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

    NARCIS (Netherlands)

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

    2011-01-01

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

  2. Laparoscopic cholecystectomy under spinal anaesthesia: A prospective, randomised study

    Directory of Open Access Journals (Sweden)

    Sangeeta Tiwari

    2013-01-01

    Full Text Available Context: Spinal anaesthesia has been reported as an alternative to general anaesthesia for performing laparoscopic cholecystectomy (LC. Aims: Study aimed to evaluate efficacy, safety and cost benefit of conducting laparoscopic cholecystectomy under spinal anaesthesia (SA in comparison to general anaesthesia(GA Settings and Design: A prospective, randomised study conducted over a two year period at an urban, non teaching hospital. Materials and Methods: Patients meeting inclusion criteria e randomised into two groups .Group A and Group B received general and spinal anaesthesia by standardised techniques. Both groups underwent standard four port laparoscopic cholecystectomy. Mean anaesthesia time, pneumoperitoneum time and surgery time defined primary outcome measures. Intraoperative events and post operative pain score were secondary outcome measure. Statistical Analysis Used: The Student t test, Pearson′s chi-square test and Fisher exact test. Results: Out of 235 cases enrolled in the study, 114 cases in Group A and 110 in Group B analysed. Mean anaesthesia time appeared to be more in the GA group (49.45 vs. 40.64, P = 0.02 while pneumoperitoneum time and corresponding the total surgery time was slightly longer in the SA group. 27/117 cases who received SA experienced intraoperative events, four significant enough to convert to GA. No postoperative complications noted in either group. Pain relief significantly more in SA group in immediate post operative period (06 and 12 hours but same as GA group at time of discharge (24 hours. No late postoperative complication or readmission noted in either group. Conclusion: Laparoscopic cholecystectomy done under spinal anaesthesia as a routine anaesthesia of choice is feasible and safe. Spinal anaesthesia can be recommended to be the anaesthesia technique of choice for conducting laparoscopic cholecystectomy in hospital setups in developing countries where cost factor is a major factor.

  3. A prospective, randomised, controlled clinical trial to evaluate the ...

    African Journals Online (AJOL)

    ... reactivity to carbon dioxide and autoregulation.1,2 ... Capnography [end-tidal carbon dioxide (EtCO2)]. ... The patients were randomised into two groups using a random ... 67% N2O in oxygen in group A, and 33% oxygen in air in group B,.

  4. A prospective, randomised trial of transapical transcatheter aortic valve implantation vs. surgical aortic valve replacement in operable elderly patients with aortic stenosis

    DEFF Research Database (Denmark)

    Nielsen, Hans Henrik Møller; Klaaborg, Kaj E; Nissen, Henrik

    2012-01-01

    In a prospective randomised trial we aimed to compare transapical transcatheter aortic valve implantation (a-TAVI) with surgical aortic valve replacement (SAVR) in operable elderly patients.......In a prospective randomised trial we aimed to compare transapical transcatheter aortic valve implantation (a-TAVI) with surgical aortic valve replacement (SAVR) in operable elderly patients....

  5. Deep brain stimulation in early stage Parkinson's disease: operative experience from a prospective randomised clinical trial.

    Science.gov (United States)

    Kahn, Elyne; D'Haese, Pierre-Francois; Dawant, Benoit; Allen, Laura; Kao, Chris; Charles, P David; Konrad, Peter

    2012-02-01

    Recent evidence suggests that deep brain stimulation of the subthalamic nucleus (STN-DBS) may have a disease modifying effect in early Parkinson's disease (PD). A randomised, prospective study is underway to determine whether STN-DBS in early PD is safe and tolerable. 15 of 30 early PD patients were randomised to receive STN-DBS implants in an institutional review board approved protocol. Operative technique, location of DBS leads and perioperative adverse events are reported. Active contact used for stimulation in these patients was compared with 47 advanced PD patients undergoing an identical procedure by the same surgeon. 14 of the 15 patients did not sustain any long term (>3 months) complications from the surgery. One subject suffered a stroke resulting in mild cognitive changes and slight right arm and face weakness. The average optimal contact used in symptomatic treatment of early PD patients was: anterior -1.1±1.7 mm, lateral 10.7±1.7 mm and superior -3.3±2.5 mm (anterior and posterior commissure coordinates). This location is statistically no different (0.77 mm, p>0.05) than the optimal contact used in the treatment of 47 advanced PD patients. The perioperative adverse events in this trial of subjects with early stage PD are comparable with those reported for STN-DBS in advanced PD. The active contact position used in early PD is not significantly different from that used in late stage disease. This is the first report of the operative experience from a randomised, surgical versus best medical therapy trial for the early treatment of PD.

  6. Sacroiliac joint pain: Prospective, randomised, experimental and comparative study of thermal radiofrequency with sacroiliac joint block.

    Science.gov (United States)

    Cánovas Martínez, L; Orduña Valls, J; Paramés Mosquera, E; Lamelas Rodríguez, L; Rojas Gil, S; Domínguez García, M

    2016-05-01

    To compare the analgesic effects between the blockade and bipolar thermal radiofrequency in the treatment of sacroiliac joint pain. Prospective, randomised and experimental study conducted on 60 patients selected in the two hospitals over a period of nine months, who had intense sacroiliac joint pain (Visual Analogue Scale [VAS]>6) that lasted more than 3 months. Patients were randomised into three groups (n=20): Group A (two intra-articular sacroiliac injections of local anaesthetic/corticosteroid guided by ultrasound in 7 days). Group B: conventional bipolar radiofrequency "palisade". Target points were the lateral branch nerves of S1, S2, and S3, distance needles 1cm. Group C: modified bipolar radiofrequency "palisade" (needle distance >1cm). Patients were evaluated at one month, three months, and one year. Demographic data, VAS reduction, and side effects of the techniques were assessed. One month after the treatment, pain reduction was >50% in the three groups PDolor. Publicado por Elsevier España, S.L.U. All rights reserved.

  7. Evaluation of a blood conservation strategy in the intensive care unit: a prospective, randomised study.

    LENUS (Irish Health Repository)

    Mahdy, Saad

    2009-06-01

    Anemia is a common problem in the ICU population. Most patients are anemic at admission, their hemoglobin concentrations declining further thereafter. The aim of the present study was to evaluate the effect of a combination strategy, involving closed arterial blood gas sampling and the use of pediatric vials for phlebotomy (Group A), on the sampling-induced blood loss and the rate of decline in hemoglobin in adult ICU patients. Combination (Group A) was compared to the current standard technique of arterial line sampling and adult vial phlebotomy (Group B) in a prospective, randomised, ethically-approved trial for the first 72 hours of their ICU stay. Peri-operative, oncology, coagulopathic and uremic patients were excluded. All other ICU patients with arterial cannulae and predicted to stay beyond 3 days, were enrolled.

  8. Dysphonia: medical treatment and a medical voice hygiene advice approach. A prospective randomised pilot study.

    Science.gov (United States)

    Pedersen, M; Beranova, A; Møller, S

    2004-07-01

    For many years all patients with dysphonia referred to in the literature as resulting from non-organic (functional) voice disorders were sent to speech therapy. Medical diagnoses were not taken into account. In our earlier Cochrane review on vocal cord nodules we discovered that evidence-based research in the area of benign voice disorders with dysphonia, and with or without slight benign swellings including nodules on the vocal cords, was lacking at that time. Therefore, a prospective randomised pilot study based on our Cochrane review has been made on dysphonic patients with non-organic (function provoked?) voice disorders as the basis for further evidence-based studies. Medical treatment was based on the scientific approach that once a micro-organic disorder caused by reflux, infection, allergy or environmental irritatants (e.g., dust or noise in the workplace) was discovered by very careful anamnesis and systematic objective routine analyses and was treated effectively, with documentation, the non-organic voice disorder disappeared, as, e.g., in the case of a diagnosis and treatment of helicobakter pylori. The reason is that the mucosal swelling/dysfunction of the vocal cords is secondary. In order to try to understand why the recommendation to all these patients for many years was only voice therapy, which the speech therapists "felt to be effective", updated voice-hygiene advice (for posture, accents of the diaphragm, intonation pattern and resonance) was given by experienced laryngologists, randomised with the updated medical diagnosis/therapy in order to elucidate what effect the training might have. No evidence-based studies in the literature document any effect. The crucial point seemed to be that doctors mostly did not examine any other diagnoses other than the "dysphonia" and did not dig down to any of the medical reasons when the vocal fold diagnosis of "non- organic disorders" was made. This should be changed in the future. This pilot study was based

  9. Multimodal system designed to reduce errors in recording and administration of drugs in anaesthesia: prospective randomised clinical evaluation

    OpenAIRE

    Merry, Alan F.; Craig S. Webster; HANNAM Jacqueline; Mitchell, Simon J.; Henderson, Robert; Reid, Papaarangi; Edwards, Kylie-Ellen; Jardim, Anisoara; Pak, Nick; Cooper, Jeremy; Hopley, Lara; Frampton, Chris; Short, Timothy G

    2011-01-01

    Objective To clinically evaluate a new patented multimodal system (SAFERSleep) designed to reduce errors in the recording and administration of drugs in anaesthesia. Design Prospective randomised open label clinical trial. Setting Five designated operating theatres in a major tertiary referral hospital. Participants Eighty nine consenting anaesthetists managing 1075 cases in which there were 10 764 drug administrations. Intervention Use of the new system (which includes customised drug trays ...

  10. Early enteral nutrition after surgical treatment of gut perforations: A prospective randomised study

    Directory of Open Access Journals (Sweden)

    Malhotra Amber

    2004-04-01

    Full Text Available BACKGROUND: Withholding enteral feeds after an elective gastrointestinal surgery is based on the hypothesis that this period of "nil by mouth" provides rest to the gut and promotes healing. AIMS: To assess whether early postoperative naso-gastric tube feeding in the form of a balanced diet formula is safe in and beneficial to patients who have undergone surgical intervention for perforation of the gut. SETTING: A surgical unit of a Medical College Hospital. DESIGN AND SUBJECTS: Prospective randomised open control study. METHODS AND MATERIAL: Patients undergoing surgical intervention for peritonitis following perforation of the gut were randomised to the study group receiving feedings of a balanced diet formula through a naso-gastric tube from the second postoperative day, or the control group in which patients were managed with the conventional regimen of intravenous fluid administration. The groups were compared for incidence and duration of complications, biochemical measurements and other characteristics like weight loss/gain. STATISTICAL ANALYSIS: Chi square test and ′T′ test. RESULTS: One hundred patients were enrolled in each group. 88% subjects in the study group achieved positive nitrogen balance on the eighth postoperative day as compared to none in the conventionally managed group. The relative risks (95% confidence interval of morbidity from wound infection, wound dehiscence, pneumonia, leakage of anastomoses and septicaemia were 0.66 (0.407-1.091, 0.44 (0.141-1.396, 0.70 (0.431-1.135, 0.54 (0.224-1.293 and 0.66 (0.374-1.503 respectively. Average loss of weight between the first and tenth day was 3.10 kg in the study group as compared to 5.10 kg in the conventionally managed group (′P′ value < 0.001, 95% Confidence Interval - 2.46 - 1.54. CONCLUSION: Early enteral nutrition is safe and is associated with beneficial effects such as lower weight loss, early achievement of positive nitrogen balance as compared to the conventional

  11. The use of head-mounted display eyeglasses for teaching surgical skills: A prospective randomised study.

    Science.gov (United States)

    Peden, Robert G; Mercer, Rachel; Tatham, Andrew J

    2016-10-01

    To investigate whether 'surgeon's eye view' videos provided via head-mounted displays can improve skill acquisition and satisfaction in basic surgical training compared with conventional wet-lab teaching. A prospective randomised study of 14 medical students with no prior suturing experience, randomised to 3 groups: 1) conventional teaching; 2) head-mounted display-assisted teaching and 3) head-mounted display self-learning. All were instructed in interrupted suturing followed by 15 minutes' practice. Head-mounted displays provided a 'surgeon's eye view' video demonstrating the technique, available during practice. Subsequently students undertook a practical assessment, where suturing was videoed and graded by masked assessors using a 10-point surgical skill score (1 = very poor technique, 10 = very good technique). Students completed a questionnaire assessing confidence and satisfaction. Suturing ability after teaching was similar between groups (P = 0.229, Kruskal-Wallis test). Median surgical skill scores were 7.5 (range 6-10), 6 (range 3-8) and 7 (range 1-7) following head-mounted display-assisted teaching, conventional teaching, and head-mounted display self-learning respectively. There was good agreement between graders regarding surgical skill scores (rho.c = 0.599, r = 0.603), and no difference in number of sutures placed between groups (P = 0.120). The head-mounted display-assisted teaching group reported greater enjoyment than those attending conventional teaching (P = 0.033). Head-mounted display self-learning was regarded as least useful (7.4 vs 9.0 for conventional teaching, P = 0.021), but more enjoyable than conventional teaching (9.6 vs 8.0, P = 0.050). Teaching augmented with head-mounted displays was significantly more enjoyable than conventional teaching. Students undertaking self-directed learning using head-mounted displays with pre-recorded videos had comparable skill acquisition to those attending traditional wet

  12. Managing central venous catheters: a prospective randomised trial of two methods.

    Science.gov (United States)

    Larwood, K A; Anstey, C M; Dunn, S V

    2000-05-01

    A randomised, prospective study was conducted to evaluate the impact on central venous catheter (CVC) infection when fluids and lines connected to a CVC were changed using a 'sterile' compared to an 'aseptic, non-touch' technique. The study sought to determine whether there were any differences in CVC tip colonisation (CTC) or CVC-related bacteraemia (CRB) as a result of the technique used for fluid and line changes. In the sterile technique (control) group, fluids and tubing were changed using full sterile technique. In the aseptic, non-touch (experimental) group, fluids and tubing attached to the CVC were changed using only a small sterile drape and a 2-minute clinical hand wash. When the CVC was removed, the tip was sampled and cultured using the semi-quantitative method. Blood cultures were also collected. In all, 111 samples from 79 patients were included in the trial: 61 in the sterile technique group and 50 in the non-touch, aseptic technique group. Results showed a CTC rate of 31 per cent in the control group and 14 per cent in the experimental group, while the CRB rate was 8.2 per cent and 6 per cent respectively. The most common organisms cultured were Staphylococcus aureus and S. epidermis respectively. This study indicates that it is safe to change fluids and lines attached to CVCs using the aseptic, non-touch technique, which has resulted in significant financial savings through less use of equipment and less nursing time required to perform fluid and line changes.

  13. Evaluation of a blood conservation strategy in the intensive care unit: a prospective, randomised study.

    LENUS (Irish Health Repository)

    Mahdy, Saad

    2012-02-01

    OBJECTIVE AND METHODS: Anemia is a common problem in the ICU population. Most patients are anemic at admission, their hemoglobin concentrations declining further thereafter. The aim of the present study was to evaluate the effect of a combination strategy, involving closed arterial blood gas sampling and the use of pediatric vials for phlebotomy (Group A), on the sampling-induced blood loss and the rate of decline in hemoglobin in adult ICU patients. Combination (Group A) was compared to the current standard technique of arterial line sampling and adult vial phlebotomy (Group B) in a prospective, randomised, ethically-approved trial for the first 72 hours of their ICU stay. Peri-operative, oncology, coagulopathic and uremic patients were excluded. All other ICU patients with arterial cannulae and predicted to stay beyond 3 days, were enrolled. RESULTS: 39 patients entered the study, 20 in Group A, and 19 in Group B. Data collection was complete for all. There was a statistically significant difference in sampling-induced blood loss between the groups over the first 72 hours of treatment (mean +\\/- standard deviation: 15.16 +\\/- 5.3 ml Group A vs 45.11 +\\/- 14 ml Group B, p<0.001). There was a smaller decline in mean hemoglobin level, which was not statistically significant (0.79 +\\/- 0.6 g\\/dL vs 1.30 +\\/- 1.13, p = 0.09). CONCLUSIONS: Overall, this strategy reduced measurable blood losses from phlebotomy. In larger trials it might also preserve hemoglobin levels.

  14. Laparoscopic versus open nephroureterectomy: perioperative and oncologic outcomes from a randomised prospective study.

    Science.gov (United States)

    Simone, Giuseppe; Papalia, Rocco; Guaglianone, Salvatore; Ferriero, Mariaconsiglia; Leonardo, Costantino; Forastiere, Ester; Gallucci, Michele

    2009-09-01

    Laparoscopic nephroureterectomy (LNU) is increasingly being used instead of open nephroureterectomy (ONU) for the treatment of urothelial carcinoma (UC) of the upper urinary tract (UUT), but the evidence of equal oncologic effectiveness is still lacking. To present perioperative and oncologic results from a prospective randomised study comparing ONU and LNU. Eighty patients with nonmetastatic UUT UC and without previous history of UC were enrolled. Of those, 40 patients (group A) randomly received ONU and 40 patients (group B) randomly received LNU. ONU was performed through a flank incision with a lower quadrant incision to allow excision of a bladder cuff. Transperitoneal LNU was performed with a four-trocar technique, and bladder cuff was detached with a 10-mm LigaSure device. Perioperative data were compared with the student t test. Bladder tumour-free survival (BTFS), metastasis-free survival (MFS), and cancer-specific survival (CSS) curves for both groups were compared with the log-rank test before and after stratifying patients for pT category and tumour grade. Operative times were comparable, while mean blood loss and mean time to discharge were significantly lower in group B (both p values ONU (p=0.039 and p=0.004, respectively, for pT3 tumours; p=0.078 and p=0.014, respectively, for high-grade tumours). The limitations of our study include the small sample size, the single-centre experience, the personal choice of laparoscopic technique, and not performing lymphadenectomies. Perioperative data and preliminary oncologic results were presented at 22nd Congress of the European Association of Urology, Berlin, Germany. In patients with organ-confined UUT UCs, LNU has the advantages of minimal invasiveness and oncologic outcomes comparable to those of ONU, while its effectiveness in patients with advanced stage diseases remains to be proven.

  15. No drain, autologous transfusion drain or suction drain? A randomised prospective study in total hip replacement surgery of 168 patients

    OpenAIRE

    Cheung, G.; Carmont, MR; Bing, AJ; Kuiper, JH; Alcock, RJ; Graham, NM

    2010-01-01

    We performed a prospective, randomised controlled trial to assess the differences in the use of a conventional suction drain, an Autologous Blood Transfusion (ABT) drain and no drain, in 168 patients. There was no significant difference between the drainage from ABT drains ( mean : 345 ml) and the suction drain (314 ml). Forty percent of patients receiving a suction drain had a haemoglobin level less than 10 g/dL at 24 hours, compared to 35% with no drain and 28% with an ABT drain. Patients t...

  16. A prospective randomised controlled trial to investigate the effect of local anaesthetic in vivo on cell culture.

    Science.gov (United States)

    Mary O'Brien, C; Breuning, Eleonore; Webb, Jill; Balderson, Debra; Nancarrow, Jeffrey

    2008-10-01

    Cell culture is an important adjunct in the management of major burns in that it enables keratinocytes derived from the patient to be grown and used to attain cover when there is little autologous skin available. The purpose of this prospective randomised trial was to determine if the type of local anaesthetic used to harvest the skin biopsy in vivo affected the subsequent culture of keratinocytes. Lignocaine 1% was compared with a eutectic mixture of local anaesthetic (EMLA) and a control. The subjects recruited were patients undergoing abdominoplasty. Sixteen patients were recruited but two were excluded from final analysis due to infection of the culture medium in one and poor yield from biopsies in all groups in the other. The tissue to be removed from the abdomen was divided into three areas. EMLA was applied to a 5x5 cm randomised area 2 h prior to surgery. Lignocaine 1% was injected into a 5x5 cm randomised area of abdominal skin immediately after anaesthesia. The third 5x5 cm randomised area was used as a control. Three 4-mm punch biopsies were harvested from each site of local anaesthetic application as well as the control area. The Rheinwald & Green method was used to culture these cells [Rheinwald JG, Green H. Serial cultivation of strains of human epidermal keratinocytes: the formation of keratinizing colonies from single cells. Cell 1975;6:331-5.] Cell counts were performed after harvesting keratinocytes from the biopsy and after 10 days of culture. Statistical analysis was undertaken. In conclusion, in contrast to in vitro studies when lignocaine 1% or EMLA is applied in vivo, there is no inhibition of cell culture. In vivo EMLA was also found to significantly increase cell multiplication.

  17. PROspective MEmory Training to improve HEart failUre Self-care (PROMETHEUS): study protocol for a randomised controlled trial.

    Science.gov (United States)

    Cameron, Jan; Rendell, Peter G; Ski, Chantal F; Kure, Christina E; McLennan, Skye N; Rose, Nathan S; Prior, David L; Thompson, David R

    2015-04-29

    Cognitive impairment is seen in up to three quarters of heart failure (HF) patients and has a significant negative impact on patients' health outcomes. Prospective memory, which is defined as memory to carry out future intentions, is important for functional independence in older adults and involves application of multiple cognitive processes that are often impaired in HF patients. The objective of this study is to examine the effects of prospective memory training on patients' engagement in HF self-care and health outcomes, carer strain and quality of life. The proposed study is a randomised, controlled trial in which 200 patients diagnosed with HF, and their carers will be recruited from 3 major hospitals across Melbourne. Eligible patients with HF will be randomised to receive either: 1) The Virtual Week Training Program - a computerised prospective memory (PM) training program (intervention) or 2) non-adaptive computer-based word puzzles (active control). HF patients' baseline cognitive function will be compared to a healthy control group (n = 60) living independently in the community. Patients will undergo a comprehensive assessment of PM, neuropsychological functioning, self-care, physical, and emotional functioning. Assessments will take place at baseline, 4 weeks and 12 months following intervention. Carers will complete measures assessing quality of life, strain, perceived control in the management of the patients' HF symptoms, and ratings of the patients' level of engagement in HF self-care behaviours. If the Virtual Week Training Program is effective in improving: 1) prospective memory; 2) self-care behaviours, and 3) wellbeing in HF patients, this study will enhance our understanding of impaired cognitive processes in HF and potentially is a mechanism to reduce healthcare costs. Australian New Zealand Clinical Trials Registry #366376; 27 May 2014. https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=366376&isClinicalTrial=False .

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

    NARCIS (Netherlands)

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

    2008-01-01

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

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

    NARCIS (Netherlands)

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

    2008-01-01

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

  20. Continued improvement of clinical outcome and cost effectiveness following intravascular ultrasound guided PCI: insights from a prospective, randomised study

    Science.gov (United States)

    Gaster, A L; Slothuus Skjoldborg, U; Larsen, J; Korsholm, L; von Birgelen, C; Jensen, S; Thayssen, P; Pedersen, K E; Haghfelt, T H

    2003-01-01

    Objective: To investigate in a prospective randomised study both long term clinical effects and cost effectiveness of percutaneous coronary interventions (PCI) with or without intravascular ultrasound (IVUS) guidance. Methods: 108 male patients with stable angina referred for PCI of a significant coronary lesion were randomly assigned to IVUS guided PCI or conventional PCI. Individual accumulated costs of the entire follow up period were calculated and compared in the randomisation groups. Effectiveness of treatment was measured by freedom from major adverse cardiac events. Results: Cost effectiveness of IVUS guided PCI that was noted at six months was maintained and even accentuated at long term follow up (median 2.5 years). The cumulated cost level was found to be lower for the IVUS guided group, with a cumulated cost of &163 672 in the IVUS guided group versus &313 706 in the coronary angiography group (p = 0.01). Throughout the study, mean cost per day was lower in the IVUS guided PCI group (&2.7 v &5.2; p = 0.01). In the IVUS group, 78% were free from major adverse cardiac events versus 59% in the coronary angiography group (p = 0.04) with an odds ratio of 2.5 in favour of IVUS guidance. Conclusion: IVUS guidance results in continued improvement of long term clinical outcome and cost effectiveness. The results of this study suggest that IVUS guidance may be used more liberally in PCI. PMID:12923023

  1. Robot-assisted total knee arthroplasty accurately restores the joint line and mechanical axis. A prospective randomised study.

    Science.gov (United States)

    Liow, Ming Han Lincoln; Xia, Zhan; Wong, Merng Koon; Tay, Keng Jin; Yeo, Seng Jin; Chin, Pak Lin

    2014-12-01

    Robot-assisted Total Knee Arthroplasty (TKA) improves the accuracy and precision of component implantation and mechanical axis (MA) alignment. Joint-line restoration in robot-assisted TKA is not widely described and joint-line deviation of>5mm results in mid-flexion instability and poor outcomes. We prospectively randomised 60 patients into two groups: 31 patients (robot-assisted), 29 patients (conventional). No MA outliers (>±3° from neutral) or notching was noted in the robot-assisted group as compared with 19.4% (P=0.049) and 10.3% (P=0.238) respectively in the conventional group. The robot-assisted group had 3.23% joint-line outliers (>5mm) as compared to 20.6% in the conventional group (P=0.049). Robot-assisted TKA produces similar short-term clinical outcomes when compared to conventional methods with reduction of MA alignment and joint-line deviation outliers.

  2. The effect of a collar and surface finish on cemented femoral stems: a prospective randomised trial of four stem designs.

    Science.gov (United States)

    Hutt, Jonathan; Hazlerigg, Alexandra; Aneel, Ansari; Epie, Geoffrey; Dabis, Husam; Twyman, Roy; Cobb, Andrew

    2014-06-01

    The optimal design for a cemented femoral stem remains a matter of debate. Over time, the shape, surface finish and collar have all been modified in various ways. A clear consensus has not yet emerged regarding the relative merits of even the most basic design features of the stem. We undertook a prospective randomised trial comparing surface finish and the effect of a collar on cemented femoral component subsidence, survivorship and clinical function. One hundred and sixty three primary total hip replacement patients were recruited prospectively and randomised to one of four groups to receive a cemented femoral stem with either a matt or polished finish, and with or without a collar. At two years, although there was a trend for increased subsidence in the matt collarless group, this was not statistically significant (p = 0.18). At a mean of 10.1 years follow-up, WOMAC scores for the surviving implants were good, (Range of means 89-93) without significant differences. Using revision or radiographic loosening as the endpoint, survivorship of the entire cohort was 93 % at 11 yrs, (CI 87-97 %). There were no significant differences in survivorship between the two groups with polished stems or the two groups with matt stems. A comparison of the two collarless stems demonstrated a statistically significant difference in survivorship between polished (100 %) and matt (88 %) finishes (p = 0.02). In the presence of a collar, surface finish did not significantly affect survivorship or function. Between the two collarless groups a polished surface conferred an improved survivorship.

  3. A Proficiency Based Stepwise Endovascular Curricular Training (PROSPECT) Program Enhances Operative Performance in Real Life: A Randomised Controlled Trial.

    Science.gov (United States)

    Maertens, H; Aggarwal, R; Moreels, N; Vermassen, F; Van Herzeele, I

    2017-09-01

    Healthcare evolution requires optimisation of surgical training to provide safe patient care. Operating room performance after completion of proficiency based training in vascular surgery has not been investigated. A randomised controlled trial evaluated the impact of a Proficiency based Stepwise Endovascular Curricular Training program (PROSPECT) on the acquisition of endovascular skills and the transferability of these skills to real life interventions. All subjects performed two endovascular interventions treating patients with symptomatic iliac and/or superficial femoral artery stenosis under supervision. Primary outcomes were technical performances (Global Rating Scale [GRS]; Examiner Checklist), operative metrics, and patient outcomes, adjusted for case difficulty and trainee experience. Secondary outcomes included knowledge and technical performance after 6 weeks and 3 months. Thirty-two general surgical trainees were randomised into three groups. Besides traditional training, the first group (n = 11) received e-learning and simulation training (PROSPECT), the second group (n = 10) only had access to e-learning, while controls (n = 11) did not receive supplementary training. Twenty-nine trainees (3 dropouts) performed 58 procedures. Trainees who completed PROSPECT showed superior technical performance (GRS 39.36 ± 2.05; Checklist 63.51 ± 3.18) in real life with significantly fewer supervisor takeovers compared with trainees receiving e-learning alone (GRS 28.42 ± 2.15; p = .001; Checklist 53.63 ± 3.34; p = .027) or traditional education (GRS 23.09 ± 2.18; p = .001; Checklist 38.72 ± 3.38; p = .001). Supervisors felt more confident in allowing PROSPECT trained physicians to perform basic (p = .006) and complex (p = .003) procedures. No differences were detected in procedural parameters (such as fluoroscopy time, DAP, procedure time, etc.) or complications. Proficiency levels were maintained up to 3 months. A structured

  4. A prospective randomised controlled trial of capnography vs. bronchoscopy for Blue Rhino percutaneous tracheostomy.

    Science.gov (United States)

    Mallick, A; Venkatanath, D; Elliot, S C; Hollins, T; Nanda Kumar, C G

    2003-09-01

    A crucial step for successful percutaneous tracheostomy is the introduction of the needle and guide wire into the trachea. Capnography has recently been proposed as one way to confirm tracheal needle placement. In this randomised controlled study, we used capnography in 26 patients and bronchoscopy in 29 patients to confirm needle placement for percutaneous tracheostomy using Blue Rhino kit. The operating times and the incidence of peri-operative complications were similar for both groups. Capnography proved to be as effective as bronchoscopy in confirming correct needle placement.

  5. Physiotherapy Post Lumbar Discectomy: Prospective Feasibility and Pilot Randomised Controlled Trial.

    Directory of Open Access Journals (Sweden)

    Alison Rushton

    Full Text Available To evaluate: acceptability and feasibility of trial procedures; distribution of scores on the Roland Morris Disability Questionnaire (RMDQ, planned primary outcome; and efficient working of trial components.A feasibility and external pilot randomised controlled trial (ISRCTN33808269, assigned 10/12/2012 was conducted across 2 UK secondary care outpatient physiotherapy departments associated with regional spinal surgery centres.Consecutive consenting patients aged >18 years; post primary, single level, lumbar discectomy.Participants were randomised to either 1:1 physiotherapy outpatient management including patient leaflet, or patient leaflet alone.Blinded assessments were made at 4 weeks post surgery (baseline and 12 weeks post baseline (proposed primary end point. Secondary outcomes included: Global Perceived Effect, back/leg pain, straight leg raise, return to work/function, quality of life, fear avoidance, range of movement, medication, re-operation.At discharge, 110 (44% eligible patients gave consent to be contacted. 59 (54% patients were recruited. Loss to follow up was 39% at 12 weeks, with one site contributing 83% losses. Mean (SD RMDQ was 10.07 (5.58 leaflet and 10.52 (5.94 physiotherapy/leaflet at baseline; and 5.37 (4.91 leaflet and 5.53 (4.49 physiotherapy/leaflet at 12 weeks. 5.1% zero scores at 12 weeks illustrated no floor effect. Sensitivity to change was assessed at 12 weeks with mean (SD change -4.53 (6.41, 95%CI -7.61 to -1.44 for leaflet; and -6.18 (5.59, 95%CI -9.01 to -3.30 for physiotherapy/leaflet. RMDQ mean difference (95%CI between change from baseline to twelve weeks was 1.65(-2.46 to 5.75. Mean difference (95%CI between groups at 12 weeks was -0.16 (-3.36 to 3.04. Participant adherence with treatment was good. No adverse events were reported.Both interventions were acceptable, and it is promising that they both demonstrated a trend in reducing disability in this population. A randomised controlled trial, using a

  6. Effects of a training program after surgically treated ankle fracture: a prospective randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Ekdahl Charlotte S

    2009-09-01

    Full Text Available Abstract Background Despite conflicting results after surgically treated ankle fractures few studies have evaluated the effects of different types of training programs performed after plaster removal. The aim of this study was to evaluate the effects of a 12-week standardised but individually suited training program (training group versus usual care (control group after plaster removal in adults with surgically treated ankle fractures. Methods In total, 110 men and women, 18-64 years of age, with surgically treated ankle fracture were included and randomised to either a 12-week training program or to a control group. Six and twelve months after the injury the subjects were examined by the same physiotherapist who was blinded to the treatment group. The main outcome measure was the Olerud-Molander Ankle Score (OMAS which rates symptoms and subjectively scored function. Secondary outcome measures were: quality of life (SF-36, timed walking tests, ankle mobility tests, muscle strength tests and radiological status. Results 52 patients were randomised to the training group and 58 to the control group. Five patients dropped out before the six-month follow-up resulting in 50 patients in the training group and 55 in the control group. Nine patients dropped out between the six- and twelve-month follow-up resulting in 48 patients in both groups. When analysing the results in a mixed model analysis on repeated measures including interaction between age-group and treatment effect the training group demonstrated significantly improved results compared to the control group in subjects younger than 40 years of age regarding OMAS (p = 0.028, muscle strength in the plantar flexors (p = 0.029 and dorsiflexors (p = 0.030. Conclusion The results of this study suggest that when adjusting for interaction between age-group and treatment effect the training model employed in this study was superior to usual care in patients under the age of 40. However, as only three

  7. Telemonitoring in fasting individuals with Type 2 Diabetes Mellitus during Ramadan: A prospective, randomised controlled study.

    Science.gov (United States)

    Lee, Jun Yang; Wong, Chee Piau; Tan, Christina San San; Nasir, Nazrila Hairizan; Lee, Shaun Wen Huey

    2017-08-31

    We determined the impact of a remote blood glucose telemonitoring program with feedback in type 2 diabetes mellitus patients fasting during Ramadan compared to conventional self-monitoring method. A twelve-week cluster randomised study, with 85 participants who wish to fast for at least 15 days during Ramadan was conducted. Self-measurement and transmission of blood glucose results were performed six times daily during Ramadan. Results were transmitted to a secure website for review with feedback from case manager if necessary. The control group received usual care. The main outcome was the number of participants experiencing hypoglycaemia during Ramadan and at the end of the study. During Ramadan, the number of participants reporting hypoglycaemia was significantly lower in the telemonitoring group [Odds ratio (OR): 0.186, 95% confidence interval: 0.04-0.936; p = 0.04]. Similarly, the proportion of participants reporting symptomatic hypoglycaemia at the end of the study was significantly lower in the telemonitoring group (OR: 0.257, 95% CI: 0.07-0.89; p = 0.03). A reduction of 1.07% in glycated haemoglobin levels was observed in the telemonitoring group compared to 0.24% in the control group (p telemonitoring was a useful adjunct to reduce the risk of hypoglycaemia during Ramadan with no deterioration in glycaemic control.

  8. A prospective randomised study of local anaesthetic injection after multiple rubber band ligation of haemorrhoids.

    Science.gov (United States)

    Gokalp, Avni; Baskonus, Ilyas; Maralcan, Gokturk

    2003-01-01

    One hundred and forty-two patients with second and third degree internal haemorrhoids were randomised to rubber band ligation only (n = 72) or rubber band ligation + local anaesthetic injection (n = 70). Pain was assessed by the patients at intervals of 6 hours and 1, 2, 3 and 4 days after banding. Other symptoms, complications, analgesic requirements and patient satisfaction were also recorded for 10 days following the treatment. There was a significant reduction in pain at 60 minutes and 6 hours after the procedure in the rubber band ligation plus local anaesthetic injection patients compared with the rubber band ligation only group (P rubber band ligation only on days 1, 2, 3 and 4 days after ligation. On day 10 after banding, there was no difference between the two groups with respect to symptoms such as nausea, feeling of heaviness and/or tenesmus, fainting; complications, analgesic consumption or overall patient satisfaction. Bupivacaine injection after multiple rubber band ligation may be useful in reducing pain during the first 6 hours of the postbanding period.

  9. No drain, autologous transfusion drain or suction drain? A randomised prospective study in total hip replacement surgery of 168 patients.

    Science.gov (United States)

    Cheung, Graham; Carmont, Michael R; Bing, Andrew J F; Kuiper, Jan-Herman; Alcock, Robert J; Graham, Niall M

    2010-10-01

    We performed a prospective, randomised controlled trial to assess the differences in the use of a conventional suction drain, an Autologous Blood Transfusion (ABT) drain and no drain, in 168 patients. There was no significant difference between the drainage from ABT drains ( mean : 345 ml) and the suction drain (314 ml). Forty percent of patients receiving a suction drain had a haemoglobin level less than 10 g/dL at 24 hours, compared to 35% with no drain and 28% with an ABT drain. Patients that had no drains had wounds that were dry significantly sooner, mean 3.0 days compared to a mean of 3.9 days with an ABT drain and a mean of 4 days with a suction drain. Patients that did not have a drain inserted stayed in hospital a significantly shorter period of time, compared with drains. We feel the benefits of quicker drying wounds, shorter hospital stays and the economic savings justify the conclusion that no drain is required after hip replacement.

  10. Effect of dexamethasone added to lidocaine in supraclavicular brachial plexus block: A prospective, randomised, double-blind study

    Directory of Open Access Journals (Sweden)

    Prashant A Biradar

    2013-01-01

    Full Text Available Background: Different additives have been used to prolong brachial plexus block. We performed a prospective, randomised, double-blind study to evaluate the effect of dexamethasone added to lidocaine on the onset and duration of supraclavicular brachial plexus block as this is the most common type of brachial block performed in our institute. Methods: Sixty American Society of Anaesthesiologist′s physical status I and II patients undergoing elective hand, forearm and elbow surgery under brachial plexus block were randomly allocated to receive either 1.5% lidocaine (7 mg/kg with adrenaline (1:200,000 and 2 ml of normal saline (group C, n=30 or 1.5% lidocaine (7 mg/kg with adrenaline (1:200,000 and 2 ml of dexamethasone (8 mg (group D, n=30. The block was performed using a nerve stimulator. Onset and duration of sensory and motor blockade were assessed. The sensory and motor blockade of radial, median, ulnar and musculocutaneous nerves were evaluated and recorded at 5, 10, 20, 120 min, and at every 30 min thereafter. Results: Two patients were excluded from the study because of block failure. The onset of sensory and motor blockade (13.4±2.8 vs. 16.0±2.3 min and 16.0±2.7 vs. 18.7±2.8 min, respectively were significantly more rapid in the dexamethasone group than in the control group ( P=0.001. The duration of sensory and motor blockade (326±58.6 vs. 159±20.1 and 290.6±52.7 vs. 135.5±20.3 min, respectively were significantly longer in the dexamethasone group than in the control group ( P=0.001. Conclusion: Addition of dexamethasone to 1.5% lidocaine with adrenaline in supraclavicular brachial plexus block speeds the onset and prolongs the duration of sensory and motor blockade.

  11. Twenty-four hours or 10 days? A prospective randomised controlled trial in children comparing head bandages following pinnaplasty.

    Science.gov (United States)

    Ramkumar, S; Narayanan, V; Laing, J H E

    2006-01-01

    The perceived benefits of bandaging for 10 days following pinnaplasty have been questioned by previous studies. The problems arising from these dressings are many [Powell BWEM. The value of head dressings in the postoperative management of the prominent ear. Br J Plast Surg 1989;42:692-4. Bartley J. How long should ears be bandaged after otoplasty? J Laryngol Otol 1998;112:531-2. Wong MC, Sylaidis P. Head dressings for pinnaplasty: a tradition not supported by evidence. Br J Plast Surg 2001;54:81-2], including their slippage [Powell BWEM. The value of head dressings in the postoperative management of the prominent ear. Br J Plast Surg 1989;42:692-4. Bradbury ET, Hewison J, Timmons MJ. Psychological and social outcome of prominent ear correction in children. Br J Plast Surg 1992;45:97-100. Jeffery SLA. Complications following correction of prominent ears: an audit review of 122 cases. Br J Plast Surg 1999;52:588-90]. Eighty children were recruited into a prospective randomised controlled trial comparing the use of a head bandage for only 24 h with a standard practise of a 10-day head bandage. A preoperative measurement of the lateral ear projection (LEP) was made. The outcome measures recorded during the two planned postoperative visits at 10 days (visit 1) and 2 months (visit 2) were: patient satisfaction score, LEP, complications and any unscheduled hospital visits associated with the surgery. There was no significant difference in LEP and patient satisfaction between the two groups at both the scheduled postoperative visits. Differences between the groups in the number of unscheduled visits (p=0.21) did not reach statistical significance. The findings indicate that it is safe and effective to use head bandage for only 24 h following surgical correction of prominent ears. This study shows no benefit from the application of a formal head bandage for any longer than 1 day.

  12. Evaluation of hyperglycaemic response to intra-operative dexamethasone administration in patients undergoing elective intracranial surgery: A randomised, prospective study

    Science.gov (United States)

    Sethi, Rakesh; Naqash, Imtiaz A.; Bajwa, Sukhminder Jit Singh; Dutta, Vikas; Ramzan, Altaf Umar; Zahoor, Syed Amir

    2016-01-01

    Background and Aim: The glucocorticoid dexamethasone in a bolus dose of 8-10 mg followed by quarterly dose of 4 mg is commonly used during intracranial surgery so as to reduce oedema and vascular permeability. However, the detrimental hyperglycaemic effects of dexamethasone may override its potentially beneficial effects. The present prospective, randomised study aimed at comparing the degree and magnitude of hyperglycaemia induced by prophylactic administration of dexamethasone in patients undergoing elective craniotomy. Materials and Methods: Sixty American Society of Anaesthesiologist (ASA) grade-I and II patients were randomly assigned to three groups of 20 patients each. Group-I received dexamethasone during surgery for the first time. Group-II received dexamethasone in addition to receiving it pre-operatively, whereas Group-III (control group) patients were administered normal saline as placebo. Baseline blood glucose (BG) was measured in all the three groups before induction of anaesthesia and thereafter after every hour for 4 h and then two-hourly. Besides intra- and intergroup comparison of BG, peak BG concentration was also recorded for each patient. Statistical analysis was carried out with analysis of variance (ANOVA) and Student's t-test and value of P < 0.05 was considered statistically significant. Results: Baseline BG reading were higher and statistically significant in Group-II as compared with Group-I and Group-III (P < 0.05). However, peak BG levels were significantly higher in Group-I than in Group-II and III (P < 0.05). Similarly, the magnitude of change in peak BG was significantly higher in Group-I as compared to Group-II and III (P < 0.05). Conclusion: Peri-operative administration of dexamethasone during neurosurgical procedures can cause significant increase in BG concentration especially in patients who receive dexamethasone intra-operatively only. PMID:27057213

  13. Does a foamy-block mattress system prevent pressure sores ? A prospective randomised clinical trial in 1729 patients.

    Science.gov (United States)

    Berthe, J V; Bustillo, A; Mélot, C; de Fontaine, S

    2007-01-01

    Pressure ulcers are a frequent complication of bed rest. The development of an efficient and low cost pressure relieving system for the prevention of bed-sores would be of considerable hospital health and economic interest. Our study was designed to determine the effectiveness in pressure-sore prevention of an interface pressure-decreasing mattress, the Kliniplot mattress, used in our institution since 1978. In a prospective randomised controlled 7-month clinical trial we compared the Kliniplot mattress with our standard hospital mattress in 1729 patients admitted to medical and surgical departments (neurology, cardiology, oncology-haematology, neurosurgery, thoracic surgery and orthopaedic surgery). Two groups (Klinipot mattress and standard hospital mattress) were monitored for the prevention of pressure sores. The patients were evaluated on a daily basis from their admission until the eventual occurrence of a bed-sore. Patients' characteristics and pressure-sore risk factors were similar at the baseline in both groups. Patients presenting with a pressure sore at the time of admission were excluded. Forty-two of the 1729 patients (2.4%) who entered the study developed at least one pressure sore. Twenty-one of the 657 patients (3.2%) nursed on the Kliniplot mattress, and 21 of the 1072 patients (1.9%) on the standard mattress developed bed-sores (p = 0.154). The median time for the occurrence of pressure sores was 31 days (range 6-87) with the Kliniplot mattress and 18 days (range 2 to 38) with the standard mattress (p sores using the modified Ek's scale were no different at the baseline between both groups (p = 0.764). The severity of the pressure sores was no different between both groups (p = 0.918). Our results show that the occurrence of pressure sores is not reduced but is delayed when patients are nursed on a Kliniplot pressure-decreasing mattress.

  14. Randomised prospective study for the effect of therapy on residual beta cell function in type-1 diabetes mellitus [ISRCTN70703138

    Directory of Open Access Journals (Sweden)

    Bretzel Reinhard G

    2003-12-01

    Full Text Available Abstract Background Newly diagnosed insulin-dependent diabetes mellitus is characterised by a temporary recovery of endogeneous insulin ("remission" after the beginning of medical treatment with subcutaneous insulin injections. Although most diabetologists think, that insulin reserve is related to reduced occurrence of diabetic long-term complications, such as eye, nerve and kidney disease, there is only one prospective controlled clinical study (the DCCT addressing this question, however as secondary hypothesis. Methods/Design Therefore, we composed a trial consisting of two cohorts with two therapeutic options within each cohort (conventional versus intensive therapy and a three-year follow-up. In one group the patients are randomly assigned to the treatment regimes to test the statistical alternative hypothesis if variable insulin dosage is superior to fixed insulin injection in preserving insulin reserve measured by C-peptide in serum. Another group includes patients who prefer one of the two therapies, decline randomisation, but consent to follow-up. Apart from the determination of insulin reserve as a biological parameter a second primary endpoint was defined as 'therapeutic failure' according to the criteria of the European Association for the Study of Diabetes. Patients pass a training program to help them self-manage diabetes. A standardised protocol is being set up to minimize centre effects and bias of health care providers. Potential patient dependent bias will be investigated by questionnaires measuring psychic coping processes of people with diabetes. Management of visit dates is directly navigated by the database. Automated visit-reminders are mailed to patients and caregivers to optimise the number of visits on schedule. Data quality is regularly monitored and centres are informed on the results of continuous data management.

  15. A prospective randomised trial of isolated pathogens of surgical site infections (SSI).

    Science.gov (United States)

    Alexiou, Konstantinos; Drikos, Ioannis; Terzopoulou, Maria; Sikalias, Nikolaos; Ioannidis, Argyrios; Economou, Nikolaos

    2017-09-01

    Every surgical wound is colonized by bacteria, but only a small percentage displays symptoms of infection. The distribution of pathogens isolated in surgical site infections has not significantly changed over the last decades. Staph. Aureus, Coag(-) Staphylococci, Enterococcus spp and E. Coli are the main strains appearing. In addition, a continuously rising proportion of surgical site infections caused by resistant bacterial species (MRSA, C. Albicans) has been reported. This prospective and randomized clinical study was performed in the 1st Surgical Clinic of Sismanoglion General Hospital of Athens, from February 2009 to February 2015. Patients undergoing elective surgery in the upper or lower digestive system were randomized to receive antimicrobial treatment as chemoprophylaxis. Each patient filled a special monitoring form, recording epidemiological data, surgery related information, surgical site infections (deep and superficial), as well as postoperative morbidity (urinary and respiratory infections included). The monitoring of patients was carried by multiple visits on a daily basis during their hospitalization and continued after they were discharged via phone to postoperative day 30. Our overall SSI incidence was 4,3% (31patients out of a whole of 715 patients). Specifically, the incidence of SSIs for scheduled surgery of the upper GI tract was 2,2% (11 out of 500 patients) and for the lower GI tract was 9,3% (20 out of 215 patients). Seven main pathogens were isolated from patients with SSIs: Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Pseudomonas aeruginosa, Bacteroides fragilis, Staphylococcus aureus and Enterococcus faecalis. Their growth rates were respectively: S. Aureus (17,3%), E. faecalis (19,5%), P. aeruginosa (10,5%), B. Fragilis (13,4%) E. coli (20,4%), Enterobacter cloacae (9,1%) and K. Pneumoniae (9,8%). In addition, all the SSIs were found to be multimicrobial. Several studies have already revealed that patient

  16. Retraction statement: Manuka honey vs. hydrogel - a prospective, open label, multicentre, randomised controlled trial to compare desloughing efficacy and healing outcomes in venous ulcers.

    Science.gov (United States)

    2015-09-01

    The following article from Journal of Clinical Nursing, 'Manuka honey vs. hydrogel - a prospective, open label, multicentre, randomised controlled trial to compare desloughing efficacy and healing outcomes in venous ulcers' by Georgina Gethin and Seamus Cowman published online on 25 August 2008 in Wiley Online Library (wileyonlinelibrary.com) and in Volume 18, pp. 466-474, has been retracted by agreement between the journal Editor-in-Chief, the authors and John Wiley & Sons, Ltd. The retraction has been agreed due to errors in the data analysis which affect the article's findings.

  17. Five-year results of a prospective randomised controlled clinical trial of posterior computer-aided design-computer-aided manufacturing ZrSiO4 -ceramic crowns.

    Science.gov (United States)

    Passia, N; Stampf, S; Strub, J R

    2013-08-01

    The aim of this prospective randomised controlled clinical trial was to evaluate the clinical outcome of shrinkage-free ZrSiO4 -ceramic full-coverage crowns on premolars and molars in comparison with conventional gold crowns over a 5-year period. Two hundred and twenty-three patients were included and randomly divided into two treatment groups. One hundred and twenty-three patients were restored with 123 ZrSiO4 -ceramic crowns, and 100 patients received 100 gold crowns, which served as the control. All crowns were conventionally cemented with glass-ionomer cement. After an observation period of 6, 12, 24, 36, 48 and 60 months, the survival probability (Kaplan-Meier) for the shrinkage-free ZrSiO4 -ceramic crowns was 98·3%, 92·0%, 84·7%, 79% and 73·2% and for the gold crowns, 99%, 97·9%, 95·7%, 94·6% and 92·3%, respectively. The difference between the test and control group was statistically significant (P = 0·0027). The gold crowns showed a better marginal integrity with less marginal discoloration than the ceramic crowns. The most common failure in the ceramic crown group was fracture of the crown. The 60-month results of this prospective randomised controlled clinical trial suggest that the use of these shrinkage-free ZrSiO4 -ceramic crowns in posterior tooth restorations cannot be recommended.

  18. PTFE bypass to below-knee arteries: distal vein collar or not? A prospective randomised multicentre study

    DEFF Research Database (Denmark)

    Lundgren, Fredrik; Bergqvist, David; Norgren, Lars

    2010-01-01

    Patency and limb salvage after synthetic bypass to the arteries below-knee are inferior to that which can be achieved with autologous vein. Use of a vein collar at the distal anastomosis has been suggested to improve patency and limb salvage, a problem that is analysed in this randomised clinical...

  19. Intracoronary cardiosphere-derived cells for heart regeneration after myocardial infarction (CADUCEUS): a prospective, randomised phase 1 trial.

    Science.gov (United States)

    Makkar, Raj R; Smith, Rachel R; Cheng, Ke; Malliaras, Konstantinos; Thomson, Louise E J; Berman, Daniel; Czer, Lawrence S C; Marbán, Linda; Mendizabal, Adam; Johnston, Peter V; Russell, Stuart D; Schuleri, Karl H; Lardo, Albert C; Gerstenblith, Gary; Marbán, Eduardo

    2012-03-10

    Cardiosphere-derived cells (CDCs) reduce scarring after myocardial infarction, increase viable myocardium, and boost cardiac function in preclinical models. We aimed to assess safety of such an approach in patients with left ventricular dysfunction after myocardial infarction. In the prospective, randomised CArdiosphere-Derived aUtologous stem CElls to reverse ventricUlar dySfunction (CADUCEUS) trial, we enrolled patients 2-4 weeks after myocardial infarction (with left ventricular ejection fraction of 25-45%) at two medical centres in the USA. An independent data coordinating centre randomly allocated patients in a 2:1 ratio to receive CDCs or standard care. For patients assigned to receive CDCs, autologous cells grown from endomyocardial biopsy specimens were infused into the infarct-related artery 1·5-3 months after myocardial infarction. The primary endpoint was proportion of patients at 6 months who died due to ventricular tachycardia, ventricular fibrillation, or sudden unexpected death, or had myocardial infarction after cell infusion, new cardiac tumour formation on MRI, or a major adverse cardiac event (MACE; composite of death and hospital admission for heart failure or non-fatal recurrent myocardial infarction). We also assessed preliminary efficacy endpoints on MRI by 6 months. Data analysers were masked to group assignment. This study is registered with ClinicalTrials.gov, NCT00893360. Between May 5, 2009, and Dec 16, 2010, we randomly allocated 31 eligible participants of whom 25 were included in a per-protocol analysis (17 to CDC group and eight to standard of care). Mean baseline left ventricular ejection fraction (LVEF) was 39% (SD 12) and scar occupied 24% (10) of left ventricular mass. Biopsy samples yielded prescribed cell doses within 36 days (SD 6). No complications were reported within 24 h of CDC infusion. By 6 months, no patients had died, developed cardiac tumours, or MACE in either group. Four patients (24%) in the CDC group had serious

  20. Prospective, double-blinded, randomised controlled trial assessing the effect of an Octenidine-based hydrogel on bacterial colonisation and epithelialization of skin graft wounds in burn patients.

    Science.gov (United States)

    W, Eisenbeiß; F, Siemers; G, Amtsberg; P, Hinz; B, Hartmann; T, Kohlmann; A, Ekkernkamp; U, Albrecht; O, Assadian; A, Kramer

    2012-01-01

    Moist wound treatment improves healing of skin graft donor site wounds. Microbial colonised wounds represent an increased risk of wound infection; while antimicrobially active, topical antiseptics may impair epithelialization. The aim of this prospective randomised controlled clinical trial was to examine the influence of an Octenidine-dihydrochloride (OCT) hydrogel on bacterial colonisation and epithelialization of skin graft donor sites. The study was designed as a randomised, double-blinded, controlled clinical trial. Skin graft donor sites from a total of 61 patients were covered either with 0.05% OCT (n=31) or an OCT-free placebo wound hydrogel (n=30). Potential interaction with wound healing was assessed by measuring the time until 100% re-epithelialization. In addition, microbial wound colonisation was quantitatively determined in all skin graft donor sites. There was no statistically significant difference in the time for complete epithelialization of skin graft donor sites in the OCT and the placebo group (7.3±0.2 vs. 6.9±0.2 days; p=0.236). Microbial wound colonisation was significantly lower in the OCT group than in the placebo group (p=0.014). The OCT-based hydrogel showed no delay in wound epithelialization and demonstrated a significantly lower bacterial colonisation of skin graft donor site wounds.

  1. Effects of a silicone-coated polyamide net dressing and calcium alginate on the healing of split skin graft donor sites: a prospective randomised trial.

    LENUS (Irish Health Repository)

    O'Donoghue, J M

    2012-02-03

    An open randomised prospectively controlled trial was performed to assess the healing efficacy, slippage rate and degree of discomfort on removal of calcium alginate and a silicone-coated polyamide net dressing on split skin graft donor sites. Sixteen patients were randomised to the calcium alginate group and 14 to the silicone-coated group. The donor sites were assessed at days 7, 10, 14 and up to day 21. The mean time to healing in the calcium alginate group was 8.75 +\\/- 0.78 days (range 7 to 14 days) compared to 12 +\\/- 0.62 days (range 7 to 16 days) for the silicone-coated group (p < 0.01). Although more silicone-coated dressings slipped (5 versus 1), the difference was not statistically significant. Pain during the first dressing change was assessed using a visual analogue pain scale. Although no significant differences were found between the groups, it was necessary to change the dressing protocol in the silicone-coated arm of the trial after entering the first two patients. Overlaid absorbent gauze adhered to the donor site through the fenestrations in the dressing necessitating the placement of paraffin gauze between the experimental dressing and the overlying cotton gauze. There was one infection in the study, occurring in the alginate group. Based on these results we recommend calcium alginate as the dressing of choice for split skin graft donor sites.

  2. [Single Subcutaneous Palmar Injection vs. 2 Dorsal Injections for Finger Anaesthesia in Hand Surgery - Randomised Prospective Comparison of Application Pain and Efficacy].

    Science.gov (United States)

    Schelhorn, N; Lamm, S; Fricker, R

    2016-08-01

    This randomised prospective study compared pain during application and efficacy of the palmar subcutaneous single injection block (PSSIB) and the traditional dorsal 2 injection block (DTIB). During a 2 year period, a total of 190 patients with an average age of 43 years (18-82) and an isolated finger injury were included in the study. The injection was applied by residents (n=29) of the emergency department. 96 patients received PSSIB (72 men, 24 women) and 94 DTIB (55 men, 39 women) with 3 ml of Mepicavain(®) 1%. Randomisation was performed by even/odd hospital admission number. Thumb injury, progressive infection with visible redness at injection point. Application pain was recorded immediately after injection and registered on a VAS (0-10). Efficacy was checked 5 min after application. The patients quoted the efficacy as complete pain-free, almost pain-free and inadequate anesthesia (second injection was necessary). Statistical analysis was performed using the chi-quadrat and the t test; the level of significance was set at pinjections. Application pain was rated as being significantly (p=0.002) less painful for PSSIB (3.2) than for DTIB (4,0). This study shows that PSSIB gives reliable analgesia and the application pain is significant less than during DTIB. © Georg Thieme Verlag KG Stuttgart · New York.

  3. Comparison of the Supraglottic Airway Devices Classic, Fastrach and Supreme Laryngeal Mask Airway: A Prospective Randomised Clinical Trial of Efficacy, Safety and Complications.

    Science.gov (United States)

    Kömür, Erdal; Bakan, Nurten; Tomruk, Şenay Göksu; Karaören, Gülşah; Doğan, Zelin Topaç

    2015-12-01

    This prospective randomised study was designed to compare the Laryngeal Mask Airway (LMA) Classic, LMA Fastrach and LMA Supreme regarding ease of insertion and insertion time as primary outcomes and reposition, success rate of trials, effects on haemodynamic parameters, provision of an adequate and safe airway, amount of leakage and oropharyngeal and systemic complications as secondary outcomes. In this clinical trial, 90 patients aged 18-70 years of American Society of Anesthesiologists (ASA) group I-II were randomised into three groups as providing airway via LMA Classic, LMA Fastrach or LMA Supreme instead of tracheal intubation. No muscle relaxant was used. The allocated LMA was inserted by the same anaesthetist; bispectral index (BIS) was between 40% and 60%. There was no statistical difference among the groups regarding the ease of insertion and insertion time as primary outcomes; the incidence of repositioning during placement was significantly higher in the LMA Classic group than that in other groups (p<0.05) and the rates of bloodstain on the device as well as oropharyngeal mucosal oedema were higher in the LMA Fastrach group than those in other groups (p<0.05) as secondary outcomes. We suggest that LMA Classic, LMA Supreme and LMA Fastrach had similar effectiveness regarding efficiency and airway safety. However, LMA Supreme seems to be more advantageous as it is more appropriate for fewer oropharyngeal complications and there was no repositioning.

  4. A prospective, randomised study to compare extracorporeal shock-wave therapy and injection of steroid for the treatment of tennis elbow.

    Science.gov (United States)

    Crowther, M A A; Bannister, G C; Huma, H; Rooker, G D

    2002-07-01

    We undertook a prospective, randomised study to compare the analgesic effect of injection of steroid and of extracorporeal shock-wave therapy (ESWT) for the treatment of tennis elbow. Group 1 received a single injection of 20 mg of triamcinolone with lignocaine while group 2 received 2000 shock waves in three sessions at weekly intervals. After six weeks there was a significant difference between the groups with the mean pain score for the injection group falling from 66 to 21 compared with a decrease from 61 to 35 in the shock-wave group (p = 0.05). After three months, 84% of patients in group 1 were considered to have had successful treatment compared with 60% in group 2. In the medium term local injection of steroid is more successful and 100 times less expensive than ESWT in the treatment of tennis elbow.

  5. Safety and efficacy of vardenafil versus sertraline in the treatment of premature ejaculation: a randomised, prospective and crossover study.

    Science.gov (United States)

    Mathers, M J; Klotz, T; Roth, S; Lümmen, G; Sommer, F

    2009-06-01

    We investigated safety and efficacy of vardenafil and sertraline in premature ejaculation (PE). Seventy-two men graded their primary PE on a scale of 0-8 (0 = almost never, 8 = almost always). Intravaginal ejaculatory latency time (IELT) was measured. Patients were included if they scored their PE as 4 or greater and their IELTs were less than 1.30 min. After 6 weeks of behavioural psychosexual therapy, 49 patients still had a PE of 4 or greater and an IELT less than 1.30 min and they were randomised: 6 weeks vardenafil (10 mg) or sertraline (50 mg). After a wash-out phase for 1 week, medication was changed in a cross-over design. Initially, all 72 men with PE received behavioural therapy. Twenty-three men were satisfied with treatment and excluded. The remaining 49 men graded their PE as 5.94 +/- 1.6 and IELT was 0.59 min and patients were randomised. Four men discontinued the study. Vardenafil improved PE grading: 2.7 +/- 2.1 (P IELT increased to 5.01 +/- 3.69 (P IELT 3.12 +/- 1.89 (P < 0.001) with sertraline. It is concluded that vardenafil and sertraline are useful agents in the pharmacological treatment of PE.

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

    Science.gov (United States)

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

    2015-11-01

    Existing approaches for the screening and treatment of asymptomatic bacteriuria in pregnancy are based on trials that were done more than 30 years ago. In this study, we reassessed the consequences of treated and untreated asymptomatic bacteriuria in pregnancy. In this multicentre prospective cohort study with an embedded randomised controlled trial, we screened women (aged ≥18 years) at eight hospitals and five ultrasound centres in the Netherlands with a singleton pregnancy between 16 and 22 weeks' gestation for asymptomatic bacteriuria. Screening was done with a single dipslide and two culture media. Dipslides were judged positive when the colony concentration was at least 1×10(5) colony-forming units (CFU) per mL of a single microorganism or when two different colony types were present but one had a concentration of at least 1×10(5) CFU per mL. Asymptomatic bacteriuria-positive women were eligible to participate in the randomised controlled trial comparing nitrofurantoin with placebo treatment. In this trial, participants were randomly assigned 1:1 to receive either nitrofurantoin 100 mg or identical placebo tablets, and were instructed to self-administer these tablets twice daily for 5 consecutive days. Randomisation was done by a web-based application with a computer-generated list with random block sizes of two, four, or six participants rendered by an independent data manager. 1 week after the end of treatment, they provided us with a follow-up dipslide. Women, treating physicians, and researchers all remained unaware of the bacteriuria status and treatment allocation. Women who refused to participate in the randomised controlled trial did not receive any antibiotics, but their outcomes were collected for analysis in the cohort study. We compared untreated and placebo-treated asymptomatic bacteriuria-positive women with asymptomatic bacteriuria-negative women and nitrofurantoin-treated asymptomatic bacteriuria-positive women. The primary endpoint was a

  7. A prospective, randomised comparative study of weekly versus biweekly application of dehydrated human amnion/chorion membrane allograft in the management of diabetic foot ulcers

    Science.gov (United States)

    Zelen, Charles M; Serena, Thomas E; Snyder, Robert J

    2014-01-01

    The aim of this study is to determine if weekly application of dehydrated human amnion/chorion membrane allograft reduce time to heal more effectively than biweekly application for treatment of diabetic foot ulcers. This was an institutional review board-approved, registered, prospective, randomised, comparative, non-blinded, single-centre clinical trial. Patients with non-infected ulcers of ≥ 4 weeks duration were included for the study. They were randomised to receive weekly or biweekly application of allograft in addition to a non-adherent, moist dressing with compressive wrapping. All wounds were offloaded. The primary study outcome was mean time to healing. Overall, during the 12-week study period, 92·5% (37/40) ulcers completely healed. Mean time to complete healing was 4·1 ± 2·9 versus 2·4 ± 1·8 weeks (P = 0·039) in the biweekly versus weekly groups, respectively. Complete healing occurred in 50% versus 90% by 4 weeks in the biweekly and weekly groups, respectively (P = 0·014). Number of grafts applied to healed wounds was similar at 2·4 ± 1·5 and 2·3 ± 1·8 for biweekly versus weekly groups, respectively (P = 0·841). These results validate previous studies showing that the allograft is an effective treatment for diabetic ulcers and show that wounds treated with weekly application heal more rapidly than with biweekly application. More rapid healing may decrease clinical operational costs and prevent long-term medical complications. PMID:24618401

  8. Comparison of calcium alginate and carboxymethyl cellulose for nasal packing after endoscopic sinus surgery: a prospective, randomised, controlled single-blinded trial.

    Science.gov (United States)

    Park, D-Y; Chung, H J; Sim, N S; Jo, K H; Kim, D H; Kim, C-H; Yoon, J-H

    2016-06-01

    Calcium alginate is a biodegradable gel-transforming agent widely used for nasal packing. It can reduce pain and improve comfort. However, few randomised controlled trials have compared the efficacy of calcium alginate nasal packing with that of other biodegradable gel-transforming materials. Prospective, randomised, single-blinded controlled study. Yonsei University Severance Hospital, a tertiary academic medical centre. Twenty-seven patients (54 nostrils) with chronic rhinosinusitis who were scheduled for bilateral endoscopic sinus surgery were enrolled. After surgery, one nostril was packed with calcium alginate and the other with carboxymethyl cellulose. Only patients with an intersinus chronic rhinosinusitis severity score difference of ≤1 were included. Visual analogue scale (VAS) scores for postoperative pain, discomfort from nasal discharge and pain during packing removal were analysed. Two independent rhinologists who were blinded to the assessments separately scored adhesions, oedema and infection by endoscopic digital photography at 1, 4 and 8 weeks postoperatively. There were no significant differences in VAS scores for postoperative pain, discomfort from nasal discharge or pain during packing removal between calcium alginate packings and carboxymethyl cellulose packings. Inter-rater variability of adhesion, oedema and infection scores was acceptable. Adhesion severity and oedema scores at 4 weeks were significantly lower with calcium alginate packing than with carboxymethyl cellulose. Infection severity scores also tended to be lower with calcium alginate than with carboxymethyl cellulose, but the difference was not significant. Calcium alginate nasal packing is associated with reduced severity of oedema and adhesions after endoscopic sinus surgery. © 2015 John Wiley & Sons Ltd.

  9. Optimising exercise training in prevention and treatment of diastolic heart failure (OptimEx-CLIN): rationale and design of a prospective, randomised, controlled trial.

    Science.gov (United States)

    Suchy, Christiane; Massen, Lilian; Rognmo, Oivind; Van Craenenbroeck, Emeline M; Beckers, Paul; Kraigher-Krainer, Elisabeth; Linke, Axel; Adams, Volker; Wisløff, Ulrik; Pieske, Burkert; Halle, Martin

    2014-11-01

    Heart failure with preserved left ventricular ejection fraction (HFpEF) currently affects more than seven million Europeans and is the only cardiovascular disease increasing in prevalence and incidence. No pharmacological agent has yet been shown to improve symptoms or prognosis. The most promising way to improve pathophysiology and deprived exercise-tolerance in HFpEF patients seems to be exercise training, but the optimal approach and dose of exercise is still unknown. The major objective of the optimising exercise training in prevention and treatment of diastolic heart failure study (OptimEx-CLIN) is to define the optimal dose of exercise training in patients with HFpEF. In order to optimise adherence, supervision and economic aspects of exercise training a novel telemedical approach will be introduced and investigated. In a prospective randomised multi-centre study, 180 patients with stable symptomatic HFpEF will be randomised (1:1:1) to moderate intensity continuous training, high intensity interval training, or a control group. The training intervention includes three months supervised followed by nine months of telemedically monitored home-based training. The primary endpoint is change in exercise capacity, defined as change in peak oxygen uptake (VO2peak) after three months, assessed by cardiopulmonary exercise testing. Secondary endpoints include diastolic filling pressure (E/e') and further echocardiographic and cardiopulmonary exercise testing (CPX) parameters, biomarkers, quality of life and endothelial function. Training sessions and physical activity will be monitored and documented throughout the study with accelerometers and heart rate monitors developed on a telemedical platform for the OptimEx-CLIN study. Inclusion of patients started in July 2014, first results are expected in 2017. © Authors 2014 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav.

  10. Radiographic results after plaster cast fixation for 10 days versus 1 month in reduced distal radius fractures: a prospective randomised study.

    Science.gov (United States)

    Christersson, Albert; Larsson, Sune; Östlund, Bengt; Sandén, Bengt

    2016-11-21

    The aim of this study was to examine whether reduced distal radius fractures can be treated with early mobilisation without affecting the radiographic results. In a prospective randomised study, 109 patients (mean age 65.8 (range 50-92)) with moderately displaced distal radius fractures were treated with closed reduction and plaster cast fixation for about 10 days (range 8-13 days) followed by randomisation to one of two groups: early mobilisation (n = 54, active group) or continued plaster cast fixation for another 3 weeks (n = 55, control group). For three patients in the active group (6%), treatment proved unsuccessful because of severe displacement of the fracture (n = 2) or perceived instability (n = 1). From 10 days to 1 month, i.e. the only period when the treatment differed between the two groups, the active group displaced significantly more in dorsal angulation (4.5°, p < 0.001), radial angulation (2.0°, p < 0.001) and axial compression (0.5 mm, p = 0.01) compared with the control group. However, during the entire study period (i.e. from admission to 12 months), the active group displaced significantly more than the controls only in radial angulation (3.2°, p = 0.002) and axial compression (0.7 mm, p = 0.02). Early mobilisation 10 days after reduction of moderately displaced distal radius fractures resulted in both an increased number of treatment failures and increased displacement in radial angulation and axial compression as compared with the control group. Mobilisation 10 days after reduction cannot be recommended for the routine treatment of reduced distal radius fractures. ClinicalTrail.gov, NCT02798614 . Retrospectively registered 16 June 2016.

  11. A prospective randomised study of anatomical single-bundle versus double-bundle anterior cruciate ligament reconstruction: quantitative evaluation using an electromagnetic measurement system.

    Science.gov (United States)

    Araki, Daisuke; Kuroda, Ryosuke; Kubo, Seiji; Fujita, Norifumi; Tei, Katsumasa; Nishimoto, Koji; Hoshino, Yuichi; Matsushita, Takehiko; Matsumoto, Tomoyuki; Nagamune, Koki; Kurosaka, Masahiro

    2011-03-01

    We conducted a prospective randomised study of anatomical single-bundle (A-SB group) versus double-bundle (A-DB group) anterior cruciate ligament (ACL) reconstruction using the hamstrings tendons. Twenty patients with unilateral ACL deficiency were randomised into two groups. We created the bone tunnels at the position of the original insertion of the anteromedial bundle footprint and posterolateral bundle footprint in the A-DB group and at the central position between these two bundles in the A-SB group. All of the patients were tested before ACL reconstruction and one year after surgery. The KT-1000 measurements, isokinetic muscle peak torque and heel-height difference were evaluated and the general knee condition was assessed by Lysholm score. For pre- and postoperative stability assessment, we used the six-degrees-of-freedom of knee kinematic measurement system using an electromagnetic device (the EMS) for quantitative assessment during the Lachman test and the pivot shift test. There were no significant differences in the KT-1000 measurements, isokinetic muscle peak torque, heel-height difference, and Lysholm score at one-year follow-up between these two groups. The EMS data showed there were significant differences in the acceleration of the pivot shift test between the operated knee and the contralateral normal knees in the A-SB group. In conclusion, clinical outcomes were equally good in both groups. However, the EMS data showed the anatomical double-bundle ACL reconstruction tended to be biomechanically superior to the single-bundle reconstruction.

  12. A pollen extract (Cernilton) in patients with inflammatory chronic prostatitis-chronic pelvic pain syndrome: a multicentre, randomised, prospective, double-blind, placebo-controlled phase 3 study.

    Science.gov (United States)

    Wagenlehner, Florian M E; Schneider, Henning; Ludwig, Martin; Schnitker, Jörg; Brähler, Elmar; Weidner, Wolfgang

    2009-09-01

    National Institutes of Health (NIH) category III prostatitis/chronic pelvic pain syndrome (CP/CPPS) is a prevalent condition for which no standardised treatment exists. To assess the safety and efficacy of a standardised pollen extract in men with inflammatory CP/CPPS. We conducted a multicentre, prospective, randomised, double-blind, placebo-controlled phase 3 study comparing the pollen extract (Cernilton) to placebo in men with CP/CPPS (NIH IIIA) attending urologic centres. Participants were randomised to receive oral capsules of the pollen extract (two capsules q8h) or placebo for 12 wk. The primary endpoint of the study was symptomatic improvement in the pain domain of the NIH Chronic Prostatitis Symptom Index (NIH-CPSI). Participants were evaluated using the NIH-CPSI individual domains and total score, the number of leukocytes in post-prostatic massage urine (VB3), the International Prostate Symptom Score (IPSS), and the sexuality domain of a life satisfaction questionnaire at baseline and after 6 and 12 wk. In the intention-to-treat analysis, 139 men were randomly allocated to the pollen extract (n=70) or placebo (n=69). The individual domains pain (p=0.0086) and quality of life (QoL; p=0.0250) as well as the total NIH-CPSI score (p=0.0126) were significantly improved after 12 wk of treatment with pollen extract compared to placebo. Response, defined as a decrease of the NIH-CPSI total score by at least 25% or at least 6 points, was seen in the pollen extract versus placebo group in 70.6% and 50.0% (p=0.0141), respectively. Adverse events were minor in all patients studied. Compared to placebo, the pollen extract significantly improved total symptoms, pain, and QoL in patients with inflammatory CP/CPPS without severe side-effects.

  13. PROSPECTIVE RANDOMISED CONTROL STUDY OF POST OP EPIDURAL ANALGESIA WITH BUPIVACAINE AND FENTANYL VS. BUPIVACAINE AND CLONIDINE

    Directory of Open Access Journals (Sweden)

    Rachana

    2014-07-01

    Full Text Available The aim of the study was to compare the relative potencies and clinical characteristics of epidural Clonidine and Fentanyl with Bupivacaine in lower limb and lower abdominal surgeries using patient-controlled analgesia. In a randomised double-blinded study, 60 ASA I or II patients requiring epidural analgesia for post- operative pain relief were allocated to receive either 0.125% Bupivacaine with Clonidine 1µg/kg or 0.125% Bupivacaine with Fentanyl 1µg/kg via a sterile syringe by trained anaesthesiologists. Analgesia was established with 10-15 ml bolus of study solution. There were significant differences in onset time, duration and quality of analgesia, local anaesthetic consumption, between the two groups. We conclude that 0.125% Bupivacaine with Clonidine 1µg/kg group of patients clinically had better quality of analgesia and for a longer duration in comparison with patients receiving 0.125% Bupivacaine with Fentanyl 1µg/kg.

  14. Comparative evaluation of propofol, sevoflurane and desflurane for neuroanaesthesia: A prospective randomised study in patients undergoing elective supratentorial craniotomy

    Science.gov (United States)

    Bastola, Priska; Bhagat, Hemant; Wig, Jyotsna

    2015-01-01

    Background and Aims: Both inhalational and intravenous anaesthetic agents are being used for neuroanaesthesia. Clinical trials comparing “propofol and sevoflurane” and “desflurane and sevoflurane” have been published. However, the comparison of all the three anaesthetics in neurosurgical patients has not been done. A randomised clinical study was carried out comparing propofol, sevoflurane and desflurane to find the ideal neuroanaesthetic agent. Methods: A total of 75 adult patients undergoing elective craniotomy for supratentorial tumours were included in the study. The patients were induced with morphine 0.1 mg/kg and thiopentone 4-6 mg/kg. Neuromuscular blockade was facilitated with vecuronium. The patients were randomised to receive propofol, sevoflurane or desflurane along with nitrous oxide in oxygen for maintenance of anaesthesia. The neuromuscular blockade was reversed following the surgery once the patients opened eyes or responded to verbal commands. The three anaesthetics were compared for their effects on haemodynamics, brain relaxation and emergence characteristics. Results: The mean arterial blood pressure during anaesthesia was comparable among the groups. The patients receiving sevoflurane had faster heart rates intraoperatively when compared to desflurane (P 0.05). The time to response to verbal commands were significantly prolonged with use of sevoflurane (8.0 ± 2.9 min) when compared to propofol (5.3 ± 2.9 min) and desflurane (5.2 ± 2.6 min) (P = 0.003). However, the time to emergence and the number of patients who had early emergence ( 0.05). The quality of emergence (coughing and emergence agitation), as well as postoperative complications, were also comparable among the three groups. Conclusions: All the three anaesthetic agents-propofol, sevoflurane and desflurane appear comparable and acceptable with regard to their clinical profile during anaesthesia in patients undergoing elective supratentorial surgeries. PMID:26019353

  15. Comparative evaluation of propofol, sevoflurane and desflurane for neuroanaesthesia: A prospective randomised study in patients undergoing elective supratentorial craniotomy

    Directory of Open Access Journals (Sweden)

    Priska Bastola

    2015-01-01

    Full Text Available Background and Aims: Both inhalational and intravenous anaesthetic agents are being used for neuroanaesthesia. Clinical trials comparing "propofol and sevoflurane" and "desflurane and sevoflurane" have been published. However, the comparison of all the three anaesthetics in neurosurgical patients has not been done. A randomised clinical study was carried out comparing propofol, sevoflurane and desflurane to find the ideal neuroanaesthetic agent. Methods: A total of 75 adult patients undergoing elective craniotomy for supratentorial tumours were included in the study. The patients were induced with morphine 0.1 mg/kg and thiopentone 4-6 mg/kg. Neuromuscular blockade was facilitated with vecuronium. The patients were randomised to receive propofol, sevoflurane or desflurane along with nitrous oxide in oxygen for maintenance of anaesthesia. The neuromuscular blockade was reversed following the surgery once the patients opened eyes or responded to verbal commands. The three anaesthetics were compared for their effects on haemodynamics, brain relaxation and emergence characteristics. Results: The mean arterial blood pressure during anaesthesia was comparable among the groups. The patients receiving sevoflurane had faster heart rates intraoperatively when compared to desflurane (P 0.05. The time to response to verbal commands were significantly prolonged with use of sevoflurane (8.0 ± 2.9 min when compared to propofol (5.3 ± 2.9 min and desflurane (5.2 ± 2.6 min (P = 0.003. However, the time to emergence and the number of patients who had early emergence ( 0.05. The quality of emergence (coughing and emergence agitation, as well as postoperative complications, were also comparable among the three groups. Conclusions: All the three anaesthetic agents-propofol, sevoflurane and desflurane appear comparable and acceptable with regard to their clinical profile during anaesthesia in patients undergoing elective supratentorial surgeries.

  16. Prospective randomised controlled trial of nanocrystalline silver dressing versus plain gauze as the initial post-debridement management of military wounds on wound microbiology and healing.

    Science.gov (United States)

    Fries, C A; Ayalew, Y; Penn-Barwell, J G; Porter, K; Jeffery, S L A; Midwinter, M J

    2014-07-01

    Recent conflicts have been characterised by the use of improvised explosive devices causing devastating injuries, including heavily contaminated wounds requiring meticulous surgical debridement. After being rendered surgical clean, these wounds are dressed and the patient transferred back to the UK for on-going treatment. A dressing that would prevent wounds from becoming colonised during transit would be desirable. The aim of this study was to establish whether using nanocrystalline silver dressings, as an adjunct to the initial debridement, would positively affect wound microbiology and wound healing compared to standard plain gauze dressings. Patients were prospectively randomised to receive either silver dressings, in a nanocrystalline preparation (Acticoat™), or standard of care dressings (plain gauze) following their initial debridement in the field hospital. On repatriation to the UK microbiological swabs were taken from the dressing and the wound, and an odour score recorded. Wounds were followed prospectively and time to wound healing was recorded. Additionally, patient demographic data were recorded, as well as the mechanism of injury and Injury Severity Score. 76 patients were recruited to the trial between February 2010 and February 2012. 39 received current dressings and 37 received the trial dressings. Eleven patients were not swabbed. There was no difference (p=0.1384, Fishers) in the primary outcome measure of wound colonisation between the treatment arm (14/33) and the control arm (20/32). Similarly time to wound healing was not statistically different (p=0.5009, Mann-Whitney). Wounds in the control group were scored as being significantly more malodorous (p=0.002, Mann-Whitney) than those in the treatment arm. This is the first randomised controlled trial to report results from an active theatre of war. Performing research under these conditions poses additional challenges to military clinicians. Meticulous debridement of wounds remains the

  17. Effect of oronasopharyngeal suction on arterial oxygen saturation in normal, term infants delivered vaginally: a prospective randomised controlled trial.

    Science.gov (United States)

    Modarres Nejad, V; Hosseini, R; Sarrafi Nejad, A; Shafiee, G

    2014-07-01

    Oronasopharyngeal suction (ONPS) with a suction bulb at birth is a traditional practice in the initial management of healthy infants in Iran and many other countries. The purpose of this study was to compare the effects of oronasopharyngeal suction (ONPS) with those of no suction in normal, term newborns delivered vaginally. A total of 170 healthy term infants of first and single uncomplicated pregnancies, with clear amniotic fluid, vaginal delivery and cephalic presentation, enrolled in the trial during labour. Newborns were randomised into one of the two groups, according to the use of the ONPS procedure. Arterial oxygen saturation (SaO2) levels, heart rates, blood gases of umbilical cord and Apgar scores were determined. The mean SaO2 values over the first and fifth min of birth were similar in the two groups. The maximum time to reach SaO2 of ≥ 92% was shorter in the no suction group. There were no statistically significant differences in the mean of heart rates, respiratory rates and Apgar scores between the groups. Apgar scores at 5 and 10 min were between 8 and 10 for all infants, respectively. Newborns receiving suction showed a statistically significant, lower mean partial carbon dioxide pressure (PCO2) and a significantly higher partial oxygen pressure (PO2) of umbilical artery. Although the differences were statistically significant, these were not considered clinically significant because values remained within normal ranges. According to this study, ONPS is not recommended as a routine procedure in normal, term infants delivered vaginally.

  18. A prospective randomised controlled study on efficacies of acupuncture and steroid in treatment of idiopathic peripheral facial paralysis.

    Science.gov (United States)

    Tong, Fu Man; Chow, Shun Kit; Chan, Patrick Yiu Bong; Wong, Alex Kam Wah; Wan, Sambo Shuk Ying; Ng, Rebecca Ka Wah; Chan, Geoffrey; Chan, Wing Shan; Ng, Angela; Law, Chi Keung

    2009-12-01

    A randomised controlled trial was undertaken to evaluate the efficacy of acupuncture in comparison with steroid in treatment of idiopathic peripheral facial paralysis (Bell's palsy). A total of 119 patients attending Ear, Nose and Throat Clinic of Pamela Youde Nethersole Eastern Hospital from February 2003 to December 2005 were randomly allocated to groups of acupuncture, steroid and control (conventional expectant treatment). There were 53 in the steroid group, 28 in the acupuncture group and 38 in the control group. Patients were assessed weekly by blinded assessors, using the House-Brackmann facial nerve grading system. The efficacy of treatment in three groups was compared, in terms of degree of recovery and speed of recovery. Intention-to-treat analyses were performed. Results were analysed with SPSS software. Distribution of initial grade on presentation was analysed with the Pearson chi-square test and showed uneven distribution in the three groups in the intention-to-treat analysis. The overall improvement (grade 3 or better) was 86.9% in the steroid group, 96.4% in the acupuncture group and 89.5% in the control group respectively. However, the difference in degree of recovery and speed of recovery in the three groups was not statistically significant. The efficacies of acupuncture, steroid and conventional expectant treatment (natural course of recovery) in idiopathic peripheral facial palsy (Bell's palsy) in the study were the same with respect to the degree of recovery and speed of recovery.

  19. Segmental mobility, disc height and patient-reported outcomes after surgery for degenerative disc disease: a prospective randomised trial comparing disc replacement and multidisciplinary rehabilitation.

    Science.gov (United States)

    Johnsen, L G; Brinckmann, P; Hellum, C; Rossvoll, I; Leivseth, G

    2013-01-01

    This prospective multicentre study was undertaken to determine segmental movement, disc height and sagittal alignment after total disc replacement (TDR) in the lumbosacral spine and to assess the correlation of biomechanical properties to clinical outcomes.A total of 173 patients with degenerative disc disease and low back pain for more than one year were randomised to receive either TDR or multidisciplinary rehabilitation (MDR). Segmental movement in the sagittal plane and disc height were measured using distortion compensated roentgen analysis (DCRA) comparing radiographs in active flexion and extension. Correlation analysis between the range of movement or disc height and patient-reported outcomes was performed in both groups. After two years, no significant change in movement in the sagittal plane was found in segments with TDR or between the two treatment groups. It remained the same or increased slightly in untreated segments in the TDR group and in this group there was a significant increase in disc height in the operated segments. There was no correlation between segmental movement or disc height and patient-reported outcomes in either group.In this study, insertion of an intervertebral disc prosthesis TDR did not increase movement in the sagittal plane and segmental movement did not correlate with patient-reported outcomes. This suggests that in the lumbar spine the movement preserving properties of TDR are not major determinants of clinical outcomes.

  20. The Effects of Clinical Hypnosis versus Neurolinguistic Programming (NLP) before External Cephalic Version (ECV): A Prospective Off-Centre Randomised, Double-Blind, Controlled Trial.

    Science.gov (United States)

    Reinhard, Joscha; Peiffer, Swati; Sänger, Nicole; Herrmann, Eva; Yuan, Juping; Louwen, Frank

    2012-01-01

    Objective. To examine the effects of clinical hypnosis versus NLP intervention on the success rate of ECV procedures in comparison to a control group. Methods. A prospective off-centre randomised trial of a clinical hypnosis intervention against NLP of women with a singleton breech fetus at or after 37(0/7) (259 days) weeks of gestation and normal amniotic fluid index. All 80 participants heard a 20-minute recorded intervention via head phones. Main outcome assessed was success rate of ECV. The intervention groups were compared with a control group with standard medical care alone (n = 122). Results. A total of 42 women, who received a hypnosis intervention prior to ECV, had a 40.5% (n = 17), successful ECV, whereas 38 women, who received NLP, had a 44.7% (n = 17) successful ECV (P > 0.05). The control group had similar patient characteristics compared to the intervention groups (P > 0.05). In the control group (n = 122) 27.3% (n = 33) had a statistically significant lower successful ECV procedure than NLP (P = 0.05) and hypnosis and NLP (P = 0.03). Conclusions. These findings suggest that prior clinical hypnosis and NLP have similar success rates of ECV procedures and are both superior to standard medical care alone.

  1. Evaluation of a diclofenac transdermal patch for the attenuation of venous cannulation pain: a prospective, randomised, double-blind, placebo-controlled study.

    Science.gov (United States)

    Agarwal, A; Dhiraaj, S; Kumar, A; Singhal, V; Singh, U

    2006-04-01

    Venous cannulation, although a minor procedure, is often painful. The present study was planned to evaluate the efficacy of a diclofenac transdermal patch placed over the venepuncture site in decreasing the pain of cannulation. Seventy-two adults undergoing elective surgery were included in this randomised, prospective, double-blind, placebo-controlled study. Patients were divided into three equal groups. The Control group had a placebo adhesive patch placed on the both the dorsum of hand and the buttock; the Diclofenac-Buttock group had a placebo patch placed on the dorsum of the hand and a diclofenac transdermal patch on the buttock; the Diclofenac-Hand group had a diclofenac transdermal patch placed on the dorsum of hand and a placebo patch on the buttock. The patches were applied 1 h before cannulation. An 18G cannula was used for all venous cannulations. Pain during cannulation was assessed on a non-graduated 10-cm visual analogue scale. Median [interquartile range] pain scores were 3.0 [2.0-4.0] in the Diclofenac-Hand group, 5.0 [4.3-7.8] in the Diclofenac-Buttock group and 6.5 [4.5-7.0] in the Control group, p Diclofenac-Buttock and Diclofenac-Hand groups, respectively. The application of a diclofenac transdermal patch at the cannulation site appears to be effective in decreasing cannulation pain.

  2. Cistus incanus (CYSTUS052) for treating patients with infection of the upper respiratory tract. A prospective, randomised, placebo-controlled clinical study.

    Science.gov (United States)

    Kalus, Ulrich; Grigorov, Alexandre; Kadecki, Oliver; Jansen, Jan-Peter; Kiesewetter, Holger; Radtke, Hartmut

    2009-12-01

    In this prospective, randomized, placebo-controlled clinical study we aimed to investigate the clinical effect of a Cistus extract (CYSTUS052) in 160 patients with infections of the upper respiratory tract. The extract contains a high percentage of highly polymeric polyphenols. In cell culture and in a mouse model it exerts antiviral and antimicrobial activities. Principal active constituents of the genus Cistus are polyphenolic compounds. Plant-derived polyphenols have been shown to be strong antioxidants with potential health benefits. Various reports have appeared on the antiviral and antibacterial potential, including several reports describing the antiviral activity of polyphenols against influenza virus. Clinical studies on the effectiveness of Cistus incanus are scarce. Only one controlled application observation study demonstrated the effectiveness of a Cistus extract. The present randomised, placebo-controlled clinical study was designed to compare the symptom scores in patients with common cold treated either with CYSTUS052 or with placebo. A score of subjective symptoms decreased significantly over the course of treatment with Cistus, whereas treatment with placebo resulted in a less distinct decrease of symptoms. Among the inflammatory markers investigated, the C-reactive protein was mostly affected by Cistus and decreased significantly in the treatment group.

  3. Effectiveness of telemedicine and distance learning applications for patients with chronic heart failure. A protocol for prospective parallel group non-randomised open label study.

    Science.gov (United States)

    Vanagas, Giedrius; Umbrasiene, Jelena; Slapikas, Rimvydas

    2012-01-01

    Chronic heart failure in Baltic Sea Region is responsible for more hospitalisations than all forms of cancer combined and is one of the leading causes of hospitalisations in elderly patients. Frequent hospitalisations, along with other direct and indirect costs, place financial burden on healthcare systems. We aim to test the hypothesis that telemedicine and distance learning applications is superior to the current standard of home care. Prospective parallel group non-randomised open label study in patients with New York Heart Association (NYHA) II-III chronic heart failure will be carried out in six Baltic Sea Region countries. The study is organised into two 6-month follow-up periods. The first 6-month period is based on active implementation of tele-education and/or telemedicine for patients in two groups (active run period) and one standard care group (passive run period). The second 6-month period of observation will be based on standard care model (passive run period) to all three groups. Our proposed practice change is based on translational research with empirically supported interventions brought to practice and aims to find the home care model that is most effective to patient needs. This study has been approved by National Bioethics Committee (2011-03-07; Registration No: BE-2-11). This study has been registered in Australian New Zealand Clinical Trials Registry (ANZCTR) with registration number ACTRN12611000834954.

  4. Prospective randomised comparison of diagnostic confidence and image quality with normal-dose and low-dose CT pulmonary angiography at various body weights

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    Szucs-Farkas, Zsolt [University Hospital Bern, University Institute of Diagnostic, Interventional and Paediatric Radiology, Inselspital, Berne (Switzerland); Hospital Centre of Biel, Institute of Radiology, Biel/Bienne (Switzerland); Megyeri, Boglarka [University of Debrecen, Health and Medical Science Centre, Department of Anaesthesiology and Intensive Care, Debrecen (Hungary); Christe, Andreas; Vock, Peter; Heverhagen, Johannes T. [University Hospital Bern, University Institute of Diagnostic, Interventional and Paediatric Radiology, Inselspital, Berne (Switzerland); Schindera, Sebastian T. [University Hospital Bern, University Institute of Diagnostic, Interventional and Paediatric Radiology, Inselspital, Berne (Switzerland); University Hospital Basel, Department of Radiology, Basel (Switzerland)

    2014-08-15

    To find a threshold body weight (BW) below 100 kg above which computed tomography pulmonary angiography (CTPA) using reduced radiation and a reduced contrast material (CM) dose provides significantly impaired quality and diagnostic confidence compared with standard-dose CTPA. In this prospectively randomised study of 501 patients with suspected pulmonary embolism and BW <100 kg, 246 were allocated into the low-dose group (80 kVp, 75 ml CM) and 255 into the normal-dose group (100 kVp, 100 ml CM). Contrast-to-noise ratio (CNR) in the pulmonary trunk was calculated. Two blinded chest radiologists independently evaluated subjective image quality and diagnostic confidence. Data were compared between the normal-dose and low-dose groups in five BW subgroups. Vessel attenuation did not differ between the normal-dose and low-dose groups within each BW subgroup (P = 1.0). The CNR was higher with the normal-dose compared with the low-dose protocol (P < 0.006) in all BW subgroups except for the 90-99 kg subgroup (P = 0.812). Subjective image quality and diagnostic confidence did not differ between CT protocols in all subgroups (P between 0.960 and 1.0). Subjective image quality and diagnostic confidence with 80 kVp CTPA is not different from normal-dose protocol in any BW group up to 100 kg. (orig.)

  5. A prospective randomised study comparing a GnRH-antagonist versus a GnRH-agonist short protocol for ovarian stimulation in patients referred for IVF.

    Science.gov (United States)

    Gordts, S; Van Turnhout, C; Campo, R; Puttemans, P; Valkenburg, M; Gordts, S

    2012-01-01

    To compare two short protocols for ovarian stimulation in IVF cycles using an antagonist and an agonist short protocol. The outcomes studied were dosis rec FSH needed, days of stimulation, number of oocytes retrieved and pregnancy outcome. A prospective randomised study design. first or second IVF attempt in women younger than 40 years. In the agonist protocol (Suprefact®) nasal spray was used. In the antagonist protocol (Orgalutran)® was started as soon as at least 1 follicle of 12 mm was visualized on ultrasound. 160 cycles were included in the study: 80 in the antagonist group and 80 in the agonist group. A higher dosis of recombinant FSH (rec FSH) was used for stimulation in the antagonist group (1897 IU versus 1655 IU). Pregnancy rate per ET in the antagonist group was 37% with an ongoing pregnancy rate of 21%/ET and an -implantation rate of 22%; versus respectively 39%, 20% and 22% in the agonist treated group. Live birth rate per started cylce was 19% in the antagonist group versus 20% in the agonist group. This study shows that implantation rates, ongoing pregnancy rates and live birth rates are equal in both groups. An identical number of oocytes was retrieved, with no difference in duration of the stimulation although a higher dosis of rec FSH was needed in the antagonist group.

  6. The Effects of Clinical Hypnosis versus Neurolinguistic Programming (NLP before External Cephalic Version (ECV: A Prospective Off-Centre Randomised, Double-Blind, Controlled Trial

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    Joscha Reinhard

    2012-01-01

    Full Text Available Objective. To examine the effects of clinical hypnosis versus NLP intervention on the success rate of ECV procedures in comparison to a control group. Methods. A prospective off-centre randomised trial of a clinical hypnosis intervention against NLP of women with a singleton breech fetus at or after 370/7 (259 days weeks of gestation and normal amniotic fluid index. All 80 participants heard a 20-minute recorded intervention via head phones. Main outcome assessed was success rate of ECV. The intervention groups were compared with a control group with standard medical care alone (=122. Results. A total of 42 women, who received a hypnosis intervention prior to ECV, had a 40.5% (=17, successful ECV, whereas 38 women, who received NLP, had a 44.7% (=17 successful ECV (>0.05. The control group had similar patient characteristics compared to the intervention groups (>0.05. In the control group (=122 27.3% (=33 had a statistically significant lower successful ECV procedure than NLP (=0.05 and hypnosis and NLP (=0.03. Conclusions. These findings suggest that prior clinical hypnosis and NLP have similar success rates of ECV procedures and are both superior to standard medical care alone.

  7. Effect of discontinuing morning dose of antihypertensive for renal transplant surgery on haemodynamic and early graft functioning: A prospective, double-blind, randomised study

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    Kumar, Vinod; Arya, Virendra Kumar; Sondekoppam, Rakesh V; Arora, Suman; Minz, Mukut; Garg, Rakesh; Gupta, Nishkarsh

    2017-01-01

    Background and Aims: Antihypertensive drugs are continued until the day of renal transplant surgery. These are associated with increased incidence of hypotension and bradycardia. Hence, this study was designed to evaluate perioperative haemodynamic and early graft functioning in renal recipients with discontinuation of antihypertensive drugs on the morning of surgery. Methods: This prospective, randomised, double-blind study recruited 120 patients. Group 1 patients received placebo tablet while Group 2 patients received usual antihypertensive drugs on the day of surgery. Perioperative haemodynamics and time for reinstitution of antihypertensives were the primary outcome measures. The secondary outcome measures were need for inotropic support and graft function. Perioperative haemodynamics were analysed using ANOVA and Student's t-tests with Bonferroni correction. Fischer's exact test was used for analysis. Results: Systolic blood pressure (SBP) declined, which was more in Group 2. Forty-one patients developed significant hypotension; a correlation was found between the maximum observed hypotension and number of antihypertensive medications (P = 0.003). Four cases had slow graft function (one in Group 1 and three in Group 2). Twenty-eight patients in Group 2 required mephentermine boluses to maintain their SBP compared to 13 patients in Group 1 (P drugs can be omitted on the morning of surgery without any haemodynamic fluctuations and graft function in controlled hypertensive end-stage renal disease renal transplant patients receiving a combined epidural and general anaesthesia.

  8. [Analgesic efficacy of TENS therapy in patients with gonarthrosis. A prospective, randomised, placebo-controlled, double-blind study].

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    Gschiel, B; Kager, H; Pipam, W; Weichart, K; Likar, R

    2010-09-01

    The goal of the study was to substantiate the influence of TENS on pain development and medication needs of patients with proven gonarthrosis and chronic pain. The study included a 3-week stimulation period and 2-week observation period after the end of stimulation. Patients (at least 20 per group) were assigned to either an active treatment group or placebo group in a randomised, double-blind, placebo-controlled trial. For the active treatment group the TENS therapy device with HAN stimulation (alternating phase of stimulation) was used (TENStem eco).Total length of time: 30 min at least two times a day. The length of therapy was 3 weeks (therapy), followed by an observation period of 2 weeks (follow-up). The total length of the study was 5 weeks, whereby at the beginning and at the end of weeks 1, 3 and 5 the SF-36, WOMAC score and Lysholm score were documented; the pain score was documented daily. There are no significant demographic differences between the groups. In the active treatment group there was clear relief in pain intensity in the morning, midday and evening over the 3-week period of therapy. The Lysholm score in the active treatment group was 53.4 at the beginning, 90 after 1 week, 94.5 after the third week and 91 by the fifth week (significant difference). There were no side effects. TENS therapy with HAN stimulation resulted in pain relief in patients with gonarthrosis during the therapy period with TENS, but the pain relief did not last beyond the end of the TENS therapy. There was an improvement in the Lysholm score and the WOMAC score during the therapy. This improvement remained over the following 2-week period of observation without further TENS therapy. TENS therapy is a simple and effective method to treat gonarthrosis with very few side effects.

  9. Addition of sub-anaesthetic dose of ketamine reduces gag reflex during propofol based sedation for upper gastrointestinal endoscopy: A prospective randomised double-blind study

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    Manish Tandon

    2014-01-01

    Full Text Available Background and Aims: Gag reflex is unwanted during upper gastrointestinal endoscopy (UGIE. Experimental studies have demonstrated that N-methyl-D-aspartate receptor antagonism prevents gag reflex. We conducted a study to determine if sub-anaesthetic doses of ketamine, added to propofol, reduce the incidence of gag reflex. Methods: This prospective, randomised, double-blind and placebo-controlled study was done in a tertiary care hospital. A total of 270 patients undergoing UGIE, were randomised to propofol (P group (n = 135 or propofol plus ketamine (PK group (n = 135. All patients received propofol boluses titrated to Ramsay sedation score of not <4. Patients in PK group in addition received ketamine, 0.15 mg/kg immediately before the first-propofol dose. Top-up doses of propofol were given as required. Stata 11 software (StataCorp. was used to calculate the proportion of patients with gag reflex and the corresponding relative risk. Propofol consumed and time to recovery in the two groups was compared using Student′s t-test and Cox proportional hazards regression respectively. Results: Significantly, fewer patients in the PK group had gag reflex compared to the P group (3 vs. 23, risk ratio = 0.214, 95% confidence interval [CI], 0.07-0.62; P = 0.005. The incidence of hypotension (6 vs. 16, risk ratio = 0.519, 95% CI = 0.25-1.038; P = 0.06, number of required airway manoeuvres (4 vs. 19, risk ratio = 0.32, 95% CI = 0.13-0.74; P = 0.014, median time to recovery (4 min vs. 5 min, hazard ratio = 1.311, 95% CI = 1.029-1.671; P = 0.028 and propofol dose administered (152 mg vs. 167 mg, 95% CI = 4.74-24.55; P = 0.004 was also less in the PK group compared to the P group. Conclusion: Ketamine in sub-anaesthetic dose decreases gag reflex during UGIE.

  10. Hands-on time during cardiopulmonary resuscitation is affected by the process of teambuilding: a prospective randomised simulator-based trial

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    Breuer Marc

    2009-02-01

    Full Text Available Abstract Background Cardiac arrests are handled by teams rather than by individual health-care workers. Recent investigations demonstrate that adherence to CPR guidelines can be less than optimal, that deviations from treatment algorithms are associated with lower survival rates, and that deficits in performance are associated with shortcomings in the process of team-building. The aim of this study was to explore and quantify the effects of ad-hoc team-building on the adherence to the algorithms of CPR among two types of physicians that play an important role as first responders during CPR: general practitioners and hospital physicians. Methods To unmask team-building this prospective randomised study compared the performance of preformed teams, i.e. teams that had undergone their process of team-building prior to the onset of a cardiac arrest, with that of teams that had to form ad-hoc during the cardiac arrest. 50 teams consisting of three general practitioners each and 50 teams consisting of three hospital physicians each, were randomised to two different versions of a simulated witnessed cardiac arrest: the arrest occurred either in the presence of only one physician while the remaining two physicians were summoned to help ("ad-hoc", or it occurred in the presence of all three physicians ("preformed". All scenarios were videotaped and performance was analysed post-hoc by two independent observers. Results Compared to preformed teams, ad-hoc forming teams had less hands-on time during the first 180 seconds of the arrest (93 ± 37 vs. 124 ± 33 sec, P Conclusion Hands-on time and time to defibrillation, two performance markers of CPR with a proven relevance for medical outcome, are negatively affected by shortcomings in the process of ad-hoc team-building and particularly deficits in leadership. Team-building has thus to be regarded as an additional task imposed on teams forming ad-hoc during CPR. All physicians should be aware that early

  11. Efficacy of cognitive behavioural therapy for sleep improvement in patients with persistent delusions and hallucinations (BEST): a prospective, assessor-blind, randomised controlled pilot trial.

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    Freeman, Daniel; Waite, Felicity; Startup, Helen; Myers, Elissa; Lister, Rachel; McInerney, Josephine; Harvey, Allison G; Geddes, John; Zaiwalla, Zenobia; Luengo-Fernandez, Ramon; Foster, Russell; Clifton, Lei; Yu, Ly-Mee

    2015-11-01

    Sleep disturbance occurs in most patients with delusions or hallucinations and should be treated as a clinical problem in its own right. However, cognitive behavioural therapy (CBT)-the best evidence-based treatment for insomnia-has not been tested in this patient population. We aimed to pilot procedures for a randomised trial testing CBT for sleep problems in patients with current psychotic experiences, and to provide a preliminary assessment of potential benefit. We did this prospective, assessor-blind, randomised controlled pilot trial (Better Sleep Trial [BEST]) at two mental health centres in the UK. Patients (aged 18-65 years) with persistent distressing delusions or hallucinations in the context of insomnia and a schizophrenia spectrum diagnosis were randomly assigned (1:1), via a web-based randomisation system with minimisation to balance for sex, insomnia severity, and psychotic experiences, to receive either eight sessions of CBT plus standard care (medication and contact with the local clinical team) or standard care alone. Research assessors were masked to group allocation. Assessment of outcome was done at weeks 0, 12 (post-treatment), and 24 (follow-up). The primary efficacy outcomes were insomnia assessed by the Insomnia Severity Index (ISI) and delusions and hallucinations assessed by the Psychotic Symptoms Rating Scale (PSYRATS) at week 12. We did analysis by intention to treat, with an aim to provide confidence interval estimation of treatment effects. This study is registered with ISRCTN, number 33695128. Between Dec 14, 2012, and May 22, 2013, and Nov 7, 2013, and Aug 26, 2014, we randomly assigned 50 patients to receive CBT plus standard care (n=24) or standard care alone (n=26). The last assessments were completed on Feb 10, 2015. 48 (96%) patients provided follow-up data. 23 (96%) patients offered CBT took up the intervention. Compared with standard care, CBT led to reductions in insomnia in the large effect size range at week 12 (adjusted

  12. [Arthroscopic transcapsular iliopsoas tenotomy from the peripheral versus the central compartment in internal snapping hip syndrome. Short-term results of a prospective randomised study].

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    Zeman, P; Cibulková, J; Kormunda, S; Koudela, K; Nepraš, P; Matějka, J

    2013-01-01

    In this prospective randomised study, the short-term results of arthroscopic transcapsular iliopsoas tenotomy approached from the peripheral versus the central compartment for internal snapping hip syndrome are presented. A group of 19 patients (15 women and four men; mean age, 24.3 years) who underwent arthroscopic transcapsular iliopsoas tenotomy for internal snapping hip syndrome in the period between September 2010 and December 2011 were prospectively evaluated. No injury, hip surgery or feeling of hip instability was recorded in their personal histories. Radiographs did not show any dysplasia, retroversion of the acetabulum or cam lesions. The patients were allocated to two groups using sealed envelope randomisation: Group 1 patients (n=10) were treated by tenotomy from the peripheral compartment and group 2 patients (n=9) underwent tenotomy from the central compartment during traction of the lower extremity. The evaluation included pre-operative 3T MRI findings, arthroscopically detected intra-articular lesions, duration of traction and post-operative complications. The pre-operative WOMAC scores were compared with those at one-year follow-up. In comparison of the two groups, the Mann-Whitney exact test was used for WOMAC scores and Fisher's exact test for post-operative complications. Statistical significance was set at a 0.05 level. In comparing post-operative complications, a significant difference (p=0.0468) between the groups was found only for genital paresthesia, which did not occur in group 1. The other differences were not statistically significant. The pre-operative WOMAC scores did not differ significantly between the groups (p=0.79). The post-operative WOMAC scores were significantly higher in group 1 (p=0.02). In each group the change in WOMAC scores was different and was statistically significant in group 1 (p=0.0014). Associated intra-articular hip pathologies, most frequently synovitis of the peripheral compartment, acetabular chondropathy, or

  13. Cognitive behavioural therapy versus supportive therapy for persistent positive symptoms in psychotic disorders: The POSITIVE Study, a multicenter, prospective, single-blind, randomised controlled clinical trial

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    Sartory Gudrun

    2010-12-01

    Full Text Available Abstract Background It has been demonstrated that cognitive behavioural therapy (CBT has a moderate effect on symptom reduction and on general well being of patients suffering from psychosis. However, questions regarding the specific efficacy of CBT, the treatment safety, the cost-effectiveness, and the moderators and mediators of treatment effects are still a major issue. The major objective of this trial is to investigate whether CBT is specifically efficacious in reducing positive symptoms when compared with non-specific supportive therapy (ST which does not implement CBT-techniques but provides comparable therapeutic attention. Methods/Design The POSITIVE study is a multicenter, prospective, single-blind, parallel group, randomised clinical trial, comparing CBT and ST with respect to the efficacy in reducing positive symptoms in psychotic disorders. CBT as well as ST consist of 20 sessions altogether, 165 participants receiving CBT and 165 participants receiving ST. Major methodological aspects of the study are systematic recruitment, explicit inclusion criteria, reliability checks of assessments with control for rater shift, analysis by intention to treat, data management using remote data entry, measures of quality assurance (e.g. on-site monitoring with source data verification, regular query process, advanced statistical analysis, manualized treatment, checks of adherence and competence of therapists. Research relating the psychotherapy process with outcome, neurobiological research addressing basic questions of delusion formation using fMRI and neuropsychological assessment and treatment research investigating adaptations of CBT for adolescents is combined in this network. Problems of transfer into routine clinical care will be identified and addressed by a project focusing on cost efficiency. Discussion This clinical trial is part of efforts to intensify psychotherapy research in the field of psychosis in Germany, to contribute to the

  14. Treatment of postoperative pain after total hip arthroplasty: comparison between metamizol and paracetamol as adjunctive to opioid analgesics-prospective, double-blind, randomised study.

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    Oreskovic, Zrinka; Bicanic, Goran; Hrabac, Pero; Tripkovic, Branko; Delimar, Domagoj

    2014-05-01

    Metamizole use has been limited because of its risk of agranulocytosis. However, more recent literature seems to support its safety. This prospective, randomised, double-blind study was conducted to compare the analgesic effects of intravenous metamizole or intravenous paracetamol in combination with morphine PCA during the first 24 h following total hip arthroplasty. One hundred ten consecutive patients were selected for study. The two study groups were (A) metamizole, (B) paracetamol. Postoperative pain therapy was provided by Morphine PCA pump. In the first treatment group (A group), all patients received intravenous metamizole 1.5 g every 8 h during the first 24 postoperative hours. In the second treatment group (B group), all patients received intravenous paracetamol 1 g every 8 h during the first 24 postoperative hours. Postoperative pain intensity was measured 1, 2, 3, 4, 6, 8, 10, 14, 18, 22 h after the end of surgery by a VAS. Statistically significant differences in VAS pain values favoring metamizole were reported at 6-h (p = 0.038), 8-h (p = 0.036), 14-h (p = 0.011), 18-h (p metamizole and 30.6 for paracetamol. In this study, we have also shown excellent efficacy of paracetamol and metamizole combined with opioids, but metamizole proved to be a better analgesic than paracetamol. It is also necessary to mention the financial aspect considering that intravenous paracetamol is about ten times more expensive than an equivalent analgesic doses of intravenous metamizole.

  15. Comparison of analgesic efficacy of caudal dexmedetomidine versus caudal tramadol with ropivacaine in paediatric infraumbilical surgeries: A prospective, randomised, double-blinded clinical study.

    Science.gov (United States)

    Gupta, Savita; Sharma, Rashmi

    2017-06-01

    Caudal epidural analgesia is commonly practised regional block technique in children undergoing infraumbilical surgeries but has a short duration of action after single shot local anaesthetic injection. The aim of this study was to compare ropivacaine 0.25% with dexmedetomidine and tramadol in caudal anaesthesia in paediatric infraumbilical surgeries. In a randomised, prospective, double-blinded study, sixty children (1-8 years) belonging to American Society of Anesthesiologists' physical status I or II scheduled for infraumbilical surgeries were included. They were randomly assigned into two groups: Group ropivacaine with tramadol (RT) (n = 30) received 0.25% ropivacaine 1 mL/kg with 2 mg/kg of tramadol, and Group ropivacaine with dexmedetomidine (RD) (n = 30) received 0.25% ropivacaine 1 mL/kg with dexmedetomidine 2 μg/kg. The primary outcome variable was the duration of analgesia, and the secondary outcome variables included motor block, sedation score, time from caudal block to skin incision, emergence time and adverse effects. The mean duration of analgesia was 654.20 ± 78.38 min in Group RT, while in Group RD, it was 780.29 ± 71.21 min (P = 0.0001). The difference between the mean sedation score and mean emergence time between the two groups were statistically significant (P = 0.0001 and 0.0411, respectively). No significant difference was observed in the incidence of haemodynamic changes or side effects. Caudal dexmedetomidine with ropivacaine prolongs post-operative analgesia compared to caudal tramadol with ropivacaine.

  16. Effects of low and standard intra-abdominal pressure on systemic inflammation and immune response in laparoscopic adrenalectomy: A prospective randomised study

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    Mario Schietroma

    2016-01-01

    Full Text Available Background: The advantages of laparoscopic adrenalectomy (LA over open adrenalectomy are undeniable. Nevertheless, carbon dioxide (CO2 pneumoperitoneum may have an unfavourable effect on the local immune response. The aim of this study was to compare changes in the systemic inflammation and immune response in the early post-operative (p.o. period after LA performed with standard and low-pressure CO2pneumoperitoneum. Materials and Methods: We studied, in a prospective randomised study, 51 patients consecutively with documented adrenal lesion who had undergone a LA: 26 using standard-pressure (12-14 mmHg and 25 using low-pressure (6-8 mmHg pneumoperitoneum. White blood cells (WBC, peripheral lymphocyte subpopulation, human leucocyte antigen-DR (HLA-DR, neutrophil elastase, interleukin (IL-6 and IL-1, and C-reactive protein (CRP were investigated. Results: Significantly higher concentrations of neutrophil elastase, IL-6 and IL-1 and CRP were detected p.o. in the standard-pressure group of patients in comparison with the low-pressure group (P < 0.05. A statistically significant change in HLA-DR expression was recorded p.o. at 24 h, as a reduction of this antigen expressed on the monocyte surface in patients from the standard group; no changes were noted in low-pressure group patients (P < 0.05. Conclusions: This study demonstrated that reducing the pressure of the pneumoperitoneum to 6-8 mmHg during LA reduced p.o. inflammatory response and averted p.o. immunosuppression.

  17. Effect of intravenous GLutamine supplementation IN Trauma patients receiving enteral nutrition study protocol (GLINT Study): a prospective, blinded, randomised, placebo-controlled clinical trial.

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    Al Balushi, Ruqaiya M; Paratz, Jennifer D; Cohen, Jeremy; Banks, Merrilyn; Dulhunty, Joel; Roberts, Jason A; Lipman, Jeffrey

    2011-01-01

    Background Trauma patients are characterised by alterations in the immune system, increased exposure to infectious complications, sepsis and potentially organ failure and death. Glutamine supplementation to parenteral nutrition has been proven to be associated with improved clinical outcomes. However, glutamine supplementation in patients receiving enteral nutrition and its best route are still controversial. Previous trials have been limited by a small sample size, use of surrogate outcomes or a limited period of supplementation. The aim of this trial is to investigate if intravenous glutamine supplementation to trauma patients receiving enteral nutrition is associated with improved clinical outcomes in terms of decreased organ dysfunction, infectious complications and other secondary outcomes. Methods/design Eighty-eight critically ill patients with multiple trauma receiving enteral nutrition will be recruited in this prospective, triple-blind, block-randomised, placebo-controlled clinical trial to receive either 0.5 g/kg/day intravenous undiluted alanyl-glutamine or intravenous placebo by continuous infusion (24 h/day). Both groups will be receiving the same standard enteral nutrition protocol and the same standard intensive care unit care. Supplementation will continue until discharge from the intensive care unit, death or a maximum duration of 3 weeks. The primary outcome will be organ-dysfunction evaluation assessed by the pattern of change in sequential organ failure assessment score over a 10-day period. The secondary outcomes are: the changes in total sequential organ failure assessment score on the last day of treatment, infectious complications during the ICU stay, 60-day mortality, length of stay in the intensive care unit and body-composition analysis. Discussion This study is the first trial to investigate the effect of intravenous alanyl-glutamine supplementation in multiple trauma patients receiving enteral nutrition on reducing severity of organ

  18. Five-year follow-up of a prospective randomised trial comparing ceramic-on-metal and metal-on-metal bearing surfaces in total hip arthroplasty.

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    Schouten, R; Malone, A A; Frampton, C M; Tiffen, C; Hooper, G

    2017-10-01

    The primary aim of this independent prospective randomised trial was to compare serum metal ion levels for ceramic-on-metal (CoM) and metal-on-metal (MoM) bearing surfaces in total hip arthroplasty (THA). Our one-year results demonstrated elevation in metal ion levels above baseline with no significant difference between the CoM and MoM groups. This paper reviews the five-year data. The implants used in each patient differed only in respect to the type of femoral head (ceramic or metal). At five-year follow-up of the 83 enrolled patients, data from 67 (36 CoM, 31 MoM) was available for comparison. The mean serum cobalt (Co) and chromium (Cr) ion levels remained above baseline in both groups (CoM: Co 1.16 μg/l (0.41 to 14.67), Cr 1.05 μg/l (0.16 to 12.58); MoM: Co 2.93 μg/l (0.35 to 30.29), Cr 1.85 μg/l (0.36 to 17.00)) but the increase was significantly less in the CoM cohort (Co difference p = 0.001, Cr difference p = 0.002). These medium-term results, coupled with lower revision rates from national joint registries, suggest that the performance of CoM THA may be superior to that of MoM. While both bearing combinations have since been withdrawn these results provide useful information for planning clinical surveillance of CoM THAs and warrants continued monitoring. Cite this article: Bone Joint J 2017;99-B:1298-1303. ©2017 The British Editorial Society of Bone & Joint Surgery.

  19. A prospective, randomised, double-blind study of comparative efficacy of immediate versus daily cleaning of stethoscope using 66% ethyl alcohol

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    Parmar Ramesh

    2004-10-01

    Full Text Available OBJECTIVE: Studies have demonstrated frequent contamination of stethoscope and usefulness of different disinfectants. Albeit, studies on the precise mode of cleaning and frequency of cleaning are lacking. This study was carried out to determine efficacy of 66% ethyl alcohol as disinfectant, rate of recontamination without cleaning and benefits of daily versus immediate cleaning. METHODOLOGY: Prospective, randomised, double blind study of 100 stethoscopes. Four cultures were obtained: before cleaning (Group A, immediately after cleaning with 66% ethyl alcohol (Group B, at the end of 4 days without cleaning (Group C and at the end of 4 days after cleaning once a day (Group D. Samples were analysed using standard microbiological methods and Colony-forming unit (CFU count and residual microorganism was computed for all the positive cultures. Medical staff was asked about the cleaning practices. Statistical analysis was carried out using 95% confidence interval and Chi-square test. RESULTS: 90% of the stethoscopes were contaminated with one or more microorganisms. Immediate cleaning and daily cleaning were associated with a significant reduction in the rate of contamination to 28% and 25% respectively. CFU count in groups B and D dropped to less than 10 in 75% and 84.7%, while the mean residual rates were 5.2% and 3.65% respectively. Groups B and D showed no statistically significant difference in terms of efficacy of disinfection. CONCLUSIONS: 66% ethyl alcohol is an effective disinfectant. The effects of immediate cleaning and cleaning once a day on residual flora on the diaphragm of stethoscope is comparable.

  20. Efficacy of 1% acetic acid in the treatment of chronic wounds infected with Pseudomonas aeruginosa: prospective randomised controlled clinical trial.

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    Madhusudhan, V L

    2016-12-01

    Chronic wounds are those wounds that are persistent and do not respond to any sort of treatment. The concept of using topical antiseptics on open wounds is to prevent and treat infections. They also help to shorten the time taken to heal the wounds. The use of topical agents on wounds to prevent infection is a minimal ability to develop resistance to the microorganisms. Pseudomonas aeruginosa is a Gram-negative opportunistic pathogen with innate resistance to many antibiotics. In places that are economically backward, these problems get compounded by the inability of patients to afford newer expensive drugs. Topically applied dilute acetic acid, which is cheap and easily available, has been found to be effective in such chronic wounds. In the present study, an attempt has been made to use 1% acetic acid as the sole antimicrobial agent for the treatment of pseudomonal wound infections. A control limb was used in which the wounds were treated with normal saline. Our objective was to evaluate the efficacy of acetic acid in low concentration of 1% in chronic wounds infected with P. aeruginosa. This was a prospective study conducted over a period of 6 months.

  1. Intrarectal ice application prior to transrectal prostate biopsy: a prospective randomised trial accessing pain and collateral effects

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    Baris Çaliskan

    2015-02-01

    Full Text Available Objectives To analyze the efficacy of intrarectal ice application as an anesthetic method prior to transrectal ultrasound (TRUS guided prostate biopsy. Materials and Methods A total of 120 consecutive men were included into the study prospectively. Patients were equally randomized as group 1 and 2 with 60 patients each. Ice was applied as an anesthetic method 5 minutes before procedure to the patients in group 1. Patients in group 2 were applied 10 ml of 2% lidocaine gel 10 minutes before procedure. Twelve core biopsy procedure was performed for all patients. The pain level was evaluated using a visual analogue scale (VAS. Results Median pain score was 3.5 (1-8 in group 1 and 5 (1-8 in group 2. There is significantly difference between groups regarding the mean sense of pain level during the procedure. (p=0.007 There was also no difference in complications between two groups about presence and duration of macroscopic hematuria and rectal bleeding. Conclusions Intrarectal ice application prior to TRUS prostate biopsy has an effect on reducing pain. Development of new techniques about cold effect or ice can make this method more useful and decrease complication rates.

  2. Does the timed up and go test predict future falls among British community-dwelling older people? Prospective cohort study nested within a randomised controlled trial.

    Science.gov (United States)

    Kojima, Gotaro; Masud, Tahir; Kendrick, Denise; Morris, Richard; Gawler, Sheena; Treml, Jonathan; Iliffe, Steve

    2015-04-03

    Falling is common among older people. The Timed-Up-and-Go Test (TUG) is recommended as a screening tool for falls but its predictive value has been challenged. The objectives of this study were to examine the ability of TUG to predict future falls and to estimate the optimal cut-off point to identify those with higher risk for future falls. This is a prospective cohort study nested within a randomised controlled trial including 259 British community-dwelling older people ≥65 years undergoing usual care. TUG was measured at baseline. Prospective diaries captured falls over 24 weeks. A Receiver Operating Characteristic curve analysis determined the optimal cut-off point to classify future falls risk with sensitivity, specificity, and predictive values of TUG times. Logistic regression models examined future falls risk by TUG time. Sixty participants (23%) fell during the 24 weeks. The area under the curve was 0.58 (95% confidence interval (95% CI) = 0.49-0.67, p = 0.06), suggesting limited predictive value. The optimal cut-off point was 12.6 seconds and the corresponding sensitivity, specificity, and positive and negative predictive values were 30.5%, 89.5%, 46.2%, and 81.4%. Logistic regression models showed each second increase in TUG time (adjusted for age, gender, comorbidities, medications and past history of two falls) was significantly associated with future falls (adjusted odds ratio (OR) = 1.09, 95% CI = 1.00-1.19, p = 0.05). A TUG time ≥12.6 seconds (adjusted OR = 3.94, 95% CI = 1.69-9.21, p = 0.002) was significantly associated with future falls, after the same adjustments. TUG times were significantly and independently associated with future falls. The ability of TUG to predict future falls was limited but with high specificity and negative predictive value. TUG may be most useful in ruling in those with a high risk of falling rather than as a primary measure in the ascertainment of risk.

  3. DEXMEDETOMIDINE AND CLONIDINE AS ADJUVANTS TO LEVOBUPIVACAINE IN SUPRACLAVICULAR BRACHIAL PLEXUS BLOCK: A COMPARATIVE RANDOMISED PROSPECTIVE CONTROLLED STUDY

    Directory of Open Access Journals (Sweden)

    Karthik

    2015-03-01

    Full Text Available BACKGROUND: There are always efforts to find better and safer local anaesthetics along with adjuvants for supraclavicular brachial plexus block. Levobupivacaine, has strongly emerged as a safer alternative for regional anesthesia than its racemic sibling, bupivacaine. Alpha 2 agonists are combined with local anaesthetics to improve the quality of regional anesthesia. AIMS AND OBJECTIVES: This study was conducted to evaluate and compare the onset, duration of sensory and motor blockade along with the duration of analges ia between dexmedetomidine and clonidine when administered along with 0.5% levobupivacaine in supraclavicular brachial plexus block for upper limb orthopaedic surgeries. MATERIALS AND METHODS: A prospective randomized study was carried out in the departmen t of Anaesthesia at Rajarajeswari Medical College and Hospital which included 50 adult patients between the ages of 20 and 50 years (of ASA I/II grade who underwent upper limb orthopaedic surgeries. The patients were randomly allocated into two groups; le vobupivacaine + dexmedetomidine (LD and levobupivacaine + clonidine (LC, comprising of 25 patients each. Group LD was administered 30 ml of 0.5% levobupivacaine and 1μg/kg of dexmedetomidine, while group LC received admixture of 30 ml of 0.5% levobupivac aine and 1 μg/kg of Clonidine. Onset, duration of sensory and motor blockade and duration of analgesia were observed. STATISTICAL ANALYSIS: Statistical analysis was done using student t test, chi - square test and Fisher Exact test. The Statistical Software namely SAS 9.2, SPSS 15.0, Stata 10.1, MedCalc 9.0.1, Sysatat 12.0 and R environment ver.2.11.1 were also used for the analysis of the data and Microsoft word and Excel have been used to generate graphs, tables etc. The value of P <0.05 was considered significant and P < 0.001 as highly significant. RESULTS: The onset of sensory and motor blockade was faster in Group LD when compared to Group LC. The duration of sensory

  4. Intrauterine administration of human chorionic gonadotropin does not improve pregnancy and life birth rates independently of blastocyst quality: a randomised prospective study.

    Science.gov (United States)

    Wirleitner, Barbara; Schuff, Maximilian; Vanderzwalmen, Pierre; Stecher, Astrid; Okhowat, Jasmin; Hradecký, Libor; Kohoutek, Tomáš; Králícková, Milena; Spitzer, Dietmar; Zech, Nicolas H

    2015-07-04

    Successful embryo implantation depends on a well-timed maternal-embryonic crosstalk. Human chorionic gonadotropin (hCG) secreted by the embryo is known to play a key role in this process and to trigger a complex signal transduction cascade allowing the apposition, attachment, and invasion of the embryo into the decidualized uterus. Production of hCG was reported to be dependent on blastocyst quality and several articles suggested that intrauterine hCG injection increases pregnancy and implantation rates in IVF patients. However, no study has as yet analysed birth rates as final outcome. Our objective was to determine whether clinical outcome after blastocyst transfer can be improved by intrauterine injection of hCG and whether this is dependent on blastocyst quality. A prospective randomised study was conducted in two settings. In cohort A, hCG application was performed two days before blastocyst transfer. In cohort B, the administration of hCG occurred just prior to embryo transfer on day 5. For both cohorts, patients were randomised to either intrauterine hCG application or to the control group that received culture medium. Clinical outcome was analysed according to blastocyst quality of transferred embryos. The outcome of 182 IVF-cycles (cohort A) and 1004 IVF-cycles (cohort B) was analysed. All patients received a fresh autologous blastocyst transfer on day five. Primary outcomes were pregnancy rates (PR), clinical pregnancy rates (cPR), miscarriage rates (MR), and live birth rates (LBR). No improvement of clinical outcome after intrauterine hCG administration on day 3 (cohort A) or day 5 (cohort B) was found, independently of blastocyst quality transferred. The final outcome in cohort A: LBR after transfer of top blastocysts was 50.0 % with hCG and 53.3 % in the control group. With non-top blastocysts, LBR of 17.1 % (hCG) and 18.2 % (control) were observed (n.s.). In cohort B, LBR with top blastocysts was 53.3 % (hCG) and 48.4 % (control), with non

  5. THE EFFICACY OF PREGABALIN AS A PREMEDICANT IN ATTENUATING NEUROENDOCRINE STRESS RESPONSE DURING GENERAL ANAESTHESIA IN ELECTIVE SURGERIES: A PROSPECTIVE RANDOMISED PLACEBO CONTROLLED STUDY

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    Bhavani Muthukrishnan

    2016-06-01

    Full Text Available BACKGROUND The stress response to surgery is characterised by increased secretion of pituitary hormones and activation of the sympathetic nervous system. The changes triggered by the stress response are short-lived and well tolerated by normal healthy patients belonging to ASA 1 and 2. In patients with other comorbidities like myocardial ischaemia, renal insufficiency, uncontrolled diabetes, liver disease and cerebrovascular diseases, these changes can be life threatening. The recognition of the factors which initiate the stress response can be considered for modification in the preoperative period itself. Various anaesthetic techniques and pain management strategies have been put into use to control the stress response. AIM To study the rise in serum cortisol levels during surgery after administering oral pregabalin as a premedicant. SETTINGS AND DESIGN A Prospective Randomised Placebo Controlled Study. MATERIALS AND METHODS All consented patients were aged between 18 and 50 years belonging to ASA 1 & 2 undergoing elective surgical procedures under general anaesthesia of duration between 30 minutes and 180 minutes. Group A received oral placebo, Group B oral pregabalin 150 mg 60-90 minutes before surgery with sips of water. They were randomly allocated to a particular group using computer generated numbers. The ward staff nurse administered the drug kept in sealed envelopes. Both the patients and the person administering anaesthesia were unaware of the group. STATISTICAL ANALYSIS The results were analysed using SPSS Version 17 software with the help of the statistician. The students’ paired t-test was used to compare the mean change in the cortisol levels in the two groups. RESULTS There was a significant [p < 0.01] reduction in the intraoperative cortisol levels after premedication with pregabalin. There was an increase in serum cortisol levels after extubation in both the groups which was statistically significant (p < 0.01. CONCLUSION

  6. Improving patient safety through better teamwork: how effective are different methods of simulation debriefing? Protocol for a pragmatic, prospective and randomised study.

    Science.gov (United States)

    Freytag, Julia; Stroben, Fabian; Hautz, Wolf E; Eisenmann, Dorothea; Kämmer, Juliane E

    2017-06-30

    Medical errors have an incidence of 9% and may lead to worse patient outcome. Teamwork training has the capacity to significantly reduce medical errors and therefore improve patient outcome. One common framework for teamwork training is crisis resource management, adapted from aviation and usually trained in simulation settings. Debriefing after simulation is thought to be crucial to learning teamwork-related concepts and behaviours but it remains unclear how best to debrief these aspects. Furthermore, teamwork-training sessions and studies examining education effects on undergraduates are rare. The study aims to evaluate the effects of two teamwork-focused debriefings on team performance after an extensive medical student teamwork training. A prospective experimental study has been designed to compare a well-established three-phase debriefing method (gather-analyse-summarise; the GAS method) to a newly developed and more structured debriefing approach that extends the GAS method with TeamTAG (teamwork techniques analysis grid). TeamTAG is a cognitive aid listing preselected teamwork principles and descriptions of behavioural anchors that serve as observable patterns of teamwork and is supposed to help structure teamwork-focused debriefing. Both debriefing methods will be tested during an emergency room teamwork-training simulation comprising six emergency medicine cases faced by 35 final-year medical students in teams of five. Teams will be randomised into the two debriefing conditions. Team performance during simulation and the number of principles discussed during debriefing will be evaluated. Learning opportunities, helpfulness and feasibility will be rated by participants and instructors. Analyses will include descriptive, inferential and explorative statistics. The study protocol was approved by the institutional office for data protection and the ethics committee of Charité Medical School Berlin and registered under EA2/172/16. All students will participate

  7. Acute uncomplicated appendicitis study: rationale and protocol for a multicentre, prospective randomised controlled non-inferiority study to evaluate the safety and effectiveness of non-operative management in children with acute uncomplicated appendicitis

    Science.gov (United States)

    Xu, Jane; Liu, Yingrui Cyril; Adams, Susan; Karpelowsky, Jonathan

    2016-01-01

    Introduction This article presents an overview of a prospective randomised controlled non-inferiority study designed to evaluate the safety and effectiveness of non-operative management (NOM) with operative management in children with acute uncomplicated appendicitis (AUA). Here, we present the study protocol for this APRES study, a multicentre Australian study. The rationale and details of future analysis, in particular, non-inferiority calculations, cost-effectiveness, feasibility and acceptability of each intervention. Design A multicentre, prospective randomised controlled clinical trial, conducted in 2 Australian tertiary paediatric hospitals. Participants Children who meet the inclusion criteria of an age between 5 and 15 years and a clinical diagnosis of AUA will be invited to participate, and after consent will be randomised via a computer-based program into treatment groups. The study started in June 2016, and the target recruitment is 220 patients. Interventions Children in the control group will be treated with prophylactic antibiotics and appendicectomy, and those in the intervention group will be treated with antibiotic therapy alone. Primary outcome measures include unplanned or unnecessary operation and complications at 30 days. Secondary outcomes include longer term complications within 1 year, length of stay, time off work and school analgesic requirements and cost. Analysis Data analyses will be on the intention-to-treat principle using non-inferiority analysis. Analysis will include the Pearson χ2 test for categorical variables and independent sample t-test or Mann-Whitney test for continuous variables. Non-inferiority for NOM will be tested using 1-sided Wald tests with an α level of 0.05. Ethics and dissemination The research has been approved by the Human Research Ethics Committee of the Sydney Children's Hospital Network. In addition, results will be reported through academic journals, seminars and conference presentations. Trial

  8. RADAR – A randomised, multi-centre, prospective study comparing best medical treatment versus best medical treatment plus renal artery stenting in patients with haemodynamically relevant atherosclerotic renal artery stenosis

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    Hauk Michael

    2009-07-01

    Full Text Available Abstract Background Prospective, international, multi-centre, randomised (1:1 trial to evaluate the clinical impact of percutaneous transluminal renal artery stenting (PTRAS on the impaired renal function measured by the estimated glomerular filtration rate (eGFR in patients with haemodynamically significant atherosclerotic renal artery stenosis. Methods Patients will be randomised to receive either PTRAS using the Dynamic Renal Stent system plus best medical treatment or best medical treatment. Renal stenting will be performed under angiographic imaging. For patients randomised to best medical treatment the degree of stenosis measured by renal duplex sonography (RDS will be confirmed by MR angio or multi-slice CT where possible. Best medical treatment will be initiated at randomisation or post procedure (for PTRAS arm only, and adjusted as needed at all visits. Best medical treatment is defined as optimal drug therapy for control of the major risk factors (blood pressure ≤ 125/80 mmHg, LDL cholesterol ≤ 100 mg/dL, HbA1c ≤ 6.5%. Data recordings include serum creatinine values, eGFR, brain natriuretic peptide, patients' medical history and concomitant medication, clinical events, quality of life questionnaire (SF-12v2™, 24 hour ambulatory blood pressure measurement, renal artery duplex ultrasound and echocardiography. Follow-up intervals are at 2, 6, 12 and 36 months following randomisation. The primary endpoint is the difference between treatments in change of eGFR over 12 months. Major secondary endpoints are technical success, change of renal function based on the eGFR slope change between pre-treatment and post-treatment (i.e. improvement, stabilisation, failure, clinical events overall such as renal or cardiac death, stroke, myocardial infarction, hospitalisation for congestive heart failure, progressive renal insufficiency (i.e. need for dialysis, need of target vessel revascularisation or target lesion revascularisation, change in

  9. Radial extracorporeal shock-wave therapy in patients with chronic rotator cuff tendinitis: a prospective randomised double-blind placebo-controlled multicentre trial

    NARCIS (Netherlands)

    Kolk, A. van der; Yang, K.G.; Tamminga, R.; Hoeven, H. van der

    2013-01-01

    The aim of this study was to determine the effect of radial extracorporeal shock-wave therapy (rESWT) on patients with chronic tendinitis of the rotator cuff. This was a randomised controlled trial in which 82 patients (mean age 47 years (24 to 67)) with chronic tendinitis diagnosed clinically were

  10. Radial extracorporeal shock-wave therapy in patients with chronic rotator cuff tendinitis: a prospective randomised double-blind placebo-controlled multicentre trial

    NARCIS (Netherlands)

    Kolk, A. van der; Yang, K.G.; Tamminga, R.; Hoeven, H. van der

    2013-01-01

    The aim of this study was to determine the effect of radial extracorporeal shock-wave therapy (rESWT) on patients with chronic tendinitis of the rotator cuff. This was a randomised controlled trial in which 82 patients (mean age 47 years (24 to 67)) with chronic tendinitis diagnosed clinically were

  11. A comparison of Kneipp hydrotherapy with conventional physiotherapy in the treatment of osteoarthritis of the hip or knee: protocol of a prospective randomised controlled clinical trial

    Directory of Open Access Journals (Sweden)

    Deutsch Tobias

    2009-08-01

    Full Text Available Abstract Background The increasing age of the population, especially in the western world, means that the prevalence of osteoarthritis is also increasing, with corresponding socioeconomic consequences. Although there is no curative intervention at present, in accordance with US and European guidelines, pharmacotherapeutic and non-pharmacological approaches aim at pain control and the reduction of functional restriction. It has been established that hydrotherapy for osteoarthritis of the hip or knee joint using serial cold and warm water stimulation not only improves the range of movement but also reduces pain significantly and increases quality of life over a period of up to three months. Weight reduction is important for patients with osteoarthritis of the hip or knee. In addition, conventional physiotherapy and exercise therapy have both been shown, at a high level of evidence, to be cost-effective and to have long-term benefits for pain relief, movement in the affected joint, and patient quality of life. Methods/design The study design consists of a prospective randomised controlled three-armed clinical trial, which will be carried out at a specialist clinic for integrative medicine, to investigate the clinical effects of hydrotherapy on osteoarthritis of the knee or hip joint, in comparison with conventional physiotherapy. One hundred and eighty patients diagnosed with osteoarthritis of hip or knee will be randomly assigned to one of three intervention groups: hydrotherapy, physiotherapy, and both physiotherapy and hydrotherapy of the affected joint. In the first group, patients will receive Kneipp hydrotherapy daily, with water applied in the form of alternate cold and warm thigh affusions (alternating cold and warm water stimulation is particularly relevant to the knee and hip regions. Patients in the second group will receive physiotherapy of the hip or knee joint three times a week. Patients in the physiotherapy-hydrotherapy combination

  12. A prospective randomised controlled clinical trial comparing the efficacy of different molecular weight hyaluronan solutions in the treatment of knee osteoarthritis.

    Science.gov (United States)

    Kotevoglu, Nurdan; Iyibozkurt, Pinar Cakil; Hiz, Ozcan; Toktas, Hasan; Kuran, Banu

    2006-02-01

    Viscosupplementation consists of injecting exagenous hyaluronan (HA) into the synovial joints to restore the normal rheological environment which deteriorates severely in osteoarthritic (OA) joints. Efficacy might be related to the rheological properties and molecular weight (MW) of the hyaluronan preparations. This prospective, controlled, double-blind, randomised clinical trial was aimed at comparing the elastoviscous properties of a high molecular weight viscosupplement, hylan G-F 20, with that of a lower molecular weight hyaluronan product in order to determine the relationship of elastoviscosity to efficacy, alongside placebo, in the treatment of patients with knee OA. The results were analysed as a "completers" analysis with 59 patients. Primary outcome measures included the Western Ontario and Mc Master Universities' Osteoarthritis Index (WOMAC) for pain, stiffness and function scores, and patient and physician global assessments (0-100 scale). For patient (PGA) and physician global assessments (PhGA), the 0-100 scale was used, with 100 being the worst. Follow-up assessments were made at intervals of 1, 3 and 6 months after the first injection. Local adverse events, such as transient pain at the injection site or warm knee lasting for one night, were recorded in two patients (3%). In all groups, the WOMAC pain score exhibited a significant difference from the baseline value; neither treatment group was significantly different from the placebo group, but total pain score was significantly better than baseline for both of the HA groups at the end of 6 months (p < 0.05). Improvement in WOMAC physical function score favoured both sodium hyaluronate and hylan G-F 20 after the first month, and remained significant until the end of 6 months (p < 0.01). In the placebo group, the physical function scores became worse after the end of the 1st month; the scores at the end of 6 months were no different from those at the beginning. The WOMAC stiffness scores of both of

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

    Science.gov (United States)

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

    2017-09-01

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

  14. Efficacy of cognitive behavioural therapy for sleep improvement in patients with persistent delusions and hallucinations (BEST): A prospective, assessor-blind, randomised controlled pilot trial

    OpenAIRE

    Freeman, D; Waite, F.; Startup, H; Myers, E; Lister, R.; McInerney, J; Harvey, AG; Geddes, J.; Zaiwalla, Z; Luengo-Fernandez, R.; Foster, R.; Clifton, L; Yu, LM

    2015-01-01

    Summary Background Sleep disturbance occurs in most patients with delusions or hallucinations and should be treated as a clinical problem in its own right. However, cognitive behavioural therapy (CBT)—the best evidence-based treatment for insomnia—has not been tested in this patient population. We aimed to pilot procedures for a randomised trial testing CBT for sleep problems in patients with current psychotic experiences, and to provide a preliminary assessment of potential benefit. Methods ...

  15. Efficacy and tolerability of natural synergised pyrethrins in a new thermo labile foam formulation in topical treatment of scabies: a prospective, randomised, investigator-blinded, comparative trial vs. permethrin cream.

    Science.gov (United States)

    Amerio, PierLuigi; Capizzi, Rodolfo; Milani, Massimo

    2003-01-01

    We compared in a prospective, randomised, investigator-blinded trial, the efficacy and tolerability of a new synergised-pyrethrins thermo-labile foam (F) formulation with permethrin 5 % cream (P) in 40 patients with scabies. Clinical evolution of scabetic lesions (Clinical grading = CG) and itching intensity (IS) were assessed, using a 5-point semi-quantitative score, at baseline, at week 2 and 4. F and P were equally effective in the clinical resolution of scabetic lesions. As compared to baseline, P reduced CG and IS from 3.4 0.7 and 3.1 0.4 to 0.2 0.6 and 1.4 1, at week 2, and to 0.0 0.0 and 0.1 0.3 at week 4, respectively (P treatment of scabies. In comparison with permethrin the foam induced a more rapid and complete resolution of itching.

  16. Efficacy of orally disintegrating film of ondansetron versus intravenous ondansetron in prophylaxis of postoperative nausea and vomiting in patients undergoing elective gynaecological laparoscopic procedures: A prospective randomised, double-blind placebo-controlled study

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    Harihar V Hegde

    2014-01-01

    Full Text Available Background and Aims: Ondansetron is one of the most widely used drugs for postoperative nausea and vomiting (PONV prophylaxis. Orally disintegrating film (ODF formulations are relatively recent innovations. We evaluated the efficacy of ODF of ondansetron for the prophylaxis of PONV. Methods: One hundred and eighty American Society of Anaesthesiologists-I or II women, in the age group 18-65 years, scheduled for elective gynaecological laparoscopic procedures were studied in a prospective randomised, double-blind, placebo-controlled trial. The patients were randomised into four groups: Placebo, intravenous (IV ondansetron 4 mg, ODF of ondansetron 4 mg (ODF4 and 8 mg (ODF8 groups. PONV was assessed in two epochs of 0-6 and 7-24 h. Primary outcome measure was the incidence of PONV and secondary outcome measures were severity of nausea, need for rescue anti-emetic, analgesic consumption, time to oral intake, overall patient satisfaction and side effects such as headache and dizziness. PONV was compared using analysis of variance or Mann-Whitney U-test as applicable. Results: Data of 173 patients were analysed. The incidence of postoperative nausea was significantly lower (P = 0.04 only during the 0-6 h in the ODF8 group when compared with the placebo group. During the 0-6 h interval postoperatively, the ODF8 group had a significantly lower incidence of vomiting when compared with the placebo (P = 0.002 and the IV group (P = 0.044. During the 0-24 h interval postoperatively, ODF4 (P = 0.01 and ODF8 (P = 0.002 groups had a significantly lower incidence of vomiting compared to the placebo group. Conclusions: Orally disintegrating film of ondansetron is an efficacious, novel, convenient and may be a cost-effective option for the prophylaxis of PONV.

  17. Effects of dabigatran on the cellular and protein phase of coagulation in patients with coronary artery disease on dual antiplatelet therapy with aspirin and clopidogrel. Results from a prospective, randomised, double-blind, placebo-controlled study.

    Science.gov (United States)

    Franchi, Francesco; Rollini, Fabiana; Cho, Jung Rae; King, Rhodri; Phoenix, Fladia; Bhatti, Mona; DeGroat, Christopher; Tello-Montoliu, Antonio; Zenni, Martin M; Guzman, Luis A; Bass, Theodore A; Ajjan, Ramzi A; Angiolillo, Dominick J

    2016-03-01

    There is growing interest in understanding the effects of adding an oral anticoagulant in patients on dual antiplatelet therapy (DAPT). Vitamin K antagonists (VKAs) and clopidogrel represent the most broadly utilised oral anticoagulant and P2Y12 receptor inhibitor, respectively. However, VKAs can interfere with clopidogrel metabolism via the cytochrome P450 (CYP) system which in turn may result in an increase in platelet reactivity. Dabigatran is a direct acting (anti-II) oral anticoagulant which does not interfere with CYP and has favourable safety and efficacy profiles compared with VKAs. The pharmacodynamic (PD) effects on platelet reactivity and clot kinetic of adjunctive dabigatran therapy in patients on DAPT are poorly explored. In this prospective, randomised, double-blind, placebo-controlled PD study, patients (n=30) on maintenance DAPT with aspirin and clopidogrel were randomised to either dabigatran 150 mg bid or placebo for seven days. PD testing was performed before and after treatment using four different assays exploring multiple pathways of platelet aggregation and fibrin clot kinetics: light transmittance aggregometry (LTA), multiple electrode aggregometry (MEA), kaolin-activated thromboelastography (TEG) and turbidimetric assays. There were no differences in multiple measures of platelet reactivity investigating purinergic and non-purinergic signaling pathways assessed by LTA, MEA and TEG platelet mapping. Dabigatran significantly increased parameters related to thrombin activity and thrombus generation, and delayed fibrin clot formation, without affecting clot structure or fibrinolysis. In conclusion, in patients on DAPT with aspirin and clopidogrel, adjunctive dabigatran therapy is not associated with modulation of profiles of platelet reactivity as determined by several assays assessing multiple platelet signalling pathways. However, dabigatran significantly interferes with parameters related to thrombin activity and delays fibrin clot formation.

  18. Cost-effectiveness of decompression according to Gill versus instrumented spondylodesis in the treatment of sciatica due to low grade spondylolytic spondylolisthesis: A prospective randomised controlled trial [NTR1300

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    Brand Ronald

    2008-09-01

    Full Text Available Abstract Background Nerve root decompression with instrumented spondylodesis is the most frequently performed surgical procedure in the treatment of patients with symptomatic low-grade spondylolytic spondylolisthesis. Nerve root decompression without instrumented fusion, i.e. Gill's procedure, is an alternative and less invasive approach. A comparative cost-effectiveness study has not been performed yet. We present the design of a randomised controlled trial on cost-effectiveness of decompression according to Gill versus instrumented spondylodesis. Methods/design All patients (age between 18 and 70 years with sciatica or neurogenic claudication lasting more than 3 months due to spondylolytic spondylolisthesis grade I or II, are eligible for inclusion. Patients will be randomly allocated to nerve root decompression according to Gill, either unilateral or bilateral, or pedicle screw fixation with interbody fusion. The main primary outcome measure is the functional assessment of the patient measured with the Roland Disability Questionnaire for Sciatica at 12 weeks and 2 years. Other primary outcome measures are perceived recovery and intensity of leg pain and low back pain. The secondary outcome measures include, incidence of re-operations, complications, serum creatine phosphokinase, quality of life, medical consumption, costs, absenteeism, work perception, depression and anxiety, and treatment preference. The study is a randomised prospective multicenter trial in which two surgical techniques are compared in a parallel group design. Patients and research nurse will not be blinded during the follow-up period of 2 years. Discussion Currently, nerve root decompression with instrumented fusion is the golden standard in the surgical treatment of low-grade spondylolytic spondylolisthesis, although scientific proof justifying instrumented spondylodesis over simple decompression is lacking. This trial is designed to elucidate the controversy in best

  19. A prospective randomised cross-over study of the effect of insulin analogues and human insulin on the frequency of severe hypoglycaemia in patients with type 1 diabetes and recurrent hypoglycaemia (the HypoAna trial: study rationale and design

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    Kristensen Peter

    2012-06-01

    Full Text Available Abstract Background Severe hypoglycaemia still represents a significant problem in insulin-treated diabetes. Most patients do not experience severe hypoglycaemia often. However, 20% of patients with type 1 diabetes experience recurrent severe hypoglycaemia corresponding to at least two episodes per year. The effect of insulin analogues on glycaemic control has been documented in large trials, while their effect on the frequency of severe hypoglycaemia is less clear, especially in patients with recurrent severe hypoglycaemia. The HypoAna Trial is designed to investigate whether short-acting and long-acting insulin analogues in comparison with human insulin are superior in reducing the occurrence of severe hypoglycaemic episodes in patients with recurrent hypoglycaemia. This paper reports the study design of the HypoAna Trial. Methods/design The study is a Danish two-year investigator-initiated, prospective, randomised, open, blinded endpoint (PROBE, multicentre, cross-over trial investigating the effect of insulin analogues versus human insulin on the frequency of severe hypoglycaemia in subjects with type 1 diabetes. Patients are randomised to treatment with basal-bolus therapy with insulin detemir / insulin aspart or human NPH insulin / human regular insulin in random order. The major inclusion criterion is history of two or more episodes of severe hypoglycaemia in the preceding year. Discussion In contrast to almost all other studies in this field the HypoAna Trial includes only patients with major problems with hypoglycaemia. The HypoAna Trial will elucidate whether basal-bolus regimen with short-acting and long-acting insulin analogues in comparison with human insulin are superior in reducing occurrence of severe hypoglycaemic episodes in hypoglycaemia prone patients with type 1 diabetes. http://www.clinicaltrials.gov: NCT00346996.

  20. Cost-effectiveness of decompression according to Gill versus instrumented spondylodesis in the treatment of sciatica due to low grade spondylolytic spondylolisthesis: a prospective randomised controlled trial [NTR1300].

    Science.gov (United States)

    Arts, Mark P; Verstegen, Marco J T; Brand, Ronald; Koes, Bart W; van den Akker, M Elske; Peul, Wilco C

    2008-09-28

    Nerve root decompression with instrumented spondylodesis is the most frequently performed surgical procedure in the treatment of patients with symptomatic low-grade spondylolytic spondylolisthesis. Nerve root decompression without instrumented fusion, i.e. Gill's procedure, is an alternative and less invasive approach. A comparative cost-effectiveness study has not been performed yet. We present the design of a randomised controlled trial on cost-effectiveness of decompression according to Gill versus instrumented spondylodesis. All patients (age between 18 and 70 years) with sciatica or neurogenic claudication lasting more than 3 months due to spondylolytic spondylolisthesis grade I or II, are eligible for inclusion. Patients will be randomly allocated to nerve root decompression according to Gill, either unilateral or bilateral, or pedicle screw fixation with interbody fusion. The main primary outcome measure is the functional assessment of the patient measured with the Roland Disability Questionnaire for Sciatica at 12 weeks and 2 years. Other primary outcome measures are perceived recovery and intensity of leg pain and low back pain. The secondary outcome measures include, incidence of re-operations, complications, serum creatine phosphokinase, quality of life, medical consumption, costs, absenteeism, work perception, depression and anxiety, and treatment preference. The study is a randomised prospective multicenter trial in which two surgical techniques are compared in a parallel group design. Patients and research nurse will not be blinded during the follow-up period of 2 years. Currently, nerve root decompression with instrumented fusion is the golden standard in the surgical treatment of low-grade spondylolytic spondylolisthesis, although scientific proof justifying instrumented spondylodesis over simple decompression is lacking. This trial is designed to elucidate the controversy in best surgical treatment of symptomatic patients with low

  1. Effects of an interactive mHealth innovation for early detection of patient-reported symptom distress with focus on participatory care: protocol for a study based on prospective, randomised, controlled trials in patients with prostate and breast cancer.

    Science.gov (United States)

    Langius-Eklöf, Ann; Crafoord, Marie-Therése; Christiansen, Mats; Fjell, Maria; Sundberg, Kay

    2017-07-04

    Cancer patients are predominantly treated as out-patients and as they often experience difficult symptoms and side effects it is important to facilitate and improve patient-clinician communication to support symptom management and self-care. Although the number of projects within supportive cancer care evaluating mobile health is increasing, few evidence-based interventions are described in the literature and thus there is a need for good quality clinical studies with a randomised design and sufficient power to guide future implementations. An interactive information and communications technology platform, including a smartphone/computer tablet app for reporting symptoms during cancer treatment was created in collaboration with a company specialising in health care management. The aim of this paper is to evaluate the effects of using the platform for patients with breast cancer during neo adjuvant chemotherapy treatment and patients with locally advanced prostate cancer during curative radiotherapy treatment. The main hypothesis is that the use of the platform will improve clinical management, reduce costs, and promote safe and participatory care. The study is a prospective, randomised, controlled trial for each patient group and it is based on repeated measurements. Patients are consecutively included and randomised. The intervention groups report symptoms via the app daily, during treatment and up to three weeks after end of treatment, as a complement to standard care. Patients in the control groups receive standard care alone. Outcomes targeted are symptom burden, quality of life, health literacy (capacity to understand and communicate health needs and promote healthy behaviours), disease progress and health care costs. Data will be collected before and after treatment by questionnaires, registers, medical records and biomarkers. Lastly, participants will be interviewed about participatory and meaningful care. Results will generate knowledge to enhance

  2. Effects of 12 weeks' treatment with a proton pump inhibitor on insulin secretion, glucose metabolism and markers of cardiovascular risk in patients with type 2 diabetes: a randomised double-blind prospective placebo-controlled study.

    Science.gov (United States)

    Hove, K D; Brøns, C; Færch, K; Lund, S S; Petersen, J S; Karlsen, A E; Rossing, P; Rehfeld, J F; Vaag, A

    2013-01-01

    Recent studies suggest that proton pump inhibitor treatment may increase insulin secretion and improve glucose metabolism in type 2 diabetes. In a randomised double-blind prospective placebo-controlled 2 × 2 factorial study, we examined the effect of esomeprazole on insulin secretion, HbA(1c) and cardiovascular risk factors in type 2 diabetes. Forty-one patients with type 2 diabetes using dietary control or oral glucose-lowering treatment were randomised to receive add-on esomeprazole 40 mg (n = 20) or placebo (n = 21) for 12 weeks. Randomisation was carried out prior to inclusion on the basis of a computer-generated random-number list. The allocation sequence was concealed in sealed envelopes from the researcher enrolling and assessing participants. The study was undertaken at Steno Diabetes Center, Gentofte, Denmark. The primary outcome was change in AUC for insulin levels during a meal test. Secondary outcomes were the levels of HbA(1c) and biochemical markers of cardiovascular risk, including lipids, coagulation factors, inflammation markers, markers of endothelial function and 24 h ambulatory BP measurements. Forty-one participants were analysed. In the esomeprazole-treated group the AUC for insulin did not change (before vs after treatment: 28,049 ± 17,659 vs 27,270 ± 32,004 pmol/l × min (p = 0.838). In the placebo group AUC for insulin decreased from 27,392 ± 14,348 pmol/l × min to 22,938 ± 11,936 pmol/l × min (p = 0.002). Esomeprazole treatment (n = 20) caused a ninefold increase in the AUC for gastrin. HbA(1c) increased from 7.0 ± 0.6% (53 ± 5 mmol/mol) to 7.3 ± 0.8% (56 ± 6 mmol/mol) in the esomeprazole-treated group and from 7.0 ± 0.6% (53 ± 5 mmol/mol) to 7.4 ± 0.8% (57 ± 6 mmol/mol) in the placebo group (n = 21) (p for difference in change >0.05). Except for BP, there were no differences between the groups in the markers of cardiovascular risk (p > 0.05). Monitoring of 24 h ambulatory BP showed a significant decrease in daytime systolic

  3. A prospective randomised comparison of the LMA ProSeal™ versus endotracheal tube on the severity of postoperative pain following gynaecological laparoscopy.

    Science.gov (United States)

    Griffiths, J D; Nguyen, M; Lau, H; Grant, S; Williams, D I

    2013-01-01

    Pain and postoperative nausea and vomiting (PONV) are common problems after gynaecologic laparoscopy. Two recent studies have shown that morphine requirements and PONV are lower when an LMA ProSeal™ is used, rather than an endotracheal tube (ETT), for female patients undergoing breast and gynaecological surgery. We conducted a patient and observer-blinded randomised controlled trial, recruiting non-obese women without gastro-oesophageal reflux undergoing laparoscopic gynaecological surgery. Patients received a standardised relaxant general anaesthetic and then were randomised to receive either an LMA ProSeal or an endotracheal tube. Patients were assessed at two and 24 hours post-anaesthesia. The primary outcome was postoperative pain score and secondary endpoints included morphine consumption, postoperative emesis and adverse upper airway symptoms. We recruited 116 patients to the study, 57 patients in the ETT group and 59 patients in the LMA ProSeal group. The patients were similar in demographic and surgical characteristics. At two hours, the ETT group was similar to the LMA ProSeal group in regards to pain scores (Visual Analogue Scale 3.0 vs 3.5, P=0.86), morphine consumption (7.2 vs 7.4 mg, P=0.56) and PONV (47.4 vs 47.5%, P=0.99). After 24 hours, pain scores and PONV rates were also similar. No significant difference in rates of sore throat or dysphagia was observed between the ETT and LMA ProSeal groups. No significant complications were attributable to either airway device. The LMA ProSeal did not decrease pain or PONV in patients undergoing gynaecological laparoscopy when compared to endotracheal intubation.

  4. A randomised half body prospective study of low and medium dose regimens using the 308 nm excimer laser in the treatment of localised psoriasis.

    Science.gov (United States)

    Higgins, Eleanor; Ralph, Nicola; Ryan, Sheila; Koik, Nicola; Honari, Bahman; Lally, Aoife; Collins, Paul

    2017-02-01

    This study compared two dose-escalation regimens using the 308 nm excimer laser treating localised plaque psoriasis, to determine the optimal regimen. A randomised, left-right body trial was designed including patients aged >18 years with localised plaque psoriasis (<10% body surface area). The standard/low dose regimen started at 70% of the minimal erythema dose (MED), with 20% dose increments. The medium dose regimen commenced at 200% MED, with 25% increments. Patients were treated until disease clearance or a maximum of 36 treatments. Fifteen patients aged 28-55 years completed the study. Psoriasis severity index scores analysed at weeks 0, 6 and 12 showed a significant reduction with each regimen (p < 0.0001). Six patients cleared, seven had significant improvement with uneven clearance of plaques and two failed. Average remission was four months (range 1-12 months). There was a significant reduction in DLQI (p = 0.014). Excimer laser improved psoriasis and reduced DLQI scores, but clearance was incomplete for many patients and remission was short-lived. Adverse effects of pain and blistering were commoner with the medium dose regimen, without any benefit in psoriasis clearance.

  5. Radial extracorporeal shock-wave therapy in patients with chronic rotator cuff tendinitis: a prospective randomised double-blind placebo-controlled multicentre trial.

    Science.gov (United States)

    Kolk, A; Yang, K G Auw; Tamminga, R; van der Hoeven, H

    2013-11-01

    The aim of this study was to determine the effect of radial extracorporeal shock-wave therapy (rESWT) on patients with chronic tendinitis of the rotator cuff. This was a randomised controlled trial in which 82 patients (mean age 47 years (24 to 67)) with chronic tendinitis diagnosed clinically were randomly allocated to a treatment group who received low-dose rESWT (three sessions at an interval 10 to 14 days, 2000 pulses, 0.11 mJ/mm(2), 8 Hz) or to a placebo group, with a follow-up of six months. The patients and the treating orthopaedic surgeon, who were both blinded to the treatment, evaluated the results. A total of 44 patients were allocated to the rESWT group and 38 patients to the placebo group. A visual analogue scale (VAS) score for pain, a Constant-Murley (CMS) score and a simple shoulder test (SST) score significantly improved in both groups at three and six months compared with baseline (all p ≤ 0.012). The mean VAS was similar in both groups at three (p = 0.43) and six months (p = 0.262). Also, the mean CMS and SST scores were similar in both groups at six months (p = 0.815 and p = 0.834, respectively). It would thus seem that low-dose rESWT does not reduce pain or improve function in patients chronic rotator cuff tendinitis compared with placebo treatment.

  6. A prospective randomised controlled trial comparing chronic groin pain and quality of life in lightweight versus heavyweight polypropylene mesh in laparoscopic inguinal hernia repair

    Directory of Open Access Journals (Sweden)

    Pradeep Prakash

    2016-01-01

    Full Text Available Background: The aim of our study was to compare chronic groin pain and quality of life (QOL after laparoscopic lightweight (LW and heavyweight (HW mesh repair for groin hernia. Materials and Methods: One hundred and forty adult patients with uncomplicated inguinal hernia were randomised into HW mesh group or LW mesh group. Return to activity, chronic groin pain and recurrence rates were assessed. Short form-36 v2 health survey was used for QOL analysis. Results: One hundred and thirty-one completed follow-up of 3 months, 66 in HW mesh group and 65 in LW mesh group. Early post-operative convalescence was better in LW mesh group in terms of early return to walking (P = 0.01 and driving (P = 0.05. The incidence of early post-operative pain, chronic groin pain and QOL and recurrences were comparable. Conclusion: Outcomes following laparoscopic inguinal hernia repair using HW and LW mesh are comparable in the short-term as well as long-term.

  7. Serenoa repens associated with Urtica dioica (ProstaMEV) and curcumin and quercitin (FlogMEV) extracts are able to improve the efficacy of prulifloxacin in bacterial prostatitis patients: results from a prospective randomised study.

    Science.gov (United States)

    Cai, Tommaso; Mazzoli, Sandra; Bechi, Adriano; Addonisio, Patrizia; Mondaini, Nicola; Pagliai, Roberto Castricchi; Bartoletti, Riccardo

    2009-06-01

    We report the results of a prospective randomised study to evaluate the therapeutic effect of Serenoa repens, Urtica dioica (ProstaMEV), quercitin and curcumin (FlogMEV) extracts associated with prulifloxacin in patients affected by chronic bacterial prostatitis (CBP). From a whole population of 284 patients, 143 patients affected by CBP [National Institutes of Health (NIH) class II prostatitis] were enrolled. All patients received prulifloxacin 600 mg daily for 14 days, in accordance with antibiogram results. Patients were split into two groups: Group A received prulifloxacin associated with ProstaMEV and FlogMEV; Group B received only antibiotic therapy. Microbiological and clinical efficacies were tested by two follow-up visits at 1 month and 6 months, respectively. Quality of life (QoL) was measured using the NIH Chronic Prostatitis Symptom Index (CPSI) and International Prostatic Symptom Score (IPSS) questionnaires. Group A comprised 106 patients and Group B comprised 37 patients. One month after treatment, 89.6% of patients who had received prulifloxacin associated with ProstaMEV and FlogMEV did not report any symptoms related to CBP, whilst only 27% of patients who received antibiotic therapy alone were recurrence-free (P patients in Group A had recurrence of disease whilst two patients in Group B did. Questionnaire results demonstrated statistically significant differences between groups (all P patients affected by CBP.

  8. Postoperative pharyngolaryngeal adverse events with laryngeal mask airway (LMA Supreme) in laparoscopic surgical procedures with cuff pressure limiting 25 cmH₂O: prospective, blind, and randomised study.

    Science.gov (United States)

    Kang, Joo-Eun; Oh, Chung-Sik; Choi, Jae Won; Son, Il Soon; Kim, Seong-Hyop

    2014-01-01

    To reduce the incidence of postoperative pharyngolaryngeal adverse events, laryngeal mask airway (LMA) manufacturers recommend maximum cuff pressures not exceeding 60 cmH₂O. We performed a prospective randomised study, comparing efficacy and adverse events among patients undergoing laparoscopic surgical procedures who were allocated randomly into low (limiting 25 cmH₂O, L group) and high (at 60 cmH₂O, H group) LMA cuff pressure groups with LMA Supreme. Postoperative pharyngolaryngeal adverse events were evaluated at discharge from postanaesthetic care unit (PACU) (postoperative day 1, POD 1) and 24 hours after discharge from PACU (postoperative day 2, POD 2). All patients were well tolerated with LMA without ventilation failure. Before pneumoperitoneum, cuff volume and pressure and oropharyngeal leak pressure (OLP) showed significant differences. Postoperative sore throat at POD 2 (3 versus 12 patients) and postoperative dysphagia at POD 1 and POD 2 (0 versus 4 patients at POD 1; 0 versus 4 patients at POD 2) were significantly lower in L group, compared with H group. In conclusion, LMA with cuff pressure limiting 25 cmH₂O allowed both efficacy of airway management and lower incidence of postoperative adverse events in laparoscopic surgical procedures. This clinical trial is registered with KCT0000334.

  9. Postoperative Pharyngolaryngeal Adverse Events with Laryngeal Mask Airway (LMA Supreme in Laparoscopic Surgical Procedures with Cuff Pressure Limiting 25 cmH2O: Prospective, Blind, and Randomised Study

    Directory of Open Access Journals (Sweden)

    Joo-Eun Kang

    2014-01-01

    Full Text Available To reduce the incidence of postoperative pharyngolaryngeal adverse events, laryngeal mask airway (LMA manufacturers recommend maximum cuff pressures not exceeding 60 cmH2O. We performed a prospective randomised study, comparing efficacy and adverse events among patients undergoing laparoscopic surgical procedures who were allocated randomly into low (limiting 25 cmH2O, L group and high (at 60 cmH2O, H group LMA cuff pressure groups with LMA Supreme. Postoperative pharyngolaryngeal adverse events were evaluated at discharge from postanaesthetic care unit (PACU (postoperative day 1, POD 1 and 24 hours after discharge from PACU (postoperative day 2, POD 2. All patients were well tolerated with LMA without ventilation failure. Before pneumoperitoneum, cuff volume and pressure and oropharyngeal leak pressure (OLP showed significant differences. Postoperative sore throat at POD 2 (3 versus 12 patients and postoperative dysphagia at POD 1 and POD 2 (0 versus 4 patients at POD 1; 0 versus 4 patients at POD 2 were significantly lower in L group, compared with H group. In conclusion, LMA with cuff pressure limiting 25 cmH2O allowed both efficacy of airway management and lower incidence of postoperative adverse events in laparoscopic surgical procedures. This clinical trial is registered with KCT0000334.

  10. Postoperative Pharyngolaryngeal Adverse Events with Laryngeal Mask Airway (LMA Supreme) in Laparoscopic Surgical Procedures with Cuff Pressure Limiting 25 cmH2O: Prospective, Blind, and Randomised Study

    Science.gov (United States)

    Kang, Joo-Eun; Choi, Jae Won; Son, Il Soon

    2014-01-01

    To reduce the incidence of postoperative pharyngolaryngeal adverse events, laryngeal mask airway (LMA) manufacturers recommend maximum cuff pressures not exceeding 60 cmH2O. We performed a prospective randomised study, comparing efficacy and adverse events among patients undergoing laparoscopic surgical procedures who were allocated randomly into low (limiting 25 cmH2O, L group) and high (at 60 cmH2O, H group) LMA cuff pressure groups with LMA Supreme. Postoperative pharyngolaryngeal adverse events were evaluated at discharge from postanaesthetic care unit (PACU) (postoperative day 1, POD 1) and 24 hours after discharge from PACU (postoperative day 2, POD 2). All patients were well tolerated with LMA without ventilation failure. Before pneumoperitoneum, cuff volume and pressure and oropharyngeal leak pressure (OLP) showed significant differences. Postoperative sore throat at POD 2 (3 versus 12 patients) and postoperative dysphagia at POD 1 and POD 2 (0 versus 4 patients at POD 1; 0 versus 4 patients at POD 2) were significantly lower in L group, compared with H group. In conclusion, LMA with cuff pressure limiting 25 cmH2O allowed both efficacy of airway management and lower incidence of postoperative adverse events in laparoscopic surgical procedures. This clinical trial is registered with KCT0000334. PMID:24778598

  11. Early rehabilitation in sepsis: a prospective randomised controlled trial investigating functional and physiological outcomes The i-PERFORM Trial (Protocol Article

    Directory of Open Access Journals (Sweden)

    Kayambu Geetha

    2011-10-01

    Full Text Available Abstract Background Patients with sepsis syndromes in comparison to general intensive care patients can have worse outcomes for physical function, quality of life and survival. Early intensive care rehabilitation can improve the outcome in general Intensive Care Unit (ICU patients, however no investigations have specifically looked at patients with sepsis syndromes. The 'i-PERFORM Trial' will investigate if early targeted rehabilitation is both safe and effective in patients with sepsis syndromes admitted to ICU. Methods/Design A single-centred blinded randomized controlled trial will be conducted in Brisbane, Australia. Participants (n = 252 will include those ≥ 18 years, mechanically ventilated for ≥ 48 hours and diagnosed with a sepsis syndrome. Participants will be randomised to an intervention arm which will undergo an early targeted rehabilitation program according to the level of arousal, strength and cardiovascular stability and a control group which will receive normal care. The primary outcome measures will be physical function tests on discharge from ICU (The Acute Care Index of Function and The Physical Function ICU Test. Health-related quality of life will be measured using the Short Form-36 and the psychological component will be tested using The Hospital Anxiety and Depression Scale. Secondary measures will include inflammatory biomarkers; Interleukin-6, Interleukin-10 and Tumour Necrosis Factor-α, peripheral blood mitochondrial DNA content and lactate, fat free muscle mass, tissue oxygenation and microcirculatory flow. Discussion The 'i-PERFORM Trial' will determine whether early rehabilitation for patients with sepsis is effective at improving patient outcomes with functional and physiological parameters reflecting long and short-term effects of early exercise and the safety in its application in critical illness. Trial Registration Australia and New Zealand Clinical Trials Register (ANZCTR: ACTRN12610000808044

  12. Comparison of actual and ideal body weight for selection of appropriate size of ProSeal™ laryngeal mask airway in overweight and obese patients: A prospective, randomised study

    Directory of Open Access Journals (Sweden)

    Sohan Lal Solanki

    2017-01-01

    Full Text Available Background and Aims: The ProSeal™ laryngeal mask airway (PLMA has advantages of providing better cuff seal and the presence of a gastric drain tube. The manufacturer recommends actual body weight (ABW for size selection. Pharyngeal area reduces with increase in body mass index (BMI; hence, in overweight patients, PLMA selected on ABW may not fit well. We hypothesised that the ideal body weight (IBW would be more appropriate in size selection of PLMA. Methods: This randomised, single-blind study included 124 patients of 20–60 years and American Society of Anesthesiologists Class I–II, with BMI> 25. Patients were randomly divided into two groups. In Group ABW, PLMA was selected based on ABW (62 patients and in Group IBW, PLMA was selected based on IBW (62 patients. The primary outcome was the first-attempt insertion success rate. Oropharyngeal air leaks, gastric air leaks, drain tube air leaks, insertion difficulty scores and postoperative complications were assessed. Fibre-optic view (Grade I–IV was assessed for proper placement by a blinded assessor. Statistical analyses were performed using Chi-square test or Fisher's exact test. Results: First-attempt insertion success rate and overall insertion success rates were similar in both the groups. Group IBW patients had significantly less resistance during insertion, lower peak airway pressures, successful nasogastric tube insertions, better fibre-optic views and less post-operative complications. Oropharyngeal leak pressure and instrumentation used for insertion were comparable. Conclusion: IBW is preferable for the size selection of the PLMA in overweight and obese patients compared to the ABW.

  13. Comparison of actual and ideal body weight for selection of appropriate size of ProSeal™ laryngeal mask airway in overweight and obese patients: A prospective, randomised study.

    Science.gov (United States)

    Solanki, Sohan Lal; Doctor, Jeson R; Shekhawat, Kamlesh K; Myatra, Sheila Nainan; Joshi, Malini; Divatia, Jigeeshu V

    2017-05-01

    The ProSeal™ laryngeal mask airway (PLMA) has advantages of providing better cuff seal and the presence of a gastric drain tube. The manufacturer recommends actual body weight (ABW) for size selection. Pharyngeal area reduces with increase in body mass index (BMI); hence, in overweight patients, PLMA selected on ABW may not fit well. We hypothesised that the ideal body weight (IBW) would be more appropriate in size selection of PLMA. This randomised, single-blind study included 124 patients of 20-60 years and American Society of Anesthesiologists Class I-II, with BMI >25. Patients were randomly divided into two groups. In Group ABW, PLMA was selected based on ABW (62 patients) and in Group IBW, PLMA was selected based on IBW (62 patients). The primary outcome was the first-attempt insertion success rate. Oropharyngeal air leaks, gastric air leaks, drain tube air leaks, insertion difficulty scores and postoperative complications were assessed. Fibre-optic view (Grade I-IV) was assessed for proper placement by a blinded assessor. Statistical analyses were performed using Chi-square test or Fisher's exact test. First-attempt insertion success rate and overall insertion success rates were similar in both the groups. Group IBW patients had significantly less resistance during insertion, lower peak airway pressures, successful nasogastric tube insertions, better fibre-optic views and less post-operative complications. Oropharyngeal leak pressure and instrumentation used for insertion were comparable. IBW is preferable for the size selection of the PLMA in overweight and obese patients compared to the ABW.

  14. The novel intubating laryngeal tube (iLTS-D) is comparable to the intubating laryngeal mask (Fastrach) - a prospective randomised manikin study.

    Science.gov (United States)

    Ott, Thomas; Fischer, Matthias; Limbach, Tobias; Schmidtmann, Irene; Piepho, Tim; Noppens, Ruediger R

    2015-06-08

    Supraglottic devices are helpful for inexperienced providers who perform ventilation in emergency situations. Most supraglottic devices do not allow secondary tracheal intubation through the device. The novel intubating laryngeal tube (iLTS-D) and the intubating laryngeal mask (Fastrach) are devices that offer supraglottic ventilation and secondary tracheal intubation. We evaluated the novel iLTS-D and compared it to the established Fastrach using a manikin-based study. Participants used both devices in a randomised order. The participants conducted four consecutive trials on a manikin. One trial was composed of the following procedures. First, participants ventilated the manikin using either iLTS-D or Fastrach. 'Time to ventilation', success rates and number of attempts were recorded for the supraglottic device. Second, participants intubated the manikin through the previously inserted supraglottic device. 'Time to tracheal ventilation', success rate and tube localisation were recorded. The primary endpoint was the results of the final fourth trial, which mirrored the standardised training of trials 1, 2 and 3. A total of 64 participants were enrolled. All of the participants successfully inserted both devices on their first attempt in trial 4. Fastrach was applied 1 s faster in trial 4 than the iLTS-D (median 'time to ventilation' Fastrach: 13.5 s., iLTS-D: 14.5 s., p = 0.04). All participants successfully intubated through both devices in trial 4. There was no difference in 'time to tracheal ventilation' by tracheal intubation between either device (median 'time to tracheal ventilation': Fastrach: 14.0 s., iLTS-D: 14.0 s., p = 0.16). The iLTS-D performed similarly to the ILMA in insertion and intubation times in a manikin setting.

  15. Local application of adipose-derived mesenchymal stem cells supports the healing of fistula: prospective randomised study on rat model of fistulising Crohn's disease.

    Science.gov (United States)

    Ryska, Ondrej; Serclova, Zuzana; Mestak, Ondrej; Matouskova, Eva; Vesely, Pavel; Mrazova, Iveta

    2017-05-01

    Local application of adipose-derived mesenchymal stem cells (ADSC) represents a novel approach for the management of perianal fistula in patients with Crohn's disease. A randomised study on an animal model was performed to investigate the efficacy and to detect the distribution of implanted ADSCs by bioluminescence (BLI). A caecostomy was used as a fistula model in 32 Lewis rats. The ADSCs were isolated from transgenic donor expressing firefly luciferase. Animals were randomly assigned to groups given injections of 4 × 10(6) cells (n = 16, group A) or placebo (n = 16, group B) in the perifistular tissue. Fistula drainage assessment was used to evaluate the fistula healing. After application of D-luciferin, cell viability and distribution was detected using an IVIS Lumina XR camera on days 0, 2, 7, 14 and 30. The fistula was identified as healed in 6 (38%) animals in group A vs. 1 case (6.3%) in group B (p = .033). The BLI was strongest immediately after administration of ADSCs 31.2 × 10(4) (6.09-111 × 10(4)) p/s/cm(2)/sr. The fastest decrease was observed within the first 2 days when values fell by 50.2%. The BLI 30 days after injection was significantly higher in animals with healed fistulas - 8.23 × 10(4) (1.18-16.9 × 10(4)) vs. 1.74 × 10(4) (0.156-6.88 × 10(4)); p = .0393. Local application of ADSCs resulted in significantly higher fistula closure rate on an animal model. BLI monitoring was proved to be feasible and showed rapid reduction of the ADSC mass after application. More viable cells were detected in animals with healed fistula at the end of the follow-up.

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

    Science.gov (United States)

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

    2016-01-01

    Introduction Ischaemic heart disease (IHD) is one of the most common causes of death in the UK and treatment of patients with IHD costs the National Health System (NHS) billions of pounds each year. Allopurinol is a xanthine oxidase inhibitor used to prevent gout that also has several positive effects on the cardiovascular system. The ALL-HEART study aims to determine whether allopurinol improves cardiovascular outcomes in patients with IHD. Methods and analysis The ALL-HEART study is a multicentre, controlled, prospective, randomised, open-label blinded end point (PROBE) trial of allopurinol (up to 600 mg daily) versus no treatment in a 1:1 ratio, added to usual care, in 5215 patients aged 60 years and over with IHD. Patients are followed up by electronic record linkage and annual questionnaires for an average of 4 years. The primary outcome is the composite of non-fatal myocardial infarction, non-fatal stroke or cardiovascular death. Secondary outcomes include all-cause mortality, quality of life and cost-effectiveness of allopurinol. The study will end when 631 adjudicated primary outcomes have occurred. The study is powered at 80% to detect a 20% reduction in the primary end point for the intervention. Patient recruitment to the ALL-HEART study started in February 2014. Ethics and dissemination The study received ethical approval from the East of Scotland Research Ethics Service (EoSRES) REC 2 (13/ES/0104). The study is event-driven and results are expected after 2019. Results will be reported in peer-reviewed journals and at scientific meetings. Results will also be disseminated to guideline committees, NHS organisations and patient groups. Trial registration number 32017426, pre-results. PMID:27609859

  17. Extracorporeal shock wave therapy in the treatment of primary bone marrow edema syndrome of the knee: a prospective randomised controlled study.

    Science.gov (United States)

    Gao, Fuqiang; Sun, Wei; Li, Zirong; Guo, Wanshou; Wang, Weiguo; Cheng, Liming; Yue, Debo; Zhang, Nianfei; Savarin, Amanda

    2015-12-05

    The aim of this prospective study was to evaluate the effectiveness of extracorporeal shock wave therapy (ESWT) in normalizing the symptoms and imaging features of primary bone marrow edema syndrome (BMES) of the knee. This study compared the outcomes of ESWT (Group A) (n = 20) and intravenously applied prostacyclin and bisphosphonate (Group B) (n = 20) in the treatment of BMES of the knee in our department between 2011 and 2013. The Visual Analog Scale for pain (VAS, 100 mm), the Western Ontario and McMaster University Osteoarthritis Index (WOMAC), the SF-36 scores and MRI scans as well as plain radiographs were obtained before and after therapy between two groups. Compared with Group B, we found greater improvement in VAS, the WOMAC Osteoarthritis Index and SF-36 score at 1, 3 and 6 months post-treatment in Group A (P edema at 6 months in Group A (95 vs. 65 %; P = 0.018). The MRI at 1 year follow-up showed complete regression in all patients in Group A. However, two cases in Group B continued to normalize over the subsequent follow-up period. ESWT can produce rapid pain relief and functional improvement. It may be an effective, reliable, and non-invasive technique for rapid treatment of BMES of the knee. Research Registry UIN 528, September 03, 2015.

  18. Prediction of difficult intubations using conventional indicators; Does rapid sequence intubation ease difficult intubations? A prospective randomised study in a tertiary care teaching hospital

    Directory of Open Access Journals (Sweden)

    Gangadharan Lakshmi

    2011-01-01

    Full Text Available Background : Endotracheal intubations performed in the Emergency Department. Aims : To assess whether conventional indicators of difficult airway can predict a difficult intubation in the Emergency Setting and to investigate the effect of rapid sequence intubation (RSI on ease of intubation. Settings and Design : A prospective randomized study was designed involving 60 patients requiring intubation, over a period of 4 months. Materials and Methods : Demographic profile, details of methods used, airway assessment, ease of intubation, and Cormack and Lehane score were recorded. Airway assessment score and ease of intubation criteria were devised and assessed. Statistical Analysis : Descriptive statistical analysis was carried out. Chi-square/2 × 2, 2 × 3, 3 × 3, Fisher Exact test have been used to find the significance of study parameters on categorical scale between two or more groups. Results : Patients with a Mallampatti score of three or four were found to have worse laryngoscopic views (Cormack-Lehane score, 3 or 4. Of all airway indicators assessed, an increased Mallampatti score was found to have significant correlation with increased difficulty in intubation. The use of RSI was associated with better laryngoscopic views, and easier intubations. Conclusions : An airway assessment using the Mallampatti score is invaluable as a tool to predict a difficult airway and should be performed routinely if possible. RSI aids intubation ease. If not otherwise contraindicated, it should be performed routinely for all intubations in the ED.

  19. Effects of bariatric surgery on gout incidence in the Swedish Obese Subjects study: a non-randomised, prospective, controlled intervention trial.

    Science.gov (United States)

    Maglio, Cristina; Peltonen, Markku; Neovius, Martin; Jacobson, Peter; Jacobsson, Lennart; Rudin, Anna; Carlsson, Lena M S

    2017-04-01

    To assess the long-term effect of bariatric surgery on the incidence of gout and hyperuricaemia in participants of the Swedish Obese Subjects (SOS) study. This report includes 1982 subjects who underwent bariatric surgery and 1999 obese controls from the SOS study, a prospective intervention trial designed to assess the effect of bariatric surgery compared with conventional treatment. None of the subjects had gout at baseline. An endpoint on gout incidence was created based on information on gout diagnosis and use of gout medications through national registers and questionnaires. Median follow-up for the incidence of gout was about 19 years for both groups. Moreover, the incidence of hyperuricaemia over up to 20 years was examined in a subgroup of participants having baseline uric acid levels gout compared with usual care (adjusted HR 0.60, 95% CI 0.48 to 0.75, pgout event was 32 (95% CI 22 to 59). The effect of bariatric surgery on gout incidence was not influenced by baseline risk factors, including body mass index. During follow-up, the surgery group had a lower incidence of hyperuricaemia (adjusted HR 0.47, 95% CI 0.39 to 0.58, pgout and hyperuricaemia in obese subjects. NCT01479452; Results. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  20. An extract of pomegranate fruit and galangal rhizome increases the numbers of motile sperm: a prospective, randomised, controlled, double-blinded trial.

    Directory of Open Access Journals (Sweden)

    Maja D K Fedder

    Full Text Available Pomegranate fruit (Punica granatum and galangal (Alpinia galanga have separately been shown to stimulate spermatogenesis and to increase sperm counts and motility in rodents. Within traditional medicine, pomegranate fruit has long been used to increase fertility, however studies on the effect on spermatogenesis in humans have never been published. With this study we investigated whether oral intake of tablets containing standardised amounts of extract of pomegranate fruit and powder of greater galangal rhizome (Punalpin would increase the total number of motile spermatozoa. The study was designed as a prospective, randomized, controlled, double-blinded trial. Enrolment was based on the mean total number of motile spermatozoa of two ejaculates. The participants delivered an ejaculate after 4-8 days of tablet intake and two ejaculates just before they stopped taking the tablets. Seventy adult men with a semen quality not meeting the standards for commercial application at Nordic Cryobank, but without azoospermia, were included in the study. Participants were randomized to take tablets containing extract of pomegranate fruit (standardised with respect to punicalagin A+B, punicalin and ellagic acid and freeze-dried rhizome of greater galangal (standardised with respect to 1'S-1'-acetoxychavicol acetate or placebo on a daily basis for three months. Sixty-six participants completed the intervention (active treatment: n = 34; placebo: n = 32. After the intervention the total number of motile spermatozoa was increased in participants treated with plant extracts compared with the placebo group (p = 0.026. After three months of active treatment, the average total number of motile sperm increased by 62% (from 23.4 to 37.8 millions, while for the placebo group, the number of motile sperm increased by 20%. Sperm morphology was not affected by the treatment. Our findings may help subfertile men to gain an improved amount of motile ejaculated sperm by taking

  1. EFFECT OF CEREBROPROTEIN HYDROLYSATE WITH CITICOLINE VERSUS CITICOLINE ALONE IN THE INITIAL MANAGEMENT OF HEAD INJURY AND ITS CLINICAL OUTCOME “A PROSPECTIVE RANDOMISED COMPARATIVE STUDY”

    Directory of Open Access Journals (Sweden)

    Varadaraju D. N

    2017-06-01

    Full Text Available BACKGROUND Traumatic brain injury is an important cause of morbidity. It also represents the most frequent reason for neurological illness after headache. Compared with other types of brain insult, traumatic brain injury produces more diffuse injury causing more cognitive and neuropsychiatric disturbances. Various drugs have been used in an attempt to improve the clinical outcome, citicoline and Cerebrolysin hydrolysate have been used to improve the clinical outcome in traumatic brain injury. The evidence thus far has been conflicting with reports in favour and against the use of these drugs in the clinical benefit of the patients with traumatic brain injury. We attempt to determine the benefits and advantages of using these drugs in the management of traumatic brain injury. MATERIALS AND METHODS This is a prospective study comprising 60 patients of head injury admitted in the Department of Neurosurgery at Vydehi Institute of Medical Sciences and Research Centre, Bangalore. The purpose of the current study is to evaluate the effect of cerebroprotein hydrolysate with citicoline compared to citicoline alone in the initial management of head injury and its clinical outcome and to assess the improvement. RESULTS Sixty patients with head injury were recruited and divided into group A and group B randomly. The mean age was 43.5 years with 43 male patients and 17 female patients. The GCS at admission of 27 patients was mild head injury and of 33 patients was moderate head injury. Group A had 13 patients with mild head injury and 17 patients with moderate head injury. Group B had 14 patients with mild and 16 patients with moderate head injury at the time of admission. The GCS was assessed at 1 week and 3 weeks. On assessing the patients at 1 week, group A had 14 patients with mild head injury and 16 patients with moderate head injury, whereas group B had 14 patients with mild and 16 patients with moderate head injury. The extended Glasgow Outcome Scale

  2. A prospective randomised controlled trial to determine the early and late reactions after the use of iopamidol 340 (Niopam{sup TM}) and iomeprol 350 (Iomeron[reg]) in cardiac catheterisation

    Energy Technology Data Exchange (ETDEWEB)

    Vijayalakshmi, Kunadian [Department of Cardiology, James Cook University Hospital, Marton Road, Middlesbrough TS4 3BW (United Kingdom)]. E-mail: kunadianvijay@aol.com; Kunadian, Babu [Department of Cardiology, James Cook University Hospital, Marton Road, Middlesbrough TS4 3BW (United Kingdom); Wright, Robert A. [Department of Cardiology, James Cook University Hospital, Marton Road, Middlesbrough TS4 3BW (United Kingdom); Hall, James A. [Department of Cardiology, James Cook University Hospital, Marton Road, Middlesbrough TS4 3BW (United Kingdom); Stewart, Michael J. [Department of Cardiology, James Cook University Hospital, Marton Road, Middlesbrough TS4 3BW (United Kingdom); Davies, Adrian [Department of Cardiology, James Cook University Hospital, Marton Road, Middlesbrough TS4 3BW (United Kingdom); Sutton, Andrew [Department of Cardiology, James Cook University Hospital, Marton Road, Middlesbrough TS4 3BW (United Kingdom); Belder, Mark A. de [Department of Cardiology, James Cook University Hospital, Marton Road, Middlesbrough TS4 3BW (United Kingdom)]. E-mail: mark.debelder@stees.nhs.uk

    2007-02-15

    A new generation of intravascular contrast agents, the non-ionic monomers have safety profiles that are superior to those of older ionic compounds. There are, however, significant differences between these agents. Aim: The aim of this study was to determine the incidence of early (<24 h) and late (>24 h to 7 days) reactions to two non-ionic contrast agents currently used during cardiac catheterisation: iopamidol 340 (Niopam{sup TM} Bracco UK Ltd.) and iomeprol 350 (Iomeron[reg] Bracco UK Ltd.). Methods: This was a prospective, randomised, double blinded trial. One thousand nine hundred and eighty-five patients undergoing cardiac catheterisation received one of the following contrast agents on a weekly basis: iopamidol 340 (Niopam{sup TM}) and iomeprol 350 (Iomeron[reg]). Reactions that were possibly related to the contrast agents were recorded on predefined data collection forms during the first 24 h of the procedure (early reaction) and after 24 h to 7 days (late reaction) by means of a questionnaire. Results: The baseline characteristics were matched in both the groups. There was no significant difference in the incidence of heat sensation experienced between the two groups (p = 0.1). Early non-heat reactions occurred in 2.7% of patients receiving iopamidol 340 (Niopam{sup TM}) and 4% of those receiving iomeprol 350 (Iomeron[reg]) (p = 0.1). Significant electrocardiographic changes were recorded in 1.7% of patients who received iopamidol 340 (Niopam{sup TM}), and 1% of those who received iomeprol 350 (Iomeron[reg]) (p = 0.2). Bradycardia occurred more frequently in the iopamidol 350 group (0.8%) compared to the iomeprol 350 group (0.1%) p = 0.02. Late reactions occurred in 16.2% of those receiving iopamidol 340 (Niopam{sup TM}) and 21.7% of those receiving iomeprol 350 (Iomeron[reg] (p = 0.02). A total of 23 (3.7%) patients in the iopamidol group and 39 (6.2%) patients in the iomeprol group reported nausea, p = 0.01. Conclusions: The incidence of early adverse

  3. Short-term antidiabetic treatment with insulin or metformin has a similar impact on the components of metabolic syndrome in women with gestational diabetes mellitus requiring antidiabetic agents: results of a prospective, randomised study.

    Science.gov (United States)

    Zawiejska, A; Wender-Ozegowska, E; Grewling-Szmit, K; Brazert, M; Brazert, J

    2016-04-01

    Gestational diabetes mellitus (GDM) is associated with an increased prevalence of fetal and maternal complications primarily caused by maternal hyperglycemia, which results in abnormal fetal growth. Diet modification is a common first step in the treatment of GDM, followed by antidiabetic pharmacotherapy if this approach fails. Insulin therapy is generally accepted; however, oral hypoglycemic agents have been used in this population. In this prospective, randomised study, we compared maternal metabolic status after treatment with insulin or metformin. Pregnant women (gestational age: ≥ 20 weeks) with GDM requiring medical hypoglycemic treatment were randomly allocated to the Metformin (n = 35) or Insulin (n = 43) Groups. Maternal metabolic status - assessed by glycated hemoglobin (HBA1c) level, glycemic profile, insulin concentration, Homeostatic Model Assessment - Insulin Resistance index, and lipids - was recorded at booking and throughout pregnancy. The characteristics of the study group were: maternal age 33.5 ± 5.9 years, gestational age at baseline 28.5 ± 3.5 weeks, prepregnancy body mass index (BMI) 32.2 ± 3.5 kg/m(2), HbA1c at baseline 5.6 ± 0.6%, and average daily glycemia 5.9 ± 0.6 mmol/dl. Fasting glycemia at term was significantly lower in the Insulin Group but there were no significant differences in mean daily glycemia, HbA1c and BMI at term between the groups. Longitudinally, there was a small but significant increase in BMI and a significant increase in high-density lipoprotein-cholesterol in the Insulin Group and a significant increase in the atherogenic index of plasma (AIP) and a trend towards higher triglycerides in the Metformin Group. Both fasting and average daily glycemia were significantly reduced following treatment in both groups. No such change was evident for HbA1c. In a relative risk analysis, metformin treatment was associated with an insignificant elevated risk of HbA1c, triglycerides and lipid indices falling within the

  4. Accuracy and reliability of the sensory test performed using the laryngopharyngeal endoscopic esthesiometer and rangefinder in patients with suspected obstructive sleep apnoea hypopnoea: protocol for a prospective double-blinded, randomised, exploratory study.

    Science.gov (United States)

    Giraldo-Cadavid, Luis Fernando; Bastidas, Alirio Rodrigo; Padilla-Ortiz, Diana Marcela; Concha-Galan, Diana Carolina; Bazurto, María Angelica; Vargas, Leslie

    2017-08-21

    Patients with obstructive sleep apnoea hypopnoea syndrome (OSA) might have varying degrees of laryngopharyngeal mechanical hyposensitivity that might impair the brain's capacity to prevent airway collapse during sleep. However, this knowledge about sensory compromises in OSA comes from studies performed using methods with little evidence of their validity. Hence, the purpose of this study is to assess the reliability and accuracy of the measurement of laryngopharyngeal mechanosensitivity in patients with OSA using a recently developed laryngopharyngeal endoscopic esthesiometer and rangefinder (LPEER). The study will be prospective and double blinded, with a randomised crossover assignment of raters performing the sensory tests. Subjects will be recruited from patients with suspected OSA referred for baseline polysomnography to a university hospital sleep laboratory. Intra-rater and inter-rater reliability will be evaluated using the Bland-Altman's limits of agreement plot, the intraclass correlation coefficient, and the Pearson or Spearman correlation coefficient, depending on the distribution of the variables. Diagnostic accuracy will be evaluated plotting ROC curves using standard baseline polysomnography as a reference. The sensory threshold values ​​for patients with mild, moderate and severe OSA will be determined and compared using ANOVA or the Kruskal-Wallis test, depending on the distribution of the variables. The LPEER could be a new tool for evaluating and monitoring laryngopharyngeal sensory impairment in patients with OSA. If it is shown to be valid, it could help to increase our understanding of the pathophysiological mechanisms of this condition and potentially help in finding new therapeutic interventions for OSA. The protocol has been approved by the Institutional Review Board of Fundacion Neumologica Colombiana. The results will be disseminated through conference presentations and peer-reviewed publication. This trial was registered at Clinical

  5. Prognosis of patients with peritoneal metastatic colorectal cancer given systemic therapy : an analysis of individual patient data from prospective randomised trials from the Analysis and Research in Cancers of the Digestive System (ARCAD) database

    OpenAIRE

    Franko, Jan; Shi, Qian; Meyers, Jeffrey P.; Maughan, Timothy S; Adams, Richard A.; Matthew T. Seymour; Saltz, Leonard; Punt, Cornelis J. A.; Koopman, Miriam; Tournigand, Christophe; Tebbutt, Niall C.; Diaz-Rubio, Eduardo; Souglakos, John; Falcone, Alfredo; Chibaudel, Benoist

    2016-01-01

    BACKGROUND: Patients with peritoneal metastatic colorectal cancer have reduced overall survival compared with patients with metastatic colorectal cancer without peritoneal involvement. Here we further investigated the effect of the number and location of metastases in patients receiving first-line systemic chemotherapy. METHODS: We analysed individual patient data for previously untreated patients enrolled in 14 phase 3 randomised trials done between 1997 and 2008. Trials were included if pro...

  6. Treatment of antipsychotic-associated obesity with a GLP-1 receptor agonist: Protocol for an investigator-initiated prospective, randomised, placebo-controlled, double-blinded intervention study – the TAO study

    DEFF Research Database (Denmark)

    Ishøy, Pelle Lau; Knop, Filip Krag; Broberg, Brian Villumsen

    Introduction: Antipsychotic medication is widely associated with dysmetabolism including obesity and type 2 diabetes, cardiovascular-related diseases and early death. Obesity is considered the single most important risk factor for cardiovascular morbidity and mortality. Interventions against...... with a GLP-1 receptor agonist (exenatide once-weekly) is safe and facilitates weight loss in non-diabetic schizophrenia patients with antipsychotic-associated obesity. Methods and analysis: Forty obese patients with schizophrenia or schizoaffective disorder treated with antipsychotic drugs will be randomised...

  7. Surgery and postoperative radiotherapy versus surgery alone for patients with stage-1 endometrial carcinoma : multicentre randomised trial

    NARCIS (Netherlands)

    Creutzberg, CL; van Putten, WLJ; Koper, PCM; Lybeert, MLM; Jobsen, JJ; Warlam-Rodenhuis, CC; De Winter, KAJ; Lutgens, LCHW; van den Bergh, ACM; van de Steen-Banasik, E; Beerman, H; van Lent, M

    2000-01-01

    Background Postoperative radiotherapy for international Federation of Gynaecology and Obstetrics (FIGO) stage-1 endometrial carcinoma is a subject of controversy due to the low relapse rate and the lack of data from randomised trials. We did a multicentre prospective randomised trial to find whether

  8. Effectiveness of two psychological interventions for pain management, emotional regulation and promotion of quality of life among adult Portuguese men with haemophilia (PSY-HaEMOPEQ): study protocol for a single-centre prospective randomised controlled trial

    Science.gov (United States)

    Pinto, Patrícia Ribeiro; Paredes, Ana Cristina; Costa, Patrício; Carvalho, Manuela; Lopes, Manuela; Fernandes, Susana; Almeida, Armando

    2017-01-01

    Introduction Haemophilia is a bleeding disorder associated with significant pain, emotional distress, quality of life (QoL) impairment and considerable healthcare costs. Psychosocial health and effective pain management are considered essential end points for optimal haemophilia care, but there is a significant gap in evidence-based treatments targeting these outcomes in people with haemophilia (PWH). Psychological interventions are cost-effective in promoting emotional well-being, QoL and pain control, although these have been scarcely used in haemophilia field. This investigation aims to evaluate the effectiveness of two psychological interventions for pain management, emotional regulation and promotion of QoL in PWH. Methods and analysis This is a single-centre parallel randomised controlled trial conducted at a European Haemophilia Comprehensive Care Centre in Portugal, with five assessment points: baseline (T0), postintervention (T1), 3 (T2), 6 (T3) and 12 (T4) months follow-up. Eligible adult males, with moderate or severe haemophilia A or B will be randomised to experimental (EG) or control (CG) group. Intervention is either cognitive-behavioural therapy (EG1) or hypnosis (EG2), both consisting of four weekly sessions following standardised scripts delivered by trained psychologists. Randomisation will be computer generated, allocation concealment will be guaranteed and outcome assessors will be blind to EG/CG allocation. Main outcomes are pain and haemophilia-related QoL and secondary outcomes include clinical (clotting factor replacement consumption, joint bleeding episodes, analgesic intake) and psychological (pain coping strategies, anxiety, depression, illness perceptions) variables, functional assessment of the joints, inflammatory biomarkers (cytokines, high-sensitivity C reactive protein) and white blood cell count. Ethics and dissemination This study was approved by the competent authorities and all procedures will comply with international ethical

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

    Science.gov (United States)

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

    2013-01-01

    Objectives To compare the pharmacokinetics (PK), safety and efficacy of innovator infliximab (INX) and CT-P13, a biosimilar to INX, in patients with active ankylosing spondylitis (AS). Methods Phase 1 randomised, double-blind, multicentre, multinational, parallel-group study. Patients were randomised to receive 5 mg/kg of CT-P13 (n=125) or INX (n=125). Primary endpoints were area under the concentration-time curve (AUC) at steady state and observed maximum steady state serum concentration (Cmax,ss) between weeks 22 and 30. Additional PK, efficacy endpoints, including 20% and 40% improvement response according to Assessment in Ankylosing Spondylitis International Working Group criteria (ASAS20 and ASAS40), and safety outcomes were also assessed. Results Geometric mean AUC was 32 765.8 μgh/ml for CT-P13 and 31 359.3 μgh/ml for INX. Geometric mean Cmax,ss was 147.0  μg/ml for CT-P13 and 144.8 μg/ml for INX. The ratio of geometric means was 104.5% (90% CI 94% to 116%) for AUC and 101.5% (90% CI 95% to 109%) for Cmax,ss. ASAS20 and ASAS40 responses at week 30 were 70.5% and 51.8% for CT-P13 and 72.4% and 47.4% for INX, respectively. In the CT-P13 and INX groups more than one adverse event occurred in 64.8% and 63.9% of patients, infusion reactions occurred in 3.9% and 4.9%, active tuberculosis occurred in 1.6% and 0.8%, and 27.4% and 22.5% of patients tested positive for anti-drug antibodies, respectively. Conclusions The PK profiles of CT-P13 and INX were equivalent in patients with active AS. CT-P13 was well tolerated, with an efficacy and safety profile comparable to that of INX up to week 30. PMID:23687259

  10. Tamoxifen vs Tamoxifen plus 13-cis-retinoic acid vs Tamoxifen plus Interferon alpha-2a as first-line endocrine treatments in advanced breast cancer: updated results of a phase II, prospective, randomised multicentre trial.

    Science.gov (United States)

    Chiesa, Matteo Dalla; Passalacqua, Rodolfo; Michiara, Maria; Franciosi, Vittorio; Di Costanzo, Francesco; Bisagni, Giancarlo; Camisa, Roberta; Buti, Sebastiano; Tomasello, Gianluca; Cocconi, Giorgio

    2007-12-01

    To demonstrate the efficacy of 13-cis-retinoic acid (RA) or Interferon alpha-2a (IFN alpha-2a) with Tamoxifen (TAM) in the treatment of advanced breast cancer. Ninety-nine postmenopausal patients with advanced breast cancer, and a positive or unknown estrogen (ER) or progesterone (PgR) receptor status, were randomised to receive TAM 20 mg/m2/day orally (arm A), or TAM plus RA 1 mg/kg/day orally (arm B), or TAM plus IFN alpha-2a 3 MU thrice a week intramuscular (arm C). The three treatment groups were well balanced in terms of the main prognostic factors. Response was evaluable in 32 of the patients in arm A, 32 in arm B, and 30 in arm C. Intention-to-treat analysis showed no significant difference of response rate in the three arms (44% vs 38% vs 42%). After an eight years median follow-up, there was no significant between-group difference in median overall survival: 47.4 vs 38.2 vs 45.1 months. Side effects were negligible in arm A, but cutaneous (39%) and mucosal (62%) toxicities were frequent in arm B, and flu-like syndrome and/or myalgia (46%) in arm C. The administration of RA or IFN alpha-2a does not add anything to the therapeutic effects of TAM.

  11. [Impact of a pre-operative mobilisation program using the Viv-Arte training model based on kinesthetic mobilisation on mobility, pain, and post-operation length of stay of patients receiving an elective medial laparotomy: a prospective, randomised, controlled pilot study].

    Science.gov (United States)

    Haasenritter, Jörg; Eisenschink, Anna Maria; Kirchner, Elisabeth; Bauder-Missbach, Heidi; Brach, Michael; Veith, Jessica; Sander, Silvia; Panfil, Eva-Maria

    2009-02-01

    A medial incision is a common surgical technique to obtain access to the abdomen. Thereby, the muscles involved in movement are manipulated, leading to post-operative restrictions in mobility and pain determined by movement. The aim of this pilot study was to assess the impact of a pre-operative training session using the Viv-Arte model, which is based on kinesthetic mobilisation principles. The parameters to be measured were mobility, pain, and length of hospital stay for patients, who were undergoing elective medial laparotomy. In addition, the study tested the research design and to identify possible effect sizes. The method chosen was a prospective, randomised, controlled, and unblinded design. Twenty-seven patients were involved (median=63 years, 19 of the patients were male) who were to have a medial incision for cystectomy. The intervention involved pre-operative training of post-operative mobility techniques. Mobility was tested using the "Mobilitätstest für Patienten im Akutkrankenhaus (MOTPA) (Mobility test for patients in hospital)"; pain intensity was assessed using the visual analogue scale. The intervention and control groups were comparable for all variables. There were no significant differences in the two groups related to the objectives. It is possible that the study groups or the operationalisation were not appropriate for testing the effects of the intervention. It seems important to continue to develop instruments that are appropriate for measuring the effect of mobility-related interventions.

  12. Efficacy of orally disintegrating film of ondansetron versus intravenous ondansetron in prophylaxis of postoperative nausea and vomiting in patients undergoing elective gynaecological laparoscopic procedures: A prospective randomised, double-blind placebo-controlled study

    OpenAIRE

    2014-01-01

    Background and Aims: Ondansetron is one of the most widely used drugs for postoperative nausea and vomiting (PONV) prophylaxis. Orally disintegrating film (ODF) formulations are relatively recent innovations. We evaluated the efficacy of ODF of ondansetron for the prophylaxis of PONV. Methods: One hundred and eighty American Society of Anaesthesiologists-I or II women, in the age group 18-65 years, scheduled for elective gynaecological laparoscopic procedures were studied in a prospective ran...

  13. 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.

  14. Prospective multicentre randomised, double-blind, equivalence study comparing clonidine and midazolam as intravenous sedative agents in critically ill children: the SLEEPS (Safety profiLe, Efficacy and Equivalence in Paediatric intensive care Sedation) study.

    Science.gov (United States)

    Wolf, Andrew; McKay, Andrew; Spowart, Catherine; Granville, Heather; Boland, Angela; Petrou, Stavros; Sutherland, Adam; Gamble, Carrol

    2014-12-01

    Children in paediatric intensive care units (PICUs) require analgesia and sedation but both undersedation and oversedation can be harmful. Evaluation of intravenous (i.v.) clonidine as an alternative to i.v. midazolam. Multicentre, double-blind, randomised equivalence trial. Ten UK PICUs. Children (30 days to 15 years inclusive) weighing ≤ 50 kg, expected to require ventilation on PICU for > 12 hours. Clonidine (3 µg/kg loading then 0-3 µg/kg/hour) versus midazolam (200 µg/kg loading then 0-200 µg/kg/hour). Maintenance infusion rates adjusted according to behavioural assessment (COMFORT score). Both groups also received morphine. Primary end point Adequate sedation defined by COMFORT score of 17-26 for ≥ 80% of the time with a ± 0.15 margin of equivalence. Secondary end points Percentage of time spent adequately sedated, increase in sedation/analgesia, recovery after sedation, side effects and safety data. The study planned to recruit 1000 children. In total, 129 children were randomised, of whom 120 (93%) contributed data for the primary outcome. The proportion of children who were adequately sedated for ≥ 80% of the time was 21 of 61 (34.4%) - clonidine, and 18 of 59 (30.5%) - midazolam. The difference in proportions for clonidine-midazolam was 0.04 [95% confidence interval (CI) -0.13 to 0.21], and, with the 95% CI including values outside the range of equivalence (-0.15 to 0.15), equivalence was not demonstrated; however, the study was underpowered. Non-inferiority of clonidine to midazolam was established, with the only values outside the equivalence range favouring clonidine. Times to reach maximum sedation and analgesia were comparable hazard ratios: 0.99 (95% CI 0.53 to 1.82) and 1.18 (95% CI 0.49 to 2.86), respectively. Percentage time spent adequately sedated was similar [medians clonidine 73.8% vs. midazolam 72.8%: difference in medians 0.66 (95% CI -5.25 to 7.24)]. Treatment failure was 12 of 64 (18.8%) on clonidine and

  15. The haemodynamic effects of the perioperative terlipressin infusion in living donor liver transplantation: A randomised controlled study

    OpenAIRE

    Nagwa Ibrahim; Ashraf Hasanin; Sabry Abd Allah; Eman Sayed; Mohamed Afifi; Khaled Yassen; Wesam Saber; Magdy Khalil

    2015-01-01

    Background and Aims: Liver disease is usually accompanied with a decline in systemic vascular resistance (SVR). We decided to assess effects of the peri-operative terlipressin infusion on liver donor liver transplantation recipients with respect to haemodynamics and renal parameters. Methods: After Ethical Committee approval for this prospective randomised controlled study, 50 recipients were enrolled and allotted to control (n = 25) or terlipressin group (n = 25) with simple randomisation me...

  16. PROSPECTIVE RANDOMISED COMPARATIVE STUDY OF THE EFFECTS OF 0.06% TRYPAN BLUE DYE AS AGAINST 0.03% TRYPAN BLUE DYE AFTER CORTICAL CLEAVING HYDRO-DISSECTION IN AN EFFORT TO IMPEDE THE FORMATION OF POSTERIOR CAPSULAR OPACIFICATION(PCO

    Directory of Open Access Journals (Sweden)

    Vishnu S.

    2014-11-01

    Full Text Available PURPOSE: Effect of 0.06% Trypan blue dye as against 0.03% Trypan blue dye after cortical cleaving hydro-dissection in eyes undergoing phacoemulsification. SETTING: V. M. M. C & Safdarjung hospital, New Delhi (Tertiary health care centre. DESIGN: Prospective randomised double-blind (Patient and examiner blind comparative study. MATERIALS AND METHODS : 150 eyes of 150 patients undergoing phacoemulsification were randomized to have 0.2mL of Trypan blue dye 0.06%(Group A or 0.2 mL of Trypan blue 0.03%(Group B or 0.2mL of balanced salt solution(Group C injected subcapsularly at 2 sites 180 degrees apart after cortical-cleaving hydro dissection. 6 month and 12 month postoperative PCO was analyzed by a masked examiner using the ‘Evaluation of Posterior capsule Opacification (EPCO’ score using the EPCO-2000 software on digitalised images of slitlamp retroillumination. Best corrected visual acuity (BCVA on Snellen’s charts and Nd-YAG capsulotomy rates were also recorded. RESULTS: The difference in mean EPCO score between Group A and Group C was statistically significant both at 6 months (p=0.038 and even at 12 months (p=0.032 using the independent-t-test. The difference in Nd-YAG capsulotomy rates between Group A and Group C was statistically significant both at 6 months (p=0.018 and even at 12 months (p=0.014 using the chi-square test. BCVA ranged from 6/6 to 6/12P Snellen depending on the age-related changes in the cornea and retina. CONCLUSION: 0.06% Trypan blue dye reduced the incidence of posterior capsular opacification (PCO at 6 month and 12 month follow-up as compared to 0.03% trypan blue dye or balanced salt solution in similar manner

  17. 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

    Directory of Open Access Journals (Sweden)

    Hemmen Bena

    2009-01-01

    Full Text Available 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 rehabilitation centre, a nursing home or the community. Typically, each of the CTCS partners may have its own more or less autonomous treatment perspective. Clinical evidence, however, suggests that an integrated multi-trauma rehabilitation approach ('Supported Fast-track multi-Trauma Rehabilitation Service': SFTRS, featuring: 1 earlier transfer to a specialised trauma rehabilitation unit; 2 earlier start of 'non-weight-bearing' training and multidisciplinary treatment; 3 well-documented treatment protocols; 4 early individual goal-setting; 5 co-ordination of treatment between trauma surgeon and physiatrist, and 6 shorter lengths-of-stay, may be more (cost-effective. This paper describes the design of a prospective cohort study evaluating the (cost- effectiveness of SFTRS relative to CTCS. Methods/design The study population includes multi-trauma patients, admitted to one of the participating hospitals, with an Injury Severity Scale score > = 16, complex multiple injuries in several extremities or complex pelvic and/or acetabulum fractures. In a prospective cohort study CTCS and SFTRS will be contrasted. The inclusion period is 19 months. The duration of follow-up is 12 months, with measurements taken at baseline, and at 3,6,9 and 12 months post-injury. Primary outcome measures are 'quality of life' (SF-36 and 'functional health status' (Functional Independence Measure. Secondary outcome measures are the Hospital Anxiety & Depression Scale, the Mini-Mental State Examination as an indicator of cognitive functioning, and the Canadian Occupational Performance Measure measuring the extent to which individual ADL treatment goals are met. Costs will be assessed

  18. Randomised clinical trial

    DEFF Research Database (Denmark)

    Reimer, C; Lødrup, A B; Smith, G;

    2016-01-01

    BACKGROUND: Many reflux patients remain symptomatic on a standard dose of proton pump inhibitor (PPI). Alginates decrease the number of reflux events by forming a raft on top of the stomach content and thus offer a supplemental mechanism of action to acid suppression. AIM: To assess the efficacy...... of an alginate (Gaviscon Advance, Reckitt Benckiser, Slough, UK) on reflux symptoms in patients with persistent symptoms despite once daily PPI. METHODS: This was a multicentre, randomised, placebo-controlled, 7-day double-blind trial preceded by a 7-day run-in period. Reflux symptoms were assessed using......: In patients with residual reflux symptoms despite PPI treatment, adding an alginate offers additional decrease in the burden of reflux symptoms (EudraCT/IND Number: 2011-005486-21)....

  19. The significance of clinical experience on learning outcome from resuscitation training-a randomised controlled study

    DEFF Research Database (Denmark)

    Jensen, Morten Lind; Lippert, Freddy; Hesselfeldt, Rasmus

    2009-01-01

    and retention of learning. Materials and methods: This was a prospective single blinded randomised controlled study of the learning outcome from a standard ALS course on a volunteer sample of the entire cohort of newly graduated doctors from Copenhagen University. The outcome measurement was ALS...... a small but statistically significant impact on the retention of learning, but not on the immediate learning outcome....

  20. Reducing chemotherapy use in clinically high-risk, genomically low-risk pN0 and pN1 early breast cancer patients: five-year data from the prospective, randomised phase 3 West German Study Group (WSG) PlanB trial.

    Science.gov (United States)

    Nitz, Ulrike; Gluz, Oleg; Christgen, Matthias; Kates, Ronald E; Clemens, Michael; Malter, Wolfram; Nuding, Benno; Aktas, Bahriye; Kuemmel, Sherko; Reimer, Toralf; Stefek, Andrea; Lorenz-Salehi, Fatemeh; Krabisch, Petra; Just, Marianne; Augustin, Doris; Liedtke, Cornelia; Chao, Calvin; Shak, Steven; Wuerstlein, Rachel; Kreipe, Hans H; Harbeck, Nadia

    2017-06-29

    The prospective phase 3 PlanB trial used the Oncotype DX(®) Recurrence Score(®) (RS) to define a genomically low-risk subset of clinically high-risk pN0-1 early breast cancer (EBC) patients for treatment with adjuvant endocrine therapy (ET) alone. Here, we report five-year data evaluating the prognostic value of RS, Ki-67, and other traditional clinicopathological parameters. A central tumour bank was prospectively established within PlanB. Following an early amendment, hormone receptor (HR)+ , pN0-1 RS ≤ 11 patients were recommended to omit chemotherapy. Patients with RS ≥ 12, pN2-3, or HR-negative/HER2-negative disease were randomised to anthracycline-containing or anthracycline-free chemotherapy. Primary endpoint: disease-free survival (DFS). PlanB Clinicaltrials.gov identifier: NCT01049425. From 2009 to 2011, PlanB enrolled 3198 patients (central tumour bank, n = 3073) with the median age of 56 years, 41.1% pN+, and 32.5% grade 3 EBC. Chemotherapy was omitted in 348/404 (86.1%) eligible RS ≤ 11 patients. After 55 months of median follow-up, five-year DFS in ET-treated RS ≤ 11 patients was 94% (in both pN0 and pN1) versus 94% (RS 12-25) and 84% (RS > 25) in chemotherapy-treated patients (p five-year overall survival (OS) was 99 versus 97% and 93%, respectively (p 2 cm, and RS, but not IHC4 or Ki-67 were independent adverse factors. If RS was excluded, IHC4 or both Ki-67 and PR entered the model. The impact of RS was particularly pronounced in patients with intermediate Ki-67 (>10%, five-year outcomes in clinically high-risk, genomically low-risk (RS ≤ 11) pN0-1 patients without adjuvant chemotherapy support using RS with standardised pathology for treatment decisions in HR+ HER2-negative EBC. Ki-67 has the potential to support patient selection for genomic testing.

  1. Risk of high-grade cervical intraepithelial neoplasia during follow-up in HPV-positive women according to baseline p16-INK4A results: a prospective analysis of a nested substudy of the NTCC randomised controlled trial.

    Science.gov (United States)

    Carozzi, Francesca; Gillio-Tos, Anna; Confortini, Massimo; Del Mistro, Annarosa; Sani, Cristina; De Marco, Laura; Girlando, Salvatore; Rosso, Stefano; Naldoni, Carlo; Dalla Palma, Paolo; Zorzi, Manuel; Giorgi-Rossi, Paolo; Segnan, Nereo; Cuzick, Jack; Ronco, Guglielmo

    2013-02-01

    Immunostaining for p16-INK4A (henceforth p16) is a sensitive and specific method for detection of high-grade cervical intraepithelial neoplasia (CIN) in women infected with human papillomavirus (HPV), but longitudinal data have not been obtained. We investigated the relation between p16 status and risk of CIN during 3 years of follow-up. Women aged 25-60 years were enrolled between June 10, 2003, and Dec 31, 2004, in a multicentre randomised trial comparing HPV testing with cytology. HPV-positive women were referred for colposcopy and, in seven of nine centres, were tested for p16 overexpression by immunostaining. If no CIN was detected, these women were followed up at yearly intervals until clearance of HPV infection. The primary endpoint was histologically confirmed CIN of grade 2 or worse (CIN of grade 2 [CIN2], CIN of grade 3 [CIN3], or invasive cervical cancer) at recruitment or during follow-up. We calculated the absolute and relative risks by p16 status at recruitment. We also calculated the longitudinal sensitivity of p16 testing. Additionally, we assessed the relative sensitivity of an alternative strategy (referral to colposcopy and follow-up of only HPV-positive, p16-positive women) versus conventional cytology in two age groups. Percentages were weighted by the inverse of the tested fraction. The trial in which this study is nested is registered, number ISRCTN81678807. Of 1042 HPV-positive women who were tested for p16 with no CIN detected during the first round of screening, 944 (91%) had further HPV tests. 793 (84%) of these 944 were followed up until detection of CIN2 or worse, HPV infection clearance, or for at least 3 years. CIN2 or worse was detected during follow-up in more p16-positive women (31 of 365, 8·8% [95% CI 5·8-11·8]) than in p16-negative women (17 of 579, 3·7% [1·9-5·4]; relative risk [RR] 2·61 [95% CI 1·49-4·59]). RR was higher in women aged 35-60 years at recruitment (3·37 [1·39-8·15]) than in those aged 25-34 years (2

  2. Immune response gene expression in colorectal cancer carries distinct prognostic implications according to tissue, stage and site: a prospective retrospective translational study in the context of a hellenic cooperative oncology group randomised trial.

    Directory of Open Access Journals (Sweden)

    George Pentheroudakis

    Full Text Available Although host immune response is an emerging prognostic factor for colorectal cancer, there is no consensus on the optimal methodology, surrogate markers or tissue for study.Tumour blocks were prospectively collected from 344 patients with stage II/III colorectal cancer (CRC treated with adjuvant chemotherapy. Whole section lymphocytic infiltration was studied along with mRNA expression of CD3Z, CD8, CD4, CXCL9, CXCL13, IGHM, FOXP3, SNAI2 and ESR1 by qRT-qPCR in tissue microarray (TMA cores from the centre of tumour, invasive margin and adjacent normal mucosa.Lymphocytic infiltration, deficient MMR (10.9%, KRAS (40.7% and BRAF (4.9% mutations or single mRNA gene expression were not prognostic. Tumour ESR1 gene expression (Hazard Ratio [HR] for relapse 2.33, 95% CI 1.35-4.02; HR for death 1.74, 95% CI 1.02-2.97 and absence of necrosis (HR for relapse 1.71, 95% CI 1.05-2.71; HR for death 1.98, 95% CI 1.14-3.43 were adverse prognostic features. We used CD3Z and CD8 expression in order to devise the mRNA-based Immune Score (mIS and proceeded to partitioning analysis in 267 patients, with age, stage, tumour site (Right vs Left CRC, KRAS mutation and tumour mIS as input factors. Only in patients with stage III right-sided colon cancer, a low immune response was associated with inferior disease-free survival (mIS-low, HR for relapse 2.28, 95% CI 1.05-8.02. No prognostic significance was seen for tumour mIS in any other stage or site of CRC, or for a similar mIS score derived from adjacent normal mucosa. Independent adverse prognostic significance was retained in multivariable analysis for absence of necrosis, tumour ESR1 expression in all patients and low tumour mIS in stage III right-sided CRC.In localised CRC, mRNA-based CD3Z/CD8 profiling of tumour immune response may have stage, site and tissue-specific prognostic significance, along with ESR1 expression.ANZCTR.org.au ACTRN12610000509066.

  3. A critical appraisal of Vlasselaers D, Milants I, Desmet L, et al: intensive insulin therapy for patients in paediatric intensive care: a prospective, randomised controlled study. Lancet 2009; 373:547-556.

    Science.gov (United States)

    Ulate, Kalia P

    2011-07-01

    To review findings and discuss implications of strict glycemic control in children. Critical appraisal of a randomized controlled trial. This is the largest prospective randomized controlled trial to date, comparing intensive insulin therapy (glycemic targets: 50.4-79.2 mg/dL [2.8-4.4 mmol/L] and 70.2-99 mg/dL [3.9-5.5 mmol/L] [for infants and children, respectively]) and conventional insulin therapy (target: 180-215 mg/dl [10-11.9 mmol/L]) among critically ill children. Groups were similar at enrollment and had comparable forms of nutrition and glucose infusion rates. Steroid use and vasoactive-inotrope scores were not compared. Intensive insulin therapy reduced pediatric intensive care unit length of stay (primary outcome measure) and attenuated C-reactive protein concentrations >5 days. The effect of intensive insulin therapy on secondary outcome measures was precise in regards to significant reductions in secondary infection occurrence (absolute risk reduction = 7.6% [95% confidence interval: 0.6-14.4], number needed to treat = 14 [95% confidence interval: 7-179]) and need for vasoactive support beyond 2 days (absolute risk reduction = 10.4% [95% confidence interval: 3-17], number needed to treat = 10 [95% confidence interval: 6-30]). Mortality decreased with intensive insulin therapy (p = .038); however, this finding was imprecise (absolute risk reduction = 3.1% [95% confidence interval: 0.2-5.4], number needed to treat = 33 [95% confidence interval: 18.6-597.3]). The incidence of hypoglycemia was significantly higher with intensive insulin therapy (absolute risk increase = 23.5% [95% confidence interval: 20-25%], number needed to harm = 4 [95% confidence interval: 4-5]). Long-term effects on outcomes were not evaluated, and the authors recognize the need for such follow-up studies. This study demonstrated efficacy of intensive insulin therapy at the same institution where the original adult intensive insulin therapy trial was conducted, but it may not

  4. [Topical versus contact anaesthesia in conventional trabeculectomy. Prospective randomised study].

    Science.gov (United States)

    Pablo Júlvez, L E; Pérez-Oliván, S; Ferreras Amed, A; Larrosa Poves, J M; Gómez Martínez, M L; Honrubia López, F M

    2003-05-01

    To compare the pain rates, comfort levels and safety between conventional topical anaesthesia and the application of a long lasting lidocaine soaked film or contact anaesthesia. Fifty patients undergoing conventional trabeculectomy with or without Mitomycin-C were included. One half received topical anaesthesia and the other half contact anaesthesia in a random fashion. Pain and discomfort rates before, during and after surgery were evaluated on a scale from 0 to 5, also, surgeon subjective stress and complications observed were included in the clinical protocol. Significant differences were found between both groups regarding pain rates, during and after surgery, and surgeon stress level. Sedation and change of anesthesic method were required more frequently by the patients included in the topical anaesthesia group. Topical anaesthesia provides sufficient level of anaesthesia for performing a trabeculectomy. Nevertheless pain rate differences between contact and conventional topical anaesthesia were patent during and after surgery. Contact anaesthesia appears to be a valid and practical alternative in a wide range of patients undergoing glaucoma surgery.

  5. PROSPECTIVE NON-RANDOMISED OBSERVATIONAL CASE STUDY DIABETIC MACULOPATHY

    Directory of Open Access Journals (Sweden)

    Sivaraman M

    2017-03-01

    Full Text Available BACKGROUND The epidemiological study of diabetic maculopathy in Indian population for the period of three years duration and study the treatment outcome following laser photocoagulation for various type of diabetic maculopathy. MATERIALS AND METHODS The study was conducted from July 2000 to November 2002 in 96 eyes of 50 patients. Diabetic patients either referred or detected at GOH are taken into study. History regarding onset, duration, family history, drug schedule and dietary habits. Associated systemic factors HT, IHD, renal diseases are recorded. Patients are tested for BCVA using Snellen’s chart, IOP using Goldmann applanation tonometer, slit lamp examination, fundus examination using direct and indirect ophthalmoscope and 90D biomicroscopy. Fundus photography taken using fundus camera. FFA done in all cases. RESULTS 32 patients were above 50 years of age and 18 patients are below 50 years of age. The ratio of male-to-female is 2.85:1 and 92% of patients have bilateral involvement. 28% of patients with maculopathy had diabetes mellitus of 6-10 years duration and 24% of patients had 11-15 years duration. 18.7% cases had clinically significant macular oedema. In FFA study showed 44.8% had focal lesions, 34.4% had diffuse lesions and 28.8% had ischaemic lesions. 76.9% of focal lesions improved with focal photocoagulation and 50% of diffuse lesions improved with grid photocoagulation. CONCLUSION Diabetic maculopathy is the commonest cause of visual loss in patient with diabetic retinopathy. Periodic follow up and examination are necessary to detect the involvement of macula at an earlier stage. Early treatment with photocoagulation can stabilise the visual acuity and prevent visual loss.

  6. Effect of diathermy on pain and healing in tonsillectomy, compared with other methods of haemostasis: a randomised study

    DEFF Research Database (Denmark)

    Hahn, C.H.; Rungby, J.A.; Overgaard, T.

    2008-01-01

    Objective:To compare three methods of haemostasis used for 'cold steel' tonsillectomy, in terms of pain scores and morbidity.Method and material:Prospective, randomised, single-blinded, controlled clinical study. Three haemostasis methods were compared: compression of the tonsillar fossae...

  7. Effect of training traditional birth attendants on neonatal mortality (Lufwanyama Neonatal Survival Project): randomised controlled study

    OpenAIRE

    Gill, Christopher J.; Phiri-Mazala, Grace; Guerina, Nicholas G.; Kasimba, Joshua; Mulenga, Charity; MacLeod, William B; Waitolo, Nelson; Knapp, Anna B; Mirochnick, Mark; Mazimba, Arthur; Matthew P Fox; Sabin, Lora; Seidenberg, Philip; SIMON, Jonathon L.; Hamer, Davidson H

    2011-01-01

    Objective To determine whether training traditional birth attendants to manage several common perinatal conditions could reduce neonatal mortality in the setting of a resource poor country with limited access to healthcare. Design Prospective, cluster randomised and controlled effectiveness study. Setting Lufwanyama, an agrarian, poorly developed district located in the Copperbelt province, Zambia. All births carried out by study birth attendants occurred at mothers’ homes, in rural village s...

  8. Cereal fibre and type 2 diabetes: time now for randomised controlled trials?

    Science.gov (United States)

    Whincup, Peter H; Donin, Angela S

    2015-07-01

    Diet and nutrition are strongly implicated in the aetiology of type 2 diabetes; low dietary fibre intake could be an important factor. Evidence from prospective observational studies has suggested that it may be low cereal fibre intake, rather than low fruit and vegetable fibre intake, which is particularly important. In this issue of Diabetologia (DOI 10.1007/s00125-015-3585-9 ) Kuijsten et al report on the prospective associations between different dietary fibre sources and type 2 diabetes risk in the European Prospective Investigation of Cancer and Nutrition (EPIC)-Interact study and set their findings in context with a meta-analysis of relevant published prospective studies. The results presented strengthen the evidence implicating cereal fibre as an important determinant of type 2 diabetes risk and suggest that randomised controlled trials examining the effect of cereal fibre supplementation on type 2 diabetes risk are now needed.

  9. PROSPECTING EXPLORATION

    Institute of Scientific and Technical Information of China (English)

    2008-01-01

    <正>20082879 Chen Yaoyu(No.3 Geology and Mineral Exploration Team,Gansu Provincial Bureau of Geology and Mineral Exploration and Development,Lanzhou 730050,China); Gong Quansheng Discussion on the Division of Deposit Scale and the Index of Ore Prospecting(Gansu Geology,ISSN 1004—4116,CN62—1191/P,16(3),2007,p.6—11,4 tables,6 refs.) Key words:prospecting and exploration of mineral

  10. Pneumatic retinopexy versus scleral buckling: a randomised controlled trial.

    Science.gov (United States)

    Mulvihill, A; Fulcher, T; Datta, V; Acheson, R

    1996-01-01

    Pneumatic retinopexy (PR) is a technique for repairing certain retinal detachments which is easier to perform than conventional sceral buckling (SB) surgery but has comparable results. We performed a prospective, randomised, controlled trial to determine for ourselves whether PR is a safe and acceptable procedure. Twenty patients presenting consecutively with retinal detachments which fulfilled the selection criteria were randomised to have their detachments repaired by either PR or SB, ten patients in each group. The suitable patients had a single retinal break or small group of breaks of not greater than one clock hour in size, situated within the superior eight clock hours of retina. Patients with significant proliferative vitreoretinopathy or other fundus disorders were excluded. All patients in the PR group had local anaesthesia while all those in the SB group had general anaesthesia. Successful reattachment of the retina was achieved with one or more procedures in 90 percent of the PR group and in 100 percent of the SB group. We feel that narrowing the selection criteria for PR may further improve the success rate.

  11. Supported employment: randomised controlled trial*

    Science.gov (United States)

    Howard, Louise M.; Heslin, Margaret; Leese, Morven; McCrone, Paul; Rice, Christopher; Jarrett, Manuela; Spokes, Terry; Huxley, Peter; Thornicroft, Graham

    2010-01-01

    Background There is evidence from North American trials that supported employment using the individual placement and support (IPS) model is effective in helping individuals with severe mental illness gain competitive employment. There have been few trials in other parts of the world. Aims To investigate the effectiveness and cost-effectiveness of IPS in the UK. Method Individuals with severe mental illness in South London were randomised to IPS or local traditional vocational services (treatment as usual) (ISRCTN96677673). Results Two hundred and nineteen participants were randomised, and 90% assessed 1 year later. There were no significant differences between the treatment as usual and intervention groups in obtaining competitive employment (13% in the intervention group and 7% in controls; risk ratio 1.35, 95% CI 0.95–1.93, P = 0.15), nor in secondary outcomes. Conclusions There was no evidence that IPS was of significant benefit in achieving competitive employment for individuals in South London at 1-year follow-up, which may reflect suboptimal implementation. Implementation of IPS can be challenging in the UK context where IPS is not structurally integrated with mental health services, and economic disincentives may lead to lower levels of motivation in individuals with severe mental illness and psychiatric professionals. PMID:20435968

  12. A randomised, controlled study of peri-operative low dose s(+)-ketamine in combination with postoperative patient-controlled s(+)-ketamine and morphine after radical prostatectomy.

    NARCIS (Netherlands)

    Snijdelaar, D.G.; Cornelisse, H.B.; Schmid, R.L.; Katz, J.

    2004-01-01

    In a randomised, double-blind prospective study we compared the effects on postoperative pain and analgesic consumption of intra-operative s(+)-ketamine (100 microg.kg-1 bolus and a continuous infusion of 2 microg.kg-1.min-1) followed by postoperative patient-controlled analgesia with morphine (1 mg

  13. Efficacy and tolerability of urate-lowering drugs in gout : a randomised controlled trial of benzbromarone versus probenecid after failure of allopurinol

    NARCIS (Netherlands)

    Reinders, Mattheus; van Roon, E.N.; Jansen, T.L.; Delsing, J.; Griep, E.N.; Hoekstra, M.; van de Laar, M.F.; Brouwers, J.R.

    Objectives: To investigate the efficacy and tolerability of allopurinol as the first-choice antihyperuricaemic treatment for gout, and compare the efficacy and tolerability of benzbromarone and probenecid as second-choice treatment. Methods: Prospective, multicentre, open-label, two-stage randomised

  14. Extensively hydrolysed casein formula supplemented with Lactobacillus rhamnosus GG maintains hypoallergenic status : randomised double-blind, placebo-controlled crossover trial

    NARCIS (Netherlands)

    Muraro, Antonella; Hoekstra, Maarten O.; Meijer, Yolanda; Lifschitz, Carlos; Wampler, Jennifer L.; Harris, Cheryl; Scalabrin, Deolinda M. F.

    2012-01-01

    Objective: To evaluate the hypoallergenicity of an extensively hydrolysed (EH) casein formula supplemented with Lactobacillus rhamnosus GG (LGG). Design: A prospective, randomised, double-blind, placebo-controlled crossover trial. Setting: Two study sites in Italy and The Netherlands. Study particip

  15. A randomised, controlled study of peri-operative low dose s(+)-ketamine in combination with postoperative patient-controlled s(+)-ketamine and morphine after radical prostatectomy.

    NARCIS (Netherlands)

    Snijdelaar, D.G.; Cornelisse, H.B.; Schmid, R.L.; Katz, J.

    2004-01-01

    In a randomised, double-blind prospective study we compared the effects on postoperative pain and analgesic consumption of intra-operative s(+)-ketamine (100 microg.kg-1 bolus and a continuous infusion of 2 microg.kg-1.min-1) followed by postoperative patient-controlled analgesia with morphine (1 mg

  16. Efficacy and tolerability of urate-lowering drugs in gout : a randomised controlled trial of benzbromarone versus probenecid after failure of allopurinol

    NARCIS (Netherlands)

    Reinders, Mattheus; van Roon, E.N.; Jansen, T.L.; Delsing, J.; Griep, E.N.; Hoekstra, M.; van de Laar, M.F.; Brouwers, J.R.

    2009-01-01

    Objectives: To investigate the efficacy and tolerability of allopurinol as the first-choice antihyperuricaemic treatment for gout, and compare the efficacy and tolerability of benzbromarone and probenecid as second-choice treatment. Methods: Prospective, multicentre, open-label, two-stage randomised

  17. Biodiversity Prospecting.

    Science.gov (United States)

    Sittenfeld, Ana; Lovejoy, Annie

    1994-01-01

    Examines the use of biodiversity prospecting as a method for tropical countries to value biodiversity and contribute to conservation upkeep costs. Discusses the first agreement between a public interest organization and pharmaceutical company for the extraction of plant and animal materials in Costa Rica. (LZ)

  18. Randomised trial on episodic cluster headache with an angiotensin II receptor blocker

    DEFF Research Database (Denmark)

    Tronvik, Erling; Wienecke, Troels; Monstad, Inge

    2013-01-01

    OBJECTIVES: The aim of this study was to evaluate the angiotensin II receptor antagonist candesartan as prophylactic medication in patients with episodic cluster headache. METHODS: This study comprised a prospective, placebo-controlled, double-blind, parallel-designed trial performed in seven...... centres in Scandinavia. Forty (40) patients with episodic cluster headache (ICHD-2) were recruited and randomised over a five-year period to placebo or 16 mg candesartan in the first week, and placebo or 32 mg candesartan in the second and third week. RESULTS: The number of cluster headache attacks...

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

    DEFF Research Database (Denmark)

    2009-01-01

    OBJECTIVE: To assess the effect of virtual reality training on an actual laparoscopic operation. DESIGN: Prospective randomised controlled and blinded trial. SETTING: Seven gynaecological departments in the Zeeland region of Denmark. PARTICIPANTS: 24 first and second year registrars specialising...... in gynaecology and obstetrics. INTERVENTIONS: Proficiency based virtual reality simulator training in laparoscopic salpingectomy and standard clinical education (controls). MAIN OUTCOME MEASURE: The main outcome measure was technical performance assessed by two independent observers blinded to trainee......-14 minutes) and in the control group was 24 (20-29) minutes (Pvirtual reality simulator training. The performance level of novices...

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

    Directory of Open Access Journals (Sweden)

    Dijkgraaf Marcel G

    2010-03-01

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

  1. 64-Slice CT angiography of the abdominal aorta and abdominal arteries: comparison of the diagnostic efficacy of iobitridol 350 mgI/ml versus iomeprol 400 mgI/ml in a prospective, randomised, double-blind multi-centre trial

    Energy Technology Data Exchange (ETDEWEB)

    Loewe, Christian; Schernthaner, Melanie; Lammer, Johannes [Medical University Vienna, Section of Cardiovascular and Interventional Radiology, Department of Radiology, Vienna (Austria); Becker, Christoph R.; Hittinger, Markus [University Hospital Grosshadern, Department of Clinical Radiology, Munich (Germany); Berletti, Riccardo; Favat, Massimo [Belluno Civil Hospital, Department of Radiology, Belluno (Italy); Cametti, Carlo Alberto; Marangoni, Roberto [ASL TO2 Ospedale San G. Bosco, Department of Radiology, Torino (Italy); Caudron, Jerome; Lestrat, Jean-Pierre [University Hospital of Rouen, Department of Radiology, Rouen (France); Coudyzer, Walter; Heye, Sam [UZ Leuven, Department of Radiology, Leuven (Belgium); Mey, Johan de; Nieboer, Koenraad [UZ Brussel, Department of Radiology, Brussels (Belgium); Heautot, Jean-Francois; Larralde, Antoine [Pontchaillou Hospital, Department of Radiology, Rennes (France); Reimer, Peter; Schwarz, Martin [Staedt. Klinikum Karlsruhe, Department of Radiology, Karlsruhe (Germany)

    2010-03-15

    The purpose of this study was to assess the influence of iodine concentration on diagnostic efficacy in multi-detector-row computed tomography (MDCT) angiography of the abdominal aorta and abdominal arteries. IRB approval and informed consent were obtained. In this double-blind trial, patients were randomised to undergo MDCT angiography of the abdominal arteries during administration of iobitridol (350 mgI/ml) or iomeprol (400 mgI/ml). Each centre applied its own technique for delivery of contrast medium, regardless of iodine concentration. Diagnostic efficacy, image quality, visualisation of the arterial wall and arterial enhancement were evaluated. A total of 153 patients received iobitridol and 154 received iomeprol. The ability to reach a diagnosis was ''satisfactory'' to ''totally satisfactory'' in 152 (99.3%) and 153 (99.4%) patients respectively. Image quality was rated as being ''good'' to ''excellent'' in 94.7 and 94.8% segments respectively. Similar results were observed for image quality of arterial walls (84.3 vs. 83.2%). The mean relative changes in arterial enhancement between baseline and arterial phase images showed no statistically significant differences. This study demonstrated the non-inferiority of the 350 versus 400 mgI/ml iodine concentration, in terms of diagnostic efficacy, in abdominal MDCT angiography. It also confirmed the high robustness and reliability of this technique across multi-national practices. (orig.)

  2. 64-Slice CT angiography of the abdominal aorta and abdominal arteries: comparison of the diagnostic efficacy of iobitridol 350 mgI/ml versus iomeprol 400 mgI/ml in a prospective, randomised, double-blind multi-centre trial.

    Science.gov (United States)

    Loewe, Christian; Becker, Christoph R; Berletti, Riccardo; Cametti, Carlo Alberto; Caudron, Jerome; Coudyzer, Walter; De Mey, Johan; Favat, Massimo; Heautot, Jean-François; Heye, Sam; Hittinger, Markus; Larralde, Antoine; Lestrat, Jean-Pierre; Marangoni, Roberto; Nieboer, Koenraad; Reimer, Peter; Schwarz, Martin; Schernthaner, Melanie; Lammer, Johannes

    2010-03-01

    The purpose of this study was to assess the influence of iodine concentration on diagnostic efficacy in multi-detector-row computed tomography (MDCT) angiography of the abdominal aorta and abdominal arteries. IRB approval and informed consent were obtained. In this double-blind trial, patients were randomised to undergo MDCT angiography of the abdominal arteries during administration of iobitridol (350 mgI/ml) or iomeprol (400 mgI/ml). Each centre applied its own technique for delivery of contrast medium, regardless of iodine concentration. Diagnostic efficacy, image quality, visualisation of the arterial wall and arterial enhancement were evaluated. A total of 153 patients received iobitridol and 154 received iomeprol. The ability to reach a diagnosis was "satisfactory" to "totally satisfactory" in 152 (99.3%) and 153 (99.4%) patients respectively. Image quality was rated as being "good" to "excellent" in 94.7 and 94.8% segments respectively. Similar results were observed for image quality of arterial walls (84.3 vs. 83.2%). The mean relative changes in arterial enhancement between baseline and arterial phase images showed no statistically significant differences. This study demonstrated the non-inferiority of the 350 versus 400 mgI/ml iodine concentration, in terms of diagnostic efficacy, in abdominal MDCT angiography. It also confirmed the high robustness and reliability of this technique across multi-national practices.

  3. Is the randomised controlled trial the best?

    African Journals Online (AJOL)

    is taken out of the analysis, or to the exaggeration of effect; in a large study, for ... randomisation was 64 years; yet most often hormone replacement therapy (HRT) is ... in labour, and not the aggressive syntocinon augmentation, in the highly ...

  4. Two-stage implant-based breast reconstruction compared with immediate one-stage implant-based breast reconstruction augmented with an acellular dermal matrix : An open-label, phase 4, multicentre, randomised, controlled trial

    NARCIS (Netherlands)

    Dikmans, Rieky E. G.; Negenborn, Vera L.; Bouman, Mark-Bram; Winters, Hay A. H.; Twisk, Jos W. R.; Ruhe, P. Quinten; Mureau, Marc A M; Smit, J.M.; Tuinder, Stefania; Eltahir, Yassir; Posch, Nicole A.; van Steveninck-Barends, Josephina M.; Meesters-Caberg, Marleen A.; van der Hulst, Rene R. W. J.; Ritt, Marco J. P. F.; Mullender, Margriet G.

    Background The evidence justifying the use of acellular dermal matrices (ADMs) in implant-based breast reconstruction (IBBR) is limited. We did a prospective randomised trial to compare the safety of IBBR with an ADM immediately after mastectomy with that of two-stage IBBR. Methods We did an

  5. A PROSPECTIVE STUDY TO ASSESS EFFICACY OF DIRECTLY OBSERVED TREATMENT SHORT - COURSE INTERMITTENT REGIME IN DIFFERENT STAGES OF SPINAL TUBERCULOSIS

    OpenAIRE

    Manoj Kumar; Somashekara; Shivaraj; Abhijit Patil; Suresh

    2015-01-01

    STUDY DESIGN: A Prospective non - randomised study . INTRODUCTION: Management of Tuberculosis spine still possesses many challenges. Availability of anti - tubercular drugs has changed the outcome. However, present recommendation by the WHO of Directly Observed Treatment Short - course (DOTS) has sound scientific basis, but the optimum duration is ...

  6. Increasing recruitment to randomised trials: a review of randomised controlled trials

    Directory of Open Access Journals (Sweden)

    Torgerson David J

    2006-07-01

    Full Text Available Abstract Background Poor recruitment to randomised controlled trials (RCTs is a widespread and important problem. With poor recruitment being such an important issue with respect to the conduct of randomised trials, a systematic review of controlled trials on recruitment methods was undertaken in order to identify strategies that are effective. Methods We searched the register of trials in Cochrane library from 1996 to end of 2004. We also searched Web of Science for 2004. Additional trials were identified from personal knowledge. Included studies had to use random allocation and participants had to be allocated to different methods of recruitment to a 'real' randomised trial. Trials that randomised participants to 'mock' trials and trials of recruitment to non-randomised studies (e.g., case control studies were excluded. Information on the study design, intervention and control, and number of patients recruited was extracted by the 2 authors. Results We identified 14 papers describing 20 different interventions. Effective interventions included: telephone reminders; questionnaire inclusion; monetary incentives; using an 'open' rather than placebo design; and making trial materials culturally sensitive. Conclusion Few trials have been undertaken to test interventions to improve trial recruitment. There is an urgent need for more RCTs of recruitment strategies.

  7. The haemodynamic effects of the perioperative terlipressin infusion in living donor liver transplantation: A randomised controlled study

    Directory of Open Access Journals (Sweden)

    Nagwa Ibrahim

    2015-01-01

    Full Text Available Background and Aims: Liver disease is usually accompanied with a decline in systemic vascular resistance (SVR. We decided to assess effects of the peri-operative terlipressin infusion on liver donor liver transplantation recipients with respect to haemodynamics and renal parameters. Methods: After Ethical Committee approval for this prospective randomised controlled study, 50 recipients were enrolled and allotted to control (n = 25 or terlipressin group (n = 25 with simple randomisation method. Terlipressin was infused at 1.0 μg/kg/h and later titrated 1.0-4.0 μg/kg/h to maintain mean arterial pressure (MAP >65 mmHg and SVR index 0.05 and was sustained post-operatively. Conclusion: Terlipressin improved SVR and MAP with less need for catecholamines particularly post-reperfusion. Terlipressin reduced PPV without hepatic artery vasoconstriction and improved post-operative UOP.

  8. The haemodynamic effects of the perioperative terlipressin infusion in living donor liver transplantation: A randomised controlled study

    Science.gov (United States)

    Ibrahim, Nagwa; Hasanin, Ashraf; Allah, Sabry Abd; Sayed, Eman; Afifi, Mohamed; Yassen, Khaled; Saber, Wesam; Khalil, Magdy

    2015-01-01

    Background and Aims: Liver disease is usually accompanied with a decline in systemic vascular resistance (SVR). We decided to assess effects of the peri-operative terlipressin infusion on liver donor liver transplantation recipients with respect to haemodynamics and renal parameters. Methods: After Ethical Committee approval for this prospective randomised controlled study, 50 recipients were enrolled and allotted to control (n = 25) or terlipressin group (n = 25) with simple randomisation method. Terlipressin was infused at 1.0 μg/kg/h and later titrated 1.0–4.0 μg/kg/h to maintain mean arterial pressure (MAP) >65 mmHg and SVR index 0.05) and was sustained post-operatively. Conclusion: Terlipressin improved SVR and MAP with less need for catecholamines particularly post-reperfusion. Terlipressin reduced PPV without hepatic artery vasoconstriction and improved post-operative UOP. PMID:25838587

  9. Randomised controlled trials: important but overrated?

    LENUS (Irish Health Repository)

    Boylan, J F

    2012-02-01

    Practising physicians individualise treatments, hoping to achieve optimal outcomes by tackling relevant patient variables. The randomised controlled trial (RCT) is universally accepted as the best means of comparison. Yet doctors sometimes wonder if particular patients might benefit more from treatments that fared worse in the RCT comparisons. Such clinicians may even feel ostracised by their peers for stepping outside treatments based on RCTs and guidelines. Are RCTs the only acceptable evaluations of how patient care can be assessed and delivered? In this controversy we explore the interpretation of RCT data for practising clinicians facing individualised patient choices. First, critical care anaesthetists John Boylan and Brian Kavanagh emphasise the dangers of bias and show how Bayesian approaches utilise prior probabilities to improve posterior (combined) probability estimates. Secondly, Jane Armitage, of the Clinical Trial Service Unit in Oxford, argues why RCTs remain essential and explores how the quality of randomisation can be improved through systematic reviews and by avoiding selective reporting.

  10. Razors versus clippers. A randomised controlled trial.

    Science.gov (United States)

    Taylor, Tracy; Tanner, Judith

    2005-12-01

    The purpose of this randomised controlled trial was to determine if patients showed a preference for preoperative hair removal with razors or clippers and to identify if one method was associated with more trauma or postoperative infections. The trial took place in a day surgery unit with patients who were having a range of surgical procedures including hernias and varicose veins. This study was sponsored by an award from the NATN/3M Clinical Fellowship.

  11. The Carvedilol Prospective Randomized Cumulative Survival (COPERNICUS) trial.

    Science.gov (United States)

    Eichhorn, Eric J; Bristow, Michael R

    2001-01-01

    Previous trials (Metoprolol CR/XL Randomised Intervention Trial in Congestive Heart Failure [MERIT-HF], Cardiac Insufficiency Bisoprolol Study [CIBIS] II) have demonstrated a mortality benefit of beta-adrenergic blockade in patients with mild to moderate heart failure. The recent Carvedilol Prospective Randomized Cumulative Survival (COPERNICUS) trial has extended these results to a more advanced patient population. This trial did not, however, include patients who could not reach compensation, patients with far advanced heart failure symptoms, or a significant number of black patients. Future studies of beta-blockade may focus on these patients or patients with asymptomatic left ventricular dysfunction.

  12. The Carvedilol Prospective Randomized Cumulative Survival (COPERNICUS trial

    Directory of Open Access Journals (Sweden)

    Bristow Michael R

    2001-02-01

    Full Text Available Abstract Previous trials (Metoprolol CR/XL Randomised Intervention Trial in Congestive Heart Failure [MERIT-HF], Cardiac Insufficiency Bisoprolol Study [CIBIS] II have demonstrated a mortality benefit of β-adrenergic blockade in patients with mild to moderate heart failure. The recent Carvedilol Prospective Randomized Cumulative Survival (COPERNICUS trial has extended these results to a more advanced patient population. This trial did not, however, include patients who could not reach compensation, patients with far advanced heart failure symptoms, or a significant number of black patients. Future studies of β-blockade may focus on these patients or patients with asymptomatic left ventricular dysfunction.

  13. Observer bias in randomised clinical trials with binary outcomes

    DEFF Research Database (Denmark)

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

    2012-01-01

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

  14. Observer bias in randomised clinical trials with binary outcomes

    DEFF Research Database (Denmark)

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

    2012-01-01

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

  15. A randomised controlled trial evaluating family mediated exercise (FAME therapy following stroke

    Directory of Open Access Journals (Sweden)

    Stokes Emma

    2008-06-01

    Full Text Available Abstract Background Stroke is a leading cause of disability among adults worldwide. Evidence suggests that increased duration of exercise therapy following stroke has a positive impact on functional outcome following stroke. The main objective of this randomised controlled trial is to evaluate the impact of additional family assisted exercise therapy in people with acute stroke. Methods/Design A prospective multi-centre single blind randomised controlled trial will be conducted. Forty patients with acute stroke will be randomised into either an experimental or control group. The experimental group will receive routine therapy and additional lower limb exercise therapy in the form of family assisted exercises. The control group will receive routine therapy with no additional formal input from their family members. Participants will be assessed at baseline, post intervention and followed up at three months using a series of standardised outcome measures. A secondary aim of the project is to evaluate the impact of the family mediated exercise programme on the person with stroke and the individual(s assisting in the delivery of exercises using a qualitative methodology. The study has gained ethical approval from the Research Ethics Committees of each of the clinical sites involved in the study. Discussion This study will evaluate a structured programme of exercises that can be delivered to people with stroke by their 'family members/friends'. Given that the progressive increase in the population of older people is likely to lead to an increased prevalence of stroke in the future, it is important to reduce the burden of this illness on the individual, the family and society. Family mediated exercises can maximise the carry over outside formal physiotherapy sessions, giving patients the opportunity for informal practice. Trial Registration The protocol for this study is registered with the US NIH Clinical trials registry (NCT00666744

  16. Randomised double-blind comparative study of dexmedetomidine and tramadol for post-spinal anaesthesia shivering

    Directory of Open Access Journals (Sweden)

    Geeta Mittal

    2014-01-01

    Full Text Available Background and Aims: Dexmedetomidine (α2 adrenergic agonist has been used for prevention of post anaesthesia shivering. Its use for the treatment of post-spinal anaesthesia shivering has not been evaluated. The aim of this study was to evaluate and compare the efficacy, haemodynamic and adverse effects of dexmedetomidine with those of tramadol, when used for control of post-spinal anaesthesia shivering. Methods: A prospective, randomised, and double-blind study was conducted in 50 American Society of Anaesthesiologists Grade I and II patients of either gender, aged between 18 and 65 years, scheduled for various surgical procedures under spinal anaesthesia. The patients were randomised in two groups of 25 patients each to receive either dexmedetomidine 0.5 μg/kg or tramadol 0.5 mg/kg as a slow intravenous bolus. Grade of shivering, onset of shivering, time for cessation of shivering, recurrence, response rate, and adverse effects were observed at scheduled intervals. Unpaired t-test was used for analysing the data. Results: Time taken for cessation of shivering was significantly less with dexmedetomidine when compared to tramadol. Nausea and vomiting was observed only in tramadol group (28% and; 20% respectively. There was not much difference in the sedation profile of both the drugs. Conclusion: We conclude that although both drugs are effective, the time taken for cessation of shivering is less with dexmedetomidine when compared to tramadol. Moreover, dexmedetomidine has negligible adverse effects, whereas tramadol is associated with significant nausea and vomiting.

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

    Science.gov (United States)

    Stensrud, Mats Julius

    2016-06-01

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

  18. A randomised trial comparing the i-gel (TM) with the LMA Classic (TM) in children.

    Science.gov (United States)

    Lee, J-R; Kim, M-S; Kim, J-T; Byon, H-J; Park, Y-H; Kim, H-S; Kim, C-S

    2012-06-01

    We performed a prospective, randomised trial comparing the i-gel(TM) with the LMA Classic(TM) in children undergoing general anaesthesia. Ninety-nine healthy patients were randomly assigned to either the i-gel or the LMA Classic. The outcomes measured were airway leak pressure, ease of insertion, time taken for insertion, fibreoptic examination and complications. Median (IQR [range]) time to successful device placement was shorter with the i-gel (17.0 (13.8-20.0 [10.0-20.0]) s) compared with the LMA Classic (21.0 (17.5-25.0 [15.0-70.0]) s, p = 0.002). There was no significant difference in oropharyngeal leak pressure between the two devices. A good fibreoptic view of the glottis was obtained in 74% of the i-gel group and in 43% of the LMA Classic group (p LMA Classic in children.

  19. Efficacy of labral repair, biceps tenodesis, and diagnostic arthroscopy for SLAP Lesions of the shoulder: a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Mowinckel Petter

    2010-10-01

    Full Text Available Abstract Background Surgery for type II SLAP (superior labral anterior posterior lesions of the shoulder is a promising but unproven treatment. The procedures include labral repair or biceps tenodesis. Retrospective cohort studies have suggested that the benefits of tenodesis include pain relief and improved function, and higher patient satisfaction, which was reported in a prospective non-randomised study. There have been no completed randomised controlled trials of surgery for type II SLAP lesions. The aims of this participant and observer blinded randomised placebo-controlled trial are to compare the short-term (6 months and long-term (2 years efficacy of labral repair, biceps tenodesis, and placebo (diagnostic arthroscopy for alleviating pain and improving function for type II SLAP lesions. Methods/Design A double-blind randomised controlled trial are performed using 120 patients, aged 18 to 60 years, with a history for type II SLAP lesions and clinical signs suggesting type II SLAP lesion, which were documented by MR arthrography and arthroscopy. Exclusion criteria include patients who have previously undergone operations for SLAP lesions or recurrent shoulder dislocations, and ruptures of the rotator cuff or biceps tendon. Outcomes will be assessed at baseline, three, six, 12, and 24 months. Primary outcome measures will be the clinical Rowe Score (1988-version and the Western Ontario Instability Index (WOSI at six and 24 months. Secondary outcome measures will include the Shoulder Instability Questionnaire (SIQ, the generic EuroQol (EQ-5 D and EQ-VAS, return to work and previous sports activity, complications, and the number of reoperations. Discussion The results of this trial will be of international importance and the results will be translatable into clinical practice. Trial Registration [ClinicalTrials.gov NCT00586742

  20. Psychophysiology of prospective memory.

    Science.gov (United States)

    Rothen, Nicolas; Meier, Beat

    2014-01-01

    Prospective memory involves the self-initiated retrieval of an intention upon an appropriate retrieval cue. Cue identification can be considered as an orienting reaction and may thus trigger a psychophysiological response. Here we present two experiments in which skin conductance responses (SCRs) elicited by prospective memory cues were compared to SCRs elicited by aversive stimuli to test whether a single prospective memory cue triggers a similar SCR as an aversive stimulus. In Experiment 2 we also assessed whether cue specificity had a differential influence on prospective memory performance and on SCRs. We found that detecting a single prospective memory cue is as likely to elicit a SCR as an aversive stimulus. Missed prospective memory cues also elicited SCRs. On a behavioural level, specific intentions led to better prospective memory performance. However, on a psychophysiological level specificity had no influence. More generally, the results indicate reliable SCRs for prospective memory cues and point to psychophysiological measures as valuable approach, which offers a new way to study one-off prospective memory tasks. Moreover, the findings are consistent with a theory that posits multiple prospective memory retrieval stages.

  1. Wound healing with honey - a randomised controlled trial

    African Journals Online (AJOL)

    Gold Mining and Westonaria Gold Mining from September. 1995 to July 1996 ... glycol20%, starch copolymer 2% and water 78%. ... Table I. Wound types randomised by block for treatment with honey or IntraSite Gel (withdrawn from analysis)*.

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

    Science.gov (United States)

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

    2017-06-01

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

  3. The Hawthorne Effect: a randomised, controlled trial

    Directory of Open Access Journals (Sweden)

    van Haselen Robbert

    2007-07-01

    Full Text Available Abstract Background The 'Hawthorne Effect' may be an important factor affecting the generalisability of clinical research to routine practice, but has been little studied. Hawthorne Effects have been reported in previous clinical trials in dementia but to our knowledge, no attempt has been made to quantify them. Our aim was to compare minimal follow-up to intensive follow-up in participants in a placebo controlled trial of Ginkgo biloba for treating mild-moderate dementia. Methods Participants in a dementia trial were randomised to intensive follow-up (with comprehensive assessment visits at baseline and two, four and six months post randomisation or minimal follow-up (with an abbreviated assessment at baseline and a full assessment at six months. Our primary outcomes were cognitive functioning (ADAS-Cog and participant and carer-rated quality of life (QOL-AD. Results We recruited 176 participants, mainly through general practices. The main analysis was based on Intention to treat (ITT, with available data. In the ANCOVA model with baseline score as a co-variate, follow-up group had a significant effect on outcome at six months on the ADAS-Cog score (n = 140; mean difference = -2.018; 95%CI -3.914, -0.121; p = 0.037 favouring the intensive follow-up group, and on participant-rated quality of life score (n = 142; mean difference = -1.382; 95%CI -2.642, -0.122; p = 0.032 favouring minimal follow-up group. There was no significant difference on carer quality of life. Conclusion We found that more intensive follow-up of individuals in a placebo-controlled clinical trial of Ginkgo biloba for treating mild-moderate dementia resulted in a better outcome than minimal follow-up, as measured by their cognitive functioning. Trial registration Current controlled trials: ISRCTN45577048

  4. Lessons from randomised direct comparative trials.

    Science.gov (United States)

    Achiron, Anat; Fredrikson, Sten

    2009-02-01

    For over a decade, four immunomodulatory therapies have been available for the treatment of relapsing remitting multiple sclerosis. However, few direct comparative data were available to facilitate the choice of treatment. This choice has been influenced by the perception that interferon-beta preparations have greater efficacy than glatiramer acetate, due to apparently more rapid and robust reduction of gadolinium-enhancing lesions seen on magnetic resonance imaging in the pivotal trials of these agents. This situation has changed in the last year, with the outcomes of three randomised clinical trials comparing the efficacy and safety of glatiramer acetate with that of a high-dose interferon-beta in relapsing remitting multiple sclerosis. These are the REGARD, BEYOND and BECOME trials. In the REGARD trial, 764 patients were randomised to treatment with either interferon-beta 1a sc 44 microg or glatiramer acetate for 96 weeks; no significant difference in the time to first relapse was observed. The largest of the three comparative studies, the BEYOND trial, compared treatment with interferon-beta 1b sc 500 microg, interferon-beta 1b sc 250 microg or glatiramer acetate for two years in 2,244 patients. The hazard ratio for multiple relapses was close to unity for comparisons between all groups, indicating equivalent efficacy in all three treatment arms. Relapse rates (around 0.3 relapses/year) in all these studies were much lower than anticipated and lower than those reported a decade previously in the pivotal trials of beta-interferons and glatiramer acetate. No unexpected safety issues were identified in any of these studies. The completion of these direct comparative studies has considerably enriched the clinical evidence database by contributing large numbers of patients. This provides an invaluable contribution for helping the physician make an informed choice about treatment. The results of the direct comparative studies provide evidence that glatiramer acetate

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

    Science.gov (United States)

    Bennett, Derrick A; Holmes, Michael V

    2017-09-01

    Understanding the causal role of biomarkers in cardiovascular and other diseases is crucial in order to find effective approaches (including pharmacological therapies) for disease treatment and prevention. Classical observational studies provide naïve estimates of the likely role of biomarkers in disease development; however, such studies are prone to bias. This has direct relevance for drug development as if drug targets track to non-causal biomarkers, this can lead to expensive failure of these drugs in phase III randomised controlled trials. In an effort to provide a more reliable indication of the likely causal role of a biomarker in the development of disease, Mendelian randomisation studies are increasingly used, and this is facilitated by the availability of large-scale genetic data. We conducted a narrative review in order to provide a description of the utility of Mendelian randomisation for clinicians engaged in cardiovascular research. We describe the rationale and provide a basic description of the methods and potential limitations of Mendelian randomisation. We give examples from the literature where Mendelian randomisation has provided pivotal information for drug discovery including predicting efficacy, informing on target-mediated adverse effects and providing potential new evidence for drug repurposing. The variety of the examples presented illustrates the importance of Mendelian randomisation in order to prioritise drug targets for cardiovascular research. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

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

    Science.gov (United States)

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

    2015-08-01

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

  7. EURAMOS-1, an international randomised study for osteosarcoma: results from pre-randomisation treatment.

    Science.gov (United States)

    Whelan, J S; Bielack, S S; Marina, N; Smeland, S; Jovic, G; Hook, J M; Krailo, M; Anninga, J; Butterfass-Bahloul, T; Böhling, T; Calaminus, G; Capra, M; Deffenbaugh, C; Dhooge, C; Eriksson, M; Flanagan, A M; Gelderblom, H; Goorin, A; Gorlick, R; Gosheger, G; Grimer, R J; Hall, K S; Helmke, K; Hogendoorn, P C W; Jundt, G; Kager, L; Kuehne, T; Lau, C C; Letson, G D; Meyer, J; Meyers, P A; Morris, C; Mottl, H; Nadel, H; Nagarajan, R; Randall, R L; Schomberg, P; Schwarz, R; Teot, L A; Sydes, M R; Bernstein, M

    2015-02-01

    Four international study groups undertook a large study in resectable osteosarcoma, which included two randomised controlled trials, to determine the effect on survival of changing post-operative chemotherapy based on histological response. Patients with resectable osteosarcoma aged ≤40 years were treated with the MAP regimen, comprising pre-operatively of two 5-week cycles of cisplatin 120 mg/m(2), doxorubicin 75 mg/m(2), methotrexate 12 g/m(2) × 2 (MAP) and post-operatively two further cycles of MAP and two cycles of just MA. Patients were randomised after surgery. Those with ≥10% viable tumour in the resected specimen received MAP or MAP with ifosfamide and etoposide. Those with osteosarcoma study to date in 75 months. Commencing March 2005, 2260 patients were registered from 326 centres across 17 countries. About 1334 of 2260 registered patients (59%) were randomised. Pre-operative chemotherapy was completed according to protocol in 94%. Grade 3-4 neutropenia affected 83% of cycles and 59% were complicated by infection. There were three (0.13%) deaths related to pre-operative chemotherapy. At definitive surgery, 50% of patients had at least 90% necrosis in the resected specimen. New models of collaboration are required to successfully conduct trials to improve outcomes of patients with rare cancers; EURAMOS-1 demonstrates achievability. Considerable regulatory, financial and operational challenges must be overcome to develop similar studies in the future. The trial is registered as NCT00134030 and ISRCTN 67613327. © The Author 2014. Published by Oxford University Press on behalf of the European Society for Medical Oncology.

  8. Promoting public awareness of randomised clinical trials using the media: the 'Get Randomised' campaign.

    Science.gov (United States)

    Mackenzie, Isla S; Wei, Li; Rutherford, Daniel; Findlay, Evelyn A; Saywood, Wendy; Campbell, Marion K; Macdonald, Thomas M

    2010-02-01

    WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT * Recruitment is key to the success of clinical trials. * Many clinical trials fail to achieve adequate recruitment. * Public understanding and engagement in clinical research could be improved. WHAT THIS STUDY ADDS * 'Get Randomised' is the first campaign of its kind in the UK. * It is possible to improve public awareness of clinical research using the media. * Further work is needed to determine whether improved public awareness leads to increased participation in clinical research in the future. AIM To increase public awareness and understanding of clinical research in Scotland. METHODS A generic media campaign to raise public awareness of clinical research was launched in 2008. The 'Get Randomised' campaign was a Scotland-wide initiative led by the University of Dundee in collaboration with other Scottish universities. Television, radio and newspaper advertising showed leading clinical researchers, general practitioners and patients informing the public about the importance of randomised clinical trials (RCTs). 'Get Randomised' was the central message and interested individuals were directed to the http://www.getrandomised.org website for more information. To assess the impact of the campaign, cross-sectional surveys were conducted in representative samples of 1040 adults in Scotland prior to campaign launch and again 6 months later. RESULTS There was an improvement in public awareness of clinical trials following the campaign; 56.7% [95% confidence interval (CI) 51.8, 61.6] of the sample recalled seeing or hearing advertising about RCTs following the campaign compared with 14.8% (10.8, 18.9) prior to the campaign launch (difference = 41.4%; 95% CI for difference 35.6, 48.3; P advertising, 49% felt that the main message was that people should take part more in medical research. However, on whether they would personally take part in a clinical trial if asked, there was little difference in response following the campaign

  9. The RESOLVE Trial for people with chronic low back pain: protocol for a randomised clinical trial.

    Science.gov (United States)

    Bagg, Matthew K; Hübscher, Markus; Rabey, Martin; Wand, Benedict M; O'Hagan, Edel; Moseley, G Lorimer; Stanton, Tasha R; Maher, Chris G; Goodall, Stephen; Saing, Sopany; O'Connell, Neil E; Luomajoki, Hannu; McAuley, James H

    2017-01-01

    Low back pain is the leading worldwide cause of disability, and results in significant personal hardship. Most available treatments, when tested in high-quality randomised, controlled trials, achieve only modest improvements in pain, at best. Recently, treatments that target central nervous system function have been developed and tested in small studies. Combining treatments that target central nervous system function with traditional treatments directed towards functioning of the back is a promising approach that has yet to be tested in adequately powered, prospectively registered, clinical trials. The RESOLVE trial will be the first high-quality assessment of two treatment programs that combine central nervous system-directed and traditional interventions in order to improve chronic low back pain. To compare the effectiveness of two treatment programs that combine central nervous system-directed and traditional interventions at reducing pain intensity at 18 weeks post randomisation in a randomised clinical trial of people with chronic low back pain. Two-group, randomised, clinical trial with blinding of participants and assessors. Two hundred and seventy-five participants with chronic low back pain that has persisted longer than 3 months and no specific spinal pathology will be recruited from the community and primary care in Sydney, Australia. Both of the interventions contain treatments that target central nervous system function combined with treatments directed towards functioning of the back. Adherence to the intervention will be monitored using an individual treatment diary and adverse events recorded through passive capture. Participants are informed prior to providing informed consent that some of the treatments are not active. Blinding is maintained by not disclosing any further information. Complete disclosure of the contents of the intervention has been made with the UNSW HREC (HC15357) and an embargoed project registration has been made on the Open

  10. Influence of reported study design characteristics on intervention effect estimates from randomised controlled trials

    DEFF Research Database (Denmark)

    Savović, J; Jones, He; Altman, Dg

    2012-01-01

    The design of randomised controlled trials (RCTs) should incorporate characteristics (such as concealment of randomised allocation and blinding of participants and personnel) that avoid biases resulting from lack of comparability of the intervention and control groups. Empirical evidence suggests...

  11. Structured risk assessment and violence in acute psychiatric wards: randomised controlled trial

    National Research Council Canada - National Science Library

    Abderhalden, Christoph; Needham, Ian; Dassen, Theo; Halfens, Ruud; Haug, Hans-Joachim; Fischer, Joachim E

    2008-01-01

    .... To assess whether such risk assessments decrease the incidence of violence and coercion. A cluster randomised controlled trial was conducted with 14 acute psychiatric admission wards as the units of randomisation, including a preference arm...

  12. Chocolate bar as an incentive did not increase response rate among physiotherapists: a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Dahm Kristin

    2008-06-01

    Full Text Available Abstract Background The aim of this study was to assess the effect of a small incentive, a bar of dark chocolate, on response rate in a study of physiotherapy performance in patients with knee osteoarthritis. Findings Norwegian physiotherapists from private practice were randomised in blocks to an intervention group (n = 1027 receiving a bar of dark chocolate together with a data-collection form, and a control group (n = 1027 that received the data-collection form only. The physiotherapists were asked to prospectively complete the data-collection form by reporting treatments provided to one patient with knee osteoarthritis through 12 treatment sessions. The outcome measure was response rate of completed forms. Out of the 510 physiotherapists that responded, 280 had completed the data-collection form by the end of the study period. There was no difference between the chocolate and no-chocolate group in response rate of those who sent in completed forms. In the chocolate group, 142 (13.8% returned completed forms compared to 138 (13.4% in the control group, ARR = 0.4 (95% CI: -3.44 to 2.6. Conclusion A bar of dark chocolate did not increase response rate in a prospective study of physiotherapy performance. Stronger incentives than chocolate seem to be necessary to increase the response rate among professionals who are asked to report about their practice. Trial Registration Current Controlled Trials register: ISRCTN02397855

  13. Two-year follow-up of a randomised trial with repeated antenatal betamethasone.

    Science.gov (United States)

    Peltoniemi, O M; Kari, M A; Lano, A; Yliherva, A; Puosi, R; Lehtonen, L; Tammela, O; Hallman, M

    2009-11-01

    Weekly repeated antenatal corticosteroid treatment improves respiratory outcome but decreases fetal growth and may impair neurodevelopmental outcome. We have previously reported that a single repeat betamethasone (BM) dose neither decreased fetal growth nor improved the outcome of preterm infants during the first hospitalisation. To study prospectively whether a single repeat dose of BM influences neurodevelopment and growth within 2 years. Women with imminent delivery before 34.0 gestational weeks were eligible if they remained undelivered for >7 days after a single course of antenatal BM. After stratification, a single repeat dose of BM (12 mg) or placebo was given. The children underwent neurological and psychometric examinations and a speech evaluation at a corrected age of 2 years. Prospective, blinded evaluation following the randomised multicentre trial. 259 (82%) surviving infants completed the 2-year follow-up, 120 in the BM group and 139 in the placebo group. The rate of survival without severe neurodevelopmental impairment was similar in both groups (BM 98%, placebo 99%). The risk of cerebral palsy (BM 2%, placebo 1%), growth or re-hospitalisation rates (BM 60%, placebo 50%) did not differ between the groups. A single repeat dose of antenatal BM tended not to influence physical growth or neurodevelopment at 2 years of age.

  14. Laparoscopic cholecystectomy under spinal-epidural anesthesia vs. general anaesthesia: a prospective randomised study.

    Science.gov (United States)

    Donmez, Turgut; Erdem, Vuslat Muslu; Uzman, Sinan; Yildirim, Dogan; Avaroglu, Huseyin; Ferahman, Sina; Sunamak, Oguzhan

    2017-03-01

    Laparoscopic cholecystectomy (LC) is usually performed under the general anesthesia (GA). Aim of the study is to investigate the availability, safety and side effects of combined spinal/epidural anesthesia (CSEA) and comparison it with GA for LC. Forty-nine patients who have a LC plan were included into the study. The patients were randomly divided into GA (n = 25) and CSEA (n = 24) groups. Intraoperative and postoperative adverse events, postoperative pain levels were compared between groups. Anesthesia procedures and surgeries for all patients were successfully completed. After the organization of pneumoperitoneum in CSEA group, 3 patients suffered from shoulder pain (12.5%) and 4 patients suffered from abdominal discomfort (16.6%). All these complaints were recovered with IV fentanyl administration. Only 1 patient developed hypotension which is recovered with fluid replacement and no need to use vasopressor treatment. Postoperative shoulder pain was significantly less observed in CSEA group (25% vs. 60%). Incidence of postoperative nausea and vomiting (PONV) was less observed in CSEA group but not statistically significant (4.2% vs. 20%). In the group of CSEA, 3 patients suffered from urinary retention (12.5%) and 2 patients suffered from spinal headache (8.3%). All postoperative pain parameters except 6th hour, were less observed in CSEA group, less VAS scores and less need to analgesic treatment in CSEA group comparing with GA group. CSEA can be used safely for laparoscopic cholecystectomies. Less postoperative surgical field pain, shoulder pain and PONV are the advantages of CSEA compared to GA.

  15. Endotracheal suctioning versus minimally invasive airway suctioning in intubated patients : a prospective randomised controlled trial

    NARCIS (Netherlands)

    Van de Leur, JP; Zwaveling, JH; Loef, BG; Van der Schans, CP

    Study objective: Endotracheal suctioning in intubated patients is routinely applied in most ICUs but may have negative side effects. We hypothesised that on-demand minimally invasive suctioning would have fewer side effects than routine deep endotracheal suctioning, and would be comparable in

  16. A prospective randomised trial of isolated pathogens of surgical site infections (SSI

    Directory of Open Access Journals (Sweden)

    Konstantinos Alexiou

    2017-09-01

    Conclusions: In conclusion, surgical site infections are important complications affecting the healthcare services, the cost of hospitalization and the patient himself. Future thorough studies are expected to reveal much more data, regarding predisposing and precautionary patient and hospital characteristics.

  17. Endotracheal suctioning versus minimally invasive airway suctioning in intubated patients : a prospective randomised controlled trial

    NARCIS (Netherlands)

    Van de Leur, JP; Zwaveling, JH; Loef, BG; Van der Schans, CP

    2003-01-01

    Study objective: Endotracheal suctioning in intubated patients is routinely applied in most ICUs but may have negative side effects. We hypothesised that on-demand minimally invasive suctioning would have fewer side effects than routine deep endotracheal suctioning, and would be comparable in durati

  18. Two Oral Midazolam Preparations in Pediatric Dental Patients: A Prospective Randomised Clinical Trial

    OpenAIRE

    Katayoun Salem; Shaqayegh Kamranzadeh; Maryam Kousha; Shahnaz Shaeghi; Fatemeh AbdollahGorgi

    2015-01-01

    Pharmacological sedation is an alternative behavior management strategy in pediatric dentistry. The aim of this study was to compare the behavioral and physiologic effects of “commercially midazolam syrup” versus “orally administered IV midazolam dosage form (extemporaneous midazolam (EF))” in uncooperative pediatric dental patients. Eighty-eight children between 4 to 7 years of age received 0.2–0.5 mg/kg midazolam in this parallel trial. Physiologic parameters were recorded at baseline and e...

  19. Two mechanical methods for thromboembolism prophylaxis after gynaecological pelvic surgery: a prospective, randomised study

    Institute of Scientific and Technical Information of China (English)

    GAO Jie; JIANG Ying; ZHAO Na; ZHANG Zhen-yu; LI Zhan; LIU Chong-dong; ZHAN Yu-xin; QIAO Bao-li; SANG Cui-qin; GUO Shu-li; WANG Shu-zhen

    2012-01-01

    Background Venous thromboembolism is known to be an important social and health care problem because of its high incidence among patients who undergo surgery.Studies on the mechanical prophylaxis of thromboembolism after gynaecological pelvic surgery are few.The aim of our study was to evaluate the effect of mechanical thromboembolism prophylaxis after gynaecological pelvic surgery using a combination of graduated compression stockings (GCS) and intermittent pneumatic compression (IPC) or GCS alone.Methods The study was performed on 108 patients who were randomly assigned to two groups.The first group received GCS before the operation and IPC during the operation (IPC+GCS group).The second group received GCS before the operation (GCS group).To analyze the effect of the preventive measures and the laboratory examination on the incidence of thrombosis and to compare the safety of these measures,the incidence of adverse reactions was assessed.Results The morbidity associated with DVT was 4.8% (5/104) in the IPC+GCS group and 12.5% (14/112) in the GCS group.There were significant statistical differences between the two groups.There were no adverse effects in either group.Conclusions The therapeutic combination of GCS and IPC was more effective than GCS alone for thrombosis prevention in high-risk patients undergoing gynaecological pelvic surgery,and there were no adverse effects in either group.(No.ChiCTR-PRC-10000935).

  20. Preventing musculoskeletal injuries among recreational adult volleyball players : design of a randomised prospective controlled trial

    NARCIS (Netherlands)

    Gouttebarge, Vincent; Zwerver, Johannes; Verhagen, Evert

    2017-01-01

    BACKGROUND: Both acute and overuse injuries are common among recreational volleyball players, especially finger/wrist, ankle, shoulder and knee injuries. Consequently, an intervention ('VolleyVeilig') was developed to prevent or reduce the occurrence of finger/wrist, shoulder, knee and ankle

  1. Laparoscopic cholecystectomy under spinal-epidural anesthesia vs. general anaesthesia: a prospective randomised study

    Science.gov (United States)

    Erdem, Vuslat Muslu; Uzman, Sinan; Yildirim, Dogan; Avaroglu, Huseyin; Ferahman, Sina; Sunamak, Oguzhan

    2017-01-01

    Purpose Laparoscopic cholecystectomy (LC) is usually performed under the general anesthesia (GA). Aim of the study is to investigate the availability, safety and side effects of combined spinal/epidural anesthesia (CSEA) and comparison it with GA for LC. Methods Forty-nine patients who have a LC plan were included into the study. The patients were randomly divided into GA (n = 25) and CSEA (n = 24) groups. Intraoperative and postoperative adverse events, postoperative pain levels were compared between groups. Results Anesthesia procedures and surgeries for all patients were successfully completed. After the organization of pneumoperitoneum in CSEA group, 3 patients suffered from shoulder pain (12.5%) and 4 patients suffered from abdominal discomfort (16.6%). All these complaints were recovered with IV fentanyl administration. Only 1 patient developed hypotension which is recovered with fluid replacement and no need to use vasopressor treatment. Postoperative shoulder pain was significantly less observed in CSEA group (25% vs. 60%). Incidence of postoperative nausea and vomiting (PONV) was less observed in CSEA group but not statistically significant (4.2% vs. 20%). In the group of CSEA, 3 patients suffered from urinary retention (12.5%) and 2 patients suffered from spinal headache (8.3%). All postoperative pain parameters except 6th hour, were less observed in CSEA group, less VAS scores and less need to analgesic treatment in CSEA group comparing with GA group. Conclusion CSEA can be used safely for laparoscopic cholecystectomies. Less postoperative surgical field pain, shoulder pain and PONV are the advantages of CSEA compared to GA.

  2. Endotracheal suctioning versus minimally invasive airway suctioning in intubated patients : a prospective randomised controlled trial

    NARCIS (Netherlands)

    Van de Leur, JP; Zwaveling, JH; Loef, BG; Van der Schans, CP

    2003-01-01

    Study objective: Endotracheal suctioning in intubated patients is routinely applied in most ICUs but may have negative side effects. We hypothesised that on-demand minimally invasive suctioning would have fewer side effects than routine deep endotracheal suctioning, and would be comparable in durati

  3. Two Oral Midazolam Preparations in Pediatric Dental Patients: A Prospective Randomised Clinical Trial

    Directory of Open Access Journals (Sweden)

    Katayoun Salem

    2015-01-01

    Full Text Available Pharmacological sedation is an alternative behavior management strategy in pediatric dentistry. The aim of this study was to compare the behavioral and physiologic effects of “commercially midazolam syrup” versus “orally administered IV midazolam dosage form (extemporaneous midazolam (EF” in uncooperative pediatric dental patients. Eighty-eight children between 4 to 7 years of age received 0.2–0.5 mg/kg midazolam in this parallel trial. Physiologic parameters were recorded at baseline and every 15 minutes. Behavior assessment was conducted objectively by Houpt scale throughout the sedation and North Carolina at baseline and during injection and cavity preparation. No significant difference in behavior was noted by Houpt or North Carolina scale. Acceptable behavior (excellent, very good, and good was observed in 90.9% of syrup and 79.5% of EF subjects, respectively. Physiological parameters remained in normal range without significant difference between groups and no adverse effect was observed. It is concluded that EF midazolam preparation can be used as an acceptable alternative to midazolam syrup.

  4. Systemic inflammatory responses during laparoscopic and open inguinal hernia repair: a randomised prospective study

    DEFF Research Database (Denmark)

    Jess, P; Schultz, Karen; Bendtzen, K

    2000-01-01

    To see if the inflammatory responses during and after laparoscopic and open inguinal hernia repairs differed.......To see if the inflammatory responses during and after laparoscopic and open inguinal hernia repairs differed....

  5. Early active mobilisation versus immobilisation after extrinsic extensor tendon repair: A prospective randomised trial

    Directory of Open Access Journals (Sweden)

    R K Patil

    2012-01-01

    Full Text Available Background: Whether to splint the extensor tendon repairs or to mobilise them early is debatable. Recently, mobilisation has shown favourable results in a few studies. This study was aimed to compare the two favoured protocols (immobilisation vs. early active motion in Indian population. Patients and Methods: Between June 2005 and June 2007, patients with extensor tendon injuries in zones V-VIII were randomly distributed in two groups: Group A, early active motion; and group B, immobilisation. Their results at 8 and 12 weeks and 6 months were compared. Results: Patients in early active motion group were found to have better total active motion and early return to work. This difference was statistically significant up to 12 weeks, but not at 6 months. Conclusion: Early active motion following extensor tendon repair hastens patients′ recovery and helps patients to gain complete range of motion at earlier postoperative period. With improved grip strength, the early return to work is facilitated, though these advantages are not sustained statistically significantly over long term.

  6. The PROSPECT Physics Program

    CERN Document Server

    Ashenfelter, J; Band, H R; Barclay, G; Bass, C D; Berish, D; Bowden, N S; Bowes, A; Bryan, C D; Brodsky, J P; Cherwinka, J J; Chu, R; Classen, T; Commeford, K; Davee, D; Dean, D; Deichert, G; Diwan, M V; Dolinski, M J; Dolph, J; Gaison, J K; Galindo-Uribarri, A; Gilje, K; Glenn, A; Goddard, B W; Green, M; Han, K; Hans, S; Heeger, K M; Heffron, B; Jaffe, D E; Jones, D; Langford, T J; Littlejohn, B R; Caicedo, D A Martinez; McKeown, R D; Mendenhall, M P; Mueller, P; Mumm, H P; Napolitano, J; Neilson, R; Norcini, D; Pushin, D; Qian, X; Romero, E; Rosero, R; Seilhan, B S; Sharma, R; Sheets, S; Surukuchi, P T; Varner, R L; Viren, B; Wang, W; White, B; White, C; Wilhelmi, J; Williams, C; Wise, T; Yao, H; Yeh, M; Yen, Y -R; Zangakis, G; Zhang, C; Zhang, X

    2015-01-01

    The Precision Reactor Oscillation and Spectrum Experiment, PROSPECT, is designed to make a precise measurement of the antineutrino spectrum from a highly-enriched uranium reactor and probe eV-scale sterile neutrinos by searching for neutrino oscillations over meter-long distances. PROSPECT is conceived as a 2-phase experiment utilizing segmented $^6$Li-doped liquid scintillator detectors for both efficient detection of reactor antineutrinos through the inverse beta decay reaction and excellent background discrimination. PROSPECT Phase I consists of a movable 3-ton antineutrino detector at distances of 7 - 12 m from the reactor core. It will probe the best-fit point of the $\

  7. A randomised comparison of cognitive behavioural therapy

    Directory of Open Access Journals (Sweden)

    Carlijn de Roos

    2011-04-01

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

  8. Prospective ergonomics: origin, goal, and prospects.

    Science.gov (United States)

    Robert, Jean-Marc; Brangier, Eric

    2012-01-01

    So far ergonomics has been concerned with two categories of activities: correction and design. We propose to add a third category: prospection, and by so doing, we introduce a new series of activities that opens up the future of ergonomics. Corrective ergonomics relates to the past and comes with a demand and a client. It is turned towards the correction of existing situations and aims to reduce or eliminate problems. Here, after delimiting and defining the problem, the challenge is to find the best solution. Ergonomics for design relates to the present and also comes with a demand and a client. It is turned towards the design of new artefacts that have already been identified by a client, and that will allow users to do some activity and attain their goals. Here, after defining the scope of the project and the functional requirements, the challenge is to do the best design. Finally, prospective ergonomics relates to the future and does not come with a demand and a client. It is turned towards the creation of future things that have not been identified yet. Here the challenge is to detect existing user needs or anticipate future ones, and imagine solutions. These three categories of activities overlap and are not exclusive of each other. In this paper we define prospective ergonomics and compare it with corrective ergonomics and ergonomics for design. We describe its origin, goal, and prospects, we analyze its impacts on education and practice, and we emphasize the need of new collaboration between ergonomics and other disciplines.

  9. The impact of lipoprotein apheresis in patients with refractory angina and raised lipoprotein(a): Objectives and methods of a randomised controlled trial.

    Science.gov (United States)

    Khan, Tina Z; Pottle, Alison; Pennell, Dudley J; Barbir, Mahmoud S

    2015-05-01

    It is well established that Lipoprotein(a) [Lp(a)] is an independent cardiovascular risk factor and predictor of major adverse cardiovascular events. Lipoprotein apheresis is currently the most effective approved treatment available, with minimal effect conferred by conventional lipid lowering agents. A growing body of evidence suggests that aggressively lowering raised Lp(a) may improve cardiovascular and clinical outcomes, although more prospective research is required in this field. Angina which is refractory to conventional medical therapy and revascularisation is extremely challenging to manage. There is a significant unmet need to establish therapeutic options. Our goal is to determine the impact of lipoprotein apheresis on clinical parameters and symptoms of patients with refractory angina secondary to advanced coronary disease and raised Lp(a). Determining whether we should aggressively lower Lp(a) in such patients remains a very important question, which could potentially impact on the management of a large population. We will also gain insight into how this treatment works and the mechanisms via which Lp(a) increases cardiovascular risk. We are currently conducting a prospective, randomised controlled crossover study of patients with refractory angina and raised Lp(a), randomised to undergoing three months of weekly lipoprotein apheresis or sham apheresis. Patients will then crossover to the opposite study arm after a 1 month wash-out phase. We will assess myocardial perfusion, carotid atherosclerosis, endothelial vascular function, thrombogenesis, oxidised LDL and their antibodies, exercise capacity, angina and quality of life at the beginning and end of treatment, to determine the net true treatment effect on the above parameters. This is a novel area of research, as previous studies have not assessed the role of lipoprotein apheresis in patients with refractory angina and raised Lp(a) in a prospective randomised controlled manner.

  10. Problems, Prospects And Challenges.

    African Journals Online (AJOL)

    Urban Road Transportation in Nigeria From 1960 To 2006: Problems, Prospects And Challenges. ... Ethiopian Journal of Environmental Studies and Management ... The paper suggested the construction of more motor-able roads within cities ...

  11. Spa therapy in the treatment of knee osteoarthritis: a large randomised multicentre trial

    Science.gov (United States)

    Forestier, R; Desfour, H; Tessier, J-M; Françon, A; Foote, A M; Genty, C; Rolland, C; Roques, C-F; Bosson, J-L

    2010-01-01

    Objective To determine whether spa therapy, plus home exercises and usual medical treatment provides any benefit over exercises and usual treatment, in the management of knee osteoarthritis. Methods Large multicentre randomised prospective clinical trial of patients with knee osteoarthritis according to the American College of Rheumatology criteria, attending French spa resorts as outpatients between June 2006 and April 2007. Zelen randomisation was used so patients were ignorant of the other group and spa personnel were not told which patients were participating. The main endpoint criteria were patient self-assessed. All patients continued usual treatments and performed daily standardised home exercises. The spa therapy group also received 18 days of spa therapy (massages, showers, mud and pool sessions). Main Endpoint The number of patients achieving minimal clinically important improvement (MCII) at 6 months, defined as ≥19.9 mm on the visual analogue pain scale and/or ≥9.1 points in a normalised Western Ontario and McMaster Universities osteoarthritis index function score and no knee surgery. Results The intention to treat analysis included 187 controls and 195 spa therapy patients. At 6 months, 99/195 (50.8%) spa group patients had MCII and 68/187 (36.4%) controls (χ2=8.05; df=1; p=0.005). However, no improvement in quality of life (Short Form 36) or patient acceptable symptom state was observed at 6 months. Conclusion For patients with knee osteoarthritis a 3-week course of spa therapy together with home exercises and usual pharmacological treatments offers benefit after 6 months compared with exercises and usual treatment alone, and is well tolerated. Trial registration number NCT00348777. PMID:19734131

  12. Ice‐water immersion and delayed‐onset muscle soreness: a randomised controlled trial

    Science.gov (United States)

    Sellwood, Kylie Louise; Brukner, Peter; Williams, David; Nicol, Alastair; Hinman, Rana

    2007-01-01

    Objective To determine if ice‐water immersion after eccentric quadriceps exercise minimises the symptoms of delayed‐onset muscle soreness (DOMS). Design A prospective randomised double‐blind controlled trial was undertaken. 40 untrained volunteers performed an eccentric loading protocol with their non‐dominant leg. Interventions Participants were randomised to three 1‐min immersions in either ice water (5±1°C) or tepid water (24°C). Main outcome measures Pain and tenderness (visual analogue scale), swelling (thigh circumference), function (one‐legged hop for distance), maximal isometric strength and serum creatine kinase (CK) recorded at baseline, 24, 48 and 72 h after exercise. Changes in outcome measures over time were compared to determine the effect of group allocation using independent t tests or Mann–Whitney U tests. Results No significant differences were observed between groups with regard to changes in most pain parameters, tenderness, isometric strength, swelling, hop‐for‐distance or serum CK over time. There was a significant difference in pain on sit‐to‐stand at 24 h, with the intervention group demonstrating a greater increase in pain than the control group (median change 8.0 vs 2.0 mm, respectively, p = 0.009). Conclusions The protocol of ice‐water immersion used in this study was ineffectual in minimising markers of DOMS in untrained individuals. This study challenges the wide use of this intervention as a recovery strategy by athletes. PMID:17261562

  13. Increasing organ donation via anticipated regret (INORDAR: protocol for a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    O'Carroll Ronan E

    2012-03-01

    Full Text Available Abstract Background Throughout the world there is an insufficient supply of donor organs to meet the demand for organ transplantations. This paper presents a protocol for a randomised controlled trial, testing whether a simple, theory-based anticipated regret manipulation leads to a significant increase in posthumous organ donor registrations. Methods We will use a between-groups, prospective randomised controlled design. A random sample of 14,520 members of the adult Scottish general public will be contacted via post. These participants will be randomly allocated into 1 of the 4 conditions. The no questionnaire control (NQC group will simply receive a letter and donor registration form. The questionnaire control (QC arm will receive a questionnaire measuring their emotions and non-cognitive affective attitudes towards organ donation. The theory of planned behavior (TPB group will complete the emotions and affective attitudes questionnaire plus additional items assessing their cognitive attitudes towards organ donation, perceived control over registration and how they think significant others view this action. Finally, the anticipated regret (AR group will complete the same indices as the TPB group, plus two additional anticipated regret items. These items will assess the extent to which the participant anticipates regret for not registering as an organ donor in the near future. The outcome variable will be NHS Blood and Transplant verified registrations as an organ donor within 6 months of receiving our postal intervention. Discussion This study will assess whether simply asking people to reflect on the extent to which they may anticipate regret for not registering as an organ donor increases organ donor registration 6 months later. If successful, this simple and easy to administer theory-based intervention has the potential to save lives and money for the NHS by reducing the number of people receiving treatments such as dialysis. This

  14. Effectiveness of fixed dose combination medication ('polypills') compared with usual care in patients with cardiovascular disease or at high risk : A prospective, individual patient data meta-analysis of 3140 patients in six countries

    NARCIS (Netherlands)

    Webster, Ruth; Patel, Anushka; Selak, Vanessa; Billot, Laurent; Bots, Michiel L.; Brown, Alex; Bullen, Chris; Cass, Alan; Crengle, Sue; Raina Elley, C.; Grobbee, Diederick E.; Neal, Bruce; Peiris, David; Poulter, Neil; Prabhakaran, Dorairaj; Rafter, Natasha; Stanton, Alice; Stepien, Sandrine; Thom, Simon; Usherwood, Tim; Wadham, Angela; Rodgers, Anthony

    2016-01-01

    Aims To conduct a prospective, individual participant data (IPD) meta-analysis of randomised controlled trials comparing a polypill-based approach with usual care in high risk individuals. Methods and results Three trials comparing polypill-based care with usual care in individuals with CVD or high

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

    Directory of Open Access Journals (Sweden)

    Myles Judy

    2009-07-01

    Full Text Available Abstract Background There is a wealth of evidence regarding the detrimental impact of excessive alcohol consumption on the physical, psychological and social health of the population. There also exists a substantial evidence base for the efficacy of brief interventions aimed at reducing alcohol consumption across a range of healthcare settings. Primary research conducted in emergency departments has reinforced the current evidence regarding the potential effectiveness and cost-effectiveness. Within this body of evidence there is marked variation in the intensity of brief intervention delivered, from very minimal interventions to more intensive behavioural or lifestyle counselling approaches. Further the majority of primary research has been conducted in single centre and there is little evidence of the wider issues of generalisability and implementation of brief interventions across emergency departments. Methods/design The study design is a prospective pragmatic factorial cluster randomised controlled trial. Individual Emergency Departments (ED (n = 9 are randomised with equal probability to a combination of screening tool (M-SASQ vs FAST vs SIPS-PAT and an intervention (Minimal intervention vs Brief advice vs Brief lifestyle counselling. The primary hypothesis is that brief lifestyle counselling delivered by an Alcohol Health Worker (AHW is more effective than Brief Advice or a minimal intervention delivered by ED staff. Secondary hypotheses address whether short screening instruments are more acceptable and as efficient as longer screening instruments and the cost-effectiveness of screening and brief interventions in ED. Individual participants will be followed up at 6 and 12 months after consent. The primary outcome measure is performance using a gold-standard screening test (AUDIT. Secondary outcomes include; quantity and frequency of alcohol consumed, alcohol-related problems, motivation to change, health related quality of life and

  16. Bedtime ingestion of hypertension medications reduces the risk of new-onset type 2 diabetes: a randomised controlled trial.

    Science.gov (United States)

    Hermida, Ramón C; Ayala, Diana E; Mojón, Artemio; Fernández, José R

    2016-02-01

    We investigated whether therapy with the entire daily dose of ≥ 1 hypertension medications at bedtime exerts greater reduction in the risk of new-onset diabetes than therapy with all medications upon awakening. We conducted a prospective, randomised, open-label, blinded endpoint trial of 2,012 hypertensive patients without diabetes, 976 men and 1,036 women, 52.7 ± 13.6 years of age. Patients were randomised, using a computer-generated allocation table, to ingest all their prescribed hypertension medications upon awakening or the entire daily dose of ≥ 1 of them at bedtime. Investigators blinded to the hypertension treatment scheme of the patients assessed the development of new-onset diabetes. During a 5.9-year median follow-up, 171 participants developed type 2 diabetes. Patients of the bedtime, compared with the morning-treatment group, showed: (1) significantly lower asleep BP mean, greater sleep-time relative BP decline and attenuated prevalence of non-dipping at the final evaluation (32% vs 52%, p Ciencia e Innovación (SAF2006-6254-FEDER; SAF2009-7028-FEDER); Xunta de Galicia (PGIDIT03-PXIB-32201PR; INCITE07-PXI-322003ES; INCITE08-E1R-322063ES; INCITE09-E2R-322099ES; 09CSA018322PR); and Vicerrectorado de Investigación, University of Vigo.

  17. Symptoms and quality of life in patients with suspected angina undergoing CT coronary angiography: a randomised controlled trial

    Science.gov (United States)

    Hunter, Amanda; Shah, Anoop; Assi, Valentina; Lewis, Stephanie; Mangion, Kenneth; Berry, Colin; Boon, Nicholas A; Clark, Elizabeth; Flather, Marcus; Forbes, John; McLean, Scott; Roditi, Giles; van Beek, Edwin JR; Timmis, Adam D; Newby, David E

    2017-01-01

    Background In patients with suspected angina pectoris, CT coronary angiography (CTCA) clarifies the diagnosis, directs appropriate investigations and therapies, and reduces clinical events. The effect on patient symptoms is currently unknown. Methods In a prospective open-label parallel group multicentre randomised controlled trial, 4146 patients with suspected angina due to coronary heart disease were randomised 1:1 to receive standard care or standard care plus CTCA. Symptoms and quality of life were assessed over 6 months using the Seattle Angina Questionnaire and Short Form 12. Results Baseline scores indicated mild physical limitation (74±0.4), moderate angina stability (44±0.4), modest angina frequency (68±0.4), excellent treatment satisfaction (92±0.2) and moderate impairment of quality of life (55±0.3). Compared with standard care alone, CTCA was associated with less marked improvements in physical limitation (difference −1.74 (95% CIs, −3.34 to −0.14), p=0.0329), angina frequency (difference −1.55 (−2.85 to −0.25), p=0.0198) and quality of life (difference −3.48 (−4.95 to −2.01), pcoronary arteries or who had their preventative therapy discontinued, and least in those with moderate non-obstructive disease or had a new prescription of preventative therapy (pcoronary artery disease. Trial registration number: NCT01149590. PMID:28246175

  18. The PROSPECT physics program

    Science.gov (United States)

    Ashenfelter, J.; Balantekin, A. B.; Band, H. R.; Barclay, G.; Bass, C. D.; Berish, D.; Bignell, L.; Bowden, N. S.; Bowes, A.; Brodsky, J. P.; Bryan, C. D.; Cherwinka, J. J.; Chu, R.; Classen, T.; Commeford, K.; Conant, A. J.; Davee, D.; Dean, D.; Deichert, G.; Diwan, M. V.; Dolinski, M. J.; Dolph, J.; DuVernois, M.; Erikson, A. S.; Febbraro, M. T.; Gaison, J. K.; Galindo-Uribarri, A.; Gilje, K.; Glenn, A.; Goddard, B. W.; Green, M.; Hackett, B. T.; Han, K.; Hans, S.; Heeger, K. M.; Heffron, B.; Insler, J.; Jaffe, D. E.; Jones, D.; Langford, T. J.; Littlejohn, B. R.; Martinez Caicedo, D. A.; Matta, J. T.; McKeown, R. D.; Mendenhall, M. P.; Mueller, P. E.; Mumm, H. P.; Napolitano, J.; Neilson, R.; Nikkel, J. A.; Norcini, D.; Pushin, D.; Qian, X.; Romero, E.; Rosero, R.; Seilhan, B. S.; Sharma, R.; Sheets, S.; Surukuchi, P. T.; Trinh, C.; Varner, R. L.; Viren, B.; Wang, W.; White, B.; White, C.; Wilhelmi, J.; Williams, C.; Wise, T.; Yao, H.; Yeh, M.; Yen, Y.-R.; Zangakis, G. Z.; Zhang, C.; Zhang, X.; PROSPECT Collaboration

    2016-11-01

    The precision reactor oscillation and spectrum experiment, PROSPECT, is designed to make a precise measurement of the antineutrino spectrum from a highly-enriched uranium reactor and probe eV-scale sterile neutrinos by searching for neutrino oscillations over a distance of several meters. PROSPECT is conceived as a 2-phase experiment utilizing segmented 6Li-doped liquid scintillator detectors for both efficient detection of reactor antineutrinos through the inverse beta decay reaction and excellent background discrimination. PROSPECT Phase I consists of a movable 3 ton antineutrino detector at distances of 7-12 m from the reactor core. It will probe the best-fit point of the {ν }e disappearance experiments at 4σ in 1 year and the favored region of the sterile neutrino parameter space at \\gt 3σ in 3 years. With a second antineutrino detector at 15-19 m from the reactor, Phase II of PROSPECT can probe the entire allowed parameter space below 10 eV2 at 5σ in 3 additional years. The measurement of the reactor antineutrino spectrum and the search for short-baseline oscillations with PROSPECT will test the origin of the spectral deviations observed in recent {θ }13 experiments, search for sterile neutrinos, and conclusively address the hypothesis of sterile neutrinos as an explanation of the reactor anomaly.

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

    NARCIS (Netherlands)

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

    2000-01-01

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

  20. The SafeBoosC Phase II Randomised Clinical Trial

    DEFF Research Database (Denmark)

    Pellicer, Adelina; Greisen, Gorm; Benders, Manon

    2013-01-01

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

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

    NARCIS (Netherlands)

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

    2000-01-01

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

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

    NARCIS (Netherlands)

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

    2012-01-01

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

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

    NARCIS (Netherlands)

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

    2012-01-01

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

  4. The effect of orthodontic referral guidelines: A randomised controlled trial

    OpenAIRE

    Conboy, Frances; O'Brien, K.

    2000-01-01

    Objective To develop and evaluate the effectiveness of referral guidelines for the referral of orthodontic patients to consultant and specialist practijioner orthodontists. Design Single centre randomised controlled trial with random allocation of referral guidelines for orthodontic treatment to general dental practitioners. Setting Hospital orthodontic departments and specialist orthodontic practices in Manchester and Stockport. Subjects General dental practitioners and the patients they ref...

  5. Effect of ultrasound-guided interstitial laser photocoagulation on benign solitary solid cold thyroid nodules - a randomised study

    DEFF Research Database (Denmark)

    Døssing, Helle; Bennedbaek, Finn Noe; Hegedüs, Laszlo

    2005-01-01

    AIM: To evaluate the efficacy of ultrasound (US)-guided interstitial laser photocoagulation (ILP) on thyroid function, nodule size and patient satisfaction in benign solitary solid cold thyroid nodules by comparing one ILP session with no treatment in a prospective randomised study. MATERIALS...... AND METHODS: Thirty euthyroid outpatients with a benign solitary solid and a scintigraphically cold thyroid nodule causing local discomfort were assigned to one session of ILP (n = 15) or observation (n = 15) and followed for 6 months. Thyroid nodule volume and total thyroid volume were assessed by US...... and thyroid function was determined by routine assays before and during follow-up. Pressure and cosmetic complaints before and at 6 months were evaluated on a visual analogue scale. ILP was performed under US guidance and with an output power of 2.5-3.5 W. RESULTS: In the ILP group, the nodule volume...

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

    Directory of Open Access Journals (Sweden)

    Lynch Deirdre

    2008-12-01

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

  7. Effectiveness of ovarian suspension in preventing post-operative ovarian adhesions in women with pelvic endometriosis: A randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Pandis George

    2011-05-01

    Full Text Available Abstract Background Endometriosis is a common benign condition, which is characterized by the growth of endometrial-like tissue in ectopic sites outside the uterus. Laparoscopic excision of the disease is frequently carried out for the treatment of severe endometriosis. Pelvic adhesions often develop following surgery and they can compromise the success of treatment. Ovarian suspension (elevating both ovaries to the anterior abdominal wall using a Prolene suture is a simple procedure which has been used to facilitate ovarian retraction during surgery for severe pelvic endometriosis. The study aims to assess the effect of temporary ovarian suspension following laparoscopic surgery for severe pelvic endometriosis on the prevalence of post-operative ovarian adhesions. Methods A prospective double blind randomised controlled trial for patients with severe pelvic endometriosis requiring extensive laparoscopic dissection with preservation of the uterus and ovaries. Severity of the disease and eligibility for inclusion will be confirmed at surgery. Patients unable to provide written consent, inability to tolerate a transvaginal ultrasound scan, unsuccessful surgeries or suffer complications leading to oophorectomies, bowel injuries or open surgery will be excluded. Both ovaries are routinely suspended to the anterior abdominal wall during surgery. At the end of the operation, each participant will be randomised to having only one ovary suspended post-operatively. A new transabdominal suture will be reinserted to act as a placebo. Both sutures will be cut 36 to 48 hours after surgery before the woman is discharged home. Three months after surgery, all randomised patients will have a transvaginal ultrasound scan to assess for ovarian mobility. Both the patients and the person performing the scan will be blinded to the randomisation process. The primary outcome is the prevalence of ovarian adhesions on ultrasound examination. Secondary outcomes are the

  8. A new stratified risk assessment tool for whiplash injuries developed from a prospective observational study

    DEFF Research Database (Denmark)

    Kasch, Helge; Kongsted, Alice; Qerama, Erisela;

    2013-01-01

    (pafter whiplash. Neck......OBJECTIVES: An initial stratification of acute whiplash patients into seven risk-strata in relation to 1-year work disability as primary outcome is presented. DESIGN: The design was an observational prospective study of risk factors embedded in a randomised controlled study. SETTING: Acute whiplash...... patients from units, general practitioners in four Danish counties were referred to two research centres. PARTICIPANTS: During a 2-year inclusion period, acute consecutive whiplash-injured (age 18-70 years, rear-end or frontal-end car accident and WAD (whiplash-associated disorders) grades I-III, symptoms...

  9. Effects of patient safety culture interventions on incident reporting in general practice : A cluster randomised trial a cluster randomised trial

    NARCIS (Netherlands)

    Verbakel, Natasha J.; Langelaan, Maaike; Verheij, Theo J M; Wagner, Cordula; Zwart, Dorien L M

    2015-01-01

    Background: A constructive safety culture is essential for the successful implementation of patient safety improvements. Aim: To assess the effect of two patient safety culture interventions on incident reporting as a proxy of safety culture. Design and setting: A three-arm cluster randomised trial

  10. Vitamin D3 Supplementation Does Not Improve Sprint Performance in Professional Rugby Players: A Randomised, Placebo-Controlled Double Blind Intervention Study.

    Science.gov (United States)

    Fairbairn, Kirsty A; Ceelen, Ingrid Jm; Skeaff, C Murray; Cameron, Claire M; Perry, Tracy L

    2017-08-03

    Vitamin D insufficiency is common in athletes and may lower physical performance. Many cross-sectional studies associate vitamin D status with physical performance in athletes, however there have been few prospective randomised controlled trials with adequate statistical power to test this relationship, and none in the southern hemisphere. Thus, a prospective double blind, randomised placebo-controlled intervention trial was conducted, involving 57 professional rugby union players in New Zealand. Participants were randomised to receive 50,000 IU of cholecalciferol (equivalent to 3,570 IU/day) or placebo once every two weeks over 11-12 weeks. Serum 25(OH)D concentrations and physical performance were measured at baseline, weeks 5-6 and weeks 11-12. Mean (SD) serum 25(OH)D concentrations for all participants at baseline was 94 (18) nmol/L, with all players above 50 nmol/L. Vitamin D supplementation significantly increased serum 25(OH)D concentrations compared to placebo, with a 32 nmol/L difference between groups at 11-12 weeks (95%CI, 26 to 38; P 0.05). Performance on the weighted reverse-grip chin up was significantly higher in players receiving vitamin D compared with placebo, by 5.5 kg (95%CI, 2.0 to 8.9; P = 0.002). Despite significantly improving vitamin D status in these professional rugby union players, vitamin D supplementation had little impact on physical performance outcomes. Thus, it is unlikely that vitamin D supplementation is an ergogenic aid in this group of athletes.

  11. Evaluation of efficacy and tolerability of eperisone and thiocolchicoside in treatment of low back pain associated with muscle spasm: An open label, prospective, randomized controlled trial

    OpenAIRE

    Syed H. Maaz; Prakash N. Khandelwal; Shiraz M. Baig; Sudhakar M. Doifode; Ulhas M. Ghotkar

    2016-01-01

    Background: Low back pain has a high prevalence in adult population. Because of reflex muscle spasm, muscle relaxants are frequently used either alone or in combination with analgesics. Eperisone inhibits voltage gated sodium channels in brain stem and Thiocolchicoside acts via GABA-mediated mechanism to relax muscle spasm and relieves pain. Methods: This was a prospective; open labeled, randomized, two-arm, parallel group, controlled, clinical trial. 113 patients were randomised to two gr...

  12. Randomised controlled trial of vancomycin for pseudomembranous colitis and postoperative diarrhoea.

    Science.gov (United States)

    Keighley, M R; Burdon, D W; Arabi, Y; Williams, J A; Thompson, H; Youngs, D; Johnson, M; Bentley, S; George, R H; Mogg, G A

    1978-12-16

    The efficacy of vancomycin in pseudomembranous colitis was assessed in a prospective randomised controlled trial. Forty-four patients with postoperative diarrhoea were allocated to five days' treatment with either 125 mg vancomycin six-hourly or a placebo. Sixteen patients had high titres of the neutralised faecal toxin characteristic of pseudomembranous colitis; nine received vancomycin and seven placebo. At the end of treatment faecal toxins were present in one patient given vancomycin compared with five of the controls. Vancomycin caused the disappearance of Clostridum difficile from the stool in all except one patient, whereas toxicogenic strains of Cl difficile persisted in all but one of the controls. Histological evidence of psuedomembranous colitis had disappeared by the end of treatment in six out of seven patients given vancomycin compared with only one out of seven patients given vancomycin compared with only one out of five patients given placebo. In patients with faecal toxins bowel habit had returned to normal in seven of the vancomycin group compared with only one of the controls, but there was no significant difference in clinical response among patients without faecaal toxins. The results suggest that vancomycin eliminates toxin-producing Cl difficile from the colon and is associated with rapid clinical and histological improvement in patients with pseudomembranous colitis.

  13. Recovery in mechanical muscle strength following resurfacing vs standard total hip arthroplasty - a randomised clinical trial

    DEFF Research Database (Denmark)

    Jensen, Carsten; Aagaard, Per; Overgaard, S

    2011-01-01

    OBJECTIVES: To evaluate the effect of resurfacing vs standard total hip replacement on post-surgery hip and knee muscle strength recovery in a prospective randomised controlled trial at the Department of Orthopaedics, University Hospital, Odense, Denmark. METHODS: Forty-three patients were......-29%) with the affected side being weakest (P ≤ 0.05) and hip flexors being most affected. Asymmetry was present in half of the muscle groups at 26 wks (P ≤ 0.05), and remained present for the hip flexors and hip adductors at 52 wks (P ≤ 0.05). CONCLUSIONS: R-THA patients showed an attenuated and delayed recovery...... in maximal lower limb muscle strength (in 2/6 muscle groups) compared to S-THA. Notably, the attenuated strength recovery following R-THA was most markedly manifested in the late phase (1 yr) of post-surgical recovery, and appeared to be due to the detachment of the lower half of the gluteus maximus muscle...

  14. Assessment of an electronic voting system within the tutorial setting: A randomised controlled trial [ISRCTN54535861

    Directory of Open Access Journals (Sweden)

    De Young Neville J

    2005-07-01

    Full Text Available Abstract Background Electronic voting systems have been used in various educational settings with little measurement of the educational impact on students. The goal of this study was to measure the effects of the inclusion of an electronic voting system within a small group tutorial. Method A prospective randomised controlled trial was run at the Royal Adelaide Hospital, a teaching hospital in Adelaide, Australia. 102 students in their first clinical year of medical school participated in the study where an electronic voting system was introduced as a teaching aid into a standard tutorial. Long-term retention of knowledge and understanding of the topics discussed in the tutorials was measured and student response to the introduction of the electronic voting system was assessed. Results Students using the electronic voting system had improved long-term retention of understanding of material taught in the tutorial. Students had a positive response to the use of this teaching aid. Conclusion Electronic voting systems can provide a stimulating learning environment for students and in a small group tutorial may improve educational outcomes.

  15. Methods for meta-analysis of individual participant data from Mendelian randomisation studies with binary outcomes.

    Science.gov (United States)

    Burgess, Stephen; Thompson, Simon G

    2016-02-01

    Mendelian randomisation is an epidemiological method for estimating causal associations from observational data by using genetic variants as instrumental variables. Typically the genetic variants explain only a small proportion of the variation in the risk factor of interest, and so large sample sizes are required, necessitating data from multiple sources. Meta-analysis based on individual patient data requires synthesis of studies which differ in many aspects. A proposed Bayesian framework is able to estimate a causal effect from each study, and combine these using a hierarchical model. The method is illustrated for data on C-reactive protein and coronary heart disease (CHD) from the C-reactive protein CHD Genetics Collaboration (CCGC). Studies from the CCGC differ in terms of the genetic variants measured, the study design (prospective or retrospective, population-based or case-control), whether C-reactive protein was measured, the time of C-reactive protein measurement (pre- or post-disease), and whether full or tabular data were shared. We show how these data can be combined in an efficient way to give a single estimate of causal association based on the totality of the data available. Compared to a two-stage analysis, the Bayesian method is able to incorporate data on 23% additional participants and 51% more events, leading to a 23-26% gain in efficiency.

  16. a prospective study

    OpenAIRE

    Rörster, Elisa geb. Pätel

    2012-01-01

    Bulk fractures only occur on very rare occasions in bilayered all-ceramic crowns, where as veneer fractures, above all chippings, still present a frequent amount of clinical complications. The purpose of the current prospective study was to examine the clinical performance of an anatomically modified framework for a period of two years. All crowns were manufactured following the Cercon process (DeguDent GmbH, Hanau). As is common practice, the frameworks for the control group were made of ...

  17. Bright Economic Prospects

    Institute of Scientific and Technical Information of China (English)

    Zhang Minqiu

    2004-01-01

    @@ India is expected to register an 8.2% growth rate for the 2003-04 fiscal year. The overall economic situation this year has been satisfactory despite the scaled down 6-6.5% growth rate for the new fiscal year due to oil price hikes, reduced monsoon volume and some 7% inflation. Judging from the following factors, bright prospects are in store for the country down the road.

  18. Prospecting for lunar resources

    Science.gov (United States)

    Taylor, G.; Martel, L.

    Large space settlements on the Moon (thousands of people) will require use of indigenous resources to build and maintain the infrastructure and generate products for export. Prospecting for these resources is a crucial step in human migration to space and needs to begin before settlement and the establishment of industrial complexes. We are devising a multi-faceted approach to prospect for resources. A central part of this work is developing the methodology for prospecting the Moon and other planetary bodies. This involves a number of investigations: (1) It is essential to analyze the economics of planetary ore deposits. Ore deposits are planetary materials that we can mine, process, and deliver to customers at a profit. The planetary context tosses in some interesting twists to this definition. (2) We are also making a comprehensive theoretical assessment of potential lunar ore deposits. Our understanding of the compositions, geological histories, and geological processes on the Moon will lead to significant differences in how we assess wh a t types of ores could be present. For example, the bone-dry nature of the Moon (except at the poles) eliminates all ore deposits associated with hydrothermal fluids. (3) We intend to search for resources using existing data for the Moon. Thus, prospecting can begin immediately. We have a wealth of remote sensing data for the Moon. We also have a good sampling of the Moon by the Apollo and Luna missions, and from lunar meteorites. We can target specific types of deposits already identified (e.g. lunar pyroclastic deposits) and look for other geological settings that might have produced ores and other materials of economic value. Another approach we will take is to examine all data available to look for anomalies. Examples are unusual spectral properties, large disagreements between independent techniques that measure the same property, unusual elemental ratios, or simply exceptional properties such as elemental abundances much

  19. Probiotics in the prevention of eczema: a randomised controlled trial

    OpenAIRE

    Allen, Stephen J; Jordan, Sue; Storey, Melanie; Catherine A Thornton; Gravenor, Michael B.; Garaiova, Iveta; Plummer, Susan F; Wang, Duolao; Morgan, Gareth

    2014-01-01

    Objective To evaluate a multistrain, high-dose probiotic in the prevention of eczema. Design A randomised, double-blind, placebo-controlled, parallel group trial. Settings Antenatal clinics, research clinic, children at home. Patients Pregnant women and their infants. Interventions Women from 36 weeks gestation and their infants to age 6 months received daily either the probiotic (Lactobacillus salivarius CUL61, Lactobacillus paracasei CUL08, Bifidobacterium animalis subspecies lactis CUL34 a...

  20. A randomised controlled trial of complete denture impression materials.

    Science.gov (United States)

    Hyde, T P; Craddock, H L; Gray, J C; Pavitt, S H; Hulme, C; Godfrey, M; Fernandez, C; Navarro-Coy, N; Dillon, S; Wright, J; Brown, S; Dukanovic, G; Brunton, P A

    2014-08-01

    There is continuing demand for non-implant prosthodontic treatment and yet there is a paucity of high quality Randomised Controlled Trial (RCT) evidence for best practice. The aim of this research was to provide evidence for best practice in prosthodontic impressions by comparing two impression materials in a double-blind, randomised, crossover, controlled, clinical trial. Eighty-five patients were recruited, using published eligibility criteria, to the trial at Leeds Dental Institute, UK. Each patient received two sets of dentures; made using either alginate or silicone impressions. Randomisations determined the order of assessment and order of impressions. The primary outcome was patient blinded preference for unadjusted dentures. Secondary outcomes were patient preference for the adjusted dentures, rating of comfort, stability and chewing efficiency, experience of each impression, and an OHIP-EDENT questionnaire. Seventy-eight (91.8%) patients completed the primary assessment. 53(67.9%) patients preferred dentures made from silicone impressions while 14(17.9%) preferred alginate impressions. 4(5.1%) patients found both dentures equally satisfactory and 7 (9.0%) found both equally unsatisfactory. There was a 50% difference in preference rates (in favour of silicone) (95%CI 32.7-67.3%, pUnilever Hatton Award of the International Assocation for Dental Research, Capetown, South Africa, June 2014. Copyright © 2014 The Authors. Published by Elsevier Ltd.. All rights reserved.

  1. Posterior superior alveolar nerve blocks: a randomised controlled, double blind trial.

    Science.gov (United States)

    Singla, Himanshi; Alexander, Mohan

    2015-06-01

    Local anesthesia has been a boon for dentistry to allay the most common fear of pain among dental patients. Several techniques to achieve anesthesia for posterior maxillae have been advocated albeit with minor differences. We compared two techniques of posterior superior alveolar nerve block (PSANB), the one claimed to be "most accurate" to the one "most commonly used." This study was conducted to assess and compare the efficacy as well as complications of "the straight needle technique" to that of "the bent needle technique" for PSANB. We conducted a prospective, randomised, double blind study on 120 patients divided into two groups, using a 26-gauge, 38 mm long needle with 2 ml of 2 % lignocaine hydrochloride with 1:200,000 adrenaline solution. Objective symptoms were evaluated by a single investigator. Cold test using ice was used to evaluate the status of pulpal anesthesia. Data thus obtained was subjected to statistical analysis. Out of the 120 blocks, 19 blocks failed. Statistical analysis found straight needle technique to be more successful than the bent needle technique (p = 0.002). Both the techniques were equally effective for the first molar region on both right and left side (p = 0.66 on right side and p = 0.20 on left side). However, in the second and third molar region technique A was more effective than B (p = 0.01) on right side only. On Left side, both techniques were equally effective (p = 0.08). Sensitivity of the cold test was 82 % which is quite high but the specificity was 68 % which seems to be falling in the above average range only. Positive predictive value of 75 and negative predictive value of 76 was observed. We did not encounter any complications in this study. To the best of our knowledge, this is the first randomised controlled clinical study on PSANB techniques. This study suggests that the PSANB using the straight needle technique as advocated by Malamed [1] can be routinely and safely used to achieve anesthesia in

  2. Applied Astronomy: Asteroid Prospecting

    Science.gov (United States)

    Elvis, M.

    2013-09-01

    In the age of asteroid mining the ability to find promising ore-bearing bodies will be valuable. This will give rise to a new discipline- "Applied Astronomy". Just as most geologists work in industry, not in academia, the same will be true of astronomers. Just how rare or common ore-rich asteroids are likely to be, and the skills needed to assay their value, are discussed here, with an emphasis on remote - telescopic - methods. Also considered are the resources needed to conduct extensive surveys of asteroids for prospecting purposes, and the cost and timescale involved. The longer-term need for applied astronomers is also covered.

  3. Astronautics summary and prospects

    CERN Document Server

    Kiselev, Anatoly Ivanovich; Menshikov, Valery Alexandrovich

    2003-01-01

    The monograph by A.I.Kiselev, A.A. Medvedev and Y.A.Menshikov, Astronautics: Summary and Prospects, aroused enthusiasm both among experts and the public at large. This is due to the felicitous choice of presentation that combines a simple description of complex space matters with scientificsubstantiation of the sub­ jectmatter described. The wealth of color photos makes the book still more attractive, and it was nominated for an award at the 14th International Moscow Book Fair, being singled out as the "best publication of the book fair". The book's popularity led to a second edition, substantially revised and enlarged. Since the first edition did not sufficiently cover the issues of space impact on ecology and the prospective development of space systems, the authors revised the entire volume, including in it the chapter "Space activity and ecology" and the section "Multi-function space systems". Using the federal monitoring system, now in the phase of system engi­ neering, as an example, the authors consi...

  4. Endovenous laser ablation of the great saphenous vein using a bare fibre versus a tulip fibre: a randomised clinical trial.

    Science.gov (United States)

    Vuylsteke, M E; Thomis, S; Mahieu, P; Mordon, S; Fourneau, I

    2012-12-01

    This clinical trial aimed to evaluate the clinical results of the use of a tulip fibre versus the use of a bare fibre for endovenous laser ablation. In a multicentre prospective randomised trial 174 patients were randomised for the treatment of great saphenous vein reflux. A duplex scan was scheduled 1 month, 6 months and 1 year postoperatively. Ecchymosis was measured on the 5th postoperative day. In addition, pain, analgesics requirement, postoperative quality of life (CIVIQ 2) and patient satisfaction rate were noted. Patients treated with a tulip fibre had significantly less postoperative ecchymosis (0.04 vs. 0.21; p < 0.001) and pain (5th day) (1.00 vs. 2.00; p < 0.001) and had a better postoperative quality of life (27 vs. 32; p = 0.023). There was no difference in analgesic intake (p = 0.11) and patient satisfaction rate (p = 0.564). The total occlusion rate at 1 year was 97.02% and there was no significant difference between the two groups (p = 0.309). Using a tulip fibre for EVLA of the great saphenous vein results, when compared with the use of a bare fibre, in equal occlusion rates at 1 year but causes less postoperative ecchymosis and pain and in a better postoperative quality of life. Copyright © 2012 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved.

  5. Open versus laparoscopically-assisted oesophagectomy for cancer: a multicentre randomised controlled phase III trial - the MIRO trial

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    Msika Simon

    2011-07-01

    Full Text Available Abstract Background Open transthoracic oesophagectomy is the standard treatment for infracarinal resectable oesophageal carcinomas, although it is associated with high mortality and morbidity rates of 2 to 10% and 30 to 50%, respectively, for both the abdominal and thoracic approaches. The worldwide popularity of laparoscopic techniques is based on promising results, including lower postoperative morbidity rates, which are related to the reduced postoperative trauma. We hypothesise that the laparoscopic abdominal approach (laparoscopic gastric mobilisation in oesophageal cancer surgery will decrease the major postoperative complication rate due to the reduced surgical trauma. Methods/Design The MIRO trial is an open, controlled, prospective, randomised multicentre phase III trial. Patients in study arm A will receive laparoscopic-assisted oesophagectomy, i.e., a transthoracic oesophagectomy with two-field lymphadenectomy and laparoscopic gastric mobilisation. Patients in study arm B will receive the same procedure, but with the conventional open abdominal approach. The primary objective of the study is to evaluate the major postoperative 30-day morbidity. Secondary objectives are to assess the overall 30-day morbidity, 30-day mortality, 30-day pulmonary morbidity, disease-free survival, overall survival as well as quality of life and to perform medico-economic analysis. A total of 200 patients will be enrolled, and two safety analyses will be performed using 25 and 50 patients included in arm A. Discussion Postoperative morbidity remains high after oesophageal cancer surgery, especially due to major pulmonary complications, which are responsible for 50% of the postoperative deaths. This study represents the first randomised controlled phase III trial to evaluate the benefits of the minimally invasive approach with respect to the postoperative course and oncological outcomes in oesophageal cancer surgery. Trial Registration NCT00937456 (ClinicalTrials.gov

  6. Metered-dose inhaler ipratropium bromide in moderate acute asthma in children: A single-blinded randomised controlled trial.

    Science.gov (United States)

    Wyatt, Emma L; Borland, Meredith L; Doyle, Sarah K; Geelhoed, Gary C

    2015-02-01

    To determine if the addition of ipratropium bromide (IB) by metered-dose inhaler in moderate acute asthma in children affects hospital admission rates when compared with inhaled salbutamol and oral prednisolone alone. A prospective, single-blinded, randomised, controlled, equivalence trial in a tertiary paediatric emergency department. Patients aged 2-15 years with acute, moderate asthma were randomised to two groups, one receiving salbutamol, prednisolone and IB, the other receiving only salbutamol and prednisolone. The managing doctor was blinded to treatment. Admission rates were compared, and less than 15% difference was accepted as statistically equivalent. Recruitment ran from June 2007 until January 2011. Three hundred forty-seven subjects were analysed. The admission rate in the IB group was 70.1% (122/174) compared with 64.2% (111/173) in the non-IB group. The absolute difference of +5.9% (95% confidence interval -4.0% to 15.8%) is not statistically equivalent but does not show a statistically significant decrease in admission rates when IB was given. Adverse effects were more prevalent in the IB group, at 13.2% (23/174), compared with 4.6% (8/173) in the non-IB group, a relative risk of 2.86 (95% confidence interval 1.31-6.21). In children with acute asthma of moderate severity who are treated with adequate doses of salbutamol and prednisolone, the addition of IB is not significantly associated with a reduction in admission rates. There is a significantly higher rate of adverse effects if IB is given. IB should be reserved for children with severe asthma exacerbations. © 2014 The Authors. Journal of Paediatrics and Child Health © 2014 Paediatrics and Child Health Division (Royal Australasian College of Physicians).

  7. Effects of pacifier use on transition to full breastfeeding and sucking skills in preterm infants: a randomised controlled trial.

    Science.gov (United States)

    Kaya, Vildan; Aytekin, Aynur

    2017-07-01

    To determine the effects of pacifier use on transition to full breastfeeding and sucking skills in preterm infants. Feeding problems in preterm infants cause delays in hospital discharge, extend mother-infant reunification and increase medical cost. Nutritive sucking skills of preterm infants may develop by improving non-nutritive sucking skills and increasing sucking experiences. A prospective, randomised controlled trial conducted in the Eastern Turkey. Seventy infants were randomised into two groups: a pacifier group (n = 34) and a control group (n = 36). Pacifier use was applied in the preterm infants in the pacifier group, up to switching to full breastfeeding. The infants in the control group did not use pacifiers. Data were collected by a researcher using the Preterm Infant Introductory Information Form, the Preterm Infant Monitoring Form and the LATCH Breastfeeding Assessment Tool. For the study, ethics committee approval, official permission and written informed consents of the families were obtained. The time to transition to full breastfeeding (123·06 ± 66·56 hours) and the time to discharge (434·50 ± 133·29 hours) in the pacifier group were significantly shorter compared to the control group (167·78 ± 91·77 and 593·63 ± 385·32 hours, respectively) (p preterm infants receiving complementary feeding. Pacifier use may be recommended to accelerate transition to full breastfeeding and to improve the sucking skills in preterm infants who were fed by both oral route and complementary feeding in the neonatal intensive care units. © 2016 John Wiley & Sons Ltd.

  8. Impact of the early reduction of cyclosporine on renal function in heart transplant patients: a French randomised controlled trial.

    Science.gov (United States)

    Boissonnat, Pascale; Gaillard, Ségolène; Mercier, Catherine; Redonnet, Michel; Lelong, Bernard; Mattei, Marie-Françoise; Mouly-Bandini, Annick; Pattier, Sabine; Sirinelli, Agnès; Epailly, Eric; Varnous, Shaida; Billes, Marc-Alain; Sebbag, Laurent; Ecochard, René; Cornu, Catherine; Gueyffier, François

    2012-12-03

    Using reduced doses of Cyclosporine A immediately after heart transplantation in clinical trials may suggest benefits for renal function by reducing serum creatinine levels without a significant change in clinical endpoints. However, these trials were not sufficiently powered to prove clinical outcomes. In a prospective, multicentre, open-label, parallel-group controlled trial, 95 patients aged 18 to 65 years old, undergoing de novo heart transplantation were centrally randomised to receive either a low (130 Cyclosporine A (200 transplant months along with mycophenolate mofetil and corticosteroids. Participants had a stable haemodynamic status, a serum creatinine level transplants were excluded. The change in serum creatinine level over 12 months was used as the main criterion for renal function. Intention-to-treat analysis was performed on the 95 randomised patients and a mixed generalised linear model of covariance was applied. At 12 months, the mean (± SD) creatinine value was 120.7 μmol/L (± 35.8) in the low-dose group and 132.3 μmol/L (± 49.1) in the standard-dose group (P = 0.162). Post hoc analyses suggested that patients with higher creatinine levels at baseline benefited significantly from the lower Cyclosporine A target. The number of patients with at least one rejection episode was not significantly different but one patient in the low-dose group and six in the standard-dose group required dialysis. In patients with de novo cardiac transplantation, early Cyclosporine A dose reduction was not associated with renal benefit at 12 months. However, the strategy may benefit patients with high creatinine levels before transplantation. ClinicalTrials.gov NCT00159159.

  9. A multidisciplinary primary care team consultation in a socio-economically deprived community: An exploratory randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Gibney David

    2011-01-01

    Full Text Available Abstract Background Psychosocial problems in socioeconomically deprived communities are not always amenable to traditional medical approaches. Mothers living in these areas are a particularly vulnerable group. The objective of this study was to evaluate the effectiveness of a lengthened multi-disciplinary team consultation in primary care in reducing anxiety and depression in mothers. Methods This was a prospective randomised controlled trial of a multidisciplinary team consultation against normal care. 94 mothers were recruited from three general practices from an area of extreme socio-economic deprivation. Mothers randomised into the intervention group attended a multidisciplinary consultation with up to four case-specific health care professionals. Consultations addressed medical, psychological and social problems and lasted up to one hour. Conventional primary care continued to be available to the intervention families. Control group families received normal primary care services. The outcomes measured were anxiety and depression as using the Hospital Anxiety and Depression Scale (HADS, health status using SF36v2, and quality of life using the abbreviated Schedule for the Evaluation of Individual Quality of Life (SEIQoL-DW at baseline, 6 months and 12 months. Results Ordered logistic regression was used to analyse the data. There was no significant difference found between intervention and control groups after 6 months and 12 months in all of the measured outcomes. Conclusions The new lengthened multi-disciplinary team consultation did not have any impact on the mental health, general health, and quality of life of mothers after 6 and 12 months. Other methods of primary health care delivery in socio-economically deprived communities need to be evaluated.

  10. Haemodynamic Optimization by Oesophageal Doppler and Pulse Power Wave Analysis in Liver Surgery: A Randomised Controlled Trial.

    Directory of Open Access Journals (Sweden)

    Aarne Feldheiser

    Full Text Available Liver surgery is still associated with a high rate of morbidity and mortality. We aimed to compare different haemodynamic treatments in liver surgery. In a prospective, blinded, randomised, controlled pilot trial patients undergoing liver resection were randomised to receive haemodynamic management guided by conventional haemodynamic parameters or by oesophageal Doppler monitor (ODM, CardioQ-ODM or by pulse power wave analysis (PPA, LiDCOrapid within a goal-directed algorithm adapted for liver surgery. The primary endpoint was stroke volume index before intra-operative start of liver resection. Secondary endpoints were the haemodynamic course during surgery and postoperative pain levels. Due to an unbalance in the extension of the surgical procedures with a high rate of only minor procedures the conventional group was dropped from the analysis. Eleven patients in the ODM group and 10 patients in the PPA group were eligible for statistical analysis. Stroke volume index before start of liver resection was 49 (37; 53 ml/m2 and 48 (41; 56 ml/m2 in the ODM and PPA group, respectively (p=0.397. The ODM guided group was haemodynamically stable as shown by ODM and PPA measurements. However, the PPA guided group showed a significant increase of pulse-pressure-variability (p=0.002 that was not accompanied by a decline of stroke volume index displayed by the PPA (p=0.556 but indicated by a decline of stroke volume index by the ODM (p<0.001. The PPA group had significantly higher postoperative pain levels than the ODM group (p=0.036. In conclusion, goal-directed optimization by ODM and PPA showed differences in intraoperative cardiovascular parameters indicating that haemodynamic optimization is not consistent between the two monitors.ISRCTN.com ISRCTN64578872.

  11. Protocol for a randomised controlled trial of treatment of asymptomatic candidiasis for the prevention of preterm birth [ACTRN12610000607077

    Directory of Open Access Journals (Sweden)

    Rickard Kristen R

    2011-03-01

    Full Text Available Abstract Background Prevention of preterm birth remains one of the most important challenges in maternity care. We propose a randomised trial with: a simple Candida testing protocol that can be easily incorporated into usual antenatal care; a simple, well accepted, treatment intervention; and assessment of outcomes from validated, routinely-collected, computerised databases. Methods/Design Using a prospective, randomised, open-label, blinded-endpoint (PROBE study design, we aim to evaluate whether treating women with asymptomatic vaginal candidiasis early in pregnancy is effective in preventing spontaneous preterm birth. Pregnant women presenting for antenatal care The study protocol draws on the usual antenatal care schedule, has been pilot-tested and the intervention involves only a minor modification of current practice. Women who agree to participate will self-collect a vaginal swab and those who are culture positive for Candida will be randomised (central, telephone to open-label treatment or usual care (screening result is not revealed, no treatment, routine antenatal care. Outcomes will be obtained from population databases. A sample size of 3,208 women with Candida colonisation (1,604 per arm is required to detect a 40% reduction in the spontaneous preterm birth rate among women with asymptomatic candidiasis from 5.0% in the control group to 3.0% in women treated with clotrimazole (significance 0.05, power 0.8. Analyses will be by intention to treat. Discussion For our hypothesis, a placebo-controlled trial had major disadvantages: a placebo arm would not represent current clinical practice; knowledge of vaginal colonisation with Candida may change participants' behaviour; and a placebo with an alcohol preservative may have an independent affect on vaginal flora. These disadvantages can be overcome by the PROBE study design. This trial will provide definitive evidence on whether screening for and treating asymptomatic candidiasis in

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

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    Forder Peta M

    2011-04-01

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

  13. Access to a polymerase chain reaction assay method targeting 13 respiratory viruses can reduce antibiotics: a randomised, controlled trial

    Directory of Open Access Journals (Sweden)

    Lindh Magnus

    2011-04-01

    Full Text Available Abstract Background Viral respiratory infections are common worldwide and range from completely benign disease to life-threatening illness. Symptoms can be unspecific, and an etiologic diagnosis is rarely established because of a lack of suitable diagnostic tools. Improper use of antibiotics is common in this setting, which is detrimental in light of the development of bacterial resistance. It has been suggested that the use of diagnostic tests could reduce antibiotic prescription rates. The objective of this study was to evaluate whether access to a multiplex polymerase chain reaction (PCR assay panel for etiologic diagnosis of acute respiratory tract infections (ARTIs would have an impact on antibiotic prescription rate in primary care clinical settings. Methods Adult patients with symptoms of ARTI were prospectively included. Nasopharyngeal and throat swabs were analysed by using a multiplex real-time PCR method targeting thirteen viruses and two bacteria. Patients were recruited at 12 outpatient units from October 2006 through April 2009, and samples were collected on the day of inclusion (initial visit and after 10 days (follow-up visit. Patients were randomised in an open-label treatment protocol to receive a rapid or delayed result (on the following day or after eight to twelve days. The primary outcome measure was the antibiotic prescription rate at the initial visit, and the secondary outcome was the total antibiotic prescription rate during the study period. Results A total sample of 447 patients was randomised. Forty-one were excluded, leaving 406 patients for analysis. In the group of patients randomised for a rapid result, 4.5% (9 of 202 of patients received antibiotics at the initial visit, compared to 12.3% (25 of 204 (P = 0.005 of patients in the delayed result group. At follow-up, there was no significant difference between the groups: 13.9% (28 of 202 in the rapid result group and 17.2% (35 of 204 in the delayed result group (P

  14. Applicability and generalisability of published results of randomised controlled trials and non-randomised studies evaluating four orthopaedic procedures: methodological systematic review.

    Science.gov (United States)

    Pibouleau, Leslie; Boutron, Isabelle; Reeves, Barnaby C; Nizard, Rémy; Ravaud, Philippe

    2009-11-17

    To compare the reporting of essential applicability data from randomised controlled trials and non-randomised studies evaluating four new orthopaedic surgical procedures. Medline and the Cochrane central register of controlled trials. All articles of comparative studies assessing total hip or knee arthroplasty carried out by a minimally invasive approach or computer assisted navigation system. Items judged to be essential for interpreting the applicability of findings about such procedures were identified by a survey of a sample of orthopaedic surgeons (77 of 512 completed the survey). Reports were evaluated for data describing these "essential" items and the number of centres and surgeons involved in the trials. When data on the number of centres and surgeons were not reported, the corresponding author of the selected trials was contacted. Results 84 articles were identified (38 randomised controlled trials, 46 non-randomised studies). The median percentage (interquartile range) of essential items reported for non-randomised studies compared with randomised controlled trials was 38% (25-63%) versus 44% (38-45%) for items about patients, 71% (43-86%) versus 71% (57-86%) for items considered essential for all interventions, and 38% (25-50%) versus 50% (25-50%) for items about the context of care. More than 80% of both study types were single centre studies, with one or two participating surgeons. The reporting of data related to the applicability of results was poor in published articles of both non-randomised studies and randomised controlled trials and did not differ by study design. The applicability of results from the trials and studies was similar in terms of number of centres and surgeons involved and the reproducibility of the intervention.

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

    Directory of Open Access Journals (Sweden)

    Palmer Edward

    2007-07-01

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

  16. A Randomised Controlled Trial of complete denture impression materials

    Science.gov (United States)

    Hyde, T.P.; Craddock, H.L.; Gray, J.C.; Pavitt, S.H.; Hulme, C.; Godfrey, M.; Fernandez, C.; Navarro-Coy, N.; Dillon, S.; Wright, J.; Brown, S.; Dukanovic, G.; Brunton, P.A.

    2014-01-01

    Objectives There is continuing demand for non-implant prosthodontic treatment and yet there is a paucity of high quality Randomised Controlled Trial (RCT) evidence for best practice. The aim of this research was to provide evidence for best practice in prosthodontic impressions by comparing two impression materials in a double-blind, randomised, crossover, controlled, clinical trial. Methods Eighty-five patients were recruited, using published eligibility criteria, to the trial at Leeds Dental Institute, UK. Each patient received two sets of dentures; made using either alginate or silicone impressions. Randomisations determined the order of assessment and order of impressions. The primary outcome was patient blinded preference for unadjusted dentures. Secondary outcomes were patient preference for the adjusted dentures, rating of comfort, stability and chewing efficiency, experience of each impression, and an OHIP-EDENT questionnaire. Results Seventy-eight (91.8%) patients completed the primary assessment. 53(67.9%) patients preferred dentures made from silicone impressions while 14(17.9%) preferred alginate impressions. 4(5.1%) patients found both dentures equally satisfactory and 7 (9.0%) found both equally unsatisfactory. There was a 50% difference in preference rates (in favour of silicone) (95%CI 32.7–67.3%, p silicone impressions were preferred by patients. Clinical significance Given the strength of the clinical findings within this paper, dentists should consider choosing silicone rather than alginate as their material of choice for secondary impressions for complete dentures. Trial Registration: ISRCTN 01528038.

 This article forms part of a project for which the author (TPH) won the Senior Clinical Unilever Hatton Award of the International Assocation for Dental Research, Capetown, South Africa, June 2014. PMID:24995473

  17. Five-year comparison of wear using oxidised zirconium and cobalt-chrome femoral heads in total hip arthroplasty: a multicentre randomised controlled trial.

    Science.gov (United States)

    Jassim, S S; Patel, S; Wardle, N; Tahmassebi, J; Middleton, R; Shardlow, D L; Stephen, A; Hutchinson, J; Haddad, F S

    2015-07-01

    Oxidised zirconium (OxZi) has been developed as an alternative bearing surface for femoral heads in total hip arthroplasty (THA). This study has investigated polyethylene wear, functional outcomes and complications, comparing OxZi and cobalt-chrome (CoCr) as part of a three-arm, multicentre randomised controlled trial. Patients undergoing THA from four institutions were prospectively randomised into three groups. Group A received a CoCr femoral head and highly cross-linked polyethylene (XLPE) liner; Group B received an OxZi femoral head and XLPE liner; Group C received an OxZi femoral head and ultra-high molecular weight polyethylene (UHMWPE) liner. At five years, 368 patients had no statistically significant differences in short-form-36 (p = 0.176 mental, p = 0.756 physical), Western Ontario and McMaster Universities Osteoarthritis Index (p = 0.847), pain scores (p = 0.458) or complications. The mean rate of linear wear was 0.028 mm/year (standard deviation (SD) 0.010) for Group A, 0.023 mm/year (SD 0.010) for Group B, and 0.09 mm/year (SD 0.045) for Group C. Penetration was significantly higher in the UHMWPE liner group compared with both XLPE liner groups (p < 0.001) but no significant difference was noted between CoCr and OxZi when articulating with XLPE (p = 0.153). In this, the largest randomised study of this bearing surface, it appears that using a XLPE acetabular liner is more important in reducing THA component wear than the choice of femoral head bearing, at mid-term follow-up. There is a non-significant trend towards lower wear, coupling OxZi rather than CoCr with XLPE but long-term analysis is required to see if this observation changes with time and becomes significant.

  18. Compliance with trial registration in five core journals of clinical geriatrics: a survey of original publications on randomised controlled trials from 2008 to 2012.

    Science.gov (United States)

    Mann, Eva; Nguyen, Natalie; Fleischer, Steffen; Meyer, Gabriele

    2014-11-01

    to assess the proportion of registered randomised controlled trials in five core clinical geriatric journals and to analyse whether registered study outcomes correspond with published outcomes. survey of original papers published 2008 to 2012. two independent reviewers retrieved the sample through search in the web-based archives of Age and Ageing, the Journal of the American Geriatric Society, the American Journal of Geriatric Psychiatry, the Journal of the American Medical Directors Association and International Psychogeriatrics. Data extraction was performed by two independent reviewers using a pre-tested 13-item checklist. Registration status was checked and information provided in registers compared with information presented in the original publication. A third reviewer was consulted if no consensus could be reached. the sample comprised 220 original publications on randomised controlled trials. A total of 140 (63.6%) were registered. Registration was in accordance with the ICMJE requirements in 54 out of 140 registered trials (38.6%). Less than one-third of registered papers (n = 40) reported on all study outcomes listed in the study register. In 74 out of the 80 non-registered trials, the missing registration was not declared in the publication. There was no consistent upward trend towards higher registration compliance throughout journals and years. our survey shows that prospective trial registration and compliance between outcomes declared in the registry and reported in the publication is poor. Concerted action of authors, editors and peer-reviewers is overdue aimed to irreversibly implement the imperative of registration of randomised controlled trials and complete outcome reporting. © The Author 2014. Published by Oxford University Press on behalf of the British Geriatrics Society. All rights reserved. For Permissions, please email: journals.permissions@ oup.com.

  19. Evaluating the feasibility and effectiveness of a critical care discharge information pack for patients and their families: a pilot cluster randomised controlled trial

    Science.gov (United States)

    Bench, Suzanne; Day, Tina; Heelas, Karina; Hopkins, Philip; White, Catherine; Griffiths, Peter

    2015-01-01

    Objectives To evaluate the feasibility and effectiveness of an information pack, based on self-regulation theory, designed to support patients and their families immediately before, during and after discharge from an intensive care unit (ICU). Design and setting Prospective assessor-blinded pilot cluster randomised controlled trial (RCT; in conjunction with a questionnaire survey of trial participants’ experience) in 2 ICUs in England. Participants Patients (+/− a family member) who had spent at least 72 h in an ICU, declared medically fit for discharge to a general ward. Randomisation Cluster randomisation (by day of discharge decision) was used to allocate participants to 1 of 3 study groups. Intervention A user-centred critical care discharge information pack (UCCDIP) containing 2 booklets; 1 for the patient (which included a personalised discharge summary) and 1 for the family, given prior to discharge to the ward. Primary outcome Psychological well-being measured using Hospital Anxiety and Depression Scores (HADS), assessed at 5±1 days postunit discharge and 28 days/hospital discharge. Statistical significance (p≤0.05) was determined using χ2 and Kruskal-Wallis (H). Results 158 patients were allocated to: intervention (UCCDIP; n=51), control 1: ad hoc verbal information (n=59), control 2: booklet published by ICUsteps (n=48). There were no statistically significant differences in the primary outcome. The a priori enrolment goal was not reached and attrition was high. Using HADS as a primary outcome measure, an estimated sample size of 286 is required to power a definitive trial. Conclusions Findings from this pilot RCT provide important preliminary data regarding the circumstances under which an intervention based on the principles of UCCDIP could be effective, and the sample size required to demonstrate this. Trial registration number Current Controlled Trials ISRCTN47262088; results. PMID:26614615

  20. Standardised versus individualised multiherb Chinese herbal medicine for oligomenorrhoea and amenorrhoea in polycystic ovary syndrome: a randomised feasibility and pilot study in the UK

    Science.gov (United States)

    Flower, Andrew; Prescott, Philip; Wing, Trevor; Moore, Michael; Lewith, George

    2017-01-01

    Objectives To explore feasibility of a randomised study using standardised or individualised multiherb Chinese herbal medicine (CHM) for oligomenorrhoea and amenorrhoea in women with polycystic ovary syndrome (PCOS), to pilot study methods and to obtain clinical data to support sample size calculations. Design Prospective, pragmatic, randomised feasibility and pilot study with participant and practitioner blinding. Setting 2 private herbal practices in the UK. Participants 40 women diagnosed with PCOS and oligomenorrhoea or amenorrhoea following Rotterdam criteria. Intervention 6 months of either standardised CHM or individualised CHM, 16 g daily taken orally as a tea. Main outcome measures Our primary objective was to determine whether oligomenorrhoea and amenorrhoea were appropriate as the primary outcome measures for the main study. Estimates of treatment effects were obtained for menstrual rate, body mass index (BMI), weight and hirsutism. Data were collected regarding safety, feasibility and acceptability. Results Of the 40 participants recruited, 29 (72.5%) completed the study. The most frequently cited symptoms of concern were hirsutism, weight and menstrual irregularity. Statistically significant improvements in menstrual rates were found at 6 months within group for both standardised CHM (mean difference (MD) 0.18±0.06, 95% CI 0.06 to 0.29; p=0.0027) and individualised CHM (MD 0.27±0.06, 95% CI 0.15 to 0.39; phirsutism scores found within group for both groups were not statistically significant between group (p=0.09). Liver and kidney function and adverse events data were largely normal. Participant feedback suggests changing to tablet administration could facilitate adherence. Conclusions A CHM randomised controlled trial for PCOS is feasible and preliminary data suggest that both individualised and standardised multiherb CHMs have similar safety profiles and clinical effects on promoting menstrual regularity. These data will inform the design of

  1. Comparison of efficacy and safety between benidipine and hydrochlorothiazide in fosinopril-treated hypertensive patients with chronic kidney disease: protocol for a randomised controlled trial

    Science.gov (United States)

    Xue, Cheng; Zhou, Chenchen; Yang, Bo; Lv, Jiayi; Dai, Bing; Yu, Shengqiang; Wang, Yi; Zhao, Guanren; Mei, Changlin

    2017-01-01

    Introduction Co-administration of a diuretic or calcium channel blocker with an ACE inhibitor are both preferred combinations in patients with hypertensive chronic kidney disease (CKD). According to the available evidence, it is still unknown which combination plays a more active role in renal protection. We hypothesised that a combination of fosinopril and benidipine may delay the progression of CKD more effectively than a combination of fosinopril and hydrochlorothiazide (HCTZ). Methods and analysis This study will be a multicentred, prospective, double-blind, randomised parallel controlled trial for hypertensive CKD patients in China. Patients will be randomised to one of two treatment groups: a combination of benidipine 4–8 mg/day and fosinopril 20 mg/day; or a combination of HCTZ 12.5–25 mg/day and fosinopril 20 mg/day. Patients will be followed up for 24 months after a month's fosinopril run-in. There will be dose-titration after 1 and 2 months. The primary endpoint is changes in estimated glomerular filtration rate (eGFR) from baseline to month 24. Secondary endpoints include changes in home blood pressure (BP), ambulatory BP, proteinuria, urinary albumin/creatinine ratio, and composite renal events in 24 months. Inclusion criteria are: age 18–80 years, non-dialysis CKD patients with eGFR >30 mL/min/1.73 m2, home BP >130 mm Hg systolic or BP >80 mm Hg diastolic at the screening and randomisation, and 24 hour proteinuria power 1-β=0.90). Ethics and dissemination BEAHIT (Benidipine and Hydrochlorothiazide in Fosinopril Treated Chronic Kidney Disease Patients with Hypertension) was approved by Changzheng Hospital Ethics Committee (CZ-20160504-16). The outcomes will be published in a peer-reviewed journal. Trial registration number NCT02646397. PMID:28237959

  2. A double-blind, randomised, placebo-controlled trial of Ganoderma lucidum for the treatment of cardiovascular risk factors of metabolic syndrome.

    Science.gov (United States)

    Klupp, Nerida L; Kiat, Hosen; Bensoussan, Alan; Steiner, Genevieve Z; Chang, Dennis H

    2016-08-11

    This study aimed to evaluate the efficacy and safety of Ganoderma lucidum for the treatment of hyperglycaemia and other cardiovascular risk components of metabolic syndrome using a prospective, double-blind, randomised, placebo-controlled trial. Eighty-four participants with type 2 diabetes mellitus and metabolic syndrome were randomised to one of three intervention groups: Ganoderma lucidum, Ganoderma lucidum with Cordyceps sinensis, or placebo. The dosage was 3 g/day of Ganoderma lucidum, with or without Cordyceps sinensis, for 16 weeks. The primary outcome measure was blood glucose (glycosylated haemoglobin [HbA1c] and fasting plasma glucose [FPG]); a number of secondary outcome measures were also tested. Data from the two intervention groups were combined. The combined intervention had no effect on any of the primary (baseline-adjusted difference in means: HbA1c = 0.13%, 95% CI [-0.35, 0.60], p = 0.60; FPG = 0.03 mmol/L, 95% CI [-0.90, 0.96], p = 0.95) or secondary outcome measures over the course of the 16-week trial, and no overall increased risk of adverse events with either active treatment. Evidence from this randomised clinical trial does not support the use of Ganoderma lucidum for treatment of cardiovascular risk factors in people with diabetes mellitus or metabolic syndrome. This Clinical Trial was registered with the Australian New Zealand Clinical Trials Registry on November 23, 2006. Trial ID: ACTRN12606000485538 and can be accessed here: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=81705.

  3. Randomised clinical trials with clinician-preferred treatment.

    Science.gov (United States)

    Korn, E L; Baumrind, S

    1991-01-19

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

  4. Prospect Theory and Coercive Bargaining

    Science.gov (United States)

    Butler, Christopher K.

    2007-01-01

    Despite many applications of prospect theory's concepts to explain political and strategic phenomena, formal analyses of strategic problems using prospect theory are rare. Using Fearon's model of bargaining, Tversky and Kahneman's value function, and an existing probability weighting function, I construct a model that demonstrates the differences…

  5. Technical specifications on randomised sampling for harmonised monitoring of antimicrobial resistance in zoonotic and commensal bacteria

    Directory of Open Access Journals (Sweden)

    European Food Safety Authority

    2014-05-01

    Full Text Available To monitor antimicrobial resistance in zoonotic and indicator bacteria from food-producing animal populations and meat thereof under Decision 2013/652/EC, a guidance for randomised sampling procedures is provided. Prospective and retrospective sampling plans for samples and isolates are addressed. The former involves collecting sufficient numbers of representative animal and food samples from which recovered isolates are tested for susceptibility; the latter involves selecting randomly Salmonella isolates from collections constituted within the framework of either the national control programmes in poultry flocks or from verification of the compliance with process hygiene criterion in broiler carcases. A generic proportionate stratified sampling process is proposed and numerical illustrations of proportional allocation are provided. Stratified sampling of Salmonella isolates from poultry primary productions is performed with proportional allocation to the size of the isolate collections available in the official laboratories. An alternative approach would be a simple random sampling within the sampling frame of flocks positive for Salmonella. Stratified sampling of caecal samples, accounting for at least 60 % of the domestic production of food-producing animal populations monitored, with proportionate allocation to the slaughterhouse production, allows for the collection of representative isolates of Campylobacter and indicator E. coli and enterococci in various animal populations. Stratified sampling of Salmonella isolates from broiler carcases is proposed with proportional allocation to the size of the isolate collections available in the official laboratories involved in verifying the compliance with the Salmonella process hygiene criterion. These isolates may be complemented with those recovered by the food business operator. Sampling of different chilled fresh meat categories is targeted at retail outlets serving the final consumer, with

  6. Do early quadriceps exercises affect the outcome of ACL reconstruction? A randomised controlled trial.

    Science.gov (United States)

    Shaw, Triston; Williams, Marie T; Chipchase, Lucy S

    2005-01-01

    A prospective, blinded, randomised controlled trial investigated the effectiveness of quadriceps exercises following anterior cruciate ligament reconstruction. A treatment group (Quadriceps exercise group) performed straight leg raises and isometric quadriceps contractions throughout the first two postoperative weeks, and a second group (No quadriceps exercise group) did not. A battery of outcome measures assessed subjects postoperatively at day one, two weeks, and one, three and six months. A total of 103 patients (Quadriceps exercise n = 48, No quadriceps exercise n = 55) commenced the study with 91 subjects available at final follow up (Quadriceps exercise n = 47, No quadriceps exercise n = 44). Performance of quadriceps exercises significantly improved a number of knee flexion and extension range of motion measurements (p = 0.01 to 0.04). No significant differences were found between the two groups at any postoperative period for quadriceps lag (p = 0.36), functional hop testing (p = 0.49 to 0.51), isokinetic quadriceps strength (p = 0.70 to 0.72), the majority of numerical analogue scores (p = 0.1 to 0.94) and Cincinnati scores (p = 0.10 to 0.84). Subjects performing quadriceps exercises reported significantly higher pain scores with exercise on the first postoperative day (p = 0.02). At six months postoperatively, the Quadriceps exercise subjects reported significantly more favourable Cincinnati scores for symptoms (p = 0.005) and problems with sport (p = 0.05). While average knee laxity was not significantly different between treatment groups over time (p = 0.27 to 0.94), quadriceps exercise performance was associated with a significantly lower incidence of abnormal knee laxity. Isometric quadriceps exercises and straight leg raises can be safely prescribed during the first two postoperative weeks and confer advantages for faster recovery of knee range of motion and stability. It remains to be proven whether the magnitude of differences between groups is

  7. A randomised controlled study comparing Drotaverine hydrochloride and Valethamate bromide in the augmentation of labour.

    Science.gov (United States)

    Madhu, Chendrimada; Mahavarkar, Suvarna; Bhave, Sudhir

    2010-07-01

    Cervical dilatation is a poorly understood process. Various drugs have been used to facilitate this process and reduce the duration of labour and thereby reduce feto-maternal complications. The present study is an attempt to compare and evaluate the efficacy of Drotaverine hydrochloride and Valethamate bromide in the process of cervical dilatation and labour augmentation. A prospective randomised trial of 146 low-risk women in spontaneous labour was conducted. 49 women were given Drotaverine (Group 1), 49 women were given Valethamate (Group 2) and 48 women were given placebo (Group 3). At 4 cm of cervical dilatation, elective amniotomy was done and the injection was given intramuscularly, and repeated every hour for a maximum of three doses. There was a statistically significant difference in the mean injection-delivery times (time from first injection to delivery of the baby), which was 183.2 min (SD 78.8) in the Drotaverine group compared to 206.5 min (SD 69.7) in the Valethamate group, and 245 min (SD 70.9) in the control group. The mean cervical dilatation rate (cm/h) was 3 (SD 1.4), 2.4 (SD 0.9) and 1.9 (SD 0.6) in groups 1, 2 and 3, respectively, and these differences were statistically significant. There were no statistically significant differences in the duration of second and third stage of labour. Transient side effects such as foeto-maternal tachycardia, flushing of the face and dryness of mouth were noted with Valethamate. A few patients complained of headache in the Drotaverine group. Both Drotaverine and Valethamate appear to significantly help cervical dilatation and augment first stage of labour. But, Drotaverine is superior to Valethamate with fewer side effects.

  8. A randomised controlled trial comparing highly cross-linked and contemporary annealed polyethylene after a minimal eight-year follow-up in total hip arthroplasty using cemented acetabular components.

    Science.gov (United States)

    Langlois, J; Atlan, F; Scemama, C; Courpied, J P; Hamadouche, M

    2015-11-01

    Most published randomised controlled trials which compare the rates of wear of conventional and cross-linked (XL) polyethylene (PE) in total hip arthroplasty (THA) have described their use with a cementless acetabular component. We conducted a prospective randomised study to assess the rates of penetration of two distinct types of PE in otherwise identical cemented all-PE acetabular components. A total of 100 consecutive patients for THA were randomised to receive an acetabular component which had been either highly XL then remelted or moderately XL then annealed. After a minimum of eight years follow-up, 38 hips in the XL group and 30 hips in the annealed group had complete data (mean follow-up of 9.1 years (7.6 to 10.7) and 8.7 years (7.2 to 10.2), respectively). In the XL group, the steady state rate of penetration from one year onwards was -0.0002 mm/year (sd 0.108): in the annealed group it was 0.1382 mm/year (sd 0.129) (Mann-Whitney U test, p XLPE cemented acetabular component.

  9. Rationale and design of the Edwards SAPIEN-3 periprosthetic leakage evaluation versus Medtronic CoreValve in transfemoral aortic valve implantation (ELECT) trial : A randomised comparison of balloon-expandable versus self-expanding transcatheter aortic valve prostheses.

    Science.gov (United States)

    Abawi, M; Agostoni, P; Kooistra, N H M; Samim, M; Nijhoff, F; Voskuil, M; Nathoe, H; Doevendans, P A; Chamuleau, S A; Urgel, K; Hendrikse, J; Leiner, T; Abrahams, A C; van der Worp, B; Stella, P R

    2017-05-01

    Periprosthetic aortic regurgitation (PPR) after transcatheter aortic valve implantation (TAVI) remains an important issue associated with impaired long-term outcomes. The current randomised study aims to evaluate potential differences between the balloon-expandable Edwards SAPIEN-3 and the self-expanding Medtronic CoreValve system with the main focus on post-TAVI PPR by means of novel imaging endpoints, and an additional focus on other clinical endpoints. The primary endpoint of this study is quantitative assessment of the severity of post-procedural PPR using cardiac magnetic resonance imaging. Several other novel imaging modalities (X-ray contrast angiography, echocardiography) are used as secondary imaging modalities for the assessment of PPR following TAVI. Secondary objectives of the study include clinical outcomes such as cerebral and kidney injury related to TAVI, and quality of life. The ELECT study is a single-centre, prospective, two-armed randomised controlled trial. For the purpose of this study, 108 consecutive adult patients suitable for transfemoral TAVI will be randomly allocated to receive the SAPIEN-3 (n = 54) or the CoreValve system (n = 54). The ELECT trial is the first randomised controlled trial to quantitatively compare the extent of post-TAVI PPR between the SAPIEN-3 and CoreValve. Furthermore, it will evaluate potential differences between the two prostheses with regard to mid-term clinical outcome and quality of life.

  10. A comparison of three induction regimens using succinylcholine, vecuronium, or no muscle relaxant: impact on the intraoperative monitoring of the lateral spread response in hemifacial spasm surgery: study protocol for a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Fang Yuan

    2012-09-01

    Full Text Available Abstract Background Surgical microvascular decompression (MVD is the curative treatment for hemifacial spasm (HFS. Monitoring MVD by recording the lateral spread response (LSR intraoperatively can predict a successful clinical outcome. However, the rate of the LSR varies between trials, and the reason for this variation is unclear. The aim of our trial is to evaluate the rate of the LSR after intubation following treatment with succinylcholine, vecuronium, or no muscle relaxant. Methods and design This trial is a prospective randomised controlled trial of 96 patients with HFS (ASA status I or II undergoing MVD under general anaesthesia. Patients are randomised to receive succinylcholine, vecuronium, or no muscle relaxant before intubation. Intraoperative LSR will be recorded until dural opening. The primary outcome of this study is the rate of the LSR, and the secondary outcomes are post-intubation pharyngolaryngeal symptoms, the rate of difficult intubations, the rate of adverse haemodynamic events and the relationship between the measurement of LSR or not, and clinical success rates at 30 days after surgery. Discussion This study aims to evaluate the impact of muscle relaxants on the rate of the LSR, and the study may provide evidence supporting the use of muscle relaxants before intubation in patients with HFS undergoing MVD surgery. Trials registration http://www.chictr.org/ ChiCTR-TRC-11001504 Date of registration: 24 June, 2011. The date the first patient was randomised: 30 September, 2011.

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

    Science.gov (United States)

    2013-01-01

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

  12. Reappraisal of metformin efficacy in the treatment of type 2 diabetes: a meta-analysis of randomised controlled trials.

    Directory of Open Access Journals (Sweden)

    Rémy Boussageon

    Full Text Available BACKGROUND: The UK Prospective Diabetes Study showed that metformin decreases mortality compared to diet alone in overweight patients with type 2 diabetes mellitus. Since then, it has been the first-line treatment in overweight patients with type 2 diabetes. However, metformin-sulphonylurea bitherapy may increase mortality. METHODS AND FINDINGS: This meta-analysis of randomised controlled trials evaluated metformin efficacy (in studies of metformin versus diet alone, versus placebo, and versus no treatment; metformin as an add-on therapy; and metformin withdrawal against cardiovascular morbidity or mortality in patients with type 2 diabetes. We searched Medline, Embase, and the Cochrane database. Primary end points were all-cause mortality and cardiovascular death. Secondary end points included all myocardial infarctions, all strokes, congestive heart failure, peripheral vascular disease, leg amputations, and microvascular complications. Thirteen randomised controlled trials (13,110 patients were retrieved; 9,560 patients were given metformin, and 3,550 patients were given conventional treatment or placebo. Metformin did not significantly affect the primary outcomes all-cause mortality, risk ratio (RR=0.99 (95% CI: 0.75 to 1.31, and cardiovascular mortality, RR=1.05 (95% CI: 0.67 to 1.64. The secondary outcomes were also unaffected by metformin treatment: all myocardial infarctions, RR=0.90 (95% CI: 0.74 to 1.09; all strokes, RR=0.76 (95% CI: 0.51 to 1.14; heart failure, RR=1.03 (95% CI: 0.67 to 1.59; peripheral vascular disease, RR=0.90 (95% CI: 0.46 to 1.78; leg amputations, RR=1.04 (95% CI: 0.44 to 2.44; and microvascular complications, RR=0.83 (95% CI: 0.59 to 1.17. For all-cause mortality and cardiovascular mortality, there was significant heterogeneity when including the UK Prospective Diabetes Study subgroups (I(2=41% and 59%. There was significant interaction with sulphonylurea as a concomitant treatment for myocardial infarction (p=0

  13. ATLAS Detector Upgrade Prospects

    Science.gov (United States)

    Dobre, M.; ATLAS Collaboration

    2017-01-01

    After the successful operation at the centre-of-mass energies of 7 and 8 TeV in 2010-2012, the LHC was ramped up and successfully took data at the centre-of-mass energies of 13 TeV in 2015 and 2016. Meanwhile, plans are actively advancing for a series of upgrades of the accelerator, culminating roughly ten years from now in the high-luminosity LHC (HL-LHC) project, which will deliver of the order of five times the LHC nominal instantaneous luminosity along with luminosity levelling. The ultimate goal is to extend the dataset from about few hundred fb ‑1 expected for LHC running by the end of 2018 to 3000 fb ‑1 by around 2035 for ATLAS and CMS. The challenge of coping with the HL-LHC instantaneous and integrated luminosity, along with the associated radiation levels, requires further major changes to the ATLAS detector. The designs are developing rapidly for a new all-silicon tracker, significant upgrades of the calorimeter and muon systems, as well as improved triggers and data acquisition. ATLAS is also examining potential benefits of extensions to larger pseudorapidity, particularly in tracking and muon systems. This report summarizes various improvements to the ATLAS detector required to cope with the anticipated evolution of the LHC luminosity during this decade and the next. A brief overview is also given on physics prospects with a pp centre-of-mass energy of 14 TeV.

  14. German energy technology prospects.

    Science.gov (United States)

    Popp, M

    1982-12-24

    After more than 25 years of development of nuclear power and almost 10 years of research and development in numerous areas of nonnuclear energy, there is now a good basis for judging the future prospects of energy technologies in the Federal Republic of Germany. The development of nuclear power has provided an important and economically advantageous new source of energy. Further efforts are needed to establish the nuclear fuel cycle in all stages and to exploit the potential of advanced reactors. In all other areas of energy technology, including energy conservation, new energy sources, and coal, economics has turned out to be the key problem, even at today's energy prices. Opportunities to overcome these economic problems through additional R & D are limited. There is some potential for special applications, and there are many technologies that could contribute to the energy supply of developing countries. In general, however, progress in energy conservation and the use of renewable energy sources will depend on the degree to which energy policy measures can improve their economic basis. For some technologies, such as solar thermal power stations and coal liquefaction, large-scale economic deployment cannot be foreseen today. Instead of establishing costly demonstration projects, emphasis will be put on improving key components of these technologies with the aim of having the most advanced technology available when the economic parameters are more favorable.

  15. ANAIS: Status and prospects

    CERN Document Server

    Amaré, Julio; Cuesta, Clara; García, Eduardo; Ginestra, Carlos; Martínez, María; Oliván, Miguel A; Ortigoza, Ysrael; de Solórzano, Alfonso Ortíz; Pobes, Carlos; Puimedón, Jorge; Sarsa, María Luisa; Villar, José Ángel; Villar, Patricia

    2015-01-01

    ANAIS experiment will look for dark matter annual modulation with large mass of ultra-pure NaI(Tl) scintillators at the Canfranc Underground Laboratory (LSC), aiming to confirm the DAMA/LIBRA positive signal in a model-independent way. Two 12.5 kg each NaI(Tl) crystals provided by Alpha Spectra are currently taking data at the LSC. Present status of ANAIS detectors background and general performance is summarized; in particular, thanks to the high light collection efficiency prospects of lowering the threshold down to 1 keVee are reachable. Crystal radiopurity goals are fulfilled for $^{232}$Th and $^{238}$U chains and $^{40}$K activity, although higher than original goal, could be accepted; however, high $^{210}$Pb contamination out-of-equilibrium has been identified. More radiopure detectors are being built by Alpha Spectra. The ongoing high quantum efficiency PMT tests and muon veto characterization are also presented. Finally, the sensitivity of the experiment for the annual modulation in the WIMP signal,...

  16. IPY Progress and Prospects

    Science.gov (United States)

    Carlson, D.

    2008-12-01

    We can summarize the IPY goals as: (a) make major advances in polar knowledge and understanding; (b) leave a legacy of new or enhanced observational systems, facilities and infrastructure; (c) excite a new generation of polar scientists and engineers, and (d) elicit exceptional interest and participation from polar residents, schoolchildren, the general public, and decision-makers, worldwide. This talk reports on the progress and prospects in each of those areas from an overall international view; separate talks will describe details of future researcher and the IPY outreach efforts. To achieve major advances in knowledge, IPY has entrained the intellectual resources of thousands of scientists, many more than expected, often from 'non- polar' nations, and representing an unprecedented breadth of scientific specialties; integration of those efforts across disciplines to achieve integrated system-level understanding remains a substantial challenge. Many national and international organizations prepare plans to sustain new and improved observational systems, but clear outcomes and the necessary resources remain elusive. International outreach networks gradually build breadth and strength, largely through IPY Polar Science Days and other internationally- coordinated IPY events. A new Association of Polar Early Career Scientists (APECS) devotes talent and energy to shaping the future of polar research. These activities and networks may, with time and with continued international coordination, achieve an exceptional level of interest and participation. In all areas, much work remains.

  17. A randomised, controlled, double-blind trial of ultrasound-guided phrenic nerve block to prevent shoulder pain after thoracic surgery

    DEFF Research Database (Denmark)

    Blichfeldt-Eckhardt, M R; Laursen, C B; Berg, H

    2016-01-01

    to receive an ultrasound-guided supraclavicular phrenic nerve block with 10 ml ropivacaine or 10 ml saline (placebo) immediately following surgery. A nerve catheter was subsequently inserted and treatment continued for 3 days. The study drug was pharmaceutically pre-packed in sequentially numbered identical......Moderate to severe ipsilateral shoulder pain is a common complaint following thoracic surgery. In this prospective, parallel-group study at Odense University Hospital, 76 patients (aged > 18 years) scheduled for lobectomy or pneumonectomy were randomised 1:1 using a computer-generated list...... that ultrasound-guided supraclavicular phrenic nerve block is an effective technique for reducing the incidence of ipsilateral shoulder pain after thoracic surgery....

  18. COMPARISON BETWEEN TAB. CLONIDINE AND TAB. LABETALOL AS ORAL PREMEDICATION IN ATTENUATION OF HAEMODYNAMIC CHANGES DURING LAPAROSCOPIC SURGERY: A RANDOMISED DOUBLE BLIND STUDY

    Directory of Open Access Journals (Sweden)

    Saroj

    2016-02-01

    Full Text Available BACKGROUND AND AIMS To study and compare Labetalol and Clonidine as premedication to attenuate haemodynamic changes to Laparoscopy through oral route, as it is safe method of administration and easy to prescribe. METHODS In a prospective, comparative randomised study, 60 adult patients of both sexes of ASA Grade I and II were divided randomly into 2 groups of 30 each, Group L and Group C. Group L were given Tab. Labetalol 200mg orally 60-90 minutes before induction. Group C were given Tab. Clonidine 300µg orally 60-90 minutes before induction. We compared the degree of attenuation of haemodynamic changes during laparoscopic surgeries. RESULTS Oral Clonidine has better control on the rise in heart rate and mean arterial pressure (MAP during laryngoscopy for laparoscopy compared to oral Labetalol. CONCLUSION We conclude that oral Clonidine showed better attenuation of haemodynamic changes than oral Labetalol.

  19. Acute effects of traditional Thai massage on cortisol levels, arterial blood pressure and stress perception in academic stress condition: A single blind randomised controlled trial.

    Science.gov (United States)

    Bennett, Surussawadi; Bennett, Michael John; Chatchawan, Uraiwon; Jenjaiwit, Patcharaporn; Pantumethakul, Rungthip; Kunhasura, Soontorn; Eungpinichpong, Wichai

    2016-04-01

    Traditional Thai massage (TTM) has been applied widely to promote relaxation. However, there is little evidence to support its efficacy on academic stress. A randomised controlled trial was performed to examine the acute effects of TTM on cortisol level, blood pressure, heart rate and stress perception in academic stress. This prospective trial included 36 physiotherapy students with a self perceived stress score of between 3 and 5. They were randomly allocated into the TTM (18 people) group or the control group (18 people). Saliva cortisol level, blood pressure, heart rate and stress perception rating were measured before and after the intervention. Both groups showed a significant reduction in cortisol level and heart rate when compared with baseline (p stress of TTM.

  20. 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.

  1. 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.

  2. Efficacy and safety of acupuncture for the treatment of non-specific acute low back pain: a randomised controlled multicentre trial protocol [ISRCTN65814467

    Directory of Open Access Journals (Sweden)

    Martinez Barquin Dulce

    2006-04-01

    Full Text Available Abstract Background Low back pain and its associated incapacitating effects constitute an important healthcare and socioeconomic problem, as well as being one of the main causes of disability among adults of working age. The prevalence of non-specific low back pain is very high among the general population, and 60–70% of adults are believed to have suffered this problem at some time. Nevertheless, few randomised clinical trials have been made of the efficacy and efficiency of acupuncture with respect to acute low back pain. The present study is intended to assess the efficacy of acupuncture for acute low back pain in terms of the improvement reported on the Roland Morris Questionnaire (RMQ on low back pain incapacity, to estimate the specific and non-specific effects produced by the technique, and to carry out a cost-effectiveness analysis. Methods/Design Randomised four-branch controlled multicentre prospective study made to compare semi-standardised real acupuncture, sham acupuncture (acupuncture at non-specific points, placebo acupuncture and conventional treatment. The patients are blinded to the real, sham and placebo acupuncture treatments. Patients in the sample present symptoms of non specific acute low back pain, with a case history of 2 weeks or less, and will be selected from working-age patients, whether in paid employment or not, referred by General Practitioners from Primary Healthcare Clinics to the four clinics participating in this study. In order to assess the primary and secondary result measures, the patients will be requested to fill in a questionnaire before the randomisation and again at 3, 12 and 48 weeks after starting the treatment. The primary result measure will be the clinical relevant improvement (CRI at 3 weeks after randomisation. We define CRI as a reduction of 35% or more in the RMQ results. Discussion This study is intended to obtain further evidence on the effectiveness of acupuncture on acute low back pain

  3. Labour: A Prospective, Descriptive Study

    African Journals Online (AJOL)

    Symphysis Fundus Height Measurements during Labour: A Prospective, Descriptive Study 49. Introduction ... 800g in about 50% of cases,2 and in term preg- nancies to be as .... Discussion. Prematurity and low birthweight are major causes.

  4. Prospect of ultralight airplanes development

    Directory of Open Access Journals (Sweden)

    Adam KONICZEK

    2015-09-01

    Full Text Available The article presents characteristic of ultralight airplanes, rules and current interest of them. The purpose is to determine prospect of ultralight airplanes development on the basis of Civil Aviation Authority statistics analysis and trend of aviation market.

  5. A Prospective Study of Pravastatin in the Elderly at Risk (PROSPER): Screening Experience and Baseline Characteristics.

    LENUS (Irish Health Repository)

    Ford, Ian

    2002-05-20

    BACKGROUND: PROSPER was designed to investigate the benefits of treatment with pravastatin in elderly patients for whom a typical doctor might consider the prescription of statin therapy to be a realistic option. METHODS: The PROspective Study of Pravastatin in the Elderly at Risk (PROSPER) is a randomised, double blind, placebo-controlled trial to test the hypothesis that treatment with pravastatin (40 mg\\/day) will reduce the risk of coronary heart disease death, non-fatal myocardial infarction, and fatal or non-fatal stroke in elderly men and women with pre-existing vascular disease or with significant risk of developing this condition. RESULTS: In Scotland, Ireland, and the Netherlands, 23,770 individuals were screened, and 5,804 subjects (2,804 men and 3,000 women), aged 70 to 82 years (average 75 years) and with baseline cholesterol 4.0-9.0 mmol\\/l, were randomised. Randomised subjects had similar distributions with respect to age, blood pressure, and body mass index when compared to the entire group of screenees, but had a higher prevalence of smoking, diabetes, hypertension, and a history of vascular disease. The average total cholesterol level at baseline was 5.4 mmol\\/l (men) and 6.0 mmol\\/l (women). CONCLUSIONS: Compared with previous prevention trials of cholesterol-lowering drugs, the PROSPER cohort is significantly older and for the first time includes a majority of women. The study, having achieved its initial goal of recruiting more than 5,500 elderly high-risk men and women, aims to complete all final subject follow-up visits in the first half of 2002 with the main results being available in the fourth quarter of 2002.

  6. A Prospective Study of Pravastatin in the Elderly at Risk (PROSPER: Screening Experience and Baseline Characteristics

    Directory of Open Access Journals (Sweden)

    Lagaay A Margot

    2002-05-01

    Full Text Available Abstract Background PROSPER was designed to investigate the benefits of treatment with pravastatin in elderly patients for whom a typical doctor might consider the prescription of statin therapy to be a realistic option. Methods The PROspective Study of Pravastatin in the Elderly at Risk (PROSPER is a randomised, double blind, placebo-controlled trial to test the hypothesis that treatment with pravastatin (40 mg/day will reduce the risk of coronary heart disease death, non-fatal myocardial infarction, and fatal or non-fatal stroke in elderly men and women with pre-existing vascular disease or with significant risk of developing this condition. Results In Scotland, Ireland, and the Netherlands, 23,770 individuals were screened, and 5,804 subjects (2,804 men and 3,000 women, aged 70 to 82 years (average 75 years and with baseline cholesterol 4.0–9.0 mmol/l, were randomised. Randomised subjects had similar distributions with respect to age, blood pressure, and body mass index when compared to the entire group of screenees, but had a higher prevalence of smoking, diabetes, hypertension, and a history of vascular disease. The average total cholesterol level at baseline was 5.4 mmol/l (men and 6.0 mmol/l (women. Conclusions Compared with previous prevention trials of cholesterol-lowering drugs, the PROSPER cohort is significantly older and for the first time includes a majority of women. The study, having achieved its initial goal of recruiting more than 5,500 elderly high-risk men and women, aims to complete all final subject follow-up visits in the first half of 2002 with the main results being available in the fourth quarter of 2002.

  7. Preoperative airway assessment - experience gained from a multicentre cluster randomised trial and the Danish Anaesthesia Database.

    Science.gov (United States)

    Nørskov, Anders Kehlet

    2016-05-01

    Difficulties with airway management in relation to general anaesthesia have been a challenge for the anaesthesiologist since the birth of anaesthesia. Massive landmark improvements have been made and general anaesthesia is now regarded as a safe procedure. However, rare, difficult airway management still occurs and it prompts increased risk of morbidity and mortality - especially when not anticipated. Several preoperative risk factors for airway difficulties have been identified, yet none have convincing diagnostic accuracy as stand alone tests. Combining several risk factors increase the predictive value of the test and multivariable risk models have been developed. The Simplified Airway Risk Index (SARI) is a predictive model developed for anticipation of a difficult direct laryngoscopy. However, neither the diagnostic accuracy of the SARI nor of any other model has been tested prospectively and compared with existing practice for airway assessment in a randomised trial setting. The first objective of this thesis was to quantify the proportion of unanticipated difficult intubation and difficult mask ventilation in Denmark. The second objective was to design a cluster randomised trial, using state of the art methodology, in order to test the clinical impact of using the SARI for preoperative airway assessment compared with a clinical judgement based on usual practice for airway assessment. Finally, to test if implementation of the SARI would reduce the proportion of unanticipated difficult intubation compared with usual care for airway assessment. This thesis is based on data from the Danish Anaesthesia Database (DAD). Paper 1 presents an observational cohort study on 188,064 patients who underwent tracheal intubation from 2008 to 2011. Data on the anaesthesiologists' preoperative anticipations of airway difficulties was compared with actual airway management conditions, thus enabling an estimation of the proportion of unanticipated difficulties with intubation

  8. A pragmatic cluster randomised trial evaluating three implementation interventions

    Directory of Open Access Journals (Sweden)

    Rycroft-Malone Jo

    2012-08-01

    Full Text Available Abstract Background Implementation research is concerned with bridging the gap between evidence and practice through the study of methods to promote the uptake of research into routine practice. Good quality evidence has been summarised into guideline recommendations to show that peri-operative fasting times could be considerably shorter than patients currently experience. The objective of this trial was to evaluate the effectiveness of three strategies for the implementation of recommendations about peri-operative fasting. Methods A pragmatic cluster randomised trial underpinned by the PARIHS framework was conducted during 2006 to 2009 with a national sample of UK hospitals using time series with mixed methods process evaluation and cost analysis. Hospitals were randomised to one of three interventions: standard dissemination (SD of a guideline package, SD plus a web-based resource championed by an opinion leader, and SD plus plan-do-study-act (PDSA. The primary outcome was duration of fluid fast prior to induction of anaesthesia. Secondary outcomes included duration of food fast, patients’ experiences, and stakeholders’ experiences of implementation, including influences. ANOVA was used to test differences over time and interventions. Results Nineteen acute NHS hospitals participated. Across timepoints, 3,505 duration of fasting observations were recorded. No significant effect of the interventions was observed for either fluid or food fasting times. The effect size was 0.33 for the web-based intervention compared to SD alone for the change in fluid fasting and was 0.12 for PDSA compared to SD alone. The process evaluation showed different types of impact, including changes to practices, policies, and attitudes. A rich picture of the implementation challenges emerged, including inter-professional tensions and a lack of clarity for decision-making authority and responsibility. Conclusions This was a large, complex study and one of the first

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

    Science.gov (United States)

    2007-01-01

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

  10. Financial incentives for smoking cessation in pregnancy: randomised controlled trial.

    Science.gov (United States)

    Tappin, David; Bauld, Linda; Purves, David; Boyd, Kathleen; Sinclair, Lesley; MacAskill, Susan; McKell, Jennifer; Friel, Brenda; McConnachie, Alex; de Caestecker, Linda; Tannahill, Carol; Radley, Andrew; Coleman, Tim

    2015-01-27

    To assess the efficacy of a financial incentive added to routine specialist pregnancy stop smoking services versus routine care to help pregnant smokers quit. Phase II therapeutic exploratory single centre, individually randomised controlled parallel group superiority trial. One large health board area with a materially deprived, inner city population in the west of Scotland, United Kingdom. 612 self reported pregnant smokers in NHS Greater Glasgow and Clyde who were English speaking, at least 16 years of age, less than 24 weeks pregnant, and had an exhaled carbon monoxide breath test result of 7 ppm or more. 306 women were randomised to incentives and 306 to control. The control group received routine care, which was the offer of a face to face appointment to discuss smoking and cessation and, for those who attended and set a quit date, the offer of free nicotine replacement therapy for 10 weeks provided by pharmacy services, and four, weekly support phone calls. The intervention group received routine care plus the offer of up to £400 of shopping vouchers: £50 for attending a face to face appointment and setting a quit date; then another £50 if at four weeks' post-quit date exhaled carbon monoxide confirmed quitting; a further £100 was provided for continued validated abstinence of exhaled carbon monoxide after 12 weeks; a final £200 voucher was provided for validated abstinence of exhaled carbon monoxide at 34-38 weeks' gestation. The primary outcome was cotinine verified cessation at 34-38 weeks' gestation through saliva (incentives were documented. Significantly more smokers in the incentives group than control group stopped smoking: 69 (22.5%) versus 26 (8.6%). The relative risk of not smoking at the end of pregnancy was 2.63 (95% confidence interval 1.73 to 4.01) Pincentives need to be offered to achieve one extra quitter in late pregnancy) was 7.2 (95% confidence interval 5.1 to 12.2). The mean birth weight was 3140 g (SD 600 g) in the incentives group

  11. Education and coronary heart disease: mendelian randomisation study.

    Science.gov (United States)

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

    2017-08-30

    Objective To determine whether educational attainment is a causal risk factor in the development of coronary heart disease.Design Mendelian randomisation study, using genetic data as proxies for education to minimise confounding.Setting The main analysis used genetic data from two large consortia (CARDIoGRAMplusC4D and SSGAC), comprising 112 studies from predominantly high income countries. Findings from mendelian randomisation analyses were then compared against results from traditional observational studies (164 170 participants). Finally, genetic data from six additional consortia were analysed to investigate whether longer education can causally alter the common cardiovascular risk factors.Participants The main analysis was of 543 733 men and women (from CARDIoGRAMplusC4D and SSGAC), predominantly of European origin.Exposure A one standard deviation increase in the genetic predisposition towards higher education (3.6 years of additional schooling), measured by 162 genetic variants that have been previously associated with education.Main outcome measure Combined fatal and non-fatal coronary heart disease (63 746 events in CARDIoGRAMplusC4D).Results Genetic predisposition towards 3.6 years of additional education was associated with a one third lower risk of coronary heart disease (odds ratio 0.67, 95% confidence interval 0.59 to 0.77; P=3×10(-8)). This was comparable to findings from traditional observational studies (prevalence odds ratio 0.73, 0.68 to 0.78; incidence odds ratio 0.80, 0.76 to 0.83). Sensitivity analyses were consistent with a causal interpretation in which major bias from genetic pleiotropy was unlikely, although this remains an untestable possibility. Genetic predisposition towards longer education was additionally associated with less smoking, lower body mass index, and a favourable blood lipid profile.Conclusions This mendelian randomisation study found support for the hypothesis that low education is a causal risk factor in the

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

    Science.gov (United States)

    Duggan, Paul M; Palmer, Edward; Devitt, Peter

    2007-07-27

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

  13. Neuromuscular training with injury prevention counselling to decrease the risk of acute musculoskeletal injury in young men during military service: a population-based, randomised study

    Directory of Open Access Journals (Sweden)

    Suni Jaana

    2011-04-01

    Full Text Available Abstract Background The rapidly increasing number of activity-induced musculoskeletal injuries among adolescents and young adults is currently a true public health burden. The objective of this study was to investigate whether a neuromuscular training programme with injury prevention counselling is effective in preventing acute musculoskeletal injuries in young men during military service. Methods The trial design was a population-based, randomised study. Two successive cohorts of male conscripts in four companies of one brigade in the Finnish Defence Forces were first followed prospectively for one 6-month term to determine the baseline incidence of injury. After this period, two new successive cohorts in the same four companies were randomised into two groups and followed prospectively for 6 months. Military service is compulsory for about 90% of 19-year-old Finnish men annually, who comprised the cohort in this study. This randomised, controlled trial included 968 conscripts comprising 501 conscripts in the intervention group and 467 conscripts in the control group. A neuromuscular training programme was used to enhance conscripts' motor skills and body control, and an educational injury prevention programme was used to increase knowledge and awareness of acute musculoskeletal injuries. The main outcome measures were acute injuries of the lower and upper limbs. Results In the intervention groups, the risk for acute ankle injury decreased significantly compared to control groups (adjusted hazards ratio (HR = 0.34, 95% confidence interval (95% CI = 0.15 to 0.78, P = 0.011. This risk decline was observed in conscripts with low as well as moderate to high baseline fitness levels. In the latter group of conscripts, the risk of upper-extremity injuries also decreased significantly (adjusted HR = 0.37, 95% CI 0.14 to 0.99, P = 0.047. In addition, the intervention groups tended to have less time loss due to injuries (adjusted HR = 0.55, 95% CI 0

  14. Promotion of physical activity and fitness in sedentary patients with Parkinson's disease : randomised controlled trial

    NARCIS (Netherlands)

    van Nimwegen, Marlies; Speelman, Arlene D.; Overeem, Sebastiaan; van de Warrenburg, Bart P.; Smulders, Katrijn; Dontje, Manon L.; Borm, George F.; Backx, Frank J. G.; Bloem, Bastiaan R.; Munneke, Marten

    2013-01-01

    Objective To evaluate whether a multifaceted behavioural change programme increases physical activities in patients with Parkinson's disease. Design Multicentre randomised controlled trial. Setting 32 community hospitals in the Netherlands, collaborating in a nationwide network (ParkinsonNet). Parti

  15. Promotion of physical activity and fitness in sedentary patients with Parkinson's disease : randomised controlled trial

    NARCIS (Netherlands)

    van Nimwegen, Marlies; Speelman, Arlene D.; Overeem, Sebastiaan; van de Warrenburg, Bart P.; Smulders, Katrijn; Dontje, Manon L.; Borm, George F.; Backx, Frank J. G.; Bloem, Bastiaan R.; Munneke, Marten

    2013-01-01

    Objective To evaluate whether a multifaceted behavioural change programme increases physical activities in patients with Parkinson's disease. Design Multicentre randomised controlled trial. Setting 32 community hospitals in the Netherlands, collaborating in a nationwide network (ParkinsonNet). Parti

  16. Patient controlled analgesia with remifentanil versus epidural analgesia in labour : randomised multicentre equivalence trial

    NARCIS (Netherlands)

    Freeman, Liv M; Bloemenkamp, Kitty W; Franssen, Maureen T; Papatsonis, Dimitri N; Hajenius, Petra J; Hollmann, Markus W; Woiski, Mallory D; Porath, Martina; van den Berg, Hans J; van Beek, Erik; Borchert, Odette W H M; Schuitemaker, Nico; Sikkema, J Marko; Kuipers, A H M; Logtenberg, Sabine L M; van der Salm, Paulien C M; Oude Rengerink, Katrien; Lopriore, Enrico; van den Akker-van Marle, M Elske; le Cessie, Saskia; van Lith, Jan M; Struys, Michel M; Mol, Ben Willem J; Dahan, Albert; Middeldorp, Johanna M; Oude Rengerink, K

    2015-01-01

    OBJECTIVE: To determine women's satisfaction with pain relief using patient controlled analgesia with remifentanil compared with epidural analgesia during labour. DESIGN: Multicentre randomised controlled equivalence trial. SETTING: 15 hospitals in the Netherlands. PARTICIPANTS: Women with an interm

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

    NARCIS (Netherlands)

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

    2000-01-01

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

  18. [Effects of a stepwise approach to behavioural problems in dementia: a cluster randomised controlled trial

    NARCIS (Netherlands)

    Pieper, M.J.; Francke, A.L.; Steen, J.T. van der; Scherder, E.J.; Twisk, J.W.R.; Kovach, C.R.; Achterberg, W.P.

    2016-01-01

    OBJECTIVE: To investigate whether implementation of a stepwise multidisciplinary intervention ('STA OP!' ['STAND UP!']) is effective in reducing behavioural problems and depressive symptoms in nursing home residents with advanced dementia. DESIGN: Cluster randomised controlled trial. METHOD: We

  19. The RESOLVE Trial for people with chronic low back pain: protocol for a randomised clinical trial

    Directory of Open Access Journals (Sweden)

    Matthew K Bagg

    2017-01-01

    Full Text Available Introduction: Low back pain is the leading worldwide cause of disability, and results in significant personal hardship. Most available treatments, when tested in high-quality randomised, controlled trials

  20. Representation of people with intellectual disabilities in randomised controlled trials on antipsychotic treatment for behavioural problems

    NARCIS (Netherlands)

    Scheifes, A.; Stolker, J.J.; Nijman, H.L.I.; Egberts, A.C.G.; Heerdink, E.R.

    2011-01-01

    Background Behavioural problems are common in people with intellectual disability (ID) and are often treated with antipsychotics. Aim To establish the frequency and characteristics of people with ID included in randomised controlled trials (RCTs) on antipsychotic treatment for behavioural problems

  1. Aprotinin and transfusion requirements in orthotopic liver transplantation : a multicentre randomised double-blind study

    NARCIS (Netherlands)

    Porte, RJ; Molenaar, IQ; Begliomini, B; Groenland, THN; Januszkiewicz, A; Lindgren, L; Palareti, G; Hermans, J; Terpstra, OT

    2000-01-01

    Background Intraoperative hyperfibrinolysis contributes to bleeding during adult orthotopic liver transplantation. We aimed to find out whether aprotinin, a potent antifibrinolytic agent, reduces blood loss and transfusion requirements. Methods We did a randomised, double-blind placebo-controlled tr

  2. Rizatriptan vs. ibuprofen in migraine: a randomised placebo-controlled trial

    OpenAIRE

    Misra, Usha Kant; Kalita, Jayantee; Yadav, Rama Kant

    2007-01-01

    The objective of this study was to compare the efficacy of rizatriptan and ibuprofen in migraine. The study was a randomised placebo-controlled trial in a tertiary care teaching hospital. Migraine patients with

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

    NARCIS (Netherlands)

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

    2009-01-01

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

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

    NARCIS (Netherlands)

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

    2009-01-01

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

  5. Labour pain with remifentanil patient-controlled analgesia versus epidural analgesia : a randomised equivalence trial

    NARCIS (Netherlands)

    Logtenberg, Slm; Oude Rengerink, K; Verhoeven, C J; Freeman, L M; van den Akker, Esa; Godfried, M B; van Beek, E; Borchert, Owhm; Schuitemaker, N; van Woerkens, Ecsm; Hostijn, I; Middeldorp, J M; van der Post, J A; Mol, B W

    OBJECTIVE: To distinguish satisfaction with pain relief using remifentanil patient-controlled analgesia (RPCA) compared with epidural analgesia (EA) in low-risk labouring women. DESIGN: Randomised controlled equivalence trial. SETTING: Eighteen midwifery practices and six hospitals in the

  6. Choosing a control intervention for a randomised clinical trial

    Directory of Open Access Journals (Sweden)

    Djulbegovic Benjamin

    2003-04-01

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

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

    DEFF Research Database (Denmark)

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

    2013-01-01

    the focus to reflect everyday practices would foster better targeted public health campaigns. This article is based on our participation in FINE, a multidisciplinary Danish research project. The core methodology of FINE was a randomised controlled trial in which 61 moderately overweight men were put...... into different exercise groups. In this article we analyse the scientific work of the trial as representing entangled processes of bodywork, where data are extracted and objectified bodies are manipulated and care practices address the emotional, social and mundane aspects of the participants' everyday lives....... Care practices are an inherent part of producing scientific facts but they are removed from the recognised results of scientific practice and thus from common public health recommendations. However, knowledge about the strategic use of care practices in lifestyle interventions is important for public...

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

    Science.gov (United States)

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

    1992-01-01

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

  9. Reported challenges in nurse-led randomised controlled trials

    DEFF Research Database (Denmark)

    Wang Vedelø, Tina; Lomborg, Kirsten

    2011-01-01

    , nursing research, nursing, research, challenges, barriers, nurse's role, nurse attitude, attitude of health personnel. Findings: The literature on reported challenges and barriers between 1999 and 2009 showed that the most often experienced problems were (i) sufficient patient recruitment, (ii......Aims: The purpose of this integrative literature review was to explore and discuss the methodological challenges nurse researchers report after conducting nurse-led randomised controlled trials in clinical hospital settings. Our research questions were (i) what are the most commonly experienced...... and the clinical nursing staff. Two lessons learned from this integrative review can be highlighted. First, we recommend researchers openly to share their experiences of barriers and challenges. They should describe factors that may have inhibited the desired outcome. Second, efforts to improve the collaboration...

  10. Is voice therapy an effective treatment for dysphonia? A randomised controlled trial

    OpenAIRE

    MacKenzie, K.; Millar, A; Wilson, J. A.; Sellars, C.; Deary, I. J.

    2001-01-01

    OBJECTIVES: To assess the overall efficacy of voice therapy for dysphonia. DESIGN: Single blind randomised controlled trial. SETTING: Outpatient clinic in a teaching hospital. Participants: 204 outpatients aged 17-87 with a primary symptom of persistent hoarseness for at least two months. INTERVENTIONS: After baseline assessments, patients were randomised to six weeks of either voice therapy or no treatment. Assessments were repeated at six weeks on the 145 (71%) patients who continued to thi...

  11. Barriers to the conduct of randomised clinical trials within all disease areas

    DEFF Research Database (Denmark)

    Djurisic, Snezana; Rath, Ana; Gaber, Sabrina

    2017-01-01

    BACKGROUND: Randomised clinical trials are key to advancing medical knowledge and to enhancing patient care, but major barriers to their conduct exist. The present paper presents some of these barriers. METHODS: We performed systematic literature searches and internal European Clinical Research...... and trial methodology; lack of funding; excessive monitoring; restrictive privacy law and lack of transparency; complex regulatory requirements; and inadequate infrastructures. There is a need for more pragmatic randomised clinical trials conducted with low risks of systematic and random errors...

  12. A randomised study evaluating the use of pyridoxine to avoid capecitabine dose modifications

    OpenAIRE

    2012-01-01

    Background: Pyridoxine is frequently used to treat capecitabine-induced hand–foot syndrome (HFS), although the evidence of benefit is lacking. We performed a randomised placebo-controlled trial to determine whether pyridoxine could avoid the need for capecitabine dose modifications and improve outcomes. Methods: A total of 106 patients planned for palliative single-agent capecitabine (53 in each arm, 65%/ 35% colorectal/breast cancer) were randomised to receive either concomitant pyridoxine (...

  13. In veterinary trials reporting and communication regarding randomisation procedures is suboptimal.

    Science.gov (United States)

    Di Girolamo, N; Giuffrida, M A; Winter, A L; Meursinge Reynders, R

    2017-08-19

    To evaluate randomisation mechanisms in the veterinary literature, all trials defined as 'randomised' were extracted from five leading veterinary journals for the year 2013. Three blinded investigators evaluated (1) if the random sequence generation was actually non-random, and (2) whether method (CONSORT item 8A) and (3) type of randomisation (CONSORT item 8B) were reported. Trialists were contacted via email to establish (1) willingness to respond to questions on randomisation procedures, (2) whether reporting of randomisation improved following a suggestion to use the CONSORT 2010 guideline. Seven per cent ((95 per cent CI 2 to 12 per cent); 8/114) of the trials defined as 'randomised' explicitly used methods that are considered non-random. Almost half of the trials (49 per cent (40 to 59 per cent); 52/106) did not report any mechanism of randomisation. Only 13 trials (12.3 per cent (6 to 19 per cent); 13/106) reported both items. 39 of 114 (34.2 per cent) trialists contacted were willing to respond to further questions on randomisation mechanisms; 4 (3.5 per cent) trialists were unwilling and 71 (62.3 per cent) trialists did not respond. Email correspondence resulted in a mean clarification of 0.7 items (95 per cent CI 0.4 to 1.0) for the 15 trials for trialists that replied. Improved adherence to CONSORT guidelines and trialists communication is imperative to increase the quality of published evidence in veterinary medicine and to reduce research waste. British Veterinary Association.

  14. Early treatment of posterior crossbite - a randomised clinical trial

    Science.gov (United States)

    2013-01-01

    Background The aim of this randomised clinical trial was to assess the effect of early orthodontic treatment in contrast to normal growth effects for functional unilateral posterior crossbite in the late deciduous and early mixed dentition by means of three-dimensional digital model analysis. Methods This randomised clinical trial was assessed to analyse the orthodontic treatment effects for patients with functional unilateral posterior crossbite in the late deciduous and early mixed dentition using a two-step procedure: initial maxillary expansion followed by a U-bow activator therapy. In the treatment group 31 patients and in the control group 35 patients with a mean age of 7.3 years (SD 2.1) were monitored. The time between the initial assessment (T1) and the follow-up (T2) was one year. The orthodontic analysis was done by a three-dimensional digital model analysis. Using the ‘Digimodel’ software, the orthodontic measurements in the maxilla and mandible and for the midline deviation, the overjet and overbite were recorded. Results Significant differences between the control and the therapy group at T2 were detected for the anterior, median and posterior transversal dimensions of the maxilla, the palatal depth, the palatal base arch length, the maxillary arch length and inclination, the midline deviation, the overjet and the overbite. Conclusions Orthodontic treatment of a functional unilateral posterior crossbite with a bonded maxillary expansion device followed by U-bow activator therapy in the late deciduous and early mixed dentition is an effective therapeutic method, as evidenced by the results of this RCT. It leads to three-dimensional therapeutically induced maxillary growth effects. Dental occlusion is significantly improved, and the prognosis for normal craniofacial growth is enhanced. Trial registration Registration trial DRKS00003497 on DRKS PMID:23339736

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

    Directory of Open Access Journals (Sweden)

    Bolaji Emmanuel Egbewale

    2015-05-01

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

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

    Institute of Scientific and Technical Information of China (English)

    Bolaji; Emmanuel; Egbewale

    2015-01-01

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

  17. Effects of renal denervation on vascular remodelling in patients with heart failure and preserved ejection fraction: A randomised control trial

    Science.gov (United States)

    Hayward, Carl; Keegan, Jennifer; Gatehouse, Peter D; Rajani, Ronak; Khattar, Rajdeep S; Mohiaddin, Raad H; Rosen, Stuart D; Lyon, Alexander R; di Mario, Carlo

    2017-01-01

    Objective To assess the effect of renal denervation (RDT) on micro- and macro-vascular function in patients with heart failure with preserved ejection fraction (HFpEF). Design A prospective, randomised, open-controlled trial with blinded end-point analysis. Setting A single-centre London teaching hospital. Participants Twenty-five patients with HFpEF who were recruited into the RDT-PEF trial. Main outcome measures Macro-vascular: 24-h ambulatory pulse pressure, aorta distensibilty (from cardiac magnetic resonance imaging (CMR), aorta pulse wave velocity (CMR), augmentation index (peripheral tonometry) and renal artery blood flow indices (renal MR). Micro-vascular: endothelial function (peripheral tonometry) and urine microalbuminuria. Results At baseline, 15 patients were normotensive, 9 were hypertensive and 1 was hypotensive. RDT did not lower any of the blood pressure indices. Though there was evidence of abnormal vascular function at rest, RDT did not affect these at 3 or 12 months follow-up. Conclusions RDT did not improve markers of macro- and micro-vascular function. PMID:28228942

  18. A randomised controlled trial investigating the analgesic efficacy of transversus abdominis plane block for adult laparoscopic appendicectomy.

    Science.gov (United States)

    Tupper-Carey, Darell Alexander; Fathil, Shahridan Mohd; Tan, Yin Kiat Glenn; Kan, Yuk Man; Cheong, Chern Yuen; Siddiqui, Fahad Javaid; Assam, Pryseley Nkouibert

    2017-08-01

    We conducted a single-centre, prospective randomised clinical trial to investigate the analgesic efficacy of transversus abdominis plane (TAP) block in adult patients undergoing laparoscopic appendicectomy. Patients undergoing urgent laparoscopic appendicectomy under general anaesthesia alone (control group) and general anaesthesia supplemented by TAP block (TAP intervention group) were compared. All patients received a multimodal analgesia regime, which included postoperative morphine via a patient-controlled analgesia device. The primary endpoints were morphine consumption at 12 hours and 24 hours postoperatively. Secondary endpoints included pain scores, incidence of nausea and vomiting, and time to hospital discharge. A total of 58 patients were recruited, with 29 patients in each group. Mean postoperative morphine consumption at 12 hours (control group: 11.45 ± 7.64 mg, TAP intervention group: 9.79 ± 8.09 mg; p = 0.4264) and 24 hours (control group: 13.38 ± 8.72 mg, TAP intervention group: 11.31 ± 8.66 mg; p = 0.3686) for the control and TAP intervention groups were not statistically different. Secondary outcomes were also not different between the two groups. Length of stay in the post-anaesthesia care unit was significantly shorter for the TAP intervention group, with a trend toward faster hospital discharge being observed. TAP block, a regional anaesthetic procedure performed immediately prior to skin incision for laparoscopic appendicectomy, did not significantly improve postoperative analgesia outcomes.

  19. Acupuncture for acute non-specific low back pain: a randomised, controlled, double-blind, placebo trial.

    Science.gov (United States)

    Hasegawa, Tatiana Molinas; Baptista, Andréia Salvador; de Souza, Marcelo Cardoso; Yoshizumi, Alexandre Massao; Natour, Jamil

    2014-04-01

    To assess the efficacy of Yamamoto's acupuncture method on pain, drug intake, functional capacity and quality of life for the treatment of acute non-specific low back pain (ANLBP). A prospective, randomised, parallel-group, double-blind, placebo-controlled trial was performed in 80 men and women with ANLBP who were randomly assigned to five acupuncture sessions (intervention group (IG), n=40) and to five non-penetrating acupuncture sessions (sham group (SG), n=40). Patients were evaluated at baseline and at 3, 7, 14, 21 and 28 days. The measurements used were: visual analogue scale (VAS) for cumulative pain (before intervention, VAS1) and immediate pain (after intervention, VAS2); function (Roland-Morris Disability Questionnaire (RM)); quality of life (SF-36); improvement rating; and number of anti-inflammatory tablets taken. The primary endpoint was a decrease of at least 2 cm in VAS1. Pain VAS improved significantly in the IG from day 14 onwards compared with the SG, but the difference did not reach the prespecified clinically relevant value of 2 cm. The IG was significantly superior to the SG in the following outcomes: cumulative pain, function, pain (SF-36) and vitality (SF-36) at days 14, 21 and 28 (pnew scalp acupuncture was more effective than sham treatment with regard to decrease in pain and anti-inflammatory intake as well as improving functional status and quality of life for patients with ANLBP. NCT 01124955.

  20. Goserelin acetate before transurethral resection of moderately enlarged benign prostatic hyperplasia: Prospective randomised-controlled clinical trial

    Science.gov (United States)

    Abo El-Enen, Mohamed; Tawfik, Ahmed; El-Abd, Ahmed S.; Ragab, Maged; El-Abd, Sherin; Elrashidy, Mohamed; Elmashad, Nehal; Rasheed, Mohamed; El-Abd, Shawky

    2015-01-01

    Objective To evaluate the impact of a luteinising hormone-releasing hormone (LHRH) agonist, goserelin acetate (GA), on surgical blood loss during transurethral resection of the prostate (TURP), as well as its histopathological effect on prostatic microvessel density (MVD). Patients and methods Patients who underwent TURP due to benign prostatic enlargement (60–100 mL) were randomly subdivided into two equal groups according to whether they received preoperative GA administration (3.6 mg; group A) or not (group B). Evaluation parameters were operative time, weight of resected prostatic tissue, perioperative haematocrit (HCT) changes, estimation of intraoperative blood loss, and suburethral and stromal prostatic MVD. Effects of GA on prostate weight and any possible side-effects were also monitored. Results In all, 35 and 33 patients were included in groups A and B, respectively. Operative time and HCT values’ changes were significantly less in group A (P < 0.05). Also, operative blood loss (both total and adjusted per weight of resected tissue) was lower in group A, at a mean (SD) of 178.13 (77.71) mL and 3.74 (1.52) mL/g vs 371.75 (91.09) mL and 8.59 (2.42) mL/g (P < 0.001). The median MVD in both suburethral [8 vs 11 vessels/high-power field (HPF)] and stromal tissues (9 vs 17 vessels/HPF) were significantly lower in group A (P < 0.001). Side-effects were minimal. Conclusion A single dose of GA, a LHRH agonist, before TURP is safe and effective in reducing surgical blood loss. It significantly reduced MVD in both suburethral and stromal nodular prostatic tissues without regional discrepancy. PMID:26966595

  1. Prospective registration, bias risk and outcome-reporting bias in randomised clinical trials of traditional Chinese medicine

    DEFF Research Database (Denmark)

    Liu, Jian-Ping; Han, Mei; Li, Xin-Xue;

    2013-01-01

    Clinical trials on Traditional Chinese Medicine (TCM) should be registered in a publicly accessible international trial register and report on all outcomes. We systematically assessed and evaluated TCM trials in registries with their subsequent publications.......Clinical trials on Traditional Chinese Medicine (TCM) should be registered in a publicly accessible international trial register and report on all outcomes. We systematically assessed and evaluated TCM trials in registries with their subsequent publications....

  2. A Comparison Of Pressor Response To Induction & Endotracheal Intubation With Thiopentone And Propofol.Prospective,Randomised Study.

    OpenAIRE

    belekar, virendra rewaramji

    2012-01-01

    Aims And Objectives-To quantify and compare cardiovascular response to direct laryngoscopy and endotracheal intubation using Thiopentone and Propofol. Material and Methods-  200 patients of  ASA-Grade –I and II between 15-60 years, of either sex scheduled for elective and emergency surgery were selected.  Group A received Inj. Thiopentone sodium 5 mg/kg (2.5%) and Group B received Inj. Propofol 2 mg/kg (1%) ,100 patients in each group. Pulse rate(PR), systolic and diastolic blood pressure(SBP...

  3. Robotic and Open Radical Prostatectomy: The First Prospective Randomised Controlled Trial Fuels Debate Rather than Closing the Question.

    Science.gov (United States)

    Fossati, Nicola; Wiklund, Peter; Rochat, Charles-Henry; Montorsi, Francesco; Dasgupta, Prokar; Sanchez-Salas, Rafael; Canda, Abdullah E; Piechaud, Thierry; Artibani, Walter; Mottrie, Alexandre

    2017-03-01

    Despite the finally acquired level 1 evidence, the urologic debate on open versus robotic prostatectomy still persists. This trial from Brisbane will encourage future studies that will better inform this debate and define what robotic surgery offers.

  4. A prospective randomised longitudinal MRI study of left ventricular adaptation to endurance and resistance exercise training in humans.

    Science.gov (United States)

    Spence, Angela L; Naylor, Louise H; Carter, Howard H; Buck, Christopher L; Dembo, Lawrence; Murray, Conor P; Watson, Philip; Oxborough, David; George, Keith P; Green, Daniel J

    2011-11-15

    The principle that 'concentric' cardiac hypertrophy occurs in response to strength training, whilst 'eccentric' hypertrophy results from endurance exercise has been a fundamental tenet of exercise science. This notion is largely based on cross-sectional comparisons of athletes using echocardiography. In this study, young (27.4 ± 1.1 years) untrained subjects were randomly assigned to supervised, intensive, endurance (END, n = 10) or resistance (RES, n = 13) exercise and cardiac MRI scans and myocardial speckle tracking echocardiography were performed at baseline, after 6 months of training and after a subsequent 6 weeks of detraining. Aerobic fitness increased significantly in END (3.5 to 3.8 l min(-1), P exercise training. Detraining reduced aerobic fitness, LV mass and wall thickness in END (P < 0.05), whereas LVEDV remained elevated. This study is the first to use MRI to compare LV adaptation in response to intensive supervised endurance and resistance training. Our findings provide some support for the 'Morganroth hypothesis', as it pertains to LV remodelling in response to endurance training, but cast some doubt over the proposal that remodelling occurs in response to resistance training.

  5. A prospective randomised double-blinded study of intranasal midazolam atomizer spray for procedural sedation in paediatric patients

    Directory of Open Access Journals (Sweden)

    Vijaykumara

    2016-09-01

    Conclusions: We can thereby say that administration of preservative free intranasal midazolam atomizer spray in dose of 0.2mg/kg as premedication in paediatric patients produces satisfactory level of sedation and anxiolysis with minimal adverse effects. [Int J Res Med Sci 2016; 4(9.000: 3850-3854

  6. Surgical treatment of zygomatic bone fracture using two points fixation versus three point fixation-a randomised prospective clinical trial

    Directory of Open Access Journals (Sweden)

    Rana Majeed

    2012-04-01

    Full Text Available Abstract Background The zygoma plays an important role in the facial contour for both cosmetic and functional reasons; therefore zygomatic bone injuries should be properly diagnosed and adequately treated. Comparison of various surgical approaches and their complications can only be done objectively using outcome measurements which in turn require protocol management and long-term follow up. The preference for open reduction and internal fixation of zygomatic fractures at three points has continued to grow in response to observations of inadequate results from two point and one point fixation techniques. The objectives of this study were to compare the efficacy of zygomatic bone after treatment with ORIF using 2 point fixation and ORIF using 3 point fixation and compare the outcome of two procedures. Methods 100 patients were randomly divided equally into two groups. In group A, 50 patients were treated by ORIF using two point fixation by miniplates and in group B, 50 patients were treated by ORIF using three point fixation by miniplates. They were evaluated for their complications during and after surgery with their advantages and disadvantages and the difference between the two groups was observed. Results A total of 100 fractures were sustained. We found that postoperative complication like decreased malar height and vertical dystopia was more common in those patients who were treated by two point fixation than those who were treated with three point fixation. Conclusions Based on this study open reduction and internal fixation using three point fixation by miniplates is the best available method for the treatment zygomatic bone fractures.

  7. A prospective randomised study of periprosthetic femoral bone remodeling using four different bearings in hybrid total hip arthroplasty

    DEFF Research Database (Denmark)

    Zerahn, Bo; Borgwardt, Lotte; Ribel-Madsen, Søren

    2011-01-01

    Abstract: We performed a study to assess whether different bearing materials have an impact on femoral bone remodeling within the first four years after a hybrid total hip arthroplasty. 205 of 300 patients were available for 4 years follow-up after being randomly allocated to four prosthetic...... 1, 6, and 7.Bone remodeling after total hip arthroplasty may depend on the composition of bearing materials, but age, height, weight, and stem size are also related to changes in BMD....

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

    DEFF Research Database (Denmark)

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

    2015-01-01

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

  9. The impact of routine open nonsuction drainage on fluid accumulation after thyroid surgery: a prospective randomised clinical trial.

    LENUS (Irish Health Repository)

    Neary, Peter M

    2012-01-01

    Thyroid drains following thyroid surgery are routinely used despite minimal supportive evidence. Our aim in this study is to determine the impact of routine open drainage of the thyroid bed postoperatively on ultrasound-determined fluid accumulation at 24 hours.

  10. A randomised prospective comparison of Rotecno versus new Gore occlusive surgical gowns using bacterial air counts in ultraclean air.

    Science.gov (United States)

    Gulihar, A; Taub, N A; Taylor, G J S

    2009-09-01

    Ultraclean air (UCA) in operating theatres is defined as air counts of 1 cfu/m(3) with Rotecno gowns and 0.5 cfu/m(3) with body exhaust suits in total knee arthroplasty (TKA). This study compared bacterial air counts using Rotecno gowns with a new type of occlusive gown made from Gore liquid-proof fabric, which were superior to the Rotecno gowns on standard EN13795 laboratory testing. Fifty-six joint replacements were allocated randomly either to Rotecno or to Gore gowns with stratification into TKA, total hip arthroplasty (THA) or revision THA. Airborne bacteria were collected from within 30 cm of the wound for the first 10 min of surgery using a Casella slit sampler. The new gowns were associated with higher air counts (3.7 cfu/m(3)) than the Rotecno gowns (1.2 cfu/m(3)) (Pair standard of 10 cfu/m(3). In TKA patients, the existing Rotecno gowns, now many years old, had higher air counts (2.0 cfu/m(3)) than in the 2003 trial (0.8 cfu/m(3)) (Pimportance of testing new materials in a clinical environment with UCA; in-vitro testing alone is probably not an adequate assessment.

  11. Surgical treatment of zygomatic bone fracture using two points fixation versus three point fixation-a randomised prospective clinical trial

    OpenAIRE

    2012-01-01

    Abstract Background The zygoma plays an important role in the facial contour for both cosmetic and functional reasons; therefore zygomatic bone injuries should be properly diagnosed and adequately treated. Comparison of various surgical approaches and their complications can only be done objectively using outcome measurements which in turn require protocol management and long-term follow up. The preference for open reduction and internal fixation of zygomatic fractures at three points has con...

  12. A prospective randomised controlled trial of the LMA Supreme vs cuffed tracheal tube as the airway device during percutaneous tracheostomy.

    Science.gov (United States)

    Price, G C; McLellan, S; Paterson, R L; Hay, A

    2014-07-01

    We studied the performance of the LMA Supreme against a cuffed tracheal tube, our standard method of airway control during percutaneous tracheostomy, in 50 consecutive patients from three general critical care units. The primary outcome measure was adequacy of ventilation calculated as the difference in arterial carbon dioxide tension before and after tracheostomy. On an intention-to-treat analysis, there was no difference in the increase in arterial carbon dioxide tension between groups, with a median (IQR [range]) for the LMA Supreme of 0.9 (0.3-1.6 [0-2.8]) kPa, and for the tracheal tube of 0.8 (0.4-1.2 [0-2.5]) kPa, p = 0.82. Eight patients out of 25 (32%) crossed over from the LMA Supreme group to the tracheal tube group before commencement of tracheostomy due to airway or ventilation problems, compared with none out of 25 in the tracheal tube group, p = 0.01, and tracheostomy was postponed in two patients in the LMA Supreme group due to poor oxygenation. There were more clinically important complications in the LMA Supreme group compared with the tracheal tube group.

  13. 'Six sigma approach' - an objective strategy in digital assessment of postoperative air leaks: a prospective randomised study.

    Science.gov (United States)

    Bertolaccini, Luca; Rizzardi, Giovanna; Filice, Mary Jo; Terzi, Alberto

    2011-05-01

    Until now, only way to report air leaks (ALs) has been with an analogue score in an inherently subjective manner. The Six Sigma quality improvement methodology is a data-driven approach applicable to evaluate the quality of the quantification method of repetitive procedures. We applied the Six Sigma concept to improve the process of AL evaluation. A digital device for AL measurement (Drentech PALM, Redax S.r.l., Mirandola (MO), Italy) was applied to 49 consecutive patients, who underwent pulmonary intervention, compared with a similar population with classical chest drainage. Data recorded were postoperative AL, chest-tube removal days, number of chest roentgenograms, hospital length of stay; device setup time, average time rating AL and patient satisfaction. Bivariable comparisons were made using the Mann-Whitney test, the χ² test and Fisher's exact test. Analysis of quality was conducted using the Six Sigma methodology. There were no significant differences regarding AL (p=0.075), although not statistically significant; there was a reduction of postoperative chest X-rays (four vs five) and of hospital length of stay (6.5 vs 7.1 days); and a marginally significant difference was found between chest-tube removal days (p=0.056). There were significant differences regarding device setup time (p=0.001), average time rating AL (p=0.001), inter-observer variability (p=0.001) and patient satisfaction (p=0.002). Six Sigma analyses revealed accurate assessment of AL. Continuous digital measurement of AL reduces degree of variability of AL score, gives more assurance for tube removal, and reports AL without the apprehension of observer error. Efficiency and effectiveness improved with the use of a digital device. We have noted that the AL curves depict actually sealing of AL. The clinical importance of AL curves requires further study. Copyright © 2010 European Association for Cardio-Thoracic Surgery. Published by Elsevier B.V. All rights reserved.

  14. Comparison of infection and urosepsis rates of ciprofloxacin and ceftriaxone prophylaxis before percutaneous nephrolithotomy: a prospective and randomised study.

    Science.gov (United States)

    Demirtas, Abdullah; Yildirim, Yunus Emre; Sofikerim, Mustafa; Kaya, Esma Gunduz; Akinsal, Emre Can; Tombul, Sevket Tolga; Ekmekcioglu, Oguz; Gulmez, Ibrahim

    2012-01-01

    This study aimed at determining the choice and administration duration of ideal antibiotic prophylaxis before percutaneous nephrolithotomy (PNL) operation, a treatment modality for nephrolithiasis. The study included 90 patients who had no internal problem, yet had a negative urine culture and underwent a PNL operation. We compared infection rates between ciprofloxacin and ceftriaxone groups and their subgroups. The results showed no statistical difference between ciprofloxacin and ceftriaxone groups in terms of systemic inflammatory response syndrome (SIRS) (CIP(P) = 0.306,  CTX P = 0.334. As a result of this study no statistical difference was observed between ciprofloxacin and ceftriaxone in terms of SIRS. It seems, however, reasonable to choose ceftriaxone, considering antibiotic sensitivity of microorganisms and detection of three cases accepted as urosepsis in the ciprofloxacin group. As there is no difference between short, and long-term prophylactic use of these antibiotics, preference of short-term prophylaxis for patients with no risk of infection will be important to avoid inappropriate antibiotic usage.

  15. Prevention of heterotopic bone formation after total hip arthroplasty: a prospective randomised study comparing postoperative radiation therapy with indomethacin medication.

    Science.gov (United States)

    Kienapfel, H; Koller, M; Wüst, A; Sprey, C; Merte, H; Engenhart-Cabillic, R; Griss, P

    1999-01-01

    Heterotopic ossification (HO) after total hip arthroplasty is known to be a major complication with an impact on the functional outcome. Efforts have been made to prevent the occurrence of HO by means of either radiation therapy or pharmacotherapy. To date, there are no data available regarding the relative benefit of radiation versus medication with non-steroidal anti-inflammatory drugs. The objective of this study was to compare single-dose 600-cGy radiation therapy with indomethacin medication for their effect on the prevention of heterotopic bone formation after total hip arthroplasty. In all, 154 patients were included in the study. All patients underwent primary total hip arthroplasty due to osteoarthritis. Patients were randomly assigned to three different therapeutic groups. (a) The radiation group received a single radiation dose of 600 cGy between the 2nd and 4th postoperative day. (b) The indomethacin group received an oral application of indomethacin 2 x 50 mg per day from the 1st to 42nd postoperative day. (c) The control group received neither radiation nor indomethacin medication. There were significant group differences (P < 0.001). A least significant difference test (LSD) revealed that the mean of the control group was significantly different from that of the radiation and indomethacin groups. The 13 patients (8.4%) classified Brooker 3 or 4 were all in the control group. Again, this effect was statistically significant (chi-square, P < 0.001). In conclusion, this study demonstrated that both radiation and indomethacin therapy are effective in the prevention of postoperative HO. The choice for either one of the treatments has to be based on availability, contraindications, side-effects, practicability, standardisation and cost. Based on these considerations together with the results of this study, we currently use postoperative radiation with 600 cGy for all patients undergoing primary total hip arthroplasty.

  16. Comparison of Infection and Urosepsis Rates of Ciprofloxacin and Ceftriaxone Prophylaxis before Percutaneous Nephrolithotomy: A Prospective and Randomised Study

    Directory of Open Access Journals (Sweden)

    Abdullah Demirtas

    2012-01-01

    Full Text Available This study aimed at determining the choice and administration duration of ideal antibiotic prophylaxis before percutaneous nephrolithotomy (PNL operation, a treatment modality for nephrolithiasis. The study included 90 patients who had no internal problem, yet had a negative urine culture and underwent a PNL operation. We compared infection rates between ciprofloxacin and ceftriaxone groups and their subgroups. The results showed no statistical difference between ciprofloxacin and ceftriaxone groups in terms of systemic inflammatory response syndrome (SIRS (CIPP=0.306, CTX P=0.334. As a result of this study no statistical difference was observed between ciprofloxacin and ceftriaxone in terms of SIRS. It seems, however, reasonable to choose ceftriaxone, considering antibiotic sensitivity of microorganisms and detection of three cases accepted as urosepsis in the ciprofloxacin group. As there is no difference between short, and long-term prophylactic use of these antibiotics, preference of short-term prophylaxis for patients with no risk of infection will be important to avoid inappropriate antibiotic usage.

  17. A prospective randomised study comparing the jubilee dressing method to a standard adhesive dressing for total hip and knee replacements.

    LENUS (Irish Health Repository)

    Burke, Neil G

    2012-08-01

    It is important to reduce potential wound complications in total hip and total knee arthroplasty procedures. The purpose of this study was to compare the jubilee dressing method to a standard adhesive dressing.

  18. Impact of probiotics on colonic microflora in patients with colitis: A prospective double blind randomised crossover study

    DEFF Research Database (Denmark)

    Ahmed, Jamil; Reddy, Bala S.; Mølbak, Lars

    2013-01-01

    restriction fragments (T-RF's) was identified in each patient. Dice cluster analysis showed that each patient had a unique microbial composition which did not change significantly at different time points in the study, irrespective of whether they had probiotics or the placebo. Probiotic organisms were...

  19. [Prospective study of 420 biopsies realised in patients with duodenal ulcer with positive Helicobacter pylori].

    Science.gov (United States)

    Khayat, Olfa; Kilani, Afef; Chedly-Debbiche, Achraf; Zeddini, Abdelfattah; Gargouri, Dalila; Kharrat, Jamel; Souissi, Adnene; Ghorbel, Abdel Jabbar; Ben Ayed, Mohamed; Ben Khelifa, Habib

    2006-06-01

    It's a prospective study leaded between September 1997 and july 1999 (23 months ) in 75 patients with duodenal ulcer and positif for Helicobacter pylori. All patients had a first endoscopy with antral, fundic and duodenal biopsies, followed one month later by a second control fibroscopy with biopsies of the same sites. A total of 420 biopsies was realised. Chronic gastritis was evaluated according to sydney system. Patients was divided by randomisation in 4 groups. Every group was received a different therapeutic association. The results was conform to liberation concering activity 80%, intestinal metaplasia 12%. inflammation 100%. Atrophy was observed in 56% of cases, this percentage is variable in literature; chronic gastritis was predominant in antre relatively to fundus (pomeprazol, amoxcillin, metronidazol by comparison with the others 3 groups (p<0.005).

  20. PROSPECTIVE ISLAMIC LAW IN INDONESIA

    Directory of Open Access Journals (Sweden)

    Mohdar Yanlua

    2015-02-01

    Full Text Available This paper discusses the Prospective Islamic law in Indonesia. The enforcement of Islamic law in Indonesia experienced the ups and downs, ranging from the colonial period with the Government of Indonesia to the Netherlands in order to reform it.In this study it was found that a prospective law of Islam in Indonesia the development of any regime of the Government of Indonesia is experiencing developments. By the Government of Indonesia does not accept or reject the extremes, but instead selectively receive (not the totality and gradual.Such a step is done for the sake of maintaining the stability and integrity of the country.

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

    Science.gov (United States)

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

    2015-06-05

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

  2. Subgroup analyses in randomised controlled trials: cohort study on trial protocols and journal publications.

    Science.gov (United States)

    Kasenda, Benjamin; Schandelmaier, Stefan; Sun, Xin; von Elm, Erik; You, John; Blümle, Anette; Tomonaga, Yuki; Saccilotto, Ramon; Amstutz, Alain; Bengough, Theresa; Meerpohl, Joerg J; Stegert, Mihaela; Olu, Kelechi K; Tikkinen, Kari A O; Neumann, Ignacio; Carrasco-Labra, Alonso; Faulhaber, Markus; Mulla, Sohail M; Mertz, Dominik; Akl, Elie A; Bassler, Dirk; Busse, Jason W; Ferreira-González, Ignacio; Lamontagne, Francois; Nordmann, Alain; Gloy, Viktoria; Raatz, Heike; Moja, Lorenzo; Rosenthal, Rachel; Ebrahim, Shanil; Vandvik, Per O; Johnston, Bradley C; Walter, Martin A; Burnand, Bernard; Schwenkglenks, Matthias; Hemkens, Lars G; Bucher, Heiner C; Guyatt, Gordon H; Briel, Matthias

    2014-07-16

    To investigate the planning of subgroup analyses in protocols of randomised controlled trials and the agreement with corresponding full journal publications. Cohort of protocols of randomised controlled trial and subsequent full journal publications. Six research ethics committees in Switzerland, Germany, and Canada. 894 protocols of randomised controlled trial involving patients approved by participating research ethics committees between 2000 and 2003 and 515 subsequent full journal publications. Of 894 protocols of randomised controlled trials, 252 (28.2%) included one or more planned subgroup analyses. Of those, 17 (6.7%) provided a clear hypothesis for at least one subgroup analysis, 10 (4.0%) anticipated the direction of a subgroup effect, and 87 (34.5%) planned a statistical test for interaction. Industry sponsored trials more often planned subgroup analyses compared with investigator sponsored trials (195/551 (35.4%) v 57/343 (16.6%), P<0.001). Of 515 identified journal publications, 246 (47.8%) reported at least one subgroup analysis. In 81 (32.9%) of the 246 publications reporting subgroup analyses, authors stated that subgroup analyses were prespecified, but this was not supported by 28 (34.6%) corresponding protocols. In 86 publications, authors claimed a subgroup effect, but only 36 (41.9%) corresponding protocols reported a planned subgroup analysis. Subgroup analyses are insufficiently described in the protocols of randomised controlled trials submitted to research ethics committees, and investigators rarely specify the anticipated direction of subgroup effects. More than one third of statements in publications of randomised controlled trials about subgroup prespecification had no documentation in the corresponding protocols. Definitive judgments regarding credibility of claimed subgroup effects are not possible without access to protocols and analysis plans of randomised controlled trials. © The DISCO study group 2014.

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

    Directory of Open Access Journals (Sweden)

    Thoresen Marianne

    2008-04-01

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

  4. Improving outcomes of preschool language delay in the community: protocol for the Language for Learning randomised controlled trial

    Science.gov (United States)

    2012-01-01

    Background Early language delay is a high-prevalence condition of concern to parents and professionals. It may result in lifelong deficits not only in language function, but also in social, emotional/behavioural, academic and economic well-being. Such delays can lead to considerable costs to the individual, the family and to society more widely. The Language for Learning trial tests a population-based intervention in 4 year olds with measured language delay, to determine (1) if it improves language and associated outcomes at ages 5 and 6 years and (2) its cost-effectiveness for families and the health care system. Methods/Design A large-scale randomised trial of a year-long intervention targeting preschoolers with language delay, nested within a well-documented, prospective, population-based cohort of 1464 children in Melbourne, Australia. All children received a 1.25-1.5 hour formal language assessment at their 4th birthday. The 200 children with expressive and/or receptive language scores more than 1.25 standard deviations below the mean were randomised into intervention or ‘usual care’ control arms. The 20-session intervention program comprises 18 one-hour home-based therapeutic sessions in three 6-week blocks, an outcome assessment, and a final feed-back/forward planning session. The therapy utilises a ‘step up-step down’ therapeutic approach depending on the child’s language profile, severity and progress, with standardised, manualised activities covering the four language development domains of: vocabulary and grammar; narrative skills; comprehension monitoring; and phonological awareness/pre-literacy skills. Blinded follow-up assessments at ages 5 and 6 years measure the primary outcome of receptive and expressive language, and secondary outcomes of vocabulary, narrative, and phonological skills. Discussion A key strength of this robust study is the implementation of a therapeutic framework that provides a standardised yet tailored approach for

  5. Multifactorial intervention to prevent cardiovascular disease in patients with early rheumatoid arthritis: protocol for a multicentre randomised controlled trial

    Science.gov (United States)

    Svensson, Annemarie Lyng; Løgstrup, Brian Bridal; Giraldi, Annamaria; Graugaard, Christian; Blegvad, Jesper; Thygesen, Tina; Sheetal, Ekta; Svendsen, Lone; Emmertsen, Henrik

    2016-01-01

    Introduction Cardiovascular morbidity is a major burden in patients with rheumatoid arthritis (RA). In this study, we compare the effect of a targeted, intensified, multifactorial intervention with that of conventional treatment of modifiable risk factors for cardiovascular disease (CVD) in patients with early RA fulfilling the 2010 American College of Rheumatology European League Against Rheumatism (ACR/EULAR) criteria. Methods and analysis The study is a prospective, randomised, open label trial with blinded end point assessment and balanced randomisation (1:1) conducted in 10 outpatient clinics in Denmark. The primary end point after 5 years of follow-up is a composite of death from cardiovascular causes, non-fatal myocardial infarction, non-fatal stroke and cardiac revascularisation. Secondary outcomes are: the proportion of patients achieving low-density lipoprotein cholesterol <2.5 mmol/L, glycated haemoglobin <48 mmol/mol, blood pressure <140/90 mm  Hg for patients without diabetes and <130/80 mm Hg for patients with diabetes and normoalbuminuria (urinary albumin creatinine ratio <30 mg/g) after 1 year of follow-up and the proportion of patients in each treatment group achieving low RA disease activity after 1 year, defined as a disease activity score C-reactive protein (DAS28-CRP) <3.2 and a DAS28-CRP score <2.6 after 12, 24 and 60 months. Furthermore, all hospitalisations for acute and elective reasons will be adjudicated by the event committee after 12, 24 and 60 months. Three hundred treatment-naive patients with early RA will be randomly assigned (1:1) to receive either conventional treatment administered and monitored by their general practitioner according to national guidelines (control group) or a stepwise implementation administered and monitored in a quarterly rheumatological nurse-administered set-up of behaviour modification and pharmacological therapy targeting (1) hyperlipidaemia, (2) hypertension, (3) hyperglycaemia

  6. Efficacy of the FIFA 11+ Warm-Up Programme in Male Youth Football: A Cluster Randomised Controlled Trial

    Directory of Open Access Journals (Sweden)

    Oluwatoyosi B. A. Owoeye

    2014-06-01

    Full Text Available The FIFA 11+ is a structured warm-up programme specially designed to prevent injuries among football players from age 14 years and above. However, studies to prove its efficacy are generally few and it is yet to be tested in male youth footballers and among African players. The purpose of the study was to examine the efficacy of the FIFA 11+ programme in reducing the risk of injuries among male youth football players of the Lagos Junior League. A cluster randomised controlled trial was conducted. All the 20 teams (414 players aged 14 -19 years in the Premier League division were block-randomised into either an intervention (INT or a control (CON group. The INT group performed the FIFA 11+ exercises as warm-up during training sessions and the CON group performed usual warm-up. Participating teams were prospectively followed through an entire league season of 6 months in which they were visited every week to assess injured players for time-loss injuries in both groups. The primary outcomes were any injury to the players, injuries by type of exposure and injuries specific to the lower extremities. The secondary outcomes were injuries reported by body location, aetiology, mechanism and severity. In total, 130 injuries were recorded affecting 104 (25% of the 416 players. Team and player compliance with the INT was 60% and 74% respectively. Based on the primary outcome measures of the study, the FIFA 11+ programme significantly reduced the overall rate of injury in the INT group by 41% [RR = 0.59 (95% CI: 0.40 – 0.86; p = 0.006] and all lower extremity injuries by 48% [RR = 0.52 (95% CI: 0.34 – 0.82; p = 0.004]. However, the rate of injury reduction based on secondary outcomes mostly did not reach the level of statistical significance. The FIFA 11+ programme is effective in reducing the rates of injuries in male youth football players.

  7. Three-dimensional, task-specific robot therapy of the arm after stroke: a multicentre, parallel-group randomised trial.

    Science.gov (United States)

    Klamroth-Marganska, Verena; Blanco, Javier; Campen, Katrin; Curt, Armin; Dietz, Volker; Ettlin, Thierry; Felder, Morena; Fellinghauer, Bernd; Guidali, Marco; Kollmar, Anja; Luft, Andreas; Nef, Tobias; Schuster-Amft, Corina; Stahel, Werner; Riener, Robert

    2014-02-01

    Arm hemiparesis secondary to stroke is common and disabling. We aimed to assess whether robotic training of an affected arm with ARMin--an exoskeleton robot that allows task-specific training in three dimensions-reduces motor impairment more effectively than does conventional therapy. In a prospective, multicentre, parallel-group randomised trial, we enrolled patients who had had motor impairment for more than 6 months and moderate-to-severe arm paresis after a cerebrovascular accident who met our eligibility criteria from four centres in Switzerland. Eligible patients were randomly assigned (1:1) to receive robotic or conventional therapy using a centre-stratified randomisation procedure. For both groups, therapy was given for at least 45 min three times a week for 8 weeks (total 24 sessions). The primary outcome was change in score on the arm (upper extremity) section of the Fugl-Meyer assessment (FMA-UE). Assessors tested patients immediately before therapy, after 4 weeks of therapy, at the end of therapy, and 16 weeks and 34 weeks after start of therapy. Assessors were masked to treatment allocation, but patients, therapists, and data analysts were unmasked. Analyses were by modified intention to treat. This study is registered with ClinicalTrials.gov, number NCT00719433. Between May 4, 2009, and Sept 3, 2012, 143 individuals were tested for eligibility, of whom 77 were eligible and agreed to participate. 38 patients assigned to robotic therapy and 35 assigned to conventional therapy were included in analyses. Patients assigned to robotic therapy had significantly greater improvements in motor function in the affected arm over the course of the study as measured by FMA-UE than did those assigned to conventional therapy (F=4.1, p=0.041; mean difference in score 0.78 points, 95% CI 0.03-1.53). No serious adverse events related to the study occurred. Neurorehabilitation therapy including task-oriented training with an exoskeleton robot can enhance improvement of

  8. Randomised, controlled trial of avocado–soybean unsaponifiable (Piascledine) effect on structure modification in hip osteoarthritis: the ERADIAS study

    Science.gov (United States)

    Maheu, Emmanuel; Cadet, Christian; Marty, Marc; Moyse, Dominique; Kerloch, Isabelle; Coste, Philippe; Dougados, Maxime; Mazières, Bernard; Spector, Tim D; Halhol, Hafid; Grouin, Jean-Marie; Lequesne, Michel

    2014-01-01

    Objective To assess the ability of avocado–soybean unsaponifiable—Expanscience (ASU-E) to slow radiographic progression in symptomatic hip osteoarthritis (OA). Methods Prospective, randomised, double blind, parallel group, placebo controlled 3 year trial. Patients with symptomatic (painful ≥1 year, Lequesne Index between 3 and 10) hip OA (American College of Rheumatology criteria) and a minimum joint space width (JSW) of the target hip between 1 and 4 mm on a pelvic radiograph were randomly assigned to 300 mg/day ASU-E or placebo. Standing pelvis, target hip anteroposterior (AP) and oblique views were taken annually. The primary outcome was JSW change at year 3, measured at the narrowest point on pelvic or target hip AP view (manual measure using a 0.1 mm graduated magnifying glass). The full analysis dataset (FAS) included all patients having at least two successive radiographs. An analysis of covariance Mixed Model for Repeated Measurements with Missing at Random (for missing data) was performed to compare adjusted 3 year JSW changes (primary outcome) and the percentages of ‘progressors’ (JSW loss≥0.5 mm) between groups. Results 399 patients were randomised (345 kept in the FAS), aged 62 (35–84) years, 54% women, mean body mass index 27 (SD 4) kg/m2, mean symptom duration 4 (SD 5) years, 0–100 normalised Lequesne Index 30 (SD 9) and global pain visual analogue scale 37 (SD 23) mm. Mean baseline JSW was 2.8 (0.9) mm. There was no significant difference on mean JSW loss (−0.638 mm vs −0.672 mm, p=0.72, in the ASU-E and placebo groups, respectively) but there were 20% less progressors in the ASU-E than in the placebo group (40% vs 50%, respectively, p=0.040). No difference was observed on clinical outcomes. Safety was excellent. Conclusions 3 year treatment with ASU-E reduces the percentage of JSW progressors, indicating a potential structure modifying effect in hip OA to be confirmed, and the clinical relevance requires

  9. C-MAC videolaryngoscope compared with direct laryngoscopy for rapid sequence intubation in an emergency department: A randomised clinical trial.

    Science.gov (United States)

    Sulser, Simon; Ubmann, Dirk; Schlaepfer, Martin; Brueesch, Martin; Goliasch, Georg; Seifert, Burkhardt; Spahn, Donat R; Ruetzler, Kurt

    2016-12-01

    Airway management in the emergency room can be challenging when patients suffer from life-threatening conditions. Mental stress, ignorance of the patient's medical history, potential cervical injury or immobilisation and the presence of vomit and/or blood may also contribute to a difficult airway. Videolaryngoscopes have been introduced into clinical practice to visualise the airway and ultimately increase the success rate of airway management. The aim of this study was to test the hypothesis that the C-MAC videolaryngoscope improves first-attempt intubation success rate compared with direct laryngoscopy in patients undergoing emergency rapid sequence intubation in the emergency room setting. A randomised clinical trial. Emergency Department of the University Hospital, Zurich, Switzerland. With approval of the local ethics committee, we prospectively enrolled 150 patients between 18 and 99 years of age requiring emergency rapid sequence intubation in the emergency room of the University Hospital Zurich. Patients were randomised (1 : 1) to undergo tracheal intubation using the C-MAC videolaryngoscope or by direct laryngoscopy. Owing to ethical considerations, patients who had sustained maxillo-facial trauma, immobilised cervical spine, known difficult airway or ongoing cardiopulmonary resuscitation were excluded from our study. All intubations were performed by one of three very experienced anaesthesia consultants. First-attempt success rate served as our primary outcome parameter. Secondary outcome parameters were time to intubation; total number of intubation attempts; Cormack and Lehane score; inadvertent oesophageal intubation; ease of intubation; complications including violations of the teeth, injury/bleeding of the larynx/pharynx and aspiration/regurgitation of gastric contents; necessity of using further alternative airway devices for successful intubation; maximum decrease of oxygen saturation and technical problems with the device. A total of 150

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

    Directory of Open Access Journals (Sweden)

    Russell Stuart J

    2012-02-01

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

  11. Effect of emollient therapy on clinical outcomes in preterm neonates in Pakistan: a randomised controlled trial.

    Science.gov (United States)

    Salam, Rehana A; Darmstadt, Gary L; Bhutta, Zulfiqar A

    2015-05-01

    Newborn oil massage, a traditional community practice, could potentially benefit thermoregulation and skin barrier function, and prevent serious infections, morbidity and mortality in high-risk preterm infants, but has only been evaluated in limited studies in low income settings. To assess the efficacy of topical coconut oil applications among a cohort of hospital-born preterm infants. A prospective, individually randomised controlled clinical trial. Nursery and neonatal intensive care unit at Aga Khan University Hospital, Pakistan. Of 270 eligible neonates, a consecutive cohort of 258 hospital-born preterm infants (gestational age ≥26 weeks and ≤37 weeks). Twice daily topical application of coconut oil by nurses from birth until discharge and continued thereafter by mothers at home until completion of the 28th day of life. Incidence of hospital-acquired bloodstream infections. Weight gain, skin condition and neonatal mortality. 23% of the enrolled neonates developed clinically suspected sepsis while 14% developed blood culture proven infection. The unadjusted hazard for developing hospital-acquired infection in the control group was 4.7 (95% CI 1.8 to 12.4) compared with the intervention group. After adjusting for gestational age, birth weight, duration of intubation and duration of hospitalisation for possible confounding, the hazard for hospital-acquired infection in the control group was 6.0 (95% CI 2.3 to 16) compared with the intervention group. The rate of hospital-acquired infections in the control and intervention groups was 219.1 and 39.5 per 1000 patient-days, respectively. Mean weight gain was 11.3 g/day higher (95% CI 8.1 to 14.6, peffects such as local irritation or local infection were observed among newborns receiving coconut oil applications. Topical emollient therapy was effective in maintaining skin integrity and reducing the risk of bloodstream infection in preterm infants in a tertiary hospital setting in Pakistan. The effectiveness of

  12. External validity of a randomised controlled trial on the treatment of severe infections caused by MRSA

    Science.gov (United States)

    Paul, Mical; Bronstein, Ella; Yahav, Dafna; Goldberg, Elad; Bishara, Jihad; Leibovici, Leonard

    2015-01-01

    Objectives To assess the external validity of a pragmatic, investigator-initiated RCT on treatment of severe infections caused by methicillin-resistant Staphylococcus aureus (MRSA), we compared patient characteristics and treatment effect estimates for patients included in the RCT versus those excluded. Participants and outcomes The RCT included hospitalised patients with documented or highly-probable invasive MRSA infections who were randomised to vancomycin versus trimethoprim-sulfamethoxazole (TMP-SMX) treatment, between 2007 and 2014. A concomitant observational study prospectively included all consecutive patients, between 2008 and 2011, who were excluded from the RCT due to no consent, meningitis, left-sided endocarditis, severe neutropaenia, chronic renal dialysis or treatment with study medications for longer than 48 h. The primary outcomes were clinical failure at day 7 and 30-day mortality for both studies. We compared baseline and infection characteristics, outcome rates and treatment effect estimates for included versus excluded patients. Results The RCT included 252 patients who were compared with 220 excluded patients who were observed. Inability to provide informed consent was the main reason for patient exclusion. Excluded patients’ functional and cognitive performance was significantly poorer than that of included patients. Sepsis was more severe among excluded patients (higher rates of mechanical ventilation, indwelling catheters, septic shock and organ failure). Clinical failure occurred in 83/252 (32.9%) versus 175/220 (79.5%) and deaths in 32 (12.7%) versus 64 (29.1%) for included versus excluded patients, p<0.001 for both comparisons. Comparing vancomycin to TMP-SMX, in the RCT mortality, was non-significantly lower with vancomycin (OR 0.76, 95% CIs 0.36 to 1.62), while in the observational analysis of excluded patients, mortality was significantly higher with vancomycin (OR 2.63, 1.04 to 6.65), p=0.04 for the difference. Conclusions

  13. The effectiveness of video interaction guidance in parents of premature infants: A multicenter randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Tooten Anneke

    2012-06-01

    Full Text Available Abstract Background Studies have consistently found a high incidence of neonatal medical problems, premature births and low birth weights in abused and neglected children. One of the explanations proposed for the relation between neonatal problems and adverse parenting is a possible delay or disturbance in the bonding process between the parent and infant. This hypothesis suggests that due to neonatal problems, the development of an affectionate bond between the parent and the infant is impeded. The disruption of an optimal parent-infant bond -on its turn- may predispose to distorted parent-infant interactions and thus facilitate abusive or neglectful behaviours. Video Interaction Guidance (VIG is expected to promote the bond between parents and newborns and is expected to diminish non-optimal parenting behaviour. Methods/design This study is a multi-center randomised controlled trial to evaluate the effectiveness of Video Interaction Guidance in parents of premature infants. In this study 210 newborn infants with their parents will be included: n = 70 healthy term infants (>37 weeks GA, n = 70 moderate term infants (32–37 weeks GA which are recruited from maternity wards of 6 general hospitals and n = 70 extremely preterm infants or very low birth weight infants (i.e. full term infants and their parents, receiving care as usual, a control group (i.e. premature infants and their parents, receiving care as usual and an intervention group (i.e. premature infants and their parents, receiving VIG. The data will be collected during the first six months after birth using observations of parent-infant interactions, questionnaires and semi-structured interviews. Primary outcomes are the quality of parental bonding and parent-infant interactive behaviour. Parental secondary outcomes are (posttraumatic stress symptoms, depression, anxiety and feelings of anger and hostility. Infant secondary outcomes are behavioral aspects such as crying

  14. Mindfulness-based stress reduction for people with multiple sclerosis - a feasibility randomised controlled trial.

    Science.gov (United States)

    Simpson, Robert; Mair, Frances S; Mercer, Stewart W

    2017-05-16

    Multiple sclerosis (MS) is a stressful condition. Mental health comorbidity is common. Stress can increase the risk of depression, reduce quality of life (QOL), and possibly exacerbate disease activity in MS. Mindfulness-Based Stress Reduction (MBSR) may help, but has been little studied in MS, particularly among more disabled individuals. The objective of this study was to test the feasibility and likely effectiveness of a standard MBSR course for people with MS. Participant eligibility included: age > 18, any type of MS, an Expanded Disability Status Scale (EDSS) randomised (25 per group). Trial retention and outcome measure completion rates were 90% at post-intervention, and 88% at 3 months. Sixty percent of participants completed the course. Immediately post-MBSR, perceived stress improved with a large effect size (ES 0.93; p < 0.01), compared to very small beneficial effects on QOL (ES 0.17; p = 0.48). Depression (ES 1.35; p < 0.05), positive affect (ES 0.87; p = 0.13), anxiety (ES 0.85; p = 0.05), and self-compassion (ES 0.80; p < 0.01) also improved with large effect sizes. At three-months post-MBSR (study endpoint) improvements in perceived stress were diminished to a small effect size (ES 0.26; p = 0.39), were negligible for QOL (ES 0.08; p = 0.71), but were large for mindfulness (ES 1.13; p < 0.001), positive affect (ES 0.90; p = 0.54), self-compassion (ES 0.83; p < 0.05), anxiety (ES 0.82; p = 0.15), and prospective memory (ES 0.81; p < 0.05). Recruitment, retention, and data collection demonstrate that a RCT of MBSR is feasible for people with MS. Trends towards improved outcomes suggest that a larger definitive RCT may be warranted. However

  15. Randomised controlled trial of tailored interventions to improve the management of anxiety and depressive disorders in primary care

    Directory of Open Access Journals (Sweden)

    Terluin Berend

    2011-07-01

    Full Text Available Abstract Background Anxiety and depressive disorders are highly prevalent disorders and are mostly treated in primary care. The management of these disorders by general practitioners is not always consistent with prevailing guidelines because of a variety of factors. Designing implementation strategies tailored to prospectively identified barriers could lead to more guideline-recommended care. Although tailoring of implementation strategies is promoted in practice, little is known about the effect on improving the quality of care for the early recognition, diagnosis, and stepped care treatment allocation in patients with anxiety or depressive disorders in general practice. This study examines whether the tailored strategy supplemented with training and feedback is more effective than providing training and feedback alone. Methods In this cluster randomised controlled trial, a total of 22 general practices will be assigned to one of two conditions: (1 training, feedback, and tailored interventions and (2 training and feedback. The primary outcome measure is the proportion of patients who have been recognised to have anxiety and/or depressive disorder. The secondary outcome measures in patients are severity of anxiety and depressive symptoms, level of functioning, expectation towards and experience with care, quality of life, and economic costs. Measures are taken after the start of the intervention at baseline and at three- and six-month follow-ups. Secondary outcome measures in general practitioners are adherence to guideline-recommended care in care that has been delivered, the proportion of antidepressant prescriptions, and number of referrals to specialised mental healthcare facilities. Data will be gathered from the electronic medical patient records from the patients included in the study. In a process evaluation, the identification of barriers to change and the relations between prospectively identified barriers and improvement

  16. PROSPECT FOR CHINA'S PETROLEUM INDUSTRY

    Institute of Scientific and Technical Information of China (English)

    Cha Quanheng

    2001-01-01

    @@ Many people show concerns over the prospect forChina's petroleum industry.They may raise the question about whether the country's resources are on the brink of exhaustion. Such questions should be answered only by the exploration results because petroleum production is based on the reserves.

  17. Job Prospects for Electrical Engineers.

    Science.gov (United States)

    Basta, Nicholas

    1986-01-01

    Discusses the career outlook for electrical/electronics engineers. Explains that the number of bachelor degree graduates continues to rise, along with average starting salaries. Reveals that although the availability of jobs in the computer industry is leveling off, prospects in the robotics and telecommunication fields are growing. (TW)

  18. Handbook for Prospective Single Parents.

    Science.gov (United States)

    Marindin, Hope

    This handbook for prospective single adoptive parents provides information on locating and adopting a child, necessary clothing and supplies for children of various ages, health and day care arrangements, expenses incurred after adoption, various financial benefits and subsidies available to the adoptive parent, and legal and financial provisions…

  19. Job Prospects for Civil Engineers.

    Science.gov (United States)

    Basta, Nicholas

    1985-01-01

    Government programs and renewed industrial activity have combined with stable enrollments to create bright job prospects for civil engineers. Areas with good opportunities include highway reconstruction and rehabilitation, water-resource management, and new factory construction. The subspecialty of structural engineering has a growing need in…

  20. Autism Research: Prospects and Priorities.

    Science.gov (United States)

    Rutter, Michael

    1996-01-01

    Research prospects and priorities in autism are discussed with respect to: (1) diagnosis, classification, and epidemiology; (2) clinical research; (3) neuropsychological research; (4) genetics; (5) structural and functional brain imaging; (6) postmortem studies; (7) other biological research; and (8) treatment research. Application of research…

  1. The UK Prospective Diabetes Study

    DEFF Research Database (Denmark)

    Olivarius, Niels de Fine; Andreasen, A.H.

    1998-01-01

    Læserbrev, som kritiserer det store UK Prospective Diabetes Study's forfattere for at overfortolke deres fund, idet marginalt signifikante p-værdier tages som udtryk for slående effekt (af at sænke blodsukkeret). Det sker selvom der f.eks. indgår effektvariabler, som kunne påvirkes af patienternes...

  2. Rose breeding: past, present, prospects

    NARCIS (Netherlands)

    Vries, de D.P.; Dubois, L.A.M.

    1996-01-01

    In this review the PAST, PRESENT and PROSPECT will be considered as three separate periods in the history of the breeding and development of rose cultivars. The recurring theme is the genetic variation. This theme was chosen because there is justified doubt as to sufficient genetic variation

  3. Job Prospects for Electrical Engineers.

    Science.gov (United States)

    Basta, Nicholas

    1986-01-01

    Discusses the career outlook for electrical/electronics engineers. Explains that the number of bachelor degree graduates continues to rise, along with average starting salaries. Reveals that although the availability of jobs in the computer industry is leveling off, prospects in the robotics and telecommunication fields are growing. (TW)

  4. Rose breeding: past, present, prospects

    NARCIS (Netherlands)

    Vries, de D.P.; Dubois, L.A.M.

    1996-01-01

    In this review the PAST, PRESENT and PROSPECT will be considered as three separate periods in the history of the breeding and development of rose cultivars. The recurring theme is the genetic variation. This theme was chosen because there is justified doubt as to sufficient genetic variation availab

  5. Protocol for north of England and Scotland study of tonsillectomy and adeno-tonsillectomy in children (NESSTAC. A pragmatic randomised controlled trial comparing surgical intervention with conventional medical treatment in children with recurrent sore throats

    Directory of Open Access Journals (Sweden)

    Lock Catherine

    2006-08-01

    Full Text Available Abstract Background Uncertainties surrounding the effectiveness and cost-effectiveness of childhood tonsillectomy for recurrent sore throat led the NHS Health Technology Assessment Programme to commission this research to evaluate the effectiveness and cost-effectiveness of tonsillectomy and adeno-tonsillectomy in comparison with standard non-surgical management in children aged under 16 with recurrent throat infections. The aim is to evaluate if tonsillectomy and adeno-tonsillectomy reduces the number of episodes of sore throats among children to a clinically significant extent. Methods/design A simple prospective pragmatic randomised controlled trial with economic analysis and prospective cohort study of non-trial participants comparing surgical intervention with conventional medical treatment. The treatment arm will receive tonsillectomy and adeno-tonsillectomy while in the control arm non-surgical conventional medical treatment only will be used. The primary outcome measure will be reported number of episodes of sore throat over two years with secondary outcomes measures of reported number of episodes of sore throat, otitis media and upper respiratory tract infection which invoke a GP consultation; reported number of symptom-free days; reported severity of sore throats and surgical and anaesthetic morbidity. The study will take place in five hospitals in the UK. The trial population will be 406 children aged 4–15 on their last birthday with recurrent sore throat referred by primary care to the 5 otolaryngology departments. The duration of the study is seven years (July 2001- July 2008. Discussion As with all pragmatic randomised controlled trials it is impossible to control the external environment in which the research is taking place. Since this trial began a number of factors have arisen which could affect the outcome including; a reduction in the incidence of respiratory tract infections, marked socio-economic differences in

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

    Science.gov (United States)

    Allmark, P; Mason, S

    2006-09-01

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

  7. Impact of industry collaboration on randomised controlled trials in oncology.

    Science.gov (United States)

    Linker, Anne; Yang, Annie; Roper, Nitin; Whitaker, Evans; Korenstein, Deborah

    2017-02-01

    Industry funders can simply provide money or collaborate in trial design, analysis or reporting of clinical trials. Our aim was to assess the impact of industry collaboration on trial methodology and results of randomised controlled trials (RCT). We searched PubMed for oncology RCTs published May 2013 to December 2015 in peer-reviewed journals with impact factor > 5 requiring reporting of funder role. Two authors extracted methodologic (primary end-point; blinding of the patient, clinician and outcomes assessor; and analysis) and outcome data. We used descriptive statistics and two-sided Fisher exact tests to compare characteristics of trials with collaboration, with industry funding only, and without industry funding. We included 224 trials. Compared to those without industry funding, trials with collaboration used more placebo control (RR 3·59, 95% CI [1·88-6·83], p industry collaboration were more likely to use some high-quality methods than those without industry funding, with similar rates of positive results. Our findings suggest that collaboration is not associated with trial outcomes and that mandatory disclosure of funder roles may mitigate bias. Copyright © 2016 Elsevier Ltd. All rights reserved.

  8. Self Management Activation Randomised Trial for Prostatitis (SMART-P: study protocol for a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Rochester Mark

    2011-09-01

    Full Text Available Abstract Background Chronic prostatitis otherwise known as chronic pelvic pain syndrome is a common urological diagnosis that causes many men significant morbidity and has a detrimental effect on their quality of life. Standard treatment with antibiotics and simple analgesia are often ineffective and many patients are managed by the chronic pain services. Cognitive behavioural therapy has been shown to be helpful in the management of many chronic diseases and has recently been proposed as an effective treatment for chronic prostatitis. Furthermore, a self management programme administered to groups of men with lower urinary tract symptoms has been shown to be more effective than standard treatments including surgery. Therefore, we have developed a cognitive behavioural therapy programme specifically for men with chronic prostatitis. This novel treatment approach will be compared to conventional therapy in the pain clinic such as atypical analgesia and local anaesthetic injections in the context of a randomised controlled trial. Methods/Design Men will be recruited from general urology outpatient clinics following the exclusion of other diagnoses that could be responsible for their symptoms. Men will be randomised to attend either a self management healthcare and education programme or to pain clinic referral alone. The self management programme will be administered by a clinical psychologist to small groups of men over six consecutive weekly sessions each lasting two hours. Patients will be taught techniques of problem-solving and goal-setting and will learn coping mechanisms and how to modify catastrophic cognition. The primary outcome will be change from baseline in the National Institute of Health Chronic Prostatitis Symptom Index, a validated instrument for the assessment of men with chronic prostatitis. Secondary outcomes include generic quality of life scores and analgesic and drug usage. Outcomes will be assessed at 2, 6 and 12 months

  9. Self Management Activation Randomised Trial for Prostatitis (SMART-P): study protocol for a randomised controlled trial.

    Science.gov (United States)

    Rochester, Mark; Armitage, James; Sanders, Mark; Christmas, Paula

    2011-09-26

    Chronic prostatitis otherwise known as chronic pelvic pain syndrome is a common urological diagnosis that causes many men significant morbidity and has a detrimental effect on their quality of life. Standard treatment with antibiotics and simple analgesia are often ineffective and many patients are managed by the chronic pain services.Cognitive behavioural therapy has been shown to be helpful in the management of many chronic diseases and has recently been proposed as an effective treatment for chronic prostatitis. Furthermore, a self management programme administered to groups of men with lower urinary tract symptoms has been shown to be more effective than standard treatments including surgery.Therefore, we have developed a cognitive behavioural therapy programme specifically for men with chronic prostatitis. This novel treatment approach will be compared to conventional therapy in the pain clinic such as atypical analgesia and local anaesthetic injections in the context of a randomised controlled trial. Men will be recruited from general urology outpatient clinics following the exclusion of other diagnoses that could be responsible for their symptoms. Men will be randomised to attend either a self management healthcare and education programme or to pain clinic referral alone. The self management programme will be administered by a clinical psychologist to small groups of men over six consecutive weekly sessions each lasting two hours. Patients will be taught techniques of problem-solving and goal-setting and will learn coping mechanisms and how to modify catastrophic cognition.The primary outcome will be change from baseline in the National Institute of Health Chronic Prostatitis Symptom Index, a validated instrument for the assessment of men with chronic prostatitis. Secondary outcomes include generic quality of life scores and analgesic and drug usage. Outcomes will be assessed at 2, 6 and 12 months. If this group administered self management programme is

  10. Prednisone versus prednisone plus ciclosporin versus prednisone plus methotrexate in new-onset juvenile dermatomyositis : a randomised trial

    NARCIS (Netherlands)

    Ruperto, Nicolino; Pistorio, Angela; Oliveira, Sheila; Zulian, Francesco; Cuttica, Ruben; Ravelli, Angelo; Fischbach, Michel; Magnusson, Bo; Sterba, Gary; Avcin, Tadej; Brochard, Karine; Corona, Fabrizia; Dressler, Frank; Gerloni, Valeria; Apaz, Maria T; Bracaglia, Claudia; Cespedes-Cruz, Adriana; Cimaz, Rolando; Couillault, Gerard; Joos, Rik; Quartier, Pierre; Russo, Ricardo; Tardieu, Marc; Wulffraat, Nico; Bica, Blanca; Dolezalova, Pavla; Ferriani, Virginia; Flato, Berit; Bernard-Medina, Ana G; Herlin, Troels; Trachana, Maria; Meini, Antonella; Allain-Launay, Emma; Pilkington, Clarissa; Vargova, Veronika; Wouters, Carine; Angioloni, Simona; Martini, Alberto

    2016-01-01

    BACKGROUND: Most data for treatment of dermatomyositis and juvenile dermatomyositis are from anecdotal, non-randomised case series. We aimed to compare, in a randomised trial, the efficacy and safety of prednisone alone with that of prednisone plus either methotrexate or ciclosporin in children with

  11. Cervical occlusion in women with cervical insufficiency: protocol for a randomised, controlled trial with cerclage, with and without cervical occlusion

    DEFF Research Database (Denmark)

    Secher, Niels Jørgen; MaCormack, CD; Weber, Tom;

    2007-01-01

    , without the membranes being exposed to the vagina. 6. Tertiary cerclage: Short cervix, membranes exposed to the vagina. Observational study: Eligible women who refuse to be randomised will participate in an observational study. 7. Repeat/requested cervical occlusion. METHODS: The women will be randomised...

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

    DEFF Research Database (Denmark)

    Juul, AB; Gluud, C; Wetterslev, J;

    2005-01-01

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

  13. Randomised comparison of leucocyte-depleted versus buffy-coat-poor blood transfusion and complications after colorectal surgery

    DEFF Research Database (Denmark)

    Jensen, L S; Kissmeyer-Nielsen, P; Wolff, B;

    1996-01-01

    surgery were randomised to receive buffy-coat poor (n = 299) or filtered leucocyte-depleted red-cells (n = 290) when transfusion was indicated. 260 patients actually received blood transfusion. Three patients were excluded from analysis. FINDINGS: The 142 patients randomised to and transfused with buffy...

  14. Evaluating the effects of sevelamer carbonate on cardiovascular structure and function in chronic renal impairment in Birmingham: the CRIB-PHOS randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Steeds Richard P

    2011-02-01

    Full Text Available Abstract Background Serum phosphate is an independent predictor of cardiovascular morbidity and mortality in patients with chronic kidney disease and the general population. There is accumulating evidence that phosphate promotes arterial stiffening through structural vascular alterations such as medial calcification, which are already apparent in the early stages of chronic kidney disease. Aim To determine the effects of phosphate binding with sevelamer carbonate on left ventricular mass and function together with arterial stiffness in patients with stage 3 chronic kidney disease. Methods/Design A single-centre, prospective, randomised, double-blind, placebo-controlled trial of 120 subjects with stage 3 chronic kidney disease recruited from University Hospitals Birmingham NHS Foundation Trust. Baseline investigations include transthoracic echocardiography and cardiac magnetic resonance imaging to assess ventricular mass, volumes and function, applanation tonometry to determine pulse wave velocity and pulse wave analysis as surrogate measures of arterial stiffness and dual energy x-ray absorptiometry scanning to determine bone density. During an open-label run in phase, subjects will receive 1600 mg sevelamer carbonate with meals for four weeks. They will then be randomised to either continue sevelamer carbonate or receive an identical placebo (60 subjects per arm for the remaining 36 weeks. Four-weekly monitoring of serum electrolytes and bone biochemistry will be performed. All baseline investigations will be repeated at the end of the treatment period. The primary endpoint of the study is a reduction in left ventricular mass after 40 weeks of treatment. Secondary endpoints are: i change in aortic compliance; ii change in arterial stiffness; iii change in arterial elastance; iv change in left ventricular systolic and diastolic elastance; v change in left ventricular function; and vi change in bone density. Trial Registration This trial is

  15. Supported self-management for adults with type 2 diabetes and a learning disability (OK-Diabetes): study protocol for a randomised controlled feasibility trial.

    Science.gov (United States)

    Walwyn, Rebecca E A; Russell, Amy M; Bryant, Louise D; Farrin, Amanda J; Wright-Hughes, Alexandra M; Graham, Elizabeth H; Hulme, Claire; O'Dwyer, John L; Latchford, Gary J; Stansfield, Alison J; Nagi, Dinesh; Ajjan, Ramzi A; House, Allan O

    2015-08-08

    Individuals with a learning disability (LD) are at higher risk of developing type 2 diabetes, but LD is not straightforward to define or identify, especially at the milder end of the spectrum, which makes case finding difficult. While supported self-management of health problems is now established, current material is largely educational and didactic with little that facilitates behavioural change. The interaction between the person with diabetes and others supporting their care is also largely unknown. For these reasons, there is considerable work needed to prepare for a definitive trial. The aim of this paper is to publish the abridged protocol of this preparatory work. Phase I is a prospective case-finding study (target n = 120 to 350) to identify and characterise potential participants, while developing a standardised supported self-management intervention. Phase II is a randomised feasibility trial (target n = 80) with blinded outcome assessment. Patients identified in Phase I will be interviewed and consented prior to being randomised to (1) standard treatment, or (2) supported self-management. Both arms will also be provided with an 'easy read' accessible information resource on managing type 2 diabetes. The intervention will be standardised but delivered flexibly depending on patient need, including components for the participant, a supporter, and shared activities. Outcomes will be (i) robust estimates of eligibility, consent and recruitment rates with refined recruitment procedures; (ii) characterisation of the eligible population; (iii) a standardised intervention with associated written materials, (iv) adherence and negative outcomes measures; (v) preliminary estimates of adherence, acceptability, follow-up and missing data rates, along with refined procedures; and (vi) description of standard treatment. Our study will provide important information on the nature of type 2 diabetes in adults with LD living in the community, on the challenges of

  16. Rationale and design of an independent randomised controlled trial evaluating the effectiveness of aripiprazole or haloperidol in combination with clozapine for treatment-resistant schizophrenia

    Directory of Open Access Journals (Sweden)

    Piantato Ennio

    2009-05-01

    Full Text Available Abstract Background One third to two thirds of people with schizophrenia have persistent psychotic symptoms despite clozapine treatment. Under real-world circumstances, the need to provide effective therapeutic interventions to patients who do not have an optimal response to clozapine has been cited as the most common reason for simultaneously prescribing a second antipsychotic drug in combination treatment strategies. In a clinical area where the pressing need of providing therapeutic answers has progressively increased the occurrence of antipsychotic polypharmacy, despite the lack of robust evidence of its efficacy, we sought to implement a pre-planned protocol where two alternative therapeutic answers are systematically provided and evaluated within the context of a pragmatic, multicentre, independent randomised study. Methods/Design The principal clinical question to be answered by the present project is the relative efficacy and tolerability of combination treatment with clozapine plus aripiprazole compared with combination treatment with clozapine plus haloperidol in patients with an incomplete response to treatment with clozapine over an appropriate period of time. This project is a prospective, multicentre, randomized, parallel-group, superiority trial that follow patients over a period of 12 months. Withdrawal from allocated treatment within 3 months is the primary outcome. Discussion The implementation of the protocol presented here shows that it is possible to create a network of community psychiatric services that accept the idea of using their everyday clinical practice to produce randomised knowledge. The employed pragmatic attitude allowed to randomly allocate more than 100 individuals, which means that this study is the largest antipsychotic combination trial conducted so far in Western countries. We expect that the current project, by generating evidence on whether it is clinically useful to combine clozapine with aripiprazole

  17. The Tao of bao: a randomised controlled trial examining the effect of steamed bun consumption on night-call inpatient course and mortality.

    Science.gov (United States)

    Tan, Min-Han; Lee, Ziying; Ng, Beatrice; Sim, Eng Swen; Chua, Ying Ying; Tien, Mark; Ooi, Choon Jin

    2008-03-01

    Medical superstitions remain prevalent in today's stressful and technology driven healthcare environment. These irrational beliefs commonly involve night calls, which are periods of volatile workload. In Singapore and Hong Kong, it is commonly held that consumption of steamed buns ("bao") by on-call physicians is associated with increased patient admissions and mortality, due to a homonymous interpretation of the word "bao" in dialect. A prospective unblinded randomised controlled trial with a permuted block randomisation design was performed on weekdays over 6 weeks. Steamed buns or control food were offered to the internal medicine night-call team of a tertiary-care hospital on a nightly basis. Information on admissions and mortality was collected from the hospital electronic database. Data on sleep patterns and shift duration were obtained by interview. There were no significant differences in the median number of hours slept on days on "bao" administration versus "control" intervention (2 +/- median absolute variation of 1.5 h vs 2 +/- 1.5 h, P = 0.30) or in the number of hours spent in the hospital (30.8 +/- 1.9 h vs 30.5 +/- 2.2 h, P = 0.09). There were no significant differences in the median number of general ward admissions per night (n = 73 +/- 6 versus 71 +/- 7 admissions, P = 0.35), monitored care unit admissions (4 +/- 1.5 vs 4 +/- 1.5 admissions, P = 0.65) or inpatient mortality (2 +/- 1.5 vs 2 +/- 1.5 deaths per night, P = 0.47). The consumption of steamed buns ("bao") has no effect on inpatient admissions, mortality, or sleep duration on call. Regardless, our results indicate that the night call in Singapore remains a challenge in terms of workload and shift duration.

  18. Rationale and design of an independent randomised controlled trial evaluating the effectiveness of aripiprazole or haloperidol in combination with clozapine for treatment-resistant schizophrenia

    Science.gov (United States)

    Nosè, Michela; Accordini, Simone; Artioli, Paola; Barale, Francesco; Barbui, Corrado; Beneduce, Rossella; Berardi, Domenico; Bertolazzi, Gerardo; Biancosino, Bruno; Bisogno, Alfredo; Bivi, Raffaella; Bogetto, Filippo; Boso, Marianna; Bozzani, Alberto; Bucolo, Piera; Casale, Marcello; Cascone, Liliana; Ciammella, Luisa; Cicolini, Alessia; Cipresso, Gabriele; Cipriani, Andrea; Colombo, Paola; Dal Santo, Barbara; De Francesco, Michele; Di Lorenzo, Giorgio; Di Munzio, Walter; Ducci, Giuseppe; Erlicher, Arcadio; Esposito, Eleonora; Ferrannini, Luigi; Ferrato, Farida; Ferro, Antonio; Fragomeno, Nicoletta; Parise, Vincenzo Fricchione; Frova, Maria; Gardellin, Francesco; Garzotto, Nicola; Giambartolomei, Andrea; Giupponi, Giancarlo; Grassi, Luigi; Grazian, Natalia; Grecu, Lorella; Guerrini, Gualtiero; Laddomada, Francesco; Lazzarin, Ermanna; Lintas, Camilla; Malchiodi, Francesca; Malvini, Lara; Marchiaro, Livio; Marsilio, Alessandra; Mauri, Massimo Carlo; Mautone, Antonio; Menchetti, Marco; Migliorini, Giuseppe; Mollica, Marco; Moretti, Daniele; Mulè, Serena; Nicholau, Stylianos; Nosè, Flavio; Occhionero, Guglielmo; Pacilli, Anna Maria; Pecchioli, Stefania; Percudani, Mauro; Piantato, Ennio; Piazza, Carlo; Pontarollo, Francesco; Pycha, Roger; Quartesan, Roberto; Rillosi, Luciana; Risso, Francesco; Rizzo, Raffella; Rocca, Paola; Roma, Stefania; Rossattini, Matteo; Rossi, Giuseppe; Rossi, Giovanni; Sala, Alessandra; Santilli, Claudio; Saraò, Giuseppe; Sarnicola, Antonio; Sartore, Francesca; Scarone, Silvio; Sciarma, Tiziana; Siracusano, Alberto; Strizzolo, Stefania; Tansella, Michele; Targa, Gino; Tasser, Annamarie; Tomasi, Rodolfo; Travaglini, Rossana; Veronese, Antonio; Ziero, Simona

    2009-01-01

    Background One third to two thirds of people with schizophrenia have persistent psychotic symptoms despite clozapine treatment. Under real-world circumstances, the need to provide effective therapeutic interventions to patients who do not have an optimal response to clozapine has been cited as the most common reason for simultaneously prescribing a second antipsychotic drug in combination treatment strategies. In a clinical area where the pressing need of providing therapeutic answers has progressively increased the occurrence of antipsychotic polypharmacy, despite the lack of robust evidence of its efficacy, we sought to implement a pre-planned protocol where two alternative therapeutic answers are systematically provided and evaluated within the context of a pragmatic, multicentre, independent randomised study. Methods/Design The principal clinical question to be answered by the present project is the relative efficacy and tolerability of combination treatment with clozapine plus aripiprazole compared with combination treatment with clozapine plus haloperidol in patients with an incomplete response to treatment with clozapine over an appropriate period of time. This project is a prospective, multicentre, randomized, parallel-group, superiority trial that follow patients over a period of 12 months. Withdrawal from allocated treatment within 3 months is the primary outcome. Discussion The implementation of the protocol presented here shows that it is possible to create a network of community psychiatric services that accept the idea of using their everyday clinical practice to produce randomised knowledge. The employed pragmatic attitude allowed to randomly allocate more than 100 individuals, which means that this study is the largest antipsychotic combination trial conducted so far in Western countries. We expect that the current project, by generating evidence on whether it is clinically useful to combine clozapine with aripiprazole rather than with haloperidol

  19. Intra-Operative Fluid Management in Adult Neurosurgical Patients Undergoing Intracranial Tumour Surgery: Randomised Control Trial Comparing Pulse Pressure Variance (PPV) and Central Venous Pressure (CVP)

    Science.gov (United States)

    Salins, Serina Ruth; Kumar, Amar Nandha; Korula, Grace

    2016-01-01

    Introduction Fluid management in neurosurgery presents specific challenges to the anaesthesiologist. Dynamic para-meters like Pulse Pressure Variation (PPV) have been used successfully to guide fluid management. Aim To compare PPV against Central Venous Pressure (CVP) in neurosurgical patients to assess hemodynamic stability and perfusion status. Materials and Methods This was a single centre prospective randomised control trial at a tertiary care centre. A total of 60 patients undergoing intracranial tumour excision in supine and lateral positions were randomised to two groups (Group 1, CVP n=30), (Group 2, PPV n=30). Intra-operative fluid management was titrated to maintain baseline CVP in Group 1(5-10cm of water) and in Group 2 fluids were given to maintain PPV less than 13%. Acid base status, vital signs and blood loss were monitored. Results Although intra-operative hypotension and acid base changes were comparable between the groups, the patients in the CVP group had more episodes of hypotension requiring fluid boluses in the first 24 hours post surgery. {CVP group median (25, 75) 2400ml (1850, 3110) versus PPV group 2100ml (1350, 2200) p=0.03} The patients in the PPV group received more fluids than the CVP group which was clinically significant. {2250 ml (1500, 3000) versus 1500ml (1200, 2000) median (25, 75) (p=0.002)}. The blood loss was not significantly different between the groups The median blood loss in the CVP group was 600ml and in the PPV group was 850 ml; p value 0.09. Conclusion PPV can be used as a reliable index to guide fluid management in neurosurgical patients undergoing tumour excision surgery in supine and lateral positions and can effectively augment CVP as a guide to fluid management. Patients in PPV group had better hemodynamic stability and less post operative fluid requirement. PMID:27437329

  20. A randomised trial of screening with digital breast tomosynthesis plus conventional digital 2D mammography versus 2D mammography alone in younger higher risk women.

    Science.gov (United States)

    Maxwell, Anthony J; Michell, Michael; Lim, Yit Y; Astley, Susan M; Wilson, Mary; Hurley, Emma; Evans, D Gareth; Howell, Anthony; Iqbal, Asif; Kotre, John; Duffy, Stephen; Morris, Julie

    2017-06-30

    Digital breast tomosynthesis (DBT) has been shown to increase invasive cancer detection rates at screening compared to full field digital (2D) mammography alone, and some studies have reported a reduction in the screening recall rate. No prospective randomised studies of DBT have previously been published. This study compares recall rates with 2D mammography with and without concurrent DBT in women in their forties with a family history of breast cancer undergoing incident screening. Asymptomatic women aged 40-49 who had previously undergone mammography for an increased risk of breast cancer were recruited in two screening centres. Participants were randomised to screening with 2D mammography only at the first study screen followed a year later by screening with 2D plus DBT, or vice versa. Recall rates were compared using an intention to treat analysis. Reading performance was analysed for the larger centre. 1227 women were recruited. 1221 first screens (604 2D, 617 2D+DBT) and 1124second screens (558 2D+DBT, 566 2D) were analysed. Eleven women had screen-detected cancers: 5 after 2D, 6 after 2D+DBT. The false positive recall rates were 2.4% for 2D and 2.2% for 2D+DBT (p=0.89). There was a significantly greater reduction between rounds in the number of women with abnormal reads who were not recalled after consensus/arbitration with 2D+DBT than 2D (p=0.023). The addition of DBT to 2D mammography in incident screening did not lead to a significant reduction in recall rate. DBT may increase reader uncertainty until DBT screening experience is acquired. Copyright © 2017 Elsevier B.V. All rights reserved.

  1. Evaluation of the effect of patient education on rates of falls in older hospital patients: Description of a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Hoffmann Tammy

    2009-04-01

    Full Text Available Abstract Background Accidental falls by older patients in hospital are one of the most commonly reported adverse events. Falls after discharge are also common. These falls have enormous physical, psychological and social consequences for older patients, including serious physical injury and reduced quality of life, and are also a source of substantial cost to health systems worldwide. There have been a limited number of randomised controlled trials, mainly using multifactorial interventions, aiming to prevent older people falling whilst inpatients. Trials to date have produced conflicting results and recent meta-analyses highlight that there is still insufficient evidence to clearly identify which interventions may reduce the rate of falls, and falls related injuries, in this population. Methods and design A prospective randomised controlled trial (n = 1206 is being conducted at two hospitals in Australia. Patients are eligible to be included in the trial if they are over 60 years of age and they, or their family or guardian, give written consent. Participants are randomised into three groups. The control group continues to receive usual care. Both intervention groups receive a specifically designed patient education intervention on minimising falls in addition to usual care. The education is delivered by Digital Video Disc (DVD and written workbook and aims to promote falls prevention activities by participants. One of the intervention groups also receives follow up education training visits by a health professional. Blinded assessors conduct baseline and discharge assessments and follow up participants for 6 months after discharge. The primary outcome measure is falls by participants in hospital. Secondary outcome measures include falls at home after discharge, knowledge of falls prevention strategies and motivation to engage in falls prevention activities after discharge. All analyses will be based on intention to treat principle. Discussion

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

    Directory of Open Access Journals (Sweden)

    2003-12-01

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

  3. Evaluation of computed tomography in patients with atypical angina or chest pain clinically referred for invasive coronary angiography: randomised controlled trial

    Science.gov (United States)

    Rief, Matthias; Martus, Peter; Kendziora, Benjamin; Feger, Sarah; Dreger, Henryk; Priem, Sascha; Knebel, Fabian; Böhm, Marko; Schlattmann, Peter; Hamm, Bernd; Schönenberger, Eva; Laule, Michael; Zimmermann, Elke

    2016-01-01

    Objective To evaluate whether invasive coronary angiography or computed tomography (CT) should be performed in patients clinically referred for coronary angiography with an intermediate probability of coronary artery disease. Design Prospective randomised single centre trial. Setting University hospital in Germany. Participants 340 patients with suspected coronary artery disease and a clinical indication for coronary angiography on the basis of atypical angina or chest pain. Interventions 168 patients were randomised to CT and 172 to coronary angiography. After randomisation one patient declined CT and 10 patients declined coronary angiography, leaving 167 patients (88 women) and 162 patients (78 women) for analysis. Allocation could not be blinded, but blinded independent investigators assessed outcomes. Main outcome measure The primary outcome measure was major procedural complications within 48 hours of the last procedure related to CT or angiography. Results Cardiac CT reduced the need for coronary angiography from 100% to 14% (95% confidence interval 9% to 20%, Pcoronary angiography: 75% (53% to 90%) v 15% (10% to 22%), Pcoronary angiography group: 3.6% (1% to 8%) v 10.5% (6% to 16%), P=0.014. CT shortened the median length of stay in the angiography group from 52.9 hours (interquartile range 49.5-76.4 hours) to 30.0 hours (3.5-77.3 hours, Pcoronary angiography group (adjusted hazard ratio 0.90, 95% confidence interval 0.30 to 2.69, P=0.86). 79% of patients stated that they would prefer CT for subsequent testing. The study was conducted at a University hospital in Germany and thus the performance of CT may be different in routine clinical practice. The prevalence was lower than expected, resulting in an underpowered study for the predefined primary outcome. Conclusions CT increased the diagnostic yield and was a safe gatekeeper for coronary angiography with no increase in long term events. The length of stay was shortened by 22.9 hours with CT, and

  4. Methodology for the Randomised Injecting Opioid Treatment Trial (RIOTT: evaluating injectable methadone and injectable heroin treatment versus optimised oral methadone treatment in the UK

    Directory of Open Access Journals (Sweden)

    Byford Sarah

    2006-09-01

    Full Text Available Abstract Whilst unsupervised injectable methadone and diamorphine treatment has been part of the British treatment system for decades, the numbers receiving injectable opioid treatment (IOT has been steadily diminishing in recent years. In contrast, there has been a recent expansion of supervised injectable diamorphine programs under trial conditions in a number of European and North American cities, although the evidence regarding the safety, efficacy and cost effectiveness of this treatment approach remains equivocal. Recent British clinical guidance indicates that IOT should be a second-line treatment for those patients in high-quality oral methadone treatment who continue to regularly inject heroin, and that treatment be initiated in newly-developed supervised injecting clinics. The Randomised Injectable Opioid Treatment Trial (RIOTT is a multisite, prospective open-label randomised controlled trial (RCT examining the role of treatment with injected opioids (methadone and heroin for the management of heroin dependence in patients not responding to conventional substitution treatment. Specifically, the study examines whether efforts should be made to optimise methadone treatment for such patients (e.g. regular attendance, supervised dosing, high oral doses, access to psychosocial services, or whether such patients should be treated with injected methadone or heroin. Eligible patients (in oral substitution treatment and injecting illicit heroin on a regular basis are randomised to one of three conditions: (1 optimized oral methadone treatment (Control group; (2 injected methadone treatment; or (3 injected heroin treatment (with access to oral methadone doses. Subjects are followed up for 6-months, with between-group comparisons on an intention-to-treat basis across a range of outcome measures. The primary outcome is the proportion of patients who discontinue regular illicit heroin use (operationalised as providing >50% urine drug screens

  5. How to build and evaluate an integrated health care system for chronic patients: study design of a clustered randomised controlled trial in rural China

    Directory of Open Access Journals (Sweden)

    Wenxi Tang

    2015-03-01

    Full Text Available Background: While integrated health care system has been proved an effective way to help improving patient health and system efficiency, the exact behaviour model and motivation approach are not so clear in poor rural areas where health human resources and continuous service provision are urgently needed. To gather solid evidence, we initiated a comprehensive intervention project in Qianjiang District, southwest part of rural China in 2012. And after one-year's pilot, we developed an intervention package of team service, comprehensive pathway and prospective- and performance-based payment system.Methods: To testify the potential influence of payment interventions, we use clustered randomised controlled trial, 60 clusters are grouped into two treatment groups and one control group to compare the time and group differences. Difference-in-differences model and structural equation modelling will be used to analyse the intervention effects and pathway. The outcomes are: quality of care, disease burden, supplier cooperative behaviour and patient utilisation behaviour and system efficiency. Repeated multivariate variance analysis will be used to statistically examine the outcome differences.Discussion: This is the first trial of its kind to prove the effects and efficiency of integrated care. Though we adopted randomised controlled trial to gather the highest rank of evidence, still the fully randomisation was hard to realise in health policy reform experiment. To compensate, the designer should take efforts on control for the potential confounders as much as possible. With this trial, we assume the effects will come from: (1 improvement on the quality of life through risk factors control and lifestyles change on patient's behaviours; (2 improvement on quality of care through continuous care and coordinated supplier behaviours; (3 improvement on the system efficiency through active interaction between suppliers and patients

  6. Liraglutide efficacy and action in non-alcoholic steatohepatitis (LEAN): study protocol for a phase II multicentre, double-blinded, randomised, controlled trial.

    Science.gov (United States)

    Armstrong, Matthew J; Barton, Darren; Gaunt, Piers; Hull, Diana; Guo, Kathy; Stocken, Deborah; Gough, Stephen C L; Tomlinson, Jeremy W; Brown, Rachel M; Hübscher, Stefan G; Newsome, Philip N

    2013-11-04

    Non-alcoholic steatohepatitis (NASH) is now the commonest cause of chronic liver disease. Despite this, there are no universally accepted pharmacological therapies for NASH. Liraglutide (Victoza), a human glucagon-like peptide-1 (GLP-1) analogue, has been shown to improve weight loss, glycaemic control and liver enzymes in type 2 diabetes. There is currently a lack of prospective-controlled studies investigating the efficacy of GLP-1 analogues in patients with NASH. Liraglutide efficacy and action in NASH (LEAN) is a phase II, multicentre, double-blinded, placebo-controlled, randomised clinical trial designed to investigate whether a 48-week treatment with 1.8 mg liraglutide will result in improvements in liver histology in patients with NASH. Adult, overweight (body mass index ≥25 kg/m(2)) patients with biopsy-confirmed NASH were assessed for eligibility at five recruitment centres in the UK. Patients who satisfied the eligibility criteria were randomly assigned (1:1) to receive once-daily subcutaneous injections of either 1.8 mg liraglutide or liraglutide-placebo (control). Using A'Hern's single stage phase II methodology (significance level 0.05; power 0.90) and accounting for an estimated 20% withdrawal rate, a minimum of 25 patients were randomised to each treatment group. The primary outcome measure will be centrally assessed using an intention-to-treat analysis of the proportion of evaluable patients achieving an improvement in liver histology between liver biopsies at baseline and after 48 weeks of treatment. Histological improvement will be defined as a combination of the disappearance of active NASH and no worsening in fibrosis. The protocol was approved by the National Research Ethics Service (East Midlands-Northampton committee; 10/H0402/32) and the Medicines and Healthcare products Regulatory Agency. Recruitment into the LEAN started in August 2010 and ended in May 2013, with 52 patients randomised. The treatment follow-up of LEAN participants is

  7. Validated adherence scales used in a measurement-guided medication management approach to target and tailor a medication adherence intervention: a randomised controlled trial.

    Science.gov (United States)

    Nguyen, Thi-My-Uyen; La Caze, Adam; Cottrell, Neil

    2016-11-30

    To determine if a targeted and tailored intervention based on a discussion informed by validated adherence scales will improve medication adherence. Prospective randomised trial. 2 community pharmacies in Brisbane, Australia. Patients recently initiated on a cardiovascular or oral hypoglycaemic medication within the past 4-12 weeks were recruited from two community pharmacies. Participants identified as non-adherent using the Medication Adherence Questionnaire (MAQ) were randomised into the intervention or control group. The intervention group received a tailored intervention based on a discussion informed by responses to the MAQ, Beliefs about Medicines Questionnaire-Specific and Brief Illness Perception Questionnaire. Adherence was measured using the MAQ at 3 and 6 months following the intervention. A total of 408 patients were assessed for eligibility, from which 152 participants were enrolled into the study. 120 participants were identified as non-adherent using the MAQ and randomised to the 'intervention' or 'control' group. The mean MAQ score at baseline in the intervention and control were similar (1.58: 95% CI (1.38 to 1.78) and 1.60: 95% CI (1.43 to 1.77), respectively). There was a statistically significant improvement in adherence in the intervention group compared to control at 3 months (mean MAQ score 0.42: 95% CI (0.27 to 0.57) vs 1.58: 95% CI (1.42 to 1.75); p<0.001). The significant improvement in MAQ score in the intervention group compared to control was sustained at 6 months (0.48: 95% CI (0.31 to 0.65) vs 1.48: 95% CI (1.27 to 1.69); p<0.001). An intervention that targeted non-adherent participants and tailored to participant-specific reasons for non-adherence was successful at improving medication adherence. ACTRN12613000162718; Results. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  8. How to build and evaluate an integrated health care system for chronic patients: study design of a clustered randomised controlled trial in rural China

    Directory of Open Access Journals (Sweden)

    Wenxi Tang

    2015-03-01

    Full Text Available Background: While integrated health care system has been proved an effective way to help improving patient health and system efficiency, the exact behaviour model and motivation approach are not so clear in poor rural areas where health human resources and continuous service provision are urgently needed. To gather solid evidence, we initiated a comprehensive intervention project in Qianjiang District, southwest part of rural China in 2012. And after one-year's pilot, we developed an intervention package of team service, comprehensive pathway and prospective- and performance-based payment system. Methods: To testify the potential influence of payment interventions, we use clustered randomised controlled trial, 60 clusters are grouped into two treatment groups and one control group to compare the time and group differences. Difference-in-differences model and structural equation modelling will be used to analyse the intervention effects and pathway. The outcomes are: quality of care, disease burden, supplier cooperative behaviour and patient utilisation behaviour and system efficiency. Repeated multivariate variance analysis will be used to statistically examine the outcome differences. Discussion: This is the first trial of its kind to prove the effects and efficiency of integrated care. Though we adopted randomised controlled trial to gather the highest rank of evidence, still the fully randomisation was hard to realise in health policy reform experiment. To compensate, the designer should take efforts on control for the potential confounders as much as possible. With this trial, we assume the effects will come from: (1 improvement on the quality of life through risk factors control and lifestyles change on patient's behaviours; (2 improvement on quality of care through continuous care and coordinated supplier behaviours; (3 improvement on the system efficiency through active interaction between suppliers and patients. Conclusion

  9. Prospects for Future Collider Physics

    CERN Document Server

    Ellis, John

    2016-01-01

    One item on the agenda of future colliders is certain to be the Higgs boson. What is it trying to tell us? The primary objective of any future collider must surely be to identify physics beyond the Standard Model, and supersymmetry is one of the most studied options. it Is supersymmetry waiting for us and, if so, can LHC Run 2 find it? The big surprise from the initial 13-TeV LHC data has been the appearance of a possible signal for a new boson X with a mass ~750 GeV. What are the prospects for future colliders if the X(750) exists? One of the most intriguing possibilities in electroweak physics would be the discovery of non-perturbative phenomena. What are the prospects for observing sphalerons at the LHC or a future collider?

  10. Prospects for de-automatization.

    Science.gov (United States)

    Kihlstrom, John F

    2011-06-01

    Research by Raz and his associates has repeatedly found that suggestions for hypnotic agnosia, administered to highly hypnotizable subjects, reduce or even eliminate Stroop interference. The present paper sought unsuccessfully to extend these findings to negative priming in the Stroop task. Nevertheless, the reduction of Stroop interference has broad theoretical implications, both for our understanding of automaticity and for the prospect of de-automatizing cognition in meditation and other altered states of consciousness.

  11. Atmospheric neutrinos: Status and prospects

    OpenAIRE

    2016-01-01

    We present an overview of the current status of neutrino oscillation studies at atmospheric neutrino experiments. While the current data gives some tentalising hints regarding the neutrino mass hierarchy, octant of $\\theta_{23}$ and $\\delta_{CP}$, the hints are not statistically significant. We summarise the sensitivity to these sub-dominant three-generation effects from the next-generation proposed atmospheric neutrino experiments. We next present the prospects of new physics searches such a...

  12. Prospects for nuclear safety research

    Energy Technology Data Exchange (ETDEWEB)

    Beckjord, E.S.

    1995-04-01

    This document is the text of a paper presented by Eric S. Beckjord (Director, Nuclear Regulatory Research/NRC) at the 22nd Water Reactor Safety Meeting in Bethesda, MD in October 1994. The following topics are briefly reviewed: (1) Reactor vessel research, (2) Probabilistic risk assessment, (3) Direct containment heating, (4) Advanced LWR research, (5) Nuclear energy prospects in the US, and (6) Future nuclear safety research. Subtopics within the last category include economics, waste disposal, and health and safety.

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

    Directory of Open Access Journals (Sweden)

    Fewtrell MS

    2012-03-01

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

  14. The NEtherlands Cervical Kinematics (NECK Trial. Cost-effectiveness of anterior cervical discectomy with or without interbody fusion and arthroplasty in the treatment of cervical disc herniation; a double-blind randomised multicenter study

    Directory of Open Access Journals (Sweden)

    van den Akker Elske

    2010-06-01

    Full Text Available Abstract Background Patients with cervical radicular syndrome due to disc herniation refractory to conservative treatment are offered surgical treatment. Anterior cervical discectomy is the standard procedure, often in combination with interbody fusion. Accelerated adjacent disc degeneration is a known entity on the long term. Recently, cervical disc prostheses are developed to maintain motion and possibly reduce the incidence of adjacent disc degeneration. A comparative cost-effectiveness study focused on adjacent segment degeneration and functional outcome has not been performed yet. We present the design of the NECK trial, a randomised study on cost-effectiveness of anterior cervical discectomy with or without interbody fusion and arthroplasty in patients with cervical disc herniation. Methods/Design Patients (age 18-65 years presenting with radicular signs due to single level cervical disc herniation lasting more than 8 weeks are included. Patients will be randomised into 3 groups: anterior discectomy only, anterior discectomy with interbody fusion, and anterior discectomy with disc prosthesis. The primary outcome measure is symptomatic adjacent disc degeneration at 2 and 5 years after surgery. Other outcome parameters will be the Neck Disability Index, perceived recovery, arm and neck pain, complications, re-operations, quality of life, job satisfaction, anxiety and depression assessment, medical consumption, absenteeism, and costs. The study is a randomised prospective multicenter trial, in which 3 surgical techniques are compared in a parallel group design. Patients and research nurses will be kept blinded of the allocated treatment for 2 years. The follow-up period is 5 years. Discussion Currently, anterior cervical discectomy with fusion is the golden standard in the surgical treatment of cervical disc herniation. Whether additional interbody fusion or disc prothesis is necessary and cost-effective will be determined by this trial

  15. Does antenatal pelvic floor muscle training affect the outcome of labour? A randomised controlled trial.

    Science.gov (United States)

    Agur, Wael; Steggles, Pippin; Waterfield, Malcolm; Freeman, Robert

    2008-01-01

    It is thought that antenatal pelvic floor muscle training (PFMT) might produce a strong pelvic floor resulting in prolonged labour, whilst some believe it produces well-controlled muscles that facilitate rotation of the foetal head and shortens the duration of labour. This secondary analysis (of a previously published randomised controlled trial) assesses the labour and delivery details of 268 primigravidae who were originally randomised at approximately 20 weeks gestation to supervised PFMT or a control group. Between the two groups, there was no difference in the duration of the second stage of labour or in the need for instrumental delivery. PFMT does not appear to facilitate or obstruct labour.

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

    Energy Technology Data Exchange (ETDEWEB)

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

    1982-11-01

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

  17. Stress debriefing after childbirth: a randomised controlled trial.

    Science.gov (United States)

    Priest, Susan R; Henderson, Jenni; Evans, Sharon F; Hagan, Ronald

    2003-06-02

    To test whether critical incident stress debriefing after childbirth reduces the incidence of postnatal psychological disorders. Randomised single-blind controlled trial stratified for parity and delivery mode. Two large maternity hospitals in Perth. 1745 women who delivered healthy term infants between April 1996 and December 1997 (875 allocated to intervention and 870 to control group). An individual, standardised debriefing session based on the principles of critical incident stress debriefing carried out within 72 hours of delivery. Diagnosis of stress disorders or depression in the 12 months postpartum, using structured psychological interview and criteria of the Diagnostic and statistical manual of mental disorders, 4th edition. Follow-up information was available for 1730 women (99.1%), 482 of whom underwent psychological interview. There were no significant differences between control and intervention groups in scores on Impact of Events or Edinburgh Postnatal Depression Scales at 2, 6 or 12 months postpartum, or in proportions of women who met diagnostic criteria for a stress disorder (intervention, 0.6% v control, 0.8%; P = 0.58) or major or minor depression (intervention, 17.8% v control, 18.2%; relative risk [95% CI], 0.99 [0.87-1.11]) during the postpartum year. Nor were there differences in median time to onset of depression (intervention, 6 [interquartile range, 4-9] weeks v control, 4 [3-8] weeks; P = 0.84), or duration of depression (intervention, 24 [12-46] weeks v control, 22 [10-52] weeks; P = 0.98). There is a high prevalence of depression in women during the first year after childbirth. A session of midwife-led, critical incident stress debriefing was not effective in preventing postnatal psychological disorders, but had no adverse effects.

  18. Chinese Obstetrics & Gynecology journal club: a randomised controlled trial.

    Science.gov (United States)

    Tsui, Ilene K; Dodson, William C; Kunselman, Allen R; Kuang, Hongying; Han, Feng-Juan; Legro, Richard S; Wu, Xiao-Ke

    2016-01-28

    To assess whether a journal club model could improve comprehension and written and spoken medical English in a population of Chinese medical professionals. The study population consisted of 52 medical professionals who were residents or postgraduate master or PhD students in the Department of Obstetrics and Gynecology, Heilongjiang University of Chinese Medicine, China. After a three-part baseline examination to assess medical English comprehension, participants were randomised to either (1) an intensive journal club treatment arm or (2) a self-study group. At the conclusion of the 8-week intervention participants (n=52) were re-tested with new questions. The primary outcome was the change in score on a multiple choice examination. Secondary outcomes included change in scores on written and oral examinations which were modelled on the Test of English as a Foreign Language (TOEFL). Both groups had improved scores on the multiple choice examination without a statistically significant difference between them (90% power). However, there was a statistically significant difference between the groups in mean improvement in scores for both written (95% CI 1.1 to 5.0; p=0.003) and spoken English (95% CI 0.06 to 3.7; p=0.04) favouring the journal club intervention. Interacting with colleagues and an English-speaking facilitator in a journal club improved both written and spoken medical English in Chinese medical professionals. Journal clubs may be suitable for use as a self-sustainable teaching model to improve fluency in medical English in foreign medical professionals. NCT01844609. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

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

    Directory of Open Access Journals (Sweden)

    Kim Ae-Ran

    2009-12-01

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

  20. Promoting childbirth companions in South Africa: a randomised pilot study

    Directory of Open Access Journals (Sweden)

    Smith Helen

    2007-04-01

    Full Text Available Abstract Background Most women delivering in South African State Maternity Hospitals do not have a childbirth companion; in addition, the quality of care could be better, and at times women are treated inhumanely. We piloted a multi-faceted intervention to encourage uptake of childbirth companions in state hospitals, and hypothesised that lay carers would improve the behaviour of health professionals. Methods We conducted a pilot randomised controlled trial of an intervention to promote childbirth companions in hospital deliveries. We promoted evidence-based information for maternity staff at 10 hospitals through access to the World Health Organization Reproductive Health Library (RHL, computer hardware and training to all ten hospitals. We surveyed 200 women at each site, measuring companionship, and indicators of good obstetric practice and humanity of care. Five hospitals were then randomly allocated to receive an educational intervention to promote childbirth companions, and we surveyed all hospitals again at eight months through a repeat survey of postnatal women. Changes in median values between intervention and control hospitals were examined. Results At baseline, the majority of hospitals did not allow a companion, or access to food or fluids. A third of women were given an episiotomy. Some women were shouted at (17.7%, N = 2085, and a few reported being slapped or struck (4.3%, N = 2080. Despite an initial positive response from staff to the childbirth companion intervention, we detected no difference between intervention and control hospitals in relation to whether a companion was allowed by nursing staff, good obstetric practice or humanity of care. Conclusion The quality and humanity of care in these state hospitals needs to improve. Introducing childbirth companions was more difficult than we anticipated, particularly in under-resourced health care systems with frequent staff changes. We were unable to determine whether the presence

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

    Science.gov (United States)

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

    2009-06-01

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

  2. Home telemonitoring study for Japanese patients with heart failure (HOMES-HF): protocol for a multicentre randomised controlled trial.

    Science.gov (United States)

    Kotooka, Norihiko; Asaka, Machiko; Sato, Yasunori; Kinugasa, Yoshiharu; Nochioka, Kotaro; Mizuno, Atsushi; Nagatomo, Daisuke; Mine, Daigo; Yamada, Yoko; Eguchi, Kazuo; Hanaoka, Hideki; Inomata, Takayuki; Fukumoto, Yoshihiro; Yamamoto, Kazuhiro; Tsutsui, Hiroyuki; Masuyama, Tohru; Kitakaze, Masafumi; Inoue, Teruo; Shimokawa, Hiroaki; Momomura, Shin-Ichi; Seino, Yoshihiko; Node, Koichi

    2013-06-20

    Despite the encouraging results from several randomised controlled trials (RCTs) and meta-analyses, the ability of home telemonitoring for heart failure (HF) to improve patient outcomes remains controversial as a consequence of the two recent large-scale RCTs. However, it has been suggested that there is a subgroup of patients with HF who may benefit from telemonitoring. The aim of the present study was to investigate whether an HF management programme using telemonitoring could improve outcomes in patients with HF under the Japanese healthcare system. The Home Telemonitoring Study for Japanese Patients with Heart Failure (HOMES-HF) study is a prospective, multicentre RCT to investigate the effectiveness of home telemonitoring on the primary composite endpoint of all-cause death and rehospitalisation due to worsening HF in recently admitted HF patients (aged 20 and older, New York Heart Association classes II-III). The telemonitoring system is an automated physiological monitoring system including body weight, blood pressure and pulse rate by full-time nurses 7 days a week. Additionally, the system was designed to make it a high priority to support patient's self-care instead of an early detection of HF decompensation. A total sample size of 420 patients is planned according to the Schoenfeld and Richter method. Eligible patients are randomly assigned via a website to either the telemonitoring group or the usual care group by using a minimisation method with biased-coin assignment balancing on age, left ventricular ejection fraction and a history of ischaemic heart disease. Participants will be enrolled until August 2013 and followed until August 2014. Time to events will be estimated using the Kaplan-Meier method, and HRs and 95% CIs will be calculated using the Cox proportional hazards models with stratification factors. The study is registered at UMIN Clinical Trials Registry (UMIN000006839).

  3. A randomised, open-label, comparative study of tranexamic acid microinjections and tranexamic acid with microneedling in patients with melasma

    Directory of Open Access Journals (Sweden)

    Leelavathy Budamakuntla

    2013-01-01

    Full Text Available Background: Melasma is a common cause of facial hyperpigmentation with significant cosmetic deformity. Although several treatment modalities are available, none is satisfactory. Aim: To compare the therapeutic efficacy and safety of tranexamic acid (TA microinjections versus tranexamic acid with microneedling in melasma. Materials and Methods: This is a prospective, randomised, open-label study with a sample size of 60; 30 in each treatment arms. Thirty patients were administered with localised microinjections of TA in one arm, and other 30 with TA with microneedling. The procedure was done at monthly intervals (0, 4 and 8 weeks and followed up for three consecutive months. Clinical images were taken at each visit including modified Melasma Area Severity Index MASI scoring, patient global assessment and physician global assessment to assess the clinical response. Results: In the microinjection group, there was 35.72% improvement in the MASI score compared to 44.41% in the microneedling group, at the end of third follow-up visit. Six patients (26.09% in the microinjections group, as compared to 12 patients (41.38% in the microneedling group, showed more than 50% improvement. However, there were no major adverse events observed in both the treatment groups. Conclusions: On the basis of these results, TA can be used as potentially a new, effective, safe and promising therapeutic agent in melasma. The medication is easily available and affordable. Better therapeutic response to treatment in the microneedling group could be attributed to the deeper and uniform delivery of the medication through microchannels created by microneedling.

  4. A Randomised, Open-label, Comparative Study of Tranexamic Acid Microinjections and Tranexamic Acid with Microneedling in Patients with Melasma

    Science.gov (United States)

    Budamakuntla, Leelavathy; Loganathan, Eswari; Suresh, Deepak Hurkudli; Shanmugam, Sharavana; Suryanarayan, Shwetha; Dongare, Aparna; Venkataramiah, Lakshmi Dammaningala; Prabhu, Namitha

    2013-01-01

    Background: Melasma is a common cause of facial hyperpigmentation with significant cosmetic deformity. Although several treatment modalities are available, none is satisfactory. Aim: To compare the therapeutic efficacy and safety of tranexamic acid (TA) microinjections versus tranexamic acid with microneedling in melasma. Materials and Methods: This is a prospective, randomised, open-label study with a sample size of 60; 30 in each treatment arms. Thirty patients were administered with localised microinjections of TA in one arm, and other 30 with TA with microneedling. The procedure was done at monthly intervals (0, 4 and 8 weeks) and followed up for three consecutive months. Clinical images were taken at each visit including modified Melasma Area Severity Index MASI scoring, patient global assessment and physician global assessment to assess the clinical response. Results: In the microinjection group, there was 35.72% improvement in the MASI score compared to 44.41% in the microneedling group, at the end of third follow-up visit. Six patients (26.09%) in the microinjections group, as compared to 12 patients (41.38%) in the microneedling group, showed more than 50% improvement. However, there were no major adverse events observed in both the treatment groups. Conclusions: On the basis of these results, TA can be used as potentially a new, effective, safe and promising therapeutic agent in melasma. The medication is easily available and affordable. Better therapeutic response to treatment in the microneedling group could be attributed to the deeper and uniform delivery of the medication through microchannels created by microneedling. PMID:24163529

  5. A double-blind randomised controlled study comparing subacromial injection of tenoxicam or methylprednisolone in patients with subacromial impingement.

    Science.gov (United States)

    Karthikeyan, S; Kwong, H T; Upadhyay, P K; Parsons, N; Drew, S J; Griffin, D

    2010-01-01

    We have carried out a prospective double-blind randomised controlled trial to compare the efficacy of a single subacromial injection of the non-steroidal anti-inflammatory drug, tenoxicam, with a single injection of methylprednisolone in patients with subacromial impingement. A total of 58 patients were randomly allocated into two groups. Group A received 40 mg of methylprednisolone and group B 20 mg of tenoxicam as a subacromial injection along with lignocaine. The Constant-Murley shoulder score was used as the primary outcome measure and the Disability of Arm, Shoulder and Hand (DASH) and the Oxford Shoulder Score (OSS) as secondary measures. Six weeks after injection the improvement in the Constant-Murley score was significantly greater in the methylprednisolone group (p = 0.003) than in the tenoxicam group. The improvement in the DASH score was greater in the steroid group and the difference was statistically significant and consistent two (p < 0.01), four (p < 0.01) and six weeks (p < 0.020) after the injection. The improvement in the OSS was consistently greater in the steroid group than in the tenoxicam group. Although the difference was statistically significant at two (p < 0.001) and four (p = 0.003) weeks after the injection, it was not at six weeks (p = 0.055). Subacromial injection of tenoxicam does not offer an equivalent outcome to subacromial injection of corticosteroid at six weeks. Corticosteroid is significantly better than tenoxicam for improving shoulder function in tendonitis of the rotator cuff after six weeks.

  6. CobraPLUS and Cookgas air-Q versus Fastrach for blind endotracheal intubation: a randomised controlled trial.

    Science.gov (United States)

    Erlacher, Wolfgang; Tiefenbrunner, Heide; Kästenbauer, Thomas; Schwarz, Sylvia; Fitzgerald, Robert D

    2011-03-01

    CobraPLUS and Cookgas air-Q are supraglottic airways expected to allow safe ventilation as well as reliable blind intubation. In a prospective, controlled trial, we hypothesised that quality of ventilation and success rate of blind endotracheal intubation of these new devices would be superior to the Fastrach intubating laryngeal mask airway (ILMA). When blind intubation failed the quality of fibrescope-guided intubation was investigated. To allow identification of those patients in whom blind intubation would be difficult, we investigated the predictive value of currently used predictors for ease of endotracheal intubation. One hundred and eighty adult patients with documented BMI, Mallampati score, Cormack-Lehane classification, interincisor gap and thyromental distance were randomised into three groups according to the device used. Ventilation conditions were rated as excellent, good or difficult. When blind intubation failed, fibrescope-guided intubation conditions were rated as well. Statistical analysis was performed by a χ-test. The quality of ventilation was excellent for all devices. Three patients in the CobraPLUS group and two patients in the ILMA and the Cookgas groups needed a slight reposition. Blind intubation through the CPLA was successful in 47%, through the Cookgas in 57%, whereas the Fastrach group had a success rate of 95%. Fibreoptic intubation was possible in all but one patient. None of the registered scores and measures allowed prediction of difficult blind intubation. All devices appeared to be safe airways. The Fastrach ILMA proved to be a reliable facilitator for blind intubation. CobraPLUS and Cookgas air-Q allowed an easy fibrescopic intubation. Failed blind intubations could not be predicted by the used parameters.

  7. Transrectal ultrasonography (TRUS)-guided pelvic plexus block to reduce pain during prostate biopsy: a randomised controlled trial.

    Science.gov (United States)

    Jindal, Tarun; Mukherjee, Subhabrata; Sinha, Rajan K; Kamal, Mir R; Ghosh, Nabankur; Saha, Barun; Mitra, Nilanjan; Sharma, Pramod K; Mandal, Soumendra N; Karmakar, Dilip

    2015-06-01

    To assess the role of pelvic plexus block (PPB) in reducing pain during transrectal ultrasonography(TRUS)-guided prostate biopsy, compared with the conventional periprostatic nerve block (PNB). A prospective, double-blind observational study was conducted with patients being randomised into three groups. Group-1 (47 patients) received intrarectal local anaesthesia (IRLA) with 10 mL 2% lignocaine jelly along with pelvic plexus block (PPB) with 2.5 mL 2% lignocaine injection bilaterally. Group-2 (46 patients) received IRLA with periprostatic nerve block (PNB). Group-3 (46 patients) received only IRLA without any type of nerve block. The patients were requested to rate the level of pain from 0 to 10 on a visual analogue scale (VAS) at two time points: VAS-1: during biopsy procedure and VAS-2: 30 min after the procedure. The mean age of the patients, mean volume of the prostates and mean serum PSA values were comparable among the three groups. The mean pain score during biopsy was significantly less in the PPB group [mean (range) sore of 2.91 (2-4)] compared with the PNB group [mean (range) score of 4 (3-5)], and both these groups were superior to the no nerve block group [mean score of 5.4 (3-7)]. There was no significant difference between the mean pain scores, 30 min after the procedure among the three groups with the mean (range) scores being 2.75 (2-4), 2.83 (2-4) and 2.85 (2-4), respectively. PPB is superior to conventional periprostatic nerve block (PNB) for pain control during TRUS-guided biopsy and both are in turn superior to no nerve block. © 2014 The Authors. BJU International © 2014 BJU International.

  8. Relationship between plaque score and video-monitored brushing performance after repeated instruction--a controlled, randomised clinical trial.

    Science.gov (United States)

    Schlueter, N; Klimek, J; Ganss, C

    2013-03-01

    Aim of this prospective, randomised, controlled clinical trial was to use the modified bass technique (MBT) and a specific brushing sequence to investigate whether two types of instruction methods lead to differences in plaque reduction and whether plaque reduction is related to technique adoption. Ninety-eight participants were randomly assigned to three groups: (1) control, no instruction; (2) verbal instruction by means of a leaflet; and (3) verbal instruction supported by demonstration, no leaflet. Brushing performance was video monitored. Plaque score (Turesky modified QHI (T-QHI)) was measured at baseline, afterwards participants received instructions. After 2 weeks, T-QHI was measured for a second time, and participants were re-instructed. After another 2 weeks, T-QHI was measured for a third time. At baseline, T-QHI did not differ between groups ((1) 1.99 ± 0.51, (2) 1.90 ± 0.51, (3) 1.93 ± 0.56). The second measurement revealed an improvement of T-QHI in the instructed groups and in the non-instructed control group ((1) 1.80 ± 0.47, (2) 1.58 ± 0.58, (3) 1.64 ± 0.58; n.s. between groups); in the intervention groups, remotivation achieved no further improvement ((1) 1.72 ± 0.48, (2) 1.52 ± 0.58, (3) 1.50 ± 0.69; n.s. between groups and compared to second measurement). Improvement of T-QHI was not related to proper performance of technique or brushing sequence. Those who fully adopted the brushing technique, the sequence or both did not have lower plaque scores. Technical performance and effectiveness were not linked. Within the study setting, the MBT was not effective in reducing plaque scores. The general recommendation of the MBT should be re-evaluated in further studies.

  9. Accuracy of the Precision Saw versus the Sagittal Saw during total knee arthroplasty: A randomised clinical trial.

    Science.gov (United States)

    Feczko, Peter Z; Fokkenrood, Hugo J P; van Assen, Tijmen; Deckers, Patrick; Emans, Pieter J; Arts, Jacobus J

    2017-10-01

    The aim of this study was to compare the accuracy of the oscillating tip saw system (Precision Saw=PS) with the more conventional fully oscillating blade system (Sagittal Saw=SS) during computer-assisted total knee arthroplasty (CAS-TKA). A prospective, randomised, controlled trial included 58 consecutive patients who underwent primary CAS-TKA and were randomly assigned in the PS group or the SS group to compare the accuracy of both blades. The primary outcome was the difference between the intended cutting planes and the actual cutting planes in degrees (°) in two planes of both the femur and the tibia. The secondary outcome was total surgery time. Tibia: In the VV-plane no significant differences were registered for the mean absolute deviation (p=0.28). The PS was more accurate in the AP-plane (p=0.03). Femur: The PS showed significantly fewer mean absolute deviations in the VV-plane (p=0.03); however, the SS revealed better accuracy in the FE-plane (p=0.04). The difference in the surgery time between the groups was not statistically significant (p=0.45). Two outliers were measured using the SS, while seven outliers were detected using the PS. The Precision Saw is not proven to be overall more accurate than the Sagittal Saw. Significantly better accuracy was shown with the PS in the two cutting planes, with the exception of one cutting plane that favoured the SS. Greater number of outliers were found using the PS. II. Copyright © 2017 Elsevier B.V. All rights reserved.

  10. Intrathecal clonidine with hyperbaric bupivacaine administered as a mixture and sequentially in caesarean section: A randomised controlled study

    Directory of Open Access Journals (Sweden)

    Prachee Sachan

    2014-01-01

    Full Text Available Background and Aims: Mixing adjuvants with hyperbaric bupivacaine in a single syringe before injecting the drugs intrathecally is an age old practice. In doing so, the density of the hyperbaric solution and also of the adjuvant drugs may be altered, thus affecting the spread of drugs. Administering local anaesthetic and the adjuvants separately may minimise the effect of the changes in densities. We aimed to compare block characteristics, intraoperative haemodynamics and post-operative pain relief in parturients undergoing caesarean section (CS after administering hyperbaric bupivacaine and clonidine intrathecally as a mixture and sequentially. Methods: In this single-blind prospective randomised controlled study at a tertiary care centre from 2010 to 12, 60 full-term parturients scheduled for elective CSs were divided into two groups on the basis of technique of intrathecal drug administration. Group M received mixture of clonidine (75 mcg and hyperbaric bupivacaine 0.5% (10 mg intrathecally, whereas Group B received clonidine (75 mcg followed by hyperbaric bupivacaine 0.5% (10 mg through separate syringes. Observational descriptive statistics, analysis of variance test, Wilcoxon test and Chi-square test were used as applicable. Results: Duration of analgesia was significantly longer in Group B (474.33 ± 20.79 min in which the drug was given sequentially than in Group M (337 ± 18.22 min. Furthermore, the time to achieve highest sensory block and complete motor block was significantly less in Group B without any major haemodynamic instability and neonatal outcome. Conclusions: When clonidine and hyperbaric bupivacaine were administered in a sequential manner, block characteristics improved significantly compared to the administration of the mixture of the two drugs.

  11. From hypertension control to global cardiovascular risk management: an educational intervention in a cluster-randomised controlled trial.

    Science.gov (United States)

    Mortsiefer, Achim; Meysen, Tobias; Schumacher, Martin; Abholz, Heinz-Harald; Wegscheider, Karl; In der Schmitten, Jürgen

    2015-05-07

    Guidelines on hypertension management recommend adjusting therapeutic efforts in accordance with global cardiovascular risk (CVR) rather than by blood pressure levels alone. However, this paradigm change has not yet arrived in German General Practice. We have evaluated the effect of an educational outreach visit with general practitioners (GPs), encouraging them to consider CVR in treatment decisions for patients with hypertension. Prospective cluster-randomised trial comprising 3443 patients with known hypertension treated by 87 GPs. Practices were randomly assigned to complex (A) or simple (B) intervention. Both groups received a guideline by mail; group A also received complex peer intervention promoting the concept of global CVR. Clinical data were collected at baseline and 6-9 months after intervention. Main outcome was improvement of calculated CVR in the predefined subpopulation of patients with a high CVR (10-year mortality ≥5%), but no manifest cardiovascular disease. Adjusted for baseline the follow-up CVR were 13.1% (95% CI 12.6%-13.6%) (A) and 12.6% (95% CI 12.2%-13.1%) (B) with a group difference (A vs. B) of 0.5% (-0.2%-1.1%), p = 0.179. The group difference was -0.05% in patients of GPs familiar with global CVR and 1.1% in patients of GPs not familiar with with global CVR. However, this effect modification was not significant (p = 0.165). Pooled over groups, the absolute CVR reduction from baseline was 1.0%, p educational intervention, including a clinical outreach visit, had no significant effect on CVR of patients with known hypertension at high risk compared to a simple postal intervention. ISRCTN44478543 .

  12. Impact of a web-based tool (WebCONSORT) to improve the reporting of randomised trials: results of a randomised controlled trial.

    Science.gov (United States)

    Hopewell, Sally; Boutron, Isabelle; Altman, Douglas G; Barbour, Ginny; Moher, David; Montori, Victor; Schriger, David; Cook, Jonathan; Gerry, Stephen; Omar, Omar; Dutton, Peter; Roberts, Corran; Frangou, Eleni; Clifton, Lei; Chiocchia, Virginia; Rombach, Ines; Wartolowska, Karolina; Ravaud, Philippe

    2016-11-28

    The CONSORT Statement is an evidence-informed guideline for reporting randomised controlled trials. A number of extensions have been developed that specify additional information to report for more complex trials. The aim of this study was to evaluate the impact of using a simple web-based tool (WebCONSORT, which incorporates a number of different CONSORT extensions) on the completeness of reporting of randomised trials published in biomedical publications. We conducted a parallel group randomised trial. Journals which endorsed the CONSORT Statement (i.e. referred to it in the Instruction to Authors) but do not actively implement it (i.e. require authors to submit a completed CONSORT checklist) were invited to participate. Authors of randomised trials were requested by the editor to use the web-based tool at the manuscript revision stage. Authors registering to use the tool were randomised (centralised computer generated) to WebCONSORT or control. In the WebCONSORT group, they had access to a tool allowing them to combine the different CONSORT extensions relevant to their trial and generate a customised checklist and flow diagram that they must submit to the editor. In the control group, authors had only access to a CONSORT flow diagram generator. Authors, journal editors, and outcome assessors were blinded to the allocation. The primary outcome was the proportion of CONSORT items (main and extensions) reported in each article post revision. A total of 46 journals actively recruited authors into the trial (25 March 2013 to 22 September 2015); 324 author manuscripts were randomised (WebCONSORT n = 166; control n = 158), of which 197 were reports of randomised trials (n = 94; n = 103). Over a third (39%; n = 127) of registered manuscripts were excluded from the analysis, mainly because the reported study was not a randomised trial. Of those included in the analysis, the most common CONSORT extensions selected were non-pharmacologic (n = 43; n

  13. Statistical analyses in Swedish randomised trials on mammography screening and in other randomised trials on cancer screening: a systematic review

    Science.gov (United States)

    Boniol, Mathieu; Smans, Michel; Sullivan, Richard; Boyle, Peter

    2015-01-01

    Objectives We compared calculations of relative risks of cancer death in Swedish mammography trials and in other cancer screening trials. Participants Men and women from 30 to 74 years of age. Setting Randomised trials on cancer screening. Design For each trial, we identified the intervention period, when screening was offered to screening groups and not to control groups, and the post-intervention period, when screening (or absence of screening) was the same in screening and control groups. We then examined which cancer deaths had been used for the computation of relative risk of cancer death. Main outcome measures Relative risk of cancer death. Results In 17 non-breast screening trials, deaths due to cancers diagnosed during the intervention and post-intervention periods were used for relative risk calculations. In the five Swedish trials, relative risk calculations used deaths due to breast cancers found during intervention periods, but deaths due to breast cancer found at first screening of control groups were added to these groups. After reallocation of the added breast cancer deaths to post-intervention periods of control groups, relative risks of 0.86 (0.76; 0.97) were obtained for cancers found during intervention periods and 0.83 (0.71; 0.97) for cancers found during post-intervention periods, indicating constant reduction in the risk of breast cancer death during follow-up, irrespective of screening. Conclusions The use of unconventional statistical methods in Swedish trials has led to overestimation of risk reduction in breast cancer death attributable to mammography screening. The constant risk reduction observed in screening groups was probably due to the trial design that optimised awareness and medical management of women allocated to screening groups. PMID:26152677

  14. Prevention of Overweight in Infancy (POI.nz) study: a randomised controlled trial of sleep, food and activity interventions for preventing overweight from birth.

    Science.gov (United States)

    Taylor, Barry J; Heath, Anne-Louise M; Galland, Barbara C; Gray, Andrew R; Lawrence, Julie A; Sayers, Rachel M; Dale, Kelly; Coppell, Kirsten J; Taylor, Rachael W

    2011-12-19

    Rapid weight gain during the first three years of life predicts child and adult obesity, and also later cardiovascular and other morbidities. Cross-sectional studies suggest that infant diet, activity and sleep are linked to excessive weight gain. As intervention for overweight children is difficult, the aim of the Prevention of Overweight in Infancy (POI.nz) study is to evaluate two primary prevention strategies during late pregnancy and early childhood that could be delivered separately or together as part of normal health care. This four-arm randomised controlled trial is being conducted with 800 families recruited at booking in the only maternity unit in the city of Dunedin, New Zealand. Mothers are randomised during pregnancy to either a usual care group (7 core contacts with a provider of government funded "Well Child" care over 2 years) or to one of three intervention groups given education and support in addition to "Well Child" care: the Food, Activity and Breastfeeding group which receives 8 extra parent contacts over the first 2 years of life; the Sleep group which receives at least 3 extra parent contacts over the first 6 months of life with a focus on prevention of sleep problems and then active intervention if there is a sleep problem from 6 months to 2 years; or the Combination group which receives all extra contacts. The main outcome measures are conditional weight velocity (0-6, 6-12, 12-24 months) and body mass index z-score at 24 months, with secondary outcomes including sleep and physical activity (parent report, accelerometry), duration of breastfeeding, timing of introduction of solids, diet quality, and measures of family function and wellbeing (parental depression, child mindedness, discipline practices, family quality of life and health care use). This study will contribute to a prospective meta-analysis of early life obesity prevention studies in Australasia. Infancy is likely to be the most effective time to establish patterns of

  15. Prevention of Overweight in Infancy (POI.nz study: a randomised controlled trial of sleep, food and activity interventions for preventing overweight from birth

    Directory of Open Access Journals (Sweden)

    Taylor Barry J

    2011-12-01

    Full Text Available Abstract Background Rapid weight gain during the first three years of life predicts child and adult obesity, and also later cardiovascular and other morbidities. Cross-sectional studies suggest that infant diet, activity and sleep are linked to excessive weight gain. As intervention for overweight children is difficult, the aim of the Prevention of Overweight in Infancy (POI.nz study is to evaluate two primary prevention strategies during late pregnancy and early childhood that could be delivered separately or together as part of normal health care. Methods/Design This four-arm randomised controlled trial is being conducted with 800 families recruited at booking in the only maternity unit in the city of Dunedin, New Zealand. Mothers are randomised during pregnancy to either a usual care group (7 core contacts with a provider of government funded "Well Child" care over 2 years or to one of three intervention groups given education and support in addition to "Well Child" care: the Food, Activity and Breastfeeding group which receives 8 extra parent contacts over the first 2 years of life; the Sleep group which receives at least 3 extra parent contacts over the first 6 months of life with a focus on prevention of sleep problems and then active intervention if there is a sleep problem from 6 months to 2 years; or the Combination group which receives all extra contacts. The main outcome measures are conditional weight velocity (0-6, 6-12, 12-24 months and body mass index z-score at 24 months, with secondary outcomes including sleep and physical activity (parent report, accelerometry, duration of breastfeeding, timing of introduction of solids, diet quality, and measures of family function and wellbeing (parental depression, child mindedness, discipline practices, family quality of life and health care use. This study will contribute to a prospective meta-analysis of early life obesity prevention studies in Australasia. Discussion Infancy is likely to

  16. Renewable energy prospects for implementation

    CERN Document Server

    Jackson, Tim

    1993-01-01

    Renewable Energy: Prospects for Implementation contains papers that were originally commissioned by the journal Energy Policy for a series on renewable energy appearing between January 1991 to September 1992. In view of the fast-changing demands on conventional energy supply to meet environmental imperatives, it seemed timely to reproduce here a selection of those papers with a new introduction and a revised concluding chapter by the Editor of the series, Dr Tim Jackson, a research fellow with the Stockholm Environment Institute. The book is organized into four parts. The papers in Part I

  17. Atmospheric Neutrinos: Status and Prospects

    CERN Document Server

    Choubey, Sandhya

    2016-01-01

    We present an overview of the current status of neutrino oscillation studies at atmospheric neutrino experiments. While the current data gives some tentalising hints regarding the neutrino mass hierarchy, octant of $\\theta_{23}$ and $\\delta_{CP}$, the hints are not statistically significant. We summarise the sensitivity to these sub-dominant three-generation effects from the next-generation proposed atmospheric neutrino experiments. We next present the prospects of new physics searches such as non-standard interactions, sterile neutrinos and CPT violation studies at these experiments.

  18. Atmospheric neutrinos: Status and prospects

    Science.gov (United States)

    Choubey, Sandhya

    2016-07-01

    We present an overview of the current status of neutrino oscillation studies at atmospheric neutrino experiments. While the current data gives some tantalising hints regarding the neutrino mass hierarchy, octant of θ23 and δCP, the hints are not statistically significant. We summarise the sensitivity to these sub-dominant three-generation effects from the next-generation proposed atmospheric neutrino experiments. We next present the prospects of new physics searches such as non-standard interactions, sterile neutrinos and CPT violation studies at these experiments.

  19. Space Colonization: Problems and Prospects

    Directory of Open Access Journals (Sweden)

    Krichevskiy S. V.

    2012-04-01

    Full Text Available Space colonization is the top priority of mankind and the strategic target of manned cosmonautics. It is necessary to comprehend the outcome of human space flights and to give a new impulse to space expansion, scientific and practical solving the problem of space colonization by human beings. The attention is also paid to key issues, potentials, restrictions, forecasts, and prospects of space colonization as well as to the transformation of a man into "a man of the future", "homo cosmicus", and "a universal man", to the formation of "space mankind".

  20. Prospects for $K^+ \\to \\pi^+ \

    CERN Document Server

    Palladino, Vito

    2015-01-01

    The rare decays K+ -> p + n -n are excellent processes to make tests of new physics at the highest scale complementary to LHC thanks to their theoretically cleaness. The NA62 experiment at CERN SPS aims to collect of the order of 100 events in two years of data taking, keeping the background at the level of 10%. Part of the experimental apparatus has been commissioned during a technical run in 2012. The physics prospects and the status of the experiment will be reviewed after the commissioning run of 2014 and the data taking in 2015.

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

    NARCIS (Netherlands)

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

    1997-01-01

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

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

    DEFF Research Database (Denmark)

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

    2002-01-01

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

  3. Association between alcohol and cardiovascular disease : Mendelian randomisation analysis based on individual participant data

    NARCIS (Netherlands)

    Holmes, Michael V.; Dale, Caroline E.; Zuccolo, Luisa; Silverwood, Richard J.; Guo, Yiran; Ye, Zheng; Prieto-Merino, David; Dehghan, Abbas; Trompet, Stella; Wong, Andrew; Cavadino, Alana; Drogan, Dagmar; Padmanabhan, Sandosh; Li, Shanshan; Yesupriya, Ajay; Leusink, Maarten; Sundstrom, Johan; Hubacek, Jaroslav A.; Pikhart, Hynek; Swerdlow, Daniel I.; Panayiotou, Andrie G.; Borinskaya, Svetlana A.; Finan, Chris; Shah, Sonia; Kuchenbaecker, Karoline B.; Shah, Tina; Engmann, Jorgen; Folkersen, Lasse; Eriksson, Per; Ricceri, Fulvio; Melander, Olle; Sacerdote, Carlotta; Gamble, Dale M.; Rayaprolu, Sruti; Ross, Owen A.; McLachlan, Stela; Vikhireva, Olga; Sluijs, Ivonne; Scott, Robert A.; Adamkova, Vera; Flicker, Leon; Van Bockxmeer, Frank M.; Power, Christine; Marques-Vidal, Pedro; Meade, Tom; Marmot, Michael G.; Ferro, Jose M.; Paulos-Pinheiro, Sofia; Humphries, Steve E.; Talmud, Philippa J.; Leach, Irene Mateo; Verweij, Niek; Linneberg, Allan; Skaaby, Tea; Doevendans, Pieter A.; Cramer, Maarten J.; Van Der Harst, Pim; Klungel, Olaf H.; Dowling, Nicole F.; Dominiczak, Anna F.; Kumari, Meena; Nicolaides, Andrew N.; Weikert, Cornelia; Boeing, Heiner; Ebrahim, Shah; Gaunt, Tom R.; Price, Jackie F.; Lannfelt, Lars; Peasey, Anne; Kubinova, Ruzena; Pajak, Andrzej; Malyutina, Sofia; Voevoda, Mikhail I.; Tamosiunas, Abdonas; Maitland-van Der Zee, Anke H.; Norman, Paul E.; Hankey, Graeme J.; Bergmann, Manuela M.; Hofman, Albert; Franco, Oscar H.; Cooper, Jackie; Palmen, Jutta; Spiering, Wilko; De Jong, Pim A.; Kuh, Diana; Hardy, Rebecca; Uitterlinden, Andre G.; Ikram, M. Arfan; Ford, Ian; Hyppönen, Elina; Almeida, Osvaldo P.; Wareham, Nicholas J.; Khaw, Kay Tee; Hamsten, Anders; Husemoen, Lise Lotte N; Tjønneland, Anne; Tolstrup, Janne S.; Rimm, Eric; Beulens, Joline W J; Verschuren, W. M Monique; Onland-Moret, N. Charlotte; Hofker, Marten H.; Wannamethee, S. Goya; Whincup, Peter H.; Morris, Richard; Vicente, Astrid M.; Watkins, Hugh; Farrall, Martin; Jukema, J. Wouter; Meschia, James; Cupples, L. Adrienne; Sharp, Stephen J.; Fornage, Myriam; Kooperberg, Charles; LaCroix, Andrea Z.; Dai, James Y.; Lanktree, Matthew B.; Siscovick, David S.; Jorgenson, Eric; Spring, Bonnie; Coresh, Josef; Li, Yun R.; Buxbaum, Sarah G.; Schreiner, Pamela J.; Ellison, R. Curtis; Tsai, Michael Y.; Patel, Sanjay R.; Redline, Susan; Johnson, Andrew D.; Hoogeveen, Ron C.; Hakonarson, Hakon; Rotter, Jerome I.; Boerwinkle, Eric; De Bakker, Paul I W; Kivimaki, Mika; Asselbergs, Folkert W.; Sattar, Naveed; Lawlor, Debbie A.; Whittaker, John; Smith, George Davey; Mukamal, Kenneth; Psaty, Bruce M.; Wilson, James G.; Lange, Leslie A.; Hamidovic, Ajna; Nordestgaard, Børge G.; Bobak, Martin; Leon, David A.; Langenberg, Claudia; Palmer, Tom M.; Reiner, Alex P.; Keating, Brendan J.; Dudbridge, Frank; Casas, Juan P.

    2014-01-01

    Objective: To use the rs1229984 variant in the alcohol dehydrogenase 1B gene (ADH1B) as an instrument to investigate the causal role of alcohol in cardiovascular disease. Design: Mendelian randomisation meta-analysis of 56 epidemiological studies. Participants: 261 991 individuals of European descen

  4. Association between alcohol and cardiovascular disease : Mendelian randomisation analysis based on individual participant data

    NARCIS (Netherlands)

    Holmes, Michael V.; Dale, Caroline E.; Zuccolo, Luisa; Silverwood, Richard J.; Guo, Yiran; Ye, Zheng; Prieto-Merino, David; Dehghan, Abbas; Trompet, Stella; Wong, Andrew; Cavadino, Alana; Drogan, Dagmar; Padmanabhan, Sandosh; Li, Shanshan; Yesupriya, Ajay; Leusink, Maarten; Sundstrom, Johan; Hubacek, Jaroslav A.; Pikhart, Hynek; Swerdlow, Daniel I.; Panayiotou, Andrie G.; Borinskaya, Svetlana A.; Finan, Chris; Shah, Sonia; Kuchenbaecker, Karoline B.; Shah, Tina; Engmann, Jorgen; Folkersen, Lasse; Eriksson, Per; Ricceri, Fulvio; Melander, Olle; Sacerdote, Carlotta; Gamble, Dale M.; Rayaprolu, Sruti; Ross, Owen A.; McLachlan, Stela; Vikhireva, Olga; Sluijs, Ivonne; Scott, Robert A.; Adamkova, Vera; Flicker, Leon; Van Bockxmeer, Frank M.; Power, Christine; Marques-Vidal, Pedro; Meade, Tom; Marmot, Michael G.; Ferro, Jose M.; Paulos-Pinheiro, Sofia; Humphries, Steve E.; Talmud, Philippa J.; Mateo Leach, Irene; Verweij, Niek; Linneberg, Allan; Skaaby, Tea; Doevendans, Pieter A.; Cramer, Maarten J.; Van der Harst, Pim; Klungel, Olaf H.; Dowling, Nicole F.; Dominiczak, Anna F.; Kumari, Meena; Nicolaides, Andrew N.; Weikert, Cornelia; Boeing, Heiner; Ebrahim, Shah; Gaunt, Tom R.; Price, Jackie F.; Lannfelt, Lars; Peasey, Anne; Kubinova, Ruzena; Pajak, Andrzej; Malyutina, Sofia; Voevoda, Mikhail I.; Tamosiunas, Abdonas; Maitland-van der Zee, Anke H.; Norman, Paul E.; Hankey, Graeme J.; Bergmann, Manuela M.; Hofman, Albert; Franco, Oscar H.; Cooper, Jackie; Palmen, Jutta; Spiering, Wilko; de Jong, Pim A.; Kuh, Diana; Hardy, Rebecca; Uitterlinden, Andre G.; Ikram, M. Arfan; Ford, Ian; Hyppoenen, Elina; Almeida, Osvaldo P.; Wareham, Nicholas J.; Khaw, Kay-Tee; Hamsten, Anders; Husemoen, Lise Lotte N.; Tjonneland, Anne; Tolstrup, Janne S.; Rimm, Eric; Beulens, Joline W. J.; Verschuren, W. M. Monique; Onland-Moret, N. Charlotte; Hofker, Marten H.; Wannamethee, S. Goya; Whincup, Peter H.; Morris, Richard; Vicente, Astrid M.; Watkins, Hugh; Farrall, Martin; Jukema, J. Wouter; Meschia, James; Cupples, L. Adrienne; Sharp, Stephen J.; Fornage, Myriam; Kooperberg, Charles; LaCroix, Andrea Z.; Dai, James Y.; Lanktree, Matthew B.; Siscovick, David S.; Jorgenson, Eric; Spring, Bonnie; Coresh, Josef; Li, Yun R.; Buxbaum, Sarah G.; Schreiner, Pamela J.; Ellison, R. Curtis; Tsai, Michael Y.; Patel, Sanjay R.; Redline, Susan; Johnson, Andrew D.; Hoogeveen, Ron C.; Rotter, Jerome I.; Boerwinkle, Eric; de Bakker, Paul I. W.; Kivimaki, Mika; Asselbergs, Folkert W.; Sattar, Naveed; Lawlor, Debbie A.; Whittaker, John; Smith, George Davey; Mukamal, Kenneth; Psaty, Bruce M.; Wilson, James G.; Lange, Leslie A.; Hamidovic, Ajna; Hingorani, Aroon D.; Nordestgaard, Borge G.; Bobak, Martin; Leon, David A.; Langenberg, Claudia; Palmer, Tom M.; Reiner, Alex P.; Keating, Brendan J.; Dudbridge, Frank; Casas, Juan P.

    2014-01-01

    Objective To use the rs1229984 variant in the alcohol dehydrogenase 1B gene (ADH1B) as an instrument to investigate the causal role of alcohol in cardiovascular disease. Design Mendelian randomisation meta-analysis of 56 epidemiological studies. Participants 261 991 individuals of European descent,

  5. Psychosocial consequences in the Danish randomised controlled lung cancer screening trial (DLCST)

    DEFF Research Database (Denmark)

    F. Rasmussen, Jakob; Siersma, V.; H. Pedersen, J.

    2015-01-01

    on Airway Symptoms, Stigmatisation, Introvert, and Harm of Smoking. Results: 4104 participants were randomised to the DLCST and the COS-LC completion rates for the CT group and the control group were 95.5% and 73.6%, respectively. There was a significant increase in negative psychosocial consequences from...

  6. Timing of insertion of levonorgestrel-releasing intrauterine system : a randomised controlled trial

    NARCIS (Netherlands)

    van der Heijden, Pahh; Geomini, Pmaj; Herman, M C; Veersema, S; Bongers, M Y

    OBJECTIVE: The objective was to assess whether patient-perceived pain during the insertion of the levonorgestrel-releasing intrauterine system (LNG-IUS) depends on the timing during the menstrual cycle. DESIGN: A stratified two-armed non-inferiority randomised controlled trial. SETTING: Large

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

    NARCIS (Netherlands)

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

    2015-01-01

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

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

    NARCIS (Netherlands)

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

    2010-01-01

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

  9. Effects of patient safety culture interventions on incident reporting in general practice: a cluster randomised trial.

    NARCIS (Netherlands)

    Verbakel, N.J.; Langelaan, M.; Verheij, T.J.M.; Wagner, C.; Zwart, D.L.M.

    2015-01-01

    Background A constructive safety culture is essential for the successful implementation of patient safety improvements. Aim To assess the effect of two patient safety culture interventions on incident reporting as a proxy of safety culture. Design and setting A three-arm cluster randomised trial was

  10. Prophylactic antibiotic regimens in tumour surgery (PARITY) A PILOT MULTICENTRE RANDOMISED CONTROLLED TRIAL

    NARCIS (Netherlands)

    Ghert, M.; Bhandari, M.; Deheshi, B.; Guyatt, G.; Holt, G.; O'Shea, T.; Randall, R. L.; Thabane, L.; Wunder, J.; Evaniew, N.; McKay, P.; Schneider, P.; Turcotte, R.; Madden, K.; Scott, T.; Sprague, S.; Simunovic, N.; Swinton, M.; Racano, A.; Heels-Ansdell, D.; Buckingham, L.; Rose, P.; Brigman, B.; Pullenayegum, E.; Ghert, M.; Evaniew, N.; Mckay, P.; Schneider, P.; Sobhi, G.; Chan, R.; Biljan, M.; Ferguson, P.; Wunder, J.; Griffin, A.; Mantas, I.; Wylie, A.; Han, A.; Grewal, G.; Turcotte, R.; Goulding, K.; Dandachli, F.; Matte, G.; Werier, J.; Abdelbary, H.; Paquin, K.; Cosgrove, H.; Dugal, A-M.; Fetzer, S.; Aikens, W.; Clarkson, P.; Wang, B.; Kondo, L.; Yip, J.; Isler, M.; Mottard, S.; Barry, J.; St Yves, H.; Quach, M.; Assayag, H.; Daoust, K.; Goyette, K.; Projean, D.; Dion, N.; Arteau, A.; Turmel, S.; Bertrand, A.; Gagnon, N.; Labbe, V.; Holt, G.; Halpern, J.; Schwartz, H.; Atkinson, A.; Daniels, J.; Moore, M. S.; Anderson, M.; Gebhardt, M.; Wagner, K.; Patel, H.; Jolin, H.; Anderson, M.; Gebhardt, M.; Allar, B.; Naqvi, M.; Bennett, J.; Albuquerque, S.; Randall, R. L.; Jones, K.; Crabtree, S.; Davis, R.; Sorenson, S.; Healey, J. H.; Galle, J.; O'Neill, G.; Del Corral, B.; Lopez, S.; Galli Serra, M.; Parizzia, W.; Podrzaj, A.; Foa Torres, M.; Clayer, M.; Chai, Y.; Slobodian, P.; Balach, T.; Coyle, K.; LaCasse, R.; Abraham, J.; Morrison, T.; Angelos, M.; Sailor, L.; Sadaka, R.; Miller, B.; Milhem, M.; McCurdy, N.; Kain, J.; Nohr, J.; Johnson, K.; Merriss, A.; Cheng, E.; Luke, D. G.; Scharschmidt, T. J.; Crist, M. K.; Dimeo, A.; Marmon, L.; Reimer, N.; Monson, D.; Oskouei, S.; Lomba, C.; Rogers, S.; Avedian, R.; Jordan, L.; Chinn, S.; Hamilton, M.; Ghert, M.; Evaniew, N.; McKay, P.; Schneider, P.; Sobhi, G.; Chan, R.; Bil-Jan, M.; Ferguson, P.; Wunder, J.; Griffin, A.; Mantas, I.; Wylie, A.; Han, A.; Grewal, G.; Turcotte, R.; Goulding, K.; Dandachli, F.; Matte, G.; Werier, J.; Abdelbary, H.; Paquin, K.; Cosgrove, H.; Dugal, A-M.; Fetzer, S.; Aikens, W.; Clarkson, P.; Wang, B.; Kondo, L.; Yip, J.; Isler, M.; Mottard, S.; Barry, J.; Yves, H. St.; Quach, M.; Assayag, H.; Daoust, K.; Goyette, Kristine; Projean, D.; Dion, N.; Arteau, A.; Turmel, S.; Bertrand, A.; Gagnon, N.; Labbe, V.; Holt, G.; Halpern, J.; Schwartz, H.; Atkinson, A.; Daniels, J.; Moore, M. S.; Anderson, M.; Gebhardt, M.; Wagner, K.; Patel, H.; Jolin, H.; Anderson, M.; Gebhardt, M.; Allar, B.; Naqvi, M.; Bennett, J.; Albuquerque, S.; Randall, R. L.; Jones, K.; Crabtree, S.; Davis, R.; Sorenson, S.; Healey, J. H.; Galle, J.; O'Neill, G.; Del Corral, B.; Lopez, S.; Galli Serra, M.; Parizzia, W.; Podrzaj, A.; Foa Torres, M.; Clayer, M.; Tran, N.; Slobodian, P.; Balach, T.; Coyle, K.; LaCasse, R.; Abraham, J.; Morrison, T.; Angelos, M.; Sailor, L.; Sadaka, R.; Miller, B.; Milhem, M.; McCurdy, N.; Kain, J.; Nohr, J.; Johnson, K.; Merriss, A.; Cheng, E.; Luke, D. G.; Scharschmidt, T. J.; Crist, M. K.; Dimeo, A.; Marmon, L.; Reimer, N.; Monson, D.; Oskouei, S.; Lomba, C.; Rogers, S.; Geller, D.; Hoang, B.; Tingling, J.; Solorzano, C.; Avedian, R.; Jordan, L.; Chinn, S.; Hamilton, M.; Puloski, S.; Monument, M.; Carcary, K.; Cameron, C.; Aboulafia, A.; Loo-Mis, M.; Bosley, J.; Bonvegna, R.; Kassa, M.; Damron, T.; Craig, T.; Reale, M.; Goodman, H. J.; Culbertson, M. Deza; Caruso, P.; Garling, E.; Schwab, J.; Fiore, A.; Phukan, R.; Park, C.; Joshi, L.; Aboulafia, A.; Wallace, M.; Flack, J.; Vaughan, K.; Avergas, A.; Brady, M.; Brown, S.; Schadie, N.; Battersby, R.; Weiss, K.; Goodman, M.; Heyl, A.; Yeschke, C. A.; Sumic, P.; Dudgeon, M.; Prosser, R.; Korenoski, C.; DiCaprio, M.; Palmer, B.; Cioppa, E.; Schaeffer, T. M.; Paul, P.; Toreson, J.; Cummings, J.; Schwartz, L.; Zahner, B.; Morris, C.; Laljani, V.; Mesko, N.; Joyce, M.; Lietman, S.; Wustrack, R.; O'Donnell, R.; Stevenson, C.; Carmody, E.; Tyler, W.; McIntyre, A.; Spiguel, A.; Scarborough, M.; Gibbs, C. P.; Steshyn, J.; Nunn, B.; Rosenthal, H.; Haynes, K.; Leddy, L.; Walton, Z.; Doung, Y-C.; Hayden, J.; Velez, R.; Aguirre, M.; Perez, M.; Barrera, S.; Garca Lopez, A.; Grimer, R.; Dunn, K.; Virdee, H.; Rankin, K.; Beckingsale, T.; Gerrand, C.; Campbell, I.; Allen, M.; Khan, S. Alam; Bakshi, S.; Rastogi, S.; Poudel, R.; Kumar, V. Sampath; Rai, A.; Baptista, A. M.; de Camargo, O. P.; Marais, L.; Rodseth, R.; Ferreira, N.; Rajah, C.; Gumede, S.; Gortzak, Y.; Sternheim, A.; Bickels, J.; Kolander, Y.; Lev, S.; Hettwer, W.; Petersen, M. M.; Grum-Schwensen, T.; Jutte, P.; Ploegmakers, J. J. W.; Stevens, M.; Mahendra, A.; Gupta, S.; Bergovec, M.; Leithner, A.; Funovics, P.; Dijkstra, P. D. S.; Van De Sande, M.; Hoogenstraaten, A.; Leijerzapf, N.; Steadman, P.; Steadman, P.; Boffano, M.; Piana, R.; Marone, S.; Albertini, U.; Boux, E.; Maiello, A.; Repsa, L.; Zile, S.; Aston, W.; Pollock, R.; Cool, P.; Gibbons, M.; Whit-Well, D.; Cosker, T.; Hemingway, J.; Porter, D.; Patton, S.; Navia, J.; Betancur, A. F.; Laitenen, M.; Pakarinen, K.; Nieminen, J.; Yla-Mononen, S.; Rautiainen, S.; Fiorenza, F.

    Objective Clinical studies of patients with bone sarcomas have been challenged by insufficient numbers at individual centres to draw valid conclusions. Our objective was to assess the feasibility of conducting a definitive multi-centre randomised controlled trial (RCT) to determine whether a

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

    NARCIS (Netherlands)

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

    2001-01-01

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

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

    LENUS (Irish Health Repository)

    Hung, Chi-Fa

    2014-07-01

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

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

    NARCIS (Netherlands)

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

    2011-01-01

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

  14. GP-initiated preconception counselling in a randomised controlled trial does not induce anxiety

    NARCIS (Netherlands)

    Jong-Potjer, L.C. de; Elsinga, J.; Cessie, S. le; Pal-de Bruin, K.M. van der; Knuistingh Neven, A.; Buitendijk, S.E.; Assendelft, W.J.J.

    2006-01-01

    Background: Preconception counselling (PCC) can reduce adverse pregnancy outcome by addressing risk factors prior to pregnancy. This study explores whether anxiety is induced in women either by the offer of PCC or by participation with GP-initiated PCC. Methods: Randomised trial of usual care versus

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

    NARCIS (Netherlands)

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

    2013-01-01

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

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

    NARCIS (Netherlands)

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

    2013-01-01

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

  17. Prophylactic antibiotic regimens in tumour surgery (PARITY) A PILOT MULTICENTRE RANDOMISED CONTROLLED TRIAL

    NARCIS (Netherlands)

    Ghert, M.; Bhandari, M.; Deheshi, B.; Guyatt, G.; Holt, G.; O'Shea, T.; Randall, R. L.; Thabane, L.; Wunder, J.; Evaniew, N.; McKay, P.; Schneider, P.; Turcotte, R.; Madden, K.; Scott, T.; Sprague, S.; Simunovic, N.; Swinton, M.; Racano, A.; Heels-Ansdell, D.; Buckingham, L.; Rose, P.; Brigman, B.; Pullenayegum, E.; Ghert, M.; Evaniew, N.; Mckay, P.; Schneider, P.; Sobhi, G.; Chan, R.; Biljan, M.; Ferguson, P.; Wunder, J.; Griffin, A.; Mantas, I.; Wylie, A.; Han, A.; Grewal, G.; Turcotte, R.; Goulding, K.; Dandachli, F.; Matte, G.; Werier, J.; Abdelbary, H.; Paquin, K.; Cosgrove, H.; Dugal, A-M.; Fetzer, S.; Aikens, W.; Clarkson, P.; Wang, B.; Kondo, L.; Yip, J.; Isler, M.; Mottard, S.; Barry, J.; St Yves, H.; Quach, M.; Assayag, H.; Daoust, K.; Goyette, K.; Projean, D.; Dion, N.; Arteau, A.; Turmel, S.; Bertrand, A.; Gagnon, N.; Labbe, V.; Holt, G.; Halpern, J.; Schwartz, H.; Atkinson, A.; Daniels, J.; Moore, M. S.; Anderson, M.; Gebhardt, M.; Wagner, K.; Patel, H.; Jolin, H.; Anderson, M.; Gebhardt, M.; Allar, B.; Naqvi, M.; Bennett, J.; Albuquerque, S.; Randall, R. L.; Jones, K.; Crabtree, S.; Davis, R.; Sorenson, S.; Healey, J. H.; Galle, J.; O'Neill, G.; Del Corral, B.; Lopez, S.; Galli Serra, M.; Parizzia, W.; Podrzaj, A.; Foa Torres, M.; Clayer, M.; Chai, Y.; Slobodian, P.; Balach, T.; Coyle, K.; LaCasse, R.; Abraham, J.; Morrison, T.; Angelos, M.; Sailor, L.; Sadaka, R.; Miller, B.; Milhem, M.; McCurdy, N.; Kain, J.; Nohr, J.; Johnson, K.; Merriss, A.; Cheng, E.; Luke, D. G.; Scharschmidt, T. J.; Crist, M. K.; Dimeo, A.; Marmon, L.; Reimer, N.; Monson, D.; Oskouei, S.; Lomba, C.; Rogers, S.; Avedian, R.; Jordan, L.; Chinn, S.; Hamilton, M.; Ghert, M.; Evaniew, N.; McKay, P.; Schneider, P.; Sobhi, G.; Chan, R.; Bil-Jan, M.; Ferguson, P.; Wunder, J.; Griffin, A.; Mantas, I.; Wylie, A.; Han, A.; Grewal, G.; Turcotte, R.; Goulding, K.; Dandachli, F.; Matte, G.; Werier, J.; Abdelbary, H.; Paquin, K.; Cosgrove, H.; Dugal, A-M.; Fetzer, S.; Aikens, W.; Clarkson, P.; Wang, B.; Kondo, L.; Yip, J.; Isler, M.; Mottard, S.; Barry, J.; Yves, H. St.; Quach, M.; Assayag, H.; Daoust, K.; Goyette, Kristine; Projean, D.; Dion, N.; Arteau, A.; Turmel, S.; Bertrand, A.; Gagnon, N.; Labbe, V.; Holt, G.; Halpern, J.; Schwartz, H.; Atkinson, A.; Daniels, J.; Moore, M. S.; Anderson, M.; Gebhardt, M.; Wagner, K.; Patel, H.; Jolin, H.; Anderson, M.; Gebhardt, M.; Allar, B.; Naqvi, M.; Bennett, J.; Albuquerque, S.; Randall, R. L.; Jones, K.; Crabtree, S.; Davis, R.; Sorenson, S.; Healey, J. H.; Galle, J.; O'Neill, G.; Del Corral, B.; Lopez, S.; Galli Serra, M.; Parizzia, W.; Podrzaj, A.; Foa Torres, M.; Clayer, M.; Tran, N.; Slobodian, P.; Balach, T.; Coyle, K.; LaCasse, R.; Abraham, J.; Morrison, T.; Angelos, M.; Sailor, L.; Sadaka, R.; Miller, B.; Milhem, M.; McCurdy, N.; Kain, J.; Nohr, J.; Johnson, K.; Merriss, A.; Cheng, E.; Luke, D. G.; Scharschmidt, T. J.; Crist, M. K.; Dimeo, A.; Marmon, L.; Reimer, N.; Monson, D.; Oskouei, S.; Lomba, C.; Rogers, S.; Geller, D.; Hoang, B.; Tingling, J.; Solorzano, C.; Avedian, R.; Jordan, L.; Chinn, S.; Hamilton, M.; Puloski, S.; Monument, M.; Carcary, K.; Cameron, C.; Aboulafia, A.; Loo-Mis, M.; Bosley, J.; Bonvegna, R.; Kassa, M.; Damron, T.; Craig, T.; Reale, M.; Goodman, H. J.; Culbertson, M. Deza; Caruso, P.; Garling, E.; Schwab, J.; Fiore, A.; Phukan, R.; Park, C.; Joshi, L.; Aboulafia, A.; Wallace, M.; Flack, J.; Vaughan, K.; Avergas, A.; Brady, M.; Brown, S.; Schadie, N.; Battersby, R.; Weiss, K.; Goodman, M.; Heyl, A.; Yeschke, C. A.; Sumic, P.; Dudgeon, M.; Prosser, R.; Korenoski, C.; DiCaprio, M.; Palmer, B.; Cioppa, E.; Schaeffer, T. M.; Paul, P.; Toreson, J.; Cummings, J.; Schwartz, L.; Zahner, B.; Morris, C.; Laljani, V.; Mesko, N.; Joyce, M.; Lietman, S.; Wustrack, R.; O'Donnell, R.; Stevenson, C.; Carmody, E.; Tyler, W.; McIntyre, A.; Spiguel, A.; Scarborough, M.; Gibbs, C. P.; Steshyn, J.; Nunn, B.; Rosenthal, H.; Haynes, K.; Leddy, L.; Walton, Z.; Doung, Y-C.; Hayden, J.; Velez, R.; Aguirre, M.; Perez, M.; Barrera, S.; Garca Lopez, A.; Grimer, R.; Dunn, K.; Virdee, H.; Rankin, K.; Beckingsale, T.; Gerrand, C.; Campbell, I.; Allen, M.; Khan, S. Alam; Bakshi, S.; Rastogi, S.; Poudel, R.; Kumar, V. Sampath; Rai, A.; Baptista, A. M.; de Camargo, O. P.; Marais, L.; Rodseth, R.; Ferreira, N.; Rajah, C.; Gumede, S.; Gortzak, Y.; Sternheim, A.; Bickels, J.; Kolander, Y.; Lev, S.; Hettwer, W.; Petersen, M. M.; Grum-Schwensen, T.; Jutte, P.; Ploegmakers, J. J. W.; Stevens, M.; Mahendra, A.; Gupta, S.; Bergovec, M.; Leithner, A.; Funovics, P.; Dijkstra, P. D. S.; Van De Sande, M.; Hoogenstraaten, A.; Leijerzapf, N.; Steadman, P.; Steadman, P.; Boffano, M.; Piana, R.; Marone, S.; Albertini, U.; Boux, E.; Maiello, A.; Repsa, L.; Zile, S.; Aston, W.; Pollock, R.; Cool, P.; Gibbons, M.; Whit-Well, D.; Cosker, T.; Hemingway, J.; Porter, D.; Patton, S.; Navia, J.; Betancur, A. F.; Laitenen, M.; Pakarinen, K.; Nieminen, J.; Yla-Mononen, S.; Rautiainen, S.; Fiorenza, F.

    2015-01-01

    Objective Clinical studies of patients with bone sarcomas have been challenged by insufficient numbers at individual centres to draw valid conclusions. Our objective was to assess the feasibility of conducting a definitive multi-centre randomised controlled trial (RCT) to determine whether a five-da

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

    Directory of Open Access Journals (Sweden)

    Judith Bek

    2016-01-01

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

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

    Science.gov (United States)

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

    2012-01-01

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

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

    OpenAIRE

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

    2005-01-01

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

  1. HLM in Cluster-Randomised Trials--Measuring Efficacy across Diverse Populations of Learners

    Science.gov (United States)

    Hegedus, Stephen; Tapper, John; Dalton, Sara; Sloane, Finbarr

    2013-01-01

    We describe the application of Hierarchical Linear Modelling (HLM) in a cluster-randomised study to examine learning algebraic concepts and procedures in an innovative, technology-rich environment in the US. HLM is applied to measure the impact of such treatment on learning and on contextual variables. We provide a detailed description of such…

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

    NARCIS (Netherlands)

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

    2014-01-01

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

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

    NARCIS (Netherlands)

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

    2016-01-01

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

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

    NARCIS (Netherlands)

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

    2016-01-01

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

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

    Science.gov (United States)

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

    2014-01-01

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

  6. Health effects of freshwater bathing among primary school children; Design for a randomised exposure study

    NARCIS (Netherlands)

    Asperen IA van; Medema GJ; Havelaar AH; Borgdorff MW; CIE; MGB

    1997-01-01

    To study the health effects of bathing in freshwaters that meet current water quality standard, large epidemiological studies are needed. A design is presented of a study among primary school children, that aims to evaluate current water quality standard. The study concerns a randomised exposure

  7. Physical Activity and School Performance: Evidence from a Danish Randomised School-Intervention Study

    Science.gov (United States)

    Quinto Romani, A.; Klausen, T. B.

    2017-01-01

    It has been claimed that physical activity has a positive effect on not only health but also on school performance. Using data from a randomised school-intervention study, this paper investigates whether different interventions promoting physical activity affect school performance in primary school children. The results indicate that on average,…

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

    NARCIS (Netherlands)

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

    2011-01-01

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

  9. Initiation of home mechanical ventilation at home : A randomised controlled trial of efficacy, feasibility and costs

    NARCIS (Netherlands)

    Hazenberg, A; Kerstjens, H A M; Prins, S C L; Vermeulen, K M; Wijkstra, P J

    Introduction: Home mechanical ventilation (HMV) in the Netherlands is normally initiated in hospital, but this is expensive and often a burden for the patient. In this randomised controlled study we investigated whether initiation of HMV at home in patients with chronic respiratory failure is

  10. Initiation of home mechanical ventilation at home: A randomised controlled trial of efficacy, feasibility and costs

    NARCIS (Netherlands)

    Hazenberg, A.; Kerstjens, H.A.M.; Prins, S.C.L.; Vermeulen, K.M.; Wijkstra, P.J.

    2014-01-01

    Introduction Home mechanical ventilation (HMV) in the Netherlands is normally initiated in hospital, but this is expensive and often a burden for the patient. In this randomised controlled study we investigated whether initiation of HMV at home in patients with chronic respiratory failure is

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

    NARCIS (Netherlands)

    Come, Carolyn E.; Kramer, Mordechai R.; Dransfield, Mark T.; Abu-Hijleh, Muhanned; Berkowitz, David; Bezzi, Michela; Bhatt, Surya P.; Boyd, Michael B.; Cases, Enrique; Chen, Alexander C.; Cooper, Christopher B.; Flandes, Javier; Gildea, Thomas; Gotfried, Mark; Hogarth, D. Kyle; Kolandaivelu, Kumaran; Leeds, William; Liesching, Timothy; Marchetti, Nathaniel; Marquette, Charles; Mularski, Richard A.; Pinto-Plata, Victor M.; Pritchett, Michael A.; Rafeq, Samaan; Rubio, Edmundo R.; Slebos, Dirk-Jan; Stratakos, Grigoris; Sy, Alexander; Tsai, Larry W.; Wahidi, Momen; Walsh, John; Wells, J. Michael; Whitten, Patrick E.; Yusen, Roger; Zulueta, Javier J.; Criner, Gerard J.; Washko, George R.

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

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

    NARCIS (Netherlands)

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

    2008-01-01

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

  13. Initiation of home mechanical ventilation at home : A randomised controlled trial of efficacy, feasibility and costs

    NARCIS (Netherlands)

    Hazenberg, A; Kerstjens, H A M; Prins, S C L; Vermeulen, K M; Wijkstra, P J

    2014-01-01

    Introduction: Home mechanical ventilation (HMV) in the Netherlands is normally initiated in hospital, but this is expensive and often a burden for the patient. In this randomised controlled study we investigated whether initiation of HMV at home in patients with chronic respiratory failure is non-in

  14. Delayed cord clamping in South African neonates with expected low birthweight : a randomised controlled trial

    NARCIS (Netherlands)

    Tiemersma, Sybrich; Heistein, Julia; Ruijne, Roos; Lopez, Gustavo; van Lobenstein, Jeroen; van Rheenen, Patrick

    OBJECTIVE: To evaluate safety and haematological effects of delayed cord clamping (DCC) in infants with expected low birthweight born in a resource-poor setting. METHODS: Randomised controlled trial involving pregnant women in early labour ≥18 years with intrapartum symphysal-fundal height ≤32 cm.

  15. Helmet therapy in infants with positional skull deformation: randomised controlled trial

    NARCIS (Netherlands)

    Wijk, R.M. van; Vlimmeren, L.A. van; Groothuis-Oudshoorn, C.G.M.; Ploeg, C.P.B. van der; Ijzerman, M.J.; Boere-Boonekamp, M.M.

    2014-01-01

    Objective To determine the effectiveness of helmet therapy for positional skull deformation compared with the natural course of the condition in infants aged 5-6 months.Design Pragmatic, single blinded, randomised controlled trial (HEADS, HElmet therapy Assessment in Deformed Skulls) nested in a pro

  16. The gait and balance of patients with diabetes can be improved: a randomised controlled trial.

    NARCIS (Netherlands)

    Allet, L.; Armand, S.; Bie, R.A. de; Golay, A.; Monnin, D.; Aminian, K.; Staal, J.B.; Bruin, E.D. de

    2010-01-01

    AIMS/HYPOTHESIS: Gait characteristics and balance are altered in diabetic patients. Little is known about possible treatment strategies. This study evaluates the effect of a specific training programme on gait and balance of diabetic patients. METHODS: This was a randomised controlled trial (n=71) w

  17. Implementing Randomised Control Trials in Open and Distance Learning: A Feasibility Study

    Science.gov (United States)

    Herodotou, Christothea; Heiser, Sarah; Rienties, Bart

    2017-01-01

    Randomised control trials (RCTs) are an evidence-based research approach which has not yet been adopted and widely used in open and distance education to inform educational policy and practice. Despite the challenges entailed in their application, RCTs hold the power to robustly evaluate the effects of educational interventions in distance…

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

    NARCIS (Netherlands)

    de Vries, Tjalling W; van Roon, Eric N

    2010-01-01

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

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

    NARCIS (Netherlands)

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

    2009-01-01

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

  20. Helmet therapy in infants with positional skull deformation: randomised controlled trial

    NARCIS (Netherlands)

    Wijk, R.M. van; Vlimmeren, L.A. van; Groothuis-Oudshoorn, C.G.; Ploeg, C.P. van der; IJzerman, M.J.; Boere-Boonekamp, M.M.

    2014-01-01

    OBJECTIVE: To determine the effectiveness of helmet therapy for positional skull deformation compared with the natural course of the condition in infants aged 5-6 months. DESIGN: Pragmatic, single blinded, randomised controlled trial (HEADS, HElmet therapy Assessment in Deformed Skulls) nested in a

  1. Helmet therapy in infants with positional skull deformation: randomised controlled trial

    NARCIS (Netherlands)

    Wijk, van Renske M.; Vlimmeren, van Leo A.; Groothuis-Oudshoorn, Catharina G.M.; Ploeg, van der Catharina P.B.; IJzerman, Maarten J.; Boere-Boonekamp, Magda M.

    2014-01-01

    Objective To determine the effectiveness of helmet therapy for positional skull deformation compared with the natural course of the condition in infants aged 5-6 months. Design Pragmatic, single blinded, randomised controlled trial (HEADS, HElmet therapy Assessment in Deformed Skulls) nested in a p

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

    NARCIS (Netherlands)

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

    2009-01-01

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

  3. Unilateral pallidotomy in Parkinson's disease : a randomised, single-blind, multicentre trial

    NARCIS (Netherlands)

    de Bie, RMA; de Haan, RJ; Nijssen, PCG; Rutgers, AWF; Beute, GN; Haaxma, R; Schmand, B; Staal, MJ; Speelman, J.D.

    1999-01-01

    Background The results of several cohort studies suggest that patients with advanced Parkinson's disease would benefit from unilateral pallidotomy. We have assessed the efficacy of unilateral pallidotomy in a randomised, single-blind, multicentre trial. Methods We enrolled 37 patients with advanced

  4. Association between alcohol and cardiovascular disease : Mendelian randomisation analysis based on individual participant data

    NARCIS (Netherlands)

    Holmes, Michael V.; Dale, Caroline E.; Zuccolo, Luisa; Silverwood, Richard J.; Guo, Yiran; Ye, Zheng; Prieto-Merino, David; Dehghan, Abbas; Trompet, Stella; Wong, Andrew; Cavadino, Alana; Drogan, Dagmar; Padmanabhan, Sandosh; Li, Shanshan; Yesupriya, Ajay; Leusink, Maarten; Sundstrom, Johan; Hubacek, Jaroslav A.; Pikhart, Hynek; Swerdlow, Daniel I.; Panayiotou, Andrie G.; Borinskaya, Svetlana A.; Finan, Chris; Shah, Sonia; Kuchenbaecker, Karoline B.; Shah, Tina; Engmann, Jorgen; Folkersen, Lasse; Eriksson, Per; Ricceri, Fulvio; Melander, Olle; Sacerdote, Carlotta; Gamble, Dale M.; Rayaprolu, Sruti; Ross, Owen A.; McLachlan, Stela; Vikhireva, Olga; Sluijs, Ivonne; Scott, Robert A.; Adamkova, Vera; Flicker, Leon; Van Bockxmeer, Frank M.; Power, Christine; Marques-Vidal, Pedro; Meade, Tom; Marmot, Michael G.; Ferro, Jose M.; Paulos-Pinheiro, Sofia; Humphries, Steve E.; Talmud, Philippa J.; Mateo Leach, Irene; Verweij, Niek; Linneberg, Allan; Skaaby, Tea; Doevendans, Pieter A.; Cramer, Maarten J.; Van der Harst, Pim; Klungel, Olaf H.; Dowling, Nicole F.; Dominiczak, Anna F.; Kumari, Meena; Nicolaides, Andrew N.; Weikert, Cornelia; Boeing, Heiner; Ebrahim, Shah; Gaunt, Tom R.; Price, Jackie F.; Lannfelt, Lars; Peasey, Anne; Kubinova, Ruzena; Pajak, Andrzej; Malyutina, Sofia; Voevoda, Mikhail I.; Tamosiunas, Abdonas; Maitland-van der Zee, Anke H.; Norman, Paul E.; Hankey, Graeme J.; Bergmann, Manuela M.; Hofman, Albert; Franco, Oscar H.; Cooper, Jackie; Palmen, Jutta; Spiering, Wilko; de Jong, Pim A.; Kuh, Diana; Hardy, Rebecca; Uitterlinden, Andre G.; Ikram, M. Arfan; Ford, Ian; Hyppoenen, Elina; Almeida, Osvaldo P.; Wareham, Nicholas J.; Khaw, Kay-Tee; Hamsten, Anders; Husemoen, Lise Lotte N.; Tjonneland, Anne; Tolstrup, Janne S.; Rimm, Eric; Beulens, Joline W. J.; Verschuren, W. M. Monique; Onland-Moret, N. Charlotte; Hofker, Marten H.; Wannamethee, S. Goya; Whincup, Peter H.; Morris, Richard; Vicente, Astrid M.; Watkins, Hugh; Farrall, Martin; Jukema, J. Wouter; Meschia, James; Cupples, L. Adrienne; Sharp, Stephen J.; Fornage, Myriam; Kooperberg, Charles; LaCroix, Andrea Z.; Dai, James Y.; Lanktree, Matthew B.; Siscovick, David S.; Jorgenson, Eric; Spring, Bonnie; Coresh, Josef; Li, Yun R.; Buxbaum, Sarah G.; Schreiner, Pamela J.; Ellison, R. Curtis; Tsai, Michael Y.; Patel, Sanjay R.; Redline, Susan; Johnson, Andrew D.; Hoogeveen, Ron C.; Rotter, Jerome I.; Boerwinkle, Eric; de Bakker, Paul I. W.; Kivimaki, Mika; Asselbergs, Folkert W.; Sattar, Naveed; Lawlor, Debbie A.; Whittaker, John; Smith, George Davey; Mukamal, Kenneth; Psaty, Bruce M.; Wilson, James G.; Lange, Leslie A.; Hamidovic, Ajna; Hingorani, Aroon D.; Nordestgaard, Borge G.; Bobak, Martin; Leon, David A.; Langenberg, Claudia; Palmer, Tom M.; Reiner, Alex P.; Keating, Brendan J.; Dudbridge, Frank; Casas, Juan P.

    2014-01-01

    Objective To use the rs1229984 variant in the alcohol dehydrogenase 1B gene (ADH1B) as an instrument to investigate the causal role of alcohol in cardiovascular disease. Design Mendelian randomisation meta-analysis of 56 epidemiological studies. Participants 261 991 individuals of European descent,

  5. Blood pressure response to changes in sodium and potassium intake: a metaregression analysis of randomised trials

    NARCIS (Netherlands)

    Geleijnse, J.M.; Kok, F.J.; Grobbee, D.E.

    2003-01-01

    The objective of the study was to assess the blood pressure response to changes in sodium and potassium intake and examine effect modification by age, gender, blood pressure, body weight and habitual sodium and potassium intake. Randomised trials of sodium reduction or potassium supplementation and

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

    NARCIS (Netherlands)

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

    2015-01-01

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

  7. Evaluation of benefit to patients of training mental health professionals in suicide guidelines: cluster randomised trial.

    NARCIS (Netherlands)

    Beurs, D.P. de; Groot, M.H. de; Keijser, J. de; Duijn, E. van; Winter, R.F.P. de; Kerkhof, A.J.F.M.

    2015-01-01

    Background: Randomised studies examining the effect on patients of training professionals in adherence to suicide guidelines are scarce. Aims: To assess whether patients benefited from the training of professionals in adherence to suicide guidelines. Method: In total 45 psychiatric departments were

  8. Evaluation of benefit to patients of training mental health professionals in suicide guidelines: cluster randomised trial.

    NARCIS (Netherlands)

    Beurs, D.P. de; Groot, M.H. de; Keijser, J. de; Duijn, E. van; Winter, R.F.P. de; Kerkhof, A.J.F.M.

    2016-01-01

    Background: Randomised studies examining the effect on patients of training professionals in adherence to suicide guidelines are scarce. Aims: To assess whether patients benefited from the training of professionals in adherence to suicide guidelines. Method: In total 45 psychiatric departments were

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

    Science.gov (United States)

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

    2014-01-01

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

  10. Long-Term Outcome of Combined (Percutaneous Intramyocardial and Intracoronary) Application of Autologous Bone Marrow Mononuclear Cells Post Myocardial Infarction: The 5-Year MYSTAR Study

    Science.gov (United States)

    Syeda, Bonni; Charwat, Silvia; Marzluf, Beatrice; Mascherbauer, Julia; Jakab, Andras; Zimba, Abelina; Sárközy, Márta; Pavo, Noemi; Sochor, Heinz; Graf, Senta; Lang, Irene; Maurer, Gerald; Bergler-Klein, Jutta

    2016-01-01

    Objective The long-term (5-year) outcome of early (3–6 weeks after acute myocardial infarction [AMI], BM-MNC Early group) and late (3–4 months after AMI, BM-MNC Late group) combined (percutaneous intramyocardial and intracoronary) delivery of autologous bone marrow mononuclear cells (BM-MNCs) was evaluated in patients with ejection fractions (EF) between 30–45% post-AMI. Methods Major adverse cardiac and cerebrovascular events (MACCE) and hospitalization were recorded. Left (LV) and right (RV) ventricular function were measured by transthoracic echocardiography. Cardiac magnetic resonance imaging (MRI) and myocardial single photon emission computed tomography was performed in a subgroup of patients. Pre-cell therapy myocardial voltage values of treated areas (assessed by NOGA mapping) were correlated with clinical outcome. Results Five-year MACCE incidences (7.4%. vs 24.1%) and the composite of all adverse events (11.1% vs 27.6%) were not different between the Early and Late treatment groups. The significant LV-EF increase at 1-year follow-up was preserved at the 5-year control (from baseline to 5-year: 5.3%, 95% CI:0.5–10.1, and 5.7%, 95% CI:1.7–9.6, p<0.05 in the Early and Late groups, respectively), with no significant changes between 1- and 5-year follow-ups. Similarly, RVEF increased significantly from baseline to the 5-year follow-up (Early group: 5.4%, 95% CI:1.0–9.6; and Late group: 8.4%, 95% CI:4.5–12.3). Lower baseline levels of myocardial viability of the treated cardiac area (6.3±2.4 vs 8.2±3.0 mV, p<0.05) were associated with incidence of MACCE. Conclusions Percutaneous combined delivery of autologous BM-MNCs is feasible and safe after 5 years, and may result in sustained improvement of cardiac function at 5 years in patients with low EF post-AMI (Clinicaltrials.gov NCT01395212). PMID:27764157

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

    Directory of Open Access Journals (Sweden)

    Gomersall Sjaan

    2012-10-01

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

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

    Science.gov (United States)

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

    2016-01-15

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

  13. Probiotics in the prevention of eczema: a randomised controlled trial

    Science.gov (United States)

    Allen, Stephen J; Jordan, Sue; Storey, Melanie; Thornton, Catherine A; Gravenor, Michael B; Garaiova, Iveta; Plummer, Susan F; Wang, Duolao; Morgan, Gareth

    2014-01-01

    Objective To evaluate a multistrain, high-dose probiotic in the prevention of eczema. Design A randomised, double-blind, placebo-controlled, parallel group trial. Settings Antenatal clinics, research clinic, children at home. Patients Pregnant women and their infants. Interventions Women from 36 weeks gestation and their infants to age 6 months received daily either the probiotic (Lactobacillus salivarius CUL61, Lactobacillus paracasei CUL08, Bifidobacterium animalis subspecies lactis CUL34 and Bifidobacterium bifidum CUL20; total of 1010 organisms/day) or matching placebo. Main outcome measure Diagnosed eczema at age 2 years. Infants were followed up by questionnaire. Clinical examination and skin prick tests to common allergens were done at 6 months and 2 years. Results The cumulative frequency of diagnosed eczema at 2 years was similar in the probiotic (73/214, 34.1%) and placebo arms (72/222, 32.4%; OR 1.07, 95% CI 0.72 to 1.6). Among the secondary outcomes, the cumulative frequency of skin prick sensitivity at 2 years was reduced in the probiotic (18/171; 10.5%) compared with the placebo arm (32/173; 18.5%; OR 0.52, 95% CI 0.28 to 0.98). The statistically significant differences between the arms were mainly in sensitisation to cow's milk and hen's egg proteins at 6 months. Atopic eczema occurred in 9/171 (5.3%) children in the probiotic arm and 21/173 (12.1%) in the placebo arm (OR 0.40, 95% CI 0.18 to 0.91). Conclusions The study did not provide evidence that the probiotic either prevented eczema during the study or reduced its severity. However, the probiotic seemed to prevent atopic sensitisation to common food allergens and so reduce the incidence of atopic eczema in early childhood. Trial registration Number ISRCTN26287422. PMID:24947281

  14. Atypical antipsychotics in bipolar disorder: systematic review of randomised trials

    Directory of Open Access Journals (Sweden)

    Moore R Andrew

    2007-08-01

    Full Text Available Abstract Background Atypical antipsychotics are increasingly used for treatment of mental illnesses like schizophrenia and bipolar disorder, and considered to have fewer extrapyramidal effects than older antipsychotics. Methods We examined efficacy in randomised trials of bipolar disorder where the presenting episode was either depression, or manic/mixed, comparing atypical antipsychotic with placebo or active comparator, examined withdrawals for any cause, or due to lack of efficacy or adverse events, and combined all phases for adverse event analysis. Studies were found through systematic search (PubMed, EMBASE, Cochrane Library, and data combined for analysis where there was clinical homogeneity, with especial reference to trial duration. Results In five trials (2,206 patients participants presented with a depressive episode, and in 25 trials (6,174 patients the presenting episode was manic or mixed. In 8-week studies presenting with depression, quetiapine and olanzapine produced significantly better rates of response and symptomatic remission than placebo, with NNTs of 5–6, but more adverse event withdrawals (NNH 12. With mania or mixed presentation atypical antipsychotics produced significantly better rates of response and symptomatic remission than placebo, with NNTs of about 5 up to six weeks, and 4 at 6–12 weeks, but more adverse event withdrawals (NNH of about 22 in studies of 6–12 weeks. In comparisons with established treatments, atypical antipsychotics had similar efficacy, but significantly fewer adverse event withdrawals (NNT to prevent one withdrawal about 10. In maintenance trials atypical antipsychotics had significantly fewer relapses to depression or mania than placebo or active comparator. In placebo-controlled trials, atypical antipsychotics were associated with higher rates of weight gain of ≥7% (mainly olanzapine trials, somnolence, and extrapyramidal symptoms. In active controlled trials, atypical antipsychotics

  15. Timing of birth for women with a twin pregnancy at term: a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Haslam Ross R

    2010-10-01

    Full Text Available Abstract Background There is a well recognized risk of complications for both women and infants of a twin pregnancy, increasing beyond 37 weeks gestation. Preterm birth prior to 37 weeks gestation is a recognized complication of a twin pregnancy, however, up to 50% of twins will be born after this time. The aims of this randomised trial are to assess whether elective birth at 37 weeks gestation compared with standard care in women with a twin pregnancy affects the risk of perinatal death, and serious infant complications. Methods/Design Design: Multicentred randomised trial. Inclusion Criteria: women with a twin pregnancy at 366 weeks or more without contraindication to continuation of pregnancy. Trial Entry & Randomisation: Following written informed consent, eligible women will be randomised from 36+6 weeks gestation. The randomisation schedule uses balanced variable blocks, with stratification for centre of birth and planned mode of birth. Women will be randomised to either elective birth or standard care. Treatment Schedules: Women allocated to the elective birth group will be planned for elective birth from 37 weeks gestation. Where the plan is for vaginal birth, this will involve induction of labour. Where the plan is for caesarean birth, this will involve elective caesarean section. For women allocated to standard care, birth will be planned for 38 weeks gestation or later. Where the plan is for vaginal birth, this will involve either awaiting the spontaneous onset of labour, or induction of labour if required. Where the plan is for caesarean birth, this will involve elective caesarean section (after 38 and as close to 39 weeks as possible. Primary Study Outcome: A composite of perinatal mortality or serious neonatal morbidity. Sample Size: 460 women with a twin pregnancy to show a reduction in the composite outcome from 16.3% to 6.7% with adjustment for the clustering of twin infants within mothers (p = 0.05, 80% power. Discussion This

  16. DIRECT trial. Diverticulitis recurrences or continuing symptoms: Operative versus conservative Treatment. A MULTICENTER RANDOMISED CLINICAL TRIAL

    Directory of Open Access Journals (Sweden)

    van de Wall Bryan JM

    2010-08-01

    Full Text Available Abstract Background Persisting abdominal complaints are common after an episode of diverticulitis treated conservatively. Furthermore, some patients develop frequent recurrences. These two groups of patients suffer greatly from their disease, as shown by impaired health related quality of life and increased costs due to multiple specialist consultations, pain medication and productivity losses. Both conservative and operative management of patients with persisting abdominal complaints after an episode of diverticulitis and/or frequently recurring diverticulitis are applied. However, direct comparison by a randomised controlled trial is necessary to determine which is superior in relieving symptoms, optimising health related quality of life, minimising costs and preventing diverticulitis recurrences against acceptable morbidity and mortality associated with surgery or the occurrence of a complicated recurrence after conservative management. We, therefore, constructed a randomised clinical trial comparing these two treatment strategies. Methods/design The DIRECT trial is a multicenter randomised clinical trial. Patients (18-75 years presenting themselves with persisting abdominal complaints after an episode of diverticulitis and/or three or more recurrences within 2 years will be included and randomised. Patients randomised for conservative treatment are treated according to the current daily practice (antibiotics, analgetics and/or expectant management. Patients randomised for elective resection will undergo an elective resection of the affected colon segment. Preferably, a laparoscopic approach is used. The primary outcome is health related quality of life measured by the Gastro-intestinal Quality of Life Index, Short-Form 36, EQ-5D and a visual analogue scale for pain quantification. Secondary endpoints are morbidity, mortality and total costs. The total follow-up will be three years. Discussion Considering the high incidence and the

  17. Promoting Recruitment using Information Management Efficiently (PRIME): study protocol for a stepped-wedge cluster randomised controlled trial within the REstart or STop Antithrombotics Randomised Trial (RESTART).

    Science.gov (United States)

    Maxwell, Amy E; Dennis, Martin; Rudd, Anthony; Weir, Christopher J; Parker, Richard A; Al-Shahi Salman, Rustam

    2017-03-01

    Research into methods to boost recruitment has been identified as the highest priority for randomised controlled trial (RCT) methodological research in the United Kingdom. Slow recruitment delays the delivery of research and inflates costs. Using electronic patient records has been shown to boost recruitment to ongoing RCTs in primary care by identifying potentially eligible participants, but this approach remains relatively unexplored in secondary care, and for stroke in particular. The REstart or STop Antithrombotics Randomised Trial (RESTART; ISRCTN71907627) is an ongoing RCT of secondary prevention after stroke due to intracerebral haemorrhage. Promoting Recruitment using Information Management Efficiently (PRIME) is a stepped-wedge cluster randomised trial of a complex intervention to help RESTART sites increase their recruitment and attain their own target numbers of participants. Seventy-two hospital sites that were located in England, Wales or Scotland and were active in RESTART in June 2015 opted into PRIME. Sites were randomly allocated (using a computer-generated block randomisation algorithm, stratified by hospital location in Scotland vs. England/Wales) to one of 12 months in which the intervention would be delivered. All sites began in the control state. The intervention was delivered by a recruitment co-ordinator via a teleconference with each site. The intervention involved discussing recruitment strategies, providing software for each site to extract from their own stroke audit data lists of patients who were potentially eligible for RESTART, and a second teleconference to review progress 6 months later. The recruitment co-ordinator was blinded to the timing of the intervention until 2 months before it was due at a site. Staff at RESTART sites were blinded to the nature and timing of the intervention. The primary outcome is the total number of patients randomised into RESTART per month per site and will be analysed in a negative binomial

  18. Work ethics: An Islamic prospective

    Directory of Open Access Journals (Sweden)

    Muhammad Shakil Ahmad

    2011-02-01

    Full Text Available Islamic principles completely cover all prospects of life including working in organization. The impact of management style used in an organization play an important role in employee commitment towards its work. This paper is an effort to explore impact of Islamic work ethic on human resource of organization including the prospective of work conflict, job satisfaction, job turn over, turnover intentions and organizational commitment. Data for current study was collected personally through questionnaires from 18 branches of seven banks of Pakistan who practices Islamic banking. In total, 150 Muslims employees were targeted as respondent of current study, while response rate was above 85%. Results show that there is significant impact of Islamic work ethics on organizational commitment, job satisfaction and rewards while Islamic work ethic has no significant relation with intention to quit job. Out of seven, only three hypotheses were fully supported, while two were partially supported, however number of rejected hypothesis were two. Islamic work ethics are source to built greater morale in employees resulting greater job satisfaction. Adopting Islamic work ethics improves organizational commitment, source of motivation as well as reduces the negative intentions of quitting job.

  19. I