychosocial aspects of care in fertility clinics: Findings from the Copenhagen Multi-centre Psychosocial Infertility (COMPI) Research Programme

    DEFF Research Database (Denmark)

    Schmidt, L; Holstein, B E; Boivin, J

    2003-01-01

    among infertile people. METHODS: We conducted an epidemiological study based on questionnaires among all new couples attending five fertility clinics with a response rate of 80.0% and a total of 2250 patients. RESULTS: The vast majority of both men and women considered a high level of medical......BACKGROUND: The aims were (i) to identify gender differences in motivations to seek assisted reproduction and gender differences in expectations about medical and psychosocial services and (ii) to examine factors that predict the perceived importance of, and intention to use, psychosocial services...... information and patient-centred care as important. Fewer respondents (women 10.0-20.8%, men 4.1-8.9%) felt that professional psychosocial services were important and/or had the intention to use these services. The main predictor of perceived importance of patient-centred care and professional psychosocial...

  10. Use of antibiotics and the prevalence of antibiotic-associated diarrhoea in patients with spinal cord injuries: an international, multi-centre study.

    Science.gov (United States)

    Wong, S; Santullo, P; Hirani, S P; Kumar, N; Chowdhury, J R; García-Forcada, A; Recio, M; Paz, F; Zobina, I; Kolli, S; Kiekens, C; Draulans, N; Roels, E; Martens-Bijlsma, J; O'Driscoll, J; Jamous, A; Saif, M

    2017-10-01

    Little is known about the use of antibiotics and the extent of antibiotic-associated diarrhoea (AAD) in patients with spinal cord injuries (SCIs). To record the use of antibiotics, establish the prevalence of AAD and Clostridium difficile infection (CDI), and assess if there was any seasonal variation in antibiotic use and incidence of AAD in patients with SCIs. A retrospective study was conducted in six European SCI centres between October 2014 and June 2015. AAD was defined as two or more watery stools (Bristol Stool Scale type 5, 6 or 7) over 24 h. In total, 1267 adults (median age 54 years, 30.7% female) with SCIs (52.7% tetraplegia, 59% complete SCI) were included in this study. Among the 215 (17%) patients on antibiotics, the top three indications for antibiotics were urinary tract infections (UTIs), infected pressure ulcers and other skin infections. Thirty-two of these 215 (14.9%) patients developed AAD and two patients out of the total study population (2/1267; 0.16%) developed CDI. AAD was more common in summer than in spring, autumn or winter (30.3% vs 3.8%, 7.4% and 16.9%, respectively; Pantibiotic use and high-risk antibiotic use. Summer and winter seasons and male sex were identified as independent predictors for the development of AAD. This survey found that AAD is common in patients with SCIs, and UTI is the most common cause of infection. Summer and winter seasons and male sex are unique predictors for AAD. Both AAD and UTIs are potentially preventable; therefore, further work should focus on preventing the over-use of antibiotics, and developing strategies to improve hospital infection control measures. Copyright © 2017 The Healthcare Infection Society. All rights reserved.

  11. Using mobile phone text messages to improve insulin injection technique and glycaemic control in patients with diabetes mellitus: a multi-centre study in Turkey.

    Science.gov (United States)

    Celik, Selda; Cosansu, Gulhan; Erdogan, Semra; Kahraman, Alev; Isik, Sengul; Bayrak, Gulay; Bektas, Belgin; Olgun, Nermin

    2015-06-01

    To improve the knowledge and skills of diabetic patients on insulin injections using mobile phone short message services and to evaluate the association of this intervention with metabolic outcomes. Mobile communication technologies are widely used in Turkey, which maintains a diabetic population of more than 6·5 million. However, there are a limited number of studies using mobile technologies in the challenging and complicated management of diabetes. A one group pretest-posttest design was used in this study. The study sample consisted of 221 people with type 1 and type 2 Diabetes Mellitus from eight outpatient clinics in six cities in Turkey. The 'Demographic and diabetes-related information Form' and 'Insulin Injection Technique and Knowledge Form' were used in the initial interview. Subsequently, 12 short messages related to insulin administration were sent to patients twice a week for six months. Each patient's level of knowledge and skills regarding both the insulin injection technique and glycaemic control (glycated haemoglobin A1c) levels were measured at three months and six months during the text messaging period and six months later (12 months total) when text messaging was stopped. The mean age of the patients with diabetes was 39·8 ± 16·2 years (min: 18; max: 75). More than half of the patients were females with a mean duration of diabetes of 11·01 ± 7·22 years (min 1; max: 32). Following the text message reminders, the patients' level of knowledge and skills regarding the insulin injection technique improved at month 3 and 6 (p 12 compared to the baseline values (p insulin injection sites and the frequency of rotation of skin sites for insulin injections also increased. This study demonstrated that a short message services-based information and reminder system on insulin injection administration provided to insulin-dependent patients with diabetes by nurses resulted in improved self-administration of insulin and metabolic control

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

    NARCIS (Netherlands)

    Nauta, M.H.; Festen, H.; Reichart, C.G.; Nolen, W.A.; Stant, A.D.; Bockting, C.L.H.; van der Wee, N.J.A.; Beekman, A.T.F.; Doreleijers, T.A.H.; Hartman, C.A.; de Jong, P.J.; de Vries, S.O.

    2012-01-01

    Background: Anxiety and mood disorders are highly prevalent and pose a huge burden on patients. Their offspring is at increased risk of developing these disorders as well, indicating a clear need for prevention of psychopathology in this group. Given high comorbidity and non-specificity of

  13. 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.

  14. Use of antibiotics and the prevalence of antibiotic-associated diarrhoea in patients with spinal cord injuries : An international, multi-centre study

    NARCIS (Netherlands)

    Wong, S.; Santullo, P.; Hirani, S. P.; Kumar, N.; Chowdhury, J. R.; Garcia-Forcada, A.; Recio, M.; Paz, F.; Zobina, I.; Kolli, S.; Kiekens, C.; Draulans, N.; Roels, E.; Martens-Bijlsma, J.; O'Driscoll, J.; Jamous, A.; Saif, M.

    2017-01-01

    Background: Little is known about the use of antibiotics and the extent of antibiotic-associated diarrhoea (AAD) in patients with spinal cord injuries (SCIs). Aims: To record the use of antibiotics, establish the prevalence of AAD and Clostridium difficile infection (CDI), and assess if there was

  15. Evaluation of mid- and long-term consequences, clinical and social performance in Chernobyl acute radiation syndrome patients in a multi-centre clinical follow-up study

    International Nuclear Information System (INIS)

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

    1996-01-01

    Since the Chernobyl accident in 1986 nearly all survivors (n=199) of 237 patients with suspected acute radiation syndrome (ARS) underwent regular follow-up investigations in the scientific centres in Kiev and in Moscow. In a close collaboration with these centres we investigate the health status of this population in a five step approach. An integral part of this approach to patient evaluation and analysis of the mid- and long-term consequences of the Chernobyl accident is a 'Questionnaire for clinical, laboratory and functional follow-up of radiation-exposed persons', developed with these centres. Beyond this project we report as an interim some results of analyses performed by the scientific centers in Kiev and in Moscow about disorders of the cardiovascular system and the digestive tract, formation of cataract, generalized and local skin injuries and/or disorders as well as for a subpopulation (n=89) the Karnofsky performance score and working ability

  16. Patients' attitudes to medical and psychosocial aspects of care in fertility clinics: Findings from the Copenhagen Multi-centre Psychosocial Infertility (COMPI) Research Programme

    DEFF Research Database (Denmark)

    Schmidt, L; Holstein, B E; Boivin, J

    2003-01-01

    among infertile people. METHODS: We conducted an epidemiological study based on questionnaires among all new couples attending five fertility clinics with a response rate of 80.0% and a total of 2250 patients. RESULTS: The vast majority of both men and women considered a high level of medical......BACKGROUND: The aims were (i) to identify gender differences in motivations to seek assisted reproduction and gender differences in expectations about medical and psychosocial services and (ii) to examine factors that predict the perceived importance of, and intention to use, psychosocial services...... services for both men and women was high infertility-related stress in the marital, personal and social domain. CONCLUSIONS: A supportive attitude from medical staff and the provision of both medical and psychosocial information and support should be integral aspects of medical care in fertility clinics...

  17. A multi-centre evaluation of eleven clinically feasible brain PET/MRI attenuation correction techniques using a large cohort of patients.

    Science.gov (United States)

    Ladefoged, Claes N; Law, Ian; Anazodo, Udunna; St Lawrence, Keith; Izquierdo-Garcia, David; Catana, Ciprian; Burgos, Ninon; Cardoso, M Jorge; Ourselin, Sebastien; Hutton, Brian; Mérida, Inés; Costes, Nicolas; Hammers, Alexander; Benoit, Didier; Holm, Søren; Juttukonda, Meher; An, Hongyu; Cabello, Jorge; Lukas, Mathias; Nekolla, Stephan; Ziegler, Sibylle; Fenchel, Matthias; Jakoby, Bjoern; Casey, Michael E; Benzinger, Tammie; Højgaard, Liselotte; Hansen, Adam E; Andersen, Flemming L

    2017-02-15

    methods, with the average±SD global percentage bias in PET FDG uptake for each method being: MR-AC DIXON (-11.3±3.5)%, MR-AC UTE (-5.7±2.0)%, MR-AC ONTARIO (-4.3±3.6)%, MR-AC MUNICH (3.7±2.1)%, MR-AC MLAA (-1.9±2.6)%, MR-AC SEGBONE (-1.7±3.6)%, MR-AC UCL (0.8±1.2)%, MR-AC CAR-RiDR (-0.4±1.9)%, MR-AC MAXPROB (-0.4±1.6)%, MR-AC BOSTON (-0.3±1.8)%, and MR-AC RESOLUTE (0.3±1.7)%, ordered by average bias. The overall best performing methods (MR-AC BOSTON , MR-AC MAXPROB , MR-AC RESOLUTE and MR-AC UCL , ordered alphabetically) showed regional average errors within ±3% of PET with CT-AC in all regions of the brain with FDG, and the same four methods, as well as MR-AC CAR-RiDR , showed that for 95% of the patients, 95% of brain voxels had an uptake that deviated by less than 15% from the reference. Comparable performance was obtained with PiB and florbetapir. All of the proposed novel methods have an average global performance within likely acceptable limits (±5% of CT-based reference), and the main difference among the methods was found in the robustness, outlier analysis, and clinical feasibility. Overall, the best performing methods were MR-ACBOSTON, MR-ACMAXPROB, MR-ACRESOLUTE and MR-ACUCL, ordered alphabetically. These methods all minimized the number of outliers, standard deviation, and average global and local error. The methods MR-ACMUNICH and MR-ACCAR-RiDR were both within acceptable quantitative limits, so these methods should be considered if processing time is a factor. The method MR-ACSEGBONE also demonstrates promising results, and performs well within the likely acceptable quantitative limits. For clinical routine scans where processing time can be a key factor, this vendor-provided solution currently outperforms most methods. With the performance of the methods presented here, it may be concluded that the challenge of improving the accuracy of MR-AC in adult brains with normal anatomy has been solved to a quantitatively acceptable degree, which is

  18. 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

  19. Authorship issues in multi-centre clinical trials

    DEFF Research Database (Denmark)

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

    2015-01-01

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

  20. Authorship issues in multi-centre clinical trials

    DEFF Research Database (Denmark)

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

    2015-01-01

    to qualify for authorship as defined by the International Committee of Medical Journal Editors. Therefore, rules for authorship in multi-centre trials are strongly recommended. We propose two contracts to prevent conflicts regarding authorship; both are freely available for use without pay but with reference...... to the original source....

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

    Directory of Open Access Journals (Sweden)

    Ian Nicholson

    2017-06-01

    Full Text Available Introduction: In order to practice evidence-based veterinary medicine, good quality clinical evidence needs to be produced, in order that it can be apprasied systematically by the EBVM network, and used by vets. There is very little good-quality veterinary evidence for most of the veterinary procedures carried out every day across the world. Very few, if any, individuals have all the necessary qualities (case-load, time, research expertise, financial support to be able to systematically produce good-quality, and relevant, clinical research on their own, in a timely manner. The Association for Veterinary Soft Tissue Surgery (AVSTS www.avsts.org.uk is an affiliate group with the British Small Animal Veterinary Association (BSAVA, and functions as a clinical network of like-minded individuals. In 2013 AVSTS sought to create a role for itself in facilitating the production (by its members of multi-centre clinical research of relevance to its members.Materials and methods: Members of AVSTS were asked to join the AVSTS Research Cooperative (ARC, with a veterinary epidemiologist and an experienced multi-centre veterinary clinical researcher (to help with study design and statistical planning, and the Animal Health Trust clinical research ethics committee. An email list was established, and a page was set up on the AVSTS website, to allow information to be disseminated. The AVSTS spring and autumn meetings were used as a regular forum by ARC, to discuss its direction, to generate interest, to create and promote specific studies (in order to widen participation amongst different centres, and to update members about previous studies.Results: Membership of ARC has grown to 224 people, although the epidemiologist left. One multi-centre study has been published, two have been presented and await publication, one has been accepted for presentation, two other studies are gathering data at present, and further studies are in the pipeline. There has been

  2. 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.)

  3. Flammer syndrome and potential formation of pre-metastatic niches : a multi-centred study on phenotyping, patient stratification, prediction and potential prevention of aggressive breast cancer and metastatic disease

    OpenAIRE

    Golubnitschaja, Olga; Debald, Manuel; Kuhn, Walter; Yeghiazaryan, Kristina; Bubnov, Rostyslav V.; Goncharenko, Vadym M.; Lushchyk, Ulyana; Grech, Godfrey; Konieczka, Katarzyna

    2016-01-01

    Table of contents A1 Predictive and prognostic biomarker panel for targeted application of radioembolisation improving individual outcomes in hepatocellular carcinoma Jella-Andrea Abraham, Olga Golubnitschaja A2 Integrated market access approach amplifying value of ?Rx-CDx? Ildar Akhmetov A3 Disaster response: an opportunity to improve global healthcare Russell J. Andrews, Leonidas Quintana A4 USA PPPM: proscriptive, profligate, profiteering medicine-good for 1?% wealthy, not for 99?% unhealt...

  4. The role of whole-body computed tomography in the diagnosis of thoracic injuries in severely injured patients - a retrospective multi-centre study based on the trauma registry of the German trauma society (TraumaRegister DGU®).

    Science.gov (United States)

    Lang, Patricia; Kulla, Martin; Kerwagen, Fabian; Lefering, Rolf; Friemert, Benedikt; Palm, Hans-Georg

    2017-08-15

    Thoracic injuries are a leading cause of death in polytrauma patients. Early diagnosis and treatment are of paramount importance. Whole-body computed tomography (WBCT) has largely replaced traditional imaging techniques such as conventional radiographs and focused computed tomography (CT) as diagnostic tools in severely injured patients. It is still unclear whether WBCT has led to higher rates of diagnosis of thoracic injuries and thus to a change in outcomes. In a retrospective study based on the trauma registry of the German Trauma Society (TraumaRegister DGU ® ), we analysed data from 16,545 patients who underwent treatment in 59 hospitals between 2002 and 2012 (ISS ≥ 9). The 3 years preceding and the 3 years following the introduction of WBCT as a standard imaging modality for the investigation of severely injured patients were assessed for every hospital. Accordingly, patients were assigned to either the pre-WBCT or the WBCT group. We compared the numbers of thoracic injuries and the outcomes of patients before and after the routine use of WBCT. A total of 13,564 patients (pre-WBCT: n = 5005, WBCT: n = 8559) were included. Relevant thoracic injuries were detected in 47.8%. There were no major differences between the patient groups in injury severity (pre-WBCT: median ISS 21; WBCT: median ISS 22), injury patterns and demographics. After the introduction of WBCT, only minor changes were observed regarding the rates of most thoracic injuries. Clinically relevant injuries were pulmonary contusions (pre-WBCT: 18.5%; WBCT: 28.7%), injuries to the lung parenchyma (pre-WBCT: 12.6%; WBCT: 5.9%), multiple rib fractures (pre-WBCT: 10.6%; WBCT: 21.6%), and pneumothoraces (pre-WBCT: 17.3%; WBCT: 21.6%). The length of stay in the intensive care unit (pre-WBCT: 10.8 days; WBCT: 9.7 days) and in hospital (pre-WBCT: 26.2 days; WBCT: 23.3 days) decreased. There was no difference in overall mortality (pre-WBCT: 15.5%; WBCT: 15.6%). The routine use of WBCT in the

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

    NARCIS (Netherlands)

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

    2008-01-01

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

  6. Early experience with dual mobility acetabular systems featuring highly cross-linked polyethylene liners for primary hip arthroplasty in patients under fifty five years of age: an international multi-centre preliminary study.

    Science.gov (United States)

    Epinette, Jean-Alain; Harwin, Steven F; Rowan, Fiachra E; Tracol, Philippe; Mont, Michael A; Chughtai, Morad; Westrich, Geoffrey H

    2017-03-01

    To evaluate early performance of contemporary dual mobility acetabular systems with second generation annealed highly cross-linked polyethylene for primary hip arthroplasty of patients under 55 years of age. A prospective observational five years study across five centers in Europe and the USA of 321 patients with a mean age of 48.1 years was performed. Patients were assessed for causes of revision, hip instability, intra-prosthetic dissociation, Harris hip score and radiological signs of osteolysis. There were no dislocations and no intra-prosthetic dissociations. Kaplan Meier analysis demonstrated 97.51% survivorship for all cause revision and 99.68% survivorship for acetabular component revision at five years. Mean Harris hip score was 93.6. Two acetabular shells were revised for neck-rim implant impingement without dislocation and ten femoral stems were revised for causes unrelated to dual mobility implants. Contemporary highly cross-linked polyethylene dual mobility systems demonstrate excellent early clinical, radiological, and survivorship results in a cohort of patients that demand high performance from their implants. It is envisaged that DM and second generation annealed HXLPE may reduce THA instability and wear, the two most common causes of THA revision in hip arthroplasty.

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

    NARCIS (Netherlands)

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

    2009-01-01

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

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

    DEFF Research Database (Denmark)

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

    2011-01-01

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

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

    Science.gov (United States)

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

    2017-12-01

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

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

    International Nuclear Information System (INIS)

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

    1984-01-01

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

  11. 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

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

    Science.gov (United States)

    Anisimov, Vladimir V

    2011-01-01

    This paper deals with the analysis of randomization effects in multi-centre clinical trials. The two randomization schemes most often used in clinical trials are considered: unstratified and centre-stratified block-permuted randomization. The prediction of the number of patients randomized to different treatment arms in different regions during the recruitment period accounting for the stochastic nature of the recruitment and effects of multiple centres is investigated. A new analytic approach using a Poisson-gamma patient recruitment model (patients arrive at different centres according to Poisson processes with rates sampled from a gamma distributed population) and its further extensions is proposed. Closed-form expressions for corresponding distributions of the predicted number of the patients randomized in different regions are derived. In the case of two treatments, the properties of the total imbalance in the number of patients on treatment arms caused by using centre-stratified randomization are investigated and for a large number of centres a normal approximation of imbalance is proved. The impact of imbalance on the power of the study is considered. It is shown that the loss of statistical power is practically negligible and can be compensated by a minor increase in sample size. The influence of patient dropout is also investigated. The impact of randomization on predicted drug supply overage is discussed. Copyright © 2010 John Wiley & Sons, Ltd.

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

    Directory of Open Access Journals (Sweden)

    Heeley Emma L

    2011-01-01

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

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

    Science.gov (United States)

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

    2011-08-01

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

  15. 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.

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

    Science.gov (United States)

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

    2016-03-01

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

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

    Science.gov (United States)

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

    2015-02-01

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

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

    Science.gov (United States)

    Pestel, M

    1975-01-01

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

  19. 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

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

    Directory of Open Access Journals (Sweden)

    Camille Chenevier-Gobeaux

    2018-07-01

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

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

    NARCIS (Netherlands)

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

    1998-01-01

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

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

    DEFF Research Database (Denmark)

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

    2012-01-01

    Multi-centre trials are an important part of proving the efficacy of procedures, drugs and interventions. Imaging components in such trials are becoming increasingly common; however, without sufficient control measures the usefulness of these data can be compromised. This paper describes a framew...

  3. 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

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

    DEFF Research Database (Denmark)

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

    2011-01-01

    CRP) levels are lower in UK patients with hepatocyte nuclear factor 1 alpha (HNF1A)-MODY than in other diabetes subtypes. In this large multi-centre study we aimed to assess the clinical validity of hsCRP as a diagnostic biomarker, examine the genotype-phenotype relationship and compare different hsCRP assays....... High-sensitivity CRP levels were analysed in individuals with HNF1A-MODY (n = 457), glucokinase (GCK)-MODY (n = 404), hepatocyte nuclear factor 4 alpha (HNF4A)-MODY (n = 54) and type 2 diabetes (n = 582) from seven European centres. Three common assays for hsCRP analysis were evaluated. We excluded 121......) a parts per thousand yenaEuro parts per thousand 0.91, p a parts per thousand currency signaEuro parts per thousand 1 x 10(-5)). Across the seven centres, the C-statistic for distinguishing HNF1A-MODY from young adult-onset type 2 diabetes ranged from 0.79 to 0.97, indicating high discriminative accuracy...

  5. 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.

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

    Science.gov (United States)

    Driscoll, Brandon; Jaffray, David; Coolens, Catherine

    2014-03-01

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

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

    International Nuclear Information System (INIS)

    Driscoll, Brandon; Jaffray, David; Coolens, Catherine

    2014-01-01

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

  8. 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.

  9. 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

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

    Directory of Open Access Journals (Sweden)

    Peerbooms Joost C

    2010-04-01

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

  11. 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.

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

    Directory of Open Access Journals (Sweden)

    Chojnowski Adrian J

    2008-04-01

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

  13. 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.

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

    Science.gov (United States)

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

    2018-02-08

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

  15. 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...

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

    International Nuclear Information System (INIS)

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

    2014-01-01

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

  17. 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.

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

    Science.gov (United States)

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

    1990-02-01

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

  19. 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.

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

    Science.gov (United States)

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

    2017-09-26

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

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

    Directory of Open Access Journals (Sweden)

    Logan Pip A

    2012-06-01

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

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

    Science.gov (United States)

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

    2015-07-10

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

  3. 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

  4. 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.

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

    Science.gov (United States)

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

    2011-09-01

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

  6. 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.

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

    Science.gov (United States)

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

    2018-05-02

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

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

    Science.gov (United States)

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

    2017-08-01

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

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

    Directory of Open Access Journals (Sweden)

    Bochenek Andrzej

    2011-09-01

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

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

    Science.gov (United States)

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

    2014-04-01

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

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

    International Nuclear Information System (INIS)

    McNiven, A; Jaffray, D; Letourneau, D

    2015-01-01

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

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

    Energy Technology Data Exchange (ETDEWEB)

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

    2015-06-15

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

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

    OpenAIRE

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

    2009-01-01

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

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

    Science.gov (United States)

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

    2018-04-01

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

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

    Directory of Open Access Journals (Sweden)

    Thompson Simon

    2002-01-01

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

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

    Science.gov (United States)

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

    2016-10-01

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

  17. 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.

  18. Individual patient dosimetry using quantitative SPECT imaging

    International Nuclear Information System (INIS)

    Gonzalez, J.; Oliva, J.; Baum, R.; Fisher, S.

    2002-01-01

    An approach is described to provide individual patient dosimetry for routine clinical use. Accurate quantitative SPECT imaging was achieved using appropriate methods. The volume of interest (VOI) was defined semi-automatically using a fixed threshold value obtained from phantom studies. The calibration factor to convert the voxel counts from SPECT images into activity values was determine from calibrated point source using the same threshold value as in phantom studies. From selected radionuclide the dose within and outside a sphere of voxel dimension at different distances was computed through dose point-kernels to obtain a discrete absorbed dose kernel representation around the volume source with uniform activity distribution. The spatial activity distribution from SPECT imaging was convolved with this kernel representation using the discrete Fourier transform method to yield three-dimensional absorbed dose rate distribution. The accuracy of dose rates calculation was validated by software phantoms. The absorbed dose was determined by integration of the dose rate distribution for each volume of interest (VOI). Parameters for treatment optimization such as dose rate volume histograms and dose rate statistic are provided. A patient example was used to illustrate our dosimetric calculations

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

    Science.gov (United States)

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

    2014-05-03

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

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

    Science.gov (United States)

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

    2017-01-01

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

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

    Science.gov (United States)

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

    2015-01-01

    2004 to 10% (35/9 657) in 2012/13, comprising 9% of total enrolment (7 295/83 566). By analysis closure, 14% of all patients still alive and in care were ≥50 years old. Interpretation Health services need re-orientation towards diagnosing and starting ART in older individuals. Policies are needed for long-term care of older people with HIV. Funding Supported by NIH (NIAID), USAID & South African Centre for Epidemiological Modelling & Analysis. PMID:26423550

  2. Single-course specific immunotherapy with mixed pollen allergoids: results of a multi-centre study.

    Science.gov (United States)

    Drachenberg, K J; Pröll, S; Urban, E; Woroniecki, S R

    2003-01-01

    A short-term immunotherapy vaccine for the treatment of pollen allergy has been developed utilising L-tyrosine adsorbed allergoids. The reduced number of injections could provide advantages over long-term therapy schedules. This would improve compliance and support application of specific immunotherapy (SIT) to a greater extent. We report a multicenter study to evaluate the efficacy and safety of this treatment in a clinical practice setting. Patients (n = 1808) with a diagnosis of sensitivities to various pollens and symptoms of allergic asthma and/or allergic rhinitis and/or allergic conjunctivitis were selected. The vaccine formulation was made up according to individual sensitivities and contained L-tyrosine adsorbed allergoids. The patients were treated with a 3-injection initial course followed by a 3-injection maintenance course. Efficacy was measured by consumption of symptomatic anti-allergic medication compared with that in the previous season and by physician assessment using a 5-point scale. All adverse events were recorded. Efficacy was demonstrated by a considerable decrease in regular and frequent use of medication compared with that in the previous season (p allergoid/L-tyrosine vaccine in a clinical practice setting provided a high level of efficacy with a low incidence of mainly mild adverse events.

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

    Directory of Open Access Journals (Sweden)

    Shekar Kiran

    2012-11-01

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

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

    Science.gov (United States)

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

    2017-10-25

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

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

    Science.gov (United States)

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

    2016-09-01

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

  6. [The meta-analysis of data from individual patients].

    NARCIS (Netherlands)

    Rovers, M.M.; Reitsma, J.B.

    2012-01-01

    - An IPD (Individual Participant Data) meta-analysis requires collecting original individual patient data and calculating an estimated effect based on these data.- The use of individual patient data has various advantages: the original data and the results of published analyses are verified,

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

    OpenAIRE

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

    2012-01-01

    Abstract Background People with Multiple Sclerosis (MS) frequently experience balance and mobility impairments, including reduced trunk stability. Pilates-based core stability training, which is aimed at improving control of the body's stabilising muscles, is popular as a form of exercise with people with MS and therapists. A replicated single case series study facilitated by the Therapists in MS Group in the United Kingdom (UK) provides preliminary evidence that this approach can improve bal...

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

    Science.gov (United States)

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

    2018-04-20

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

  9. 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.

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

    Science.gov (United States)

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

    2017-07-01

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

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

    DEFF Research Database (Denmark)

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

    2016-01-01

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

  12. 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.

  13. Individualized Vascular Disease Prevention in High-Risk Patients

    NARCIS (Netherlands)

    Kaasenbrood, L

    2016-01-01

    In the pharmacologic prevention of vascular events, clinicians need to translate average effects from a clinical trial to the individual patient. Prediction models can contribute to individualized vascular disease prevention by selecting patients for treatment based on estimated risk or expected

  14. 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.

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

    DEFF Research Database (Denmark)

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

    2016-01-01

    patients, relatives and professional caregivers about patients' values and care preferences. It raises awareness of the need to anticipate possible future deterioration of health. ACP has the potential to improve current and future healthcare decision-making, provide patients with a sense of control......BACKGROUND: Awareness of preferences regarding medical care should be a central component of the care of patients with advanced cancer. Open communication can facilitate this but can occur in an ad hoc or variable manner. Advance care planning (ACP) is a formalized process of communication between...... Choices program from the perspectives of patients, their Personal Representatives, healthcare providers and facilitators. DISCUSSION: Transferring the concept of ACP from care of the elderly to patients with advanced cancer, who on average are younger and retain their mental capacity for a larger part...

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

    NARCIS (Netherlands)

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

    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

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

    Directory of Open Access Journals (Sweden)

    Kingston Laura

    2008-01-01

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

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

    International Nuclear Information System (INIS)

    Lancaster, Anne; Hardy, Maryann

    2012-01-01

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

  19. Strategic verbal rehearsal in adolescents with mild intellectual disabilities: A multi-centre European study.

    Science.gov (United States)

    Poloczek, Sebastian; Henry, Lucy A; Danielson, Henrik; Büttner, Gerhard; Mähler, Claudia; Messer, David J; Schuchardt, Kirsten; Molen, Mariët J van der

    2016-11-01

    There is a long-held view that verbal short-term memory problems of individuals with intellectual disabilities (ID) might be due to a deficit in verbal rehearsal. However, the evidence is inconclusive and word length effects as indicator of rehearsal have been criticised. The aim of this multi-site European study was to investigate verbal rehearsal in adolescents with mild ID (n=90) and a comparison group of typically developing children matched individually for mental age (MA, n=90). The investigation involved: (1) a word length experiment with non-verbal recall using pointing and (2) 'self-paced' inspection times to infer whether verbal strategies were utilised when memorising a set of pictorial items. The word length effect on recall did not interact with group, suggesting that adolescents with ID and MA comparisons used similar verbal strategies, possibly phonological recoding of picture names. The inspection time data suggested that high span individuals in both groups used verbal labelling or single item rehearsal on more demanding lists, as long named items had longer inspection times. The findings suggest that verbal strategy use is not specifically impaired in adolescents with mild ID and is mental age appropriate, supporting a developmental perspective. Copyright © 2016 Elsevier Ltd. All rights reserved.

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

    NARCIS (Netherlands)

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

    2005-01-01

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

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

    NARCIS (Netherlands)

    Damen, G.W.J.A.; Krabbe, P.F.M.; Kilsby, M.; Mylanus, E.A.M.

    2005-01-01

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

  2. 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

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

    Science.gov (United States)

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

    2009-11-24

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

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

    Directory of Open Access Journals (Sweden)

    Nieder Ulrike

    2009-11-01

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

  5. Experience and outcome of ventricular-atrial shunt: a multi centre study

    International Nuclear Information System (INIS)

    Akhtar, N.; Khan, A.A.; Yousaf, M.

    2015-01-01

    Ventriculoperitoneal (VP) shunt has been widely utilized in the treatment of hydrocephalus as a safe option but there is recent literature evidence that ventricularatrial (VA) shunt is not as notorious for its complications as proclaimed, to analyse and report our success with this procedure we conducted our study. Methods: A total of 64 patients undergoing VA shunting were included in this case series study conducted at RMC and Allied hospital Rawalpindi. The data was collected over a period of 4 years from, 1st June 2010 to 1st June 2015. Result: Our study included 64 patients who underwent a VA shunt for hydrocephalus. Their age ranged from 25 to 75 years. Most of the patients were females (60%). The following complications were observed with 2 (3.12%) patients having blockage of the shunt at the neck, 3 (4.68%) suffered from glomerulonephritis, 2 (3.1%) had post-operative neck hematoma, 4 (6.25 %) had wound infection, short lower end of the tube was found in 3 (4.68%), migrated lower end (into the subclavian) was seen in 1 (1.56%). Mortality was 1(1.56%). These results were comparable to other studies. Conclusion: Neurosurgeons have been doing a VA shunt as a second procedure, after a VP shunt when the need due to a complication was encountered. We however share our experience regarding ventriculo-atrial shunting, as first choice procedure, because of its low incidence of shunt blockage unlike VP shunt, which has high rate of shunt blockage and therefore warrants repeated surgeries. (author)

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

    Directory of Open Access Journals (Sweden)

    Xiao-ming CHENG

    2011-02-01

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

  7. 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.

  8. Analysis of the individual radio sensitivity of breast cancer patients

    International Nuclear Information System (INIS)

    Auer, Judith

    2013-01-01

    Individual radiosensitivity has a crucial impact on radiotherapy related side effects. A prediction of individual radiosensitivity could avoid these side effects. Our aim was to study a breast cancer collective for its variation of individual radiosensitivity. Peripheral blood samples were obtained from 129 individuals. 67 breast cancer patients and 62 healthy and age matched individuals were looked at and their individual radiosensitivity was estimated by a 3-color Fluorescence in situ hybridization approach. Blood samples were obtained (i) before starting adjuvant radiotherapy and were in vitro irradiated by 2 Gy; (ii) after 5 single doses of 1.8 Gy and after 72 h had elapsed. DNA of lymphocytes was probed with whole chromosome painting for chromosomes 1, 2 and 4. The rate of breaks per metaphase was analyzed and used as a predictor of individual radiosensitivity. Breast cancer patients were distinctly more radio-sensitive compared to healthy controls. Additionally the distribution of the cancer patients' radiosensitivity was broader. A subgroup of 9 rather radio-sensitive and 9 rather radio-resistant patients was identified. A subgroup of patients aged between 40 and 50 was distinctly more radio-sensitive than younger or older patients. The in vivo irradiation approach was not applicable to detect individual radiosensitivity. In the breast cancer collective a distinctly resistant and sensitive subgroup is identified, which could be subject for treatment adjustment. Especially in the range of age 40 to 50 patients have an increased radiosensitivity. An in vivo irradiation in a breast cancer collective is not suitable to estimate individual radiosensitivity due to a low deposed dose.

  9. 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.

  10. 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.

  11. Diabetic retinopathy screening in New Zealand requires improvement: results from a multi-centre audit.

    Science.gov (United States)

    Hutchins, Edward; Coppell, Kirsten J; Morris, Ainsley; Sanderson, Gordon

    2012-06-01

    To determine whether diabetic retinal screening services and retinopathy referral centres in New Zealand meet the national guidelines for referral and assessment of screen detected moderate retinal and mild macular diabetic eye disease. Diabetic retinal screening pathways and the data collected at four main centre retinal screening services were described and compared with recommendations in the national diabetes retinal screening guidelines. A retrospective audit of photoscreen detected moderate retinopathy (grade R3), and mild maculopathy (grades M2B and M3) during May to August 2008 was undertaken. Data collected by retinopathy referral centres were used to examine the follow-up of screen detected cases and to make comparisons with the national recommendations. All four screening services used the guidelines for grading, but the recommended dataset was incomplete. Not all recorded data were readily accessible. The retinal photos of 157 (2.4%) patients were graded as R3, M2B, M3 or a combination. The proportion of those screened with these grades varied across the four centres from 1.2% to 3.4%. Follow-up of the 157 screen positive patients did not always comply with guideline recommendations. Seventy five (48%) were referred for review by an ophthalmologist as recommended, 45 (60% of referred) were seen within the recommended six months. Nine patients (15% of the 60 with a documented assessment) were referred for or received laser treatment at 12-months follow-up. Quality diabetic retinal screening data systems and quality assurance programs are required to improve the monitoring and quality of retinal screening in New Zealand. © 2012 The Authors. ANZJPH © 2012 Public Health Association of Australia.

  12. Multi-centre point prevalence survey of hospital-acquired infections in Ghana.

    Science.gov (United States)

    Labi, Appiah-Korang; Obeng-Nkrumah, Noah; Owusu, Enid; Bjerrum, Stephanie; Bediako-Bowan, Antoinette; Sunkwa-Mills, Gifty; Akuffo, Christiana; Fenny, Ama Pokua; Opintan, Japheth Awuletey; Enweronu-Laryea, Christabel; Debrah, Samuel; Damale, Nelson; Bannerman, Cynthia; Newman, Mercy Jemima

    2018-05-03

    There is a paucity of data describing hospital acquired infections (HAIs) in Africa. To describe the prevalence and distribution of HAIs in acute care hospitals in Ghana. Between September and December 2016, point prevalence surveys were conducted in participating hospitals using protocols of the European Centre for Disease Prevention and Control. We reviewed medical records of eligible inpatients at or before 8am on the day of survey to identify HAIs present at the time of survey. Ten hospitals were surveyed, representing 32.9% of all acute care beds in government hospitals. Of 2107 inpatients surveyed, 184 HAIs were identified among 172 patients, corresponding to an overall prevalence of 8.2%. The prevalence values in hospitals ranged from 3.5 to 14.4% with higher proportion of infections in secondary and tertiary care facilities. The most frequent HAIs were surgical site infections (32.6%), bloodstream infections (19.5%), urinary tract infections (18.5%), and respiratory tract infections (16.3%). Device-associated infections accounted for 7.1% of HAIs. For 12.5% of HAIs, a microorganism was reported; the most isolated microorganism was Escherichia coli. Approximately 61% of all patients surveyed were on antibiotics; 89.5% of patients with an HAI received at least one antimicrobial agent on the day of survey. The strongest independent predictors for HAI were the presence of invasive device before onset of infection and duration of hospital stay. We recorded a low HAI burden compared to findings from other low and middle income countries. Copyright © 2018. Published by Elsevier Ltd.

  13. 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)

  14. 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

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

    Science.gov (United States)

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

    2018-01-01

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

  16. The diagnostic and therapeutic impact of MRI: an observational multi-centre study

    Energy Technology Data Exchange (ETDEWEB)

    Hollingworth, William; Todd, Christopher J.; Bell, Matthew I.; Arafat, Qais; Girling, Simon; Karia, Kanti R.; Dixon, Adrian K

    2000-11-01

    AIM: To provide information about the diagnostic and therapeutic impact of magnetic resonance imaging (MRI) and to compare the findings across diagnostic groups. MATERIALS AND METHODS: A prospective, observational study of 2017 consecutive referrals for MRI of the head, spine or knee at four imaging centres. Clinicians completed questionnaires before MRI stating initial diagnoses, diagnostic confidence and treatment plans. After imaging, a second questionnaire evaluated clinicians' revised diagnosis and treatment plans in the light of imaging findings. Patients were grouped into nine diagnostic categories for analysis. Comparison between pre- and post-imaging was used to assess the diagnostic and therapeutic impact of MRI. RESULTS: In seven of nine diagnostic groups MRI findings were associated with a diagnostic impact. Diagnoses were revised or discarded following normal MR findings and diagnostic confidence was increased by confirmative MR findings. There was no statistically significant diagnostic impact for suspected pituitary or cerebello-pontine angle lesions. In five of nine diagnostic groups (knee meniscus, knee ligament, multiple sclerosis, lumbar and cervical spine) MRI findings had a clear impact on treatment plans. CONCLUSION: This study demonstrates that in most diagnostic categories, MRI influences diagnosis and treatment. However, experimental studies are needed to prove that these diagnostic and therapeutic impacts lead to improved health. Hollingworth (2000)

  17. 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)

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

    International Nuclear Information System (INIS)

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

    2009-01-01

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

  19. 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.

  20. 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.

  1. 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

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

    Science.gov (United States)

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

    2017-12-01

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

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

    Directory of Open Access Journals (Sweden)

    Esther Kissling

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

  4. Individualized Anemia Management Reduces Hemoglobin Variability in Hemodialysis Patients

    OpenAIRE

    Gaweda, Adam E.; Aronoff, George R.; Jacobs, Alfred A.; Rai, Shesh N.; Brier, Michael E.

    2013-01-01

    One-size-fits-all protocol-based approaches to anemia management with erythropoiesis-stimulating agents (ESAs) may result in undesired patterns of hemoglobin variability. In this single-center, double-blind, randomized controlled trial, we tested the hypothesis that individualized dosing of ESA improves hemoglobin variability over a standard population-based approach. We enrolled 62 hemodialysis patients and followed them over a 12-month period. Patients were randomly assigned to receive ESA ...

  5. Providers and Patients Caught Between Standardization and Individualization: Individualized Standardization as a Solution

    Science.gov (United States)

    Ansmann, Lena; Pfaff, Holger

    2018-01-01

    In their 2017 article, Mannion and Exworthy provide a thoughtful and theory-based analysis of two parallel trends in modern healthcare systems and their competing and conflicting logics: standardization and customization. This commentary further discusses the challenge of treatment decision-making in times of evidence-based medicine (EBM), shared decision-making and personalized medicine. From the perspective of systems theory, we propose the concept of individualized standardization as a solution to the problem. According to this concept, standardization is conceptualized as a guiding framework leaving room for individualization in the patient physician interaction. The theoretical background is the concept of context management according to systems theory. Moreover, the comment suggests multidisciplinary teams as a possible solution for the integration of standardization and individualization, using the example of multidisciplinary tumor conferences and highlighting its limitations. The comment also supports the authors’ statement of the patient as co-producer and introduces the idea that the competing logics of standardization and individualization are a matter of perspective on macro, meso and micro levels. PMID:29626403

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

    DEFF Research Database (Denmark)

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

    2011-01-01

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

  7. Patient Characteristics Predicting Readmission Among Individuals Hospitalized for Heart Failure

    Science.gov (United States)

    O'Connor, Melissa; Murtaugh, Christopher M.; Shah, Shivani; Barrón-Vaya, Yolanda; Bowles, Kathryn H.; Peng, Timothy R.; Zhu, Carolyn W.; Feldman, Penny H.

    2015-01-01

    Heart failure is difficult to manage and increasingly common with many individuals experiencing frequent hospitalizations. Little is known about patient factors consistently associated with hospital readmission. A literature review was conducted to identify heart failure patient characteristics, measured before discharge, that contribute to variation in hospital readmission rates. Database searches yielded 950 potential articles, of which 34 studies met inclusion criteria. Patient characteristics generally have a very modest effect on all-cause or heart failure–related readmission within 7 to 180 days of index hospital discharge. A range of cardiac diseases and other comorbidities only minimally increase readmission rates. No single patient characteristic stands out as a key contributor across multiple studies underscoring the challenge of developing successful interventions to reduce readmissions. Interventions may need to be general in design with the specific intervention depending on each patient's unique clinical profile. PMID:26180045

  8. Patient Characteristics Predicting Readmission Among Individuals Hospitalized for Heart Failure.

    Science.gov (United States)

    O'Connor, Melissa; Murtaugh, Christopher M; Shah, Shivani; Barrón-Vaya, Yolanda; Bowles, Kathryn H; Peng, Timothy R; Zhu, Carolyn W; Feldman, Penny H

    2016-02-01

    Heart failure is difficult to manage and increasingly common with many individuals experiencing frequent hospitalizations. Little is known about patient factors consistently associated with hospital readmission. A literature review was conducted to identify heart failure patient characteristics, measured before discharge, that contribute to variation in hospital readmission rates. Database searches yielded 950 potential articles, of which 34 studies met inclusion criteria. Patient characteristics generally have a very modest effect on all-cause or heart failure-related readmission within 7 to 180 days of index hospital discharge. A range of cardiac diseases and other comorbidities only minimally increase readmission rates. No single patient characteristic stands out as a key contributor across multiple studies underscoring the challenge of developing successful interventions to reduce readmissions. Interventions may need to be general in design with the specific intervention depending on each patient's unique clinical profile. © The Author(s) 2015.

  9. Effectiveness of 32 versus 20 weeks of prednisolone in leprosy patients with recent nerve function impairment: A randomized controlled trial.

    Science.gov (United States)

    Wagenaar, Inge; Post, Erik; Brandsma, Wim; Bowers, Bob; Alam, Khorshed; Shetty, Vanaja; Pai, Vivek; Husain, Sajid; Sigit Prakoeswa, Cita Rosita; Astari, Linda; Hagge, Deanna; Shah, Mahesh; Neupane, Kapil; Tamang, Krishna Bahadur; Nicholls, Peter; Richardus, Jan Hendrik

    2017-10-01

    While prednisolone is commonly used to treat recent nerve function impairment (NFI) in leprosy patients, the optimal treatment duration has not yet been established. In this "Treatment of Early Neuropathy in Leprosy" (TENLEP) trial, we evaluated whether a 32-week prednisolone course is more effective than a 20-week course in restoring and improving nerve function. In this multi-centre, triple-blind, randomized controlled trial, leprosy patients who had recently developed clinical NFI (leprosy patients. Twenty weeks is therefore the preferred initial treatment duration for leprosy neuropathy, after which likely only a minority of patients require further individualized treatment.

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

    Directory of Open Access Journals (Sweden)

    Maffulli Nicola

    2009-11-01

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

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

    Directory of Open Access Journals (Sweden)

    Snowdon Claire

    2007-01-01

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

  12. Individual treatment selection for patients with posttraumatic stress disorder.

    Science.gov (United States)

    Deisenhofer, Anne-Katharina; Delgadillo, Jaime; Rubel, Julian A; Böhnke, Jan R; Zimmermann, Dirk; Schwartz, Brian; Lutz, Wolfgang

    2018-04-16

    Trauma-focused cognitive behavioral therapy (Tf-CBT) and eye movement desensitization and reprocessing (EMDR) are two highly effective treatment options for posttraumatic stress disorder (PTSD). Yet, on an individual level, PTSD patients vary substantially in treatment response. The aim of the paper is to test the application of a treatment selection method based on a personalized advantage index (PAI). The study used clinical data for patients accessing treatment for PTSD in a primary care mental health service in the north of England. PTSD patients received either EMDR (N = 75) or Tf-CBT (N = 242). The Patient Health Questionnaire (PHQ-9) was used as an outcome measure for depressive symptoms associated with PTSD. Variables predicting differential treatment response were identified using an automated variable selection approach (genetic algorithm) and afterwards included in regression models, allowing the calculation of each patient's PAI. Age, employment status, gender, and functional impairment were identified as relevant variables for Tf-CBT. For EMDR, baseline depressive symptoms as well as prescribed antidepressant medication were selected as predictor variables. Fifty-six percent of the patients (n = 125) had a PAI equal or higher than one standard deviation. From those patients, 62 (50%) did not receive their model-predicted treatment and could have benefited from a treatment assignment based on the PAI. Using a PAI-based algorithm has the potential to improve clinical decision making and to enhance individual patient outcomes, although further replication is necessary before such an approach can be implemented in prospective studies. © 2018 Wiley Periodicals, Inc.

  13. Vulnerabilidade do doente versus autonomia individual The vulnerability of the patient versus individual autonomy

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    Inês Motta de Morais

    2010-12-01

    Full Text Available A autonomia é um conceito ético e individual, ao passo que a vulnerabilidade pressupõe a existência de relações desiguais entre indivíduos ou grupos. Tal desigualdade pode estar relacionada a questões sócio-econômicas. Muitas vezes os desprivilegiados têm dificuldades ou, mesmo impossibilidade de decidir. Portanto, é importante o reconhecimento dessa vulnerabilidade para garantir o direito à autonomia e respeito à dignidade de indivíduos, principalmente quando se trata de pesquisas na área da saúde. Este estudo procura analisar a importância do conceito de vulnerabilidade e seu alcance na relação com a autonomia individual. O estudo conclui que a consciência de vulnerabilidade é importante para alimentar a razão crítica que fundamenta a autonomia. Não pretende de forma alguma propor mais uma definição de autonomia individual e vulnerabilidade do doente, e sim apresentar os resultados do levantamento bibliográfico sobre o tema demonstrando os pontos convergentes e divergentes de diversos expoentes literários.Autonomy is and ethical and individual concept, while vulnerability presupposes the existence of unequal relations between individuals or groups. Such inequality may be related to socio-economic issues. The underprivileged often have difficulty in making decisions or find it impossible to do so. It is, therefore, important to recognize this vulnerability in order to ensure the right to autonomy and respect for the dignity of the individual, especially in the case of health research. This study investigates the importance of the concept of vulnerability and the extent to which it is related to individual autonomy. The study concludes that awareness of vulnerability is important in fuelling the critical reason that is the foundation of autonomy. The intention here is certainly not to put forward yet another definition of individual autonomy and patient vulnerability, but rather to present the results of a

  14. Validation of thyroid/parotid ratio (TPR) in the diagnosis of hyperthyroidism A Multi-centre study

    International Nuclear Information System (INIS)

    Das, B.K.; Pradhan, P.K.; Shukla, A.K.; Senthilnathan, M.S.

    2007-01-01

    Full text: Thyroid to Parotid Ratio (TPR) as a simple and cost effective diagnostic test in the evaluation of thyroid disorders was first reported by us in 1997P. Since then several authors have used this procedure for the diagnosis and differential diagnosis of high uptake thyroid conditions. The purpose of this multi centric study was to validate this simple technique and establish its clinical usefulness in a large number of patients at different environmental conditions and ethnic populations. Material and method: Prospective study which included following patients: 43 consecutive hyperthyroid patients (26 male and 17 female) from eastern Malaysia (high dietary iodine) sent for radio iodine therapy between May 2005 and Dec. 2006; 578 patients (212 male and 366 females) from northern part of India (endemic goiter region) diagnosed to have hyperthyroid conditions between Jan. 1996 and Dec.2002 and 19 consecutive patients (8 males and 11 females) from south India (non- endemic goiter region ) clinically and bio chemically hyperthyroid, referred between June 2005 and Dec. 2006. All patients were subjected to a standard Tc99m thyroid scan. Thyroid to Parotid Ratio (TPR) was calculated after drawing ROIs over the thyroid and parotid glands in anterior projection. Blood samples were taken on the same day for TB3B, TB4B and TSH (RIA) The TPR values were compared with the biochemical parameters. Results: The individual comparison of clinical and biochemical parameters with TPR in hyperthyroid patients showed concordance [TPR > 2.5 (normal ± 2 SD)] in over 90 % in all the three centers (Kelantan 91 %, Lucknow 93.7 % and Madurai 96.5 %). Conclusions: Calculation of TPR is extremely simple without the requirement of syringe counts or adhering to any time frame. It is highly sensitive and specific in the diagnosis of hyperthyroidism. The morphological information obtained from the scan and the objective TPR value for functional status is sufficient to start definitive

  15. 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...

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

    Science.gov (United States)

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

    2015-01-01

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

  17. Patient adherence to antihypertensive therapy and its individual psychological factors

    Directory of Open Access Journals (Sweden)

    Lidia Trachuk

    2016-09-01

    Full Text Available Background. In the treatment of chronic, especially asymptomatic pathology one of the main problem is the adherence to therapy. Patients with arterial hypertension need long-term, often lifelong medication, and how strictly they adhere to prescriptions often determines the course of the disease and the medical measures effectiveness. According to statistics, more than half of patients with hypertension are characterized by low compliance, which leads to complications of this disease. The objective of the research is to identify and analize the individual psychological factors that determine patient adherence to antihypertensive therapy. Methods and materials. This study was conducted during 2011-2013 at the cardiology departments of the Kyiv Alexander Hospital, polyclinics number 2 Shevchenko district in Kyiv, Desnyanskiy clinic №3 district in Kyiv, medical center "Adonis plus". We examined 203 patients with arterial hypertension (average age 53,5 ± 4,5 years. Methods: socio-demographic, clinical, clinical and psychological, psychodiagnostical, mathematical and statistical methods. Psychodiagnostical method included: 8-item Morisky medical adherence scale (Morisky D. E., 2008; self-assessment anxiety scale Charles D. Spielberger – Y.L Hanin (A.V. Batarshev, 2005; the Minnesota Multiphasic Personality Inventory questionnaire (MMRI (F.B. Berezin, 1994; "The level of subjective control" (A.A. Rean, 2001; "Index of attitudes to health" (S.D. Deryabo, VA Yasvin, 2000. Results. According to the results of 8-item Morisky medical adherence scale patients were divided into 3 groups according to the level of compliance - with high (26.11%, average (24.14% and low (49.75% levels of adherence to antihypertensive therapy. The individual-psychological predictors of poor adherence to antihypertensive therapy include the following personal characteristics of patients: a low level of intensity of attitude to health, internal type of subjective control, a

  18. Individualized anemia management reduces hemoglobin variability in hemodialysis patients.

    Science.gov (United States)

    Gaweda, Adam E; Aronoff, George R; Jacobs, Alfred A; Rai, Shesh N; Brier, Michael E

    2014-01-01

    One-size-fits-all protocol-based approaches to anemia management with erythropoiesis-stimulating agents (ESAs) may result in undesired patterns of hemoglobin variability. In this single-center, double-blind, randomized controlled trial, we tested the hypothesis that individualized dosing of ESA improves hemoglobin variability over a standard population-based approach. We enrolled 62 hemodialysis patients and followed them over a 12-month period. Patients were randomly assigned to receive ESA doses guided by the Smart Anemia Manager algorithm (treatment) or by a standard protocol (control). Dose recommendations, performed on a monthly basis, were validated by an expert physician anemia manager. The primary outcome was the percentage of hemoglobin concentrations between 10 and 12 g/dl over the follow-up period. A total of 258 of 356 (72.5%) hemoglobin concentrations were between 10 and 12 g/dl in the treatment group, compared with 208 of 336 (61.9%) in the control group; 42 (11.8%) hemoglobin concentrations were hemoglobin concentrations were >12 g/dl in the treatment group compared with 46 (13.4%) in the control group. The median ESA dosage per patient was 2000 IU/wk in both groups. Five participants received 6 transfusions (21 U) in the treatment group, compared with 8 participants and 13 transfusions (31 U) in the control group. These results suggest that individualized ESA dosing decreases total hemoglobin variability compared with a population protocol-based approach. As hemoglobin levels are declining in hemodialysis patients, decreasing hemoglobin variability may help reduce the risk of transfusions in this population.

  19. ENLIST 1: An International Multi-centre Cross-sectional Study of the Clinical Features of Erythema Nodosum Leprosum.

    Directory of Open Access Journals (Sweden)

    Stephen L Walker

    Full Text Available Erythema nodosum leprosum (ENL is a severe multisystem immune mediated complication of borderline lepromatous leprosy and lepromatous leprosy. ENL is associated with skin lesions, neuritis, arthritis, dactylitis, eye inflammation, osteitis, orchitis, lymphadenitis and nephritis. The treatment of ENL requires immunosuppression, which is often required for prolonged periods of time and may lead to serious adverse effects. ENL and its treatment is associated with increased mortality and economic hardship. Improved, evidence-based treatments for ENL are needed; however, defining the severity of ENL and outcome measures for treatment studies is difficult because of the multiple organ systems involved. A cross-sectional study was performed, by the members of the Erythema Nodosum Leprosum International STudy (ENLIST Group, of patients with ENL attending seven leprosy referral centres in Brazil, Ethiopia, India, Nepal, the Philippines and the United Kingdom. We systematically documented the clinical features and type of ENL, its severity and the drugs used to treat it. Patients with chronic ENL were more likely to be assessed as having severe ENL. Pain, the most frequent symptom, assessed using a semi-quantitative scale was significantly worse in individuals with "severe" ENL. Our findings will determine the items to be included in a severity scale of ENL which we are developing and validating. The study also provides data on the clinical features of ENL, which can be incorporated into a definition of ENL and used for outcome measures in treatment studies.

  20. Multimodal movement prediction - towards an individual assistance of patients.

    Directory of Open Access Journals (Sweden)

    Elsa Andrea Kirchner

    Full Text Available Assistive devices, like exoskeletons or orthoses, often make use of physiological data that allow the detection or prediction of movement onset. Movement onset can be detected at the executing site, the skeletal muscles, as by means of electromyography. Movement intention can be detected by the analysis of brain activity, recorded by, e.g., electroencephalography, or in the behavior of the subject by, e.g., eye movement analysis. These different approaches can be used depending on the kind of neuromuscular disorder, state of therapy or assistive device. In this work we conducted experiments with healthy subjects while performing self-initiated and self-paced arm movements. While other studies showed that multimodal signal analysis can improve the performance of predictions, we show that a sensible combination of electroencephalographic and electromyographic data can potentially improve the adaptability of assistive technical devices with respect to the individual demands of, e.g., early and late stages in rehabilitation therapy. In earlier stages for patients with weak muscle or motor related brain activity it is important to achieve high positive detection rates to support self-initiated movements. To detect most movement intentions from electroencephalographic or electromyographic data motivates a patient and can enhance her/his progress in rehabilitation. In a later stage for patients with stronger muscle or brain activity, reliable movement prediction is more important to encourage patients to behave more accurately and to invest more effort in the task. Further, the false detection rate needs to be reduced. We propose that both types of physiological data can be used in an and combination, where both signals must be detected to drive a movement. By this approach the behavior of the patient during later therapy can be controlled better and false positive detections, which can be very annoying for patients who are further advanced in

  1. Rofecoxib for dysmenorrhoea: meta-analysis using individual patient data

    Directory of Open Access Journals (Sweden)

    McQuay Henry J

    2004-07-01

    Full Text Available Abstract Background Individual patient meta-analysis to determine the analgesic efficacy and adverse effects of single-dose rofecoxib in primary dysmenorrhoea. Methods Individual patient information was available from three randomised, double blind, placebo and active controlled trials of rofecoxib. Data were combined through meta-analysis. Number-needed-to-treat (NNT for at least 50% pain relief and the proportion of patients who had taken rescue medication over 12 hours were calculated. Information was collected on adverse effects. Results For single-dose rofecoxib 50 mg compared with placebo, the NNTs (with 95% CI for at least 50% pain relief were 3.2 (2.4 to 4.5 at six, 3.1 (2.4 to 9.0 at eight, and 3.7 (2.8 to 5.6 at 12 hours. For naproxen sodium 550 mg they were 3.1 (2.4 to 4.4 at six, 3.0 (2.3 to 4.2 at eight, and 3.8 (2.7 to 6.1 at 12 hours. The proportion of patients who needed rescue medication within 12 hours was 27% with rofecoxib 50 mg, 29% with naproxen sodium 550 mg, and 50% with placebo. In the single-dose trial, the proportion of patients reporting any adverse effect was 8% (4/49 with rofecoxib 50 mg, 12% (6/49 with ibuprofen 400 mg, and 6% (3/49 with placebo. In the other two multiple dose trials, the proportion of patients reporting any adverse effect was 23% (42/179 with rofecoxib 50 mg, 24% (45/181 with naproxen sodium 550 mg, and 18% (33/178 with placebo. Conclusions Single dose rofecoxib 50 mg provided similar pain relief to naproxen sodium 550 mg over 12 hours. The duration of analgesia with rofecoxib 50 mg was similar to that of naproxen sodium 550 mg. Adverse effects were uncommon suggesting safety in short-term use of rofecoxib and naproxen sodium. Future research should include restriction on daily life and absence from work or school as outcomes.

  2. Individual and dyadic coping in chronic pain patients

    Directory of Open Access Journals (Sweden)

    Burri A

    2017-03-01

    Full Text Available Andrea Burri,1–3 Michèle Blank Gebre,4 Guy Bodenmann1 1Department of Psychology, University of Zurich, Zurich, Switzerland; 2Health and Rehabilitation Research Institute, Auckland University of Technology, 3Waitemata Pain Service, Department of Anaesthesia and Perioperative Medicine, North Shore Hospital, Auckland, New Zealand; 4Private Practice, Zurich, Switzerland Abstract: The purpose of the current cross-sectional study was to test the associations between individual coping responses to pain, dyadic coping, and perceived social support, with a number of pain outcomes, including pain intensity, functional disability, and pain adjustment, in a sample of N = 43 patients suffering from chronic pain in Switzerland. In contrast to previous research, we were interested not only in specific pain coping but also in more general stress coping strategies and their potential influence on pain outcomes. Analyses were performed using correlation and regression analyses. “Praying and hoping” turned out to be an independent predictor of higher pain intensity and higher anxiety levels, whereas both “coping self-instructions” and “diverting attention” were associated with higher well-being, less feelings of helplessness, and less depression and anxiety. We further found a link between “focusing on and venting emotions” and “worse pain adjustment”. No significant relationship between dyadic coping and social support with any of our pain outcomes could be observed. Overall, our results indicate that individual coping strategies outweigh the effects of social support and dyadic coping on pain-related outcomes and pain adjustment. However, results need to be interpreted with caution given the small sample size. Keywords: individual coping, dyadic coping, social support, chronic pain

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

    Directory of Open Access Journals (Sweden)

    Roeyers Herbert

    2011-04-01

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

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

    LENUS (Irish Health Repository)

    Muller, Ueli C

    2011-04-07

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

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

    DEFF Research Database (Denmark)

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

    2017-01-01

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

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

    DEFF Research Database (Denmark)

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

    2008-01-01

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

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

    Science.gov (United States)

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

    2011-12-01

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

  8. Individual dosimetry of workers and patients: implementation and perspectives

    International Nuclear Information System (INIS)

    Rannou, A.; Aubert, B.; Lahaye, Th.; Scaff, P.; Casanova, Ph.; Van Bladel, L.; Queinnec, F.; Valendru, N.; Jehanno, J.; Grude, E.; Berard, Ph.; Desbree, A.; Kafrouni, H.; Paquet, F.; Vanhavere, F.; Bridier, A.; Ginestet, Ch.; Magne, S.; Donadille, L.; Bordy, J.M.; Bottollier-Depois, J.F.; Barrere, J.L.; Ferragut, A.; Metivier, H.; Gaillard-Lecanu, E.

    2008-01-01

    These days organised by the section of the technical protection of the S.F.R.P. review the different techniques of dosimetry used in France and Europe, and present the future orientations.The different interventions are as follow: Individual exposures of the workers: historic assessment and perspectives; medical exposure: where are the doses; legal obligations in individual dosimetry: which are the objective and the need on the subject; the dosimetry follow-up of workers by the S.I.S.E.R.I. system: assessment and perspectives; impact of the norm ISO 20553 on the follow-up of internal exposure; the implementation of the patient dose measurement in Belgium; techniques of passive dosimetry used in Europe; Supervision radiation protection at EDF: long term and short term approach; Comparison active and passive dosimetry at Melox; methodology for the choice of new neutron dosemeters; the working group M.E.D.O.R.: guide of internal dosimetry for the use of practitioners; O.E.D.I.P.E.: tool of modeling for the personalized internal dosimetry; the use of the Monte-Carlo method for the planning of the cancer treatment by radiotherapy becomes a reality; the works of the committee 2 of the ICRP; passive dosimetry versus operational dosimetry: situation in Europe; Implementation of the in vivo dosimetry in a radiotherapy department: experience of the Gustave Roussy institute; experience feedback on the in vivo measures in radiotherapy, based on the use of O.S.L. pellets; multi points O.S.L. instrumentation for the radiation dose monitoring in radiotherapy; dosimetry for extremities for medical applications: principle results of the European contract C.O.N.R.A.D.; references and perspectives in dosimetry; what perspectives for numerical dosimetry, an example: Sievert; system of dose management: how to answer to needs; the last technical evolutions in terms of electronic dosimetry in nuclear power plant; the fourth generation type reactors: what dosimetry. (N.C.)

  9. Pregabalin in fibromyalgia - responder analysis from individual patient data

    Directory of Open Access Journals (Sweden)

    Paine Jocelyn

    2010-07-01

    Full Text Available Abstract Background Population mean changes are difficult to use in clinical practice. Responder analysis may be better, but needs validating for level of response and treatment duration. A consensus group has defined what constitutes minimal, moderate, and substantial benefit based on pain intensity and Patient Global Impression of Change scores. Methods We obtained individual patient data from four randomised double blind trials of pregabalin in fibromyalgia lasting eight to 14 weeks. We calculated response for all efficacy outcomes using any improvement (≥ 0%, minimal improvement (≥ 15%, moderate improvement (≥ 30%, substantial improvement (≥ 50%, and extensive improvement (≥ 70%, with numbers needed to treat (NNT for pregabalin 300 mg, 450 mg, and 600 mg daily compared with placebo. Results Information from 2,757 patients was available. Pain intensity and sleep interference showed reductions with increasing level of response, a significant difference between pregabalin and placebo, and a trend towards lower (better NNTs at higher doses. Maximum response rates occurred at 4-6 weeks for higher levels of response, and were constant thereafter. NNTs (with 95% confidence intervals for ≥ 50% improvement in pain intensity compared with placebo after 12 weeks were 22 (11 to 870 for pregabalin 300 mg, 16 (9.3 to 59 for pregabalin 450 mg, and 13 (8.1 to 31 for pregabalin 600 mg daily. NNTs for ≥ 50% improvement in sleep interference compared with placebo after 12 weeks were 13 (8.2 to 30 for pregabalin 300 mg, 8.4 (6.0 to 14 for pregabalin 450 mg, and 8.4 (6.1 to 14 for pregabalin 600 mg. Other outcomes had fewer respondents at higher response levels, but generally did not discriminate between pregabalin and placebo, or show any dose response. Shorter duration and use of 'any improvement' over-estimated treatment effect compared with longer duration and higher levels of response. Conclusions Responder analysis is useful in fibromyalgia

  10. The contribution of classical risk factors to cardiovascular disease in familial hypercholesterolaemia: data in 2400 patients

    NARCIS (Netherlands)

    Jansen, A. C. M.; van Aalst-Cohen, E. S.; Tanck, M. W.; Trip, M. D.; Lansberg, P. J.; Liem, A. H.; van Lennep, H. W. O. Roeters; Sijbrands, E. J. G.; Kastelein, J. J. P.

    2004-01-01

    Objective. To determine the contribution of classical risk factors to the development of cardiovascular disease (CVD) in patients with heterozygous familial hypercholesterolaemia (FH). Design. A retrospective, multi-centre, cohort study. Extensive data were collected by scrutinizing medical records

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

    Science.gov (United States)

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

    2011-05-01

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

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

    Science.gov (United States)

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

    2006-12-01

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

  13. Early supported discharge services for stroke patients: a meta-analysis of individual patients' data.

    Science.gov (United States)

    Langhorne, Peter; Taylor, Gillian; Murray, Gordon; Dennis, Martin; Anderson, Craig; Bautz-Holter, Erik; Dey, Paola; Indredavik, Bent; Mayo, Nancy; Power, Michael; Rodgers, Helen; Ronning, Ole Morten; Rudd, Anthony; Suwanwela, Nijasri; Widen-Holmqvist, Lotta; Wolfe, Charles

    Stroke patients conventionally undergo a substantial part of their rehabilitation in hospital. Services have been developed that offer patients early discharge from hospital with rehabilitation at home (early supported discharge [ESD]). We have assessed the effects and costs of such services. We did a meta-analysis of data from individual patients who took part in randomised trials that recruited patients with stroke in hospital to receive either conventional care or any ESD service intervention that provided rehabilitation and support in a community setting with the aim of shortening the duration of hospital care. The primary outcome was death or dependency at the end of scheduled follow-up. Outcome data were available for 11 trials (1597 patients). ESD services were mostly provided by specialist multidisciplinary teams to a selected group (median 41%) of stroke patients admitted to hospital. There was a reduced risk of death or dependency equivalent to six (95% CI one to ten) fewer adverse outcomes for every 100 patients receiving an ESD service (p=0.02). The hospital stay was 8 days shorter for patients assigned ESD services than for those assigned conventional care (pstroke patients with mild to moderate disability. Appropriately resourced ESD services provided for a selected group of stroke patients can reduce long-term dependency and admission to institutional care as well as shortening hospital stays.

  14. A multi-centre retrospective study of rituximab use in the treatment of relapsed or resistant warm autoimmune haemolytic anaemia.

    LENUS (Irish Health Repository)

    Maung, Su W

    2013-10-01

    This retrospective analysis assessed the response, safety and duration of response to standard dose rituximab 375 mg\\/m(2) weekly for four weeks as therapy for patients with primary or secondary warm autoimmune haemolytic anaemia (WAIHA), who had failed initial treatment. Thirty-four patients received rituximab for WAIHA in seven centres in the Republic of Ireland. The overall response rate was 70·6% (24\\/34) with 26·5% (9\\/34) achieving a complete response (CR). The time to response was 1 month post-initiation of rituximab in 87·5% (21\\/24) and 3 months in 12·5% (3\\/24) of patients. The median duration of follow-up was 36 months (range 6-90 months). Of the patients who responded, 50% (12\\/24) relapsed during follow up with a median time to next treatment of 16·5 months (range 6-60 months). Three patients were re-treated with rituximab 375 mg\\/m2 weekly for four weeks at relapse and responded. There was a single episode of neutropenic sepsis. Rituximab is an effective and safe treatment for WAIHA but a significant number of patients will relapse in the first two years post treatment. Re-treatment was effective in a small number of patients, suggesting that intermittent pulse treatment or maintenance treatment may improve long-term response.

  15. Management of thyroid eye disease in the United Kingdom: A multi-centre thyroid eye disease audit.

    Science.gov (United States)

    Mellington, F E; Dayan, C M; Dickinson, A J; Hickey, J L; MacEwen, C J; McLaren, J; Perros, P; Rose, G E; Uddin, J; Vaidya, B; Foley, P; Lazarus, J H; Mitchell, A; Ezra, D G

    2017-06-01

    This article aims to provide baseline data and highlight any major deficiencies in the current level of care provided for adult patients with thyroid eye disease (TED). We undertook a prospective, nonrandomized cross-sectional multicenter observational study. During a 3-month period June-August 2014, consecutive adult patients with TED who presented to nominated specialist eye clinics in the United Kingdom, completed a standardized questionnaire. Main outcome measures were: demographics, time from diagnosis to referral to tertiary centre, time from referral to review in specialist eye clinic, management of thyroid dysfunction, radioiodine and provision of steroid prophylaxis, smoking, and TED classification. 91 patients (mean age 47.88 years) were included. Female-to-male ratio was 6:1. Mean time since first symptoms of TED = 27.92 (73.71) months; from first visit to any doctor with symptoms to diagnosis = 9.37 (26.03) months; from hyperthyroidism diagnosis to euthyroidism 12.45 (16.81) months. First, 13% had received radioiodine. All those with active TED received prophylactic steroids. Seven patients who received radioiodine and did not have TED at the time went on to develop it. Then, 60% patients were current or ex-smokers. 63% current smokers had been offered smoking cessation advice. 65% patients had active TED; 4% had sight-threatening TED. A large proportion of patients (54%) were unaware of their thyroid status. Not enough patients are being provided with smoking cessation advice and information on the impact of smoking on TED and control of thyroid function.

  16. Multi-centre experience of implementing image-guided intensity-modulated radiotherapy using the TomoTherapy platform

    International Nuclear Information System (INIS)

    Dean, J.C.; Tudor, G.S.J.; Mott, J.H.; Dunlop, P.R.; Morris, S.L.; Harron, E.C.; Christian, J.A.; Sanghera, P.; Elsworthy, M.; Burnet, N.G.

    2013-01-01

    Use of image guided (IG) intensity modulated radiotherapy (IMRT) is increasing, and helical tomotherapy provides an effective, integrated solution. Practical experience of implementation, shared at a recent UK TomoTherapy Users' meeting, may help centres introducing these techniques using TomoTherapy or other platforms. Seven centres participated, with data shared from 6, varying from 2500 - 4800 new patients per year. Case selection of patients “most likely” to benefit from IG-IMRT was managed in all centres by multi-professional groups comprising clinical oncologists, physicists, treatment planners and radiographers. Radical treatments ranged from 94% to 100%. The proportions of tumour types varied substantially: head and neck: range 0%–100% (mean of centres 50%), prostate: 3%–96% (mean of centres 28%). Head and neck cases were considered most likely to benefit from IMRT, prostate cases from IGRT, or IG-IMRT if pelvic nodes were being treated. IMRT was also selected for complex target volumes, to avoid field junctions, for technical treatment difficulties, and retreatments. Across the centres, every patient was imaged every day, with positional correction before treatment. In one centre, for prostate patients including pelvic treatment, the pelvis was also imaged weekly. All centres had designed a ‘ramp up’ of patient numbers, which was similar in 5. One centre, treating 96% prostate patients, started with 3 and increased to 36 patients per day within 3 months. The variation in case mix implies wide applicability of IG-IMRT. Daily on-line IGRT with IMRT can be routinely implemented into busy departments

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

    Science.gov (United States)

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

    2018-05-01

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

  18. 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

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

    Directory of Open Access Journals (Sweden)

    Roeyers Herbert

    2011-04-01

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

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

    LENUS (Irish Health Repository)

    Muller, Ueli C

    2011-04-07

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

  1. 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.

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

    Directory of Open Access Journals (Sweden)

    Grotenhuis J André

    2007-11-01

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

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

    Science.gov (United States)

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

    2017-07-01

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

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

    NARCIS (Netherlands)

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

    2016-01-01

    textabstractBackground: Awareness of preferences regarding medical care should be a central component of the care of patients with advanced cancer. Open communication can facilitate this but can occur in an ad hoc or variable manner. Advance care planning (ACP) is a formalized process of

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

    NARCIS (Netherlands)

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

    2016-01-01

    Background: Awareness of preferences regarding medical care should be a central component of the care of patients with advanced cancer. Open communication can facilitate this but can occur in an ad hoc or variable manner. Advance care planning (ACP) is a formalized process of communication between

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

    International Nuclear Information System (INIS)

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

    2016-01-01

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

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

    International Nuclear Information System (INIS)

    Bouferguene, Ahmed; Safouhi, Hassan

    2006-01-01

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

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

    Science.gov (United States)

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

    2017-09-01

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

  10. Individual health discount rate in patients with ulcerative colitis.

    Science.gov (United States)

    Waljee, Akbar K; Morris, Arden M; Waljee, Jennifer F; Higgins, Peter D R

    2011-06-01

    In cost-effectiveness analysis, discount rates are used in calculating the value of future costs and benefits. However, standard discount rates may not accurately describe the decision-making of patients with ulcerative colitis (UC). These patients often choose the long-term risks of immunosuppressive therapy over the short-term risks of colectomy, demonstrating very high discount rates for future health. In this study we aimed to measure the discount rate in UC patients and identify variables associated with the discount rate. We surveyed patients with UC and patients who were postcolectomy for UC to measure their valuations of UC and colectomy health states. We used Standard Gamble (SG) and Time-Trade-Off (TTO) methods to assess current and future health state valuations and calculated the discount rate. Participants included 150 subjects with UC and 150 subjects who were postcolectomy for UC. Adjusted discount rates varied widely (0%-100%), with an overall median rate of 55.0% (interquartile range [IQR] 20.6-100), which was significantly higher than the standard rate of 5%. Within the normal range of discount rates, patients' expected discount rate increased by 0.80% for each additional year of age, and female patients had discount rates that averaged ≈ 8% less than their age-matched counterparts and approached statistical significance. The accepted discount rate of 5% grossly underestimates UC patients' preference for long-term over short-term risk. This might explain UC patients' frequent choice of the long-term risks of immunosuppressive medical therapy over the short-term risks of colectomy. Copyright © 2010 Crohn's & Colitis Foundation of America, Inc.

  11. Individualized music played for agitated patients with dementia: analysis of video-recorded sessions.

    Science.gov (United States)

    Ragneskog, H; Asplund, K; Kihlgren, M; Norberg, A

    2001-06-01

    Many nursing home patients with dementia suffer from symptoms of agitation (e.g. anxiety, shouting, irritability). This study investigated whether individualized music could be used as a nursing intervention to reduce such symptoms in four patients with severe dementia. The patients were video-recorded during four sessions in four periods, including a control period without music, two periods where individualized music was played, and one period where classical music was played. The recordings were analysed by systematic observations and the Facial Action Coding System. Two patients became calmer during some of the individualized music sessions; one patient remained sitting in her armchair longer, and the other patient stopped shouting. For the two patients who were most affected by dementia, the noticeable effect of music was minimal. If the nursing staff succeed in discovering the music preferences of an individual, individualized music may be an effective nursing intervention to mitigate anxiety and agitation for some patients.

  12. Individualized Plastic Reconstruction Strategy for Patients With Ectodermal Dysplasia Syndrome.

    Science.gov (United States)

    Hou, Yikang; Jin, Yunbo; Lin, Xiaoxi; Chai, Gang; Zhang, Yan; Qi, Zuoliang

    2017-06-01

    Ectodermal dysplasia syndrome is a hereditary disease of ectodermal origin. Appearances of nail dystrophy, alopecia or hypotrichosis, saddle nose deformity, and palmoplantar hyperkeratosis are usually associated with a lack of sweat glands as well as partial or complete absence of teeth. These manifestations are usually corrected only with oral rehabilitation by mounting dentures. In this study, plastic rehabilitation was developed to correct the special features of patients with ectodermal dysplasia. Four men and 1 woman with ectodermal dysplasia syndrome were treated. Four patients showed dysostosis of the midface, and rhinoplasty with costal bone was performed, whereas cosmetic operation aiming to repair soft tissue defects was adopted for the last patient. After plastic corrections, all 5 patients were satisfied with the results and had no social embarrassment.

  13. Center for Behavioral Research: Individual Interventions for Breast Cancer Patients

    National Research Council Canada - National Science Library

    Baum, Andrew

    2002-01-01

    ... and defense systems, appear to be key determinants of participation in early detection and prevention programs, effective use of chemoprevention agents, and in patient adjustment, caregiving, and quality of life...

  14. 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

  15. Personalized vascular medicine: tailoring cardiovascular disease management to the individual patient

    OpenAIRE

    Dorresteijn, J.A.N.

    2013-01-01

    Applying group-level findings to individual patients is an absolute requisite for practicing evidence-based cardiovascular medicine. Yet, because individual patient characteristics may influence the pathophysiology and prognosis of disease and the likelihood of response to therapy, such generalization is often problematic. The difficulties that are related to generalization of group level evidence to individual patients are often not well appreciated and simple pragmatic approaches are usuall...

  16. 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

  17. Stroke liaison workers for stroke patients and carers: an individual patient data meta-analysis.

    Science.gov (United States)

    Ellis, Graham; Mant, Jonathan; Langhorne, Peter; Dennis, Martin; Winner, Simon

    2010-05-12

    Many patients experience depression, social isolation and anxiety post stroke. These are associated with a poorer outcome. Ameliorating these problems may improve patient wellbeing. To evaluate the impact of a healthcare worker or volunteer whose multi-dimensional roles have been grouped under the title 'stroke liaison worker'. We searched the Cochrane Stroke Group Trials Register (searched February 2009), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library Issue 1, 2009), MEDLINE (1966 to 2009), EMBASE (1980 to 2009) and four other databases. We performed a cited reference search, searched conference proceedings and trials registers, checked reference lists and contacted authors and trial investigators. Randomised controlled trials investigating the impact of a stroke liaison worker versus usual care. We invited trialists to participate in a review of individual patient data. Primary outcomes for patients were subjective health status and extended activities of daily living. Primary outcomes for carers were subjective health status including measures of carer strain. We included 16 trials involving 4759 participants. Analysis did not show a significant overall difference for subjective health status (standardised mean difference (SMD) -0.03, 95% confidence interval (CI) -0.11 to 0.04, P = 0.34) or extended activities of daily living (SMD 0.04, 95% CI -0.03 to 0.11, P = 0.22). There was no overall significant effect for the outcome of carer subjective health status (SMD 0.04, 95% CI -0.05 to 0.14, P = 0.37). Patients with mild to moderate disability (Barthel 15 to 19) had a significant reduction in dependence (odds ratio (OR) 0.62, 95% CI 0.44 to 0.87, P = 0.006). This would equate to 10 fewer dependent patients (95% CI 17 fewer to 4 fewer) for every 100 patients seen by the stroke liaison worker. Similar results were seen for the outcome of death or dependence for the subgroup with Barthel 15 to 19 (OR 0.55, 95% CI 0.38 to 0.81, P

  18. Presentations to the Emergency Department Following Cannabis use--a Multi-Centre Case Series from Ten European Countries.

    Science.gov (United States)

    Dines, Alison M; Wood, David M; Galicia, Miguel; Yates, Christopher M; Heyerdahl, Fridtjof; Hovda, Knut Erik; Giraudon, Isabelle; Sedefov, Roumen; Dargan, Paul I

    2015-12-01

    Cannabis is the most commonly used illicit drug in Europe, and is generally regarded as having low acute toxicity. We present the findings of the first 6 months of data collection from the Euro-DEN project on presentations related to cannabis use to further understand the acute toxicity related to the use of cannabis. Data was extracted on clinical features, treatment and outcome from the Euro-DEN minimum dataset for all cases of acute recreational drug toxicity reported 1st October 2013 to 31st March 2014 for all cannabis-related presentations. Of 2198 presentations reported by 14 of the 16 Euro-DEN centres, 356 (16.2 %) involved cannabis either alone or together with other drugs/alcohol. There were 36 that involved lone use of cannabis (1.6 % of all presentations). Of the 35 non-fatal lone cannabis presentations, the most commonly reported features were neuro-behavioural (agitation/aggression 8 (22.9 %), psychosis 7 (20.0 %), anxiety 7 (20.0 %)) and vomiting 6 (17.1 %). Most patients (25, 71.4 %) received no treatment and 30 (85.7 %) were discharged/self-discharged from the ED. There was one fatality amongst these lone-cannabis cases: an 18-year-old male collapsed with an asystolic cardiac arrest whilst smoking cannabis and suffered hypoxic brain injury related to prolonged cardiac arrest. THC was detected in a urine sample taken at ED arrival; no other drugs were detected. Lone acute cannabis toxicity was typically associated with neuro-behavioural symptoms and vomiting. Although uncommon, severe toxicity including cardiovascular toxicity and death may be under-recognised, and it is important that Emergency Physicians are aware of this.

  19. The Individual Health Discount Rate in Patients with Ulcerative Colitis

    Science.gov (United States)

    Waljee, Akbar K.; Morris, Arden M.; Waljee, Jennifer F.; Higgins, Peter D.R.

    2015-01-01

    Background In cost-effectiveness analysis, discount rates are used in calculating the value of future costs and benefits. However, standard discount rates may not accurately describe the decision-making of patients with Ulcerative Colitis (UC). These patients often choose the long-term risks of immunosuppressive therapy over the short-term risks of colectomy, demonstrating very high discount rates for future health. In this study, we aimed to measure the discount rate in UC patients and identify variables associated with the discount rate. Methods We surveyed patients with UC and patients who were post-colectomy for UC to measure their valuations of UC and colectomy health states. We used Standard Gamble(SG) and Time-Trade-Off(TTO) methods to assess current and future health state valuations, and calculated the discount rate. Results Participants included 150 subjects with UC and 150 subjects who were post-colectomy for UC. Discount rates varied widely (20.6%–100%) with an overall median rate of 55.0%, which was significantly higher than the standard rate of 5%. Older age and male gender and predicted high discount rates (aversion to immediate risk in favor of distant future risk). For each additional decade of age, patients’ expected discount rate increased by 0.77%. Female gender was the only predictor of very low discount rates. Female patients’ discount rates averaged 8.1% less than age-matched males. Conclusions The accepted discount rate of 5% grossly underestimates UC patients’ preference for long-term over short-term risk. This might explain UC patients’ frequent choice of the long-term risks of immunosuppressive medical therapy over the short-term risks of colectomy. PMID:21560195

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

    Science.gov (United States)

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

    2016-11-24

    half the patients in FT-AN and nearly 60% of those in MFT-AN had started menstruating. This study confirms previous research findings demonstrating the effectiveness of eating disorder focused family therapy and highlights the additional benefits of bringing together groups of families that maximises the use of family resources and mutual support leading to improved outcomes. Current Controlled Trials ISRCTN11275465 ; Registered 29 January 2007 (retrospectively registered).

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

    NARCIS (Netherlands)

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

    2011-01-01

    Background: Drop-out is an important problem in the treatment of substance use disorder. The focus of this study was to investigate the effectiveness of within treatment assessment with feedback directly to patients with multiple substance use disorder on outpatient individual treatment adherence.

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

    NARCIS (Netherlands)

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

    2011-01-01

    BACKGROUND: Drop-out is an important problem in the treatment of substance use disorder. The focus of this study was to investigate the effectiveness of within treatment assessment with feedback directly to patients with multiple substance use disorder on outpatient individual treatment adherence.

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

    International Nuclear Information System (INIS)

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

    2007-01-01

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

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

    International Nuclear Information System (INIS)

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

    2016-01-01

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

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

    Science.gov (United States)

    Biringer, Eva; Tjoflåt, Marit

    2018-01-25

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

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

    Directory of Open Access Journals (Sweden)

    Borud Einar K

    2007-02-01

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

  7. Individual neuropsychological support and group sessions for relatives to TBI patients

    DEFF Research Database (Denmark)

    Siert, Lars

    TITLE: Individual neuropsychological support and group sessions for relatives to TBI patients. OBJECTIVE: To describe how the neuropsychologist work with early and ongoing individual support and group sessions for relatives to adult TBI patients in the acute and sub acute phase and after discharge...

  8. The tryptophan hydroxylase 1 (TPH1) gene, schizophrenia susceptibility, and suicidal behavior: a multi-centre case-control study and meta-analysis

    DEFF Research Database (Denmark)

    Saetre, Peter; Lundmark, Per; Wang, August

    2010-01-01

    Serotonin (5-hydroxytryptamin; 5-HT) alternations has since long been suspected in the pathophysiology of schizophrenia. Tryptophan hydroxylase (tryptophan 5-monooxygenase; TPH) is the rate-limiting enzyme in the biosynthesis of 5-HT, and sequence variation in intron 6 of the TPH1 gene has been...... associated with schizophrenia. The minor allele (A) of this polymorphism (A218C) is also more frequent in patients who have attempted suicide and individuals who died by suicide, than in healthy control individuals. In an attempt to replicate previous findings, five single nucleotide polymorphisms (SNPs......) were genotyped in 837 Scandinavian schizophrenia patients and 1,473 controls. Three SNPs spanning intron 6 and 7, including the A218C and A779C polymorphisms, were associated with schizophrenia susceptibility (P = 0.019). However there were no differences in allele frequencies of these loci between...

  9. Individualized robot-assisted training for MS- and stroke patients in I-TRAVLE

    OpenAIRE

    Notelaers, Sofie; De Weyer, Tom; Octavia, Johanna; Coninx, Karin; Bastiaens, Hanne; Feys, Peter

    2011-01-01

    Persons with central nervous deficits, such as MS and stroke patients, can benefit a lot from suitable training approaches that enhance their ability to perform activities in daily life. Personalized training, in accordance with the individual capabilities of the patient is a key issue in this context. We propose several techniques for individualization, including adaptive training games. Evaluations with patients and therapists reveal appreciation for the resulting ...

  10. Prediction models and development of an easy to use open-access tool for measuring lung function of individuals with motor complete spinal cord injury

    NARCIS (Netherlands)

    Mueller, Gabi; de Groot, Sonja; van der Woude, Lucas H.; Perret, Claudio; Michel, Franz; Hopman, Maria T. E.

    Objective: To develop statistical models to predict lung function and respiratory muscle strength from personal and lesion characteristics of individuals with motor complete spinal cord injury. Design: Cross-sectional, multi-centre cohort study. Subjects: A total of 440 individuals with traumatic,

  11. Individualized robot-assisted training for MS- and stroke patients in I-TRAVLE

    Directory of Open Access Journals (Sweden)

    Bastiaens Hanne

    2011-12-01

    Full Text Available Persons with central nervous deficits, such as MS and stroke patients, can benefit a lot from suitable training approaches that enhance their ability to perform activities in daily life. Personalized training, in accordance with the individual capabilities of the patient is a key issue in this context. We propose several techniques for individualization, including adaptive training games. Evaluations with patients and therapists reveal appreciation for the resulting Individualized, Technology-supported and RobotAssisted Virtual Learning Environments (I-TRAVLE system.

  12. The tryptophan hydroxylase 1 (TPH1) gene, schizophrenia susceptibility, and suicidal behavior: a multi-centre case-control study and meta-analysis

    DEFF Research Database (Denmark)

    Saetre, Peter; Lundmark, Per; Wang, August

    2010-01-01

    Serotonin (5-hydroxytryptamin; 5-HT) alternations has since long been suspected in the pathophysiology of schizophrenia. Tryptophan hydroxylase (tryptophan 5-monooxygenase; TPH) is the rate-limiting enzyme in the biosynthesis of 5-HT, and sequence variation in intron 6 of the TPH1 gene has been...... affected individuals having attempted suicide at least once and patients with no history of suicide attempts (P = 0.84). A systematic literature review and meta-analysis support the A218C polymorphism as a susceptibility locus for schizophrenia (odds ratio 1.17, 95% confidence interval 1.......07-1.29). Association studies on suicide attempts are however conflicting (heterogeneity index I(2) = 0.54) and do not support the A218C/A779C polymorphisms being a susceptibility locus for suicidal behavior among individuals diagnosed with a psychiatric disorder (OR = 0.96 [0.80-1.16]). We conclude that the TPH1 A218...

  13. Analysis of the individual radio sensitivity of breast cancer patients; Untersuchungen zur individuellen Strahlenempfindlichkeit von Brustkrebspatientinnen

    Energy Technology Data Exchange (ETDEWEB)

    Auer, Judith

    2013-04-04

    Individual radiosensitivity has a crucial impact on radiotherapy related side effects. A prediction of individual radiosensitivity could avoid these side effects. Our aim was to study a breast cancer collective for its variation of individual radiosensitivity. Peripheral blood samples were obtained from 129 individuals. 67 breast cancer patients and 62 healthy and age matched individuals were looked at and their individual radiosensitivity was estimated by a 3-color Fluorescence in situ hybridization approach. Blood samples were obtained (i) before starting adjuvant radiotherapy and were in vitro irradiated by 2 Gy; (ii) after 5 single doses of 1.8 Gy and after 72 h had elapsed. DNA of lymphocytes was probed with whole chromosome painting for chromosomes 1, 2 and 4. The rate of breaks per metaphase was analyzed and used as a predictor of individual radiosensitivity. Breast cancer patients were distinctly more radio-sensitive compared to healthy controls. Additionally the distribution of the cancer patients' radiosensitivity was broader. A subgroup of 9 rather radio-sensitive and 9 rather radio-resistant patients was identified. A subgroup of patients aged between 40 and 50 was distinctly more radio-sensitive than younger or older patients. The in vivo irradiation approach was not applicable to detect individual radiosensitivity. In the breast cancer collective a distinctly resistant and sensitive subgroup is identified, which could be subject for treatment adjustment. Especially in the range of age 40 to 50 patients have an increased radiosensitivity. An in vivo irradiation in a breast cancer collective is not suitable to estimate individual radiosensitivity due to a low deposed dose.

  14. 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

  15. A study protocol of the effectiveness of PEGASUS: a multi-centred study comparing an intervention to promote shared decision making about breast reconstruction with treatment as usual.

    Science.gov (United States)

    Harcourt, Diana; Paraskeva, Nicole; White, Paul; Powell, Jane; Clarke, Alex

    2017-10-02

    Increasingly, women elect breast reconstruction after mastectomy. However, their expectations of surgery are often not met, and dissatisfaction with outcome and ongoing psychosocial concerns and distress are common. We developed a patient-centered intervention, PEGASUS:(Patients' Expectations and Goals: Assisting Shared Understanding of Surgery) which supports shared decision making by helping women clarify their own, individual goals about reconstruction so that they can discuss these with their surgeon. Our acceptability/feasibility work has shown it is well received by patients and health professionals alike. We now need to establish whether PEGASUS improves patients' experiences of breast reconstruction decision making and outcomes. The purpose of this study is, therefore, to examine the effectiveness of PEGASUS, an intervention designed to support shared decision making about breast reconstruction. A multi-centered sequential study will compare the impact of PEGASUS with usual care, in terms of patient reported outcomes (self-reported satisfaction with the outcome of surgery, involvement in decision making and in the consultation) and health economics. Initially we will collect data from our comparison (usual care) group (90 women) who will complete standardized measures (Breast-Q, EQ5D -5 L and ICECAP- A) at the time of decision making, 3, 6 and 12 months after surgery. Health professionals will then be trained to use PEGASUS, which will be delivered to the intervention group (another 90 women completing the same measures at the time of decision making, and 3, 6 and 12 months after surgery). Health professionals and a purposefully selected sample of participants will be interviewed about whether their expectations of reconstruction were met, and their experiences of PEGASUS (if appropriate). PEGASUS may have the potential to provide health professionals with an easily accessible tool aiming to support shared decision making and improve patients

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

    DEFF Research Database (Denmark)

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

    2016-01-01

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

  17. Adaptation of Individual Meaning-Centered Psychotherapy for Chinese Immigrant Cancer Patients | Division of Cancer Prevention

    Science.gov (United States)

    The purpose of the study is to modify a type of counseling called "Individual Meaning Centered Psychotherapy" to meet the needs of Chinese cancer patients. Many cancer patients use counseling or other resources to help cope with the emotional burden of their illnesses. Counseling often helps them cope with cancer by giving them a place to express their feelings.

  18. Complex and unstable simple elbow dislocations: a review and quantitative analysis of individual patient data

    NARCIS (Netherlands)

    de Haan, Jeroen; Schep, Niels; Tuinebreijer, Wim; den Hartog, Dennis

    2010-01-01

    The primary objective of this review of the literature with quantitative analysis of individual patient data was to identify the results of available treatments for complex elbow dislocations and unstable simple elbow dislocations. The secondary objective was to compare the results of patients with

  19. Level of Perception of Individualized Care and Satisfaction With Nursing in Orthopaedic Surgery Patients.

    Science.gov (United States)

    Tekin, Fatma; Findik, Ummu Yildiz

    2015-01-01

    Lately, individualized nursing care and patient satisfaction are important and current issues being discussed. But there is not enough information for patients undergoing orthopaedic surgery. The aim of this study was to determine the individualized care perception and satisfaction in nursing care levels in orthopaedic surgery patients. This descriptive cross-sectional study was conducted with 156 patients who underwent orthopaedic surgery. Data were collected using the personal information form, the Individualized Care Scale, and the Newcastle Satisfaction With Nursing Scale. The Spearman correlation analysis and descriptive statistics were performed. The mean individualized care and satisfaction with nursing care scores were found to be close to the preset maximum value, and it was determined that an increase in the level of awareness about nursing interventions and the level of perceived individualized care caused an increase in satisfaction levels regarding nursing care. Nurses should recognize the importance of performing individualized care in order to increase the level of satisfaction with nursing care in orthopaedic surgery patients.

  20. Functional Recovery in Major Depressive Disorder: Providing Early Optimal Treatment for the Individual Patient

    Science.gov (United States)

    Katzman, Martin A; Habert, Jeffrey; McIntosh, Diane; MacQueen, Glenda M; Milev, Roumen V; McIntyre, Roger S; Blier, Pierre

    2018-01-01

    Abstract Major depressive disorder is an often chronic and recurring illness. Left untreated, major depressive disorder may result in progressive alterations in brain morphometry and circuit function. Recent findings, however, suggest that pharmacotherapy may halt and possibly reverse those effects. These findings, together with evidence that a delay in treatment is associated with poorer clinical outcomes, underscore the urgency of rapidly treating depression to full recovery. Early optimized treatment, using measurement-based care and customizing treatment to the individual patient, may afford the best possible outcomes for each patient. The aim of this article is to present recommendations for using a patient-centered approach to rapidly provide optimal pharmacological treatment to patients with major depressive disorder. Offering major depressive disorder treatment determined by individual patient characteristics (e.g., predominant symptoms, medical history, comorbidities), patient preferences and expectations, and, critically, their own definition of wellness provides the best opportunity for full functional recovery. PMID:29024974

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

    Directory of Open Access Journals (Sweden)

    Robert T Woods

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

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

    Science.gov (United States)

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

    2018-02-13

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

  3. Thalamic functional connectivity predicts seizure laterality in individual TLE patients: Application of a biomarker development strategy

    Directory of Open Access Journals (Sweden)

    Daniel S. Barron

    2015-01-01

    No significant differences in functional connection strength in patient and control groups were observed with Mann-Whitney Tests (corrected for multiple comparisons. Notwithstanding the lack of group differences, individual patient difference scores (from control mean connection strength successfully predicted seizure onset zone as shown in ROC curves: discriminant analysis (two-dimensional predicted seizure onset zone with 85% sensitivity and 91% specificity; logistic regression (four-dimensional achieved 86% sensitivity and 100% specificity. The strongest markers in both analyses were left thalamo-hippocampal and right thalamo-entorhinal cortex functional connection strength. Thus, this study shows that thalamic functional connections are sensitive and specific markers of seizure onset laterality in individual temporal lobe epilepsy patients. This study also advances an overall strategy for the programmatic development of neuroimaging biomarkers in clinical and genetic populations: a disease model informed by coordinate-based meta-analysis was used to anatomically constrain individual patient analyses.

  4. 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.

  5. Efficacy of a tool to predict short-term mortality in older people presenting at emergency departments: Protocol for a multi-centre cohort study.

    Science.gov (United States)

    Cardona, Magnolia; Lewis, Ebony T; Turner, Robin M; Alkhouri, Hatem; Asha, Stephen; Mackenzie, John; Perkins, Margaret; Suri, Sam; Holdgate, Anna; Winoto, Luis; Chang, Chan-Wei; Gallego-Luxan, Blanca; McCarthy, Sally; Kristensen, Mette R; O'Sullivan, Michael; Skjøt-Arkil, Helene; Ekmann, Anette A; Nygaard, Hanne H; Jensen, Jonas J; Jensen, Rune O; Pedersen, Jonas L; Breen, Dorothy; Petersen, John A; Jensen, Birgitte N; Mogensen, Christian Backer; Hillman, Ken; Brabrand, Mikkel

    Prognostic uncertainty inhibits clinicians from initiating timely end-of-life discussions and advance care planning. This study evaluates the efficacy of the CriSTAL (Criteria for Screening and Triaging to Appropriate aLternative care) checklist in emergency departments. Prospective cohort study of patients aged ≥65 years with any diagnosis admitted via emergency departments in ten hospitals in Australia, Denmark and Ireland. Electronic and paper clinical records will be used to extract risk factors such as nursing home residency, physiological deterioration warranting a rapid response call, personal history of active chronic disease, history of hospitalisations or intensive care unit admission in the past year, evidence of proteinuria or ECG abnormalities, and evidence of frailty to be concurrently measured with Fried Score and Clinical Frailty Scale. Patients or their informal caregivers will be contacted by telephone around three months after initial assessment to ascertain survival, self-reported health, post-discharge frailty and health service utilisation since discharge. Logistic regression and bootstrapping techniques and AUROC curves will be used to test the predictive accuracy of CriSTAL for death within 90 days of admission and in-hospital death. The CriSTAL checklist is an objective and practical tool for use in emergency departments among older patients to determine individual probability of death in the short-term. Its validation in this cohort is expected to reduce clinicians' prognostic uncertainty on the time to patients' death and encourage timely end-of-life conversations to support clinical decisions with older frail patients and their families about their imminent or future care choices. Copyright © 2018 Elsevier B.V. All rights reserved.

  6. A multi-centre evaluation of eleven clinically feasible brain PET/MRI attenuation correction techniques using a large cohort of patients

    DEFF Research Database (Denmark)

    Ladefoged, Claes Nøhr; Law, Ian; Anazodo, Udunna

    2017-01-01

    in the robustness, outlier analysis, and clinical feasibility. Overall, the best performing methods were MR-ACBOSTON, MR-ACMAXPROB, MR-ACRESOLUTE and MR-ACUCL, ordered alphabetically. These methods all minimized the number of outliers, standard deviation, and average global and local error. The methods MR...... globally and regionally, with a special focus on robustness and outlier analysis.  Results: The average performance in PET tracer uptake was within ±5% of CT for all of the proposed methods, with the average±SD global percentage bias in PET FDG uptake for each method being: MR-ACDIXON (−11.3±3.5)%, MR......-ACMUNICH and MR-ACCAR-RiDR were both within acceptable quantitative limits, so these methods should be considered if processing time is a factor. The method MR-ACSEGBONE also demonstrates promising results, and performs well within the likely acceptable quantitative limits. For clinical routine scans where...

  7. Skin autofluorescence and risk of micro- and macrovascular complications in patients with Type 2 diabetes mellitus-a multi-centre study

    NARCIS (Netherlands)

    Noordzij, M J; Mulder, D.J.; Oomen, P H N; Brouwer, T; Jager, J; Castro Cabezas, M; Lefrandt, J D; Smit, Andries

    2012-01-01

    AIMS: Skin autofluorescence is a non-invasive marker of advanced glycation end product accumulation. In a previous study, skin autofluorescence correlated with and predicted micro- and macrovascular complications in Type 2 diabetes in a primary care setting. The present cross-sectional study aims to

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

    Directory of Open Access Journals (Sweden)

    Broekaert Eric

    2011-05-01

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

  9. Patient Satisfaction in Obstetrics and Gynecology: Individualized Patient-centered Communication

    OpenAIRE

    John Yeh; Eryn E. Nagel

    2010-01-01

    Background Patient satisfaction is becoming an increasingly prevalent topic in medicine, but little is known about patient satisfaction in women's health and other specialties. We review current methods of improving patient satisfaction in the field of obstetrics and gynecology with the intent to increase patient satisfaction even further by enhancing and combining previously used strategies. Methods A search from inception to June 2010 for electronic literature was performed using Medline. T...

  10. Comparison of Serum Leptin Levels in Pulmonary Tuberculosis Patients with Acute Pneumonia Patients and Healthy Individuals

    Directory of Open Access Journals (Sweden)

    M. Naderi

    2017-10-01

    Full Text Available Aims: Leptin is one of the most important fat-derived hormones. Several studies have shown that serum leptin levels in systemic inflammatory diseases are reduced. The aim of this study was to evaluate the serum leptin levels in three groups: patients with active pulmonary tuberculosis (TB, patients with non-pulmonary infections (acute pneumonia and normal people. Materials & Methods: In this cross-sectional study, in 2010, 40 patients with active pulmonary TB (case group and 40 patients with non-pulmonary infections (positive control group admitted to Boo-Ali hospital in Zahedan and 40 healthy subjects (negative control group were selected using easy access and serum leptin levels were evaluated by ELISA. Data were analyzed by SPSS 18 software and one-way ANOVA. Findings: The mean of serum leptin levels in patients with non-pulmonary infections (p=0.030 and in patients with active pulmonary TB (p=0.004 were significantly lower than normal group, but the mean of serum leptin levels in patients with active pulmonary TB and patients with non-pulmonary infections were not significantly different (p=0.555. Conclusion: Serum leptin levels are lower in patients with active pulmonary tuberculosis and in patients with non-pulmonary infections than in normal people, but there is no difference between patients with active pulmonary tuberculosis and patients with non-pulmonary infections. Therefore, serum leptin levels are not an appropriate marker for the differentiation of active pulmonary tuberculosis from pulmonary infections (acute pneumonia.

  11. The effects of an individual, multistep intervention on adherence to treatment in hemodialysis patients.

    Science.gov (United States)

    Rafiee Vardanjani, Leila; Parvin, Neda; Mahmoodi Shan, Gholamreza

    2015-07-01

    The present study was conducted to investigate the effect of individual, multistep intervention on adherence to treatment in hemodialysis patients referred to a hemodialysis center in Shahrekord, Iran. In this interventional study, hemodialysis patients referring the center of the study were randomly assigned into two control and intervention groups (each 33). The control group received routine treatment, recommended dietary and fluid restrictions. The intervention group participated in eight individual interventional sessions accompanied routine treatment. At the beginning and the end of the study, routine laboratory tests and end-stage renal disease-adherence questionnaire were filled out for patients in both groups. The data were analyzed using Mann-Whitney and Wilcoxon tests. At the end of the study, the two groups showed a significant difference in all domains of adherence except adherence to diet and adherence was better in the intervention group (p adherence to dialysis program (p = 0.04, r = 0.254). After intervention, serum phosphorus decreased significantly in the intervention group (p Adherence to treatment is one of the major problems in hemodialysis patients; however, comprehensive interventions are required in view of individual condition. Implications for Rehabilitation Adherence to treatment means that all patients' behaviors (diet, fluids and drugs intake) should be in line with the recommendations given by healthcare professionals. There is evidence on the association between adherence to treatment and decreased risk of hospitalization in dialysis patients. Individual structured programs are most likely to be successful in encouraging adherence to treatment.

  12. Anorectal function in patients with complete rectal prolapse. Differences between continent and incontinent individuals.

    Science.gov (United States)

    Roig, J V; Buch, E; Alós, R; Solana, A; Fernández, C; Villoslada, C; García-Armengol, J; Hinojosa, J

    1998-11-01

    A study is made of the alterations in anorectal physiology among rectal prolapse patients, evaluating the differences between fecal continent and incontinent individuals. Eighteen patients with complete rectal prolapse were divided into two groups: Group A (8 continent individuals) and Group B (10 incontinent women), while 22 healthy women were used as controls (Group C). Clinical exploration and perineal level measurements were performed, along with anorectal manometry, electrophysiology, and anorectal sensitivity to electrical stimuli. The main antecedents of the continent subjects were excess straining efforts, while the incontinent women presented excess straining and complex deliveries. Pathological perineal descent was a frequent finding in both groups, with a hypotonic anal canal at rest (p rest than the continent women (p rest, regardless of whether they are continent to feces or not. Continent patients have less pudendal neuropathy and therefore less pressure alterations at voluntary sphincter squeeze than incontinent individuals.

  13. Deficits of magnetoencephalography regional power in patients with major depressive disorder:an individual spectral analysis

    Institute of Scientific and Technical Information of China (English)

    汤浩

    2014-01-01

    Objective To explore the discrepancies of individualized frequency and band power between major depressive disorder(MDD)and controls in resting state,and the association of abnormal spectral power with clinical severity of MDD.Methods Whole-head MEG recordings were collected in 19 patients with MDD and 19 non-depressed controls in eye-closed resting state.Individual spectral power of each subject was calculated based on

  14. Serum total antioxidant status in cardiovascular patients and in healthy individuals

    International Nuclear Information System (INIS)

    Gul, R.

    2010-01-01

    The previous studies suggest that low serum total antioxidant status (TAS) might be related to oxidative stress. To further examine the TAS, we investigated its relation in patients suffering from cardiovascular diseases. Total 39 samples of males and females were collected; age ranged from 18 to 86 years and divided them into two groups. Group I included 30 samples of cardiovascular patients; group 2 included 9 healthy individuals as control group. In group I, patients suffering from Myocardial infarction (Ml) showed low TAS values compared to the patients suffering from angina. The rest of the patients in group I showed TAS value within the reference range (1.3- 1.77 mmoVL). The present study concluded that the TAS value in MI patients is lower than patients suffering from angina pectoris, further it was also concluded that aging and smoking both leads to the decrease in the level of T AS. (author)

  15. Use of Piggyback Electrolytes for Patients Receiving Individually Prescribed vs Premixed Parenteral Nutrition.

    Science.gov (United States)

    Busch, Rebecca A; Curtis, Caitlin S; Leverson, Glen E; Kudsk, Kenneth A

    2015-07-01

    Parenteral nutrition (PN) is available as individualized prescriptions frequently prepared with an automated compounding device or as commercially prepared premixed solutions. Our institution exclusively used individualized PN until an amino acid shortage forced a temporary switch to premixed solutions. In general, premixed solutions contain lower electrolyte levels than individualized formulations prescribed for patients with normal organ function. We aimed to quantify supplemental intravenous piggyback (IVPB) electrolyte use in adult patients receiving individualized and premixed PN and to quantify any effect on difference in the cost of therapy. We compared use of supplemental IVPB electrolytes administered to patients receiving PN during consecutive periods prior to and during the amino acid shortage. Electrolyte IVPBs tabulated were potassium chloride, 10 and 20 mEq; magnesium sulfate, 2 g and 4 g; potassium phosphate, 7.5 and 15 mmol; and sodium phosphate, 7.5 and 15 mmol IVPB. There was no statistical difference in the number of PN formulations administered per day during each period (14.7 ± 3.9 vs 14.0 ± 2.6, individualized vs premixed, respectively). Total IVPB electrolytes prescribed per day increased significantly from the individualized PN period to the premixed PN period (7.03 ± 3.8 vs 13.8 ± 6.8; P Parenteral and Enteral Nutrition.

  16. Effect of circuit class versus individual task specific training on balance in post-stroke patients

    International Nuclear Information System (INIS)

    Basri, R.; Ali, A.; Ullah, S.; Naseem, M.; Haq, Z.U.

    2017-01-01

    Objective: To compare the efficacy of circuit class versus individual, task specific training on balance, in post stroke patients. Methods: From a total of 64 participants, 32 participants were treated in circuit based workstations, while 32 participants were treated individually for 4 weeks. Importantly, both groups were treated with standard balance physiotherapy protocols. The treatment was delivered for 5 days per week with 1.5 hours daily. The patients were evaluated for three outcome measures i.e. berg balance scale, time up and go test and for motor assessment scale at baseline and after treatment. Results: Patients in both groups reported significant improvement after 4 weeks of training program compared to baseline on all outcome measures, except time up and go test that did not significantly improve in individual group. Compared to individual group, circuit group reported more improvement on berg balance scale scores (31.33 versus 37.80), time up and go test (23.13sec versus 16.67sec) and on motor assessment scale scores (18.77 versus 20.63) respectively. Conclusion: Circuit class training is more efficacious in improving balance in stroke patients as compared to individual task specific training. (author)

  17. Effect of disease duration on personality type in multiple sclerosis patients and healthy individual

    Directory of Open Access Journals (Sweden)

    Sahar Vesal

    2016-01-01

    Full Text Available Background: Multiple sclerosis may have profound emotional consequences. The relation between psychological and physical factors could lead patients toward unforeseen disease. This study focuses on multiple sclerosis (MS disease duration on personality type A and B in relation to individuals' behaviors. Materials and Methods: This descriptive-analytical study was conducted in Isfahan Alzahra hospital in 2013. Three hundred MS patients and 100 healthy individuals were determined. The distributed questionnaires related to MS patients and considering the descriptive statistics such as demographic variables. Data were analyzed by SPSS software (version 18 based on Chi-square test and independent T-test. Results: Disease duration varied between 1 to 38 years: 30% (1-4 years, 38% (5-10 years, 20% (10-20 years, and 12% (more than 20 years. Significant relationship was observed between disease duration and tendency to type A (higher stress. This relation was positive and significant in Relapsing Remitting MS patients; but negative correlation was seen in Secondary Progressive MS patients. These patients tended to type B (lower stress when disease duration increased. Conclusions: Individuals with disease duration of one year and less than one year tend to type A personality, while patients with increment of disease duration have tendency to type B.

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

    Science.gov (United States)

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

    2013-05-24

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

  19. Clinical outcomes of individualized botulinum neurotoxin type A injection techniques in patients with essential blepharospasm.

    Science.gov (United States)

    Sung, Youngje; Nam, Sang Min; Lew, Helen

    2015-04-01

    To assess the clinical outcomes following botulinum neurotoxin type A (BoNT-A) treatment with an individualized injection technique based on the types of spasms and to compare the results of the individualized injection technique with those of the conventional injection technique in the same patients. From November 2011 to July 2013, 77 BoNT-A injections were performed in 38 patients. Eighteen patients were treated with conventional BoNT-A injections before 2011, and 20 patients were referred to our hospital for unsatisfactory results after a conventional injection technique. We classified the patients by spasm-dominant sites: the lateral orbital area, representing the orbital orbicularis-dominant group (ODG); the glabella, representing the corrugator-dominant group (CDG); and the ptosis, representing the palpebral part of the orbicularis-dominant group (PDG). We increased the injection dose into the spasm-dominant sites of the blepharospasm groups. We assessed subjective symptom scores (functional disability score, FDS) after treatment. This study included 38 patients (26 women, 12 men; mean age, 60.6 ± 10.9 years). There were 21 patients in the ODG, 10 patients in the CDG, and 7 patients in the PDG. Mean ages were 59.7 ± 12.6, 59.8 ± 8.5, and 66.8 ± 9.0 years, and mean BoNT-A injection dose was 38.8 ± 11.2, 38.8 ± 11.2, and 38.8 ± 10.8 U in each group, respectively (p = 0.44, 0.82 Kruskal-Wallis test). Mean FDS after injection was 1.7 ± 0.7 in the ODG, 1.4 ± 0.8 in the CDG, and 1.2 ± 0.3 in the PDG. There were significant differences in reading and job scale among the three groups. In a comparison between the conventional and individualized injection techniques, there was a significant improvement in mean FDS and in the reading scale in the PDG with the individualized injection technique. The success rate was 92.1% in the conventional injection group and 94.1% in the individualized injection group. The individualized injection technique of Bo

  20. Predicting the efficacy of radiotherapy in individual glioblastoma patients in vivo: a mathematical modeling approach

    International Nuclear Information System (INIS)

    Rockne, R; Alvord, E C Jr; Swanson, K R; Rockhill, J K; Kalet, I; Hendrickson, K; Mrugala, M; Spence, A M; Lai, A; Cloughesy, T

    2010-01-01

    Glioblastoma multiforme (GBM) is the most malignant form of primary brain tumors known as gliomas. They proliferate and invade extensively and yield short life expectancies despite aggressive treatment. Response to treatment is usually measured in terms of the survival of groups of patients treated similarly, but this statistical approach misses the subgroups that may have responded to or may have been injured by treatment. Such statistics offer scant reassurance to individual patients who have suffered through these treatments. Furthermore, current imaging-based treatment response metrics in individual patients ignore patient-specific differences in tumor growth kinetics, which have been shown to vary widely across patients even within the same histological diagnosis and, unfortunately, these metrics have shown only minimal success in predicting patient outcome. We consider nine newly diagnosed GBM patients receiving diagnostic biopsy followed by standard-of-care external beam radiation therapy (XRT). We present and apply a patient-specific, biologically based mathematical model for glioma growth that quantifies response to XRT in individual patients in vivo. The mathematical model uses net rates of proliferation and migration of malignant tumor cells to characterize the tumor's growth and invasion along with the linear-quadratic model for the response to radiation therapy. Using only routinely available pre-treatment MRIs to inform the patient-specific bio-mathematical model simulations, we find that radiation response in these patients, quantified by both clinical and model-generated measures, could have been predicted prior to treatment with high accuracy. Specifically, we find that the net proliferation rate is correlated with the radiation response parameter (r = 0.89, p = 0.0007), resulting in a predictive relationship that is tested with a leave-one-out cross-validation technique. This relationship predicts the tumor size post-therapy to within inter

  1. Omics approaches to individual variation: modeling networks and the virtual patient

    OpenAIRE

    Lehrach, Hans

    2016-01-01

    Every human is unique. We differ in our genomes, environment, behavior, disease history, and past and current medical treatment?a complex catalog of differences that often leads to variations in the way each of us responds to a particular therapy. We argue here that true personalization of drug therapies will rely on ?virtual patient? models based on a detailed characterization of the individual patient by molecular, imaging, and sensor techniques. The models will be based, wherever possible,...

  2. An individualized coaching program for patients with acute ischemic stroke: Feasibility study.

    Science.gov (United States)

    Vanacker, P; Standaert, D; Libbrecht, N; Vansteenkiste, I; Bernard, D; Yperzeele, L; Vanhooren, G

    2017-03-01

    An individualized stroke care program was developed to match patients' education with their needs regarding stroke knowledge, secondary prevention and rehabilitation. Our purpose was to assess feasibility of in-hospital and post-discharge, personalized stroke coaching service. Acute ischemic stroke patients enrolled in ASTRAL-B stroke registry (Sint-Lucashospital, Bruges Belgium) with: (a) hospitalization between 12/2014-12/2015, (b) hospital-to-home discharge, and (c) without cognitive decline, were selected. The stroke coach contacted patients individually twice during hospitalization (2×20min) and post-discharge via phone calls using the standardized WSO Post-Strokechecklist. Risk factor management, review of therapy and clinical evolution were discussed. Participants were contacted at 2 weeks, followed by repeat calls if necessary and ambulatory with the vascular neurologist at 1, 3, 6 and 12 months. Of all 255 patients meeting the inclusion criteria, 152 (59.7%) received individualized education during hospitalization by the stroke coach. Median age of our population was 74 years and median NIHSS 5. Majority of patients had at least two cardiovascular risk factors. Patients were not coached because of palliative care/decease (10%), unfavorable life expectancy (2%), dementia (8.5%) and lack of time due to short hospitalization (22%). A quarter of all patients were contacted at least once by phone, 12% were contacted at least twice after discharge. At three months, low stroke recurrence (5%) and mortality rates (4%) were identified, probably linked to improved adherence. We demonstrated feasibility of an individualized coaching service executed by well-trained stroke nurse. Future research will focus on developing an online portal delivering post-discharge services to patients and caregivers. Copyright © 2017 Elsevier B.V. All rights reserved.

  3. Acute infective conjunctivitis in primary care: who needs antibiotics? An individual patient data meta-analysis

    Science.gov (United States)

    Jefferis, Joanna; Perera, Rafael; Everitt, Hazel; van Weert, Henk; Rietveld, Remco; Glasziou, Paul; Rose, Peter

    2011-01-01

    Background Acute infective conjunctivitis is a common problem in primary care, traditionally managed with topical antibiotics. A number of clinical trials have questioned the benefit of topical antibiotics for patients with acute infective conjunctivitis Aim To determine the benefit of antibiotics for the treatment of acute infective conjunctivitis in primary care and which subgroups benefit most Design An individual patient data meta-analysis Method Relevant trials were identified and individual patient data gathered for meta-analysis and subgroup analysis Results Three eligible trials were identified. Individual patient data were available from all primary care trials and data were available for analysis in 622 patients. Eighty per cent (246/308) of patients who received antibiotics and 74% (233/314) of controls were cured at day 7. There was a significant benefit of antibiotics versus control for cure at seven days in all cases combined (risk difference 0.08, 95% confidence interval (CI) = 0.01 to 0.14). Subgroups that showed a significant benefit from antibiotics were patients with purulent discharge (risk difference 0.09, 95% CI = 0.01 to 0.17) and patients with mild severity of red eye (risk difference 0.10, 95% CI = 0.02 to 0.18), while the type of control used (placebo drops versus nothing) showed a statistically significant interaction (P=0.03) Conclusion Acute conjunctivitis seen in primary care can be thought of as a self-limiting condition, with most patients getting better regardless of antibiotic therapy. Patients with purulent discharge or a mild severity of red eye may have a small benefit from antibiotics. Prescribing practices need to be updated, taking into account these results PMID:22152728

  4. T helper cell subsets specific for Pseudomonas aeruginosa in healthy individuals and patients with cystic fibrosis.

    Directory of Open Access Journals (Sweden)

    Hannah K Bayes

    Full Text Available We set out to determine the magnitude of antigen-specific memory T helper cell responses to Pseudomonas aeruginosa in healthy humans and patients with cystic fibrosis.Peripheral blood human memory CD4(+ T cells were co-cultured with dendritic cells that had been infected with different strains of Pseudomonas aeruginosa. The T helper response was determined by measuring proliferation, immunoassay of cytokine output, and immunostaining of intracellular cytokines.Healthy individuals and patients with cystic fibrosis had robust antigen-specific memory CD4(+ T cell responses to Pseudomonas aeruginosa that not only contained a Th1 and Th17 component but also Th22 cells. In contrast to previous descriptions of human Th22 cells, these Pseudomonal-specific Th22 cells lacked the skin homing markers CCR4 or CCR10, although were CCR6(+. Healthy individuals and patients with cystic fibrosis had similar levels of Th22 cells, but the patient group had significantly fewer Th17 cells in peripheral blood.Th22 cells specific to Pseudomonas aeruginosa are induced in both healthy individuals and patients with cystic fibrosis. Along with Th17 cells, they may play an important role in the pulmonary response to this microbe in patients with cystic fibrosis and other conditions.

  5. Studying the Relationship between Individual and Organizational Factors and Nurses' Perception of Patient Safety Culture

    Directory of Open Access Journals (Sweden)

    Farahnaz Abdolahzadeh

    2012-11-01

    Full Text Available Introduction: Safety culture is considered as an important factor in improving patient safety. Therefore, identifying individual and organizational factors affecting safety culture is crucial. This study was carried out to determine individual and organizational factors associated with nurses' perception of patient safety culture. Methods: The present descriptive study included 940 nurses working in four training hospitals affiliated with Urmia University of Medical Sciences (Iran. Data was collected through the self-report questionnaire of patient safety culture. Descriptive (number, percent, mean, and standard deviation and inferential (t-test and analysis of variance statistics were used to analyze the data in SPSS. Results: Nurses' perception of patient safety culture was significantly correlated with marital status, workplace, and overtime hours. Conclusion: The results of this study revealed that some individual and organizational factors can impact on nurses' perception of patient safety culture. Nursing authorities should thus pay more attention to factors which promote patient safety culture and ultimately the safety of provided services.

  6. Intra-individual variability in tinnitus patients : current thoughts and perspectives.

    Science.gov (United States)

    Dauman, N; Erlandsson, S; Lundlin, L; Dauman, R

    2015-04-01

    Most tinnitus studies have attempted to compare groups of individuals, thus revealing inter-individuals differences, i.e., variations between compared subjects. For methodological reasons, inter-individual studies cannot take into account the variability of tinnitus experience, which has been known for decades to be relevant in daily practice with tinnitus patients. The concept of intra-individual variability has been promoted in the research literature, in order to shed light on this aspect of individual perception. In previous studies, unrelated to hearing, the concept of intra-individual variability implied inclusion of the environment (i.e., physical and social interactions) as a factor of individual performance. In tinnitus research, we believe that the concept of variability (within a person) could find a place beside the concept of variation (between groups of subjects). In this paper, four perspectives of tinnitus experiences from the clinical and research fields are described: (1) ENT consultation; (2) short-term group psychotherapy; (3) psychodynamic psychotherapy; and (4) clinical psychological research. Intra-individual variability stresses the importance of defining tinnitus in a dynamic way, contrary to the current definition of tinnitus as the perception of sound(s). In clinical practice, it is useful to embrace the perspective of the perceiver of tinnitus, and to include social and cultural circumstances as well as audiological/physical changes.

  7. Tracking functional brain changes in patients with depression under psychodynamic psychotherapy using individualized stimuli.

    Directory of Open Access Journals (Sweden)

    Daniel Wiswede

    Full Text Available OBJECTIVE: Neurobiological models of depression posit limbic hyperactivity that should normalize after successful treatment. For psychotherapy, though, brain changes in patients with depression show substantial variability. Two critical issues in relevant studies concern the use of unspecific stimulation experiments and relatively short treatment protocols. Therefore changes in brain reactions to individualized stimuli were studied in patients with depression after eight months of psychodynamic psychotherapy. METHODS: 18 unmedicated patients with recurrent major depressive disorder were confronted with individualized and clinically derived content in a functional MRI experiment before (T1 and after eight months (T2 of psychodynamic therapy. A control group of 17 healthy subjects was also tested twice without intervention. The experimental stimuli were sentences describing each participant's dysfunctional interpersonal relationship patterns derived from clinical interviews based on Operationalized Psychodynamic Diagnostics (OPD. RESULTS: At T1 patients showed enhanced activation compared to controls in several limbic and subcortical regions, including amygdala and basal ganglia, when confronted with OPD sentences. At T2 the differences in brain activity between patients and controls were no longer apparent. Concurrently, patients had improved significantly in depression scores. CONCLUSIONS: Using ecologically valid stimuli, this study supports the model of limbic hyperactivity in depression that normalizes after treatment. Without a control group of untreated patients measured twice, though, changes in patients' brain activity could also be attributed to other factors than psychodynamic therapy.

  8. Comparative Evaluation of Periodontal Status of Chronic Renal Failure Patients and Systemically Healthy Individuals.

    Science.gov (United States)

    Gupta, Radhika; Kumar, Uttam; Mallapragada, Siddharth; Agarwal, Pallavi

    2018-03-01

    Periodontitis, a chronic infectious disease, affects most of the population at one time or the other and its expression is a combination of hosts, microbial agents, and environmental factors. Extensive literature exists for the relationship between periodontal disease and diabetes mellitus, cardiovascular diseases, and adverse pregnancy outcomes. Only a few studies performed in a limited number of patients have reported peri-odontal health status in chronic renal failure patients. Hence, the aim of the present study is to assess and compare the periodontal status of patients with chronic renal failure undergoing dialysis, predialysis with systemically healthy individuals. A total of 90 patients were divided into three groups. Group I: 30 renal dialysis patients. Group II: 30 predialysis patients. Control group comprised 30 systemically healthy patients who formed group III. Periodontal examination was carried out using oral hygiene index-simplified (OHI-S), plaque index (PI), gingival index (GI), probing depth, and clinical attachment loss. The results of the study showed that the periodontal status of patients with chronic renal failure undergoing dialysis (dialysis group) and patients with chronic renal failure not undergoing renal dialysis (predialysis) when compared with systemically healthy subjects showed significantly higher mean scores of OHI-S, PI, and clinical attachment loss. Thus, patients with chronic renal failure showed poor oral hygiene and higher prevalence of periodontal disease. The dental community's awareness of implications of poor health within chronic renal failure patients should be elevated.

  9. Randomized trial of the effects of individual nutritional counseling in cancer patients

    DEFF Research Database (Denmark)

    Møller, Grith; Pedersen, Louise Lindkvist; Østerlind, Kell

    2014-01-01

    Cancer-related malnutrition is multifactorial and related to a bad prognosis. The aim of this study was to investigate the effect of intensive, individual dietary counseling of patients in radiotherapy and/or chemotherapy for gynecologic-, gastric-, or esophageal cancer....

  10. Is there an indication for HLA-DR typing for individual patients with rheumatoid arthritis?

    NARCIS (Netherlands)

    van Jaarsveld, C. H.; Otten, H. G.; Jacobs, J. W.; Kruize, A. A.; Brus, H. L.; Bijlsma, J. W.

    1998-01-01

    The clinical expression of rheumatoid arthritis (RA) varies considerably among individual patients. Genetic variations in human leucocyte antigen (HLA) may influence susceptibility to RA and the severity of the disease. The literature concerning the association of HLA-DR with the susceptibility to

  11. Comparison of Ecological Micro-Expression Recognition in Patients with Depression and Healthy Individuals

    Directory of Open Access Journals (Sweden)

    Chuanlin Zhu

    2017-10-01

    Full Text Available Previous studies have focused on the characteristics of ordinary facial expressions in patients with depression, and have not investigated the processing characteristics of ecological micro-expressions (MEs, i.e., MEs that presented in different background expressions in these patients. Based on this, adopting the ecological MEs recognition paradigm, this study aimed to comparatively evaluate facial ME recognition in depressed and healthy individuals. The findings of the study are as follows: (1 background expression: the accuracy (ACC in the neutral background condition tended to be higher than that in the fear background condition, and the reaction time (RT in the neutral background condition was significantly longer than that in other backgrounds. The type of ME and its interaction with the type of background expression could affect participants’ ecological MEs recognition ACC and speed. Depression type: there was no significant difference between the ecological MEs recognition ACC of patients with depression and healthy individuals, but the patients’ RT was significantly longer than that of healthy individuals; and (2 patients with depression judged happy MEs that were presented against different backgrounds as neutral and judged neutral MEs that were presented against sad backgrounds as sad. The present study suggested the following: (1 ecological MEs recognition was influenced by background expressions. The ACC of happy MEs was the highest, of neutral ME moderate and of sadness and fear the lowest. The response to the happy MEs was significantly shorter than that of identifying other MEs. It is necessary to conduct research on ecological MEs recognition; (2 the speed of patients with depression in identifying ecological MEs was slower than of healthy individuals; indicating that the patients’ cognitive function was impaired; and (3 the patients with depression showed negative bias in the ecological MEs recognition task, reflecting

  12. Individualized Comprehensive Lifestyle Intervention in Patients Undergoing Chemotherapy with Curative or Palliative Intent: Who Participates?

    Directory of Open Access Journals (Sweden)

    Karianne Vassbakk-Brovold

    Full Text Available Knowledge about determinants of participation in lifestyle interventions in cancer patients undergoing chemotherapy, particularly with palliative intent, remains poor. The objective of the present study was to identify determinants of participating in a 12 month individualized, comprehensive lifestyle intervention, focusing on diet, physical activity, mental stress and smoking cessation, in cancer patients receiving chemotherapy with curative or palliative intent. The secondary objective was to identify participation determinants 4 months into the study.Newly diagnosed cancer patients starting chemotherapy at the cancer center in Kristiansand/Norway (during a 16 month inclusion period were screened. Demographic and medical data (age, sex, body mass index, education level, marital status, smoking status, Eastern Cooperative Oncology Group performance status (ECOG, diagnosis, tumor stage and treatment intention was analyzed for screened patients.100 of 161 invited patients participated. There were more females (69 vs. 48%; P = 0.004, breast cancer patients (46 vs. 25%; P = 0.007, non-smokers (87 vs. 74%; P = 0.041, younger (mean age 60 vs. 67 yrs; P 70 years were less likely to participate at baseline and 4 months.Individualized lifestyle interventions in cancer patients undergoing chemotherapy appear to facilitate a high participation rate that declines with increasing age; both during the enrollment process and completing the intervention. Neither oncologic nor socioeconomic variables deterred participation.

  13. Elastins from patients with Williams-Beuren syndrome and healthy individuals differ on the molecular level

    DEFF Research Database (Denmark)

    Heinz, Andrea; Huertas, Angela C Mora; Schräder, Christoph U

    2016-01-01

    Williams-Beuren syndrome (WBS) is a congenital disorder, which involves the heterozygous deletion of the elastin gene and other genes on chromosome 7. Clinical symptoms that are associated with hemizygosity of the essential extracellular matrix protein elastin include premature aging of the skin...... and supravalvular aortic stenosis. However, only little is known about the molecular basis of structural abnormalities in the connective tissue of WBS patients. Therefore, for the first time this study aimed to systematically characterize and compare the structure and amount of elastin present in skin and aortic...... tissue from WBS patients and healthy individuals. Elastin fibers were isolated from tissue biopsies, and it was found that skin of WBS patients contains significantly less elastin compared to skin of healthy individuals. Scanning electron microscopy and mass spectrometric measurements combined...

  14. Internet addictive individuals share impulsivity and executive dysfunction with alcohol-dependent patients

    Directory of Open Access Journals (Sweden)

    Zhenhe eZhou

    2014-08-01

    Full Text Available Internet addiction disorder (IAD should belong to a kind of behavioral addiction. Previous studies indicated that there are many similarities in the neurobiology of behavior and substance addictions. Up to date, although individuals with IAD have difficulty suppressing their excessive online behaviors in real life, little is known about the patho-physiological and cognitive mechanisms responsible for IAD. Neuropsychological test studies have contributed significantly to our understanding of the effect of IAD on the cognitive function. The purpose of the present study was to examine whether Internet addictive individuals share impulsivity and executive dysfunction with alcohol-dependent individuals. Participants include 22 Internet addictive individuals, 22 alcohol-dependent patients (AD and 22 normal controls (NC. All participants were measured with BIS- 11, go/no-go task, WCST and Digit span task under the same experimental condition. Results showed that BIS-11 scores, false alarm rate, the total response errors, perseverative errors, failure to maintain set of IAD and AD group were significantly higher than that of NC group, and hit rate, percentage of conceptual level responses, the number of categories completed, forwards scores and backwards scores of IAD and AD group were significantly lower than that of NC group, however, no differences in above variables between IAD group and AD group were observed. These results revealed that the existence of impulsivity, deficiencies in executive function and working memory in an IAD and an AD sample, namely, Internet addictive individuals share impulsivity and executive dysfunction with alcohol-dependent patients.

  15. Metastatic involvement of the pituitary gland: a systematic review with pooled individual patient data analysis.

    Science.gov (United States)

    He, Wenzhuan; Chen, Fangxiang; Dalm, Brian; Kirby, Patricia A; Greenlee, Jeremy D W

    2015-02-01

    To report a rare case of pituitary metastasis (PM) from hepatocellular carcinoma (HCC) and help better understand the incidence of PM and its most common presenting symptoms through a pooled individual patient data analysis. Literature regarding PM was systematically reviewed with a pooled individual patient data analysis conducted. Pooled individual data analysis result is also compared with the result in a most recent systematic review. Our results demonstrate that the incidence of PM among all intracranial metastases is 0.87% (95% CI 0.56, 1.18); it is 1.9% (95% CI 1.46, 2.34) among all autopsied cancer cases; it is 11.56% (95% CI 7.08, 16.04) among all breast cancer patients who had hypophysectomies and 12.83% (95% CI 10.5, 15.16) among all autopsied breast cancer patients. The fixed effect model showed that the incidence of PM in breast cancer patients group is significantly higher (p anterior hypopituitarism (23.68 vs 39.66%, p = 0.015), visual deterioration (27.89 vs 41.38%, p = 0.039), cranial nerve palsies (21.58 vs 41.38%, p = 0.003) and headaches (15.79 vs 32.76%, p = 0.005) were reported significantly higher than previously described in the literature. Pituitary metastasis is rare in patients with cancer, and the pituitary gland is an uncommonly involved location in patients with intracranial metastases. With advanced diagnostic imaging techniques and increased awareness about the manifestation of sellar lesions, the incidence of cranial nerve palsies and anterior pituitarism are higher than reported. This information may allow earlier diagnosis of PM.

  16. Whole exome sequencing reveals concomitant mutations of multiple FA genes in individual Fanconi anemia patients.

    Science.gov (United States)

    Chang, Lixian; Yuan, Weiping; Zeng, Huimin; Zhou, Quanquan; Wei, Wei; Zhou, Jianfeng; Li, Miaomiao; Wang, Xiaomin; Xu, Mingjiang; Yang, Fengchun; Yang, Yungui; Cheng, Tao; Zhu, Xiaofan

    2014-05-15

    Fanconi anemia (FA) is a rare inherited genetic syndrome with highly variable clinical manifestations. Fifteen genetic subtypes of FA have been identified. Traditional complementation tests for grouping studies have been used generally in FA patients and in stepwise methods to identify the FA type, which can result in incomplete genetic information from FA patients. We diagnosed five pediatric patients with FA based on clinical manifestations, and we performed exome sequencing of peripheral blood specimens from these patients and their family members. The related sequencing data were then analyzed by bioinformatics, and the FANC gene mutations identified by exome sequencing were confirmed by PCR re-sequencing. Homozygous and compound heterozygous mutations of FANC genes were identified in all of the patients. The FA subtypes of the patients included FANCA, FANCM and FANCD2. Interestingly, four FA patients harbored multiple mutations in at least two FA genes, and some of these mutations have not been previously reported. These patients' clinical manifestations were vastly different from each other, as were their treatment responses to androstanazol and prednisone. This finding suggests that heterozygous mutation(s) in FA genes could also have diverse biological and/or pathophysiological effects on FA patients or FA gene carriers. Interestingly, we were not able to identify de novo mutations in the genes implicated in DNA repair pathways when the sequencing data of patients were compared with those of their parents. Our results indicate that Chinese FA patients and carriers might have higher and more complex mutation rates in FANC genes than have been conventionally recognized. Testing of the fifteen FANC genes in FA patients and their family members should be a regular clinical practice to determine the optimal care for the individual patient, to counsel the family and to obtain a better understanding of FA pathophysiology.

  17. The Accutension Stetho, an automated auscultatory device to validate automated sphygmomanometer readings in individual patients.

    Science.gov (United States)

    Alpert, Bruce S

    2018-04-06

    The aim of this report is to describe a new device that can validate, by automated auscultation, individual blood pressure (BP) readings taken by automated sphygmomanometers.The Accutension Stetho utilizes a smartphone application in conjunction with a specially designed stethoscope that interfaces directly into the smartphone via the earphone jack. The Korotkoff sounds are recorded by the application and are analyzed by the operator on the screen of the smartphone simultaneously with the images from the sphygmomanometer screen during BP estimation. Current auscultatory validation standards require at least 85 subjects and strict statistical criteria for passage. A device that passes can make no guarantee of accuracy on individual patients. The Accutension Stetho is an inexpensive smartphone/stethoscope kit combination that estimates precise BP values by auscultation to confirm the accuracy of an automated sphygmomanometer's readings on individual patients. This should be of great value for both professional and, in certain circumstances, self-measurement BP. Patients will avoid both unnecessary treatment and errors of underestimation of BP, in which the patient requires therapy. The Stetho's software has been validated in an independent ANSI/AAMI/ISO standard study. The Stetho has been shown to perform without difficulty in multiple deflation-based devices by many manufacturers.

  18. Surgery as an Adjunctive Treatment for Multidrug-Resistant Tuberculosis: An Individual Patient Data Metaanalysis.

    Science.gov (United States)

    Fox, Gregory J; Mitnick, Carole D; Benedetti, Andrea; Chan, Edward D; Becerra, Mercedes; Chiang, Chen-Yuan; Keshavjee, Salmaan; Koh, Won-Jung; Shiraishi, Yuji; Viiklepp, Piret; Yim, Jae-Joon; Pasvol, Geoffrey; Robert, Jerome; Shim, Tae Sun; Shin, Sonya S; Menzies, Dick; Ahuja, S; Ashkin, D; Avendaño, M; Banerjee, R; Bauer, M; Burgos, M; Centis, R; Cobelens, F; Cox, H; D'Ambrosio, L; de Lange, W C M; DeRiemer, K; Enarson, D; Falzon, D; Flanagan, K; Flood, J; Gandhi, N; Garcia-Garcia, L; Granich, R M; Hollm-Delgado, M G; Holtz, T H; Hopewell, P; Iseman, M; Jarlsberg, L G; Kim, H R; Lancaster, J; Lange, C; Leimane, V; Leung, C C; Li, J; Menzies, D; Migliori, G B; Narita, M; Nathanson, E; Odendaal, R; O'Riordan, P; Pai, M; Palmero, D; Park, S K; Pena, J; Pérez-Guzmán, C; Ponce-de-Leon, A; Quelapio, M I D; Quy, H T; Riekstina, V; Royce, S; Salim, M; Schaaf, H S; Seung, K J; Shah, L; Shean, K; Sifuentes-Osornio, J; Sotgiu, G; Strand, M J; Sung, S W; Tabarsi, P; Tupasi, T E; Vargas, M H; van Altena, R; van der Walt, M; van der Werf, T S; Westenhouse, J; Yew, W W

    2016-04-01

    Medical treatment for multidrug-resistant (MDR)-tuberculosis is complex, toxic, and associated with poor outcomes. Surgical lung resection may be used as an adjunct to medical therapy, with the intent of reducing bacterial burden and improving cure rates. We conducted an individual patient data metaanalysis to evaluate the effectiveness of surgery as adjunctive therapy for MDR-tuberculosis. Individual patient data, was obtained from the authors of 26 cohort studies, identified from 3 systematic reviews of MDR-tuberculosis treatment. Data included the clinical characteristics and medical and surgical therapy of each patient. Primary analyses compared treatment success (cure and completion) to a combined outcome of failure, relapse, or death. The effects of all forms of resection surgery, pneumonectomy, and partial lung resection were evaluated. A total of 4238 patients from 18 surgical studies and 2193 patients from 8 nonsurgical studies were included. Pulmonary resection surgery was performed on 478 patients. Partial lung resection surgery was associated with improved treatment success (adjusted odds ratio [aOR], 3.0; 95% confidence interval [CI], 1.5-5.9; I(2)R, 11.8%), but pneumonectomy was not (aOR, 1.1; 95% CI, .6-2.3; I(2)R, 13.2%). Treatment success was more likely when surgery was performed after culture conversion than before conversion (aOR, 2.6; 95% CI, 0.9-7.1; I(2)R, 0.2%). Partial lung resection, but not pneumonectomy, was associated with improved treatment success among patients with MDR-tuberculosis. Although improved outcomes may reflect patient selection, partial lung resection surgery after culture conversion may improve treatment outcomes in patients who receive optimal medical therapy. © The Author 2016. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail journals.permissions@oup.com.

  19. An individual rehabilitation program: evaluation by Parkinsonian patients and their physiotherapists.

    Science.gov (United States)

    Ory Magne, F; Fabre, N; Gu, C; Pastorelli, C; Tardez, S; Marchat, J-C; Marque, P; Brefel Courbon, C

    2014-11-01

    The purpose of this work was to study the feasibility of an individual Parkinson disease (PD) rehabilitation program based on each patient's prevalent symptoms and to determine the effects of this program on patient's quality of life as well as the level of patient's and physiotherapist's satisfaction with the program. In association with physiotherapists with expertise in PD, a physical medicine and rehabilitation physician, we elaborated a physical therapy program based on the core areas for physical therapy in PD: transfers; posture; balance and falls; physical capacity and inactivity. Within this program, we selected exercises tailored to each patient's main impairment and proposed this selection to their local physiotherapist for three months. Quality of life was evaluated with PDQ-39 at baseline and after three months of the individualized physical therapy program. We built an anonymous satisfaction questionnaire for patients and physiotherapists that was filled out at the end of the program. One hundred and three individuals with moderately advanced but clinically stable idiopathic PD were included. Significant improvement was found for the emotional well-being, bodily discomfort and stigma domain (P ≤ 0.05). No significant improvement was found for the other PDQ-39 domains. The mean global satisfaction figures for this program were 6.0 ± 2.4 and 7.2 ± 2.1 for patients and physiotherapists respectively. Most of the patients felt improved by the physiotherapy program and especially for transfer, balance, gait, and mobility. Our study found evidence of the potential benefits of a patient-tailored physiotherapy program. Such a program was feasible and had a favorable impact on patients' quality of life and on physiotherapists' practices for PD patients. Specific physiotherapy may be effective to limit physical mobility impairment. Our results also pointed out that physiotherapy may be efficient to confine the negative impact of social isolation, pain and

  20. INDIVIDUAL PROFILE OF FUNCTIONAL HEMISPHERIC ASYMMETRY AND QUALITY OF LIFE IN PATIENTS WITH PARKINSON'S DISEASE

    Directory of Open Access Journals (Sweden)

    M. A. Bykanova

    2014-07-01

    Full Text Available Objective — to identify the relationship between the individual profile of functional hemispheric asymmetry (IPFA and lateralization of the Parkinson's disease (PD debut, as well as assess of their impact on anxiety and depressive disorders and quality of life of patients.Materials and methods. 70 patients with PD (28 men and 42 women, average age 63,1 ± 8,1 years with disease duration 48 [36, 72] months (Me [25 %; 75 %] were included. We used Hoehn and Yahr, UPDRS, EuroQol, PDQ-39 scales, scale of anxiety and Spielberger–Hanin Hamilton Depression. IPFA was determined using the protocol survey of 48 jobs during the period of inclusion of patients in the study.Results. In patients with right-sided IPFA right-sided debut of PD was more common (p < 0.05 and in patients with mixed IPFA — leftsided(p < 0.05 PD debut. There were no significant differences in levels of reactive, personal anxiety and depression at different IPFA dependingon the side of PD debut (p > 0.05 received. Quality of life scale PDQ-39 showed worse results in patients with right-in right IPFA debut in comparison with those in patients with left debut (p < 0.05. Quality of life by EuroQol-II scale was higher in patients with rightsided IPFA with the left debut of PD than in patients with right-debut (p < 0.05, and in patients with mixed IPFA with right debut compared to patients with left debut (p < 0.05.Conclusion. With the debut of PD in leading limb and preferential involvement of the dominant hemisphere poorer quality of life was observed. IPFA and clinical asymmetry did not affect on the level of anxiety and depressive disorders, which were revealed in more than twothirds of patients with PD.

  1. Predictors for individual patient antibiotic treatment effect in hospitalized community-acquired pneumonia patients.

    Science.gov (United States)

    Simonetti, A F; van Werkhoven, C H; Schweitzer, V A; Viasus, D; Carratalà, J; Postma, D F; Oosterheert, J J; Bonten, M J M

    2017-10-01

    Our objective was to identify clinical predictors of antibiotic treatment effects in hospitalized patients with community-acquired pneumonia (CAP) who were not in the intensive care unit (ICU). Post-hoc analysis of three prospective cohorts (from the Netherlands and Spain) of adult patients with CAP admitted to a non-ICU ward having received either β-lactam monotherapy, β-lactam + macrolide, or a fluoroquinolone-based therapy as empirical antibiotic treatment. We evaluated candidate clinical predictors of treatment effects in multiple mixed-effects models by including interactions of the predictors with empirical antibiotic choice and using 30-day mortality, ICU admission and length of hospital stay as outcomes. Among 8562 patients, empirical treatment was β-lactam in 4399 (51.4%), fluoroquinolone in 3373 (39.4%), and β-lactam + macrolide in 790 (9.2%). Older age (interaction OR 1.67, 95% CI 1.23-2.29, p 0.034) and current smoking (interaction OR 2.36, 95% CI 1.34-4.17, p 0.046) were associated with lower effectiveness of fluoroquinolone on 30-day mortality. Older age was also associated with lower effectiveness of β-lactam + macrolide on length of hospital stay (interaction effect ratio 1.14, 95% CI 1.06-1.22, p 0.008). Older age and smoking could influence the response to specific antibiotic regimens. The effect modification of age and smoking should be considered hypothesis generating to be evaluated in future trials. Copyright © 2017 European Society of Clinical Microbiology and Infectious Diseases. Published by Elsevier Ltd. All rights reserved.

  2. Individual white matter fractional anisotropy analysis on patients with MRI negative partial epilepsy.

    Science.gov (United States)

    Duning, Thomas; Kellinghaus, Christoph; Mohammadi, Siawoosh; Schiffbauer, Hagen; Keller, Simon; Ringelstein, E Bernd; Knecht, Stefan; Deppe, Michael

    2010-02-01

    Conventional structural MRI fails to identify a cerebral lesion in 25% of patients with cryptogenic partial epilepsy (CPE). Diffusion tensor imaging is an MRI technique sensitive to microstructural abnormalities of cerebral white matter (WM) by quantification of fractional anisotropy (FA). The objectives of the present study were to identify focal FA abnormalities in patients with CPE who were deemed MRI negative during routine presurgical evaluation. Diffusion tensor imaging at 3 T was performed in 12 patients with CPE and normal conventional MRI and in 67 age matched healthy volunteers. WM integrity was compared between groups on the basis of automated voxel-wise statistics of FA maps using an analysis of covariance. Volumetric measurements from high resolution T1-weighted images were also performed. Significant FA reductions in WM regions encompassing diffuse areas of the brain were observed when all patients as a group were compared with controls. On an individual basis, voxel based analyses revealed widespread symmetrical FA reduction in CPE patients. Furthermore, asymmetrical temporal lobe FA reduction was consistently ipsilateral to the electroclinical focus. No significant correlations were found between FA alterations and clinical data. There were no differences in brain volumes of CPE patients compared with controls. Despite normal conventional MRI, WM integrity abnormalities in CPE patients extend far beyond the epileptogenic zone. Given that unilateral temporal lobe FA abnormalities were consistently observed ipsilateral to the seizure focus, analysis of temporal FA may provide an informative in vivo investigation into the localisation of the epileptogenic zone in MRI negative patients.

  3. Patient characteristics and perceived health status of individuals with HIV and tuberculosis coinfection in Guangxi, China.

    Science.gov (United States)

    Zhu, Yujia; Wu, Jizhou; Feng, Xue; Chen, Huanhuan; Lu, Huaxiang; Chen, Li; Luo, Liuhong; Rui, Chao

    2017-04-01

    To explore demographics, clinical and medication profiles, patients' social support, and perceived health status in HIV/TB coinfected patients in Guangxi, China.We performed a cross-sectional study in the HIV clinic of the Guigang City People's Hospital (N = 150). Health professionals conducted face-to-face interviews and collected data from patients' electronic medical records regarding patients' demographic, clinical, and medication information, as well as their social support and perceived health status. We classified all HIV/AIDS patients into HIV monoinfected and TB coinfected, at a ratio of 2:1.Compared with the HIV monoinfected, patients with HIV/TB coinfection were more likely to be older, male, less educated, unemployed, carrying health insurance, having advanced stage of HIV infection, longer history with HIV, and other opportunistic infections. Patients coinfected with TB were also more likely to hold a negative belief that their HIV treatment could prevent exacerbations, and reported significantly worse emotional/informational support, social interaction, and perceived health status. Better social support and better self-efficacy to the HIV treatment adherence was significantly associated with better perceived health status among patients with HIV and TB coinfection.Having HIV/TB coinfection was associated with poorer perceived general well-being and mental health, particularly in those undergoing TB therapy. Our findings suggest the need for mental health referrals and medication management for coinfected individuals, as well as further efforts and policies to improve coordinated care.

  4. Thalamic functional connectivity predicts seizure laterality in individual TLE patients: application of a biomarker development strategy.

    Science.gov (United States)

    Barron, Daniel S; Fox, Peter T; Pardoe, Heath; Lancaster, Jack; Price, Larry R; Blackmon, Karen; Berry, Kristen; Cavazos, Jose E; Kuzniecky, Ruben; Devinsky, Orrin; Thesen, Thomas

    2015-01-01

    Noninvasive markers of brain function could yield biomarkers in many neurological disorders. Disease models constrained by coordinate-based meta-analysis are likely to increase this yield. Here, we evaluate a thalamic model of temporal lobe epilepsy that we proposed in a coordinate-based meta-analysis and extended in a diffusion tractography study of an independent patient population. Specifically, we evaluated whether thalamic functional connectivity (resting-state fMRI-BOLD) with temporal lobe areas can predict seizure onset laterality, as established with intracranial EEG. Twenty-four lesional and non-lesional temporal lobe epilepsy patients were studied. No significant differences in functional connection strength in patient and control groups were observed with Mann-Whitney Tests (corrected for multiple comparisons). Notwithstanding the lack of group differences, individual patient difference scores (from control mean connection strength) successfully predicted seizure onset zone as shown in ROC curves: discriminant analysis (two-dimensional) predicted seizure onset zone with 85% sensitivity and 91% specificity; logistic regression (four-dimensional) achieved 86% sensitivity and 100% specificity. The strongest markers in both analyses were left thalamo-hippocampal and right thalamo-entorhinal cortex functional connection strength. Thus, this study shows that thalamic functional connections are sensitive and specific markers of seizure onset laterality in individual temporal lobe epilepsy patients. This study also advances an overall strategy for the programmatic development of neuroimaging biomarkers in clinical and genetic populations: a disease model informed by coordinate-based meta-analysis was used to anatomically constrain individual patient analyses.

  5. Concept for individualized patient allocation: ReCompare—remote comparison of particle and photon treatment plans

    International Nuclear Information System (INIS)

    Lühr, Armin; Baumann, Michael; Löck, Steffen; Roth, Klaus; Helmbrecht, Stephan; Jakobi, Annika; Petersen, Jørgen B; Just, Uwe; Krause, Mechthild; Enghardt, Wolfgang

    2014-01-01

    Identifying those patients who have a higher chance to be cured with fewer side effects by particle beam therapy than by state-of-the-art photon therapy is essential to guarantee a fair and sufficient access to specialized radiotherapy. The individualized identification requires initiatives by particle as well as non-particle radiotherapy centers to form networks, to establish procedures for the decision process, and to implement means for the remote exchange of relevant patient information. In this work, we want to contribute a practical concept that addresses these requirements. We proposed a concept for individualized patient allocation to photon or particle beam therapy at a non-particle radiotherapy institution that bases on remote treatment plan comparison. We translated this concept into the web-based software tool ReCompare (REmote COMparison of PARticlE and photon treatment plans). We substantiated the feasibility of the proposed concept by demonstrating remote exchange of treatment plans between radiotherapy institutions and the direct comparison of photon and particle treatment plans in photon treatment planning systems. ReCompare worked with several tested standard treatment planning systems, ensured patient data protection, and integrated in the clinical workflow. Our concept supports non-particle radiotherapy institutions with the patient-specific treatment decision on the optimal irradiation modality by providing expertise from a particle therapy center. The software tool ReCompare may help to improve and standardize this personalized treatment decision. It will be available from our website when proton therapy is operational at our facility

  6. Effective dose in individuals from exposure the patients treated with 131I using Monte Carlo method

    International Nuclear Information System (INIS)

    Carvalho Junior, Alberico B. de; Silva, Ademir X.

    2007-01-01

    In this work, using the Visual Monte Carlo code and the voxel phantom FAX, elaborated similar scenes of irradiation to the treatments used in the nuclear medicine, with the intention of estimate the effective dose in individuals from exposure the patients treated with 131 I. We considered often specific situations, such as doses to others while sleeping, using public or private transportation, or being in a cinema for a few hours. In the possible situations that has been considered, the value of the effective dose did not overcome 0.05 mSv, demonstrating that, for the considered parameters the patient could be release without receiving instructions from radioprotection. (author)

  7. The effects of peroral glycerol on plasma osmolarity in diabetic patients and healthy individuals

    DEFF Research Database (Denmark)

    Thornit, Dorte Nellemann; Sander, Birgit; la Cour, Morten

    2009-01-01

    Glycerol is used as a peroral treatment of increased intraocular and intracranial pressure due to its osmotic effect despite the potential increase in blood pressure and blood glucose. We examined the effects of peroral glycerol in diabetic patients and healthy individuals on blood pressure......, capillary glucose, and plasma osmolarity. On two separate days, 15 diabetic patients ingested glycerol in doses of 855 and 1710 mg/kg body weight in a randomised, unmasked sequence. Five healthy individuals ingested a dose of 1710 mg/kg body weight. Mean arterial blood pressure (MAP), capillary glucose (CG......, non-significant increase occurred in blood pressure. Maximal DeltaCG was approximately 1 mM irrespective of the dose and presence of diabetes (p > 0.1). The pOSM response was analysed with a kinetic model and found independent of the presence of diabetes (p = 0.6). The maximal fitted DeltapOSM was 12...

  8. Individual and mutual predictors of marital satisfaction among prostate cancer patients and their spouses.

    Science.gov (United States)

    Chien, Ching-Hui; Chuang, Cheng-Keng; Liu, Kuan-Lin; Huang, Xuan-Yi; Pang, See-Tong; Wu, Chun-Te; Chang, Ying-Hsu; Liu, Hsueh-Erh

    2017-12-01

    To determine the individual and mutual predictors of the marital satisfaction of couples in which the husband experienced prostate cancer. Marital satisfaction of patients with prostate cancer has been insufficiently studied in Asian countries as compared with Western countries. This study used a prospective and repeated-measures design. Seventy Taiwanese couples in which the husband had prostate cancer completed measures at 6 and 12 months post-treatment. Assessments of physical symptoms, marital satisfaction, coping behaviour and psychological distress were made. Multiple linear regression was used to analyse the data. The marital satisfaction of patients with prostate cancer and that of their spouses were significantly correlated. At 6 months, spouses' marital satisfaction, patients' appraisal of prostate cancer as a threat and patients' serum prostate-specific antigen levels were found to be the predictors of patients' marital satisfaction. Furthermore, patients' marital satisfaction and their spouses' psychological distress were predictors of spouses' marital satisfaction. At 12 months, spouses' marital satisfaction and patients' appraisal of prostate cancer as harm were predictors of patients' marital satisfaction. Finally, spouses' marital satisfaction (at 6 months) and appraisal of prostate cancer as a threat were predictors of spouses' marital satisfaction. At 6 months post-treatment, patients' and spouses' marital satisfaction will influence each other. However, at 12 months, patients' marital satisfaction exerts an insignificant effect on spouses' marital satisfaction. Moreover, patients' serum prostate-specific antigen level or the negative appraisal of prostate cancer affects their marital satisfaction. Spouses' marital satisfaction is affected by psychological distress and their negative appraisal of prostate cancer. The results can be used to develop interventions for prostate cancer couples. Such an intervention can be used to modify couples

  9. Evidence-Based Indicators of Neuropsychological Change in the Individual Patient: Relevant Concepts and Methods

    Science.gov (United States)

    Duff, Kevin

    2012-01-01

    Repeated assessments are a relatively common occurrence in clinical neuropsychology. The current paper will review some of the relevant concepts (e.g., reliability, practice effects, alternate forms) and methods (e.g., reliable change index, standardized based regression) that are used in repeated neuropsychological evaluations. The focus will be on the understanding and application of these concepts and methods in the evaluation of the individual patient through examples. Finally, some future directions for assessing change will be described. PMID:22382384

  10. Effects of low dose irradiation on NK activity of normal individuals and patients with cancer

    International Nuclear Information System (INIS)

    Tian Hailin; Su Liaoyuan

    1994-10-01

    Effects of low dose irradiation on NK activity of lymphocytes and on K 562 cells were studied. The NK activity was determined by means of 3 H-TdR release assay. While 3 H-TdR incorporation was used to reflect functional changes of K 562 cells after low dose irradiation. 21 patients with cancer and 10 normal individuals were detected. The results indicated that the NK activity of lymphocytes in normal individuals increased significantly after 10 and 50 cGy γ-ray irradiation, while in patients with cancer the NK activity of lymphocytes increased only at the dose of 50 cGy irradiation. The increase of NK activity in normal individuals was higher than that in patients with cancer after same doses of irradiation. When K 562 cells were irradiated by 10 cGy γ-rays, the 3 H-TdR incorporation value increased. After exposed to over 50 cGy the stimulating effect disappeared

  11. Anxiety Sensitivity and Metacognition in Iranian Patients with Functional Gastrointestinal Disorders and Healthy Individuals

    Directory of Open Access Journals (Sweden)

    Fatemeh Zargar

    2016-12-01

    Full Text Available Background: Psychosomatic disorders are a group of psychiatric disorders in which psychological factors play an important role in the development, maintenance, and exacerbation of medical conditions. The most important category of psychosomatic disorders is functional gastrointestinal disorders (FGID. The present study aimed to compare anxiety sensitivity (AS and metacognitions between patients with FGID and healthy individuals in Isfahan, Iran.Methods: This case-control study was conducted on 50 patients (13 men and 37 women with FGID who were diagnosed by a gastroenterologist and had the study inclusion criteria and 50 matched healthy individuals (15 men and 35 women. The subjects were randomly selected. The data collection tools consisted of the Anxiety Sensitivity Index‎-Revised (ASI-R and Metacognitive Beliefs Questionnaire (MCQ-30. The data were analyzed in SPSS software.Results: The results showed that there were significant differences in all subscales of ASI-R and MCQ-30, except the fear of publicly observable symptoms subscale in the ASI-R and negative beliefs about the uncontrollability of thoughts and corresponding danger (UD subscale in MCQ-30 between patients with FGID and healthy individuals.Conclusion: The results showed that AS and metacognitive beliefs about worry play a crucial role in psychosomatic disorders such as FGID. Anxiety has appeared as the common component between FGID. Hence, the management of anxiety in FGID by clinicians in the treatment of these disorders is recommended.

  12. Protective versus Conventional Ventilation for Surgery: A Systematic Review and Individual Patient Data Meta-analysis.

    Science.gov (United States)

    Serpa Neto, Ary; Hemmes, Sabrine N T; Barbas, Carmen S V; Beiderlinden, Martin; Biehl, Michelle; Binnekade, Jan M; Canet, Jaume; Fernandez-Bustamante, Ana; Futier, Emmanuel; Gajic, Ognjen; Hedenstierna, Göran; Hollmann, Markus W; Jaber, Samir; Kozian, Alf; Licker, Marc; Lin, Wen-Qian; Maslow, Andrew D; Memtsoudis, Stavros G; Reis Miranda, Dinis; Moine, Pierre; Ng, Thomas; Paparella, Domenico; Putensen, Christian; Ranieri, Marco; Scavonetto, Federica; Schilling, Thomas; Schmid, Werner; Selmo, Gabriele; Severgnini, Paolo; Sprung, Juraj; Sundar, Sugantha; Talmor, Daniel; Treschan, Tanja; Unzueta, Carmen; Weingarten, Toby N; Wolthuis, Esther K; Wrigge, Hermann; Gama de Abreu, Marcelo; Pelosi, Paolo; Schultz, Marcus J

    2015-07-01

    Recent studies show that intraoperative mechanical ventilation using low tidal volumes (VT) can prevent postoperative pulmonary complications (PPCs). The aim of this individual patient data meta-analysis is to evaluate the individual associations between VT size and positive end-expiratory pressure (PEEP) level and occurrence of PPC. Randomized controlled trials comparing protective ventilation (low VT with or without high levels of PEEP) and conventional ventilation (high VT with low PEEP) in patients undergoing general surgery. The primary outcome was development of PPC. Predefined prognostic factors were tested using multivariate logistic regression. Fifteen randomized controlled trials were included (2,127 patients). There were 97 cases of PPC in 1,118 patients (8.7%) assigned to protective ventilation and 148 cases in 1,009 patients (14.7%) assigned to conventional ventilation (adjusted relative risk, 0.64; 95% CI, 0.46 to 0.88; P ventilation with low VT and high PEEP levels and 63 cases in 525 patients (12%) assigned to ventilation with low VT and low PEEP levels (adjusted relative risk, 0.93; 95% CI, 0.64 to 1.37; P = 0.72). A dose-response relationship was found between the appearance of PPC and VT size (R2 = 0.39) but not between the appearance of PPC and PEEP level (R2 = 0.08). These data support the beneficial effects of ventilation with use of low VT in patients undergoing surgery. Further trials are necessary to define the role of intraoperative higher PEEP to prevent PPC during nonopen abdominal surgery.

  13. Advanced-stage III/IV follicular lymphoma. Treatment strategies for individual patients

    Energy Technology Data Exchange (ETDEWEB)

    Heinzelmann, Frank; Bamberg, Michael; Weinmann, Martin [Dept. of Radiation Oncology, Univ. of Tuebingen (Germany); Ottinger, Hellmut [Dept. of Bone Marrow Transplantation, Univ. of Essen (Germany); Engelhard, Marianne [Dept. of Radiation Oncology, Univ. of Essen (Germany); Soekler, Martin [Dept. of Internal Medicine II, Univ. of Tuebingen (Germany)

    2010-05-15

    Background: in patients with advanced-stage III/IV follicular lymphoma (FL), there are many treatment options available. The current challenge is to choose the optimal strategy for the individual patient. Methods: the literature was reviewed with respect to treatment strategies in patients with advanced FL by screening the PubMed databank. Results: in advanced-stage III/IV FL, median survival may approach 8-10 years. Treatment strategies include a watch-and-wait strategy, chemoimmunotherapy, monotherapy with rituximab, and - as an experimental approach so far - radioimmunotherapy. The use of autologous hematopoietic stem cell transplantation (HSCT) for patients in first remission or chemosensitive relapse prolongs progression-free survival while the effect on overall survival remains unclear compared to standard chemotherapy. However, long-term results are flawed by high relapse rates and risk of secondary malignancies. In patients with relapsed/chemoresistant disease, allogeneic HSCT constitutes the only curative approach but is associated with high treatment-related mortality. In the palliative setting, low-dose involved-field irradiation constitutes an effective treatment option in order to control local symptoms with potential long-lasting response. Conclusion: in case of advanced-disease FL, asymptomatic patients can be managed expectantly. In symptomatic patients, chemoimmunotherapy is regarded as standard therapy. In symptomatic elderly patients with relevant comorbidities, rituximab {+-} single-agent chemotherapy, or low-dose involved-field radiotherapy might be appropriate. For younger patients with chemoresistant/relapsed disease, allogeneic HSCT might be considered, since advances in supportive care and better patient selection have resulted in improved outcomes. (orig.)

  14. Individual quality of life in patients undergoing radiotherapy. A longitudinal survey

    International Nuclear Information System (INIS)

    Wenskus, Julia Katharina

    2015-01-01

    The way that Quality of Life (QoL) is perceived has crucially changed over the last few decades. As a consequence of demographic change and ongoing technical progress, QoL gained in importance and became established as a major outcome parameter in clinical trials. Scientists in the field of QoL differentiate between three categories: health-related, global and individual QoL. For the assessment of individual QoL, Becker et al. (2014) and Merk (2011) developed and validated an easily applicable and economical questionnaire; the SEIQoL-Q. The purpose of our study was to modify the SEIQoL-Q based on Merk's approach (2011) and apply the revised version in a longitudinal survey of different patient populations in the Clinic for Radiotherapy of the University Hospital of Freiburg. Apart from that, other crucial factors, which might affect the evaluation of one's QoL, were gathered by use of a newly established questionnaire. 132 patients undergoing radiotherapy and having been diagnosed with breast cancer (BC), prostate cancer (PC), bone metastasis (BM) or a benign disease (B) were included in our study. The participants were interviewed at four definitive times in their treatment (1. before the radiotherapy had started, 2. after 50 % of the total radiation dose had been given, 3. at the end of the therapy, 4. during the aftercare). A total of 419 interviews were carried out. While the highest possible score was 100, the average individual QoL was 60.48 (BC: 56.55; PC: 64.13; BM: 59.27; B: 58.85). Significant differences of the individual QoL were revealed between the diagnosis groups (BC vs. PC, PC vs. B, PC vs. BM), the age (< 66 years: 55.39; = 66 years: 62.27) and the gender (women: 57.11; men: 62.88). Additionally, the expectations and the mood influenced the assessment of the individual QoL. Furthermore, it could be shown that there were correlations between the individual QoL and personality, depressive tendencies, ego strength, optimism, self-concept, faith and

  15. Comparison of Plasma Neurosteroid and Prolactin Levels in Patients with Schizophrenia and Healthy Individuals

    Directory of Open Access Journals (Sweden)

    Forough Riahi

    2016-01-01

    Full Text Available Background. The present study aimed to compare plasma levels of cortisol, testosterone, dehydroepiandrosterone (DHEA, and prolactin in patients with schizophrenia and healthy individuals. Method. A total of 100 patients with schizophrenia disorder (69 men and 31 women and 190 healthy individuals (94 men and 96 women participated in this cross-sectional study. They were tested for hormone levels and completed demographic questionnaires. Data were analyzed using multivariate analysis of variance (MANOVA and one-way analysis of variance. Results. Serum testosterone level was significantly higher in men with schizophrenia than in healthy men. Women with schizophrenia had a significantly higher level of testosterone and lower level of prolactin compared to healthy women. There were no significant differences in hormone levels across various subtypes of schizophrenia. No significant differences also were observed in hormones levels in patients with first-episode schizophrenia disorder compared to those in patients with recurrent episodes. Conclusion. This study indicated that abnormal testosterone and prolactin levels might be associated with pathophysiology of schizophrenia disorder.

  16. Inter- and intra-individual variability in the levels of plasma homovanillic acid in schizophrenic patients.

    Science.gov (United States)

    Zumárraga, Mercedes; Dávila, Ricardo; González-Torres, Miguel Angel; Anguiano, Juan B; Zabalo, María José; Basterreche, Nieves; Arrúe, Aurora; Zamalloa, María Isabel; Guimón, José

    2007-04-13

    Changes in the levels of homovanillic acid in blood plasma (pHVA) may reflect changes which occur in the brain. In healthy individuals, this concentration of pHVA is stable over time. Over the course of one month, we studied 98 acute schizophrenic patients who had not been taking any medication but were administered neuroleptics upon hospital admission, together with 23 chronic schizophrenic patients on long-term treatment from whom medication was withdrawn. Blood samples were taken at regular intervals from each individual and the concentration of plasma homovanillic acid was measured. We found relative stable values of pHVA with an intraclass correlation coefficient of 0.363 in acute patients and 0.638 (ppHVA and the presence of pharmacological stimuli, we found a certain reproducibility in the levels of this dopamine metabolite. These findings are consistent with the idea that the dopaminergic activity is characterized by a constitutive value which would be under genetic control. The higher stability observed in chronic patients may reflect a weaker, age-related dopaminergic plasticity; conversely, it may indicate that a lack of plasticity in response to a pharmacological stimulus may be an indicator of poorer prognosis.

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

    Science.gov (United States)

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

    2009-09-14

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

  18. Relationship between family meal frequency and individual dietary intake among diabetic patients.

    Science.gov (United States)

    Ruhee, Divya; Mahomoodally, Fawzi

    2015-01-01

    Notoriously, the island of Mauritius has one of the highest prevalence of diabetes in the world. Management of the disease is very important and family meals are undoubtedly beneficial to patients as they promote the development of healthy eating behaviours and food choices. This study has aimed to probe into potential relationship(s) between family meal frequency and individual dietary intake among diabetic patients and to establish whether family cohesion may be a plausible mediator of this relationship. A cross-sectional survey was carried out with a random sample of 384 diabetic patients. The Family Adaptability and Cohesion Evaluation Scale III was used to obtain information on two general aspects of family functioning, that is, cohesiveness and adaptability. Chi-squared (χ (2)) tests, independent sample t-tests and one-way ANOVA were used to determine statistical significance. Pearson correlation was used to examine associations between family meal frequency, individual dietary intake and family cohesion. Hierarchical linear regression models were performed for the mediation analysis. Family meal frequency (breakfast, lunch and dinner) was observed to be positively associated with intake of fish, raw vegetables, dried and fresh fruits, low-fat milk, cheese, yogurt, nuts and light butter and negatively associated with intake of red meat, white rice, white bread, whole egg fried, chocolates, fried cakes, burgers, chips, and fried noodles/rice. Average mediation (52.6 %) was indicated by family cohesion for the association between family meal frequency and individual dietary intake among diabetic patients. Sobel's test further confirmed the trend towards complete mediation (z = 15.4; P relationship between family meal frequency and individual dietary intake among diabetic patients was recorded. The present study is one of the few studies that have examined family cohesion as a mediator of the relationship and to our best knowledge is the first work to

  19. Insulin sensitivity to trace metals (Chromium, manganese) in type 2 diabetic patients and diabetic individuals

    International Nuclear Information System (INIS)

    Hajra, B.; Orakzai, S.A.; Faryal, U.; Hassan, M.

    2016-01-01

    Background: Diabetes mellitus constitutes one of the most important problems in developing and non-developing countries. The purpose of the study to estimate the concentrations of Chromium and Manganese in diabetic and non-diabetic population of Hazara division. The cross sectional comparative study was carried out on one hundred blood samples of Type 2 Diabetic patients collected non-randomly from Ayub Teaching Hospital and one hundred normal healthy controls from Women Medical College Abbottabad from September 2014 to April 2015. Methods: The study included two hundred subjects. Among them 100 were diabetic and 100 non diabetic respectively. The blood samples were collected from Ayub Medical College, Abbottabad. The serum Chromium and Manganese levels were determined by Atomic Absorption spectrophotometer. Results: Serum Chromium and Manganese levels were decreased in diabetic and increased in non-diabetic patients. Conclusion: Low serum level of Chromium and manganese were found in diabetic patients as compare to non-diabetic individuals. (author)

  20. Host imprints on bacterial genomes--rapid, divergent evolution in individual patients.

    Directory of Open Access Journals (Sweden)

    Jaroslaw Zdziarski

    Full Text Available Bacteria lose or gain genetic material and through selection, new variants become fixed in the population. Here we provide the first, genome-wide example of a single bacterial strain's evolution in different deliberately colonized patients and the surprising insight that hosts appear to personalize their microflora. By first obtaining the complete genome sequence of the prototype asymptomatic bacteriuria strain E. coli 83972 and then resequencing its descendants after therapeutic bladder colonization of different patients, we identified 34 mutations, which affected metabolic and virulence-related genes. Further transcriptome and proteome analysis proved that these genome changes altered bacterial gene expression resulting in unique adaptation patterns in each patient. Our results provide evidence that, in addition to stochastic events, adaptive bacterial evolution is driven by individual host environments. Ongoing loss of gene function supports the hypothesis that evolution towards commensalism rather than virulence is favored during asymptomatic bladder colonization.

  1. A comparision of Brain-Behavioral Systems in patients with multiple sclerosis and normal individuals

    Directory of Open Access Journals (Sweden)

    kobra Moradi

    2016-05-01

    Full Text Available Background: The aim of this study was to compare   Brain-Behavioral Systems in patient with multiple sclerocis (MS and normal individuals. Materials and Methods: This research was a post facto comparative study, subjects included  healthy persons and all patients with MS, which in summer and autumn 2013 referred to neurologists in the Lorestan province. Of the population using as samples, 117 cases (75 patients and 42 normal subjects were selected, then Gray- Wilson Personality Questionnaire was completed for them. To analyze the data, multivariate analysis of variance (MANOVA test  was used to compare the two groups. Results: The results showed, in BAS scales, people with MS had significantly lower scores than normal subjects Conclusion: What comes from findings indicates that a low score in behavioral activation as a pathological factors in chronic diseases such as MS is concerned and is in need of psychological treatment.

  2. Individual differences in normal body temperature: longitudinal big data analysis of patient records.

    Science.gov (United States)

    Obermeyer, Ziad; Samra, Jasmeet K; Mullainathan, Sendhil

    2017-12-13

    To estimate individual level body temperature and to correlate it with other measures of physiology and health. Observational cohort study. Outpatient clinics of a large academic hospital, 2009-14. 35 488 patients who neither received a diagnosis for infections nor were prescribed antibiotics, in whom temperature was expected to be within normal limits. Baseline temperatures at individual level, estimated using random effects regression and controlling for ambient conditions at the time of measurement, body site, and time factors. Baseline temperatures were correlated with demographics, medical comorbidities, vital signs, and subsequent one year mortality. In a diverse cohort of 35 488 patients (mean age 52.9 years, 64% women, 41% non-white race) with 243 506 temperature measurements, mean temperature was 36.6°C (95% range 35.7-37.3°C, 99% range 35.3-37.7°C). Several demographic factors were linked to individual level temperature, with older people the coolest (-0.021°C for every decade, Pdata) was linked to 8.4% higher one year mortality (P=0.014). Individuals' baseline temperatures showed meaningful variation that was not due solely to measurement error or environmental factors. Baseline temperatures correlated with demographics, comorbid conditions, and physiology, but these factors explained only a small part of individual temperature variation. Unexplained variation in baseline temperature, however, strongly predicted mortality. 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.

  3. Individual differences in normal body temperature: longitudinal big data analysis of patient records

    Science.gov (United States)

    Samra, Jasmeet K; Mullainathan, Sendhil

    2017-01-01

    Abstract Objective To estimate individual level body temperature and to correlate it with other measures of physiology and health. Design Observational cohort study. Setting Outpatient clinics of a large academic hospital, 2009-14. Participants 35 488 patients who neither received a diagnosis for infections nor were prescribed antibiotics, in whom temperature was expected to be within normal limits. Main outcome measures Baseline temperatures at individual level, estimated using random effects regression and controlling for ambient conditions at the time of measurement, body site, and time factors. Baseline temperatures were correlated with demographics, medical comorbidities, vital signs, and subsequent one year mortality. Results In a diverse cohort of 35 488 patients (mean age 52.9 years, 64% women, 41% non-white race) with 243 506 temperature measurements, mean temperature was 36.6°C (95% range 35.7-37.3°C, 99% range 35.3-37.7°C). Several demographic factors were linked to individual level temperature, with older people the coolest (–0.021°C for every decade, Ptemperature (eg, hypothyroidism: –0.013°C, P=0.01) or higher temperature (eg, cancer: 0.020, Pbody mass index: 0.002 per m/kg2, Ptemperature variation. Despite this, unexplained temperature variation was a significant predictor of subsequent mortality: controlling for all measured factors, an increase of 0.149°C (1 SD of individual temperature in the data) was linked to 8.4% higher one year mortality (P=0.014). Conclusions Individuals’ baseline temperatures showed meaningful variation that was not due solely to measurement error or environmental factors. Baseline temperatures correlated with demographics, comorbid conditions, and physiology, but these factors explained only a small part of individual temperature variation. Unexplained variation in baseline temperature, however, strongly predicted mortality. PMID:29237616

  4. Fatigue, pain and patient global assessment responses to biological treatment are unpredictable, and poorly inter-connected in individual rheumatoid arthritis patients followed in the daily clinic

    DEFF Research Database (Denmark)

    Madsen, Ole Rintek; Egsmose, Eva Marie

    2016-01-01

    The objective of the study was to investigate relations on group level and agreements on the individual patient level between changes in fatigue, pain and patient global assessment (PaGl) assessed on visual analogue scales (VAS) in patients with rheumatoid arthritis (RA) after initiating...... and by baseline values. The results expose the unpredictable nature of patient-reported VAS scores in individual patients with RA....

  5. A multicenter, randomized controlled trial of individualized occupational therapy for patients with schizophrenia in Japan

    Science.gov (United States)

    Ohori, Manami; Inagaki, Yusuke; Shimooka, Yuko; Sugimura, Naoya; Ishihara, Ikuyo; Yoshida, Tomotaka

    2018-01-01

    The individualized occupational therapy (IOT) program is a psychosocial program that we developed to facilitate proactive participation in treatment and improve cognitive functioning and other outcomes for inpatients with acute schizophrenia. The program consists of motivational interviewing, self-monitoring, individualized visits, handicraft activities, individualized psychoeducation, and discharge planning. This multicenter, open-labeled, blinded-endpoint, randomized controlled trial evaluated the impact of adding IOT to a group OT (GOT) program as usual for outcomes in recently hospitalized patients with schizophrenia in Japanese psychiatric hospitals setting compared with GOT alone. Patients with schizophrenia were randomly assigned to the GOT+IOT group or the GOT alone group. Among 136 randomized patients, 129 were included in the intent-to-treat population: 66 in the GOT+IOT and 63 in the GOT alone groups. Outcomes were administered at baseline and discharge or 3 months following hospitalization including the Brief Assessment of Cognition in Schizophrenia Japanese version (BACS-J), the Schizophrenia Cognition Rating Scale Japanese version, the Social Functioning Scale Japanese version, the Global Assessment of Functioning scale, the Intrinsic Motivation Inventory Japanese version (IMI-J), the Morisky Medication Adherence Scale-8 (MMAS-8), the Positive and Negative Syndrome Scale (PANSS), and the Japanese version of Client Satisfaction Questionnaire-8 (CSQ-8J). Results of linear mixed effects models indicated that the IOT+GOT showed significant improvements in verbal memory (p IOT demonstrated significant improvements on the CSQ-8J compared with the GOT alone (p IOT program and its effectiveness for improving cognitive impairment and other outcomes in patients with schizophrenia. PMID:29621261

  6. Transport of mucoid mucus in healthy individuals and patients with chronic obstructive pulmonary disease and bronchiectasis

    Directory of Open Access Journals (Sweden)

    J. Lima Afonso

    2013-09-01

    Full Text Available Objective: To characterize and compare the in vitro transport properties of respiratory mucoid secretion in individuals with no lung disease and in stable patients with chronic obstructive pulmonary disease (COPD and bronchiectasis. Methodology: Samples of mucus were collected from 21 volunteers presenting no lung disease who had undergone surgery, from 10 patients presenting chronic COPD, and from 16 patients with bronchiectasis. Mucociliary transport (MCT, transport by cough (SCM, and contact angle (CAM were evaluated. Results: MCT was found to be greater in healthy individuals (1.0 ± 0.19 than in COPD (0.91 ± 0.17 and bronchiectasis (0.76 ± 0.23 patients (p < 0.05, whereas SCM was greater in COPD patients (16.31 ± 7.35 cm than in patients with bronchiectasis (12.16 ± 6.64 cm and healthy individuals (10.50 ± 25.8 cm (p < 0.05. No significant differences were observed between the groups regarding CAM. Conclusion: Mucus from healthy individuals allows better mucociliary transport compared to that from patients with lung diseases. However, the mucus from COPD patients allows a better transport by coughing, demonstrating that these individuals have adapted to a defence mechanism compared to patients with bronchiectasis, who have impairment in their ciliary and cough transport mechanisms. Resumo: Objetivo: Analisar e comparar as propriedades de transporte in vitro da secreção respiratória de aspeto mucoide (M de indivíduos sem doença respiratória e de pacientes com doença pulmonar obstrutiva crónica (DPOC e bronquiectasias estáveis. Métodos: Foram avaliadas 21 amostras de indivíduos sem doença pulmonar submetidos a processos cirúrgicos, 10 amostras de pacientes com DPOC e 16 amostras de pacientes com bronquiectasias quanto ao transporte mucociliar (TMC, deslocamento na máquina simuladora de tosse (MST e ângulo de contacto (AC. Resultados: Maior TMC das amostras de indivíduos sem doença respiratória (1,0

  7. From the best results of medical research to therapy involving the context of an individual patient

    Directory of Open Access Journals (Sweden)

    Małgorzata K. Szerla

    2015-01-01

    Full Text Available Contextualisation is the process of identifying specific factors of a patient’s life situation, which is focused on individualised care. In the light of reference books, contextualisation is an integral part of therapy with an active participation of the patient and/or his/her carers. Among many factors that constitute the functioning of a person, family and socio-material situation, access to professional health care, and the ability to exercise self-care are major contextual factors of the patient’s health situation. The purpose of this article is to draw attention to the fact that the limiting oneself exclusively to algorithms as procedures based on the best evidence (best evidence medical research – BEMR may raise the specific danger of underestimating the variability of individual responses of the human body under the influence of factors forming a personal context. The phenomenon of contextualisation in the treatment of an individual patient is still not adequately disseminated, although it is an important element in the decision-making process, with proven impact on the efficiency and quality of care and satisfaction of a patient.

  8. Patients' Illness Perception as a Tool to Improve Individual Disease Management in Primary Cutaneous Lymphomas.

    Science.gov (United States)

    Porkert, Stefanie; Lehner-Baumgartner, Eva; Valencak, Julia; Knobler, Robert; Riedl, Elisabeth; Jonak, Constanze

    2018-02-07

    The Revised Illness Perception Questionnaire (IPQ-R) has been shown to assess illness perception reproducibly in primary cutaneous T-cell lymphomas (CTCL). Illness perception reflects patients' individual concepts of understanding and interpretation of the disease, influencing illness behaviour and health-related quality of life (HRQOL). This study investigated the clinical relevance of the relationships between illness perception, illness behaviour, and HRQOL in CTCL and cutaneous B-cell lymphomas (CBCL). A total of 92 patients completed the IPQ-R, the Scale for the Assessment of Illness Behavior (SAIB), and a skin-specific HRQOL tool (Skindex-29). Data on illness behaviour were not evidently related to illness perception, whereas illness perception was significantly associated with HRQOL. Both, IPQ-R and HRQOL results correlated with disease entity, stage, and socio-demographics. Only IPQ-R results provided practical information on patients' needs to train personal coping strategies. IPQ-R assessment in CTCL and CBCL might be a useful instrument to improve individual disease management.

  9. Human T-cell responses to Aspergillus fumigatus : In healthy individuals and patients with Aspergillus-related disease

    NARCIS (Netherlands)

    Jolink, H.

    2017-01-01

    The T-cell mediated immune response to Aspergillus fumigatus was studied in healthy individuals and in several patient groups. In peripheral blood of healthy individuals low frequencies of Aspergillus-specific CD4+ T-cells with a Thelper 1 profile were present. In patients with invasive

  10. Relative importance and interrelations between psychosocial factors and individualized quality of life of hemodialysis patients.

    Science.gov (United States)

    Tovbin, David; Gidron, Yori; Jean, Tzipora; Granovsky, Ricardo; Schnieder, Alla

    2003-09-01

    Since quality of life (QOL) of hemodialysis (HD) patients is low and frequently difficult to improve by medical therapy, it is important to identify psychosocial correlates and life-domains important for HD patients' QOL. Our hypothesis was that psychosocial factors reflecting appraisal, external and internal resources/impediments correlate with QOL and compensate for adverse effects of disease-related variables on QOL. Forty-eight chronic HD-patients identified and rank-ordered life-domains important for QOL and rated their level of satisfaction with those domains. This was performed using a slightly modified version of the Self-Evaluated Individualized QOL (SEiQOL) Scale. Psychosocial factors included perceived-control (PC), social-support and hostility. Demographic and disease-related factors included age, gender, cardiovascular disease (CVD), diabetes, hematocrit, albumin and C-reactive protein. QOL was significantly correlated with PC (r = 0.65) and social-support (r = 0.38), and inversely correlated with hostility (r = -0.31), diabetes and hypoalbuminemia (all at least p < 0.05). PC mediated effects of certain variables (e.g., albumin, gender, hostility) and moderated effects of little social-support and hypoalbuminemia on QOL. Patients' most important QOL domains were health, with which satisfaction was lowest, followed by family, with which satisfaction was highest. Pending replication with larger samples, assessment and enhancement of PC may improve HD patients' QOL.

  11. Evaluation of individual quality of life among hemodialysis patients: nominated themes using SEIQoL-adapted.

    Science.gov (United States)

    Matlabi, Hossein; Ahmadzadeh, Sharareh

    2017-01-01

    Quality of life (QoL) has become an important issue for patients with chronic renal failure diseases who are permanently undergoing hemodialysis. In this study, an adapted schedule for the evaluation of individual quality of life (SEIQoL-adapted) was used to evaluate QoL among hemodialysis patients, to explore their views about the most important aspects of life satisfaction. A multiple approach design and convenience sampling were applied to recruit 53 patients from a hemodialysis unit in Iran. Data were collected through structured interviews and then analyzed using conventional content analysis. A total score for QoL was calculated using scale guideline. The most important aspects of life were health, family, financial status, living conditions, leisure activities, relationships and socializing, religious and spiritual issues, medical knowledge, and therapies or treatments. The calculated mean QoL score was 66.2, indicating a relatively high life satisfaction. Males had higher QoL scores than females in both married and single groups. Moreover, the relationships between the QoL scores and education, job and marital status were not statistically significant. The SEIQoL-adapted revealed reasonable lay definitions of QoL in a group of patients following chronic renal failure. The patients' views of the aspects of life could be used by health policy makers, clinicians, and caregivers as a reliable guide to the most important priorities for treatment and medical interventions.

  12. [An individual approach to the surgical treatment and medical rehabilitation of duodenal ulcer patients].

    Science.gov (United States)

    Kochetkov, A V; Barashkov, V G; Papazov, V I

    1996-01-01

    Since 1986 403 patients have been treated according to the following programme: successive preparation for surgery, the operative intervention chosen individually for each patient, the purposeful medical rehabilitation. Different types of vagotomy with draining operations were performed in 85.6% of the cases, stomach resection--in 14.4% of the patients. The mortality rate was 0%. The indications for various types of vagotomy, stomach resection and different types of draining operations were determined. Rehabilitation of 55% of the patients after the operative treatment took place at the gastroenterological department, the others--at an outpatient department. The indications for rehabilitation, its volume and time were established. The best remote results in the follow-up periods up to five years were obtained after truncal vagotomy and stomach resection. Ulcer recurrences were noted in 3.5% and 5.2% of the cases respectively. Recurrences of the disease were noted in 7.8% after combined vagotomy and in more than 20% after SPV. Nine patients out of 34 with recurrent ulcers were reoperated with good results, the others were successfully treated by conservative therapy.

  13. How to Distinguish Patients with pSS among Individuals with Dryness without Invasive Diagnostic Studies

    Directory of Open Access Journals (Sweden)

    Agata Sebastian

    2018-01-01

    Full Text Available In the course of pSS, inflammatory cell infiltration consists mainly of lymphocytes infiltrating exocrine glands, which leads to their impaired function. The characteristic feature is generalized dryness. The aim of this study was to attempt to answer the question whether it is possible to distinguish between patients with pSS and individuals with dryness caused by other pathologies without applying invasive studies. The study included 68 patients with pSS and 43 healthy controls with dryness. FS ≥ 1 was observed in 90% of patients with pSS (with or without dryness, and only in 23% of the control group (only with xerostomia. In the pSS group, anaemia (p=0.0085, lymphocytopenia (p=0.0006, elevated ERS (p=0.001, higher RF titer, and ANA antibodies were noted. Configuration of anti-SSA + SSB + Ro52 antibodies was characteristic for the pSS group. Considering the clinical symptoms, statistically significant differences were noted between pSS patients and the control group in frequency (p=0.02 and severity (p=0.042 of fatigue, lymphadenopathy, major salivary gland involvement, and photosensitivity to UV light. In conclusion, invasive methods are pivotal in pSS diagnosis in this salivary gland biopsy. Chronic fatigue syndrome is more common in pSS patients and can be subjective distinguishing factor in the group of people with dryness.

  14. Early onset facioscapulohumeral dystrophy - a systematic review using individual patient data.

    Science.gov (United States)

    Goselink, Rianne J M; Voermans, Nicol C; Okkersen, Kees; Brouwer, Oebele F; Padberg, George W; Nikolic, Ana; Tupler, Rossella; Dorobek, Malgorzata; Mah, Jean K; van Engelen, Baziel G M; Schreuder, Tim H A; Erasmus, Corrie E

    2017-12-01

    Infantile or early onset is estimated to occur in around 10% of all facioscapulohumeral dystrophy (FSHD) patients. Although small series of early onset FSHD patients have been reported, comprehensive data on the clinical phenotype is missing. We performed a systematic literature search on the clinical features of early onset FSHD comprising a total of 43 articles with individual data on 227 patients. Additional data from four cohorts was provided by the authors. Mean age at reporting was 18.8 years, and 40% of patients were wheelchair-dependent at that age. Half of the patients had systemic features, including hearing loss (40%), retinal abnormalities (37%) and developmental delay (8%). We found an inverse correlation between repeat size and disease severity, similar to adult-onset FSHD. De novo FSHD1 mutations were more prevalent than in adult-onset FSHD. Compared to adult FSHD, our findings indicate that early onset FSHD is overall characterized by a more severe muscle phenotype and a higher prevalence of systemic features. However, similar as in adults, a significant clinical heterogeneity was observed. Based on this, we consider early onset FSHD to be on the severe end of the FSHD disease spectrum. We found natural history studies and treatment studies to be very scarce in early onset FSHD, therefore longitudinal studies are needed to improve prognostication, clinical management and trial-readiness. Copyright © 2017 Elsevier B.V. All rights reserved.

  15. Inhaled Nitric Oxide in preterm infants: a systematic review and individual patient data meta-analysis

    Directory of Open Access Journals (Sweden)

    Schreiber Michael D

    2010-03-01

    Full Text Available Abstract Background Preterm infants requiring assisted ventilation are at significant risk of both pulmonary and cerebral injury. Inhaled Nitric Oxide, an effective therapy for pulmonary hypertension and hypoxic respiratory failure in the full term infant, has also been studied in preterm infants. The most recent Cochrane review of preterm infants includes 11 studies and 3,370 participants. The results show a statistically significant reduction in the combined outcome of death or chronic lung disease (CLD in two studies with routine use of iNO in intubated preterm infants. However, uncertainty remains as a larger study (Kinsella 2006 showed no significant benefit for iNO for this combined outcome. Also, trials that included very ill infants do not demonstrate significant benefit. One trial of iNO treatment at a later postnatal age reported a decrease in the incidence of CLD. The aim of this individual patient meta-analysis is to confirm or refute these potentially conflicting results and to determine the extent to which patient or treatment characteristics may explain the results and/or may predict benefit from inhaled Nitric Oxide in preterm infants. Methods/Design The Meta-Analysis of Preterm Patients on inhaled Nitric Oxide (MAPPiNO Collaboration will perform an individual patient data meta-analysis to answer these important clinical questions. Studies will be included if preterm infants receiving assisted ventilation are randomized to receive inhaled Nitric Oxide or to a control group. The individual patient data provided by the Collaborators will be analyzed on an intention-to-treat basis where possible. Binary outcomes will be analyzed using log-binomial regression models and continuous outcomes will be analyzed using linear fixed effects models. Adjustments for trial differences will be made by including the trial variable in the model specification. Discussion Thirteen (13 trials, with a total of 3567 infants are eligible for inclusion

  16. Postoperative glaucoma following infantile cataract surgery: an individual patient data meta-analysis.

    Science.gov (United States)

    Mataftsi, Asimina; Haidich, Anna-Bettina; Kokkali, Stamatia; Rabiah, Peter K; Birch, Eileen; Stager, David R; Cheong-Leen, Richard; Singh, Vineet; Egbert, James E; Astle, William F; Lambert, Scott R; Amitabh, Purohit; Khan, Arif O; Grigg, John; Arvanitidou, Malamatenia; Dimitrakos, Stavros A; Nischal, Ken K

    2014-09-01

    Infantile cataract surgery bears a significant risk for postoperative glaucoma, and no consensus exists on factors that may reduce this risk. To assess the effect of primary intraocular lens implantation and timing of surgery on the incidence of postoperative glaucoma. We searched multiple databases to July 14, 2013, to identify studies with eligible patients, including PubMed, MEDLINE, EMBASE, ISI Web of Science, Scopus, Central, Google Scholar, Intute, and Tripdata. We also searched abstracts of ophthalmology society meetings. We included studies reporting on postoperative glaucoma in infants undergoing cataract surgery with regular follow-up for at least 1 year. Infants with concurrent ocular anomalies were excluded. Authors of eligible studies were invited to contribute individual patient data on infants who met the inclusion criteria. We also performed an aggregate data meta-analysis of published studies that did not contribute to the individual patient data. Data were pooled using a random-effects model. Time to glaucoma with the effect of primary implantation, additional postoperative intraocular procedures, and age at surgery. Seven centers contributed individual patient data on 470 infants with a median age at surgery of 3.0 months and median follow-up of 6.0 years. Eighty patients (17.0%) developed glaucoma at a median follow-up of 4.3 years. Only 2 of these patients had a pseudophakic eye. The risk for postoperative glaucoma appeared to be lower after primary implantation (hazard ratio [HR], 0.10 [95% CI, 0.01-0.70]; P = .02; I(2) = 34%), higher after surgery at 4 weeks or younger (HR, 2.10 [95% CI, 1.14-3.84]; P = .02; I(2) = 0%), and higher after additional procedures (HR, 2.52 [95% CI, 1.11-5.72]; P = .03; I(2) = 32%). In multivariable analysis, additional procedures independently increased the risk for glaucoma (HR, 2.25 [95% CI, 1.20-4.21]; P = .01), and primary implantation independently reduced it (HR, 0.10 [95% CI, 0.01-0.76]; P =

  17. Double-blind comparison of etodolac and diclofenac in patients with rheumatoid arthritis

    NARCIS (Netherlands)

    Lonauer, G.; Tisscher, J. R.; Lim, H. G.; Bijlsma, J. W.

    1993-01-01

    The efficacy and tolerability of etodolac was compared to diclofenac in a multi-centre, double-blind, randomized parallel group study. Fifty-three patients with rheumatoid arthritis received etodolac (400 mg/day) and 55 patients received diclofenac (150 mg/day) for 12 weeks. Thirty-nine

  18. The effects of living distantly from peritoneal dialysis units on peritonitis risk, microbiology, treatment and outcomes: a multi-centre registry study

    Science.gov (United States)

    2012-01-01

    Background The aim of the study was to determine whether distance between residence and peritoneal dialysis (PD) unit influenced peritonitis occurrence, microbiology, treatment and outcomes. Methods The study included all patients receiving PD between 1/10/2003 and 31/12/2008, using ANZDATA Registry data. Results 365 (6%) patients lived ≥100 km from their nearest PD unit (distant group), while 6183 (94%) lived peritonitis in distant patients (1.34 years, 95% CI 1.07-1.61) was significantly shorter than in local patients (1.68 years, 95% CI 1.59-1.77, p = 0.001), whilst overall peritonitis rates were higher in distant patients (incidence rate ratio 1.32, 95% CI 1.20-1.46). Living ≥100 km away from a PD unit was independently associated with a higher risk of S. aureus peritonitis (adjusted odds ratio [OR] 1.64, 95% CI 1.09-2.47). Distant patients with first peritonitis episodes were less likely to be hospitalised (64% vs 73%, p = 0.008) and receive antifungal prophylaxis (4% vs 10%, p = 0.01), but more likely to receive vancomycin-based antibiotic regimens (52% vs 42%, p peritonitis outcomes, distant patients were more likely to be cured with antibiotics alone (OR 1.55, 95% CI 1.03-2.24). All other outcomes were comparable between the two groups. Conclusions Living ≥100 km away from a PD unit was associated with increased risk of S. aureus peritonitis, modified approaches to peritonitis treatment and peritonitis outcomes that were comparable to, or better than patients living closer to a PD unit. Staphylococcal decolonisation should receive particular consideration in remote living patients. PMID:22702659

  19. Electrical impedance tomography as possible guidance for individual positioning of patients with multiple lung injury.

    Science.gov (United States)

    Lehmann, Sylvia; Leonhardt, Steffen; Ngo, Chuong; Bergmann, Lukas; Schrading, Simone; Heimann, Konrad; Wagner, Norbert; Tenbrock, Klaus

    2018-01-01

    Electrical Impedance Tomography (EIT) is a tomographic, radiation-free technique based on the injection of a harmless alternating current. As electrical impedance strictly correlates with the variation of air content, EIT delivers highly dynamic information about global and regional ventilation. We want to demonstrate the potential of EIT individualizing ventilation by positioning. Gravity-dependent EIT findings were analyzed retrospectively in a critically ill mechanically ventilated pediatric patient with cystic fibrosis and coincident lung diseases. To further evaluate gravity-dependent changes in ventilation, six adult healthy and spontaneously breathing volunteers were investigated during simultaneous detection of EIT, breathing patterns, tidal volume (VT) and breathing frequency (BF). EIT findings in healthy lungs in five positions showed gravity-dependent effects of ventilation with overall ventilation of predominantly the right lung (except during left-side positioning) and with the ventral lung in supine, prone and upright position. These EIT-derived observations are in line with pathophysiological mechanisms and earlier EIT studies. Unexpectedly, the patient with cystic fibrosis and lobectomy of the right upper and middle lobe one year earlier, showed improvement of global and regional ventilation in the right position despite reduced lung volume and overinflation of this side. This resulted in individualized positioning and improvement of ventilation. Although therapeutic recommendations are available for gravitational influences of lung ventilation, they can be contradictory depending on the underlying lung disease. EIT has the potential to guide therapists in the positioning of patients according to their individual condition and disease, especially in case of multiple lung injury. © 2016 John Wiley & Sons Ltd.

  20. Using Individualized Brain Network for Analyzing Structural Covariance of the Cerebral Cortex in Alzheimer's Patients.

    Science.gov (United States)

    Kim, Hee-Jong; Shin, Jeong-Hyeon; Han, Cheol E; Kim, Hee Jin; Na, Duk L; Seo, Sang Won; Seong, Joon-Kyung

    2016-01-01

    Cortical thinning patterns in Alzheimer's disease (AD) have been widely reported through conventional regional analysis. In addition, the coordinated variance of cortical thickness in different brain regions has been investigated both at the individual and group network levels. In this study, we aim to investigate network architectural characteristics of a structural covariance network (SCN) in AD, and further to show that the structural covariance connectivity becomes disorganized across the brain regions in AD, while the normal control (NC) subjects maintain more clustered and consistent coordination in cortical atrophy variations. We generated SCNs directly from T1-weighted MR images of individual patients using surface-based cortical thickness data, with structural connectivity defined as similarity in cortical thickness within different brain regions. Individual SCNs were constructed using morphometric data from the Samsung Medical Center (SMC) dataset. The structural covariance connectivity showed higher clustering than randomly generated networks, as well as similar minimum path lengths, indicating that the SCNs are "small world." There were significant difference between NC and AD group in characteristic path lengths (z = -2.97, p < 0.01) and small-worldness values (z = 4.05, p < 0.01). Clustering coefficients in AD was smaller than that of NC but there was no significant difference (z = 1.81, not significant). We further observed that the AD patients had significantly disrupted structural connectivity. We also show that the coordinated variance of cortical thickness is distributed more randomly from one region to other regions in AD patients when compared to NC subjects. Our proposed SCN may provide surface-based measures for understanding interaction between two brain regions with co-atrophy of the cerebral cortex due to normal aging or AD. We applied our method to the AD Neuroimaging Initiative (ADNI) data to show consistency in results with the SMC

  1. Comparison of anxiety and depression in patients with acne vulgaris and healthy individuals

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    Golchai Javad

    2010-01-01

    Full Text Available Background: Acne vulgaris is a chronic inflammatory disease of the pilosebaceous units, which chiefly involves face and upper part of the trunk. Its prevalence is highest in adolescence, where the individual counters several psychosocial changes. Depression, suicidal thoughts, and low self esteem are reported in the patients with this disease. Aim: The goal of this study is to compare prevalence of anxiety and depression in the patients with acne vulgaris and normal population. Materials and Methods: In this cross-sectional study, 82 patients with acne vulgaris and 82 persons without acne who referred to a dermatology clinic and a specialized office for skin diseases in Rasht were studied. Anxiety and depression were evaluated by Hospital Anxiety and Depression Scale (HADS questionnaire and severity of acne was evaluated by Global Acne Grading System (GAGS. Data were analyzed by SPSS ver. 14.0 software, independent T-test, multi variate analysis of covariance (MANCOVA and chi-square test for comparison the quantitative and ordinal data, respectively; with α=0.05. Results: Prevalence of anxiety and mean of anxiety scores were 68.3% and 9.17 ± 3.52, respectively, in patients group and 39.1% and 7.10 ± 3.07, respectively, in control group in which there was a significant difference (P = 0.001. Prevalence of depression and mean of depression scores were 25.6% and 5.34 ± 3.29, respectively, in patients group and 28.1% and 5.01 ± 3.32, respectively, in control group in which there was no significant difference. Conclusion: According to high prevalence of anxiety in patients with acne vulgaris, assessment of the screening mental status of the patients by simple questionnaire such as HADS is suggested.

  2. Consolidating Risk Estimates for Radiation-Induced Complications in Individual Patient: Late Rectal Toxicity

    International Nuclear Information System (INIS)

    Prior, Phillip; Devisetty, Kiran; Tarima, Sergey S.; Lawton, Colleen A.F.; Semenenko, Vladimir A.

    2012-01-01

    Purpose: To test the feasibility of a new approach to synthesize published normal tissue complication data using late rectal toxicity in prostate cancer as an example. Methods and Materials: A data survey was performed to identify the published reports on the dose–response relationships for late rectal toxicity. The risk estimates for Grade 1 or greater, Grade 2 or greater, and Grade 3 or greater toxicity were obtained for a test cohort of patients treated at our institution. The influence of the potential factors that might have affected the reported toxicity levels was investigated. The studies that did not conform to the general data trends were excluded, and single, combined risk estimates were derived for each patient and toxicity level. Results: A total of 21 studies of nonoverlapping patient populations were identified. Three studies provided dose–response models for more than one level of toxicity. Of these 21 studies, 6, 14, and 5 were used to derive the initial risk estimates for Grade 1, 2, and 3 or greater toxicity, respectively. A comparison of risk estimates between the studies reporting rectal bleeding and rectal toxicity (bleeding plus other symptoms) or between studies with follow-up <36 months and ≥36 months did not reveal significant differences (p ≥ .29 for all comparisons). After excluding three reports that did not conform to the general data trends, the combined risk estimates were derived from 5 reports (647 patients), 11 reports (3,369 patients), and 5 reports (1,330 patients) for Grade 1, 2, and 3 or greater toxicity, respectively. Conclusions: The proposed approach is feasible and allows for more systematic use of published dose–response data to estimate the complication risks for the individual patient.

  3. Consolidating Risk Estimates for Radiation-Induced Complications in Individual Patient: Late Rectal Toxicity

    Energy Technology Data Exchange (ETDEWEB)

    Prior, Phillip; Devisetty, Kiran [Department of Radiation Oncology, Medical College of Wisconsin, Milwaukee, WI (United States); Tarima, Sergey S. [Division of Biostatistics, Institute for Health and Society, Medical College of Wisconsin, Milwaukee, WI (United States); Lawton, Colleen A.F. [Department of Radiation Oncology, Medical College of Wisconsin, Milwaukee, WI (United States); Semenenko, Vladimir A., E-mail: vsemenenko@mcw.edu [Department of Radiation Oncology, Medical College of Wisconsin, Milwaukee, WI (United States)

    2012-05-01

    Purpose: To test the feasibility of a new approach to synthesize published normal tissue complication data using late rectal toxicity in prostate cancer as an example. Methods and Materials: A data survey was performed to identify the published reports on the dose-response relationships for late rectal toxicity. The risk estimates for Grade 1 or greater, Grade 2 or greater, and Grade 3 or greater toxicity were obtained for a test cohort of patients treated at our institution. The influence of the potential factors that might have affected the reported toxicity levels was investigated. The studies that did not conform to the general data trends were excluded, and single, combined risk estimates were derived for each patient and toxicity level. Results: A total of 21 studies of nonoverlapping patient populations were identified. Three studies provided dose-response models for more than one level of toxicity. Of these 21 studies, 6, 14, and 5 were used to derive the initial risk estimates for Grade 1, 2, and 3 or greater toxicity, respectively. A comparison of risk estimates between the studies reporting rectal bleeding and rectal toxicity (bleeding plus other symptoms) or between studies with follow-up <36 months and {>=}36 months did not reveal significant differences (p {>=} .29 for all comparisons). After excluding three reports that did not conform to the general data trends, the combined risk estimates were derived from 5 reports (647 patients), 11 reports (3,369 patients), and 5 reports (1,330 patients) for Grade 1, 2, and 3 or greater toxicity, respectively. Conclusions: The proposed approach is feasible and allows for more systematic use of published dose-response data to estimate the complication risks for the individual patient.

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

    Directory of Open Access Journals (Sweden)

    J. García-Guerrero

    2010-02-01

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

  5. [Instances of alienation: portrait of the torn patient. I. Individual and context].

    Science.gov (United States)

    Stiefel, Friedrich; Bourquin, Céline; Saraga, Michael

    2014-02-12

    While the past decades were marked by an increased interest for the existential situation of man suffering from disease, the mechanisms alienating the patient from himself and from his context have been poorly investigated. These mechanisms, though operating in a dynamic interaction, will be discussed here sequentially. The first part of this article focuses on individual mechanisms of alienation emerging from the relationship the patient establishes with his body and psyche and on those related to his relational context. The aim is not to comprehensively describe these phenomena, but to discuss--based on clinical vignettes--some examples and their implications. The second part of the article describes some mechanisms of alienation that are incorporated in the medical apparatus and the dominant discourses.

  6. A multicenter, randomized controlled trial of individualized occupational therapy for patients with schizophrenia in Japan.

    Science.gov (United States)

    Shimada, Takeshi; Ohori, Manami; Inagaki, Yusuke; Shimooka, Yuko; Sugimura, Naoya; Ishihara, Ikuyo; Yoshida, Tomotaka; Kobayashi, Masayoshi

    2018-01-01

    The individualized occupational therapy (IOT) program is a psychosocial program that we developed to facilitate proactive participation in treatment and improve cognitive functioning and other outcomes for inpatients with acute schizophrenia. The program consists of motivational interviewing, self-monitoring, individualized visits, handicraft activities, individualized psychoeducation, and discharge planning. This multicenter, open-labeled, blinded-endpoint, randomized controlled trial evaluated the impact of adding IOT to a group OT (GOT) program as usual for outcomes in recently hospitalized patients with schizophrenia in Japanese psychiatric hospitals setting compared with GOT alone. Patients with schizophrenia were randomly assigned to the GOT+IOT group or the GOT alone group. Among 136 randomized patients, 129 were included in the intent-to-treat population: 66 in the GOT+IOT and 63 in the GOT alone groups. Outcomes were administered at baseline and discharge or 3 months following hospitalization including the Brief Assessment of Cognition in Schizophrenia Japanese version (BACS-J), the Schizophrenia Cognition Rating Scale Japanese version, the Social Functioning Scale Japanese version, the Global Assessment of Functioning scale, the Intrinsic Motivation Inventory Japanese version (IMI-J), the Morisky Medication Adherence Scale-8 (MMAS-8), the Positive and Negative Syndrome Scale (PANSS), and the Japanese version of Client Satisfaction Questionnaire-8 (CSQ-8J). Results of linear mixed effects models indicated that the IOT+GOT showed significant improvements in verbal memory (p <0.01), working memory (p = 0.02), verbal fluency (p < 0.01), attention (p < 0.01), and composite score (p < 0.01) on the BACS-J; interest/enjoyment (p < 0.01), value/usefulness (p < 0.01), perceived choice (p < 0.01), and IMI-J total (p < 0.01) on the IMI-J; MMAS-8 score (p < 0.01) compared with the GOT alone. Patients in the GOT+IOT demonstrated significant improvements on the CSQ-8J

  7. Neural loss aversion differences between depression patients and healthy individuals: A functional MRI investigation.

    Science.gov (United States)

    Chandrasekhar Pammi, V S; Pillai Geethabhavan Rajesh, Purushothaman; Kesavadas, Chandrasekharan; Rappai Mary, Paramban; Seema, Satish; Radhakrishnan, Ashalatha; Sitaram, Ranganatha

    2015-04-01

    Neuroeconomics employs neuroscience techniques to explain decision-making behaviours. Prospect theory, a prominent model of decision-making, features a value function with parameters for risk and loss aversion. Recent work with normal participants identified activation related to loss aversion in brain regions including the amygdala, ventral striatum, and ventromedial prefrontal cortex. However, the brain network for loss aversion in pathologies such as depression has yet to be identified. The aim of the current study is to employ the value function from prospect theory to examine behavioural and neural manifestations of loss aversion in depressed and healthy individuals to identify the neurobiological markers of loss aversion in economic behaviour. We acquired behavioural data and fMRI scans while healthy controls and patients with depression performed an economic decision-making task. Behavioural loss aversion was higher in patients with depression than in healthy controls. fMRI results revealed that the two groups shared a brain network for value function including right ventral striatum, ventromedial prefrontal cortex, and right amygdala. However, the neural loss aversion results revealed greater activations in the right dorsal striatum and the right anterior insula for controls compared with patients with depression, and higher activations in the midbrain region ventral tegmental area for patients with depression compared with controls. These results suggest that while the brain network for loss aversion is shared between depressed and healthy individuals, some differences exist with respect to differential activation of additional areas. Our findings are relevant to identifying neurobiological markers for altered decision-making in the depressed. © The Author(s) 2015 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav.

  8. Radiochromic film for individual patient QA in extracranial stereotactic lung radiotherapy

    International Nuclear Information System (INIS)

    Kron, T.; Clements, N.; Aarons, Y.; Dunn, L.; Chesson, B.; Miller, J.; Roozen, K.; Ball, D.

    2011-01-01

    Introduction: Modern radiotherapy is characterised by increasingly complex radiation delivery such as Intensity Modulated Radiation Therapy (IMRT) or extracranial stereotactic radiotherapy (ESR). It has become common practice to verify the delivery for each patient in IMRT, however, no such methods have been defined to date for ESR. It was the aim of the present work to develop a method to verify the dose distribution for ESR in a moving phantom using radiochromic film. Methods: Radiochromic film (ISP EBT2) was used in a cylindrical film cassette fitted into a QUASAR phantom (Modus Medical). The cassette can be moved forwards and backwards with motion patterns that can mimic the breathing of individual patients. The radiotherapy treatment plans of four patients were re-planned for the phantom. Between 8 and 10 radiation fields of 6 MV photons from a Varian Trilogy linear accelerator were used to deliver target doses between 18 and 26 Gy per fraction. In order to allow for measurements with EBT2 film all monitor units were divided by 3 or 4 resulting in maximum doses not exceeding 10 Gy. The film was evaluated using a transmission scan on an Epson Perfection V700 scanner with 50 dpi spatial resolution (3 colors, 48bit). A calibration curve was used to convert either the red or green component of the scan to dose. Results: Qualitative film analysis found no discernible discrepancies from planned isodose distributions in the stationary images. The dose distribution in the moving phantom was used successfully to confirm the appropriateness of the ITV construction in the planning process. Conclusions: We have developed a QA procedure that accounts for breathing patterns of individual patients in ESR for lung cancer. Radiochromic film was found to be easy to adapt to this process.

  9. Omics approaches to individual variation: modeling networks and the virtual patient.

    Science.gov (United States)

    Lehrach, Hans

    2016-09-01

    Every human is unique. We differ in our genomes, environment, behavior, disease history, and past and current medical treatment-a complex catalog of differences that often leads to variations in the way each of us responds to a particular therapy. We argue here that true personalization of drug therapies will rely on "virtual patient" models based on a detailed characterization of the individual patient by molecular, imaging, and sensor techniques. The models will be based, wherever possible, on the molecular mechanisms of disease processes and drug action but can also expand to hybrid models including statistics/machine learning/artificial intelligence-based elements trained on available data to address therapeutic areas or therapies for which insufficient information on mechanisms is available. Depending on the disease, its mechanisms, and the therapy, virtual patient models can be implemented at a fairly high level of abstraction, with molecular models representing cells, cell types, or organs relevant to the clinical question, interacting not only with each other but also the environment. In the future, "virtual patient/in-silico self" models may not only become a central element of our health care system, reducing otherwise unavoidable mistakes and unnecessary costs, but also act as "guardian angels" accompanying us through life to protect us against dangers and to help us to deal intelligently with our own health and wellness.

  10. Evaluation of insulin resistance in idiopathic hirsutism compared with polycystic ovary syndrome patients and healthy individuals.

    Science.gov (United States)

    Bonakdaran, Shokoufeh; Kiafar, Bita; Barazandeh Ahmadabadi, Fatemeh

    2016-02-01

    Hirsutism is defined as the excessive male-pattern growth of hair in women. Hirsutism is often idiopathic or the consequence of polycystic ovary syndrome (PCOS). Insulin resistance is common in PCOS (especially in obese patients) but the association between insulin resistance and idiopathic hirsutism (IH) is not clear. The aim of this study was to investigate the rate of insulin resistance in IH, compared with healthy individuals and patients with PCOS. The study included three groups, patients with idiopathic hirsutism, PCOS and healthy women. Each group included 30 non-obese women. Fasting blood sugar (FBS), insulin level and insulin resistance (estimated by the homeostasis model assessment [HOMA-IRIR]) were compared in the three groups. There was a significant difference between the age of the women with IH compared with two other groups. There were no significant difference in levels of serum insulin (P = 0.49, HOMA-IR (P = 0.47) and prevalence of insulin resistance (P = 0.07) in the three groups. The age-adjusted prevalence of insulin resistance was similar in the three groups. Insulin resistance was no more frequent in IH patients than in healthy control groups. © 2014 The Australasian College of Dermatologists.

  11. The effects of living distantly from peritoneal dialysis units on peritonitis risk, microbiology, treatment and outcomes: a multi-centre registry study

    Directory of Open Access Journals (Sweden)

    Cho Yeoungjee

    2012-06-01

    Full Text Available Abstract Background The aim of the study was to determine whether distance between residence and peritoneal dialysis (PD unit influenced peritonitis occurrence, microbiology, treatment and outcomes. Methods The study included all patients receiving PD between 1/10/2003 and 31/12/2008, using ANZDATA Registry data. Results 365 (6% patients lived ≥100 km from their nearest PD unit (distant group, while 6183 (94% lived S. aureus peritonitis (adjusted odds ratio [OR] 1.64, 95% CI 1.09-2.47. Distant patients with first peritonitis episodes were less likely to be hospitalised (64% vs 73%, p = 0.008 and receive antifungal prophylaxis (4% vs 10%, p = 0.01, but more likely to receive vancomycin-based antibiotic regimens (52% vs 42%, p  Conclusions Living ≥100 km away from a PD unit was associated with increased risk of S. aureus peritonitis, modified approaches to peritonitis treatment and peritonitis outcomes that were comparable to, or better than patients living closer to a PD unit. Staphylococcal decolonisation should receive particular consideration in remote living patients.

  12. Multiplicative surrogate standard deviation: a group metric for the glycemic variability of individual hospitalized patients.

    Science.gov (United States)

    Braithwaite, Susan S; Umpierrez, Guillermo E; Chase, J Geoffrey

    2013-09-01

    Group metrics are described to quantify blood glucose (BG) variability of hospitalized patients. The "multiplicative surrogate standard deviation" (MSSD) is the reverse-transformed group mean of the standard deviations (SDs) of the logarithmically transformed BG data set of each patient. The "geometric group mean" (GGM) is the reverse-transformed group mean of the means of the logarithmically transformed BG data set of each patient. Before reverse transformation is performed, the mean of means and mean of SDs each has its own SD, which becomes a multiplicative standard deviation (MSD) after reverse transformation. Statistical predictions and comparisons of parametric or nonparametric tests remain valid after reverse transformation. A subset of a previously published BG data set of 20 critically ill patients from the first 72 h of treatment under the SPRINT protocol was transformed logarithmically. After rank ordering according to the SD of the logarithmically transformed BG data of each patient, the cohort was divided into two equal groups, those having lower or higher variability. For the entire cohort, the GGM was 106 (÷/× 1.07) mg/dl, and MSSD was 1.24 (÷/× 1.07). For the subgroups having lower and higher variability, respectively, the GGM did not differ, 104 (÷/× 1.07) versus 109 (÷/× 1.07) mg/dl, but the MSSD differed, 1.17 (÷/× 1.03) versus 1.31 (÷/× 1.05), p = .00004. By using the MSSD with its MSD, groups can be characterized and compared according to glycemic variability of individual patient members. © 2013 Diabetes Technology Society.

  13. Morphological and molecular features of oral fluid-derived exosomes: oral cancer patients versus healthy individuals.

    Science.gov (United States)

    Zlotogorski-Hurvitz, Ayelet; Dayan, Dan; Chaushu, Gavriel; Salo, Tuula; Vered, Marilena

    2016-01-01

    Oral cancer (OC) patients are at high risk to develop recurrent disease or secondary primary cancers with no available biomarkers to detect these events until a visible lesion is readily present and diagnosed by biopsy. Exosomes secreted by cancer cells are involved in tumor growth, invasion and metastasis. We aimed to determine morphological and molecular differences between oral fluid (OF)-derived exosomes of OC patients and those isolated from healthy individuals (HI). OF from OC patients (n = 36) and HI (n = 25) was initially assessed by nanoparticle tracking analysis (NTA). Following ultracentrifugation, exosomal pellets of OC patients and HI were morphologically examined by transmission electron microscopy and atomic force microscopy (AFM). Enzyme-linked immunosorbent assay (ELISA) and western blotting (WB) were used to analyze the expression of exosomal markers--CD9, CD81 and CD63. NTA showed that OC samples of OF had a significantly higher concentration of nanoparticles/ml (p = 0.01) and modal nanoparticle size (p = 0.002) compared to HI. The difference in size was structurally highlighted by AFM three-dimensional images applied on exosomal pellets. ELISA and WB showed differential expression of exosomal markers in OC exosomes compared to HI: lower expression of CD81 and CD9 in contrast to a higher expression of CD63 (~53 kDa). OF-derived exosomes from OC patients differ both morphologically and molecularly from exosomes present in HI. This study is a baseline that provides a starting point for finding exosomal biomarkers for early detection of malignant changes in high-risk patients without overt clinical signs/lesions.

  14. Gut flora profiling and fecal metabolite composition of colorectal cancer patients and healthy individuals.

    Science.gov (United States)

    Wang, Xiaoxue; Wang, Jianping; Rao, Benqiang; Deng, Li

    2017-06-01

    Colorectal cancer is one of the most common types of cancer in the world and its morbidity and mortality rates are increasing due to alterations to human lifestyle and dietary habits. The relationship between human gut flora and colorectal cancer has attracted increasing attention. In the present study, a metabolic fingerprinting technique that combined pyrosequencing with gas chromatography-mass spectrometry was utilized to compare the differences in gut flora profiling and fecal metabolites between healthy individuals and patients with colorectal cancer. The results demonstrated that there were no significant differences in the abundance and diversity of gut flora between healthy individuals and patients with colorectal cancer (P>0.05) and the dominant bacterial phyla present in the gut of both groups included Firmicutes , Bacteroidetes and Verrucomicrobia . At the bacterial strain/genus level, significant differences were observed in the relative abundance of 18 species of bacteria (Pflora profiling and metabolite composition. These findings suggest that gut flora disorder results in the alteration of bacterial metabolism, which may be associated with the pathogenesis of colorectal cancer. The results of the present study are useful as a foundation for further studies to elucidate a potential colorectal cancer diagnostic index and therapeutic targets.

  15. [Application of evidence based medicine to the individual patient: the role of decision analysis].

    Science.gov (United States)

    Housset, B; Junod, A F

    2003-11-01

    The objective of evidence based medicine (EBM) is to contribute to medical decision making by providing the best possible information in terms of validity and relevance. This allows evaluation in a specific manner of the benefits and risks of a decision. The limitations and hazards of this approach are discussed in relation to a clinical case where the diagnosis of pulmonary embolism was under consideration. The individual details and the limited availability of some technical procedures illustrate the need to adapt the data of EBM to the circumstances. The choice between two diagnostic tests (d-dimers and ultrasound of the legs) and their optimal timing is analysed with integration of the consequences for the patient of the treatments proposed. This allows discussion of the concept of utility and the use of sensitivity analysis. If EBM is the cornerstone of rational and explicit practise it should also allow for the constraints of real life. Decision analysis, which depends on the same critical demands as EBM but can also take account of the individual features of each patient and test the robustness of a decision, gives a unique opportunity reconcile rigorous reasoning with individualisation of management.

  16. How is success achieved by individuals innovating for patient safety and quality in the NHS?

    Science.gov (United States)

    Sheard, Laura; Jackson, Cath; Lawton, Rebecca

    2017-09-11

    Innovation in healthcare is said to be notoriously difficult to achieve and sustain yet simultaneously the health service is under intense pressure to innovate given the ever increasing demands placed upon it. Whilst many studies have looked at diffusion of innovation from an organisational perspective, few have sought to understand how individuals working in healthcare innovate successfully. We took a positive deviance approach to understand how innovations are achieved by individuals working in the NHS. We conducted in depth interviews in 2015 with 15 individuals who had received a national award for being a successful UK innovator in healthcare. We invited only those people who were currently (or had recently) worked in the NHS and whose innovation focused on improving patient safety or quality. Thematic analysis was used. Four themes emerged from the data: personal determination, the ability to broker relationships and make connections, the ways in which innovators were able to navigate organisational culture to their advantage and their ability to use evidence to influence others. Determination, focus and persistence were important personal characteristics of innovators as were skills in being able to challenge the status quo. Innovators were able to connect sometimes disparate teams and people, being the broker between them in negotiating collaborative working. The culture of the organisation these participants resided in was important with some being able to use this (and the current patient safety agenda) to their advantage. Gathering robust data to demonstrate their innovation had a positive impact and was seen as essential to its progression. This paper reveals a number of factors which are important to the success of innovators in healthcare. We have uncovered that innovators have particular personal traits which encourage a propensity towards change and action. Yet, for fruitful innovation to take place, it is important for relational networks and

  17. Predictive patient-specific dosimetry and individualized dosing of pretargeted radioimmunotherapy in patients with advanced colorectal cancer

    Energy Technology Data Exchange (ETDEWEB)

    Schoffelen, Rafke; Woliner-van der Weg, Wietske; Visser, Eric P.; Oyen, Wim J.G.; Boerman, Otto C. [Radboud University Medical Center, Department of Radiology and Nuclear Medicine, PO Box 9101, Nijmegen (Netherlands); Goldenberg, David M. [Garden State Cancer Center, Morris Plains, NJ (United States); Immunomedics, Inc., Morris Plains, NJ (United States); IBC Pharmaceuticals, Inc., Morris Plains, NJ (United States); Sharkey, Robert M.; McBride, William J.; Chang, Chien-Hsing [Immunomedics, Inc., Morris Plains, NJ (United States); Rossi, Edmund A. [IBC Pharmaceuticals, Inc., Morris Plains, NJ (United States); Graaf, Winette T.A. van der [Radboud University Medical Center, Department of Medical Oncology, Nijmegen (Netherlands)

    2014-08-15

    Pretargeted radioimmunotherapy (PRIT) with bispecific antibodies (bsMAb) and a radiolabeled peptide reduces the radiation dose to normal tissues. Here we report the accuracy of an {sup 111}In-labeled pretherapy test dose for personalized dosing of {sup 177}Lu-labeled IMP288 following pretargeting with the anti-CEA x anti-hapten bsMAb, TF2, in patients with metastatic colorectal cancer (CRC). In 20 patients bone marrow absorbed doses (BMD) and doses to the kidneys were predicted based on blood samples and scintigrams acquired after {sup 111}In-IMP288 injection for individualized dosing of PRIT with {sup 177}Lu-IMP288. Different dose schedules were studied, varying the interval between the bsMAb and peptide administration (5 days vs. 1 day), increasing the bsMAb dose (75 mg vs. 150 mg), and lowering the peptide dose (100 μg vs. 25 μg). TF2 and {sup 111}In/{sup 177}Lu-IMP288 clearance was highly variable. A strong correlation was observed between peptide residence times and individual TF2 blood concentrations at the time of peptide injection (Spearman's ρ = 0.94, P < 0.0001). PRIT with 7.4 GBq {sup 177}Lu-IMP288 resulted in low radiation doses to normal tissues (BMD <0.5 Gy, kidney dose <3 Gy). Predicted {sup 177}Lu-IMP288 BMD were in good agreement with the actual measured doses (mean ± SD difference -0.0026 ± 0.028 mGy/MBq). Hematological toxicity was mild in most patients, with only two (10 %) having grade 3-4 thrombocytopenia. A correlation was found between platelet toxicity and BMD (Spearman's ρ = 0.58, P = 0.008). No nonhematological toxicity was observed. These results show that individual high activity doses in PRIT in patients with CEA-expressing CRC could be safely administered by predicting the radiation dose to red marrow and kidneys, based on dosimetric analysis of a test dose of TF2 and {sup 111}In-IMP288. (orig.)

  18. Quantitative sensory testing measures individual pain responses in emergency department patients

    Directory of Open Access Journals (Sweden)

    Duffy KJ

    2017-05-01

    Full Text Available Kevin J Duffy, Katharyn L Flickinger, Jeffrey T Kristan, Melissa J Repine, Alexandro Gianforcaro, Rebecca B Hasley, Saad Feroz, Jessica M Rupp, Jumana Al-Baghli, Maria L Pacella, Brian P Suffoletto, Clifton W Callaway Department of Emergency Medicine, School of Medicine, University of Pittsburgh, Pittsburgh, PA, USA Background: Refining and individualizing treatment of acute pain in the emergency department (ED is a high priority, given that painful complaints are the most common reasons for ED visits. Few tools exist to objectively measure pain perception in the ED setting. We speculated that variation in perception of fixed painful stimuli would explain individual variation in reported pain and response to treatment among ED patients. Materials and methods: In three studies, we 1 describe performance characteristics of brief quantitative sensory testing (QST in 50 healthy volunteers, 2 test effects of 10 mg oxycodone versus placebo on QST measures in 18 healthy volunteers, and 3 measure interindividual differences in nociception and treatment responses in 198 ED patients with a painful complaint during ED treatment. QST measures adapted for use in the ED included pressure sensation threshold, pressure pain threshold (PPT, pressure pain response (PPR, and cold pain tolerance (CPT tests. Results: First, all QST measures had high inter-rater reliability and test–retest reproducibility. Second, 10 mg oxycodone reduced PPR, increased PPT, and prolonged CPT. Third, baseline PPT and PPR revealed hyperalgesia in 31 (16% ED subjects relative to healthy volunteers. In 173 (88% ED subjects who completed repeat testing 30 minutes after pain treatment, PPT increased and PPR decreased (Cohen’s dz 0.10–0.19. Verbal pain scores (0–10 for the ED complaint decreased by 2.2 (95% confidence intervals [CI]: 1.9, 2.6 (Cohen’s dz 0.97 but did not covary with the changes in PPT and PPR (r=0.05–0.13. Treatment effects were greatest in ED subjects

  19. Design of COSMIC: a randomized, multi-centre controlled trial comparing conservative or early surgical management of incomplete cervical cord syndrome without spinal instability

    NARCIS (Netherlands)

    Bartels, R.H.M.; Hosman, A.J.F.; Meent, H.; Hofmeijer, Jeannette; Vos, P.E.; Slooff, W.B.; Öner, F.C.; Coppes, M.H.; Peul, W.C.; Verbeek, A.L.M.

    2013-01-01

    Background Incomplete cervical cord syndrome without spinal instability is a very devastating event for the patient and the family. It is estimated that up to 25 % of all traumatic spinal cord lesions belong to this category. The treatment for this type of spinal cord lesion is still subject of

  20. Design of COSMIC: a randomized, multi-centre controlled trial comparing conservative or early surgical management of incomplete cervical cord syndrome without spinal instability

    NARCIS (Netherlands)

    Bartels, R.H.M.A.; Hosman, A.J.F.; Meent, H. van de; Hofmeijer, J.; Vos, P.E.; Slooff, W.B.; Oner, F.C.; Coppes, M.H.; Peul, W.C.; Verbeek, A.L.M.

    2013-01-01

    ABSTRACT: BACKGROUND: Incomplete cervical cord syndrome without spinal instability is a very devastating event for the patient and the family. It is estimated that up to 25% of all traumatic spinal cord lesions belong to this category. The treatment for this type of spinal cord lesion is still

  1. EBUS-TBNA for the clarification of PET positive intra-thoracic lymph nodes-an international multi-centre experience

    NARCIS (Netherlands)

    Rintoul, Robert C.; Tournoy, Kurt G.; El Daly, Hesham; Carroll, Nicholas R.; Buttery, Robert C.; van Kralingen, Klaas; van Meerbeeck, Jan P.; Rabe, Klaus F.; Annema, Jouke T.

    2009-01-01

    To determine the sensitivity and accuracy of endobronchial ultrasound guided transbronchial needle aspiration (EBUS-TBNA) for clarification of the nature of fluorodeoxyglucose-positron emission tomography (FDG) positive hilar and/or mediastinal lymph nodes in patients with (suspected) lung cancer.

  2. High ratings of satisfaction with fertility treatment are common: findings from the Copenhagen Multi-centre Psychosocial Infertility (COMPI) Research Programme

    DEFF Research Database (Denmark)

    Schmidt, L; Holstein, B E; Boivin, J

    2003-01-01

    BACKGROUND: The aims were: (i). to identify gender differences in evaluation of medical and patient-centred (psychosocial) care in fertility clinics and (ii). to identify predictors of satisfaction. METHODS: An epidemiological prospective study based on questionnaire responses among all new coupl...

  3. Individual care plans for chronically ill patients within primary care in the Netherlands: Dissemination and associations with patient characteristics and patient-perceived quality of care.

    Science.gov (United States)

    Jansen, Daphne L; Heijmans, Monique; Rijken, Mieke

    2015-06-01

    To examine the use of individual care plans (ICPs) within primary chronic illness care in the Netherlands, and to explore the relationships between ICP use, patient characteristics, and patient-perceived quality of care. Cross-sectional study using survey data from a panel of chronically ill patients and medical registration data provided by their general practices. A sample of 1377 patients with somatic chronic disease(s) randomly selected in general practices throughout the Netherlands, supplemented with a sample of 225 COPD patients, also recruited from general practices. (i) Percentage of ICP use based on self-report by chronically ill patients, and (ii) patient-perceived quality of care as assessed using the Patient Assessment of Chronic Illness Care (PACIC). ICP use among the total generic sample was low (9%), but slightly higher (13%) among patients diagnosed with diabetes or COPD, diseases for which disease management programmes have been set up in the Netherlands. Patients with a low educational level and patients with poor(er) self-rated health were more likely to have an ICP. Compared with patients without an ICP, patients with an ICP more often reported that the care they received was patient-centred, proactive, planned, and included collaborative goal setting, problem-solving, and follow-up support. Findings reveal a discrepancy between practice and policy aspirations regarding ICP use in primary chronic illness care. More research is needed to gain insight into the effectiveness of ICPs to improve the quality of chronic illness care in various patient populations.

  4. Evaluation of patient involvement in a systematic review and meta-analysis of individual patient data in cervical cancer treatment

    Directory of Open Access Journals (Sweden)

    Vale Claire L

    2012-05-01

    Full Text Available Abstract Background In April 2005, researchers based at the Medical Research Council Clinical Trials Unit, set out to involve women affected by cervical cancer in a systematic review and meta-analysis of individual patient data to evaluate treatments for this disease. Each of the women had previously been treated for cervical cancer. Following completion of the meta-analysis, we aimed to evaluate the process of involvement from the researcher and research partner perspective. Methods An advisory group was first established to give advice on recruiting, supporting and involving women and led to efforts to recruit women to take part in the systematic review using different approaches. Evaluation of the process and outcomes of the partnership between the systematic reviewers and the patients, in respect to what the partnership achieved; what worked well and what were the difficulties; what was learned and the resource requirements, took place during the conduct of the meta-analysis and again after completion of the project. Results Six women, each of whom had received treatments for cervical cancer, were recruited as Patient Research Partners and five of these women subsequently took part in a variety of activities around the systematic review. They attended progress meetings and all but one attended a meeting at which the first results of the review were presented to all collaborators and gave feedback. Three of the women also became involved in a further related research project which led to an editorial publication from the patient perspective and also participated, along with two lead researchers, in the evaluation of the process and outcomes. While they were generally positive about the experience, one Patient Research Partner questioned the extent of the impact patients could make to the systematic review process. Conclusions In general, researchers and patient research partners felt that they had learned a lot from the process and considered

  5. Neural correlates of emotional distractibility in bipolar disorder patients, unaffected relatives, and individuals with hypomanic personality.

    Science.gov (United States)

    Kanske, Philipp; Heissler, Janine; Schönfelder, Sandra; Forneck, Johanna; Wessa, Michèle

    2013-12-01

    Neuropsychological deficits and emotion dysregulation are present in symptomatic and euthymic patients with bipolar disorder. However, there is little evidence on how cognitive functioning is influenced by emotion, what the neural correlates of emotional distraction effects are, and whether such deficits are a consequence or a precursor of the disorder. The authors used functional MRI (fMRI) to investigate these questions. fMRI was used first to localize the neural network specific to a certain cognitive task (mental arithmetic) and then to test the effect of emotional distractors on this network. Euthymic patients with bipolar I disorder (N=22), two populations at high risk for developing the disorder (unaffected first-degree relatives of individuals with bipolar disorder [N=17]), and healthy participants with hypomanic personality traits [N=22]) were tested, along with three age-, gender-, and education-matched healthy comparison groups (N=22, N=17, N=24, respectively). There were no differences in performance or activation in the task network for mental arithmetic. However, while all participants exhibited slower responses when emotional distractors were present, this response slowing was greatly enlarged in bipolar patients. Similarly, task-related activation was generally increased under emotional distraction; however, bipolar patients exhibited a further increase in right parietal activation that correlated positively with the response slowing effect. The results suggest that emotional dysregulation leads to exacerbated neuropsychological deficits in bipolar patients, as evidenced by behavioral slowing and task-related hyperactivation. The lack of such a deficit in high-risk populations suggests that it occurs only after disease onset, rather than representing a vulnerability marker.

  6. Design of COSMIC: a randomized, multi-centre controlled trial comparing conservative or early surgical management of incomplete cervical cord syndrome without spinal instability.

    Science.gov (United States)

    Bartels, Ronald H M A; Hosman, Allard J F; van de Meent, Henk; Hofmeijer, Jeannette; Vos, Pieter E; Slooff, Willem Bart; Öner, F Cumhur; Coppes, Maarten H; Peul, Wilco C; Verbeek, André L M

    2013-01-31

    Incomplete cervical cord syndrome without spinal instability is a very devastating event for the patient and the family. It is estimated that up to 25% of all traumatic spinal cord lesions belong to this category. The treatment for this type of spinal cord lesion is still subject of discussion. From a biological point of view early surgery could prevent secondary damage due to ongoing compression of the already damaged spinal cord. Historically, however, conservative treatment was propagated with good clinical results. Proponents for early surgery as well those favoring conservative treatment are still in debate. The proposed trial will contribute to the discussion and hopefully also to a decrease in the variability of clinical practice. A randomized controlled trial is designed to compare the clinical outcome of early surgical strategy versus a conservative approach. The primary outcome is clinical outcome according to mJOA. This also measured by ASIA score, DASH score and SCIM III score. Other endpoints are duration of the stay at a high care department (medium care, intensive care), duration of the stay at the hospital, complication rate, mortality rate, sort of rehabilitation, and quality of life. A sample size of 36 patients per group was calculated to reach a power of 95%. The data will be analyzed as intention-to-treat at regular intervals, but the end evaluation will take place at two years post-injury. At the end of the study, clinical outcomes between treatments attitudes can be compared. Efficacy, but also efficiency can be determined. A goal of the study is to determine which treatment will result in the best quality of life for the patients. This study will certainly contribute to more uniformity of treatment offered to patients with a special sort of spinal cord injury. Gov: NCT01367405.

  7. Design of COSMIC: a randomized, multi-centre controlled trial comparing conservative or early surgical management of incomplete cervical cord syndrome without spinal instability

    Directory of Open Access Journals (Sweden)

    Bartels Ronald HMA

    2013-01-01

    Full Text Available Abstract Background Incomplete cervical cord syndrome without spinal instability is a very devastating event for the patient and the family. It is estimated that up to 25% of all traumatic spinal cord lesions belong to this category. The treatment for this type of spinal cord lesion is still subject of discussion. From a biological point of view early surgery could prevent secondary damage due to ongoing compression of the already damaged spinal cord. Historically, however, conservative treatment was propagated with good clinical results. Proponents for early surgery as well those favoring conservative treatment are still in debate. The proposed trial will contribute to the discussion and hopefully also to a decrease in the variability of clinical practice. Methods/Design A randomized controlled trial is designed to compare the clinical outcome of early surgical strategy versus a conservative approach. The primary outcome is clinical outcome according to mJOA. This also measured by ASIA score, DASH score and SCIM III score. Other endpoints are duration of the stay at a high care department (medium care, intensive care, duration of the stay at the hospital, complication rate, mortality rate, sort of rehabilitation, and quality of life. A sample size of 36 patients per group was calculated to reach a power of 95%. The data will be analyzed as intention-to-treat at regular intervals, but the end evaluation will take place at two years post-injury. Discussion At the end of the study, clinical outcomes between treatments attitudes can be compared. Efficacy, but also efficiency can be determined. A goal of the study is to determine which treatment will result in the best quality of life for the patients. This study will certainly contribute to more uniformity of treatment offered to patients with a special sort of spinal cord injury. Trial Registration Gov: NCT01367405

  8. Capacity of non-invasive hepatic fibrosis algorithms to replace transient elastography to exclude cirrhosis in people with hepatitis C virus infection: A multi-centre observational study.

    Science.gov (United States)

    Kelly, Melissa Louise; Riordan, Stephen M; Bopage, Rohan; Lloyd, Andrew R; Post, Jeffrey John

    2018-01-01

    Achievement of the 2030 World Health Organisation (WHO) global hepatitis C virus (HCV) elimination targets will be underpinned by scale-up of testing and use of direct-acting antiviral treatments. In Australia, despite publically-funded testing and treatment, less than 15% of patients were treated in the first year of treatment access, highlighting the need for greater efficiency of health service delivery. To this end, non-invasive fibrosis algorithms were examined to reduce reliance on transient elastography (TE) which is currently utilised for the assessment of cirrhosis in most Australian clinical settings. This retrospective and prospective study, with derivation and validation cohorts, examined consecutive patients in a tertiary referral centre, a sexual health clinic, and a prison-based hepatitis program. The negative predictive value (NPV) of seven non-invasive algorithms were measured using published and newly derived cut-offs. The number of TEs avoided for each algorithm, or combination of algorithms, was determined. The 850 patients included 780 (92%) with HCV mono-infection, and 70 (8%) co-infected with HIV or hepatitis B. The mono-infected cohort included 612 men (79%), with an overall prevalence of cirrhosis of 16% (125/780). An 'APRI' algorithm cut-off of 1.0 had a 94% NPV (95%CI: 91-96%). Newly derived cut-offs of 'APRI' (0.49), 'FIB-4' (0.93) and 'GUCI' (0.5) algorithms each had NPVs of 99% (95%CI: 97-100%), allowing avoidance of TE in 40% (315/780), 40% (310/780) and 40% (298/749) respectively. When used in combination, NPV was retained and TE avoidance reached 54% (405/749), regardless of gender or co-infection. Non-invasive algorithms can reliably exclude cirrhosis in many patients, allowing improved efficiency of HCV assessment services in Australia and worldwide.

  9. Individual correlates of self-stigma in patients with anxiety disorders with and without comorbidities

    Directory of Open Access Journals (Sweden)

    Ociskova M

    2015-07-01

    Full Text Available Marie Ociskova,1,2 Jan Prasko,1 Dana Kamaradova,1 Ales Grambal,1 Zuzana Sigmundova1 1Department of Psychiatry, University Hospital in Olomouc, Faculty of Medicine and Dentistry, 2Department of Psychology, Faculty of Arts, Palacky University in Olomouc, Olomouc, Czech Republic Background: A number of psychiatric patients experience stigma connected to prejudices about mental disorders. It has been shown that stigma is most harmful when it is internalized. Most of the studies were performed on individuals either with psychoses or with mood disorders, and hence, there are almost no studies with other diagnostic categories. The goals of this research were to identify factors that are significantly related to self-stigma in patients with anxiety disorders and to suggest possible models of causality for these relationships.Methods: A total of 109 patients with anxiety disorders and possible comorbid depressive or personality disorders, who were admitted to the psychotherapeutic department participated in this study. All patients completed several psychodiagnostic methods, ie, the Internalized Stigma of Mental Illness Scale, Temperament and Character Inventory-Revised Version, Adult Dispositional Hope Scale, Dissociative Experiences Scale, Beck Anxiety Inventory, Beck Depression Inventory-Second Edition, and Clinical Global Impression (also completed by the senior psychiatrist.Results: The overall level of self-stigma was positively associated with a comorbid personality disorder, more severe symptomatology, more intense symptoms of anxiety and depression, and higher levels of dissociation and harm avoidance. Self-stigma was negatively related to hope, reward dependence, persistence, self-directedness, and cooperativeness. Multiple regression analysis showed that the most significant factors connected to self-stigma are harm avoidance, the intensity of depressive symptoms, and self-directedness. Two models of causality were proposed and validated. It

  10. Risk of fracture with thiazolidinediones: an individual patient data meta-analysis

    Directory of Open Access Journals (Sweden)

    Marloes T Bazelier

    2013-02-01

    Full Text Available Background: The use of thiazolidinediones (TZDs has been associated with increased fracture risks. Our aim was to estimate the risk of fracture with TZDs in three different healthcare registries, using exactly the same study design, and to perform an individual patient data meta-analysis of these three studies. Methods: Population-based cohort studies were performed utilizing the British General Practice Research Database (GPRD, the Dutch PHARMO Record Linkage System, and the Danish National Health Registers. In all three databases, the exposed cohort consisted of all patients (aged 18+ with at least one prescription of antidiabetic (AD medication. Cox proportional hazards models were used to estimate hazard ratios (HRs of fracture. The total period of follow-up for each patient was divided into periods of current exposure and past exposure, with patients moving between current and past use.Results: In all three registries, the risk of fracture was increased for women who were exposed to TZDs: HR 1.48 [1.37-1.60] in GPRD, HR 1.35 [1.15-1.58] in PHARMO and HR 1.22 [1.03-1.44] in Denmark. Combining the data in an individual patient data meta-analysis resulted, for women, in a 1.4-fold increased risk of any fracture for current TZD users versus other AD drug users (adj. HR 1.44 [1.35-1.53]. For men, there was no increased fracture risk (adj. HR 1.05 [0.96-1.14]. Risks were increased for fractures of the radius/ulna, humerus, tibia/fibula, ankle and foot, but not for hip/femur or vertebral fractures. Current TZD users with more than 25 TZD presciptions ever before had a 1.6-fold increased risk of fracture compared with other AD drug users (HR 1.59 [1.46-1.74].Conclusion: In this study, we consistently found a 1.2- to 1.5-fold increased risk of fractures for women using TZDs, but not for men, across three different healthcare registries. TZD users had an increased risk for fractures of the extremities, and risks further increased for prolonged users

  11. Exercise training improves exercise capacity in adult patients with a systemic right ventricle : a randomized clinical trial

    NARCIS (Netherlands)

    Winter, Michiel M.; van der Bom, Teun; de Vries, Leonie C. S.; Balducci, Anna; Bouma, Berto J.; Pieper, Petronella G.; van Dijk, Arie P. J.; van der Plas, Mart N.; Picchio, Fernando M.; Mulder, Barbara J. M.

    To assess whether exercise training in adult patients with a systemic right ventricle (RV) improves exercise capacity and quality of life and lowers serum N-terminal prohormone brain natriuretic peptide (NT-proBNP) levels. Multi-centre parallel randomized controlled trial. Patients with a systemic

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

    Directory of Open Access Journals (Sweden)

    Priebe Stefan

    2013-01-01

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

  13. Test-retest and interobserver reliability of quantitative sensory testing according to the protocol of the German Research Network on Neuropathic Pain (DFNS): a multi-centre study.

    Science.gov (United States)

    Geber, Christian; Klein, Thomas; Azad, Shahnaz; Birklein, Frank; Gierthmühlen, Janne; Huge, Volker; Lauchart, Meike; Nitzsche, Dorothee; Stengel, Maike; Valet, Michael; Baron, Ralf; Maier, Christoph; Tölle, Thomas; Treede, Rolf-Detlef

    2011-03-01

    Quantitative sensory testing (QST) is an instrument to assess positive and negative sensory signs, helping to identify mechanisms underlying pathologic pain conditions. In this study, we evaluated the test-retest reliability (TR-R) and the interobserver reliability (IO-R) of QST in patients with sensory disturbances of different etiologies. In 4 centres, 60 patients (37 male and 23 female, 56.4±1.9years) with lesions or diseases of the somatosensory system were included. QST comprised 13 parameters including detection and pain thresholds for thermal and mechanical stimuli. QST was performed in the clinically most affected test area and a less or unaffected control area in a morning and an afternoon session on 2 consecutive days by examiner pairs (4 QSTs/patient). For both, TR-R and IO-R, there were high correlations (r=0.80-0.93) at the affected test area, except for wind-up ratio (TR-R: r=0.67; IO-R: r=0.56) and paradoxical heat sensations (TR-R: r=0.35; IO-R: r=0.44). Mean IO-R (r=0.83, 31% unexplained variance) was slightly lower than TR-R (r=0.86, 26% unexplained variance, Ptest area (TR-R: r=0.86; IO-R: r=0.83) than in the control area (TR-R: r=0.79; IO-R: r=0.71, each Preliability of QST. We conclude that standardized QST performed by trained examiners is a valuable diagnostic instrument with good test-retest and interobserver reliability within 2days. With standardized training, observer bias is much lower than random variance. Quantitative sensory testing performed by trained examiners is a valuable diagnostic instrument with good interobserver and test-retest reliability for use in patients with sensory disturbances of different etiologies to help identify mechanisms of neuropathic and non-neuropathic pain. Copyright © 2010 International Association for the Study of Pain. Published by Elsevier B.V. All rights reserved.

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

    Directory of Open Access Journals (Sweden)

    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

  15. Providers and Patients Caught Between Standardization and Individualization: Individualized Standardization as a Solution Comment on "(Re) Making the Procrustean Bed? Standardization and Customization as Competing Logics in Healthcare".

    Science.gov (United States)

    Ansmann, Lena; Pfaff, Holger

    2017-08-12

    In their 2017 article, Mannion and Exworthy provide a thoughtful and theory-based analysis of two parallel trends in modern healthcare systems and their competing and conflicting logics: standardization and customization. This commentary further discusses the challenge of treatment decision-making in times of evidence-based medicine (EBM), shared decision-making and personalized medicine. From the perspective of systems theory, we propose the concept of individualized standardization as a solution to the problem. According to this concept, standardization is conceptualized as a guiding framework leaving room for individualization in the patient physician interaction. The theoretical background is the concept of context management according to systems theory. Moreover, the comment suggests multidisciplinary teams as a possible solution for the integration of standardization and individualization, using the example of multidisciplinary tumor conferences and highlighting its limitations. The comment also supports the authors' statement of the patient as co-producer and introduces the idea that the competing logics of standardization and individualization are a matter of perspective on macro, meso and micro levels. © 2018 The Author(s); Published by Kerman University of Medical Sciences. This is an open-access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

  16. Chemotherapy in locally advanced nasopharyngeal carcinoma: An individual patient data meta-analysis of eight randomized trials and 1753 patients

    International Nuclear Information System (INIS)

    Baujat, Bertrand; Audry, Helene; Bourhis, Jean; Chan, Anthony T.C.; Onat, Haluk; Chua, Daniel T.T.; Kwong, Dora L.W.; Al-Sarraf, Muhyi; Chi, K.-H.; Hareyama, Masato; Leung, Sing F.; Thephamongkhol, Kullathorn; Pignon, Jean-Pierre

    2006-01-01

    Objectives: To study the effect of adding chemotherapy to radiotherapy (RT) on overall survival and event-free survival for patients with nasopharyngeal carcinoma. Methods and Materials: This meta-analysis used updated individual patient data from randomized trials comparing chemotherapy plus RT with RT alone in locally advanced nasopharyngeal carcinoma. The log-rank test, stratified by trial, was used for comparisons, and the hazard ratios of death and failure were calculated. Results: Eight trials with 1753 patients were included. One trial with a 2 x 2 design was counted twice in the analysis. The analysis included 11 comparisons using the data from 1975 patients. The median follow-up was 6 years. The pooled hazard ratio of death was 0.82 (95% confidence interval, 0.71-0.94; p = 0.006), corresponding to an absolute survival benefit of 6% at 5 years from the addition of chemotherapy (from 56% to 62%). The pooled hazard ratio of tumor failure or death was 0.76 (95% confidence interval, 0.67-0.86; p < 0.0001), corresponding to an absolute event-free survival benefit of 10% at 5 years from the addition of chemotherapy (from 42% to 52%). A significant interaction was observed between the timing of chemotherapy and overall survival (p = 0.005), explaining the heterogeneity observed in the treatment effect (p = 0.03), with the highest benefit resulting from concomitant chemotherapy. Conclusion: Chemotherapy led to a small, but significant, benefit for overall survival and event-free survival. This benefit was essentially observed when chemotherapy was administered concomitantly with RT

  17. Individual patient data meta-analyses in head and neck carcinoma: what have we learnt?

    International Nuclear Information System (INIS)

    Pignon, J.P.; Baujat, B.; Bourhis, J.

    2005-01-01

    Carcinoma of the upper aero-digestive tract (oral cavity, oropharynx, hypopharynx, nasopharynx, larynx) are frequent tumors for which surgery and/or radiotherapy are the main therapeutic agents. The main results of meta-analyses based on the collection of individual patients data are reported: 1) The meta-analysis on chemotherapy, regrouping data of nearly 11,000 patients issued from 63 randomized trials showed an absolute benefit of 4% at five years in overall survival, in favor of chemotherapy (P < 0.0001). Most of the benefit was seen with concomitant radio-chemotherapy, however with a relatively large heterogeneity in this subgroup of trials. An update of this meta-analysis was performed including 24 additional trials, which confirmed the magnitude of the benefit due to concomitant chemotherapy (8% at 5 years). 2) The meta-analysis on larynx preservation, using induction chemotherapy in larynx and hypopharynx carcinomas. No significant difference was seen between the control arm with total laryngectomy and the larynx preservation approach. 3) The meta-analysis on chemotherapy in nasopharynx carcinomas, from the data of 11 randomized trials including 2722 patients, and comparing the radiotherapy to radio-chemotherapy (1979-2001). The results showed an absolute benefit of 6% at five years in overall survival, in favor of chemotherapy (P < 0.0001). Most of the benefit was seen with concomitant radio-chemotherapy. 4) Finally, a meta-analysis on altered fractionated RT, compared to conventional RT in 15 randomized trials regrouping 6515 patients. The results showed a small but significant improvement in favor of altered fractionated RT for overall survival and local control with an absolute benefit at five years of 3 and 6%, respectively. (author)

  18. Satisfactory patient-based outcomes after surgical treatment for idiopathic clubfoot: includes surgeon's individualized technique.

    Science.gov (United States)

    Mahan, Susan T; Spencer, Samantha A; Kasser, James R

    2014-09-01

    Treatment of idiopathic clubfoot has shifted towards Ponseti technique, but previously surgical management was standard. Outcomes of surgery have varied, with many authors reporting discouraging results. Our purpose was to evaluate a single surgeon's series of children with idiopathic clubfoot treated with a la carte posteromedial and lateral releases using the Pediatric Outcomes Data Collection Instrument (PODCI) with a minimum of 2-year follow-up. A total of 148 patients with idiopathic clubfoot treated surgically by a single surgeon over 15 years were identified, and mailed PODCI questionnaires. Fifty percent of the patients were located and responded, resulting in 74 complete questionnaires. Median age at surgery was 10 months (range, 5.3 to 84.7 mo), male sex 53/74 (71.6%), bilateral surgery 31/74 (41.9%), and average follow-up of 9.7 years. PODCI responses were compared with previously published normal healthy controls using t test for each separate category. Included in the methods is the individual surgeon's operative technique. In PODCIs where a parent reports for their child or adolescent, there was no difference between our data and the healthy controls in any of the 5 categories. In PODCI where an adolescent self-reports, there was no difference in 4 of 5 categories; significant difference was only found between our data (mean = 95.2; SD = 7.427) and normal controls (mean = 86.3; SD = 12.5) in Happiness Scale (P = 0.0031). In this group of idiopathic clubfoot patients, treated with judicious posteromedial release by a single surgeon, primarily when surgery was treatment of choice for clubfoot, patient-based outcomes are not different from their normal healthy peers through childhood and adolescence. While Ponseti treatment has since become the treatment of choice for clubfoot, surgical treatment, in some hands, has led to satisfactory results. Level III.

  19. Impact of individual-level social capital on quality of life among AIDS patients in China.

    Directory of Open Access Journals (Sweden)

    Ying Ma

    Full Text Available BACKGROUND: With growing recognition of the social determinants of health, social capital is an increasingly important construct in international health. However, the application of social capital discourse in response to HIV infection remains preliminary. The aim of this study was to assess the impact of social capital on quality of life (QoL among adult patients with acquired immune deficiency syndrome (AIDS. METHODS: A convenient sample of 283 patients receiving antiretroviral treatment (ART was investigated in Anhui province, China. QoL data were collected using the Medical Outcomes Study HIV Survey (MOS-HIV questionnaire. Social capital was measured using a self-developed questionnaire. Logistic regression models were used to explore associations between social capital and QoL. RESULTS: The study sample had a mean physical health summary (PHS score of 50.13 ± 9.90 and a mean mental health summary (MHS score of 41.64 ± 11.68. Cronbach's α coefficients of the five multi-item scales of social capital ranged from 0.44 to 0.79. When other variables were controlled for, lower individual levels of reciprocity and trust were associated with a greater likelihood of having a poor PHS score (odds ratio [OR] =2.02 or PHS score (OR=6.90. Additionally, the factors of social support and social networks and ties were associated positively with MHS score (OR=2.30, OR=4.17, respectively. CONCLUSIONS: This is the first report to explore the effects of social capital on QoL of AIDS patients in China. The results indicate that social capital is a promising avenue for developing strategies to improve the QoL of AIDS patients in China, suggesting that the contribution of social capital should be fully exploited, especially with enhancement of QoL through social participation. Social capital development policy may be worthy of consideration.

  20. Evaluation of individual quality of life among hemodialysis patients: nominated themes using SEIQoL-adapted

    Directory of Open Access Journals (Sweden)

    Matlabi H

    2016-12-01

    Full Text Available Hossein Matlabi, Sharareh Ahmadzadeh Department of Health Education and Promotion, Faculty of Health Sciences, Tabriz University of Medical Sciences, Tabriz, Iran Background: Quality of life (QoL has become an important issue for patients with chronic renal failure diseases who are permanently undergoing hemodialysis. In this study, an adapted schedule for the evaluation of individual quality of life (SEIQoL-adapted was used to evaluate QoL among hemodialysis patients, to explore their views about the most important aspects of life satisfaction. Methods and results: A multiple approach design and convenience sampling were applied to recruit 53 patients from a hemodialysis unit in Iran. Data were collected through structured interviews and then analyzed using conventional content analysis. A total score for QoL was calculated using scale guideline. The most important aspects of life were health, family, financial status, living conditions, leisure activities, relationships and socializing, religious and spiritual issues, medical knowledge, and therapies or treatments. The calculated mean QoL score was 66.2, indicating a relatively high life satisfaction. Males had higher QoL scores than females in both married and single groups. Moreover, the relationships between the QoL scores and education, job and marital status were not statistically significant. Conclusion: The SEIQoL-adapted revealed reasonable lay definitions of QoL in a group of patients following chronic renal failure. The patients’ views of the aspects of life could be used by health policy makers, clinicians, and caregivers as a reliable guide to the most important priorities for treatment and medical interventions. Keywords: quality of life, SEIQoL-adapted, renal dialysis

  1. Comparison of L-selectin blood level and gene polymorphism in tuberculosis patients with healthy individuals.

    Science.gov (United States)

    Eini, Peyman; Shirvani, Maria; Hajilooi, Mehrdad; Esna-Ashari, Farzaneh

    2018-02-12

    The inflammatory response to Mycobacterium tuberculosis bacilli influences tuberculosis (TB) progression. In this study, we aimed to identify the Phe206Leu polymorphism and serum L-selectin level in TB patients, compared to healthy individuals. Ninety patients with a diagnosis of TB and 90 healthy controls were selected in this study. The serum L-selectin level was determined, using ELISA. L-selectin polymorphism was also evaluated using PCR. For data analysis, SPSS was used at a significance level of 0.05. According to the findings, the mean±SD age of the participants was 57.5 ± 18.4 and 56.5 ± 17.5 years in the TB and healthy groups, respectively. The TB group showed a significantly higher serum L-selectin level (1721.1 ± 330.9) versus the healthy controls (1624 ± 279). The L-selectin Phe allele frequencies were higher than the Leu allele frequencies in the main population, whereas the patients and controls were not significantly different. Eight (0.04%) subjects had Leu/Leu genotypes, 84 (46.6%) carried Phe/Leu genotypes, and 88 (48.8%) had Phe/Phe genotypes. Our results showed that the groups were not significantly different regarding L-selectin genotypes. TB patients had a significantly higher serum L-selectin level, compared to the controls. Based on the findings, the incidence of TB and L-selectin polymorphism in the Phe206Leu gene had no significant association. © 2018 Wiley Periodicals, Inc.

  2. Individual- and neighborhood-level predictors of mortality in Florida colorectal cancer patients.

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    Stacey L Tannenbaum

    Full Text Available We examined individual-level and neighborhood-level predictors of mortality in CRC patients diagnosed in Florida to identify high-risk groups for targeted interventions.Demographic and clinical data from the Florida Cancer Data System registry (2007-2011 were linked with Agency for Health Care Administration and US Census data (n = 47,872. Cox hazard regression models were fitted with candidate predictors of CRC survival and stratified by age group (18-49, 50-64, 65+.Stratified by age group, higher mortality risk per comorbidity was found among youngest (21%, followed by middle (19%, and then oldest (14% age groups. The two younger age groups had higher mortality risk with proximal compared to those with distal cancer. Compared with private insurance, those in the middle age group were at higher death risk if not insured (HR = 1.35, or received healthcare through Medicare (HR = 1.44, Medicaid (HR = 1.53, or the Veteran's Administration (HR = 1.26. Only Medicaid in the youngest (52% higher risk and those not insured in the oldest group (24% lower risk were significantly different from their privately insured counterparts. Among 18-49 and 50-64 age groups there was a higher mortality risk among the lowest SES (1.17- and 1.23-fold higher in the middle age and 1.12- and 1.17-fold higher in the older age group, respectively compared to highest SES. Married patients were significantly better off than divorced/separated (HR = 1.22, single (HR = 1.29, or widowed (HR = 1.19 patients.Factors associated with increased risk for mortality among individuals with CRC included being older, uninsured, unmarried, more comorbidities, living in lower SES neighborhoods, and diagnosed at later disease stage. Higher risk among younger patients was attributed to proximal cancer site, Medicaid, and distant disease; however, lower SES and being unmarried were not risk factors in this age group. Targeted interventions to improve

  3. The effects of individually tailored nurse navigation for patients with newly diagnosed breast cancer

    DEFF Research Database (Denmark)

    Mertz, Birgitte Goldschmidt; Dunn-Henriksen, Anne Katrine; Kroman, Niels

    2017-01-01

    AIM: Our aim was to determine the feasibility and effectiveness of an individual, nurse-navigator intervention for relieving distress, anxiety, depression and health-related quality of life in women who have been treated for breast cancer (BC) and are experiencing moderate-to-severe psychological...... and the secondary outcomes were anxiety, depression, health-related quality of life and feasibility of the intervention. RESULTS: Women in the intervention group reported significantly greater satisfaction with treatment and rehabilitation and lower levels of distress (mean 2.7 vs. 5.1, panxiety (mean 5.1 vs...... no significant effects were observed after 6 months, we did find statistically significant effects on distress, anxiety and depression 12 months after diagnosis. Our results will assist in developing rehabilitation to the most vulnerable patients....

  4. Effectiveness of prenatal treatment for congenital toxoplasmosis: a meta-analysis of individual patients' data

    DEFF Research Database (Denmark)

    Thiébaut, Rodolphe; Leproust, Sandy; Chêne, Geneviève

    2007-01-01

    BACKGROUND: Despite three decades of prenatal screening for congenital toxoplasmosis in some European countries, uncertainty remains about the effectiveness of prenatal treatment. METHODS: We did a systematic review of cohort studies based on universal screening for congenital toxoplasmosis. We did...... a meta-analysis using individual patients' data to assess the effect of timing and type of prenatal treatment on mother-to-child transmission of infection and clinical manifestations before age 1 year. Analyses were adjusted for gestational age at maternal seroconversion and other covariates. FINDINGS......: We included 26 cohorts in the review. In 1438 treated mothers identified by prenatal screening, we found weak evidence that treatment started within 3 weeks of seroconversion reduced mother-to-child transmission compared with treatment started after 8 or more weeks (adjusted odds ratio [OR] 0.48, 95...

  5. DETERMINATION OF INDIVIDUAL FEATURES OF BALANCE RETAINING IN PATIENTS WITH CEREBRAL PALSY USING STABILOMETRY TESTING

    Directory of Open Access Journals (Sweden)

    O. D. Davydov

    2014-01-01

    Full Text Available The practical aim of the research is to develop a methodology for assessing the functional state of the musculoskeletal system in the case of complex human pathologies and associated injuries with the objective distinction of interdependent anatomical and functional disorders in the osteoarticular system, nervous and muscular subsystems, identification pathology severity in the separate subsystems and the degree of influence for each of them on the movement organization as a whole. In patients with cerebral palsy the neurological movement disturbance is a priority component, differentiation of which may by difficult due to lack of tools to evaluate objectively and display the features of functioning nervous system in normal and pathological conditions. The authors propose a set of interval indicators of stabilometric study and method to use it providing the more qualitative consideration individual characteristics and the formation of clinically interpretable representation of a visual results image as compared with the standard vector and frequency indicators.

  6. Evaluation of four methods for separation of lymphocytes from normal individuals and patients with cancer and tuberculosis.

    Science.gov (United States)

    Patrick, C C; Graber, C D; Loadholt, C B

    1976-01-01

    An optimal technique was sought for lymphocyte recovery from normal and chronic diseased individuals. Lymphocytes were separated by four techniques: Plasmagel, Ficoll--Hypaque, a commercial semiautomatic method, and simple centrifugation using blood drawn from ten normal individuals, ten cancer patients, and ten tuberculosis patients. The lymphocyte mixture obtained after using each method was analyzed for percent recovery, amount if contamination by erythrocytes and neutrophils, and percent viability. The results show that the semiautomatic method yielded the best percent recovery of lymphocytes for normal individuals, while the simple centrifugation method contributed the highest percent recovery for cancer and tuberculosis patients. The Ficoll-Hypaque method gave the lowest erythrocyte contamination for all three types of individuals tested, while the Plasmagel method gave the lowest neutrophil contamination for all three types of individuals. The simple centrifugation method yielded all viable lymphocytes and thus gave the highest percent viability.

  7. Meta-analysis of Gaussian individual patient data: Two-stage or not two-stage?

    Science.gov (United States)

    Morris, Tim P; Fisher, David J; Kenward, Michael G; Carpenter, James R

    2018-04-30

    Quantitative evidence synthesis through meta-analysis is central to evidence-based medicine. For well-documented reasons, the meta-analysis of individual patient data is held in higher regard than aggregate data. With access to individual patient data, the analysis is not restricted to a "two-stage" approach (combining estimates and standard errors) but can estimate parameters of interest by fitting a single model to all of the data, a so-called "one-stage" analysis. There has been debate about the merits of one- and two-stage analysis. Arguments for one-stage analysis have typically noted that a wider range of models can be fitted and overall estimates may be more precise. The two-stage side has emphasised that the models that can be fitted in two stages are sufficient to answer the relevant questions, with less scope for mistakes because there are fewer modelling choices to be made in the two-stage approach. For Gaussian data, we consider the statistical arguments for flexibility and precision in small-sample settings. Regarding flexibility, several of the models that can be fitted only in one stage may not be of serious interest to most meta-analysis practitioners. Regarding precision, we consider fixed- and random-effects meta-analysis and see that, for a model making certain assumptions, the number of stages used to fit this model is irrelevant; the precision will be approximately equal. Meta-analysts should choose modelling assumptions carefully. Sometimes relevant models can only be fitted in one stage. Otherwise, meta-analysts are free to use whichever procedure is most convenient to fit the identified model. © 2018 The Authors. Statistics in Medicine Published by John Wiley & Sons Ltd.

  8. Investigating the Possibility to Individualize Asthma Attack Therapy Based on Attack Severity and Patient Characteristics

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    Sárkány Zoltán

    2016-03-01

    Full Text Available Introduction: The objective of this study was to investigate with the help of a computerized simulation model whether the treatment of an acute asthma attack can be individualized based on the severity of the attack and the characteristics of the patient. Material and Method: A stochastic lung model was used to simulate the deposition of 1 nm - 10 μm particles during a mild and a moderate asthma attack. Breathing parameters were varied to maximize deposition, and simulation results were compared with those obtained in the case of a severe asthma attack. In order to investigate the effect of height on the deposition of inhaled particles, another series of simulations was carried out with identical breathing parameters, comparing patient heights of 155 cm, 175 cm and 195 cm. Results: The optimization process yielded an increase in the maximum deposition values of around 6-7% for each type of investigated asthma attack, and the difference between attacks of different degree of severity was around 5% for both the initial and the optimized values, a higher degree of obstruction increasing the amount of deposited particles. Conclusions: Our results suggest that the individualization of asthma attack treatment cannot be based on particles of different size, as the highest deposited fraction in all three types of attacks can be obtained using 0.01 μm particles. The use of a specific set of breathing parameters yields a difference between a mild and a moderate, as well as a moderate and a severe asthma attack of around 5%.

  9. Sensory impairments of the lower limb after stroke: a pooled analysis of individual patient data.

    Science.gov (United States)

    Tyson, Sarah F; Crow, J Lesley; Connell, Louise; Winward, Charlotte; Hillier, Susan

    2013-01-01

    To obtain more generalizable information on the frequency and factors influencing sensory impairment after stroke and their relationship to mobility and function. A pooled analysis of individual data of stroke survivors (N = 459); mean (SD) age = 67.2 (14.8) years, 54% male, mean (SD) time since stroke = 22.33 (63.1) days, 50% left-sided weakness. Where different measurement tools were used, data were recorded. Descriptive statistics described frequency of sensory impairments, kappa coefficients investigated relationships between sensory modalities, binary logistic regression explored the factors influencing sensory impairments, and linear regression assessed the impact of sensory impairments on activity limitations. Most patients' sensation was intact (55%), and individual sensory modalities were highly associated (κ = 0.60, P sensory impairment (P analysis showed sensation of the lower limb is grossly preserved in most stroke survivors but, when present, it affects function. Sensory modalities are highly interrelated; interventions that treat the motor system during functional tasks may be as effective at treating the sensory system as sensory retraining alone.

  10. The systematic activation method as a nursing intervention in depressed elderly: a protocol for a multi-centre cluster randomized trial.

    Science.gov (United States)

    Clignet, Frans; van Meijel, Berno; van Straten, Annemiek; Cuijpers, Pim

    2012-09-18

    Depression in later life is a common mental disorder with a prevalence rate of between 3% and 35% for minor depression and approximately 2% for Major Depressive Disorder (MDD). The most common treatment modalities for MDD are antidepressant medication and psychological interventions. Recently, Behavioral Activation (BA) has gained renewed attention as an effective treatment modality in MDD. Although BA is considered an easy accessible intervention for both patients and health care workers (such as nurses), there is no research on the effectiveness of the intervention in inpatient depressed elderly.The aim of study, described in the present proposal, is to examine the effects of BA when executed by nurses in an inpatient population of elderly persons with MDD. The study is designed as a multi-center cluster randomized controlled trial. BA, described as The Systematic Activation Method (SAM) will be compared with Treatment as Usual (TAU). We aim to include ten mental health care units in the Netherlands that will each participate as a control unit or an experimental unit. The patients will meet the following criteria: (1) a primary diagnosis of Major Depressive Disorder (MDD) according to the DSM-IV criteria; (2) 60 years or older; (3) able to read and write in Dutch; (4) have consented to participate via the informed consent procedure. Based on an effect size d = 0.7, we intend to include 51 participants per condition (n = 102). The SAM will be implemented within the experimental units as an adjunctive therapy to Treatment As Usual (TAU). All patients will be assessed at baseline, after eight weeks, and after six months. The primary outcome will be the level of depression measured by means of the Beck Depression Inventory (Dutch version). Other assessments will be activity level, mastery, costs, anxiety and quality of life. To our knowledge this is the first study to test the effect of Behavioral Activation as a nursing intervention in an inpatient elderly

  11. Attributable mortality of ventilator-associated pneumonia: a meta-analysis of individual patient data from randomised prevention studies

    NARCIS (Netherlands)

    Melsen, W.G.; Rovers, M.M.; Groenwold, R.H.; Bergmans, D.C.; Camus, C.; Bauer, T.T.; Hanisch, E.W.; Klarin, B.; Koeman, M.; Krueger, W.A.; Lacherade, J.C.; Lorente, L.; Memish, Z.A.; Morrow, L.E.; Nardi, G.; Nieuwenhoven, C.A. van; O'Keefe, G.E.; Nakos, G.; Scannapieco, F.A.; Seguin, P.; Staudinger, T.; Topeli, A.; Ferrer, M.; Bonten, M.J.

    2013-01-01

    BACKGROUND: Estimating attributable mortality of ventilator-associated pneumonia has been hampered by confounding factors, small sample sizes, and the difficulty of doing relevant subgroup analyses. We estimated the attributable mortality using the individual original patient data of published

  12. Individualized monitoring of drug bioavailability and immunogenicity in rheumatoid arthritis patients treated with the tumor necrosis factor alpha inhibitor infliximab

    DEFF Research Database (Denmark)

    Bendtzen, Klaus; Geborek, Pierre; Svenson, Morten

    2006-01-01

    Infliximab, an anti-tumor necrosis factor alpha (anti-TNFalpha) antibody, is effective in the treatment of several immunoinflammatory diseases. However, many patients experience primary or secondary response failure, suggesting that individualization of treatment regimens may be beneficial...

  13. Accounting for parameter uncertainty in the definition of parametric distributions used to describe individual patient variation in health economic models

    NARCIS (Netherlands)

    Degeling, Koen; Ijzerman, Maarten J.; Koopman, Miriam; Koffijberg, Hendrik

    2017-01-01

    Background: Parametric distributions based on individual patient data can be used to represent both stochastic and parameter uncertainty. Although general guidance is available on how parameter uncertainty should be accounted for in probabilistic sensitivity analysis, there is no comprehensive

  14. Accounting for parameter uncertainty in the definition of parametric distributions used to describe individual patient variation in health economic models

    NARCIS (Netherlands)

    Degeling, Koen; IJzerman, Maarten J; Koopman, Miriam; Koffijberg, Hendrik

    2017-01-01

    Background Parametric distributions based on individual patient data can be used to represent both stochastic and parameter uncertainty. Although general guidance is available on how parameter uncertainty should be accounted for in probabilistic sensitivity analysis, there is no comprehensive

  15. Individual patient data meta-analysis of antiplatelet regimens after noncardioembolic stroke or TIA : Rationale and design

    NARCIS (Netherlands)

    Greving, Jacoba P.; Diener, Hans Christoph; Csiba, László; Hacke, Werner; Kappelle, L. Jaap; Koudstaal, Peter J.; Leys, Didier; Mas, Jean Louis; Sacco, Ralph L.; Sivenius, Juhani; Algra, Ale

    2015-01-01

    Background: The Cerebrovascular Antiplatelet Trialists' Collaborative Group was formed to obtain and analyze individual patient data from the major randomized trials of common antiplatelet regimens after cerebral ischemia. Although the risk of stroke can be reduced by antiplatelet drugs, there

  16. Risk factors associated with repetition of self-harm in black and minority ethnic (BME) groups: a multi-centre cohort study.

    Science.gov (United States)

    Cooper, Jayne; Steeg, Sarah; Webb, Roger; Stewart, Suzanne L K; Applegate, Eve; Hawton, Keith; Bergen, Helen; Waters, Keith; Kapur, Navneet

    2013-06-01

    Little information is available to inform clinical assessments on risk of self-harm repetition in ethnic minority groups. In a prospective cohort study, using data collected from six hospitals in England for self-harm presentations occurring between 2000 and 2007, we investigated risk factors for repeat self-harm in South Asian and Black people in comparison to Whites. During the study period, 751 South Asian, 468 Black and 15,705 White people presented with self-harm in the study centres. Repeat self-harm occurred in 4379 individuals, which included 229 suicides (with eight of these fatalities being in the ethnic minority groups). The risk ratios for repetition in the South Asian and Black groups compared to the White group were 0.6, 95% CI 0.5-0.7 and 0.7, 95% CI 0.5-0.8, respectively. Risk factors for repetition were similar across all three groups, although excess risk versus Whites was seen in Black people presenting with mental health symptoms, and South Asian people reporting alcohol use and not having a partner. Additional modelling of repeat self-harm count data showed that alcohol misuse was especially strongly linked with multiple repetitions in both BME groups. Ethnicity was not recorded in a third of cases which may introduce selection bias. Differences may exist due to cultural diversity within the broad ethnic groups. Known social and psychological features that infer risk were present in South Asian and Black people who repeated self-harm. Clinical assessment in these ethnic groups should ensure recognition and treatment of mental illness and alcohol misuse. Copyright © 2012 Elsevier B.V. All rights reserved.

  17. In silico evaluation of limited blood sampling strategies for individualized recombinant factor IX prophylaxis in hemophilia B patients

    NARCIS (Netherlands)

    Preijers, T.; Hazendonk, H. C. A. M.; Fijnvandraat, K.; Leebeek, F. W. G.; Cnossen, M. H.; Mathôt, R. A. A.

    2017-01-01

    Background Patients with severe hemophilia B regularly administer prophylactic intravenous doses of clotting factor IX concentrate to maintain a trough level of at least 0.01 IU mL(-1) in order to prevent joint bleeds. Assessment of individual pharmacokinetic (PK) parameters allows individualization

  18. Analogue patients' self-reported engagement and psychophysiological arousal in a video-vignettes design: Patients versus disease-naïve individuals

    NARCIS (Netherlands)

    Visser, Leonie N. C.; Tollenaar, Marieke S.; Bosch, Jos A.; van Doornen, Lorenz J. P.; de Haes, Hanneke C. J. M.; Smets, Ellen M. A.

    2016-01-01

    The ecological validity of video-vignettes design investigating patient-provider communication hinges on the engagement of analogue patients (APs) with the vignette. The present study aimed to compare engagement in two commonly utilized groups of APs, patients and disease-naïve individuals.

  19. Specific vulnerability of face perception to noise: a similar effect in schizophrenia patients and healthy individuals.

    Science.gov (United States)

    Chen, Yue; McBain, Ryan; Norton, Daniel

    2015-02-28

    Face perception plays a foundational role in the social world. This perceptual ability is deficient in schizophrenia. A noise-filtering mechanism is essential for perceptual processing. It remains unclear as to whether a specific noise-filtering mechanism is implicated in the face perception problem or a general noise-filtering mechanism is involved which also mediates non-face visual perception problems associated with this psychiatric disorder. This study examined and compared the effects of external noise on the performance of face discrimination and car discrimination in schizophrenia patients (n=25) and healthy controls (n=27). Superimposing the external visual noise on face or car stimuli elevated perceptual thresholds (i.e. degraded performance levels) for both face and car discrimination. However, the effect of noise was significantly larger on face than on car discrimination, both in patients and controls. This pattern of results suggests specific vulnerability of face processing to noise in healthy individuals and those with schizophrenia. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  20. Meta-analysis of randomized clinical trials in the era of individual patient data sharing.

    Science.gov (United States)

    Kawahara, Takuya; Fukuda, Musashi; Oba, Koji; Sakamoto, Junichi; Buyse, Marc

    2018-06-01

    Individual patient data (IPD) meta-analysis is considered to be a gold standard when the results of several randomized trials are combined. Recent initiatives on sharing IPD from clinical trials offer unprecedented opportunities for using such data in IPD meta-analyses. First, we discuss the evidence generated and the benefits obtained by a long-established prospective IPD meta-analysis in early breast cancer. Next, we discuss a data-sharing system that has been adopted by several pharmaceutical sponsors. We review a number of retrospective IPD meta-analyses that have already been proposed using this data-sharing system. Finally, we discuss the role of data sharing in IPD meta-analysis in the future. Treatment effects can be more reliably estimated in both types of IPD meta-analyses than with summary statistics extracted from published papers. Specifically, with rich covariate information available on each patient, prognostic and predictive factors can be identified or confirmed. Also, when several endpoints are available, surrogate endpoints can be assessed statistically. Although there are difficulties in conducting, analyzing, and interpreting retrospective IPD meta-analysis utilizing the currently available data-sharing systems, data sharing will play an important role in IPD meta-analysis in the future.

  1. Proposal of a methodology for individualized iodine-131 therapy for Graves' disease in patients with hyperthyroidism

    International Nuclear Information System (INIS)

    Araujo, Francisco de; Melo, Rossana Corbo de; Rebelo, Ana Maria de Oliveira; Dantas, Bernardo Maranhao; Dantas, Ana Leticia A.; Lucena, Eder Augusto de

    2007-01-01

    Objective: Several methods are utilized for determining the radioiodine activity in the treatment of Graves' disease (hyperthyroidism). Some of this methods do not take into consideration the thyroid absorbed dose or the necessary parameters for this estimation. The association between absorbed dose and administered activity depends on effective half-life, iodine uptake and thyroid mass of each patient. The present study was aimed at developing a methodology for individualized 131 I therapy for Graves' disease in patients with hyperthyroidism of the Graves' disease. Materials and methods: A neck-thyroid phantom developed at Instituto de Radioprotecao e Dosimetria, containing a standard solution of 131 I, was utilized for calibrating the scintillation gamma camera and uptake probe installed in the Department of Nuclear Medicine of the Hospital Universitario Clementino Fraga Filho da Universidade Federal do Rio de Janeiro. Results: The view angle of the collimator/detector assembly presented values compatible with the thyroid gland size for distances of 25 cm (uptake probe) and 45.8 cm (scintillation gamma camera). Calibration factors were 39.3 ± 0.78 and 4.3 ± 0.17 cpm/kBq, respectively. The 14-30-hour interval in the retention curve allows the estimation of activity between two points for determining the effective iodine half-life in the thyroid. Conclusion: The utilization of equipment usually available in nuclear medicine clinics is feasible, so this is a simple, effective and low cost methodology. (author)

  2. [Individual therapy goals: on outcome documentation of inpatient psychotherapy from the patient and therapist viewpoint].

    Science.gov (United States)

    Heuft, G; Senf, W; Wagener, R; Pintelon, C; Lorenzen, J

    1996-01-01

    The results of a study evaluation in practicability of two newly developed documentation forms are presented. Examined are 82 inpatient treatment episodes in an already published clinical concept with different treatment settings. Parallel versions of the forms were completed by patients and therapists. The 'Erge-Doku-A-Form' allows for the naming of up to five therapy goals determined at the beginning of therapy and evaluated in relation to their achieved quality at the end of therapy. The 'Erge-Doku-B-Form' describes a variety of problem areas as well as questions related to medication and changes induced by therapy. Surprising there were a high number of 230 Individual Therapy Goals (ITG) by patients and 262 ITG by therapists which could be arranged into 89 content categories and 5 main categories. Outcome measurement shows different results. There was a significant relationship between the 'well-being', the impression of 'satisfying treatment' at the end of the inpatient period and 'success in the main ITG'. The documentation forms presented here allow an outcome-measurement depending on differential indications.

  3. The individual reminiscence therapy for patients with dementia. Assessment with SPECT and neuropsychological test

    International Nuclear Information System (INIS)

    Tanaka, Katsuaki

    2009-01-01

    We evaluated psychosocial and neuronal effects of the individual reminiscence therapy (IRT) for patients with cognitive impairment. 25 IRT- treated outpatients with Alzheimer disease were compared with 14 outpatients who were not receiving any treatments including IRT. The subjects were treated with the total of 8 IRT sessions within 4 months. The changes of cognitive function, mood, volition, and the ability of caregiver were measured with questionnaires. The changes in the regional cerebral blood flow (rCBF) with IRT were measured using single photon emission computed tomography (SPECT). In IRT group, depressed mood was improved after 4 month-IRT, which reached the significance level one year later. On the contrary, we could not observe any psychosocial changes in control group. Significant increase in regional blood flow was observed in the left dorsolateral prefrontal cortex (DLPFC) and in the right temporoparietal cortex in IRT group. On the contrary, the significant increase in the rCBF was observed only in the left DLPFC in control group. These results suggest that the IRT might improve the depressed mood and the spatial cognition in patients with cognitive impairment with neuronal change. (author)

  4. Prevalence and risk indicators of gingivitis and periodontitis in a Multi-Centre study in North Jordan: a cross sectional study

    Science.gov (United States)

    2012-01-01

    Background There are limited data about the epidemiology and risk factors/indicators of gingivitis, aggressive periodontitis (AgP) and chronic periodontitis (CP) in Jordan. The aim of this study was to assess the prevalence and risk indicators of gingivitis, AgP and CP. Methods A sample of 595 subjects was randomly selected from subjects escorting out-patients attending a Medical Center, a Dental Teaching Hospital, and 2 private dental clinics. The socio-demographic variables, oral hygiene habits, income, smoking and Body Mass Index (BMI) were recorded. Full mouth periodontal examination was performed, and radiographs were taken for sites with probing depth > 3 mm. Results About 76% had gingivitis, 2.2% had AgP and 5.5% had CP. Periodontitis was more frequent among males than females with a M: F ratio of 1.6:1 and the prevalence increased with age. Subjects who reported not using a tooth brush, smokers and subjects with BMI > 30 kg/m2 had significantly higher prevalence of periodontitis. The risk for periodontitis was greater among subjects who reported positive family history and subjects with ≤ 12 years of education. Conclusions This is the first study to report on the prevalence of gingivitis, CP and AgP in North Jordanian. Age, low education, low frequency of tooth brushing and family history were significantly associated with increased risk of periodontitis. PMID:22214223

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

    Directory of Open Access Journals (Sweden)

    Thompson Kara

    2010-12-01

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

  6. SYNERGIC TRIAL (SYNchronizing Exercises, Remedies in Gait and Cognition) a multi-Centre randomized controlled double blind trial to improve gait and cognition in mild cognitive impairment.

    Science.gov (United States)

    Montero-Odasso, Manuel; Almeida, Quincy J; Burhan, Amer M; Camicioli, Richard; Doyon, Julien; Fraser, Sarah; Li, Karen; Liu-Ambrose, Teresa; Middleton, Laura; Muir-Hunter, Susan; McIlroy, William; Morais, José A; Pieruccini-Faria, Frederico; Shoemaker, Kevin; Speechley, Mark; Vasudev, Akshya; Zou, G Y; Berryman, Nicolas; Lussier, Maxime; Vanderhaeghe, Leanne; Bherer, Louis

    2018-04-16

    and mobility outcomes in MCI. These interventions may contribute to new approaches to stabilize and reverse cognitive-mobility decline in older individuals with MCI. Identifier: NCT02808676. https://www.clinicaltrials.gov/ct2/show/NCT02808676 .

  7. MO-DE-BRA-03: The Ottawa Medical Physics Institute (OMPI): A Practical Model for Academic Program Collaboration in a Multi-Centre City

    Energy Technology Data Exchange (ETDEWEB)

    McEwen, M [National Research Council Canada, Ottawa, ON (Canada); Rogers, D [Carleton University, Ottawa, ON (Canada); Johns, P

    2016-06-15

    Purpose: To build a world-class medical physics educational program that capitalizes on expertise distributed over several clinical, government, and academic centres. Few if any of these centres would have the critical mass to solely resource a program. Methods: In order to enable an academic program, stakeholders from five institutions made a proposal to Carleton University for a) a research network with defined membership requirements and a process for accepting new members, and b) a graduate specialization (MSc and PhD) in medical physics. Both proposals were accepted and the program has grown steadily. Our courses are taught by medical physicists from across the collaboration. Our students have access to physicists in: clinical radiotherapy (the Ottawa Cancer Centre treats 4500 new patients/y), radiology, cardiology and nuclear medicine, Canada’s primary standards dosimetry laboratory, radiobiology, and university-based medical physics research. Our graduate courses emphasize the foundational physics plus applied aspects of imaging, radiotherapy, and radiobiology. Active researchers in the city-wide volunteer-run network are appointed as adjunct professors by Physics, giving them access to national funding competitions and partial student funding through teaching assistantships while opening up facilities in their institutions for student thesis research. Results: The medical physics network has grown to ∼40 members from eight institutions and includes five full-time faculty in Physics and 17 adjunct research professors. The graduate student population is ∼20. Our graduates have proceeded to a spectrum of careers. Our alumni list includes a CCPM Past-President, the current COMP President, many clinical physicists, and the heads of at least three major clinical medical physics departments. Our PhD was Ontario’s first CAMPEP-accredited program. Conclusion: A self-governing volunteer network is the foundational element that enables an MSc/PhD medical

  8. MO-DE-BRA-03: The Ottawa Medical Physics Institute (OMPI): A Practical Model for Academic Program Collaboration in a Multi-Centre City

    International Nuclear Information System (INIS)

    McEwen, M; Rogers, D; Johns, P

    2016-01-01

    Purpose: To build a world-class medical physics educational program that capitalizes on expertise distributed over several clinical, government, and academic centres. Few if any of these centres would have the critical mass to solely resource a program. Methods: In order to enable an academic program, stakeholders from five institutions made a proposal to Carleton University for a) a research network with defined membership requirements and a process for accepting new members, and b) a graduate specialization (MSc and PhD) in medical physics. Both proposals were accepted and the program has grown steadily. Our courses are taught by medical physicists from across the collaboration. Our students have access to physicists in: clinical radiotherapy (the Ottawa Cancer Centre treats 4500 new patients/y), radiology, cardiology and nuclear medicine, Canada’s primary standards dosimetry laboratory, radiobiology, and university-based medical physics research. Our graduate courses emphasize the foundational physics plus applied aspects of imaging, radiotherapy, and radiobiology. Active researchers in the city-wide volunteer-run network are appointed as adjunct professors by Physics, giving them access to national funding competitions and partial student funding through teaching assistantships while opening up facilities in their institutions for student thesis research. Results: The medical physics network has grown to ∼40 members from eight institutions and includes five full-time faculty in Physics and 17 adjunct research professors. The graduate student population is ∼20. Our graduates have proceeded to a spectrum of careers. Our alumni list includes a CCPM Past-President, the current COMP President, many clinical physicists, and the heads of at least three major clinical medical physics departments. Our PhD was Ontario’s first CAMPEP-accredited program. Conclusion: A self-governing volunteer network is the foundational element that enables an MSc/PhD medical

  9. Inter-observer agreement for Crohn's disease sub-phenotypes using the Montreal Classification: How good are we? A multi-centre Australasian study.

    Science.gov (United States)

    Krishnaprasad, Krupa; Andrews, Jane M; Lawrance, Ian C; Florin, Timothy; Gearry, Richard B; Leong, Rupert W L; Mahy, Gillian; Bampton, Peter; Prosser, Ruth; Leach, Peta; Chitti, Laurie; Cock, Charles; Grafton, Rachel; Croft, Anthony R; Cooke, Sharon; Doecke, James D; Radford-Smith, Graham L

    2012-04-01

    Crohn's disease (CD) exhibits significant clinical heterogeneity. Classification systems attempt to describe this; however, their utility and reliability depends on inter-observer agreement (IOA). We therefore sought to evaluate IOA using the Montreal Classification (MC). De-identified clinical records of 35 CD patients from 6 Australian IBD centres were presented to 13 expert practitioners from 8 Australia and New Zealand Inflammatory Bowel Disease Consortium (ANZIBDC) centres. Practitioners classified the cases using MC and forwarded data for central blinded analysis. IOA on smoking and medications was also tested. Kappa statistics, with pre-specified outcomes of κ>0.8 excellent; 0.61-0.8 good; 0.41-0.6 moderate and ≤0.4 poor, were used. 97% of study cases had colonoscopy reports, however, only 31% had undergone a complete set of diagnostic investigations (colonoscopy, histology, SB imaging). At diagnosis, IOA was excellent for age, κ=0.84; good for disease location, κ=0.73; only moderate for upper GI disease (κ=0.57) and disease behaviour, κ=0.54; and good for the presence of perianal disease, κ=0.6. At last follow-up, IOA was good for location, κ=0.68; only moderate for upper GI disease (κ=0.43) and disease behaviour, κ=0.46; but excellent for the presence/absence of perianal disease, κ=0.88. IOA for immunosuppressant use ever and presence of stricture were both good (κ=0.79 and 0.64 respectively). IOA using MC is generally good; however some areas are less consistent than others. Omissions and inaccuracies reduce the value of clinical data when comparing cohorts across different centres, and may impair the ability to translate genetic discoveries into clinical practice. Crown Copyright © 2011. Published by Elsevier B.V. All rights reserved.

  10. Incidence of infection following internal fixation of open and closed tibia fractures in India (INFINITI): a multi-centre observational cohort study.

    Science.gov (United States)

    Doshi, Prakash; Gopalan, Hitesh; Sprague, Sheila; Pradhan, Chetan; Kulkarni, Sunil; Bhandari, Mohit

    2017-04-14

    Trauma is a major public health problem, particularly in India due to the country's rapid urbanization. Tibia fractures are a common and often complicated injury that is at risk of infection following surgical fixation. The primary objectives of this cohort study were to determine the incidence of infection within one year of surgery and to describe the distribution of infections by location and time of diagnosis for tibia fractures in India. We conducted a multi-center, prospective cohort study. Patients who presented with an open or closed tibia fracture treated with internal fixation to one of the participating hospitals in India were invited to participate in the study. Participants attended follow-up visits at 3, 6, and 12 months post-surgery, where they were assessed for infections, fracture healing, and health-related quality of life as measured by the EurQol-5 Dimensions (EQ-5D). Seven hundred eighty-seven participants were included in the study and 768 participants completed the 12 month follow-up. The overall incidence of infection was 2.9% (23 infections). The incidence of infection was 1.6% (10 infections) in closed and 8.0% (13 infections) in open fractures. There were 7 deep and 16 superficial infections, with 5 being early, 7 being delayed, and 11 being late infections. Intra-operative antibiotics were given to 92.1% of participants and post-operative antibiotics were given to 96.8% of participants. Antibiotics were prescribed for an average of 8.3 days for closed fractures and 9.1 days for open fractures. Infected fractures took significantly longer to heal, and participants who had an infection had significantly lower EQ-5D scores. The incidence of infection within this cohort is similar to those seen in developed countries. The duration of prophylactic antibiotic use was longer than standard practice in North America, raising concern for the potential development of antibiotic resistant microbes within Indian orthopaedic settings. Future

  11. A comparative evaluation of dimensional stability of three types of interocclusal recording materials-an in-vitro multi-centre study.

    Science.gov (United States)

    Tejo, Sampath Kumar; Kumar, Anil G; Kattimani, Vivekanand S; Desai, Priti D; Nalla, Sandeep; Chaitanya K, Krishna

    2012-10-05

    The introduction of different interocclusal recording materials has put clinicians in dilemma that which material should be used in routine clinical practice for precise recording and transferring of accurate existing occlusal records for articulation of patient's diagnostic or working casts in the fabrication of good satisfactory prosthesis. In the era of developing world of dentistry the different materials are introduced for interocclusal record with different brand names because of this; the utility of the material is confusing for successful delivery of prosthesis with lack of in vitro or in vivo studies which will predict the property of the material with utility recommendations. The aim of this multicenter research is to evaluate the time dependent linear dimensional stability of three types of interocclusal recording materials; which gives very clear idea to clinicians in regard to its usage in routine practice and recommendations for usage of the different materials. Also to find out ideal time for articulation of three types of interocclusal recording materials with accuracy. Commercially available and ADA approved Polyether bite registration paste (Ramitec), Poly vinyl siloxane bite registration paste (Jetbite) and Zinc oxide eugenol (ZOE) bite registration paste (Super bite) were used in the study.A stainless steel die was made according to modified American dental Associations (ADA) specification no. 19. Each one of the tested materials were manipulated according to manufacturers' instructions. The materials separated from die, 3-mins after their respective setting time, resulted in disks of standard diameter. Two parallel lines and three perpendicular lines reproduced on the surface. The distance between two parallel lines was measured at different time intervals i.e. 1 hour, 24, 48 and 72 hours by using travelling microscope (magnus) and compared with standard die measurements made according to ADA specification no.19 to find out the dimensional

  12. [Predicting individual risk of high healthcare cost to identify complex chronic patients].

    Science.gov (United States)

    Coderch, Jordi; Sánchez-Pérez, Inma; Ibern, Pere; Carreras, Marc; Pérez-Berruezo, Xavier; Inoriza, José M

    2014-01-01

    To develop a predictive model for the risk of high consumption of healthcare resources, and assess the ability of the model to identify complex chronic patients. A cross-sectional study was performed within a healthcare management organization by using individual data from 2 consecutive years (88,795 people). The dependent variable consisted of healthcare costs above the 95th percentile (P95), including all services provided by the organization and pharmaceutical consumption outside of the institution. The predictive variables were age, sex, morbidity-based on clinical risk groups (CRG)-and selected data from previous utilization (use of hospitalization, use of high-cost drugs in ambulatory care, pharmaceutical expenditure). A univariate descriptive analysis was performed. We constructed a logistic regression model with a 95% confidence level and analyzed sensitivity, specificity, positive predictive values (PPV), and the area under the ROC curve (AUC). Individuals incurring costs >P95 accumulated 44% of total healthcare costs and were concentrated in ACRG3 (aggregated CRG level 3) categories related to multiple chronic diseases. All variables were statistically significant except for sex. The model had a sensitivity of 48.4% (CI: 46.9%-49.8%), specificity of 97.2% (CI: 97.0%-97.3%), PPV of 46.5% (CI: 45.0%-47.9%), and an AUC of 0.897 (CI: 0.892 to 0.902). High consumption of healthcare resources is associated with complex chronic morbidity. A model based on age, morbidity, and prior utilization is able to predict high-cost risk and identify a target population requiring proactive care. Copyright © 2013 SESPAS. Published by Elsevier Espana. All rights reserved.

  13. Low serum BDNF levels in depressed patients cannot be attributed to individual depressive symptoms or symptom cluster

    NARCIS (Netherlands)

    Bus, B. A. A.; Molendijk, M. L.; Penninx, B. W. J. H.; Buitelaar, J. K.; Prickaerts, J.; Elzinga, B. M.; Oude Voshaar, R. C.

    OBJECTIVES: Low serum BDNF levels have been found in depressed patients. No study has systematically investigated whether individual symptoms or symptom profiles within a depressed population contribute to low BDNF levels found in depressed subjects. METHODS: All 1070 patients with a past 6-month

  14. Endovascular thrombectomy after large-vessel ischaemic stroke: a meta-analysis of individual patient data from five randomised trials

    NARCIS (Netherlands)

    Goyal, Mayank; Menon, Bijoy K.; van Zwam, Wim H.; Dippel, Diederik W. J.; Mitchell, Peter J.; Demchuk, Andrew M.; Dávalos, Antoni; Majoie, Charles B. L. M.; van der Lugt, Aad; de Miquel, Maria A.; Donnan, Geoffrey A.; Roos, Yvo B. W. E. M.; Bonafe, Alain; Jahan, Reza; Diener, Hans-Christoph; van den Berg, Lucie A.; Levy, Elad I.; Berkhemer, Olvert A.; Pereira, Vitor M.; Rempel, Jeremy; Millán, Mònica; Davis, Stephen M.; Roy, Daniel; Thornton, John; Román, Luis San; Ribó, Marc; Beumer, Debbie; Stouch, Bruce; Brown, Scott; Campbell, Bruce C. V.; van Oostenbrugge, Robert J.; Saver, Jeffrey L.; Hill, Michael D.; Jovin, Tudor G.

    2016-01-01

    In 2015, five randomised trials showed efficacy of endovascular thrombectomy over standard medical care in patients with acute ischaemic stroke caused by occlusion of arteries of the proximal anterior circulation. In this meta-analysis we, the trial investigators, aimed to pool individual patient

  15. Stenting versus endarterectomy for restenosis following prior ipsilateral carotid endarterectomy : An individual patient data meta-analysis

    NARCIS (Netherlands)

    Fokkema, Margriet; Vrijenhoek, Joyce E P; Ruijter, Hester M Den; Groenwold, Rolf H H; Schermerhorn, Marc L.; Bots, Michiel L.; Pasterkamp, Gerard; Moll, Frans L.; De Borst, Gert Jan

    2015-01-01

    Objective: To study perioperative results and restenosis during follow-up of carotid artery stenting (CAS) versus carotid endarterectomy (CEA) for restenosis after prior ipsilateral CEA in an individual patient data (IPD) metaanalysis. Background: The optimal treatment strategy for patients with

  16. Individual radiosensitivity measured with lymphocytes can be used to predict the risk of fibrosis after radiotherapy of breast cancer patients

    International Nuclear Information System (INIS)

    Hoeller, U.; Borgmann, K.; Alberti, W.; Dikomey, E.

    2003-01-01

    To analyse the relationship of individual cellular radiosensitivity and fibrosis after breast conserving therapy. A new model was used describing the percentage of patients developing fibrosis per year per patients at risk . In a retrospective study, 86 patients were included, who had undergone breast conserving surgery and irradiation of the breast with a median dose of 55 Gy (54-55Gy), 2.5 Gy/fraction (n=57) or 2 Gy/fraction (n=29). Median age was 62 years (range: 44-86) and median follow up was 7.5 years (range 5-16). Patients were examined for fibrosis according to the LENT/SOMA score. For analysis, fibrosis was classified as none (G0-1) or present (G2-3). The time to complete development of fibrosis was determined by analysis of yearly mammograms. Individual cellular radiosensitivity was determined by scoring lethal chromosomal aberrations in in vitro irradiated (6 Gy) lymphocytes using metaphase technique. Patients with low/intermediate cellular radiosensitivity were compared with patients with high cellular radiosensitivity with actuarial methods. Ten patients developed fibrosis at 1-8 years after radiotherapy. Individual cellular radiosensitivity was described by normal distribution of lethal chromosomal aberrations, average 5.47 lethal aberrations per cell (standard deviation 0.71). Cellular radiosensitivity was defined as low/intermediate (le 6.18 lethal aberrations) in 73 patients and as high (> 6.18 lethal aberrations ) in 13 patients. In both groups the actuarial rate of fibrosis-free patients declined exponentially with time after radiotherapy. Patients with high cellular radiosensitivity showed a 2.3 fold higher annual rate for fibrosis than patients with intermediate and low radiosensitivity (3.6±0.1 vs. 1.6±0.3). In breast cancer patients, high individual cellular radiosensitivity as determined by the number of lethal chromosome aberrations in in vitro irradiated lymphocytes was correlated with an enhanced annual rate of fibrosis

  17. Clinical course of untreated cerebral cavernous malformations: a meta-analysis of individual patient data.

    Science.gov (United States)

    Horne, Margaret A; Flemming, Kelly D; Su, I-Chang; Stapf, Christian; Jeon, Jin Pyeong; Li, Da; Maxwell, Susanne S; White, Philip; Christianson, Teresa J; Agid, Ronit; Cho, Won-Sang; Oh, Chang Wan; Wu, Zhen; Zhang, Jun-Ting; Kim, Jeong Eun; Ter Brugge, Karel; Willinsky, Robert; Brown, Robert D; Murray, Gordon D; Al-Shahi Salman, Rustam

    2016-02-01

    Cerebral cavernous malformations (CCMs) can cause symptomatic intracranial haemorrhage (ICH), but the estimated risks are imprecise and predictors remain uncertain. We aimed to obtain precise estimates and predictors of the risk of ICH during untreated follow-up in an individual patient data meta-analysis. We invited investigators of published cohorts of people aged at least 16 years, identified by a systematic review of Ovid MEDLINE and Embase from inception to April 30, 2015, to provide individual patient data on clinical course from CCM diagnosis until first CCM treatment or last available follow-up. We used survival analysis to estimate the 5-year risk of symptomatic ICH due to CCMs (primary outcome), multivariable Cox regression to identify baseline predictors of outcome, and random-effects models to pool estimates in a meta-analysis. Among 1620 people in seven cohorts from six studies, 204 experienced ICH during 5197 person-years of follow-up (Kaplan-Meier estimated 5-year risk 15·8%, 95% CI 13·7-17·9). The primary outcome of ICH within 5 years of CCM diagnosis was associated with clinical presentation with ICH or new focal neurological deficit (FND) without brain imaging evidence of recent haemorrhage versus other modes of presentation (hazard ratio 5·6, 95% CI 3·2-9·7) and with brainstem CCM location versus other locations (4·4, 2·3-8·6), but age, sex, and CCM multiplicity did not add independent prognostic information. The 5-year estimated risk of ICH during untreated follow-up was 3·8% (95% CI 2·1-5·5) for 718 people with non-brainstem CCM presenting without ICH or FND, 8·0% (0·1-15·9) for 80 people with brainstem CCM presenting without ICH or FND, 18·4% (13·3-23·5) for 327 people with non-brainstem CCM presenting with ICH or FND, and 30·8% (26·3-35·2) for 495 people with brainstem CCM presenting with ICH or FND. Mode of clinical presentation and CCM location are independently associated with ICH within 5 years of CCM diagnosis. These

  18. Dose estimation and radiation control measures for individuals having close contact with patients administered in vivo nuclear medicine

    International Nuclear Information System (INIS)

    Konishi, E.; Abe, K.; Kusama, T.

    1993-01-01

    Patients who have been administered radiopharmaceuticals become a source of exposure to a non-occupational individual helping in support and comfort of these patients. We measured external dose rates at several distances from 84 adult patients administered radiopharmaceuticals, and urinary excretion of radioactivity in their patients. And we estimated the maximal dose for persons having close contact with patients administered radiopharmaceuticals from the combination of these measurement data and scenarios of contact with patients. On the basis of the estimated values, we proposed the following dose constraint for care givers. (1) The dose constraint for a non-occupational care givers to an adult nuclear medicine patient should in no case exceed 300 μSv per patient per examination of any kind. (2) The dose constraint in ordinary examinations employing a radionuclide should not be greater than 15 μSv per patient per examination. (3 tabs.)

  19. User-driven health care - answering multidimensional information needs in individual patients utilizing post-EBM approaches: a conceptual model.

    Science.gov (United States)

    Biswas, Rakesh; Martin, Carmel M; Sturmberg, Joachim; Shanker, Ravi; Umakanth, Shashikiran; Shanker, Shiv; Kasturi, A S

    2008-10-01

    Evidence based on average patient data, which occupies most of our present day information databases, does not fulfil the needs of individual patient-centred health care. In spite of the unprecedented expansion in medical information we still do not have the types of information required to allow us to tailor optimal care for a given individual patient. As our current information is chiefly provided in disconnected silos, we need an information system that can seamlessly integrate different types of information to meet diverse user group needs. Groups of certain individual medical learners namely patients, medical students and health professionals share the patient's need to increasingly interact with and seek knowledge and solutions offered by others (individual medical learners) who have the lived experiences that they would benefit to access and learn from. A web-based user-driven learning solution may be a stepping-stone to address the present problem of information oversupply in medicine that mostly remains underutilized, as it doesn't meet the needs of the individual patient and health professional user. The key to its success would be to relax central control and make local trust and strategic health workers feel more engaged in the project such that it is truly user-driven.

  20. Olfactory identification deficit and its relationship with hedonic traits in patients with first-episode schizophrenia and individuals with schizotypy.

    Science.gov (United States)

    Zou, Lai-Quan; Zhou, Han-Yu; Lui, Simon S Y; Wang, Yi; Wang, Ya; Gan, Jun; Zhu, Xiong-Zhao; Cheung, Eric F C; Chan, Raymond C K

    2018-04-20

    Olfactory identification impairments have been consistently found in schizophrenia patients. However, few previous studies have investigated this in first-episode patients. There are also inconsistent findings regarding olfactory identification ability in psychometrically-defined schizotypy individuals. In this study, we directly compared the olfactory identification ability of first-episode schizophrenia patients with schizotypy individuals. The relationship between olfactory identification impairments and hedonic traits was also examined. Thirty-five first-episode schizophrenia patients, 40 schizotypy individuals as defined by the Chapman's Anhedonia Scales and 40 demographically matched controls were recruited. The University of Pennsylvania Smell Identification Test was administered. Hedonic capacity was assessed using the Temporal Experience of Pleasure Scale (TEPS). The results showed that both the schizophrenia and schizotypy groups showed poorer olfactory identification ability than controls, and the impairment was significantly correlated with reduced pleasure experiences. Our findings support olfactory identification impairment as a trait marker for schizophrenia. Copyright © 2018 Elsevier Inc. All rights reserved.

  1. Tertiary individual prevention improves mental health in patients with severe occupational hand eczema.

    Science.gov (United States)

    Breuer, K; John, S M; Finkeldey, F; Boehm, D; Skudlik, C; Wulfhorst, B; Dwinger, C; Werfel, T; Diepgen, T L; Schmid-Ott, G

    2015-09-01

    Occupational hand eczema (OHE) is associated with impaired health-related quality of life (QoL) and mental distress. Interdisciplinary inpatient rehabilitation measures in the framework of tertiary individual prevention (TIP) offered by the German employers' liability insurance associations include dermatological treatment, education and psychological interventions. To investigate the effects of interdisciplinary inpatient rehabilitation in the framework of TIP on mental health in patients with severe OHE and the relationships between recovery of OHE and improvement of mental health and QoL. A total of 122 patients participated in the study. A test battery consisting of the German versions of the Hospital Anxiety and Depression Scale (HADS-D), the Dermatology Life Quality Index (DLQI), the Short Form Health Survey-36 (SF-36) and the Trier Inventory for the Assessment of Chronic Stress (TICS) was applied at the time of admission (T1) and 3 weeks after dismissal (T2). Severity of hand eczema was assessed with the Osnabrueck Hand Eczema Severity Index (OHSI). All parameters improved significantly from T1 to T2. A relationship was established between the improvement of QoL and recovery of OHE, while there was no such relationship between the improvement of mental distress and improvement of OHE. Nonresponders had significantly more cumulative days of sickness at T1. Our data underscore the importance of psychological interventions in addition to dermatological treatment in the framework of prevention measures for OHE. These measures should be applied at an early stage of OHE prior to the occurrence of sick leave. © 2015 European Academy of Dermatology and Venereology.

  2. Whole brain approaches for identification of microstructural abnormalities in individual patients: comparison of techniques applied to mild traumatic brain injury.

    Directory of Open Access Journals (Sweden)

    Namhee Kim

    Full Text Available Group-wise analyses of DTI in mTBI have demonstrated evidence of traumatic axonal injury (TAI, associated with adverse clinical outcomes. Although mTBI is likely to have a unique spatial pattern in each patient, group analyses implicitly assume that location of injury will be the same across patients. The purpose of this study was to optimize and validate a procedure for analysis of DTI images acquired in individual patients, which could detect inter-individual differences and be applied in the clinical setting, where patients must be assessed as individuals.After informed consent and in compliance with HIPAA, 34 mTBI patients and 42 normal subjects underwent 3.0 Tesla DTI. Four voxelwise assessment methods (standard Z-score, "one vs. many" t-test, Family-Wise Error Rate control using pseudo t-distribution, EZ-MAP for use in individual patients, were applied to each patient's fractional anisotropy (FA maps and tested for its ability to discriminate patients from controls. Receiver Operating Characteristic (ROC analyses were used to define optimal thresholds (voxel-level significance and spatial extent for reliable and robust detection of mTBI pathology.ROC analyses showed EZ-MAP (specificity 71%, sensitivity 71%, "one vs. many" t-test and standard Z-score (sensitivity 65%, specificity 76% for both methods resulted in a significant area under the curve (AUC score for discriminating mTBI patients from controls in terms of the total number of abnormal white matter voxels detected while the FWER test was not significant. EZ-MAP is demonstrated to be robust to assumptions of Gaussian behavior and may serve as an alternative to methods that require strict Gaussian assumptions.EZ-MAP provides a robust approach for delineation of regional abnormal anisotropy in individual mTBI patients.

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

    LENUS (Irish Health Repository)

    Murphy, Deirdre J

    2012-09-13

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

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

    Directory of Open Access Journals (Sweden)

    Murphy Deirdre J

    2012-09-01

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

  5. Meta-STEPP: subpopulation treatment effect pattern plot for individual patient data meta-analysis.

    Science.gov (United States)

    Wang, Xin Victoria; Cole, Bernard; Bonetti, Marco; Gelber, Richard D

    2016-09-20

    We have developed a method, called Meta-STEPP (subpopulation treatment effect pattern plot for meta-analysis), to explore treatment effect heterogeneity across covariate values in the meta-analysis setting for time-to-event data when the covariate of interest is continuous. Meta-STEPP forms overlapping subpopulations from individual patient data containing similar numbers of events with increasing covariate values, estimates subpopulation treatment effects using standard fixed-effects meta-analysis methodology, displays the estimated subpopulation treatment effect as a function of the covariate values, and provides a statistical test to detect possibly complex treatment-covariate interactions. Simulation studies show that this test has adequate type-I error rate recovery as well as power when reasonable window sizes are chosen. When applied to eight breast cancer trials, Meta-STEPP suggests that chemotherapy is less effective for tumors with high estrogen receptor expression compared with those with low expression. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

  6. Sequence comparison of six human microRNAs genes between tuberculosis patients and healthy individuals.

    Science.gov (United States)

    Amila, A; Acosta, A; Sarmiento, M E; Suraiya, Siti; Zafarina, Z; Panneerchelvam, S; Norazmi, M N

    2015-12-01

    MicroRNAs (miRNAs) play an important role in diseases development. Therefore, human miRNAs may be able to inhibit the survival of Mycobacterium tuberculosis (Mtb) in the human host by targeting critical genes of the pathogen. Mutations within miRNAs can alter their target selection, thereby preventing them from inhibiting Mtb genes, thus increasing host susceptibility to the disease. This study was undertaken to investigate the genetic association of pulmonary tuberculosis (TB) with six human miRNAs genes, namely, hsa-miR-370, hsa-miR-520d, hsa-miR-154, hsa-miR-497, hsa-miR-758, and hsa-miR-593, which have been predicted to interact with Mtb genes. The objective of the study was to determine the possible sequence variation of selected miRNA genes that are potentially associated with the inhibition of critical Mtb genes in TB patients. The study did not show differences in the sequences compared with healthy individuals without antecedents of TB. This result could have been influenced by the sample size and the selection of miRNA genes, which need to be addressed in future studies. Copyright © 2015 Asian African Society for Mycobacteriology. Published by Elsevier Ltd. All rights reserved.

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

    Directory of Open Access Journals (Sweden)

    Klaus Reither

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

  8. Individual utilisation thresholds and exploring how GPs' knowledge of their patients affects diagnosis: a qualitative study in primary care.

    Science.gov (United States)

    Michiels-Corsten, Matthias; Bösner, Stefan; Donner-Banzhoff, Norbert

    2017-05-01

    One of the tenets of general practice is that continuity of care has a beneficial effect on patient care. However, little is known about how continuity can have an impact on the diagnostic reasoning of GPs. To explore GPs' diagnostic strategies by examining GPs' reflections on their patients' individual thresholds for seeking medical attention, how they arrive at their estimations, and which conclusions they draw. Qualitative study with 12 GPs in urban and rural practices in Germany. After each patient consultation GPs were asked to reflect on their diagnostic reasoning for that particular case. Qualitative and quantitative analyses of consultations and interview content were undertaken. A total of 295 primary care consultations were recorded, 134 of which contained at least one diagnostic episode. When elaborating on known patients, GPs frequently commented on how 'early' or 'late' in an illness progression a patient tended to consult. The probability of serious disease was accordingly regarded as high or low. This influenced GPs' behaviour regarding further investigations or referrals, as well as reassurance and watchful waiting. GPs' explanations for a patient's utilisation threshold comprised medical history, the patient's characteristics, family background, the media, and external circumstances. The concept of an individual threshold for the utilisation of primary care would explain how GPs use their knowledge of individual patients and their previous help-seeking behaviour for their diagnostic decision making. Whether the assumption behind this concept is valid, and whether its use improves diagnostic accuracy, remains to be investigated. © British Journal of General Practice 2017.

  9. EFFECT OF ANTIHYPERTENSIVE THERAPY BASED ON NEW METHOD OF INDIVIDUAL CHOICE OF DRUGS ON LEFT VENTRICULAR HYPERTROPHY IN ELDERLY PATIENTS

    Directory of Open Access Journals (Sweden)

    K. I. Pshenichkin

    2015-12-01

    Full Text Available Aim. To study the effects of antihypertensive therapy based on consideration of individual heart rhythm variability (HRV on left ventricular hypertrophy (LVH in hypertensive elderly patients.Material and methods. 60 hypertensive elderly patients with LVH were included in the study. They were split in two groups (30 people in each one. Patients of the group-I had common antihypertensive therapy. Patients of group-II received medications prescribed with consideration of individual heart rate variability. Holter monitoring with analysis of HRV, 24-hour blood pressure monitoring and ultrasonography were conducted initially and 18 months after treatment beginning.Results. BP control was reached in the majority of patients of both groups. The patients of group-II in comparison with patients of group-I had reduction of low- high frequency power ratio (LF/HF and higher rate of LVH reduction. Relationship between LVH dynamics and ratio LF/HF was found.Conclusion. Arterial hypertension therapy considering individual HRV contributes in LVH reduction in elderly patients.

  10. Effect of hypoxia and hyperoxia on exercise performance in healthy individuals and in patients with pulmonary hypertension: a systematic review.

    Science.gov (United States)

    Ulrich, Silvia; Schneider, Simon R; Bloch, Konrad E

    2017-12-01

    Exercise performance is determined by oxygen supply to working muscles and vital organs. In healthy individuals, exercise performance is limited in the hypoxic environment at altitude, when oxygen delivery is diminished due to the reduced alveolar and arterial oxygen partial pressures. In patients with pulmonary hypertension (PH), exercise performance is already reduced near sea level due to impairments of the pulmonary circulation and gas exchange, and, presumably, these limitations are more pronounced at altitude. In studies performed near sea level in healthy subjects, as well as in patients with PH, maximal performance during progressive ramp exercise and endurance of submaximal constant-load exercise were substantially enhanced by breathing oxygen-enriched air. Both in healthy individuals and in PH patients, these improvements were mediated by a better arterial, muscular, and cerebral oxygenation, along with a reduced sympathetic excitation, as suggested by the reduced heart rate and alveolar ventilation at submaximal isoloads, and an improved pulmonary gas exchange efficiency, especially in patients with PH. In summary, in healthy individuals and in patients with PH, alterations in the inspiratory Po 2 by exposure to hypobaric hypoxia or normobaric hyperoxia reduce or enhance exercise performance, respectively, by modifying oxygen delivery to the muscles and the brain, by effects on cardiovascular and respiratory control, and by alterations in pulmonary gas exchange. The understanding of these physiological mechanisms helps in counselling individuals planning altitude or air travel and prescribing oxygen therapy to patients with PH.

  11. Effects and moderators of exercise on quality of life and physical function in patients with cancer : An individual patient data meta-analysis of 34 RCTs

    NARCIS (Netherlands)

    Buffart, Laurien M; Kalter, Joeri; Sweegers, Maike G; Courneya, Kerry S; Newton, Robert U; Aaronson, Neil K; Jacobsen, Paul B; May, Anne M; Galvão, Daniel A; Chinapaw, Mai J; Steindorf, Karen; Irwin, Melinda L; Stuiver, Martijn M; Hayes, Sandi; Griffith, Kathleen A; Lucia, Alejandro; Mesters, Ilse; van Weert, Ellen; Knoop, Hans; Goedendorp, Martine M; Mutrie, Nanette; Daley, Amanda J; McConnachie, Alex; Bohus, Martin; Thorsen, Lene; Schulz, Karl-Heinz; Short, Camille E; James, Erica L; Plotnikoff, Ron C; Arbane, Gill; Schmidt, Martina E; Potthoff, Karin; van Beurden, Marc; Oldenburg, Hester S; Sonke, Gabe S; van Harten, Wim H; Garrod, Rachel; Schmitz, Kathryn H; Winters-Stone, Kerri M; Velthuis, Miranda J; Taaffe, Dennis R; van Mechelen, Willem; Kersten, Marie-José; Nollet, Frans; Wenzel, Jennifer; Wiskemann, Joachim; Verdonck-de Leeuw, Irma M; Brug, Johannes

    This individual patient data meta-analysis aimed to evaluate the effects of exercise on quality of life (QoL) and physical function (PF) in patients with cancer, and to identify moderator effects of demographic (age, sex, marital status, education), clinical (body mass index, cancer type, presence

  12. Effects and moderators of exercise on quality of life and physical function in patients with cancer : An individual patient data meta-analysis of 34 RCTs

    NARCIS (Netherlands)

    Buffart, Laurien M.; Kalter, Joeri; Sweegers, Maike G.; Courneya, Kerry S.; Newton, Robert U.; Aaronson, Neil K.; Jacobsen, Paul B.; May, Anne M.; Galvão, Daniel A.; Chinapaw, Mai J.; Steindorf, Karen; Irwin, Melinda L.; Stuiver, Martijn M.; Hayes, Sandi; Griffith, Kathleen A.; Lucia, Alejandro; Mesters, Ilse; van Weert, Ellen; Knoop, Hans; Goedendorp, Martine M.; Mutrie, Nanette; Daley, Amanda J.; McConnachie, Alex; Bohus, Martin; Thorsen, Lene; Schulz, Karl Heinz; Short, Camille E.; James, Erica L.; Plotnikoff, Ron C.; Arbane, Gill; Schmidt, Martina E.; Potthoff, Karin; van Beurden, Marc; Oldenburg, Hester S.; Sonke, Gabe S.; van Harten, Wim H.; Garrod, Rachel; Schmitz, Kathryn H.; Winters-Stone, Kerri M.; Velthuis, Miranda J.; Taaffe, Dennis R.; van Mechelen, Willem; Kersten, Marie José; Nollet, Frans; Wenzel, Jennifer; Wiskemann, Joachim; Verdonck-de Leeuw, Irma M.; Brug, Johannes

    2017-01-01

    This individual patient data meta-analysis aimed to evaluate the effects of exercise on quality of life (QoL) and physical function (PF) in patients with cancer, and to identify moderator effects of demographic (age, sex, marital status, education), clinical (body mass index, cancer type, presence

  13. Added value of ovarian reserve testing on patient characteristics in the prediction of ovarian response and ongoing pregnancy: an individual patient data approach

    NARCIS (Netherlands)

    Broer, S.L.; Disseldorp, J. van; Broeze, K.A.; Dolleman, M.; Opmeer, B.C.; Bossuyt, P.; Eijkemans, M.J.; Mol, B.W.; Broekmans, F.J.; Anderson, R.A.; Ashrafi, M.; Bancsi, L.F.; Caroppo, E.; Copperman, A.; Ebner, T.; Eldar Geva, M.; Erdem, M.; Greenblatt, E.M.; Jayaprakasan, K.; Fenning, R.; Klinkert, E.R.; Kwee, J.; Lambalk, C.B.; La Marca, A.; McIlveen, M.; Merce, L.T.; Muttukrishna, S.; Nelson, S.M.; Ng, H.Y.; Popovic-Todorovic, B.; Smeenk, J.M.J.; Tomas, C.; Linden, P.J. van der; Rooij, I.A. van; et al.,

    2013-01-01

    BACKGROUND Although ovarian reserve tests (ORTs) are frequently used prior to IVF treatment for outcome prediction, their added predictive value is unclear. We assessed the added value of ORTs to patient characteristics in the prediction of IVF outcome. METHODS An individual patient data (IPD)

  14. High-dose statin therapy in patients with stable coronary artery disease: treating the right patients based on individualized prediction of treatment effect

    NARCIS (Netherlands)

    Dorresteijn, Johannes A. N.; Boekholdt, S. Matthijs; van der Graaf, Yolanda; Kastelein, John J. P.; LaRosa, John C.; Pedersen, Terje R.; Demicco, David A.; Ridker, Paul M.; Cook, Nancy R.; Visseren, Frank L. J.

    2013-01-01

    Clinicians need to identify coronary artery disease patients for whom the benefits of high-dose versus usual-dose statin therapy outweigh potential harm. We therefore aimed to develop and validate a model for prediction of the incremental treatment effect of high-dose statins for individual patients

  15. Health status in routine clinical practice: validity of the clinical COPD questionnaire at the individual patient level

    Directory of Open Access Journals (Sweden)

    de Vos Barbara

    2010-11-01

    Full Text Available Abstract Background There is a growing interest to use health status or disease control questionnaires in routine clinical practice. However, the validity of most questionnaires is established using techniques developed for group level validation. This study examines a new method, using patient interviews, to validate a short health status questionnaire, the Clinical COPD Questionnaire (CCQ, at the individual patient level. Methods Patients with COPD who visited an outpatient clinic completed the CCQ before the consultation, and the specialist physician completed it after the consultation. After the consultation all patients had a semi-structured in-depth interview. The patients' CCQ scores were compared with those of the treating clinician, and with mean scores from 5 clinicians from a pool of 20 who scored the CCQ after reading the transcript of the in-depth interviews only. Agreement was assessed using Lin's concordance correlation coefficient (CCC, and Blant and Altman plots. Interviews with patients with low agreement were reviewed for possible explanations. Results A total of 44 COPD patients (32 male, mean age 66 years, FEV1 45% of predicted participated. Agreement between the patients' CCQ scores and those of the treating clinicians (CCC = 0.87 and the mean score of the reviewing clinicians (CCC = 0.86 was very high. No systematic error was detected. No explanation for individuals with low agreement was found. Conclusion The validity of the CCQ on the individual patient level, as assessed by these methods, is good. Individual health status assessment with the CCQ is therefore sufficiently accurate to be used in routine clinical practice.

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

    OpenAIRE

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

    2013-01-01

    Background Large numbers of patients with psychosis have regular meetings with key clinicians in the community. There is little evidence on how these meetings should be conducted to be therapeutically effective. DIALOG, a computer mediated procedure, was shown to improve outcomes in a European multi-centre trial. DIALOG structures the patient-clinician communication and makes it patient-centred, but does not guide clinicians as to how to respond to patients? concerns. DIALOG has been further ...

  17. Flow cytometric analysis of platelet cyclooxygenase-1 and -2 and surface glycoproteins in patients with immune thrombocytopenia and healthy individuals.

    Science.gov (United States)

    Rubak, Peter; Kristensen, Steen D; Hvas, Anne-Mette

    2017-06-01

    Immature platelets may contain more platelet enzymes such as cyclooxygenase (COX)-1 and COX-2 than mature platelets. Patients with immune thrombocytopenia (ITP) have a higher fraction of immature platelets and can therefore be utilized as a biological model for investigating COX-1 and COX-2 platelet expression. The aims were to develop flow cytometric assays for platelet COX-1 and COX-2 and to investigate the COX-1 and COX-2 platelet expression, platelet turnover, and platelet glycoproteins in ITP patients (n = 10) compared with healthy individuals (n = 30). Platelet count and platelet turnover parameters (mean platelet volume (MPV), immature platelet fraction (IPF), and immature platelet count (IPC)) were measured by flow cytometry (Sysmex XE-5000). Platelet COX-1, COX-2, and the glycoproteins (GP)IIb, IX, Ib, Ia, and IIIa were all analyzed by flow cytometry (Navios) and expressed as median fluorescence intensity. COX analyses were performed in both whole blood and platelet rich plasma (PRP), whereas platelet glycoproteins were analyzed in whole blood only. ITP patients had significantly lower platelet count (55 × 10 9 /L) than healthy individuals (240 × 10 9 /L, p platelet count and IPC (both p-values Platelet COX-1 expression was higher in ITP patients than healthy individuals using whole blood (p COX-1 platelet turnover and COX-1 expression (all p-values platelet turnover and COX-1 and COX-2 expressions (all p-values platelet turnover in ITP patients (all p-values 0.14, rho = 0.11-0.28). In conclusion, ITP patients expressed higher COX-1 and platelet glycoprotein levels than healthy individuals. COX-1 and platelet glycoproteins demonstrated positive correlations with platelet turnover in ITP patients. In healthy individuals, COX-1 and COX-2 expression correlated positively with platelet turnover. PRP was more sensitive compared with whole blood as regards determination of COX. Therefore, PRP is the recommended matrix for investigating COX-1 and COX-2 in

  18. Identification of Patient Benefit From Proton Therapy for Advanced Head and Neck Cancer Patients Based on Individual and Subgroup Normal Tissue Complication Probability Analysis

    Energy Technology Data Exchange (ETDEWEB)

    Jakobi, Annika, E-mail: Annika.Jakobi@OncoRay.de [OncoRay-National Center for Radiation Research in Oncology, Faculty of Medicine and University Hospital Carl Gustav Carus, Technische Universität Dresden, Helmholtz-Zentrum Dresden-Rossendorf, Dresden (Germany); Bandurska-Luque, Anna [OncoRay-National Center for Radiation Research in Oncology, Faculty of Medicine and University Hospital Carl Gustav Carus, Technische Universität Dresden, Helmholtz-Zentrum Dresden-Rossendorf, Dresden (Germany); Department of Radiation Oncology, Faculty of Medicine and University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden (Germany); Stützer, Kristin; Haase, Robert; Löck, Steffen [OncoRay-National Center for Radiation Research in Oncology, Faculty of Medicine and University Hospital Carl Gustav Carus, Technische Universität Dresden, Helmholtz-Zentrum Dresden-Rossendorf, Dresden (Germany); Wack, Linda-Jacqueline [Section for Biomedical Physics, University Hospital for Radiation Oncology, Eberhard Karls Universät Tübingen (Germany); Mönnich, David [Section for Biomedical Physics, University Hospital for Radiation Oncology, Eberhard Karls Universät Tübingen (Germany); German Cancer Research Center, Heidelberg (Germany); German Cancer Consortium, Tübingen (Germany); Thorwarth, Daniela [Section for Biomedical Physics, University Hospital for Radiation Oncology, Eberhard Karls Universät Tübingen (Germany); and others

    2015-08-01

    Purpose: The purpose of this study was to determine, by treatment plan comparison along with normal tissue complication probability (NTCP) modeling, whether a subpopulation of patients with head and neck squamous cell carcinoma (HNSCC) could be identified that would gain substantial benefit from proton therapy in terms of NTCP. Methods and Materials: For 45 HNSCC patients, intensity modulated radiation therapy (IMRT) was compared to intensity modulated proton therapy (IMPT). Physical dose distributions were evaluated as well as the resulting NTCP values, using modern models for acute mucositis, xerostomia, aspiration, dysphagia, laryngeal edema, and trismus. Patient subgroups were defined based on primary tumor location. Results: Generally, IMPT reduced the NTCP values while keeping similar target coverage for all patients. Subgroup analyses revealed a higher individual reduction of swallowing-related side effects by IMPT for patients with tumors in the upper head and neck area, whereas the risk reduction of acute mucositis was more pronounced in patients with tumors in the larynx region. More patients with tumors in the upper head and neck area had a reduction in NTCP of more than 10%. Conclusions: Subgrouping can help to identify patients who may benefit more than others from the use of IMPT and, thus, can be a useful tool for a preselection of patients in the clinic where there are limited PT resources. Because the individual benefit differs within a subgroup, the relative merits should additionally be evaluated by individual treatment plan comparisons.

  19. Identification of Patient Benefit From Proton Therapy for Advanced Head and Neck Cancer Patients Based on Individual and Subgroup Normal Tissue Complication Probability Analysis

    International Nuclear Information System (INIS)

    Jakobi, Annika; Bandurska-Luque, Anna; Stützer, Kristin; Haase, Robert; Löck, Steffen; Wack, Linda-Jacqueline; Mönnich, David; Thorwarth, Daniela

    2015-01-01

    Purpose: The purpose of this study was to determine, by treatment plan comparison along with normal tissue complication probability (NTCP) modeling, whether a subpopulation of patients with head and neck squamous cell carcinoma (HNSCC) could be identified that would gain substantial benefit from proton therapy in terms of NTCP. Methods and Materials: For 45 HNSCC patients, intensity modulated radiation therapy (IMRT) was compared to intensity modulated proton therapy (IMPT). Physical dose distributions were evaluated as well as the resulting NTCP values, using modern models for acute mucositis, xerostomia, aspiration, dysphagia, laryngeal edema, and trismus. Patient subgroups were defined based on primary tumor location. Results: Generally, IMPT reduced the NTCP values while keeping similar target coverage for all patients. Subgroup analyses revealed a higher individual reduction of swallowing-related side effects by IMPT for patients with tumors in the upper head and neck area, whereas the risk reduction of acute mucositis was more pronounced in patients with tumors in the larynx region. More patients with tumors in the upper head and neck area had a reduction in NTCP of more than 10%. Conclusions: Subgrouping can help to identify patients who may benefit more than others from the use of IMPT and, thus, can be a useful tool for a preselection of patients in the clinic where there are limited PT resources. Because the individual benefit differs within a subgroup, the relative merits should additionally be evaluated by individual treatment plan comparisons

  20. Does Insight Affect the Efficacy of Antipsychotics in Acute Mania?: An Individual Patient Data Regression Meta-Analysis.

    Science.gov (United States)

    Welten, Carlijn C M; Koeter, Maarten W J; Wohlfarth, Tamar D; Storosum, Jitschak G; van den Brink, Wim; Gispen-de Wied, Christine C; Leufkens, Hubert G M; Denys, Damiaan A J P

    2016-02-01

    Patients having an acute manic episode of bipolar disorder often lack insight into their condition. Because little is known about the possible effect of insight on treatment efficacy, we examined whether insight at the start of treatment affects the efficacy of antipsychotic treatment in patients with acute mania. We used individual patient data from 7 randomized, double-blind, placebo-controlled registration studies of 4 antipsychotics in patients with acute mania (N = 1904). Insight was measured with item 11 of the Young Mania Rating Scale (YMRS) at baseline and study endpoint 3 weeks later. Treatment outcome was defined by (a) mean change score, (b) response defined as 50% or more improvement on YMRS, and (c) remission defined as YMRS score less than 8 at study endpoint. We used multilevel mixed effect linear (or logistic) regression analyses of individual patient data to assess the interaction between baseline insight and treatment outcomes. At treatment initiation, 1207 (63.5%) patients had impaired or no insight into their condition. Level of insight significantly modified the efficacy of treatment by mean change score (P = 0.039), response rate (P = 0.033), and remission rate (P = 0.043), with greater improvement in patients with more impaired insight. We therefore recommend that patients experiencing acute mania should be treated immediately and not be delayed until patients regain insight.

  1. Accounting for parameter uncertainty in the definition of parametric distributions used to describe individual patient variation in health economic models

    OpenAIRE

    Degeling, Koen; IJzerman, Maarten J.; Koopman, Miriam; Koffijberg, Hendrik

    2017-01-01

    Background Parametric distributions based on individual patient data can be used to represent both stochastic and parameter uncertainty. Although general guidance is available on how parameter uncertainty should be accounted for in probabilistic sensitivity analysis, there is no comprehensive guidance on reflecting parameter uncertainty in the (correlated) parameters of distributions used to represent stochastic uncertainty in patient-level models. This study aims to provide this guidance by ...

  2. Pharyngeal electrical stimulation for treatment of poststroke dysphagia: individual patient data meta-analysis of randomised controlled trials

    OpenAIRE

    Scutt, Polly; Lee, Han S.; Hamdy, Shaheen; Bath, Philip M.W.

    2015-01-01

    Background. Dysphagia after stroke is common, associated independently with poor outcome, and has limited treatment options. Pharyngeal electrical stimulation (PES) is a novel treatment being evaluated for treatment of poststroke dysphagia. Methods. We searched electronically for randomised controlled trials of PES in dysphagic patients within 3 months of stroke. Individual patient data were analysed using regression, adjusted for trial, age, severity, and baseline score. The coprimary outcom...

  3. Continuing or Temporarily Stopping Prestroke Antihypertensive Medication in Acute Stroke:An Individual Patient Data Meta-Analysis

    OpenAIRE

    Woodhouse, Lisa J.; Manning, Lisa; Potter, John F.; Berge, Eivind; Sprigg, Nikola; Wardlaw, Joanna; Lees, Kennedy R.; Bath, Philip M.; Robinson, Thompson G.; , Blood Pressure in Acute Stroke Collaboration (BASC)

    2017-01-01

    Over 50% of patients are already taking blood pressure-lowering therapy on hospital admission for acute stroke. An individual patient data meta-analysis from randomized controlled trials was undertaken to determine the effect of continuation versus temporarily stopping pre-existing antihypertensive medication in acute stroke. Key databases were searched for trials against the following inclusion criteria: randomized design; stroke onset ≤48 hours; investigating the effect of continuation vers...

  4. Granulocyte-Colony Stimulating Factor (G-CSF) for stroke: an individual patient data meta-analysis

    OpenAIRE

    England, Timothy J.; Sprigg, Nikola; Alasheev, Andrey M.; Belkin, Andrey A.; Kumar, Amit; Prasad, Kameshwar; Bath, Philip M.

    2016-01-01

    Granulocyte colony stimulating factor (G-CSF) may enhance recovery from stroke through neuroprotective mechanisms if administered early, or neurorepair if given later. Several small trials suggest administration is safe but effects on efficacy are unclear. We searched for randomised controlled trials (RCT) assessing G-CSF in patients with hyperacute, acute, subacute or chronic stroke, and asked Investigators to share individual patient data on baseline characteristics, stroke severity and typ...

  5. Multidrug resistant pulmonary tuberculosis treatment regimens and patient outcomes: an individual patient data meta-analysis of 9,153 patients.

    Directory of Open Access Journals (Sweden)

    Shama D Ahuja

    Full Text Available Treatment of multidrug resistant tuberculosis (MDR-TB is lengthy, toxic, expensive, and has generally poor outcomes. We undertook an individual patient data meta-analysis to assess the impact on outcomes of the type, number, and duration of drugs used to treat MDR-TB.Three recent systematic reviews were used to identify studies reporting treatment outcomes of microbiologically confirmed MDR-TB. Study authors were contacted to solicit individual patient data including clinical characteristics, treatment given, and outcomes. Random effects multivariable logistic meta-regression was used to estimate adjusted odds of treatment success. Adequate treatment and outcome data were provided for 9,153 patients with MDR-TB from 32 observational studies. Treatment success, compared to failure/relapse, was associated with use of: later generation quinolones, (adjusted odds ratio [aOR]: 2.5 [95% CI 1.1-6.0], ofloxacin (aOR: 2.5 [1.6-3.9], ethionamide or prothionamide (aOR: 1.7 [1.3-2.3], use of four or more likely effective drugs in the initial intensive phase (aOR: 2.3 [1.3-3.9], and three or more likely effective drugs in the continuation phase (aOR: 2.7 [1.7-4.1]. Similar results were seen for the association of treatment success compared to failure/relapse or death: later generation quinolones, (aOR: 2.7 [1.7-4.3], ofloxacin (aOR: 2.3 [1.3-3.8], ethionamide or prothionamide (aOR: 1.7 [1.4-2.1], use of four or more likely effective drugs in the initial intensive phase (aOR: 2.7 [1.9-3.9], and three or more likely effective drugs in the continuation phase (aOR: 4.5 [3.4-6.0].In this individual patient data meta-analysis of observational data, improved MDR-TB treatment success and survival were associated with use of certain fluoroquinolones, ethionamide, or prothionamide, and greater total number of effective drugs. However, randomized trials are urgently needed to optimize MDR-TB treatment. Please see later in the article for the Editors' Summary.

  6. Individual patient data meta-analysis of organ failure in acute pancreatitis: protocol of the PANCREA II study.

    Science.gov (United States)

    Das, Stephanie L M; Papachristou, George I; De Campos, Tercio; Panek, Jozefa; Poves Prim, Ignasi; Serrablo, Alejandro; Parks, Rowan W; Uomo, Generoso; Windsor, John A; Petrov, Maxim S

    2013-09-10

    Organ failure is a major determinant of mortality in patients with acute pancreatitis. These patients usually require admission to high dependency or intensive care units and consume considerable health care resources. Given a low incidence rate of organ failure and a lack of large non-interventional studies in the field of acute pancreatitis, the characteristics of organ failure that influence outcomes of patients with acute pancreatitis remain largely unknown. Therefore, the Pancreatitis Across Nations Clinical Research and Education Alliance (PANCREA) aims to conduct a meta-analysis of individual patient data from prospective non-interventional studies to determine the influence of timing, duration, sequence, and combination of different organ failures on mortality in patients with acute pancreatitis. Pancreatologists currently active with acute pancreatitis clinical research will be invited to contribute. To be eligible for inclusion patients will have to meet the criteria of acute pancreatitis, develop at least one organ failure during the first week of hospitalization, and not be enrolled into an intervention study. Raw data will then be collated and checked. Individual patient data analysis based on a logistic regression model with adjustment for confounding variables will be done. For all analyses, corresponding 95% confidence intervals and P values will be reported. This collaborative individual patient data meta-analysis will answer important clinical questions regarding patients with acute pancreatitis that develop organ failure. Information derived from this study will be used to optimize routine clinical management and improve care strategies. It can also help validate outcome definitions, allow comparability of results and form a more accurate basis for patient allocation in further clinical studies.

  7. Characteristics of the Motor Units during Sternocleidomastoid Isometric Flexion among Patients with Mechanical Neck Disorder and Asymptomatic Individuals.

    Directory of Open Access Journals (Sweden)

    Chia-Chi Yang

    Full Text Available Mechanical neck disorder is a widespread and non-neurological musculoskeletal condition resulting from modern lifestyles. Presently, the fundamental electrophysiological properties of the motor units of the sternocleidomastoid muscles and the characteristics of the short-term synchronization of the motor unit in patients with neck pain are ambiguous. This study therefore aims to clarify the fundamental electrophysiological properties of the motor units of the sternocleidomastoid muscles in patients with mechanical neck disorder and in asymptomatic individuals. We further investigated whether alterations in the degree of motor unit short-term synchronization occur. The surface electrophysiological signals of the bilateral sternal heads of the sternocleidomastoid muscles of twelve patients with mechanical neck disorder and asymptomatic individuals were detected at 25% of the maximum voluntary contraction during cervical isometric flexion and then decomposed into individual motor unit action potential trains. We found that the patients with mechanical neck disorder showed significantly higher initial and mean firing rates of the sternocleidomastoid muscles and displayed substantially lower motor unit short-term synchronization values compared with the asymptomatic subjects. Consequently, these convincing findings support the assertion that patients with mechanical neck disorder display altered neuromuscular control strategies, such as the reinforcement of motor unit recruitment firing rates in the sternocleidomastoid muscles. The motor units of these patients also revealed neural recruitment strategies with relatively poor efficiency when executing the required motor tasks.

  8. Characteristics of the Motor Units during Sternocleidomastoid Isometric Flexion among Patients with Mechanical Neck Disorder and Asymptomatic Individuals.

    Science.gov (United States)

    Yang, Chia-Chi; Su, Fong-Chin; Yang, Po-Ching; Lin, Hwai-Ting; Guo, Lan-Yuen

    2016-01-01

    Mechanical neck disorder is a widespread and non-neurological musculoskeletal condition resulting from modern lifestyles. Presently, the fundamental electrophysiological properties of the motor units of the sternocleidomastoid muscles and the characteristics of the short-term synchronization of the motor unit in patients with neck pain are ambiguous. This study therefore aims to clarify the fundamental electrophysiological properties of the motor units of the sternocleidomastoid muscles in patients with mechanical neck disorder and in asymptomatic individuals. We further investigated whether alterations in the degree of motor unit short-term synchronization occur. The surface electrophysiological signals of the bilateral sternal heads of the sternocleidomastoid muscles of twelve patients with mechanical neck disorder and asymptomatic individuals were detected at 25% of the maximum voluntary contraction during cervical isometric flexion and then decomposed into individual motor unit action potential trains. We found that the patients with mechanical neck disorder showed significantly higher initial and mean firing rates of the sternocleidomastoid muscles and displayed substantially lower motor unit short-term synchronization values compared with the asymptomatic subjects. Consequently, these convincing findings support the assertion that patients with mechanical neck disorder display altered neuromuscular control strategies, such as the reinforcement of motor unit recruitment firing rates in the sternocleidomastoid muscles. The motor units of these patients also revealed neural recruitment strategies with relatively poor efficiency when executing the required motor tasks.

  9. Novel method of fabricating individual trays for maxillectomy patients by computer-aided design and rapid prototyping.

    Science.gov (United States)

    Huang, Zhi; Wang, Xin-zhi; Hou, Yue-Zhong

    2015-02-01

    Making impressions for maxillectomy patients is an essential but difficult task. This study developed a novel method to fabricate individual trays by computer-aided design (CAD) and rapid prototyping (RP) to simplify the process and enhance patient safety. Five unilateral maxillectomy patients were recruited for this study. For each patient, a computed tomography (CT) scan was taken. Based on the 3D surface reconstruction of the target area, an individual tray was manufactured by CAD/RP. With a conventional custom tray as control, two final impressions were made using the different types of tray for each patient. The trays were sectioned, and in each section the thickness of the material was measured at six evenly distributed points. Descriptive statistics and paired t-test were used to examine the difference of the impression thickness. SAS 9.3 was applied in the statistical analysis. Afterwards, all casts were then optically 3D scanned and compared digitally to evaluate the feasibility of this method. Impressions of all five maxillectomy patients were successfully made with individual trays fabricated by CAD/RP and traditional trays. The descriptive statistics of impression thickness measurement showed slightly more uneven results in the traditional trays, but no statistical significance was shown. A 3D digital comparison showed acceptable discrepancies within 1 mm in the majority of cast areas. The largest difference of 3 mm was observed in the buccal wall of the defective areas. Moderate deviations of 1 to 2 mm were detected in the buccal and labial vestibular groove areas. This study confirmed the feasibility of a novel method of fabricating individual trays by CAD/RP. Impressions made by individual trays manufactured using CAD/RP had a uniform thickness, with an acceptable level of accuracy compared to those made through conventional processes. © 2014 by the American College of Prosthodontists.

  10. Comparative polymorphism of BAT-26 between healthy individuals and cancer patients and its cancer risk implication for local Chinese.

    Science.gov (United States)

    Zheng, Yanying; Liu, Li; Sun, Yi; Chen, Jie; Wang, Jianrong; Zhu, Changle; Lai, Rensheng; Xie, Ling

    2016-07-30

    BAT-26 is one of the representative markers for microsatellite instability evaluation and presents different polymorphisms in different ethnic populations. The current knowledge of its comparative polymorphism between healthy individuals and cancer patients in the Chinese population is insufficient. This study aims to analyze germline polymorphic variations of BAT-26 between healthy individuals and cancer patients in Chinese from Jiangsu province and the associated cancer risk implications. The various BAT-26 alleles and their percentages in cervical cells from 500 healthy women were assessed by direct sequencing. Twenty of these samples were also analyzed by fragment analysis. BAT-26 of blood DNA from 24 healthy individuals and 247 cancer patients was analyzed by fragment analysis. Compared with the sequencing results, 122.6-122.9 bp, 123.4-123.8 bp and 124.1-124.8 bp corresponded to the A25, A26 and A27 alleles, respectively. The 524 healthy individuals showed 4.58%, 92.18% and 3.24% of A25, A26 and A27, respectively. The variant alleles A18, A24, A28, A29 and A32 were only found in cancer patients, accounting for 0.81%, 0.40%, 0.40%, 0.40% and 0.40%, respectively; the A25, A26 and A27 alleles in cancer patients accounted for 6.48%, 77.33% and 13.77%. Healthy individuals had a stable BAT-26 profile within the quasimonomorphic variation range (QMVR), but cancer patients harbored variant alleles outside QMVR and showed a trend from quasimonomorph to polymonomorph, suggesting that variant alleles of BAT-26 in germline cells may be regarded as a potential marker of higher cancer risk in the Chinese population from Jiangsu province.

  11. Patient characteristics and perceived health status of individuals with HIV and tuberculosis coinfection in Guangxi, China

    OpenAIRE

    Zhu, Yujia; Wu, Jizhou; Feng, Xue; Chen, Huanhuan; Lu, Huaxiang; Chen, Li; Luo, Liuhong; Rui, Chao

    2017-01-01

    Abstract To explore demographics, clinical and medication profiles, patients? social support, and perceived health status in HIV/TB coinfected patients in Guangxi, China. We performed a cross-sectional study in the HIV clinic of the Guigang City People's Hospital (N?=?150). Health professionals conducted face-to-face interviews and collected data from patients? electronic medical records regarding patients? demographic, clinical, and medication information, as well as their social support and...

  12. Breast cancer patients' satisfaction with individual therapy goals and treatment in a standardized integrative medicine consultancy service.

    Science.gov (United States)

    Hack, Carolin C; Antoniadis, Sophia; Hackl, Janina; Langemann, Hanna; Schwitulla, Judith; Fasching, Peter A; Beckmann, Matthias W; Theuser, Anna-Katharin

    2018-04-27

    Complementary medicine services are nowadays usually quite heterogeneous, and little information is available on standards for running an integrative medicine consultancy service. This study aimed to assess patients' satisfaction with a standardized treatment service on integrative medicine. Using a cross-sectional design, 75 breast cancer patients from the integrative medicine consultancy service at the University Breast Center for Franconia were evaluated between January 2016 and March 2017. At primary consultation, patients answered a standardized questionnaire on their medical history and treatment goals regarding integrative medicine. In a subsequent interview, patients evaluated their satisfaction with the treatment service and individual treatment goals. 72% of the patients (n = 54) reported high satisfaction with the overall approach of the treatment service. 76% of the