WorldWideScience

Sample records for randomised comparative study

  1. randomised double blind study to compare effectiveness of honey

    African Journals Online (AJOL)

    2014-02-02

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

  2. 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.

  3. Abdominoplasty and seroma: a prospective randomised study comparing scalpel and handheld electrocautery dissection.

    Science.gov (United States)

    Marsh, Dan J; Fox, Andreas; Grobbelaar, Adriaan O; Chana, Jagdeep S

    2015-02-01

    Seroma formation remains a significant problem in abdominoplasty procedures--the cause of which remains to be elucidated. It has been suggested that one of the causative factors for seroma formation is the use of handheld electrocautery as opposed to scalpel for abdominal flap dissection. Prospective trial in 102 consecutive abdominoplasty patients randomised to have abdominal flap dissection with either handheld electrocautery device on 'coagulation setting' or sharp dissection with scalpel and monopolar electrocautery forceps for haemostasis. In all other aspects the surgical technique was identical between the two groups. All drains were removed at 48 h, irrespective of drain volume. Primary outcome measure is postoperative seroma formation on clinical examination, secondary outcome measures are drain volume, weight of tissue removed, effect of liposuction and patient BMI. Both study groups were similar in demographics with no significant difference in weight of tissue excised, BMI, drain output or post operative complictions. There was no significant difference in seroma formation rates between the handheld electrocautery group (17.2%) and the sharp dissection group (20.1%). Overall, the seroma rate was 18.6%. Liposuction to the flanks at the time of abdominoplasty was found to significantly increase the incidence of seroma, compared to patients having abdominoplasty alone. Use of handheld electrocautery rather than scalpel for tissue dissection does not lead to increased seroma formation in abdominoplasty patients. Concomitant liposuction at the time of abdominoplasty increases the risk of seroma formation compared to patients having abdominoplasty alone. Copyright © 2014 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved.

  4. Double blind, randomised study of continuous terbinafine compared with intermittent itraconazole in treatment of toenail onychomycosis

    Science.gov (United States)

    Evans, E Glyn V; Sigurgeirsson, Bárdur

    1999-01-01

    Objective To compare the efficacy and safety of continuous terbinafine with intermittent itraconazole in the treatment of toenail onychomycosis. Design Prospective, randomised, double blind, double dummy, multicentre, parallel group study lasting 72 weeks. Setting 35 centres in six European countries. Subjects 496 patients aged 18 to 75 years with a clinical and mycological diagnosis of dermatophyte onychomycosis of the toenail. Interventions Study patients were randomly divided into four parallel groups to receive either terbinafine 250 mg a day for 12 or 16 weeks (groups T12 and T16) or itraconazole 400 mg a day for 1 week in every 4 weeks for 12 or 16 weeks (groups I3 and I4). Main outcome measures Assessment of primary efficacy at week 72 was mycological cure, defined as negative results on microscopy and culture of samples from the target toenail. Results At week 72 the mycological cure rates were 75.7% (81/107) in the T12 group and 80.8% (80/99) in the T16 group compared with 38.3% (41/107) in the I3 group and 49.1 % (53/108) in the I4 group. All comparisons (T12 v I3, T12 v I4, T16 v I3, T16 v I4) showed significantly higher cure rates in the terbinafine groups (all Pterbinafine at week 72. There were no differences in the number or type of adverse events recorded in the terbinafine or itraconazole groups. Conclusion Continuous terbinafine is significantly more effective than intermittent itraconazole in the treatment of patients with toenail onychomycosis. Key messagesGiven a correct diagnosis, fungal nail disease (onychomycosis) is curableTerbinafine is an allylamine antifungal with a primarily fungicidal mode of actionContinuous terbinafine treatment over 12 or 16 weeks achieves higher rates of clinical and mycological cure than intermittent itraconazole given over the same periodsTerbinafine is safe and well tolerated over 12 or 16 weeks of continuous treatmentContinuous terbinafine should be the current treatment of choice for onychomycosis PMID

  5. A pragmatic, multicentre, randomised controlled trial comparing stapled haemorrhoidopexy to traditional excisional surgery for haemorrhoidal disease (eTHoS): study protocol for a randomised controlled trial.

    Science.gov (United States)

    Watson, Angus J M; Bruhn, Hanne; MacLeod, Kathleen; McDonald, Alison; McPherson, Gladys; Kilonzo, Mary; Norrie, John; Loudon, Malcolm A; McCormack, Kirsty; Buckley, Brian; Brown, Steven; Curran, Finlay; Jayne, David; Rajagopal, Ramesh; Cook, Jonathan A

    2014-11-11

    Current interventions for haemorrhoidal disease include traditional haemorrhoidectomy (TH) and stapled haemorrhoidopexy (SH) surgery. However, uncertainty remains as to how they compare from a clinical, quality of life (QoL) and economic perspective. The study is therefore designed to determine whether SH is more effective and more cost-effective, compared with TH. eTHoS (either Traditional Haemorrhoidectomy or Stapled Haemorrhoidopexy for Haemorrhoidal Disease) is a pragmatic, multicentre, randomised controlled trial. Currently, 29 secondary care centres are open to recruitment. Patients, aged 18 year or older, with circumferential haemorrhoids grade II to IV, are eligible to take part. The primary clinical and economic outcomes are QoL profile (area under the curve derived from the EuroQol Group's 5 Dimension Health Status Questionnaire (EQ-5D) at all assessment points) and incremental cost per quality adjusted life year (QALY) based on the responses to the EQ-5D at 24 months. The secondary outcomes include a comparison of the SF-36 scores, pain and symptoms sub-domains, disease recurrence, complication rates and direct and indirect costs to the National Health Service (NHS). A sample size of n =338 per group has been calculated to provide 90% power to detect a difference in the mean area under the curve (AUC) of 0.25 standard deviations derived from EQ-5D score measurements, with a two-sided significance level of 5%. Allowing for non-response, 400 participants will be randomised per group. Randomisation will utilise a minimisation algorithm that incorporates centre, grade of haemorrhoidal disease, baseline EQ-5D score and gender. Blinding of participants and outcome assessors is not attempted. This is one of the largest trials of its kind. In the United Kingdom alone, 29,000 operations for haemorrhoidal disease are done annually. The trial is therefore designed to give robust evidence on which clinicians and health service managers can base management decisions

  6. Randomised controlled trial comparing hypnotherapy versus gabapentin for the treatment of hot flashes in breast cancer survivors: a pilot study

    Science.gov (United States)

    MacLaughlan David, Shannon; Salzillo, Sandra; Bowe, Patrick; Scuncio, Sandra; Malit, Bridget; Raker, Christina; Gass, Jennifer S; Granai, C O; Dizon, Don S

    2013-01-01

    Objectives To compare the efficacy of hypnotherapy versus gabapentin for the treatment of hot flashes in breast cancer survivors, and to evaluate the feasibility of conducting a clinical trial comparing a drug with a complementary or alternative method (CAM). Design Prospective randomised trial. Setting Breast health centre of a tertiary care centre. Participants 15 women with a personal history of breast cancer or an increased risk of breast cancer who reported at least one daily hot flash. Interventions Gabapentin 900 mg daily in three divided doses (control) compared with standardised hypnotherapy. Participation lasted 8 weeks. Outcome measures The primary endpoints were the number of daily hot flashes and hot flash severity score (HFSS). The secondary endpoint was the Hot Flash Related Daily Interference Scale (HFRDIS). Results 27 women were randomised and 15 (56%) were considered evaluable for the primary endpoint (n=8 gabapentin, n=7 hypnotherapy). The median number of daily hot flashes at enrolment was 4.5 in the gabapentin arm and 5 in the hypnotherapy arm. HFSS scores were 7.5 in the gabapentin arm and 10 in the hypnotherapy arm. After 8 weeks, the median number of daily hot flashes was reduced by 33.3% in the gabapentin arm and by 80% in the hypnotherapy arm. The median HFSS was reduced by 33.3% in the gabapentin arm and by 85% in the hypnotherapy arm. HFRDIS scores improved by 51.6% in the gabapentin group and by 55.2% in the hypnotherapy group. There were no statistically significant differences between groups. Conclusions Hypnotherapy and gabapentin demonstrate efficacy in improving hot flashes. A definitive trial evaluating traditional interventions against CAM methods is feasible, but not without challenges. Further studies aimed at defining evidence-based recommendations for CAM are necessary. Trial registration clinicaltrials.gov (NCT00711529). PMID:24022390

  7. Protocol of the Australasian Malignant Pleural Effusion (AMPLE) trial: a multicentre randomised study comparing indwelling pleural catheter versus talc pleurodesis

    Science.gov (United States)

    Fysh, Edward T H; Thomas, Rajesh; Read, Catherine A; Lam, Ben C H; Yap, Elaine; Horwood, Fiona C; Lee, Pyng; Piccolo, Francesco; Shrestha, Ranjan; Garske, Luke A; Lam, David C L; Rosenstengel, Andrew; Bint, Michael; Murray, Kevin; Smith, Nicola A; Lee, Y C Gary

    2014-01-01

    Introduction Malignant pleural effusion can complicate most cancers. It causes breathlessness and requires hospitalisation for invasive pleural drainages. Malignant effusions often herald advanced cancers and limited prognosis. Minimising time spent in hospital is of high priority to patients and their families. Various treatment strategies exist for the management of malignant effusions, though there is no consensus governing the best choice. Talc pleurodesis is the conventional management but requires hospitalisation (and substantial healthcare resources), can cause significant side effects, and has a suboptimal success rate. Indwelling pleural catheters (IPCs) allow ambulatory fluid drainage without hospitalisation, and are increasingly employed for management of malignant effusions. Previous studies have only investigated the length of hospital care immediately related to IPC insertion. Whether IPC management reduces time spent in hospital in the patients’ remaining lifespan is unknown. A strategy of malignant effusion management that reduces hospital admission days will allow patients to spend more time outside hospital, reduce costs and save healthcare resources. Methods and analysis The Australasian Malignant Pleural Effusion (AMPLE) trial is a multicentred, randomised trial designed to compare IPC with talc pleurodesis for the management of malignant pleural effusion. This study will randomise 146 adults with malignant pleural effusions (1:1) to IPC management or talc slurry pleurodesis. The primary end point is the total number of days spent in hospital (for any admissions) from treatment procedure to death or end of study follow-up. Secondary end points include hospital days specific to pleural effusion management, adverse events, self-reported symptom and quality-of-life scores. Ethics and dissemination The Sir Charles Gairdner Group Human Research Ethics Committee has approved the study as have the ethics boards of all the participating hospitals. The

  8. Results of a prospective randomised study comparing a non-invasive surgical zipper versus intracutaneous sutures for wound closure

    NARCIS (Netherlands)

    Roolker, W.; Kraaneveld, E.; Been, H. D.; Marti, R. K.

    2002-01-01

    A prospective randomised study was undertaken to investigate the advantages and disadvantages of a non-invasive surgical zipper (Medizip) vs intracutaneous sutures skin closure in orthopaedic surgery. The study group consisted of 120 consecutive patients, 45 men and 75 women with a mean age of 47

  9. A multinational randomised study comparing didactic lectures with case scenario in a severe sepsis medical simulation course.

    Science.gov (United States)

    Li, Chih-Huang; Kuan, Win-Sen; Mahadevan, Malcolm; Daniel-Underwood, Lynda; Chiu, Te-Fa; Nguyen, H Bryant

    2012-07-01

    Medical simulation has been used to teach critical illness in a variety of settings. This study examined the effect of didactic lectures compared with simulated case scenario in a medical simulation course on the early management of severe sepsis. A prospective multicentre randomised study was performed enrolling resident physicians in emergency medicine from four hospitals in Asia. Participants were randomly assigned to a course that included didactic lectures followed by a skills workshop and simulated case scenario (lecture-first) or to a course that included a skills workshop and simulated case scenario followed by didactic lectures (simulation-first). A pre-test was given to the participants at the beginning of the course, post-test 1 was given after the didactic lectures or simulated case scenario depending on the study group assignment, then a final post-test 2 was given at the end of the course. Performance on the simulated case scenario was evaluated with a performance task checklist. 98 participants were enrolled in the study. Post-test 2 scores were significantly higher than pre-test scores in all participants (80.8 ± 12.0% vs 65.4 ± 12.2%, pdidactic lectures followed by simulation experience.

  10. Comparing three CPR feedback devices and standard BLS in a single rescuer scenario: a randomised simulation study.

    Science.gov (United States)

    Zapletal, Bernhard; Greif, Robert; Stumpf, Dominik; Nierscher, Franz Josef; Frantal, Sophie; Haugk, Moritz; Ruetzler, Kurt; Schlimp, Christoph; Fischer, Henrik

    2014-04-01

    Efficiently performed basic life support (BLS) after cardiac arrest is proven to be effective. However, cardiopulmonary resuscitation (CPR) is strenuous and rescuers' performance declines rapidly over time. Audio-visual feedback devices reporting CPR quality may prevent this decline. We aimed to investigate the effect of various CPR feedback devices on CPR quality. In this open, prospective, randomised, controlled trial we compared three CPR feedback devices (PocketCPR, CPRmeter, iPhone app PocketCPR) with standard BLS without feedback in a simulated scenario. 240 trained medical students performed single rescuer BLS on a manikin for 8min. Effective compression (compressions with correct depth, pressure point and sufficient decompression) as well as compression rate, flow time fraction and ventilation parameters were compared between the four groups. Study participants using the PocketCPR performed 17±19% effective compressions compared to 32±28% with CPRmeter, 25±27% with the iPhone app PocketCPR, and 35±30% applying standard BLS (PocketCPR vs. CPRmeter p=0.007, PocketCPR vs. standard BLS p=0.001, others: ns). PocketCPR and CPRmeter prevented a decline in effective compression over time, but overall performance in the PocketCPR group was considerably inferior to standard BLS. Compression depth and rate were within the range recommended in the guidelines in all groups. While we found differences between the investigated CPR feedback devices, overall BLS quality was suboptimal in all groups. Surprisingly, effective compression was not improved by any CPR feedback device compared to standard BLS. All feedback devices caused substantial delay in starting CPR, which may worsen outcome. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

  11. Comparative effectiveness of Pilates and yoga group exercise interventions for chronic mechanical neck pain: quasi-randomised parallel controlled study.

    Science.gov (United States)

    Dunleavy, K; Kava, K; Goldberg, A; Malek, M H; Talley, S A; Tutag-Lehr, V; Hildreth, J

    2016-09-01

    To determine the effectiveness of Pilates and yoga group exercise interventions for individuals with chronic neck pain (CNP). Quasi-randomised parallel controlled study. Community, university and private practice settings in four locations. Fifty-six individuals with CNP scoring ≥3/10 on the numeric pain rating scale for >3 months (controls n=17, Pilates n=20, yoga n=19). Exercise participants completed 12 small-group sessions with modifications and progressions supervised by a physiotherapist. The primary outcome measure was the Neck Disability Index (NDI). Secondary outcomes were pain ratings, range of movement and postural measurements collected at baseline, 6 weeks and 12 weeks. Follow-up was performed 6 weeks after completion of the exercise classes (Week 18). NDI decreased significantly in the Pilates {baseline: 11.1 [standard deviation (SD) 4.3] vs Week 12: 6.8 (SD 4.3); mean difference -4.3 (95% confidence interval -1.64 to -6.7); PPilates and yoga group exercise interventions with appropriate modifications and supervision were safe and equally effective for decreasing disability and pain compared with the control group for individuals with mild-to-moderate CNP. Physiotherapists may consider including these approaches in a plan of care. ClinicalTrials.gov NCT01999283. Copyright © 2015 Chartered Society of Physiotherapy. Published by Elsevier Ltd. All rights reserved.

  12. The ACCESS study a Zelen randomised controlled trial of a treatment package including problem solving therapy compared to treatment as usual in people who present to hospital after self-harm: study protocol for a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Parag Varsha

    2011-05-01

    Full Text Available Abstract Background People who present to hospital after intentionally harming themselves pose a common and important problem. Previous reviews of interventions have been inconclusive as existing trials have been under powered and done on unrepresentative populations. These reviews have however indicated that problem solving therapy and regular written communications after the self-harm attempt may be an effective treatment. This protocol describes a large pragmatic trial of a package of measures which include problem solving therapy, regular written communication, patient support, cultural assessment, improved access to primary care and a risk management strategy in people who present to hospital after self-harm using a novel design. Methods We propose to use a double consent Zelen design where participants are randomised prior to giving consent to enrol a large representative cohort of patients. The main outcome will be hospital attendance following repetition of self-harm, in the 12 months after recruitment with secondary outcomes of self reported self-harm, hopelessness, anxiety, depression, quality of life, social function and hospital use at three months and one year. Discussion A strength of the study is that it is a pragmatic trial which aims to recruit large numbers and does not exclude people if English is not their first language. A potential limitation is the analysis of the results which is complex and may underestimate any effect if a large number of people refuse their consent in the group randomised to problem solving therapy as they will effectively cross over to the treatment as usual group. However the primary analysis is a true intention to treat analysis of everyone randomised which includes both those who consent and do not consent to participate in the study. This provides information about how the intervention will work in practice in a representative population which is a major advance in this study compared to what has

  13. A Double-Blind, Randomised Study Comparing the Skin Hydration and Acceptability of Two Emollient Products in Atopic Eczema Patients with Dry Skin

    OpenAIRE

    Djokic-Gallagher, Jasmina; Rosher, Phil; Oliveira, Gabriela; Walker, Jennine

    2017-01-01

    Introduction Healthcare professionals tend to recommend emollients based primarily on patient/consumer preference and cost, with cheaper options assumed to be therapeutically equivalent. The aim of this study was therefore to compare the effects on skin hydration of two emollients prescribed in the UK, Doublebase Dayleve? gel (DELP) and a cheaper alternative, Zerobase Emollient? cream (ZBC). Methods This was a single-centre, randomised, double-blind, concurrent bi-lateral (within-patient) com...

  14. Percutaneous vertebroplasty compared to conservative treatment in patients with painful acute or subacute osteoporotic vertebral fractures.Three months follow up in a clinical randomised study

    DEFF Research Database (Denmark)

    Rousing, Rikke

    2008-01-01

    with a few exceptions. We observed 2 adjacent fractures in the PVP group and non in the conservative group. Conclusion. The majority of patients with acute or subacute painful osteoporotic compression fractures in the spine will recover after a few months of conservative treatment. The risk of adjacent......Abstract Study design. Clinical randomised study.    Objective. The aim of this study is to compare PVP to conservative treatment of patients with osteoporotic vertebral fractures in a clinical randomised study with respect to pain, physical and mental outcome, and to asses the risk of adjacent......) were included from January 2001 until January 2008. Patients with acute (treatment. Pain was assessed with a visual analogue scale and physical and mental outcome were...

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

    Science.gov (United States)

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

    2017-10-26

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

  16. TISU: Extracorporeal shockwave lithotripsy, as first treatment option, compared with direct progression to ureteroscopic treatment, for ureteric stones: study protocol for a randomised controlled trial.

    Science.gov (United States)

    McClinton, Samuel; Cameron, Sarah; Starr, Kathryn; Thomas, Ruth; MacLennan, Graeme; McDonald, Alison; Lam, Thomas; N'Dow, James; Kilonzo, Mary; Pickard, Robert; Anson, Ken; Keeley, Frank; Burgess, Neil; Clark, Charles Terry; MacLennan, Sara; Norrie, John

    2018-05-22

    Urinary stone disease is very common with an estimated prevalence among the general population of 2-3%. Ureteric stones are associated with severe pain as they pass through the urinary tract and have significant impact on patients' quality of life due to the detrimental effect on their ability to work and need for hospitalisation. Most ureteric stones can be expected to pass spontaneously with supportive care. However, between one-fifth and one-third of cases require an intervention. The two standard active intervention options are extracorporeal shockwave lithotripsy (ESWL) and ureteroscopic stone retrieval. ESWL and ureteroscopy are effective in terms of stone clearance; however, they differ in terms of invasiveness, anaesthetic requirement, treatment setting, complications, patient-reported outcomes (e.g. pain after intervention, time off work) and cost. There is uncertainty around which is the most clinically effective in terms of stone clearance and the true cost to the NHS and to society (in terms of impact on patient-reported health and economic burden). The aim of this trial is to determine whether, in adults with ureteric stones, judged to require active intervention, ESWL is not inferior and is more cost-effective compared to ureteroscopic treatment as the initial management option. The TISU study is a pragmatic multicentre non-inferiority randomised controlled trial of ESWL as the first treatment option compared with direct progression to ureteroscopic treatment for ureteric stones. Patients aged over 16 years with a ureteric stone confirmed by non-contrast computed tomography of the kidney, ureter and bladder (CTKUB) will be randomised to either ESWL or ureteroscopy. The primary clinical outcome is resolution of the stone episode (no further intervention required to facilitate stone clearance) up to six months from randomisation. The primary economic outcome is the incremental cost per quality-adjusted life years (QALYs) gained at six months from

  17. Randomised feasibility study of a more liberal haemoglobin trigger for red blood cell transfusion compared to standard practice in anaemic cancer patients treated with chemotherapy

    DEFF Research Database (Denmark)

    Yakymenko, D.; Frandsen, K. B.; Christensen, I. J.

    2017-01-01

    Objectives: The primary objective of this feasibility study was to identify quality of life (QoL) scores and symptom scales as tools for measuring patient-reported outcomes (PRO) associated with haemoglobin level in chemotherapy-treated cancer patients. Secondary objectives included comparing QoL......-An, FACT-An TOI, fatigue and dyspnoea. Conclusions: QoL scores of physical and functional domains as well as self-reported anaemia-related symptoms correlated well with haemoglobin level in chemotherapy-treated cancer patients.......Objectives: The primary objective of this feasibility study was to identify quality of life (QoL) scores and symptom scales as tools for measuring patient-reported outcomes (PRO) associated with haemoglobin level in chemotherapy-treated cancer patients. Secondary objectives included comparing Qo......L and symptoms between randomisation arms. Background: Anaemia in cancer patients undergoing chemotherapy is associated with decreased QoL. One treatment option is red blood cell transfusion (RBCT). However, the optimal haemoglobin trigger for transfusion is unknown. Methods: Patients were randomised...

  18. Two parallel, pragmatic, UK multicentre, randomised controlled trials comparing surgical options for upper compartment (vault or uterine) pelvic organ prolapse (the VUE Study): study protocol for a randomised controlled trial.

    Science.gov (United States)

    Glazener, Cathryn; Constable, Lynda; Hemming, Christine; Breeman, Suzanne; Elders, Andrew; Cooper, Kevin; Freeman, Robert; Smith, Anthony R B; Hagen, Suzanne; McDonald, Alison; McPherson, Gladys; Montgomery, Isobel; Kilonzo, Mary; Boyers, Dwayne; Goulao, Beatriz; Norrie, John

    2016-09-08

    One in three women who have a prolapse operation will go on to have another operation, though not necessarily in the same compartment. Surgery can result in greater impairment of quality of life than the original prolapse itself (such as the development of new-onset urinary incontinence, or prolapse at a different site). Anterior and posterior prolapse surgery is most common (90 % of operations), but around 43 % of women also have a uterine (34 %) or vault (9 %) procedure at the same time. There is not enough evidence from randomised controlled trials (RCTs) to guide management of vault or uterine prolapse. The Vault or Uterine prolapse surgery Evaluation (VUE) study aims to assess the surgical management of upper compartment pelvic organ prolapse (POP) in terms of clinical effectiveness, cost-effectiveness and adverse events. VUE is two parallel, pragmatic, UK multicentre, RCTs (Uterine Trial and Vault Trial). Eligible for inclusion are women with vault or uterine prolapse: requiring a surgical procedure, suitable for randomisation and willing to be randomised. Randomisation will be computer-allocated separately for each trial, minimised on: requiring concomitant anterior and/or posterior POP surgery or not, concomitant incontinence surgery or not, age (under 60 years or 60 years and older) and surgeon. Participants will be randomly assigned, with equal probability to intervention or control arms in either the Uterine Trial or the Vault Trial. Uterine Trial participants will receive either a vaginal hysterectomy or a uterine preservation procedure. Vault Trial participants will receive either a vaginal sacrospinous fixation or an abdominal sacrocolpopexy. Participants will be followed up by postal questionnaires (6 months post surgery and 12 months post randomisation) and also reviewed in clinic 12 months post surgery. The primary outcome is the participant-reported Pelvic Organ Prolapse Symptom Score (POP-SS) at 12 months post randomisation

  19. Comparing three forms of early intervention for youth with borderline personality disorder (the MOBY study): study protocol for a randomised controlled trial.

    Science.gov (United States)

    Chanen, Andrew; Jackson, Henry; Cotton, Sue M; Gleeson, John; Davey, Christopher G; Betts, Jennifer; Reid, Sophie; Thompson, Katherine; McCutcheon, Louise

    2015-10-21

    Borderline personality disorder is a severe mental disorder that usually has its onset in youth, but its diagnosis and treatment are often delayed. Psychosocial 'early intervention' is effective in improving symptoms and behaviours, but no trial has studied adaptive functioning as a primary outcome, even though this remains the major persistent impairment in this patient group. Also, the degree of complexity of treatment and requirements for implementation in mainstream health services are unclear. The primary aim of this trial is to evaluate the effectiveness of three forms of early intervention for borderline personality disorder in terms of adaptive functioning. Each treatment is defined by combining either a specialised or a general service delivery model with either an individual psychotherapy or a control psychotherapy condition. The study is a parallel-group, single-blind, randomised controlled trial, which has randomised permuted blocking, stratified by depression score, sex and age. The treatments are: (1) the specialised Helping Young People Early service model plus up to 16 sessions of individual cognitive analytic therapy; (2) the Helping Young People Early service plus up to 16 sessions of a control psychotherapy condition known as 'befriending'; (3) a general youth mental health care model plus up to 16 sessions of befriending. Participants will comprise 135 help-seeking youth aged 15-25 years with borderline personality disorder. After baseline assessment, staff blind to the study design and treatment group allocation will conduct assessments at 3, 6, 12 and 18 months. At the 12-month primary endpoint, the primary outcome is adaptive functioning (measures of social adjustment and interpersonal problems); secondary outcomes include measures of client satisfaction, borderline personality disorder features, depression and substance use. The results of this trial will help to clarify the comparative effectiveness of a specialised early intervention

  20. Drug treatment of bothersome lower urinary tract symptoms after ureteric JJ-stent insertion: A contemporary, comparative, prospective, randomised placebo-controlled study, single-centre experience.

    Science.gov (United States)

    Hekal, Ihab A

    2016-12-01

    To provide a guide for medication to alleviate bothersome lower urinary tract symptoms (LUTS) in patients after JJ ureteric stenting. Between June 2011 and June 2015, a prospective randomised placebo-controlled study was conducted on 200 consecutive cases of ureteric stones that required JJ stents. All patients had signed informed consent and JJ-stent placement confirmed by X-ray. The patients were randomised into five groups: A, solifenacin 5 mg; B, trospium chloride 20 mg; C, antispasmodic; and E, α-blocker; and a placebo group (D). A standard model was created to lessen patient selection bias. Eligible patients were enrolled and assessed for side-effects and bothersome LUTS using the validated Ureteric Stent Symptoms Questionnaire. Appropriate statistical analysis was carried out. In all, 150 male patients in the five groups were compared. LUTS were less in groups A and B ( P  JJ-stent insertion, anti-muscarinic medication, namely solifenacin 5 mg or trospium chloride 20 mg, was the best. The advantage of trospium over solifenacin is in the control of frequency rather than the other symptoms. Addition of an α-blocker (alfuzosin 10 mg) is valuable when nocturia is the predominant symptom.

  1. The TOPSHOCK study: effectiveness of radial shockwave therapy compared to focused shockwave therapy for treating patellar tendinopath - design of a randomised controlled trial.

    Science.gov (United States)

    van der Worp, Henk; Zwerver, Johannes; van den Akker-Scheek, Inge; Diercks, Ron L

    2011-10-11

    Patellar tendinopathy is a chronic overuse injury of the patellar tendon that is especially prevalent in people who are involved in jumping activities. Extracorporeal Shockwave Therapy is a relatively new treatment modality for tendinopathies. It seems to be a safe and promising part of the rehabilitation program for patellar tendinopathy. Extracorporeal Shockwave Therapy originally used focused shockwaves. Several years ago a new kind of shockwave therapy was introduced: radial shockwave therapy. Studies that investigate the effectiveness of radial shockwave therapy as treatment for patellar tendinopathy are scarce. Therefore the aim of this study is to compare the effectiveness of focussed shockwave therapy and radial shockwave therapy as treatments for patellar tendinopathy. The TOPSHOCK study (Tendinopathy Of Patella SHOCKwave) is a two-armed randomised controlled trial in which the effectiveness of focussed shockwave therapy and radial shockwave therapy are directly compared. Outcome assessors and patients are blinded as to which treatment is given. Patients undergo three sessions of either focused shockwave therapy or radial shockwave therapy at 1-week intervals, both in combination with eccentric decline squat training. Follow-up measurements are scheduled just before treatments 2 and 3, and 1, 4, 7 and 12 weeks after the final treatment. The main outcome measure is the Dutch VISA-P questionnaire, which asks for pain, function and sports participation in subjects with patellar tendinopathy. Secondary outcome measures are pain determined with a VAS during ADL, sports and decline squats, rating of subjective improvement and overall satisfaction with the treatment. Patients will also record their sports activities, pain during and after these activities, and concurrent medical treatment on a weekly basis in a web-based diary. Results will be analysed according to the intention-to-treat principle. The TOPSHOCK study is the first randomised controlled trial that

  2. Efficacy and safety of the biosimilar ABP 501 compared with adalimumab in patients with moderate to severe rheumatoid arthritis: a randomised, double-blind, phase III equivalence study.

    Science.gov (United States)

    Cohen, Stanley; Genovese, Mark C; Choy, Ernest; Perez-Ruiz, Fernando; Matsumoto, Alan; Pavelka, Karel; Pablos, Jose L; Rizzo, Warren; Hrycaj, Pawel; Zhang, Nan; Shergy, William; Kaur, Primal

    2017-10-01

    ABP 501 is a Food and Drug Administration-approved biosimilar to adalimumab; structural, functional and pharmacokinetic evaluations have shown that the two are highly similar. We report results from a phase III study comparing efficacy, safety and immunogenicity between ABP 501 and adalimumab. In this randomised, double-blind, active comparator-controlled, 26-week equivalence study, patients with moderate to severe active rheumatoid arthritis (RA) despite methotrexate were randomised (1:1) to ABP 501 or adalimumab (40 mg) every 2 weeks. Primary endpoint was risk ratio (RR) of ACR20 between groups at week 24. Primary hypothesis that the treatments were equivalent would be confirmed if the 90% CI for RR of ACR20 at week 24 fell between 0.738 and 1.355, demonstrating that ABP 501 is similar to adalimumab. Secondary endpoints included Disease Activity Score 28-joint count-C reactive protein (DAS28-CRP). Safety was assessed via adverse events (AEs) and laboratory evaluations. Antidrug antibodies were assessed to determine immunogenicity. A total of 526 patients were randomised (n=264, ABP 501; n=262 adalimumab) and 494 completed the study. ACR20 response at week 24 was 74.6% (ABP 501) and 72.4% (adalimumab). At week 24, the RR of ACR20 (90% CI) between groups was 1.039 (0.954, 1.133), confirming the primary hypothesis. Changes from baseline in DAS28-CRP, ACR50 and ACR70 were similar. There were no clinically meaningful differences in AEs and laboratory abnormalities. A total of 38.3% (ABP 501) and 38.2% (adalimumab) of patients tested positive for binding antidrug antibodies. Results from this study demonstrate that ABP 501 is similar to adalimumab in clinical efficacy, safety and immunogenicity in patients with moderate to severe RA. NCT01970475; Results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  3. Randomised, double-blind, comparative study to evaluate the efficacy and safety of ganaton (itopride hydrochloride) and mosapride citrate in the management of functional dyspepsia.

    Science.gov (United States)

    Amarapurkar, Deepak N; Rane, Priya

    2004-12-01

    Prokinetic agents like itopride hydrochloride and mosapride citrate are commonly used in the management of functional dyspepsia. However, in a recently conducted international, multicentric study, efficacy of 3 different regimens of mosapride was shown to be comparable to placebo. The objective of this phase 4 randomised, double blind, prospective study was to compare the efficacy and safety of ganaton (itopride hydrochloride) and mosapride citrate in the management of functional dyspepsia among patients attending the gastroenterology outpatient department of a tertiary care hospital. Ganaton 50 mg or mosapride citrate 5 mg three times daily before meals for a period of 2 weeks was administered orally. Thirty functional dyspepsia patients in each group (total = 60) were randomised to receive itopride hydrochloride or mosapride citrate treatment for 2 weeks. In itopride versus mosapride groups, global efficacy as judged by patients was excellent in 17 versus 9 (p itopride versus mosapride group global efficacy as judged by physician was excellent in 24 (80%) versus 15 (50%) and poor in 0 (0%) versus 3 (10%) patients respectively. The global efficacy was rated as excellent to good in significantly (p itopride (93.3%) group as compared to mosapride (63.33 %) group. None of the patients reported any adverse events with itopride treatment. In the mosapride group 5 patients (16.7%) reported adverse events. Two patients (6.7%) were withdrawn from mosapride treatment due to adverse events. The physician rated global tolerability ofitopride versus mosapride treatment as excellent in 23 (76.7%) versus 8 (26.7%) (p itopride hydrochloride) is superior in efficacy and safety over mosapride citrate in the management of functional dyspepsia.

  4. A randomised pilot study comparing 13 G vacuum-assisted biopsy and conventional 14 G core needle biopsy of axillary lymph nodes in women with breast cancer

    International Nuclear Information System (INIS)

    Maxwell, A.J.; Bundred, N.J.; Harvey, J.; Hunt, R.; Morris, J.; Lim, Y.Y.

    2016-01-01

    Aim: To compare the acceptability, safety, and feasibility of vacuum-assisted biopsy (VAB) and core needle biopsy (CNB) of axillary lymph nodes in women with breast cancer. Materials and methods: This parallel, non-blinded, randomised study was approved by the National Research Ethics Service. Following written informed consent, women with abnormal appearing axillary lymph nodes and radiologically malignant breast masses were randomised 1:1 to lymph node sampling under local anaesthetic with either 14 G CNB or 13 G VAB in a single UK centre. Primary outcomes were study uptake rate and patient willingness to undergo a repeat procedure if necessary. Procedure duration, immediate and post-procedure pain scores, diagnostic yield, complications, and surgical histopathology were recorded. Results: Ninety-five women were approached; 81 (85.3%) consented and were randomised. Forty underwent CNB; 40 underwent VAB; one was excluded. Median age was 57 years. The median procedure time was 2 minutes for both techniques. The median number of samples obtained was three for CNB and four for VAB. Median pain scores for the procedure and first 3 days were 1/10 and 1/10 for CNB and 1/10 and 2/10 for VAB (p=0.11 and 0.04). More women were prepared to undergo repeat CNB compared to VAB, but the difference was not significant (38/39 versus 33/39; p=0.11). Two patients developed a haematoma after VAB. One CNB and six VABs failed to yield adequate tissue (p=0.11), but the sensitivity was similar at 79% and 78%. Conclusion: Study uptake was high. Acceptability of the two procedures was similar, but VAB was associated with more post-procedure pain. The sensitivity appears to be similar. - Highlights: • Vacuum biopsy of axillary lymph nodes can be performed rapidly. • Post-procedure pain was slightly higher in women who underwent vacuum biopsy. • The inadequate yield rate of vacuum biopsy may be higher than that for core biopsy. • Sensitivity of 13-gauge vacuum biopsy and 14-gauge

  5. 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.

  6. A randomised controlled trial to compare opt-in and opt-out parental consent for childhood vaccine safety surveillance using data linkage: study protocol

    Directory of Open Access Journals (Sweden)

    Duszynski Katherine M

    2011-01-01

    Full Text Available Abstract Background The Vaccine Assessment using Linked Data (VALiD trial compared opt-in and opt-out parental consent for a population-based childhood vaccine safety surveillance program using data linkage. A subsequent telephone interview of all households enrolled in the trial elicited parental intent regarding the return or non-return of reply forms for opt-in and opt-out consent. This paper describes the rationale for the trial and provides an overview of the design and methods. Methods/Design Single-centre, single-blind, randomised controlled trial (RCT stratified by firstborn status. Mothers who gave birth at one tertiary South Australian hospital were randomised at six weeks post-partum to receive an opt-in or opt-out reply form, along with information explaining data linkage. The primary outcome at 10 weeks post-partum was parental participation in each arm, as indicated by the respective return or non-return of a reply form (or via telephone or email response. A subsequent telephone interview at 10 weeks post-partum elicited parental intent regarding the return or non-return of the reply form, and attitudes and knowledge about data linkage, vaccine safety, consent preferences and vaccination practices. Enrolment began in July 2009 and 1,129 households were recruited in a three-month period. Analysis has not yet been undertaken. The participation rate and selection bias for each method of consent will be compared when the data are analysed. Discussion The VALiD RCT represents the first trial of opt-in versus opt-out consent for a data linkage study that assesses consent preferences and intent compared with actual opting in or opting out behaviour, and socioeconomic factors. The limitations to generalisability are discussed. Trial registration Australian New Zealand Clinical Trials Registry ACTRN12610000332022

  7. A randomised controlled trial to compare opt-in and opt-out parental consent for childhood vaccine safety surveillance using data linkage: study protocol.

    Science.gov (United States)

    Berry, Jesia G; Ryan, Philip; Braunack-Mayer, Annette J; Duszynski, Katherine M; Xafis, Vicki; Gold, Michael S

    2011-01-04

    The Vaccine Assessment using Linked Data (VALiD) trial compared opt-in and opt-out parental consent for a population-based childhood vaccine safety surveillance program using data linkage. A subsequent telephone interview of all households enrolled in the trial elicited parental intent regarding the return or non-return of reply forms for opt-in and opt-out consent. This paper describes the rationale for the trial and provides an overview of the design and methods. Single-centre, single-blind, randomised controlled trial (RCT) stratified by firstborn status. Mothers who gave birth at one tertiary South Australian hospital were randomised at six weeks post-partum to receive an opt-in or opt-out reply form, along with information explaining data linkage. The primary outcome at 10 weeks post-partum was parental participation in each arm, as indicated by the respective return or non-return of a reply form (or via telephone or email response). A subsequent telephone interview at 10 weeks post-partum elicited parental intent regarding the return or non-return of the reply form, and attitudes and knowledge about data linkage, vaccine safety, consent preferences and vaccination practices. Enrolment began in July 2009 and 1,129 households were recruited in a three-month period. Analysis has not yet been undertaken. The participation rate and selection bias for each method of consent will be compared when the data are analysed. The VALiD RCT represents the first trial of opt-in versus opt-out consent for a data linkage study that assesses consent preferences and intent compared with actual opting in or opting out behaviour, and socioeconomic factors. The limitations to generalisability are discussed. Australian New Zealand Clinical Trials Registry ACTRN12610000332022.

  8. A randomised trial to compare cognitive outcome after gamma knife radiosurgery versus whole brain radiation therapy in patients with multiple brain metastases: research protocol CAR-study B.

    Science.gov (United States)

    Schimmel, Wietske C M; Verhaak, Eline; Hanssens, Patrick E J; Gehring, Karin; Sitskoorn, Margriet M

    2018-02-21

    Gamma Knife radiosurgery (GKRS) is increasingly applied in patients with multiple brain metastases and is expected to have less adverse effects in cognitive functioning than whole brain radiation therapy (WBRT). Effective treatment with the least negative cognitive side effects is increasingly becoming important, as more patients with brain metastases live longer due to more and better systemic treatment options. There are no published randomized trials yet directly comparing GKRS to WBRT in patients with multiple brain metastases that include objective neuropsychological testing. CAR-Study B is a prospective randomised trial comparing cognitive outcome after GKRS or WBRT in adult patients with 11-20 newly diagnosed brain metastases on a contrast-enhanced MRI-scan, KPS ≥70 and life expectancy of at least 3 months. Randomisation by the method of minimization, is stratified by the cumulative tumour volume in the brain, systemic treatment, KPS, histology, baseline cognitive functioning and age. The primary endpoint is the between-group difference in the percentage of patients with significant memory decline at 3 months. Secondary endpoints include overall survival, local control, development of new brain metastases, cognitive functioning over time, quality of life, depression, anxiety and fatigue. Cognitive functioning is assessed by a standardised neuropsychological test battery. Assessments (cognitive testing, questionnaires and MRI-scans) are scheduled at baseline and at 3, 6, 9, 12 and 15 months after treatment. Knowledge gained from this trial may be used to inform individual patients with BM more precisely about the cognitive effects they can expect from treatment, and to assist both doctors and patients in making (shared) individual treatment decisions. This trial is currently recruiting. Target accrual: 23 patients at 3-months follow-up in both groups. The Netherlands Trials Register number NTR5463. ClinicalTrials.gov registration number NCT02953717

  9. Comparing open and minimally invasive surgical procedures for oesophagectomy in the treatment of cancer: the ROMIO (Randomised Oesophagectomy: Minimally Invasive or Open) feasibility study and pilot trial.

    Science.gov (United States)

    Metcalfe, Chris; Avery, Kerry; Berrisford, Richard; Barham, Paul; Noble, Sian M; Fernandez, Aida Moure; Hanna, George; Goldin, Robert; Elliott, Jackie; Wheatley, Timothy; Sanders, Grant; Hollowood, Andrew; Falk, Stephen; Titcomb, Dan; Streets, Christopher; Donovan, Jenny L; Blazeby, Jane M

    2016-06-01

    Localised oesophageal cancer can be curatively treated with surgery (oesophagectomy) but the procedure is complex with a risk of complications, negative effects on quality of life and a recovery period of 6-9 months. Minimal-access surgery may accelerate recovery. The ROMIO (Randomised Oesophagectomy: Minimally Invasive or Open) study aimed to establish the feasibility of, and methodology for, a definitive trial comparing minimally invasive and open surgery for oesophagectomy. Objectives were to quantify the number of eligible patients in a pilot trial; develop surgical manuals as the basis for quality assurance; standardise pathological processing; establish a method to blind patients to their allocation in the first week post surgery; identify measures of postsurgical outcome of importance to patients and clinicians; and establish the main cost differences between the surgical approaches. Pilot parallel three-arm randomised controlled trial nested within feasibility work. Two UK NHS departments of upper gastrointestinal surgery. Patients aged ≥ 18 years with histopathological evidence of oesophageal or oesophagogastric junctional adenocarcinoma, squamous cell cancer or high-grade dysplasia, referred for oesophagectomy or oesophagectomy following neoadjuvant chemo(radio)therapy. Oesophagectomy, with patients randomised to open surgery, a hybrid open chest and minimally invasive abdomen or totally minimally invasive access. The primary outcome measure for the pilot trial was the number of patients recruited per month, with the main trial considered feasible if at least 2.5 patients per month were recruited. During 21 months of recruitment, 263 patients were assessed for eligibility; of these, 135 (51%) were found to be eligible and 104 (77%) agreed to participate, an average of five patients per month. In total, 41 patients were allocated to open surgery, 43 to the hybrid procedure and 20 to totally minimally invasive surgery. Recruitment is continuing

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

    OpenAIRE

    Borland Meredith; Acworth Jason; Babl Franz E; Oakley Ed; Kreiser David; Neutze Jocelyn; Theophilos Theane; Donath Susan; South Mike; Davidson Andrew

    2010-01-01

    Abstract Background Bronchiolitis is the most common reason for admission of infants to hospital in developed countries. Fluid replacement therapy is required in about 30% of children admitted with bronchiolitis. There are currently two techniques of fluid replacement therapy that are used with the same frequency-intravenous (IV) or nasogastric (NG). The evidence to determine the optimum route of hydration therapy for infants with bronchiolitis is inadequate. This randomised trial will be the...

  11. The effectiveness and cost-effectiveness of a mindfulness training programme in schools compared with normal school provision (MYRIAD): study protocol for a randomised controlled trial.

    Science.gov (United States)

    Kuyken, Willem; Nuthall, Elizabeth; Byford, Sarah; Crane, Catherine; Dalgleish, Tim; Ford, Tamsin; Greenberg, Mark T; Ukoumunne, Obioha C; Viner, Russell M; Williams, J Mark G

    2017-04-26

    Mindfulness-based approaches for adults are effective at enhancing mental health, but few controlled trials have evaluated their effectiveness or cost-effectiveness for young people. The primary aim of this trial is to evaluate the effectiveness and cost-effectiveness of a mindfulness training (MT) programme to enhance mental health, wellbeing and social-emotional behavioural functioning in adolescence. To address this aim, the design will be a superiority, cluster randomised controlled, parallel-group trial in which schools offering social and emotional provision in line with good practice (Formby et al., Personal, Social, Health and Economic (PSHE) Education: A mapping study of the prevalent models of delivery and their effectiveness, 2010; OFSTED, Not Yet Good Enough: Personal, Social, Health and Economic Education in schools, 2013) will be randomised to either continue this provision (control) or include MT in this provision (intervention). The study will recruit and randomise 76 schools (clusters) and 5700 school students aged 12 to 14 years, followed up for 2 years. The study will contribute to establishing if MT is an effective and cost-effective approach to promoting mental health in adolescence. International Standard Randomised Controlled Trials, identifier: ISRCTN86619085 . Registered on 3 June 2016.

  12. The TOPSHOCK study: Effectiveness of radial shockwave therapy compared to focused shockwave therapy for treating patellar tendinopath - design of a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Diercks Ron L

    2011-10-01

    Full Text Available Abstract Background Patellar tendinopathy is a chronic overuse injury of the patellar tendon that is especially prevalent in people who are involved in jumping activities. Extracorporeal Shockwave Therapy is a relatively new treatment modality for tendinopathies. It seems to be a safe and promising part of the rehabilitation program for patellar tendinopathy. Extracorporeal Shockwave Therapy originally used focused shockwaves. Several years ago a new kind of shockwave therapy was introduced: radial shockwave therapy. Studies that investigate the effectiveness of radial shockwave therapy as treatment for patellar tendinopathy are scarce. Therefore the aim of this study is to compare the effectiveness of focussed shockwave therapy and radial shockwave therapy as treatments for patellar tendinopathy. Methods/design The TOPSHOCK study (Tendinopathy Of Patella SHOCKwave is a two-armed randomised controlled trial in which the effectiveness of focussed shockwave therapy and radial shockwave therapy are directly compared. Outcome assessors and patients are blinded as to which treatment is given. Patients undergo three sessions of either focused shockwave therapy or radial shockwave therapy at 1-week intervals, both in combination with eccentric decline squat training. Follow-up measurements are scheduled just before treatments 2 and 3, and 1, 4, 7 and 12 weeks after the final treatment. The main outcome measure is the Dutch VISA-P questionnaire, which asks for pain, function and sports participation in subjects with patellar tendinopathy. Secondary outcome measures are pain determined with a VAS during ADL, sports and decline squats, rating of subjective improvement and overall satisfaction with the treatment. Patients will also record their sports activities, pain during and after these activities, and concurrent medical treatment on a weekly basis in a web-based diary. Results will be analysed according to the intention-to-treat principle. Discussion

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

    Directory of Open Access Journals (Sweden)

    Borland Meredith

    2010-06-01

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

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

    Science.gov (United States)

    2010-01-01

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

  15. A randomised comparative study of the short term clinical and biological effects of intravenous pulse methylprednisolone and infliximab in patients with active rheumatoid arthritis despite methotrexate treatment.

    Science.gov (United States)

    Durez, P; Nzeusseu Toukap, A; Lauwerys, B R; Manicourt, D H; Verschueren, P; Westhovens, R; Devogelaer, J-P; Houssiau, F A

    2004-09-01

    To compare the short term clinical and biological effects of intravenous (i.v.) pulse methylprednisolone (MP) and infliximab (IFX) in patients with severe active rheumatoid arthritis (RA) despite methotrexate (MTX) treatment. Patients with active RA despite MTX treatment were randomly allocated to receive a single i.v. infusion of MP (1 g) or three i.v. infusions of IFX (3 mg/kg) on weeks 0, 2, and 6. Patients were "blindly" evaluated for disease activity measures. Quality of life (QoL) was evaluated through the SF-36 health survey. Serum matrix metalloproteinase-3 (MMP-3) titres were measured at baseline, weeks 2 and 6. Compared with baseline, significant improvement was noted in all activity measures, including serum C reactive protein (CRP) titres, in the IFX group only. At week 14, 6/9 (67%) and 4/9 (44%) IFX patients met the ACR20 and 50 response criteria, while this was the case in only 1/12 (8%) and 0/12 (0%) MP patients, respectively (ptreatment, whereas some did so in the IFX group. Serum MMP-3 titres significantly decreased (41% drop) at week 6 in the IFX group, while no changes were seen in patients given MP. This short term randomised comparative study demonstrates that TNF blockade is better than MP pulse therapy in a subset of patients with severe refractory RA, with improvement in not only clinical parameters of disease activity but also biological inflammatory indices, such as serum CRP and MMP-3 titres.

  16. Study comparing 3 hour and 24 hour post-operative removal of bladder catheter and vaginal pack following vaginal surgery: a randomised controlled trial.

    Science.gov (United States)

    Rajan, Priya; Soundara Raghavan, S; Sharma, Deepak

    2017-09-11

    Traditional practice after vaginal hysterectomy was to keep the vaginal pack and urinary catheter for 24 hours post operatively. But there were studies that prolonged cathterisation was associated with urinary infection. So this study was conducted to compare the post operative outcome when the urinary catheter and vaginal pack were removed after 3 hours and after 24 hours after surgery. The study was done in the Department of Obstetrics and Gynecology, in a tertiary teaching institute of South India from September 2008 to March 2010. It was a randomised controlled trial involving 200 women undergoing vaginal surgery, who were randomly assigned to 2 groups - catheter and vaginal pack were removed either in 3 h in study group or were removed in 24 h in control group. The outcome of the study were vaginal bleeding, urinary retention, febrile morbidity, and urinary infection. There was no significant difference between the study and control groups with respect to vaginal bleeding (0 and 1%, p = 1), urinary retention (9 and 4%, p = 0.15), febrile morbidity (7 and 4%, p = 0.35), and urinary infection (26% in each group, p = 1.0). Keeping the urinary catheter and vaginal pack for 24 h following vaginal surgery does not offer any additional benefit against removing them after 3 h.

  17. Remifentanil-propofol analgo-sedation shortens duration of ventilation and length of ICU stay compared to a conventional regimen: A centre randomised, cross-over, open-label study in the Netherlands

    NARCIS (Netherlands)

    F.W. Rozendaal (Frans); P.E. Spronk (Peter); F.F. Snellen (Ferdinand); A. Schoen (Adri); A.R.H. van Zanten (Arthur); N.A. Foudraine (Norbert); P.G.H. Mulder (Paul); J. Bakker (Jan)

    2009-01-01

    textabstractObjective: Compare duration of mechanical ventilation (MV), weaning time, ICU-LOS (ICU-LOS), efficacy and safety of remifentanil-based regimen with conventional sedation and analgesia. Design: Centre randomised, open-label, crossover, 'real-life' study. Setting: 15 Dutch hospitals.

  18. NEOCENT: a randomised feasibility and translational study comparing neoadjuvant endocrine therapy with chemotherapy in ER-rich postmenopausal primary breast cancer.

    Science.gov (United States)

    Palmieri, C; Cleator, S; Kilburn, L S; Kim, S B; Ahn, S-H; Beresford, M; Gong, G; Mansi, J; Mallon, E; Reed, S; Mousa, K; Fallowfield, L; Cheang, M; Morden, J; Page, K; Guttery, D S; Rghebi, B; Primrose, L; Shaw, J A; Thompson, A M; Bliss, J M; Coombes, R C

    2014-12-01

    Neoadjuvant endocrine therapy is an alternative to chemotherapy for women with oestrogen receptor (ER)-positive early breast cancer (BC). We aimed to assess feasibility of recruiting patients to a study comparing chemotherapy versus endocrine therapy in postmenopausal women with ER-rich primary BC, and response as well as translational endpoints were assessed. Patients requiring neoadjuvant therapy were randomised to chemotherapy: 6 × 3-weekly cycles FE₁₀₀C or endocrine therapy: letrozole 2.5 mg, daily for 18-23 weeks. Primary endpoints were recruitment feasibility and tissue collection. Secondary endpoints included clinical, radiological and pathological response rates, quality of life and translational endpoints. 63/80 patients approached were eligible, of those 44 (70, 95% CI 57-81) were randomised. 12 (54.5, 95% CI 32.2-75.6) chemotherapy patients showed radiological objective response compared with 13 (59.1, 95% CI 36.4-79.3) letrozole patients. Compared with baseline, mean Ki-67 levels fell in both groups at days 2-4 and at surgery [fold change: 0.24 (95% CI 0.12-0.51) and 0.24; (95% CI 0.15-0.37), respectively]. Plasma total cfDNA levels rose from baseline to week 8 [fold change: chemotherapy 2.10 (95% CI 1.47-3.00), letrozole 1.47(95% CI 0.98-2.20)], and were maintained at surgery in the chemotherapy group [chemotherapy 2.63; 95% CI 1.56-4.41), letrozole 0.95 (95% CI 0.71-1.26)]. An increase in plasma let-7a miRNA was seen at surgery for patients with objective radiological response to chemotherapy. Recruitment and tissue collection endpoints were met; however, a larger trial was deemed unfeasible due to slow accrual. Both regimens were equally efficacious. Dynamic changes were seen in Ki-67 and circulating biomarkers in both groups with increases in cfDNA and let-7a miRNA persisting until surgery for chemotherapy patients.

  19. Randomised Study to Compare the Efficacy and Tolerability of Duloxetine and Escitalopram in subjects with Major Depressive Disorder

    Directory of Open Access Journals (Sweden)

    Kiran Haridas

    2015-02-01

    Full Text Available Management of depression presents a significant medical challenge. Drugs with improved efficacy and better tolerability are valuable additions to the present therapy of this disorder. Evidence suggests that therapy with a combined serotonin and noradrenaline reuptake inhibitor may be a more effective therapy of major depressive disorder (MDD than a single neurotransmitter inhibitor. The present study assessed the efficacy and tolerability between duloxetine (dual neurotransmitter reuptake inhibitor 40-60 mg/day and escitalopram (single neurotransmitter reuptake inhibitor 10-20mg/day in 24 patients as an open labeled randomized study over a duration of 12 weeks. The primary efficacy measure was the mean total change in 17 items Hamilton rating scale for depression (HAMD17 from baseline to end point using the last observation carrying forward. Tolerability was evaluated by assessing discontinuation rates, adverse event rates, vital signs, and laboratory tests. In the present study, the primary analysis detected a statistically significant difference at p=.025 using Fischer’s test between duloxetine and escitalopram in both response and remission rates. There was no significant difference detected in efficacy of onset between the two study groups. Response rate, remission rate and efficacy of onset were highly significant at p<0.05 using Wilcoxon signed rank test within each group. There were a few adverse effects that were mild and self limiting with both molecules. Duloxetine is superior to escitalopram in response and remission of treatment of MDD in similar clinical setting. Both duloxetine and escitalopram are well tolerated molecules at comparable doses.

  20. Randomised controlled trial comparing the effectiveness of electroacupuncture and TENS for low back pain: a preliminary study for a pragmatic trial.

    Science.gov (United States)

    Tsukayama, Hiroshi; Yamashita, Hitoshi; Amagai, Hitoshi; Tanno, Yasuo

    2002-12-01

    The objective of this study was to compare the effectiveness of electroacupuncture and TENS for low back pain when the electroacupuncture is applied in a clinically realistic manner. The study was designed as an evaluator-blinded randomised controlled trial (RCT). The study was performed at the Tsukuba College of Technology Clinic in Japan. Twenty subjects, who suffered from low back pain (LBP) without sciatica, were recruited, using leaflets in Tsukuba city. Subjects were allocated to either an electroacupuncture (EA) group (10 patients) or a transcutaneous electrical nerve stimulation (TENS) group (10 patients). The procedure for EA was in accordance with standard practice at our clinic. The main outcome measures were a pain relief scale (100 mm visual analogue scale: VAS) and a LBP score recommended by the Japanese Orthopaedic Association (JOA Score). Mean VAS value during the 2-weeks experimental period of the EA group was significantly smaller than that of the TENS group (65 mm vs 86 mm; 95% CI, 4.126 - 37.953). JOA Score in the EA group improved significantly while that in the TENS group showed no change. Although some placebo effect may be included, EA appeared more useful than TENS in the short-term effect on low back pain. We suggest that more realistic acupuncture interventions based on standard practice should be employed in pragmatic RCTs.

  1. The QICKD study protocol: a cluster randomised trial to compare quality improvement interventions to lower systolic BP in chronic kidney disease (CKD in primary care

    Directory of Open Access Journals (Sweden)

    du Bois Elizabeth

    2009-07-01

    Full Text Available Abstract Background Chronic kidney disease (CKD is a relatively newly recognised but common long-term condition affecting 5 to 10% of the population. Effective management of CKD, with emphasis on strict blood pressure (BP control, reduces cardiovascular risk and slows the progression of CKD. There is currently an unprecedented rise in referral to specialist renal services, which are often located in tertiary centres, inconvenient for patients, and wasteful of resources. National and international CKD guidelines include quality targets for primary care. However, there have been no rigorous evaluations of strategies to implement these guidelines. This study aims to test whether quality improvement interventions improve primary care management of elevated BP in CKD, reduce cardiovascular risk, and slow renal disease progression Design Cluster randomised controlled trial (CRT Methods This three-armed CRT compares two well-established quality improvement interventions with usual practice. The two interventions comprise: provision of clinical practice guidelines with prompts and audit-based education. The study population will be all individuals with CKD from general practices in eight localities across England. Randomisation will take place at the level of the general practices. The intended sample (three arms of 25 practices powers the study to detect a 3 mmHg difference in systolic BP between the different quality improvement interventions. An additional 10 practices per arm will receive a questionnaire to measure any change in confidence in managing CKD. Follow up will take place over two years. Outcomes will be measured using anonymised routinely collected data extracted from practice computer systems. Our primary outcome measure will be reduction of systolic BP in people with CKD and hypertension at two years. Secondary outcomes will include biomedical outcomes and markers of quality, including practitioner confidence in managing CKD. A small

  2. Clinical and radiological outcome of the Total Evolutive Shoulder System (TESS®) reverse shoulder arthroplasty: a prospective comparative non-randomised study.

    Science.gov (United States)

    Kadum, Bakir; Mukka, Sebastian; Englund, Erling; Sayed-Noor, Arkan; Sjödén, Göran

    2014-05-01

    The aims of this study were to assess the function and quality of life after the Total Evolutive Shoulder System (TESS) reverse shoulder arthroplasty (RSA), to evaluate the radiological stability of the stemless version and to address the effect of arm lengthening and scapular notching (SN) on the outcome. This was a prospective comparative non-randomised study. A total of 37 consecutive patients (40 shoulders) underwent TESS RSA between October 2007 and January 2012; 16 were stemless and 26 were stemmed. At a mean follow-up of 39 months (15-66), we evaluated range of motion (ROM), pain and functional outcome with QuickDASH and quality of life with EQ-5D score. Radiologically, component positioning, signs of loosening, SN and arm length difference were documented. We found a significant improvement in functional outcome and reduction of pain in both stemmed and stemless groups. No humeral loosening was evident, but there were four glenoid loosenings. In 12 shoulders that developed SN, seven already had scapular bone impression (SBI) evident on initial post-operative radiographs. Glenoid overhang seemed to decrease the risk of SN. Arm lengthening was associated with better EQ-5D but did not influence ROM or functional outcome. Reverse shoulder arthroplasty markedly improved shoulder function. SN is of concern in RSA, but proper positioning of the glenoid component may prevent its development.

  3. Improvement of primary care for patients with chronic heart failure: a study protocol for a cluster randomised trial comparing two strategies.

    Science.gov (United States)

    van Lieshout, Jan; Steenkamer, Betty; Knippenberg, Marjan; Wensing, Michel

    2011-03-25

    Many patients with chronic heart failure (CHF), a common condition with high morbidity and mortality rates, receive treatment in primary care. To improve the management of CHF in primary care, we developed an implementation programme comprised of educational and organisational components, with support by a practice visitor and focus both on drug treatment and lifestyle advice, and on organisation of care within the practice and collaboration with other healthcare providers. Tailoring has been shown to improve the success of implementation programmes, but little is known about what would be best methods for tailoring, specifically with respect to CHF in primary care. We describe the study protocol of a cluster randomised controlled trial to examine the effectiveness of tailoring a CHF implementation programme to general practices compared to a standardised way of delivering a programme. The study population will consist of 60 general practitioners (GPs) and the CHF patients they include. GPs are randomised in blocks of four, stratified according to practice size. With a tailored implementation programme GPs prioritise the issues that will form the bases of the support for the practice visits. These may comprise several issues, both educational and organizational.The primary outcome measures are patient's experience of receiving structured primary care for CHF (PACIC, a questionnaire related to the Chronic Care Model), patients' health-related utilities (EQ-5D), and drugs prescriptions using the guideline adherence index. Patients being clustered in practices, multilevel regression analyses will be used to explore the effect of practice size and type of intervention programme. In addition we will examine both changes within groups and differences at follow-up between groups with respect to drug dosages and advice on lifestyle issues. Furthermore, in interviews the feasibility of the programme and goal attainment, organisational changes in CHF care, and formalised

  4. Improvement of primary care for patients with chronic heart failure: A study protocol for a cluster randomised trial comparing two strategies

    Directory of Open Access Journals (Sweden)

    Wensing Michel

    2011-03-01

    Full Text Available Abstract Background Many patients with chronic heart failure (CHF, a common condition with high morbidity and mortality rates, receive treatment in primary care. To improve the management of CHF in primary care, we developed an implementation programme comprised of educational and organisational components, with support by a practice visitor and focus both on drug treatment and lifestyle advice, and on organisation of care within the practice and collaboration with other healthcare providers. Tailoring has been shown to improve the success of implementation programmes, but little is known about what would be best methods for tailoring, specifically with respect to CHF in primary care. Methods/design We describe the study protocol of a cluster randomised controlled trial to examine the effectiveness of tailoring a CHF implementation programme to general practices compared to a standardised way of delivering a programme. The study population will consist of 60 general practitioners (GPs and the CHF patients they include. GPs are randomised in blocks of four, stratified according to practice size. With a tailored implementation programme GPs prioritise the issues that will form the bases of the support for the practice visits. These may comprise several issues, both educational and organizational. The primary outcome measures are patient's experience of receiving structured primary care for CHF (PACIC, a questionnaire related to the Chronic Care Model, patients' health-related utilities (EQ-5D, and drugs prescriptions using the guideline adherence index. Patients being clustered in practices, multilevel regression analyses will be used to explore the effect of practice size and type of intervention programme. In addition we will examine both changes within groups and differences at follow-up between groups with respect to drug dosages and advice on lifestyle issues. Furthermore, in interviews the feasibility of the programme and goal attainment

  5. A pragmatic multicentre randomised controlled trial comparing stapled haemorrhoidopexy with traditional excisional surgery for haemorrhoidal disease: the eTHoS study.

    Science.gov (United States)

    Watson, Angus Jm; Cook, Jonathan; Hudson, Jemma; Kilonzo, Mary; Wood, Jessica; Bruhn, Hanne; Brown, Steven; Buckley, Brian; Curran, Finlay; Jayne, David; Loudon, Malcolm; Rajagopal, Ramesh; McDonald, Alison; Norrie, John

    2017-11-01

    Haemorrhoids are a benign anorectal condition and are highly prevalent in the UK population. Treatments involve clinic-based procedures and surgery. The surgical procedures available include stapled haemorrhoidopexy (SH) and traditional haemorrhoidectomy (TH), and over 25,000 operations are performed for haemorrhoids annually in the UK. The disease is therefore important both to patients and to health service commissioners. Debate remains as to which of these surgical procedures is the most clinically effective and cost-effective. The aim of this study was to compare the clinical effectiveness and cost-effectiveness of SH with that of TH. A large, open two-arm parallel-group pragmatic multicentre randomised controlled trial involving 32 UK hospitals and a within-trial cost-benefit analysis. A discrete choice experiment was conducted to estimate benefits (willingness to pay). Patients with grades II-IV haemorrhoids who had not previously undergone SH or TH were included in the study. Participants were randomised to receive either SH or TH. Randomisation was minimised at 1 : 1, in accordance with baseline EuroQol-5 Dimensions, three-level version (EQ-5D-3L) score, haemorrhoid grade, sex and centre, via an automated system. The primary outcome was area under the quality-of-life curve measured using the EQ-5D-3L descriptive system over 24 months, and the primary economic outcome was the incremental cost-effectiveness ratio. Secondary outcomes included disease-specific quality of life, recurrence, complications, further interventions and costs. Between January 2011 and August 2014, 777 patients were randomised (389 to receive SH and 388 to receive TH). There were 774 participants included in the analysis as a result of one post-randomisation exclusion in the SH arm and two in the TH arm. SH was less painful than TH in the short term. Surgical complications were similar in both arms. EQ-5D-3L score was higher for the SH arm in the first 6 weeks after surgery, but

  6. Biological effect of microengineered grooved stents on strut healing: a randomised OCT-based comparative study in humans

    Science.gov (United States)

    Vesga, Boris; Hernandez, Hector; Higuera, Sergio; Gasior, Pawel; Echeveri, Dario; Delgado, Juan A; Dager, Antonio; Arana, Camilo; Simonton, Charles; Maehara, Akiko; Palmaz, Julio; Granada, Juan F

    2017-01-01

    Objective To evaluate the biological effect of microengineered stent grooves (MSG) on early strut healing in humans by performing optical coherence tomography (OCT) analysis 3 weeks following the implantation. Background In the experimental setting, MSG accelerate endothelial cell migration and reduce neointimal proliferation compared with bare metal stent (BMS). Methods A total of 37 patients undergoing percutaneous coronary intervention with de novo coronary lesions were randomly assigned to either MSG (n=19) or an identical BMS controls (n=18). All patients underwent OCT imaging at 3 weeks. A total of 7959 struts were included in the final analysis. Results At 3 weeks following stent implantation, almost all struts analysed (~97%) had evidence of tissue coverage. The percentage of partially covered struts was comparable between both groups. However, the percentage of fully embedded struts was higher in the BMS group (81.22%, 49.75–95.52) compared with the MSG group (74.21%, 58.85–86.38). The stent-level analysis demonstrated reduction in neointimal formation (neointimal hyperplasia area and volume reduction of ~14% and ~19%, respectively) in the MSG versus the BMS group. In the strut-level analysis, an even greater reduction (~22% in neointimal thickness) was seen in the MSG group. Layered neointimal was present in ~6% of the OCT frames in the BMS group while it was not present in the MSG group. Conclusions MSG induced a more homogeneous and predictable pattern of surface healing in the early stages following stent implantation. The biological effect of MSG on stent healing has the potential to improve the safety profile of current generation drug-eluting stents. Classifications BMS, OCT, clinical trials. PMID:28674616

  7. 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

    with gauze packs; bipolar diathermy; and local anaesthesia then pack compression. The outcome measures were pain scores (derived from a visual analogue scale), peri-operative bleeding, and post-operative episodes of blood-stained saliva, consultation rate, tonsillar bed healing and days before return...... to regular diet. One hundred and five patients were included.Results:Peri-operative bleeding was significantly reduced in the local anaesthesia group compared with the other two groups. Delayed post-operative tonsillar bed healing was noted in the diathermy group. No other significant differences were found...

  8. Video-based instructions for surgical hand disinfection as a replacement for conventional tuition? A randomised, blind comparative study.

    Science.gov (United States)

    Weber, Uwe; Constantinescu, Mihai A; Woermann, Ulrich; Schmitz, Felix; Schnabel, Kai

    2016-01-01

    Various different learning methods are available for planning tuition regarding the introduction to surgical hand disinfection. These learning methods should help to organise and deal with this topic. The use of a video film is an alternative to conventional tuition due to the real presentation possibilities of practical demonstration. This study examines by way of comparison which form of communication is more effective for learning and applying surgical hand disinfection for medical students in their first year of studies: video-based instruction or conventional tuition. A total of 50 first-year medical students were randomly allocated either to the "Conventional Instruction" (CI) study group or to the "Video-based Instruction" (VI) study group. The conventional instruction was carried out by an experienced nurse preceptor/nurse educator for the operating theatre who taught the preparatory measures and the actual procedure in a two-minute lesson. The second group watched a two-minute video sequence with identical content. Afterwards, both groups demonstrated practically the knowledge they had acquired at an individual practical test station. The quality (a) of the preparation and (b) of the procedure as well as (c) the quality of the results was assessed by 6 blind experts using a check list. The acceptability of the respective teaching method was also asked about using a questionnaire. The group performance did not differ either in the preparation (t=-78, pvideo-based instruction achieved a significantly better result. In response to the question as to which of the two learning methods they would prefer, the significant majority (60.4%) of students stated video instruction. In this study, the use of the video-based instruction emerged as the more effective teaching method for learning surgical hand disinfection for medical students and is preferable to conventional instruction. The video instruction is associated with a higher learning effectiveness, efficiency

  9. Video-based instructions for surgical hand disinfection as a replacement for conventional tuition? A randomised, blind comparative study

    Directory of Open Access Journals (Sweden)

    Weber, Uwe

    2016-08-01

    Full Text Available Introduction: Various different learning methods are available for planning tuition regarding the introduction to surgical hand disinfection. These learning methods should help to organise and deal with this topic. The use of a video film is an alternative to conventional tuition due to the real presentation possibilities of practical demonstration. Objective: This study examines by way of comparison which form of communication is more effective for learning and applying surgical hand disinfection for medical students in their first year of studies: video-based instruction or conventional tuition. Methodology: A total of 50 first-year medical students were randomly allocated either to the “Conventional Instruction” (CI study group or to the “Video-based Instruction” (VI study group. The conventional instruction was carried out by an experienced nurse preceptor/nurse educator for the operating theatre who taught the preparatory measures and the actual procedure in a two-minute lesson. The second group watched a two-minute video sequence with identical content. Afterwards, both groups demonstrated practically the knowledge they had acquired at an individual practical test station. The quality (a of the preparation and (b of the procedure as well as (c the quality of the results was assessed by 6 blind experts using a check list. The acceptability of the respective teaching method was also asked about using a questionnaire.Results: The group performance did not differ either in the preparation (=-78, <0.44 or in the quality (=-99, <0.34. With respect to performance, it was possible to demonstrate a strong treatment effect. In the practical (=-3.33, <0.002, =0.943 and in the total score (=-2.65, <0.011, =0.751, the group with video-based instruction achieved a significantly better result. In response to the question as to which of the two learning methods they would prefer, the significant majority (60.4% of students stated video instruction

  10. Efficacy, tolerability and consumer acceptability of terbinafine topical spray versus terbinafine topical solution: a phase IIa, randomised, observer-blind, comparative study.

    Science.gov (United States)

    Brown, Marc; Evans, Charles; Muddle, Andrew; Turner, Rob; Lim, Sian; Reed, Jessica; Traynor, Matt

    2013-10-01

    Tinea pedis is one of the world's most prevalent dermatophyte infections. MedSpray™ tinea pedis 1 % w/w (topical spray) is a novel, easy-to-use propellant-based spray formulation containing 1 % w/w terbinafine, requiring no manipulation at the site of infection. This is in contrast to the only formulation currently approved in Europe for single application (none are approved in the USA for single use), which is Lamisil(®) Once 1 % w/w (topical solution), containing 1 % w/w terbinafine hydrochloride, which requires manipulation on the affected area. The aim of this study was to evaluate the efficacy, tolerability and consumer acceptability of a topical spray versus a topical solution in the treatment of tinea pedis. This study is a phase IIa, randomised, observer-blind, non-inferiority comparative study of the topical spray compared with the topical solution over a 12-week study period. The study was conducted at Bioskin GmbH, Hamburg and Berlin. Patients (n = 120) who presented with the presence of interdigital tinea pedis caused by dermatophytes on one or both feet were enrolled in the study. Patients were randomly assigned between the two treatment groups. Either the topical spray or the topical solution was administered by the study nurse and consisted of a single application (equivalent to 20 mg of terbinafine per foot) on day 1 of the study. No further applications were made for the duration of the study. The hypothesis formulated before commencement of the study was that the topical spray would prove to be non-inferior to the topical solution. Efficacy assessments, including clinical signs and symptoms, mycology and microscopy were performed at baseline and 1, 6 and 12 weeks after treatment. The rate of mycological cure at week 1 was statistically equivalent for both treatments. There was a significant reduction in the overall clinical score as assessed by the Physician's Global Assessment of signs and symptoms for both treatment groups. The topical

  11. A Double-Blind, Randomised Study Comparing the Skin Hydration and Acceptability of Two Emollient Products in Atopic Eczema Patients with Dry Skin.

    Science.gov (United States)

    Djokic-Gallagher, Jasmina; Rosher, Phil; Oliveira, Gabriela; Walker, Jennine

    2017-09-01

    Healthcare professionals tend to recommend emollients based primarily on patient/consumer preference and cost, with cheaper options assumed to be therapeutically equivalent. The aim of this study was therefore to compare the effects on skin hydration of two emollients prescribed in the UK, Doublebase Dayleve™ gel (DELP) and a cheaper alternative, Zerobase Emollient™ cream (ZBC). This was a single-centre, randomised, double-blind, concurrent bi-lateral (within-patient) comparison in 18 females with atopic eczema and dry skin on their lower legs. DELP gel and ZBC cream were each applied to one lower leg twice daily for 4 days and on the morning only on day 5. The efficacy of both products was assessed by hydration measurements using a Corneometer CM825 probe (Courage-Khazaka Electronic). The measurements were made three times daily on days 1 to 5. The primary efficacy variable was the area under the curve (AUC) of the change from baseline corneometer readings over the 5 days. Skin hydration using DELP gel was significantly higher than using ZBC cream (p skin hydration observed for DELP gel was substantial and long lasting. In contrast, for ZBC cream, there was no significant improvement of the cumulative skin hydration as measured by the AUC (p = 0.22). DELP gel achieved substantial, long-lasting and cumulative skin hydration, whilst ZBC cream achieved no measurable improvement in skin hydration compared to before treatment. Healthcare professionals should be aware that different emollients can perform differently. Dermal Laboratories Ltd. EudraCT number:2014-001026-16.

  12. Treatment of forefoot problems in older people: study protocol for a randomised clinical trial comparing podiatric treatment to standardised shoe advice

    Directory of Open Access Journals (Sweden)

    Peeraer Louis

    2011-03-01

    Full Text Available Abstract Background Foot problems in general and forefoot problems in particular can lead to a decrease in mobility and a higher risk of falling. Forefoot problems increase with age and are more common in women than in men. Around 20% of people over 65 suffer from non-traumatic foot problems and 60% of these problems are localised in the forefoot. Little is known about the best way to treat forefoot problems in older people. The aim of this study is to compare the effects of two common modes of treatment in the Netherlands: shoe advice and podiatric treatment. This paper describes the design of this study. Methods The study is designed as a pragmatic randomised clinical trial (RCT with 2 parallel intervention groups. People aged 50 years and over who have visited their general practitioner (GP with non traumatic pain in the forefoot in the preceding year and those who will visit their GP during the recruitment period with a similar complaint will be recruited for this study. Participants must be able to walk unaided for 7 metres and be able to fill in questionnaires. Exclusion criteria are: rheumatoid arthritis, neuropathy of the foot or pain caused by skin problems (e.g. warts, eczema. Inclusion and exclusion criteria will be assessed by a screening questionnaire and baseline assessment. Those consenting to participation will be randomly assigned to either a group receiving a standardised shoe advice leaflet (n = 100 or a group receiving podiatric treatment (n = 100. Primary outcomes will be the severity of forefoot pain (0-10 on a numerical rating scale and foot function (Foot Function 5-pts Index and Manchester Foot Pain and Disability Index. Treatment adherence, social participation and quality of life will be the secondary outcomes. All outcomes will be obtained through self-administered questionnaires at the start of the study and after 3, 6, 9 and 12 months. Data will be analysed according to the "intention-to-treat" principle using

  13. Exploratory randomised controlled clinical study to evaluate the comparative efficacy of two occluding toothpastes - a 5% calcium sodium phosphosilicate toothpaste and an 8% arginine/calcium carbonate toothpaste - for the longer-term relief of dentine hypersensitivity.

    Science.gov (United States)

    Hall, Claire; Mason, Stephen; Cooke, Jonathan

    2017-05-01

    To compare the longer-term clinical efficacy of two occlusion-technology toothpastes - a 5% calcium sodium phosphosilicate (CSPS) toothpaste and a commercially available 8% arginine/calcium carbonate toothpaste - in relieving dentine hypersensitivity (DH). Efficacy was also compared with that of a regular fluoride toothpaste control. This was an exploratory, randomised, examiner-blind, parallel-group, 11-week, controlled study in healthy adults with self-reported and clinically diagnosed DH. After an acclimatisation period, subjects were randomised to one of three study treatments with which they brushed their teeth twice daily. Sensitivity was assessed at baseline and after 1, 2, 4, 6 and 11 weeks treatment in response to evaporative (air) and tactile stimuli (measured by the Schiff Sensitivity Scale/visual analogue scale and tactile threshold, respectively). A total of 135 subjects were randomised to treatment. The two occlusion-technology toothpastes performed similarly over the 11-week treatment period. All study treatments showed statistically significant reductions from baseline in DH at all timepoints for all measures (pcarbonate anti-sensitivity toothpaste provided similar benefits. Improvements in DH continued throughout the 11-week study. Dentine hypersensitivity (DH) is a common and painful condition. Twice-daily use of a 5% calcium sodium phosphosilicate toothpaste reduces DH within 1-2 weeks of initiating use. Ongoing, twice daily use of the sensitivity toothpastes evaluated in this study was associated with continued, clinically significant improvements in DH. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

  14. The Leeds Evaluation of Efficacy of Detoxification Study (LEEDS project: An open-label pragmatic randomised control trial comparing the efficacy of differing therapeutic agents for primary care detoxification from either street heroin or methadone [ISRCTN07752728

    Directory of Open Access Journals (Sweden)

    Sheard Laura

    2004-04-01

    Full Text Available Abstract Background Heroin is a synthetic opioid with an extensive illicit market leading to large numbers of people becoming addicted. Heroin users often present to community treatment services requesting detoxification and in the UK various agents are used to control symptoms of withdrawal. Dissatisfaction with methadone detoxification 8 has lead to the use of clonidine, lofexidine, buprenorphine and dihydrocodeine; however, there remains limited evaluative research. In Leeds, a city of 700,000 people in the North of England, dihydrocodeine is the detoxification agent of choice. Sublingual buprenorphine, however, is being introduced. The comparative value of these two drugs for helping people successfully and comfortably withdraw from heroin has never been compared in a randomised trial. Additionally, there is a paucity of research evaluating interventions among drug users in the primary care setting. This study seeks to address this by randomising drug users presenting in primary care to receive either dihydrocodeine or buprenorphine. Methods/design The Leeds Evaluation of Efficacy of Detoxification Study (LEEDS project is a pragmatic randomised trial which will compare the open use of buprenorphine with dihydrocodeine for illicit opiate detoxification, in the UK primary care setting. The LEEDS project will involve consenting adults and will be run in specialist general practice surgeries throughout Leeds. The primary outcome will be the results of a urine opiate screening at the end of the detoxification regimen. Adverse effects and limited data to three and six months will be acquired.

  15. Piracetam relieves symptoms in progressive myoclonus epilepsy: a multicentre, randomised, double blind, crossover study comparing the efficacy and safety of three dosages of oral piracetam with placebo

    Science.gov (United States)

    Koskiniemi, M.; Van Vleymen, B.; Hakamies, L.; Lamusuo, S.; Taalas, J.

    1998-01-01

    OBJECTIVE—To compare the efficacy, tolerability, and safety of three daily dosage regimens of oral piracetam in patients with progressive myoclonus epilepsy.
METHODS—Twenty patients (12 men, eight women), aged 17-43 years, with classical Unverricht-Lundborg disease were enrolled in a multicentre, randomised, double blind trial of crossover design in which the effects of daily doses of 9.6 g, 16.8 g, and 24 g piracetam, given in two divided doses, were compared with placebo. The crossover design was such that patients received placebo and two of the three dosage regimens of piracetam, each for two weeks, for a total treatment period of six weeks and thus without wash out between each treatment phase. The primary outcome measure was a sum score representing the adjusted total of the ratings of six components of a myoclonus rating scale in which stimulus sensitivity, motor impairment, functional disability, handwriting, and global assessments by investigators and patients were scored. Sequential clinical assessments were made by the same neurologist in the same environment at the same time of day.
RESULTS—Treatment with 24 g/day piracetam produced significant and clinically relevant improvement in the primary outcome measure of mean sum score (p=0.005) and in the means of its subtests of motor impairment (p=0.02), functional disability (p=0.003), and in global assessments by both investigator (p=0.002) and patient (p=0.01). Significant improvement in functional disability was also found with daily doses of 9.6 g and 16.8 g. The dose-effect relation was linear and significant. More patients showed clinically relevant improvement with the highest dosage and, in individual patients, increasing the dose improved response. Piracetam was well tolerated and adverse effects were few, mild, and transient.
CONCLUSIONS—This study provides further evidence that piracetam is an effective and safe medication in patients with Unverricht-Lundborg disease. In addition

  16. Study protocol for a randomised controlled trial of meniscal surgery compared with exercise and patient education for treatment of meniscal tears in young adults

    DEFF Research Database (Denmark)

    Skou, Soren Thorgaard; Lind, Martin; Holmich, Per

    2017-01-01

    INTRODUCTION: Arthroscopic surgery is a very common orthopaedic procedure. While several trials have investigated the effect of knee arthroscopy for middle-aged and older patients with meniscal tears, there is a paucity of trials comparing meniscal surgery with non-surgical treatment for younger...... adults. The aim of this randomised controlled trial (RCT) is to investigate if early arthroscopic surgery is superior to exercise therapy and education, with the option of later surgery if needed, in improving pain, function and quality of life in younger adults with meniscal tears. METHODS AND ANALYSIS......: This is a protocol for a multicentre, parallel-group RCT conducted at six hospitals across all five healthcare regions in Denmark. 140 patients aged 18-40 years with a clinical history and symptoms consistent with a meniscal tear, verified on MRI, found eligible for meniscal surgery by an orthopaedic surgeon...

  17. Effectiveness of a multifactorial falls prevention program in community-dwelling older people when compared to usual care: study protocol for a randomised controlled trial (Prevquedas Brazil).

    Science.gov (United States)

    de Negreiros Cabral, Kelem; Perracini, Monica Rodrigues; Soares, Aline Thomaz; de Cristo Stein, Francine; Sera, Celisa Tiemi Nakagawa; Tiedemann, Anne; Sherrington, Cathie; Filho, Wilson Jacob; Paschoal, Sérgio Márcio Pacheco

    2013-03-15

    Falling in older age is a major public health concern due to its costly and disabling consequences. However very few randomised controlled trials (RCTs) have been conducted in developing countries, in which population ageing is expected to be particularly substantial in coming years. This article describes the design of an RCT to evaluate the effectiveness of a multifactorial falls prevention program in reducing the rate of falls in community-dwelling older people. Multicentre parallel-group RCT involving 612 community-dwelling men and women aged 60 years and over, who have fallen at least once in the previous year. Participants will be recruited in multiple settings in Sao Paulo, Brazil and will be randomly allocated to a control group or an intervention group. The usual care control group will undergo a fall risk factor assessment and be referred to their clinicians with the risk assessment report so that individual modifiable risk factors can be managed without any specific guidance. The intervention group will receive a 12-week Multifactorial Falls Prevention Program consisting of: an individualised medical management of modifiable risk factors, a group-based, supervised balance training exercise program plus an unsupervised home-based exercise program, an educational/behavioral intervention. Both groups will receive a leaflet containing general information about fall prevention strategies. Primary outcome measures will be the rate of falls and the proportion of fallers recorded by monthly falls diaries and telephone calls over a 12 month period. Secondary outcomes measures will include risk of falling, fall-related self-efficacy score, measures of balance, mobility and strength, fall-related health services use and independence with daily tasks. Data will be analysed using the intention-to-treat principle.The incidence of falls in the intervention and control groups will be calculated and compared using negative binomial regression analysis. This study is the

  18. The CLOSED trial; CLOnidine compared with midazolam for SEDation of paediatric patients in the intensive care unit: study protocol for a multicentre randomised controlled trial.

    Science.gov (United States)

    Neubert, Antje; Baarslag, Manuel Alberto; Dijk, Monique van; Rosmalen, Joost van; Standing, Joseph F; Sheng, Yucheng; Rascher, Wolfgang; Roberts, Deborah; Winslade, Jackie; Rawcliffe, Louise; Hanning, Sara M; Metsvaht, Tuuli; Giannuzzi, Viviana; Larsson, Peter; Pokorná, Pavla; Simonetti, Alessandra; Tibboel, Dick

    2017-06-21

    Sedation is an essential part of paediatric critical care. Midazolam, often in combination with opioids, is the current gold standard drug. However, as it is a far-from-ideal agent, clonidine is increasingly being used in children. This drug is prescribed off-label for this indication, as many drugs in paediatrics are. Therefore, the CLOSED trial aims to provide data on the pharmacokinetics, safety and efficacy of clonidine for the sedation of mechanically ventilated patients in order to obtain a paediatric-use marketing authorisation. The CLOSED study is a multicentre, double-blind, randomised, active-controlled non-inferiority trial with a 1:1 randomisation between clonidine and midazolam. Both treatment groups are stratified according to age in three groups with the same size: <28 days (n=100), 28 days to <2 years (n=100) and 2-18 years (n=100). The primary end point is defined as the occurrence of sedation failure within the study period. Secondary end points include a pharmacokinetic/pharmacodynamic relationship, pharmacogenetics, occurrence of delirium and withdrawal syndrome, opioid consumption and neurodevelopment in the neonatal age group. Logistic regression will be used for the primary end point, appropriate statistics will be used for the secondary end points. Written informed consent will be obtained from the parents/caregivers. Verbal or deferred consent will be used in the sites where national legislation allows. The study has institutional review board approval at recruiting sites. The results will be published in a peer-reviewed journal and shared with the worldwide medical community. EudraCT: 2014-003582-24; Clinicaltrials.gov: NCT02509273; pre-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  19. PIMS (Positioning In Macular hole Surgery) trial - a multicentre interventional comparative randomised controlled clinical trial comparing face-down positioning, with an inactive face-forward position on the outcome of surgery for large macular holes: study protocol for a randomised controlled trial.

    Science.gov (United States)

    Pasu, Saruban; Bunce, Catey; Hooper, Richard; Thomson, Ann; Bainbridge, James

    2015-11-17

    Idiopathic macular holes are an important cause of blindness. They have an annual incidence of 8 per 100,000 individuals, and prevalence of 0.2 to 3.3 per 1000 individuals with visual impairment. The condition occurs more frequently in adults aged 75 years or older. Macular holes can be repaired by surgery in which the causative tractional forces in the eye are released and a temporary bubble of gas is injected. To promote successful hole closure individuals may be advised to maintain a face-down position for up to 10 days following surgery. The aim of this study is to determine whether advice to position face-down improves the surgical success rate of closure of large (>400 μm) macular holes, and thereby reduces the need for further surgery. This will be a multicentre interventional, comparative randomised controlled clinical trial comparing face-down positioning with face-forward positioning. At the conclusion of standardised surgery across all sites, participants still eligible for inclusion will be allocated randomly 1:1 to 1 of the 2 treatment arms stratified by site, using random permuted blocks of size 4 or 6 in equal proportions. We will recruit 192 participants having surgery for large macular holes (>400 μm); 96 in each of the 2 arms of the study. The primary objective is to determine the impact of face-down positioning on the likelihood of closure of large (≥400 μm) full-thickness macular holes following surgery. This will be the first multicentre randomised control trial to investigate the value of face-down positioning following macular hole standardised surgery. UK CRN: 17966 (date of registration 26 November 2014).

  20. Exercise combined with Acceptance and Commitment Therapy (ExACT) compared to a supervised exercise programme for adults with chronic pain: study protocol for a randomised controlled trial.

    Science.gov (United States)

    Casey, Máire-Bríd; Smart, Keith; Segurado, Ricardo; Hearty, Conor; Gopal, Hari; Lowry, Damien; Flanagan, Dearbhail; McCracken, Lance; Doody, Catherine

    2018-03-22

    Acceptance and Commitment Therapy (ACT) is a form of cognitive behavioural therapy, which may be beneficial for people with chronic pain. The approach aims to enhance daily functioning through increased psychological flexibility. Whilst the therapeutic model behind ACT appears well suited to chronic pain, there is a need for further research to test its effectiveness in clinical practice, particularly with regards to combining ACT with physical exercise. This prospective, two-armed, parallel-group, single-centre randomised controlled trial (RCT) will assess the effectiveness of a combined Exercise and ACT programme, in comparison to supervised exercise for chronic pain. One hundred and sixty patients, aged 18 years and over, who have been diagnosed with a chronic pain condition by a physician will be recruited to the trial. Participants will be individually randomised to one of two 8-week, group interventions. The combined group will take part in weekly psychology sessions based on the ACT approach, in addition to supervised exercise classes led by a physiotherapist. The control group will attend weekly supervised exercise classes but will not take part in an ACT programme. The primary outcome will be pain interference at 12-week follow-up, measured using the Brief Pain Inventory-Interference Scale. Secondary outcomes will include self-reported pain severity, self-perception of change, patient satisfaction, quality of life, depression, anxiety and healthcare utilisation. Treatment process measures will include self-efficacy, pain catastrophising, fear avoidance, pain acceptance and committed action. Physical activity will be measured using Fitbit Zip TM activity trackers. Both groups will be followed up post intervention and again after 12 weeks. Estimates of treatment effects at follow-up will be based on an intention-to-treat framework, implemented using a linear mixed-effects model. Individual and focus group qualitative interviews will be undertaken with a

  1. Methods of a large prospective, randomised, open-label, blinded end-point study comparing morning versus evening dosing in hypertensive patients: the Treatment In Morning versus Evening (TIME) study.

    Science.gov (United States)

    Rorie, David A; Rogers, Amy; Mackenzie, Isla S; Ford, Ian; Webb, David J; Willams, Bryan; Brown, Morris; Poulter, Neil; Findlay, Evelyn; Saywood, Wendy; MacDonald, Thomas M

    2016-02-09

    Nocturnal blood pressure (BP) appears to be a better predictor of cardiovascular outcome than daytime BP. The BP lowering effects of most antihypertensive therapies are often greater in the first 12 h compared to the next 12 h. The Treatment In Morning versus Evening (TIME) study aims to establish whether evening dosing is more cardioprotective than morning dosing. The TIME study uses the prospective, randomised, open-label, blinded end-point (PROBE) design. TIME recruits participants by advertising in the community, from primary and secondary care, and from databases of consented patients in the UK. Participants must be aged over 18 years, prescribed at least one antihypertensive drug taken once a day, and have a valid email address. After the participants have self-enrolled and consented on the secure TIME website (http://www.timestudy.co.uk) they are randomised to take their antihypertensive medication in the morning or the evening. Participant follow-ups are conducted after 1 month and then every 3 months by automated email. The trial is expected to run for 5 years, randomising 10,269 participants, with average participant follow-up being 4 years. The primary end point is hospitalisation for the composite end point of non-fatal myocardial infarction (MI), non-fatal stroke (cerebrovascular accident; CVA) or any vascular death determined by record-linkage. Secondary end points are: each component of the primary end point, hospitalisation for non-fatal stroke, hospitalisation for non-fatal MI, cardiovascular death, all-cause mortality, hospitalisation or death from congestive heart failure. The primary outcome will be a comparison of time to first event comparing morning versus evening dosing using an intention-to-treat analysis. The sample size is calculated for a two-sided test to detect 20% superiority at 80% power. TIME has ethical approval in the UK, and results will be published in a peer-reviewed journal. UKCRN17071; Pre-results. Published by the BMJ

  2. Multicentre randomised study of the effect and experience of an early inhome programme (PreHomeCare) for preterm infants using video consultation and smartphone applications compared with inhospital consultations: protocol of the PreHomeCare study.

    Science.gov (United States)

    Hägi-Pedersen, Mai-Britt; Norlyk, Annelise; Dessau, Ram; Stanchev, Hristo; Kronborg, Hanne

    2017-03-09

    Although premature infants and their parents are discharged earlier to inhomecare programmes, how to optimally support parents during this transition remains unknown. The aim of this study is to compare the effects of early inhomecare (PreHomeCare) including video consultations and mobile applications with those of inhospital consultations regarding breast feeding, parental confidence and parent-infant interactions. A randomised controlled intervention study will be conducted in four neonatal departments offering PreHomeCare (ie, premature infant inhomecare) in Denmark. Parents of hospitalised premature infants who fulfil the inclusion criteria for PreHomeCare will be randomised during hospitalisation to either the intervention (n=80) or control group (n=80) using 1:1 block randomisation. During PreHomeCare, the intervention group will receive a smartphone application with a video system and an infant scale, and the control group will receive usual care (ie, hospital consultations). Additionally, both groups will have planned nurse consultations two to three times a week: the intervention group through video consultations and the control group through inhospital consultations. Data collection will occur at inclusion/baseline, at the end of PreHomeCare and 1 month after discharge using questionnaires and hospital records. The primary outcome is the proportion of exclusively breastfed infants 1 month after discharge/end of PreHomeCare, the secondary outcomes are parent-infant interactions measured by the Mother and baby interaction scale and family confidence in caring for infants measured by the Karitane Parenting Confidence Scale. The process evaluation will consist of two qualitative studies: a field study and an interview study. Data collection will initially involve field observations of three scheduled video consultations with six families from the intervention group. These families will also be interviewed 1 month after PreHomeCare has ended. The project

  3. Comparative study of two doses of intrathecal dexmedetomidine as adjuvant with low dose hyperbaric bupivacaine in ambulatory perianal surgeries: A prospective randomised controlled study

    Directory of Open Access Journals (Sweden)

    K Sudheesh

    2015-01-01

    Full Text Available Background and Aims: Dexmedetomidine (DMT, as intrathecal adjuvant has been shown to successfully prolong duration of analgesia but delay the motor recovery. Hence, this study was designed to find out the dose of DMT which can provide satisfactory analgesia without prolonging motor block. Methods: A total of 50 patients scheduled for elective perianal surgeries were randomly allocated to Groups C or D (n = 25. Group D received hyperbaric bupivacaine 0.5% 4 mg + DMT 5 μg and Group C received hyperbaric bupivacaine 0.5% 4 mg + DMT 3 μg intrathecally. Onset and duration of sensory and motor blockade, duration of analgesia, time for ambulation and first urination were recorded. Adverse effects if any were noted. Results: Demographic characters, duration of surgery were comparable. The onset of sensory block to S1 was 9.61 ± 5.53 min in Group C compared to 7.69 ± 4.80 min in Group D (P = 0.35. Duration of sensory (145.28 ± 83.17 min – C, 167.85 ± 93.75 min – D, P = 0.5 and motor block (170.53 ± 73.44 min – C, 196.14 ± 84.28 min, P = 0.39 were comparable. Duration of analgesia (337.86 ± 105.11 min – C, 340.78 ± 101.81 min – D, P = 0.9 and time for ambulation (252.46 ± 93.72 min – C, 253.64 ± 88.04 min – D, P = 0.97 were also comparable. One patient in each group had urinary retention requiring catheterization. No other side effects were observed. Conclusion: Intrathecal DMT 3 μg dose does not produce faster ambulation compared to intrathecal DMT 5 μg though it produces comparable duration of analgesia for perianal surgeries.

  4. A COMPARATIVE STUDY OF TRANEXAMIC ACID VERSUS ETHAMSYLATE USED PROPHYLACTICALLY IN LOWER SEGMENT CAESAREAN SECTION- A PROSPECTIVE RANDOMISED DOUBLE-BLINDED STUDY

    Directory of Open Access Journals (Sweden)

    Bondada Suryakumari

    2017-09-01

    Full Text Available BACKGROUND Recently, caesarean section rates are increased in developing countries like India. Postpartum haemorrhage is more after caesarean section. Most of the maternal mortality is attributed to postpartum haemorrhage. This study was undertaken to find out the drug effective in reducing blood loss in lower segment caesarean section. The aim of the study is to compare the efficacy of ethamsylate versus tranexamic acid in reducing blood loss during and after caesarean section. MATERIALS AND METHODS All women undergoing LSCS were divided in 3 groups, viz. 2 study groups and control group. All were requested for preop and postop Hb%, PCV and TRBC. Tranexamic acid and ethamsylate, 1 g diluted in 10 mL NS were given intravenously for both the study groups and control group with NS, 20 minutes prior to skin incision and blood loss was measured from placental delivery up to 2 hours in all the groups was calculated by weighing pre-weighted pads soaked in blood. RESULTS Statistical analysis was done quantitatively by Student’s t-test. Postoperative blood loss was similar and lower in both the study groups compared to the control group. Hb% change in postop period is significant in control group. CONCLUSION Ethamsylate is safe and effective alternative to tranexamic acid in preventing postpartum haemorrhage after caesarean section.

  5. Five-year follow-up of a prospective non-randomised study comparing duodenum-preserving pancreatic head resection with classic Whipple procedure in the treatment of chronic pancreatitis.

    Science.gov (United States)

    Möbius, C; Max, D; Uhlmann, D; Gumpp, K; Behrbohm, J; Horvath, K; Hauss, J; Witzigmann, H

    2007-05-01

    Three prospective randomised studies were conducted to compare pancreatoduodenectomy (PD) with duodenum-preserving pancreatic head resection (DPPHR) in patients suffering from chronic pancreatitis (cP). In these three series, the superiority of the duodenum-preserving technique with regard to quality of life (QOL) and pain relief has been demonstrated. Long-term follow-up investigations have not been published so far. The present paper reports on a 5-year follow-up study of a prospective, non-randomised trial comparing classic Whipple procedure (PD) with Beger DPPHR. Seventy patients were initially enrolled in this study. Fifty-one patients were left for the present long-term outcome analysis (PD, n = 24; DPPHR, n = 27). The follow-up included the following parameters: QOL, pain intensity, endocrine and exocrine function, and body mass index (BMI). The median follow-up was 63.5 (range 56-67) months. Two patients in the DPPHR group and none in the PD group underwent a re-operation. The QOL scores of the relevant symptom scales (nausea, pain, diarrhoea) and functional parameters (physical status, working ability, global QOL) were significantly better in the DPPHR group than in the PD group. Pain intensity as self-assessed by the patients was less pronounced in the DPPHR group (P Whipple procedure in terms of QOL and pain intensity as self-assessed by the patients.

  6. Randomised, prospective, non-blinded pilot study comparing the effect of intramuscular steroid injections and intralesional steroid injections in the management of tennis elbow

    Science.gov (United States)

    Tahir, Hasan; Biro, Izolda; Donnelly, Simon; Greenwood, Mandy

    2016-01-01

    Background Tennis elbow is an overuse injury affecting people performing repetitive forearm movements. It is a soft tissue disorder that causes significant disability and pain. The aim of the study was to establish that an intramuscular steroid injection is effective in the short-term pain relief and functional improvement of tennis elbow. The severity of pain at the injection site was monitored to determine whether the intramuscular injection is better tolerated than the intralesional injection. Methods and results 19 patients, who had no treatment for tennis elbow in the preceding 3 months, were recruited from Whipps Cross University Hospital, London, and were randomised to receive either 80 mg of intramuscular Depo-Medrone or 40 mg of intralesional Depo-Medrone injection. Blinding proved difficult as the injection sites differed and placebo arms were not included in the study. A Patient-Rated Tennis Elbow Evaluation (PRTEE) Questionnaire and a 10-point Likert scale were used to assess primary outcome. Six weeks after the treatment, there was a reduction in pain, improvement in function and total PRTEE scores in both intramuscular and intralesional groups (p=0.008) using a 95% CI for mean treatment difference of −26 to +16 points. A statistically significant result (p=0.001) in favour of intramuscular causing less pain at the injection site was noted. Conclusion Non-inferiority of intramuscular to intralesional injections was not confirmed; however, the intramuscular injection proved to be effective in reducing tennis elbow-related symptoms and was found less painful at the site of injection at the time of administration. Trial registration number EUDRACT Number: 2010-022131-11. REC Number: 10/H0718/76 (NRES, Central London REC 1). PMID:28879024

  7. A randomised trial of Supine versus Prone breast radiotherapy (SuPr study): Comparing set-up errors and respiratory motion

    International Nuclear Information System (INIS)

    Kirby, Anna M.; Evans, Philip M.; Helyer, Sarah J.; Donovan, Ellen M.; Convery, Helen M.; Yarnold, John R.

    2011-01-01

    Purpose: To test a prone position against the international-standard supine position in women undergoing whole-breast-radiotherapy (WBRT) after wide-local-excision (WLE) of early breast cancer (BC) in terms of feasibility, set-up errors, and respiratory motion. Methods: Following WLE of BC with insertion of tumour-bed clips, patients underwent 4D-CT for WBRT-planning in supine and prone positions (the latter using an in-house-designed platform). Patients were randomised to undergo WBRT fractions 1-7 in one position, switching to the alternate position for fractions 8-15 (40 Gy/15-fractions total). Cone-beam CT-images (CBCT) were acquired prior to fractions 1, 4, 7, 8, 11 and 14. CBCT data were matched to planning-CT data using (i) chest-wall and (ii) clips. Systematic and random errors were calculated. Maximal displacement of chest-wall and clips with respiration was measured on 4D-CT. Clinical- to planning-target-volume (CTV-PTV) margins were calculated. Patient-comfort-scores and treatment-times were evaluated. Results: Twenty-five patients were randomized. 192/192 (100%) planned supine fractions and 173/192 (90%) prone fractions were completed. 3D population systematic errors were 1.3-1.9 mm (supine) and 3.1-4.3 mm (prone) (p = 0.02) and random errors 2.6-3.2 mm (supine) and 3.8-5.4 mm (prone) (p = 0.02). Prone positioning reduced chest-wall and clip motion (0.5 ± 0.2 mm (prone) versus 2.7 ± 0.5 mm (supine) (p < 0.001)) with respiration. Calculated CTV-PTV margins were greater for prone (12-16 mm) than for supine treatment (10 mm). Patient-comfort-scores and treatment times were comparable (p = 0.06). Conclusions: Set-up errors were greater using our prone technique than for our standard supine technique, resulting in the need for larger CTV-PTV margins in the prone position. Further work is required to optimize the prone treatment-platform and technique before it can become a standard treatment option at our institution.

  8. A randomised crossover study to compare the cross-sectional and longitudinal approaches to ultrasound-guided peripheral venepuncture in a model.

    Science.gov (United States)

    Griffiths, James; Carnegie, Amadeus; Kendall, Richard; Madan, Rajeev

    2017-12-01

    Ultrasound-guided peripheral intravenous access may present an alternative to central or intraosseous access in patients with difficult peripheral veins. Using venepuncture of a phantom model as a proxy, we investigated whether novice ultrasound users should adopt a cross-sectional or longitudinal approach when learning to access peripheral veins under ultrasound guidance. This result would inform the development of a structured training method for this procedure. We conducted a randomised controlled trial of 30 medical students. Subjects received 35 min of training, then attempted to aspirate 1 ml of synthetic blood from a deep vein in a training model under ultrasound guidance. Subjects attempted both the cross-sectional and longitudinal approaches. Group 1 used cross-sectional first, followed by longitudinal. Group 2 used longitudinal first, then cross-sectional. We measured the time from first puncture of the model's skin to aspiration of fluid, and the number of attempts required. Subjects also reported difficulty ratings for each approach. Paired sample t-tests were used for statistical analysis. The mean number of attempts was 1.13 using the cross-sectional approach, compared with 1.30 using the longitudinal approach (p = 0.17). Mean time to aspiration of fluid was 45.1 s using the cross-sectional approach and 52.8 s using the longitudinal approach (p = 0.43). The mean difficulty score out of 10 was 3.97 for the cross-sectional approach and 3.93 for the longitudinal approach (p = 0.95). We found no significant difference in effectiveness between the cross-sectional and longitudinal approaches to ultrasound-guided venepuncture when performed on a model. We believe that both approaches should be included when teaching ultrasound-guided peripheral vascular access. To confirm which approach would be best in clinical practice, we advocate future testing of both approaches on patients.

  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

    2013-10-01

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

  10. COMPARATIVE STUDY OF EFFICACY OF INJECTION SCLEROTHERAPY VERSUS SURGERY AS PRIMARY MODALITY THERAPY IN PRIMARY VAGINAL HYDROCOELE : A RANDOMISED CONTROL STUDY

    OpenAIRE

    Jayakarthik; Patil

    2015-01-01

    CONTEXT (BACKGROUND): Primary/Idiopathic hydrocele is defined as an abnormal collection of serous fluid in tunica vaginalis whose cause is not known as it is neither associated with the disease of testis or epididymis. Surgery is considered as a definitive treatment, though th e reason of injection treatment falling out of favour is ill understood as studies have shown this technique to be efficacious, safe, cost effective treatment modality in idiopathic hydroceles. This...

  11. A randomised study comparing the effect on ovarian activity of a progestogen-only pill (POP) containing desogestrel and a new POP containing drospirenone in a 24/4 regimen

    DEFF Research Database (Denmark)

    Duijkers, Ingrid J M; Heger-Mahn, Doris; Drouin, Dominique

    2015-01-01

    OBJECTIVES: Progestogen-only pills (POPs) are safer with respect to cardiovascular risks than contraceptives containing estrogens. Despite the increased contraceptive efficacy of a desogestrel-only pill compared with a traditional POP, POPs are still not widely used due to an unpredictable bleeding...... pattern. A new POP containing 4 mg drospirenone has been developed with a 24/4 intake regimen which may improve the bleeding pattern. The objectives of this study were to investigate ovulation inhibition with the new drospirenone-only pill in comparison with the desogestrel-only pill and, in addition......, to assess the effects on cervical mucus permeability and bleeding. METHODS: Sixty-four healthy volunteers with proven ovulatory cycles were randomised and treated with either the drospirenone-only or the desogestrel-only pill during two 28-day cycles. Follicular diameter, endometrial thickness, and serum...

  12. Migration and head penetration of Vitamin-E diffused cemented polyethylene cup compared to standard cemented cup in total hip arthroplasty: study protocol for a randomised, double-blind, controlled trial (E1 HIP).

    Science.gov (United States)

    Sköldenberg, Olof; Rysinska, Agata; Chammout, Ghazi; Salemyr, Mats; Muren, Olle; Bodén, Henrik; Eisler, Thomas

    2016-07-07

    In vitro, Vitamin-E-diffused, highly cross-linked polyethylene (PE) has been shown to have superior wear resistance and improved mechanical properties when compared to those of standard highly cross-linked PE liners used in total hip arthroplasty (THA). The aim of the study is to evaluate the safety of a new cemented acetabular cup with Vitamin-E-doped PE regarding migration, head penetration and clinical results. In this single-centre, double-blinded, randomised controlled trial, we will include 50 patients with primary hip osteoarthritis scheduled for THA and randomise them in a 1:1 ratio to a cemented cup with either argon gas-sterilised PE (control group) or Vitamin-E-diffused PE (vitamin-e group). All patients and the assessor of the primary outcome will be blinded and the same uncemented stem will be used for all participants. The primary end point will be proximal migration of the cup at 2 years after surgery measured with radiostereometry. Secondary end points include proximal migration at other follow-ups, total migration, femoral head penetration, clinical outcome scores and hip-related complications. Patients will be followed up at 3 months and at 1, 2, 5 and 10 years postoperatively. Results will be analysed using 95% CIs for the effect size. A regression model will also be used to adjust for stratification factors. The ethical committee at Karolinska Institutet has approved the study. The first results from the study will be disseminated to the medical community via presentations and publications in relevant medical journals when the last patient included has been followed up for 2 years. NCT02254980. 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/

  13. 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.

    Science.gov (United States)

    Bond, John; Wilson, Janet; Eccles, Martin; Vanoli, Alessandra; Steen, Nick; Clarke, Ray; Zarod, Andrew; Lock, Catherine; Brittain, Katie; Speed, Chris; Rousseau, Nikki

    2006-08-09

    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. 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). 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 consultation rates, the results from the National Prospective Tonsillectomy

  14. 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

  15. RANDOMISED CONTROLLED STUDY COMPARING A 0.75% ROPIVACAINE TO A CONVENTIONAL DOSE OF HYPERBARIC BUPIVACAINE FOR CESARIAN SECTION BY EPIDURAL ANALGESIA

    Directory of Open Access Journals (Sweden)

    Porika

    2015-09-01

    Full Text Available Central neuraxial blocked is one of the safest and efficacious methods of anaesthesia and analgesia. It has the added advantage of prolonged pain relief into the postoperative period. Epidural analgesia has increased steadily in popularity when compared to spinal anaesthes ia due to its neurological consequences and improved post - operative analgesia with epidural Opioids and as a consequence decreased side effects and prolonged the duration of analgesia. Present study is undertaken to compare hemodynamic and analgesic charac teristics using a 0.75% ropivacaine to a conventional dose of 0.5% bupivacaine for cesarean section under epidural anaesthesia. This study was conducted in ASA Grade I 50 singleton parturient to compare hemodynamics, APGAR scores and analgesic characterist ics of ropivacaine and bupivacaine. We have observed that the onset of sensory blockade was slower with ropivacaine and the duration of sensory blockade was also less. Whereas there was no significant change in haemodynamics and APGAR scores with both the drugs.

  16. A prospective randomised study to compare the utility and outcomes of subdural and subperiosteal drains for the treatment of chronic subdural haematoma.

    LENUS (Irish Health Repository)

    Kaliaperumal, Chandrasekaran

    2012-11-01

    The usage of a drain following evacuation of a chronic subdural haematoma (CSDH) is known to reduce recurrence. In this study we aim to compare the clinical outcomes and recurrence rate of utilising two different types of drains (subperiosteal and subdural drain) following drainage of a CSDH.

  17. Protocol for a randomised crossover trial to evaluate patient and nurse satisfaction with electronic and elastomeric portable infusion pumps for the continuous administration of antibiotic therapy in the home: the Comparing Home Infusion Devices (CHID) study.

    Science.gov (United States)

    Hobbs, Jodie G; Ryan, Melissa K; Ritchie, Brett; Sluggett, Janet K; Sluggett, Andrew J; Ralton, Lucy; Reynolds, Karen J

    2017-07-31

    Previous studies comparing satisfaction with electronic and elastomeric infusion pumps are limited, and improvements in size and usability of electronic pumps have since occurred. The Comparing Home Infusion Devices (CHID) study plans to assess patient and nurse satisfaction with an elastomeric and electronic pump for delivering intravenous antibiotic treatment in the home. Secondary objectives are to determine pump-related complications and actual antibiotic dose administered, evaluate temperature variation and compare pump operating costs. The CHID study will be a randomised, crossover trial. A trained research nurse will recruit patients with infectious disease aged ≥18 years and prescribed ≥8 days of continuous intravenous antibiotic therapy from the Royal Adelaide Hospital (RAH) (Adelaide, Australia). Patients will be randomised to receive treatment at home via an elastomeric (Baxter Infusor) or an electronic (ambIT Continuous) infusion pump for 4-7 days, followed by the other for a further 4-7 days. Patient satisfaction will be assessed by a 10-item survey to be completed at the end of each arm. Nurse satisfaction will be assessed by a single 24-item survey. Patient logbooks and case notes from clinic visits will be screened to identify complications. Pumps/infusion bags will be weighed to estimate the volume of solution delivered. Temperature sensors will record skin and ambient temperatures during storage and use of the pumps throughout the infusion period. Costs relating to pumps, consumables, antibiotics and servicing will be determined. Descriptive statistics will summarise study data. This study has been approved by the RAH Human Research Ethics Committee (HREC/16/RAH/133 R20160420, version 6.0, 5 September 2016). Study results will be disseminated through peer-reviewed publications and conference presentations. The CHID study will provide key insights into patient and provider satisfaction with elastomeric and electronic infusion pumps and inform

  18. A randomised comparative study of the effect of Airtraq optical laryngoscope vs. Macintosh laryngoscope on intraocular pressure in non-ophthalmic surgery

    Directory of Open Access Journals (Sweden)

    Bikramjit Das

    2016-02-01

    Full Text Available BACKGROUND: We compared intraocular pressure changes following laryngoscopy and intubation with conventional Macintosh blade and Airtraq optical laryngoscope. METHODS: Ninety adult patients were randomly assigned to study group or control group. Study group (n = 45 - Airtraq laryngoscope was used for laryngoscopy. Control group (n = 45 - conventional Macintosh laryngoscope was used for laryngoscopy. Preoperative baseline intraocular pressure was measured with Schiotz tonometer. Laryngoscopy was done as per group protocol. Intraocular pressure and haemodynamic parameters were recorded just before insertion of the device and subsequently three times at an interval of one minute after insertion of the device. RESULTS: Patient characteristics, baseline haemodynamic parameters and baseline intraocular pressure were comparable in the two groups. Following insertion of the endotracheal tube with Macintosh laryngoscope, there was statistically significant rise in heart rate and intraocular pressure compared to Airtraq group. There was no significant change in MAP. Eight patients in Macintosh group had tongue-lip-dental trauma during intubation, while only 2 patients received upper airway trauma in Airtraq group. CONCLUSION: We conclude that Airtraq laryngoscope in comparison to Macintosh laryngoscope results in significantly fewer rises in intraocular pressure and clinically less marked increase in haemodynamic response to laryngoscopy and intubation.

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

    DEFF Research Database (Denmark)

    Harding, Keith; Gottrup, Finn; Jawień, Arkadiusz

    2011-01-01

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

  20. Similar early migration when comparing CR and PS in Triathlon™ TKA: A prospective randomised RSA trial.

    Science.gov (United States)

    Molt, Mats; Toksvig-Larsen, Sören

    2014-10-01

    The objective of this study was to compare the early migration of the cruciate retaining and posterior stabilising versions of the recently introduced Triathlon™ total knee system, with a view to predicting long term fixation performance. Sixty patients were prospectively randomised to receive either Triathlon™ posterior stabilised cemented knee prosthesis or Triathlon™ cruciate retaining cemented knee prosthesis. Tibial component migration was measured by radiostereometric analysis postoperatively and at three months, one year and two years. Clinical outcome was measured by the American Knee Society Score and Knee Osteoarthritis and Injury Outcome Score. There were no differences in rotation around the three coordinal axes or in the maximum total point motion (MTPM) during the two year follow-up. The posterior stabilised prosthesis had more posterior-anterior translation at three months and one year and more caudal-cranial translation at one year and two years. There were no differences in functional outcome between the groups. The tibial tray of the Triathlon™ cemented knee prosthesis showed similar early stability. Level I. Article focus: This was a prospective randomised trial aiming to compare the single radius posterior stabilised (PS) Triathlon™ total knee arthroplasty (TKA) to the cruciate retaining Triathlon™ TKA system with regard to fixation. Strengths and limitations of this study: Strength of this study was that it is a randomised prospective trial using an objective measuring tool. The sample size of 25-30 patients was reportedly sufficient for the screening of implants using RSA [1]. ClinicalTrials.gov Identifier: NCT00436982. Copyright © 2014 Elsevier B.V. All rights reserved.

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

    DEFF Research Database (Denmark)

    Løkkegaard, E; Lundstrøm, M; Kjær, Michael

    2015-01-01

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

  2. The 5x1 DAFNE study protocol: a cluster randomised trial comparing a standard 5 day DAFNE course delivered over 1 week against DAFNE training delivered over 1 day a week for 5 consecutive weeks

    Directory of Open Access Journals (Sweden)

    Elliott Jackie

    2012-11-01

    Full Text Available Abstract Background Structured education programmes are now established as an essential component to assist effective self-management of diabetes. In the case of Type 1 diabetes, the Dose Adjustment For Normal Eating (DAFNE programme improves both glycaemic control and quality of life. Traditionally delivered over five consecutive days, this format has been cited as a barrier to participation by some patients, such as those who work full-time. Some centres in the UK have organised structured education programmes to be delivered one day a week over several consecutive weeks. This type of format may add benefit by allowing more time in which to practice skills between sessions, but may suffer as a result of weaker peer support being generated compared to that formed over five consecutive days. Methods/design We aim to compare DAFNE delivered over five consecutive days (1 week course with DAFNE delivered one day a week over five weeks (5 week course in a randomised controlled trial. A total of 213 patients were randomised to attend either a 1 week or a 5 week course delivered in seven participating centres. Study outcomes (measured at baseline, 6 and 12 months post-course include HbA1c, weight, self-reported rates of severe hypoglycaemia, psychosocial measures of quality of life, and cost-effectiveness. Generalisability was optimised by recruiting patients from DAFNE waiting lists at each centre, and by mailing eligible patients from hospital clinic lists. The inclusion and exclusion criteria were identical to those used to recruit to a standard DAFNE course (e.g., HbA1c Discussion This trial has been designed to test the hypothesis that the benefits of delivering a structured education programme over 5 weeks are comparable to those observed after a 1 week course. The results of the trial and the qualitative sub-study will both inform the design and delivery of future DAFNE courses, and the development of structured education programmes in other

  3. The p-EVES study design and methodology: a randomised controlled trial to compare portable electronic vision enhancement systems (p-EVES) to optical magnifiers for near vision activities in visual impairment.

    Science.gov (United States)

    Taylor, John; Bambrick, Rachel; Dutton, Michelle; Harper, Robert; Ryan, Barbara; Tudor-Edwards, Rhiannon; Waterman, Heather; Whitaker, Chris; Dickinson, Chris

    2014-09-01

    To describe the study design and methodology for the p-EVES study, a trial designed to determine the effectiveness, cost-effectiveness and acceptability of portable Electronic Vision Enhancement System (p-EVES) devices and conventional optical low vision aids (LVAs) for near tasks in people with low vision. The p-EVES study is a prospective two-arm randomised cross-over trial to test the hypothesis that, in comparison to optical LVAs, p-EVES can be: used for longer duration; used for a wider range of tasks than a single optical LVA and/or enable users to do tasks that they were not able to do with optical LVAs; allow faster performance of instrumental activities of daily living; and allow faster reading. A total of 100 adult participants with visual impairment are currently being recruited from Manchester Royal Eye Hospital and randomised into either Group 1 (receiving the two interventions A and B in the order AB), or Group 2 (receiving the two interventions in the order BA). Intervention A is a 2-month period with conventional optical LVAs and a p-EVES device, and intervention B is a 2-month period with conventional optical LVAs only. The study adopts a mixed methods approach encompassing a broad range of outcome measures. The results will be obtained from the following primary outcome measures: Manchester Low Vision Questionnaire, capturing device 'usage' data (which devices are used, number of times, for what purposes, and for how long) and the MNRead test, measuring threshold print size, critical print size, and acuity reserve in addition to reading speed at high (≈90%) contrast. Results will also be obtained from a series of secondary outcome measures which include: assessment of timed instrumental activities of daily living and a 'near vision' visual functioning questionnaire. A companion qualitative study will permit comparison of results on how, where, and under what circumstances, p-EVES devices and LVAs are used in daily life. A health economic

  4. The effectiveness and cost-effectiveness of mindfulness-based cognitive therapy compared with maintenance antidepressant treatment in the prevention of depressive relapse/recurrence: results of a randomised controlled trial (the PREVENT study).

    Science.gov (United States)

    Kuyken, Willem; Hayes, Rachel; Barrett, Barbara; Byng, Richard; Dalgleish, Tim; Kessler, David; Lewis, Glyn; Watkins, Edward; Morant, Nicola; Taylor, Rod S; Byford, Sarah

    2015-09-01

    Individuals with a history of recurrent depression have a high risk of repeated depressive relapse/recurrence. Maintenance antidepressant medication (m-ADM) for at least 2 years is the current recommended treatment, but many individuals are interested in alternatives to m-ADM. Mindfulness-based cognitive therapy (MBCT) has been shown to reduce the risk of relapse/recurrence compared with usual care but has not yet been compared with m-ADM in a definitive trial. To establish whether MBCT with support to taper and/or discontinue antidepressant medication (MBCT-TS) is superior to and more cost-effective than an approach of m-ADM in a primary care setting for patients with a history of recurrent depression followed up over a 2-year period in terms of preventing depressive relapse/recurrence. Secondary aims examined MBCT's acceptability and mechanism of action. Single-blind, parallel, individual randomised controlled trial. UK general practices. Adult patients with a diagnosis of recurrent depression and who were taking m-ADM. Participants were randomised to MBCT-TS or m-ADM with stratification by centre and symptomatic status. Outcome data were collected blind to treatment allocation and the primary analysis was based on the principle of intention to treat. Process studies using quantitative and qualitative methods examined MBCT's acceptability and mechanism of action. The primary outcome measure was time to relapse/recurrence of depression. At each follow-up the following secondary outcomes were recorded: number of depression-free days, residual depressive symptoms, quality of life, health-related quality of life and psychiatric and medical comorbidities. In total, 212 patients were randomised to MBCT-TS and 212 to m-ADM. The primary analysis did not find any evidence that MBCT-TS was superior to m-ADM in terms of the primary outcome of time to depressive relapse/recurrence over 24 months [hazard ratio (HR) 0.89, 95% confidence interval (CI) 0.67 to 1.18] or for any

  5. Comparative evaluation of the effects of propofol and sevoflurane on cognitive function and memory in patients undergoing laparoscopic cholecystectomy: A randomised prospective study

    Directory of Open Access Journals (Sweden)

    Upasana Goswami

    2015-01-01

    Full Text Available Background and Aims: General anaesthesia (GA may cause post-operative impairment of cognition and memory. This is of importance where time to discharge after anaesthesia is short as after laparoscopic cholecystectomy. This study was conducted to compare the effects of propofol and sevoflurane on cognitive function in the post-operative period. Methods: After approval of the Ethical Committee, 80 female patients posted for laparoscopic cholecystectomy to be performed under GA were randomly divided into two groups. Propofol was used in Group P and sevoflurane in Group S. Data analysis was done with California verbal learning test (CVLT, digit span test (DST, Rivermead behavioural memory test (RBMT, mini mental state examination (MMSE score, and semantic memory tests. Aldrete recovery scoring system and visual analogue scale for pain were assessed post-operatively. The level of statistical significance was set at P < 0.05. Results: There was no significant difference in demographic and haemodynamic data. Cognition and explicit memory were affected more in the propofol group in the immediate post-operative period. With majority of tests, such as semantic memory test, MMSE score, DST and RBMT, the difference was insignificant at 2 and 4 h post-operatively. But CVLT values were found to be statistically significant between groups even at 4 h. Conclusion: Propofol was associated with significant impact on cognitive functions in comparison to sevoflurane in the immediate post-operative period. Sevoflurane anaesthesia might be a better option in day care surgeries.

  6. An evaluation of Croí MyAction community lifestyle modification programme compared to standard care to reduce progression to diabetes/pre-diabetes in women with prior gestational diabetes mellitus (GDM): study protocol for a randomised controlled trial.

    Science.gov (United States)

    Infanti, Jennifer J; Dunne, Fidelma P; O'Dea, Angela; Gillespie, Paddy; Gibson, Irene; Glynn, Liam G; Noctor, Eoin; Newell, John; McGuire, Brian E

    2013-05-02

    Universal screening using the International Association of Diabetes and Pregnancy Study Groups (IADPSG) criteria has identified a prevalence of gestational diabetes mellitus (GDM) of 12.4% in women living in Ireland. Women with prior GDM are at increased risk of developing type 2 diabetes later in life. A number of risk factors linked to the development of type 2 diabetes are potentially modifiable through lifestyle and behaviour changes, and medical management. No previous Irish studies have adequately investigated the efficacy of lifestyle intervention programmes in reducing these risk factors in women with prior GDM. Through a two-group, parallel randomised controlled trial (RCT), this study aims to assess the clinical impact, cost-effectiveness and psychological experience of the Croí MyAction intensive lifestyle modification programme for women with prior GDM. A total of 54 women with a history of GDM and persistent post-partum glucose dysfunction (impaired glucose tolerance (IGT) or impaired fasting glucose (IFG)), are randomly assigned to a control arm (n=27) or to the Croí MyAction intervention group (n=27). The control arm receives usual health care advice--written information on diet and lifestyle changes for reducing diabetes risks and visits with general practitioners as required. The intervention group receives usual health care as per the control group in addition to attending a 12-week intensive lifestyle modification programme known as Croí MyAction. Croí MyAction involves 2.5 hour sessions once per week (for 12 weeks) comprising a group exercise programme, group health promotion or education seminars, and one-to-one meetings with a multidisciplinary health care team to personalise risk factor reductions. Randomisation and allocation to the intervention arms is carried out by an independent researcher, ensuring that the allocation sequence is concealed from study researchers until the interventions are assigned. The primary analysis is based on

  7. A randomised study to compare salivary pH, calcium, phosphate and calculus formation after using anticavity dentifrices containing Recaldent(®) and functionalized tri-calcium phosphate.

    Science.gov (United States)

    Sharma, Ena; Vishwanathamurthy, Ramesh Alampalli; Nadella, Manjari; Savitha, A N; Gundannavar, Gayatri; Hussain, M Ahad

    2012-10-01

    The aim of this study was to estimate the pH of saliva, concentration of calcium and inorganic phosphate, and calculus formation before and after usage of Recaldent(®) (GC Tooth Mousse Plus™), Functionalized Tricalcium Phosphate (3M ESPE ClinPro™ Tooth Crème) and standard dentifrice (Colgate dental cream). Randomized double-blind study. A total of 50 subjects were recruited, the subjects were assessed at their first visit, on the 21(st) day and on the 42(nd) day. At the first visit, scaling was carried out and oral hygiene instructions were given. After 21 days, the subjects were given coded dentifrices where the operator and the subjects both were unaware of the type of dentifrice. Clinical parameters assessed were Plaque index, Gingival index, and Calculus index. Salivary samples were obtained to measure calcium, phosphate levels, and pH at 21(st) day and 42(nd) day. ANOVA test, t-test, Mann-Whitney test, Kruskal-Wallis test. The mean salivary calcium level and mean salivary phosphate level were higher in Group III (functionalized tricalcium phosphate (3M ESPE ClinPro™ Tooth Creme) as compared to Group II (Recaldent(®) GC Tooth Mousse Plus™) and Group I (Colgate dental cream) on the 42(nd) day after using dentifrices, which was statistically significant. This showed that the usage of remineralizing dentifrices led to an increase in the salivary calcium, phosphate, and pH but it did not reach the level of super saturation of the ions caused by elevated pH which could lead to calculus formation. Thought here was a statistically significant increase in salivary calcium and phosphate level in all three groups from baseline to 42(nd) day, there was no calculus formation.

  8. A prospective, randomised study of a novel transforming methacrylate dressing compared with a silver-containing sodium carboxymethylcellulose dressing on partial-thickness skin graft donor sites in burn patients.

    Science.gov (United States)

    Assadian, Ojan; Arnoldo, Brett; Purdue, Gary; Burris, Agnes; Skrinjar, Edda; Duschek, Nikolaus; Leaper, David J

    2015-06-01

    This prospective, randomised study compares a new transforming methacrylate dressing (TMD) with a silver-containing carboxymethylcellulose dressing (CMC-Ag) after application to split-thickness skin graft (STSG) donor sites. This was an unblinded, non-inferiority, between-patient, comparison study that involved patients admitted to a single-centre burn unit who required two skin graft donor sites. Each patient's donor sites were covered immediately after surgery: one donor site with TMD and the other with CMC-Ag. The donor sites were evaluated until healing or until 24 days post-application, whichever came first. Study endpoints were time to healing, daily pain scores, number of dressing changes, patient comfort and physicians' and patients' willingness to use the dressings in the future. Nineteen patients had both the dressings applied. No statistically significant difference was noted in time to healing between the two dressings (14·2 days using TMD compared with 13·2 days using CMC-Ag). When pain scores were compared, TMD resulted in statistically significantly less pain at three different time periods (2-5 days, 6-10 days and 11-15 days; P < 0·001 at all time periods). Patients also reported greater comfort with TMD (P < 0·001). Users rated TMD as being less easy to use because of the time and technique required for application. Reductions in pain and increased patient comfort with the use of the TMD dressing, compared with CMC-Ag, were seen as clinical benefits as these are the major issues in donor site management. © 2013 The Authors. International Wound Journal © 2013 Medicalhelplines.com Inc and John Wiley & Sons Ltd.

  9. Carotid artery stenting compared with endarterectomy in patients with symptomatic carotid stenosis (International Carotid Stenting Study): an interim analysis of a randomised controlled trial.

    LENUS (Irish Health Repository)

    Ederle, Jörg

    2010-03-20

    Stents are an alternative treatment to carotid endarterectomy for symptomatic carotid stenosis, but previous trials have not established equivalent safety and efficacy. We compared the safety of carotid artery stenting with that of carotid endarterectomy.

  10. Carotid artery stenting compared with endarterectomy in patients with symptomatic carotid stenosis (International Carotid Stenting Study): an interim analysis of a randomised controlled trial.

    NARCIS (Netherlands)

    Ederle, J.; Dobson, J.; Featherstone, R.L.; Bonati, L.H.; Worp, H.B. van der; Borst, G.J. de; Lo, T.H.; Gaines, P.; Dorman, P.J.; Macdonald, S.; Lyrer, P.A.; Hendriks, J.M.; McCollum, C.; Nederkoorn, P.J.; Brown, M.M.; Blankensteijn, J.D.; Leeuw, F.E. de; Schultze Kool, L.J.; Vliet, J.A. van der; et al.,

    2010-01-01

    BACKGROUND: Stents are an alternative treatment to carotid endarterectomy for symptomatic carotid stenosis, but previous trials have not established equivalent safety and efficacy. We compared the safety of carotid artery stenting with that of carotid endarterectomy. METHODS: The International

  11. Carotid artery stenting compared with endarterectomy in patients with symptomatic carotid stenosis (International Carotid Stenting Study): an interim analysis of a randomised controlled trial

    NARCIS (Netherlands)

    Ederle, Jörg; Dobson, Joanna; Featherstone, Roland L.; Bonati, Leo H.; van der Worp, H. Bart; de Borst, Gert J.; Lo, T. Hauw; Gaines, Peter; Dorman, Paul J.; Macdonald, Sumaira; Lyrer, Philippe A.; Hendriks, Johanna M.; McCollum, Charles; Nederkoorn, Paul J.; Brown, Martin M.; Algra, A.; Bamford, J.; Beard, J.; Bland, M.; Bradbury, A. W.; Brown, M. M.; Clifton, A.; Gaines, P.; Collins, R.; Molyneux, A.; Naylor, R.; Warlow, C.; Ferro, J. M.; Thomas, D.; Bonati, L. H.; Coward, L.; Dobson, J.; Ederle, J.; Featherstone, R. F.; Tindall, H.; McCabe, D. J. H.; Wallis, A.; Brooks, M.; Chambers, B.; Chan, A.; Chu, P.; Clark, D.; Dewey, H.; Donnan, G.; Fell, G.; Hoare, M.; Molan, M.; Roberts, A.; Roberts, N.; Beiles, B.; Bladin, C.; Clifford, C.; Grigg, M.; New, G.; Bell, R.; Bower, S.; Chong, W.; Holt, M.; Saunder, A.; Than, P. G.; Gett, S.; Leggett, D.; McGahan, T.; Quinn, J.; Ray, M.; Wong, A.; Woodruff, P.; Foreman, R.; Schultz, D.; Scroop, R.; Stanley, B.; Allard, B.; Atkinson, N.; Cambell, W.; Davies, S.; Field, P.; Milne, P.; Mitchell, P.; Tress, B.; Yan, B.; Beasley, A.; Dunbabin, D.; Stary, D.; Walker, S.; Cras, P.; d'Archambeau, O.; Hendriks, J. M. H.; van Schil, P.; St Blasius, A. Z.; Bosiers, M.; Deloose, K.; van Buggenhout, E.; de Letter, J.; Devos, V.; Ghekiere, J.; Vanhooren, G.; Astarci, P.; Hammer, F.; Lacroix, V.; Peeters, A.; Verbist, J.; Blair, J.-F.; Caron, J. L.; Daneault, N.; Giroux, M.-F.; Guilbert, F.; Lanthier, S.; Lebrun, L.-H.; Oliva, V.; Raymond, J.; Roy, D.; Soulez, G.; Weill, A.; Hill, M.; Hu, W.; Hudion, M.; Morrish, W.; Sutherland, G.; Wong, J.; Albäck, A.; Harno, H.; Ijäs, P.; Kaste, M.; Lepäntalo, M.; Mustanoja, S.; Paananen, T.; Porras, M.; Putaala, J.; Railo, M.; Sairanen, T.; Soinne, L.; Vehmas, A.; Vikatmaa, P.; Goertler, M.; Halloul, Z.; Skalej, M.; Brennan, P.; Kelly, C.; Leahy, A.; Moroney, J.; Thornton, J.; Koelemay, M. J. W.; Reekers, J. A. A.; Roos, Y. B. W. E. M.; Hendriks, J. M.; Koudstaal, P. J.; Pattynama, P. M. T.; van der Lugt, A.; van Dijk, L. C.; van Sambeek, M. R. H. M.; van Urk, H.; Verhagen, H. J. M.; Bruijninckx, C. M. A.; de Bruijn, S. F.; Keunen, R.; Knippenberg, B.; Mosch, A.; Treurniet, F.; van Dijk, L.; van Overhagen, H.; Wever, J.; de Beer, F. C.; van den Berg, J. S. P.; van Hasselt, B. A. A. M.; Zeilstra, D. J.; Boiten, J.; van Otterloo, J. C. A. de Mol; de Vries, A. C.; Lycklama a Nijeholt, G. J.; van der Kallen, B. F. W.; Blankensteijn, J. D.; de Leeuw, F. E.; Kool, L. J. Schultze; van der Vliet, J. A.; de Borst, G. J.; de Kort, G. A. P.; Kapelle, L. J.; Lo, T. H.; Mali, W. P. Th M.; Moll, F.; van der Worp, H. B.; Verhagen, H.; Barber, P. A.; Bourchier, R.; Hill, A.; Holden, A.; Stewart, J.; Bakke, S. J.; Krohg-Sørensen, K.; Skjelland, M.; Tennøe, B.; Bialek, P.; Biejat, Z.; Czepiel, W.; Czlonkowska, A.; Dowzenko, A.; Jedrzejewska, J.; Kobayashi, A.; Lelek, M.; Polanski, J.; Kirbis, J.; Milosevic, Z.; Zvan, B.; Blasco, J.; Chamorro, A.; Macho, J.; Obach, V.; Riambau, V.; San Roman, L.; Branera, J.; Canovas, D.; Estela, Jordi; Gaibar, A. Gimenez; Perendreu, J.; Björses, K.; Gottsater, A.; Ivancev, K.; Maetzsch, T.; Sonesson, B.; Berg, B.; Delle, M.; Formgren, J.; Gillgren, P.; Kall, T.-B.; Konrad, P.; Nyman, N.; Takolander, R.; Andersson, T.; Malmstedt, J.; Soderman, M.; Wahlgren, C.; Wahlgren, N.; Binaghi, S.; Hirt, L.; Michel, P.; Ruchat, P.; Engelter, S. T.; Fluri, F.; Guerke, L.; Jacob, A. L.; Kirsch, E.; Lyrer, P. A.; Radue, E.-W.; Stierli, P.; Wasner, M.; Wetzel, S.; Bonvin, C.; Kalangos, A.; Lovblad, K.; Murith, M.; Ruefenacht, D.; Sztajzel, R.; Higgins, N.; Kirkpatrick, P. J.; Martin, P.; Varty, K.; Adam, D.; Bell, J.; Crowe, P.; Gannon, M.; Henderson, M. J.; Sandler, D.; Shinton, R. A.; Scriven, J. M.; Wilmink, T.; D'Souza, S.; Egun, A.; Guta, R.; Punekar, S.; Seriki, D. M.; Thomson, G.; Brennan, J. A.; Enevoldson, T. P.; Gilling-Smith, G.; Gould, D. A.; Harris, P. L.; McWilliams, R. G.; Nasser, H.-C.; White, R.; Prakash, K. G.; Serracino-Inglott, F.; Subramanian, G.; Symth, J. V.; Walker, M. G.; Clarke, M.; Davis, M.; Dixit, S. A.; Dorman, P.; Dyker, A.; Ford, G.; Golkar, A.; Jackson, R.; Jayakrishnan, V.; Lambert, D.; Lees, T.; Louw, S.; Macdonald, S.; Mendelow, A. D.; Rodgers, H.; Rose, J.; Stansby, G.; Wyatt, M.; Baker, T.; Baldwin, N.; Jones, L.; Mitchell, D.; Munro, E.; Thornton, M.; Baker, D.; Davis, N.; Hamilton, G.; McCabe, D.; Platts, A.; Tibballs, J.; Cleveland, T.; Dodd, D.; Lonsdale, R.; Nair, R.; Nassef, A.; Nawaz, S.; Venables, G.; Belli, A.; Cloud, G.; Halliday, A.; Markus, H.; McFarland, R.; Morgan, R.; Pereira, A.; Thompson, A.; Chataway, J.; Cheshire, N.; Gibbs, R.; Hammady, M.; Jenkins, M.; Malik, I.; Wolfe, J.; Adiseshiah, M.; Bishop, C.; Brew, S.; Brookes, J.; Jäger, R.; Kitchen, N.; Ashleigh, R.; Butterfield, S.; Gamble, G. E.; McCollum, C.; Nasim, A.; O'Neill, P.; Edwards, R. D.; Lees, K. R.; MacKay, A. J.; Moss, J.

    2010-01-01

    BACKGROUND: Stents are an alternative treatment to carotid endarterectomy for symptomatic carotid stenosis, but previous trials have not established equivalent safety and efficacy. We compared the safety of carotid artery stenting with that of carotid endarterectomy. METHODS: The International

  12. Carotid artery stenting compared with endarterectomy in patients with symptomatic carotid stenosis (International Carotid Stenting Study) : an interim analysis of a randomised controlled trial

    NARCIS (Netherlands)

    Ederle, Joerg; Dobson, Joanna; Featherstone, Roland L.; Bonati, Leo H.; van der Worp, H. Bart; de Borst, Gert J.; Lo, T. Hauw; Gaines, Peter; Dorman, Paul J.; Macdonald, Sumaira; Lyrer, Philippe A.; Hendriks, Johanna M.; McCollum, Charles; Nederkoorn, Paul J.; Brown, Martin M.; Algra, A.; Bamford, J.; Beard, J.; Bland, M.; Bradbury, A. W.; Brown, M. M.; Clifton, A.; Gaines, P.; Hacke, W.; Halliday, A.; Malik, I.; Mas, J. L.; McGuire, A. J.; Sidhu, P.; Venables, G.; Bradbury, A.; Brown, M. M.; Clifton, A.; Gaines, P.; Collins, R.; Molynewc, A.; Naylor, R.; Warlow, C.; Ferro, J. M.; Thomas, D.; Bonati, L. H.; Coward, L.; Dobson, J.; Ederle, J.; Featherstone, R. F.; Tindall, H.; McCabe, D. J. H.; Wallis, A.; Hendriks, J. M. H.; Hendriks, J. M.

    2010-01-01

    Background Stents are an alternative treatment to carotid endarterectomy for symptomatic carotid stenosis, but previous trials have not established equivalent safety and efficacy. We compared the safety of carotid artery stenting with that of carotid endarterectomy. Methods The International Carotid

  13. Consumption of a high-fat meal containing cheese compared with a vegan alternative lowers postprandial C-reactive protein in overweight and obese individuals with metabolic abnormalities: a randomised controlled cross-over study.

    Science.gov (United States)

    Demmer, Elieke; Van Loan, Marta D; Rivera, Nancy; Rogers, Tara S; Gertz, Erik R; German, J Bruce; Zivkovic, Angela M; Smilowitz, Jennifer T

    2016-01-01

    Dietary recommendations suggest decreased consumption of SFA to minimise CVD risk; however, not all foods rich in SFA are equivalent. To evaluate the effects of SFA in a dairy food matrix, as Cheddar cheese, v. SFA from a vegan-alternative test meal on postprandial inflammatory markers, a randomised controlled cross-over trial was conducted in twenty overweight or obese adults with metabolic abnormalities. Individuals consumed two isoenergetic high-fat mixed meals separated by a 1- to 2-week washout period. Serum was collected at baseline, and at 1, 3 and 6 h postprandially and analysed for inflammatory markers (IL-6, IL-8, IL-10, IL-17, IL-18, TNFα, monocyte chemotactic protein-1 (MCP-1)), acute-phase proteins C-reactive protein (CRP) and serum amyloid-A (SAA), cellular adhesion molecules and blood lipids, glucose and insulin. Following both high-fat test meals, postprandial TAG concentrations rose steadily (P vegan-alternative test meal. A treatment effect was not observed for any other inflammatory markers; however, for both test meals, multiple markers significantly changed from baseline over the 6 h postprandial period (IL-6, IL-8, IL-18, TNFα, MCP-1, SAA). Saturated fat in the form of a cheese matrix reduced the iAUC for CRP compared with a vegan-alternative test meal during the postprandial 6 h period. The study is registered at clinicaltrials.gov under NCT01803633.

  14. Impact of Prostatic-specific Antigen Threshold and Screening Interval in Prostate Cancer Screening Outcomes: Comparing the Swedish and Finnish European Randomised Study of Screening for Prostate Cancer Centres.

    Science.gov (United States)

    Saarimäki, Lasse; Hugosson, Jonas; Tammela, Teuvo L; Carlsson, Sigrid; Talala, Kirsi; Auvinen, Anssi

    2017-08-10

    The European Randomised Study of Screening for Prostate Cancer trial has shown a 21% reduction in prostate cancer (PC) mortality with prostate-specific antigen (PSA)-based screening. Sweden used a 2-yr screening interval and showed a larger mortality reduction than Finland with a 4-yr interval and higher PSA cut-off. To evaluate the impact of screening interval and PSA cut-off on PC detection and mortality. We analysed the core age groups (55-69 yr at entry) of the Finnish (N=31 866) and Swedish (N=5901) screening arms at 13 yr and 16 yr of follow-up. Sweden used a screening interval of 2 yr and a PSA cut-off of 3.0ng/ml, while in Finland the screening interval was 4 yr and the PSA cut-off 4.0ng/ml (or PSA 3.0-3.9ng/ml with free PSAprostate-specific antigen threshold of 3ng/ml versus 4ng/ml or a screening interval of 2 yr instead of 4 yr is unlikely to explain the larger mortality reduction achieved in Sweden compared with Finland. Copyright © 2017 European Association of Urology. Published by Elsevier B.V. All rights reserved.

  15. Protective effect of budesonide/formoterol compared with formoterol, salbutamol and placebo on repeated provocations with inhaled AMP in patients with asthma: a randomised, double-blind, cross-over study

    Directory of Open Access Journals (Sweden)

    van der Woude Hanneke J

    2010-05-01

    Full Text Available Abstract Background The budesonide/formoterol combination is successfully used for fast relief of asthma symptoms in addition to its use as maintenance therapy. The temporarily increased corticosteroid dose during increasing inhaler use for symptom relief is likely to suppress any temporary increase in airway inflammation and may mitigate or prevent asthma exacerbations. The relative contribution of the budesonide and formoterol components to the improved asthma control is unclear. Methods The acute protective effect of inhaled budesonide was tested in a model of temporarily increased airway inflammation with repeated indirect airway challenges, mimicking an acute asthma exacerbation. A randomised, double-blind, cross-over study design was used. Asthmatic patients (n = 17, mean FEV1 95% of predicted who previously demonstrated a ≥30% fall in forced expiratory volume in 1 second (FEV1 after inhaling adenosine 5'-monophosphate (AMP, were challenged on four consecutive test days, with the same dose of AMP (at 09:00, 12:00 and 16:00 hours. Within 1 minute of the maximal AMP-induced bronchoconstriction at 09:00 hours, the patients inhaled one dose of either budesonide/formoterol (160/4.5 μg, formoterol (4.5 μg, salbutamol (2 × 100 μg or placebo. The protective effects of the randomised treatments were assessed by serial lung function measurements over the test day. Results In the AMP provocations at 3 and 7 hours after inhalation, the budesonide/formoterol combination provided a greater protective effect against AMP-induced bronchoconstriction compared with formoterol alone, salbutamol and placebo. In addition all three active treatments significantly increased FEV1 within 3 minutes of administration, at a time when inhaled AMP had induced the 30% fall in FEV1. Conclusions A single dose of budesonide/formoterol provided a greater protective effect against inhaled AMP-induced bronchoconstriction than formoterol alone, both at 3 and at 7 hours

  16. A randomised comparative study of the short term clinical and biological effects of intravenous pulse methylprednisolone and infliximab in patients with active rheumatoid arthritis despite methotrexate treatment

    OpenAIRE

    Durez, P; Nzeusseu, T; Lauwerys, B; Manicourt, D; Verschueren, P; Westhovens, R; Devogelaer, J; Houssiau, F

    2004-01-01

    OBJECTIVES: To compare the short term clinical and biological effects of intravenous (i.v.) pulse methylprednisolone (MP) and infliximab (IFX) in patients with severe active rheumatoid arthritis (RA) despite methotrexate (MTX) treatment. METHODS: Patients with active RA despite MTX treatment were randomly allocated to receive a single i.v. infusion of MP (1 g) or three i.v. infusions of IFX (3 mg/kg) on weeks 0, 2, and 6. Patients were "blindly" evaluated for disease activity measures. Qualit...

  17. A randomised controlled trial to compare opt-in and opt-out parental consent for childhood vaccine safety surveillance using data linkage: study protocol

    OpenAIRE

    Berry, Jesia G; Ryan, Philip; Braunack-Mayer, Annette J; Duszynski, Katherine M; Xafis, Vicki; Gold, Michael S

    2011-01-01

    Abstract Background The Vaccine Assessment using Linked Data (VALiD) trial compared opt-in and opt-out parental consent for a population-based childhood vaccine safety surveillance program using data linkage. A subsequent telephone interview of all households enrolled in the trial elicited parental intent regarding the return or non-return of reply forms for opt-in and opt-out consent. This paper describes the rationale for the trial and provides an overview of the design and methods. Methods...

  18. Principal Results of a Prospective Randomised Controlled Study: Morbidity and Mortality after Stroke — Eprosartan Compared with Nitrendipine for Secondary Prevention (MOSES

    Directory of Open Access Journals (Sweden)

    Stephan Lüders

    2005-03-01

    Full Text Available The morbidity and mortality after stroke — eprosartan compared with nitrendipine for secondary prevention (MOSES trial compared the effects of two antihypertensive agents in secondary prevention of stroke. The hypothesis of the trial was that in hypertensive stroke patients, for the same level of blood pressure (BP control, eprosartan would be more effective than nitrendipine in reducing cerebrovascular and cardiovascular morbidity and mortality.A total of 710 patients were assigned to an eprosartan-based regimen and 695 to a nitrendipine-based regimen.These patients had hypertension requiring treatment and documented cerebral ischaemia or haemorrhage. They were well matched at baseline in general characteristics, BP and concomitant disease. BP was lowered to the same extent in both treatment arms, with a very similar timeframe. A high proportion of patients in both treatment arms achieved target BP.The combined primary endpoint was a composite of total mortality and total number of cardiovascular and cerebrovascular events, including recurrent events.There were 206 endpoints in the eprosartan group and 255 endpoints in the nitrendipine group.This represents a statistically significant 21% risk reduction in favour of eprosartan. Eprosartan also had advantages over nitrendipine in respect of all cerebrovascular events and first cardiovascular events.

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

    Science.gov (United States)

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

    2018-02-21

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

  20. A randomised double-blinded crossover study comparing pain during anaesthetising the eyelids in upper blepharoplasty : First versus second eyelid and lidocaine versus prilocaine

    NARCIS (Netherlands)

    Pool, Shariselle M. W.; Struys, Michel M. R. F.; van der Lei, Berend

    Aim: The aim of this study was to investigate whether infiltration of the upper eyelid skin is less painful with prilocaine than with lidocaine. Methods: In 40 consecutive patients scheduled for bilateral upper blepharoplasty, one upper eyelid was anaesthetised with lidocaine with epinephrine and

  1. Tamoxifen effects on subjective and psychosexual well-being, in a randomised breast cancer study comparing high-dose and standard-dose chemotherapy

    NARCIS (Netherlands)

    Mourits, MJ; Bockermann, [No Value; de Vries, EG; van der Zee, AG; ten Hoor, KA; van der Graaf, WT; Sluiter, WJ; Willemse, PH

    2002-01-01

    To evaluate the impact of tamoxifen on subjective and psychosexual well-being in breast cancer patients in relation to type of prior chemotherapy and menopausal status. Longitudinal interview study in breast cancer patients during and after adjuvant tamoxifen use. Menopausal status was defined by

  2. Neoadjuvant chemotherapy in locally advanced cervical cancer: two randomised studies

    International Nuclear Information System (INIS)

    Kumar, L.; Grover, R.; Pokharel, Y.H.; Chander, S.; Kumar, S.; Singh, R.; Rath, G.K.; Kochupillai, V.

    1998-01-01

    The results of two studies looking at the place of neo-adjuvant chemotherapy in the treatment of locally advanced cervical cancer being treated with radiotherapy are presented. Between August 1990 and January 1992, 184 patients with squamous cell carcinoma of the cervix, FIGO stage II B IVA were randomised (study 1) to receive either two cycles of bleomycin, ifosfamide-mesna and cisplatin (BIP) chemotherapy (CT) followed by radiotherapy (RT). Three patients died of CT toxicity - two in study 1 and one in study 2. Cystitis, proctitis and local skin reaction after RT occurred equally in the two groups in both the studies. The neo-adjuvant chemotherapy prior to radiotherapy demonstrated a high response rate, but this did not translate into improved overall survival compared to those patients receiving radiotherapy alone

  3. 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

  4. 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...

  5. A randomised controlled trial comparing oxytocin and oxytocin + ergometrine for prevention of postpartum haemorrhage at caesarean section.

    Science.gov (United States)

    Koen, Sandy; Snyman, Leon Cornelius; Pattinson, Robert C; Makin, Jennifer A

    2016-03-07

    Globally 166 000 women die annually as a result of obstetric haemorrhage. More than 50% of these deaths occur in sub-Saharan Africa. Uterine atony is the commonest cause of severe postpartum haemorrhage (PPH). Bleeding at or after caesarean section (CS) is responsible for >30% of maternal deaths due to obstetric haemorrhage in South Africa (SA). To compare oxytocin alone with oxytocin + ergometrine in terms of primary prophylaxis for PPH at the time of CS. This was a double-blind randomised controlled interventional study comparing oxytocin with oxytocin + ergometrine administered during CS. Patients were randomised to receive oxytocin alone intravenously as a bolus or oxytocin + ergometrine intramuscularly, with the placebo being an injection of sterile water. The study population consisted of women undergoing CS at Kalafong Provincial Tertiary Hospital in Atteridgeville, Gauteng, SA. Five hundred and forty women were randomised and data for 416 women, of whom 214 received oxytocin and 202 oxytocin + ergometrine, were available for analysis. In the oxytocin group 19 women (8.9%) required blood transfusion, compared with seven (3.5%) in the oxytocin + ergometrine group (p=0.01; relative risk = 2.78; 95% confidence interval 1.21 - 6.4). There were no statistically significant differences in the mean estimated visual and mean calculated blood loss. The overall need for blood transfusion was significantly reduced by about two-thirds in women receiving the oxytocin + ergometrine combination. Consideration should be given to using oxytocin + ergometrine for prophylaxis of PPH at CS.

  6. Efficacy and safety of ABP 980 compared with reference trastuzumab in women with HER2-positive early breast cancer (LILAC study): a randomised, double-blind, phase 3 trial.

    Science.gov (United States)

    von Minckwitz, Gunter; Colleoni, Marco; Kolberg, Hans-Christian; Morales, Serafin; Santi, Patricia; Tomasevic, Zorica; Zhang, Nan; Hanes, Vladimir

    2018-06-04

    ABP 980 (Amgen Inc, Thousand Oaks, CA, USA) is a biosimilar of trastuzumab, with analytical, functional, and pharmacokinetic similarities. We compared the clinical safety and efficacy of ABP 980 with that of trastuzumab in women with HER2-positive early breast cancer. We did a randomised, multicentre, double-blind, active-controlled equivalence trial at 97 study centres in 20 countries, mainly in Europe and South America. Eligible women were aged 18 years or older, had histologically confirmed HER2-positive invasive early breast cancer, an Eastern Cooperative Oncology Group performance status score of 0 or 1, and were planning to have surgical resection of the breast tumour with sentinel or axillary lymph node dissection and neoadjuvant chemotherapy. After four cycles of run-in anthracycline-based chemotherapy, patients were assigned 1:1 to receive ABP 980 or trastuzumab with a permuted block design (blocks of four) computer-generated randomisation schedule. Patients received neoadjuvant therapy with a loading dose (8 mg/kg) of ABP 980 or trastuzumab plus paclitaxel 175 mg/m 2 in a 90 min intravenous infusion, followed by three cycles of 6 mg/kg intravenous ABP 980 or trastuzumab plus paclitaxel 175 mg/m 2 every 3 weeks in 30 min intravenous infusions (or 80 mg/m 2 paclitaxel once per week for 12 cycles if that was the local standard of care). Randomisation was stratified by T stage, node status, hormone receptor status, planned paclitaxel dosing schedule, and geographical region. Surgery was completed 3-7 weeks after the last dose of neoadjuvant treatment, after which adjuvant treatment with ABP 980 or trastuzumab was given every 3 weeks for up to 1 year after the first dose in the study. Patients had been randomly assigned at baseline to continue APB 980, continue trastuzumab, or switch from trastuzumab to APB 980 as their adjuvant treatment. The co-primary efficacy endpoints were risk difference and risk ratio (RR) of pathological complete response in breast

  7. Evaluation of the Frails' Fall Efficacy by Comparing Treatments (EFFECT on reducing fall and fear of fall in moderately frail older adults: study protocol for a randomised control trial

    Directory of Open Access Journals (Sweden)

    Chandran Manju

    2011-06-01

    Full Text Available Abstract Background Falls are common in frail older adults and often result in injuries and hospitalisation. The Nintendo® Wii™ is an easily available exercise modality in the community which has been shown to improve lower limb strength and balance. However, not much is known on the effectiveness of the Nintendo® Wii™ to improve fall efficacy and reduce falls in a moderately frail older adult. Fall efficacy is the measure of fear of falling in performing various daily activities. Fear contributes to avoidance of activities and functional decline. Methods This randomised active-control trial is a comparison between the Nintendo WiiActive programme against standard gym-based rehabilitation of the older population. Eighty subjects aged above 60, fallers and non-fallers, will be recruited from the hospital outpatient clinic. The primary outcome measure is the Modified Falls Efficacy Scale and the secondary outcome measures are self-reported falls, quadriceps strength, walking agility, dynamic balance and quality of life assessments. Discussions The study is the first randomised control trial using the Nintendo Wii as a rehabilitation modality investigating a change in fall efficacy and self-reported falls. Longitudinally, the study will investigate if the interventions can successfully reduce falls and analyse the cost-effectiveness of the programme. Trial registration Australia and New Zealand Clinical Trials Register (ANZCTR: ACTRN12610000576022

  8. Evaluation of the Frails' Fall Efficacy by Comparing Treatments (EFFECT) on reducing fall and fear of fall in moderately frail older adults: study protocol for a randomised control trial.

    Science.gov (United States)

    Kwok, Boon Chong; Mamun, Kaysar; Chandran, Manju; Wong, Chek Hooi

    2011-06-18

    Falls are common in frail older adults and often result in injuries and hospitalisation. The Nintendo® Wii™ is an easily available exercise modality in the community which has been shown to improve lower limb strength and balance. However, not much is known on the effectiveness of the Nintendo® Wii™ to improve fall efficacy and reduce falls in a moderately frail older adult. Fall efficacy is the measure of fear of falling in performing various daily activities. Fear contributes to avoidance of activities and functional decline. This randomised active-control trial is a comparison between the Nintendo WiiActive programme against standard gym-based rehabilitation of the older population. Eighty subjects aged above 60, fallers and non-fallers, will be recruited from the hospital outpatient clinic. The primary outcome measure is the Modified Falls Efficacy Scale and the secondary outcome measures are self-reported falls, quadriceps strength, walking agility, dynamic balance and quality of life assessments. The study is the first randomised control trial using the Nintendo Wii as a rehabilitation modality investigating a change in fall efficacy and self-reported falls. Longitudinally, the study will investigate if the interventions can successfully reduce falls and analyse the cost-effectiveness of the programme.

  9. 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

  10. A randomised controlled trial comparing the effect of adjuvant ...

    African Journals Online (AJOL)

    Background: Intrathecal adjuvants are added to local anaesthetics to improve the quality of neuraxial blockade and prolong the duration of analgesia during spinal anaesthesia. Used intrathecally, fentanyl improves the quality of spinal blockade as compared to plain bupivacaine and confers a short duration of post ...

  11. 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.

  12. The INeS study: prevention of multiple pregnancies: a randomised controlled trial comparing IUI COH versus IVF e SET versus MNC IVF in couples with unexplained or mild male subfertility.

    Science.gov (United States)

    Bensdorp, Alexandra J; Slappendel, Els; Koks, Carolien; Oosterhuis, Jur; Hoek, Annemieke; Hompes, Peter; Broekmans, Frank; Verhoeve, Harold; de Bruin, Jan Peter; van Weert, Janne Meije; Traas, Maaike; Maas, Jacques; Beckers, Nicole; Repping, Sjoerd; Mol, Ben W; van der Veen, Fulco; van Wely, Madelon

    2009-12-18

    Multiple pregnancies are high risk pregnancies with higher chances of maternal and neonatal mortality and morbidity. In the past decades the number of multiple pregnancies has increased. This trend is partly due to the fact that women start family planning at an increased age, but also due to the increased use of ART.Couples with unexplained or mild male subfertility generally receive intrauterine insemination IUI with controlled hormonal stimulation (IUI COH). The cumulative pregnancy rate is 40%, with a 10% multiple pregnancy rate.This study aims to reveal whether alternative treatments such as IVF elective Single Embryo Transfer (IVF e SET) or Modified Natural Cycle IVF (MNC IVF) can reduce the number of multiple pregnancy rates, but uphold similar pregnancy rates as IUI COH in couples with mild male or unexplained subfertility. Secondly, the aim is to perform a cost effective analyses and assess treatment preference of these couples. We plan a multicentre randomised controlled clinical trial in the Netherlands comparing six cycles of intra-uterine insemination with controlled ovarian hyperstimulation or six cycles of Modified Natural Cycle (MNC) IVF or three cycles with IVF-elective Single Embryo Transfer (eSET) plus cryo-cycles within a time frame of 12 months.Couples with unexplained subfertility or mild male subfertility and a poor prognosis for treatment independent pregnancy will be included. Women with anovulatory cycles, severe endometriosis, double sided tubal pathology or serious endocrine illness will be excluded.Our primary outcome is the birth of a healthy singleton. Secondary outcomes are multiple pregnancy, treatment costs, and patient experiences in each treatment arm. The analysis will be performed according tot the intention to treat principle. We will test for non-inferiority of the three arms with respect to live birth. As we accept a 12.5% loss in pregnancy rate in one of the two IVF arms to prevent multiple pregnancies, we need 200 couples

  13. The INeS study: prevention of multiple pregnancies: a randomised controlled trial comparing IUI COH versus IVF e SET versus MNC IVF in couples with unexplained or mild male subfertility

    Directory of Open Access Journals (Sweden)

    Beckers Nicole

    2009-12-01

    Full Text Available Abstract Background Multiple pregnancies are high risk pregnancies with higher chances of maternal and neonatal mortality and morbidity. In the past decades the number of multiple pregnancies has increased. This trend is partly due to the fact that women start family planning at an increased age, but also due to the increased use of ART. Couples with unexplained or mild male subfertility generally receive intrauterine insemination IUI with controlled hormonal stimulation (IUI COH. The cumulative pregnancy rate is 40%, with a 10% multiple pregnancy rate. This study aims to reveal whether alternative treatments such as IVF elective Single Embryo Transfer (IVF e SET or Modified Natural Cycle IVF (MNC IVF can reduce the number of multiple pregnancy rates, but uphold similar pregnancy rates as IUI COH in couples with mild male or unexplained subfertility. Secondly, the aim is to perform a cost effective analyses and assess treatment preference of these couples. Methods/Design We plan a multicentre randomised controlled clinical trial in the Netherlands comparing six cycles of intra-uterine insemination with controlled ovarian hyperstimulation or six cycles of Modified Natural Cycle (MNC IVF or three cycles with IVF-elective Single Embryo Transfer (eSET plus cryo-cycles within a time frame of 12 months. Couples with unexplained subfertility or mild male subfertility and a poor prognosis for treatment independent pregnancy will be included. Women with anovulatory cycles, severe endometriosis, double sided tubal pathology or serious endocrine illness will be excluded. Our primary outcome is the birth of a healthy singleton. Secondary outcomes are multiple pregnancy, treatment costs, and patient experiences in each treatment arm. The analysis will be performed according tot the intention to treat principle. We will test for non-inferiority of the three arms with respect to live birth. As we accept a 12.5% loss in pregnancy rate in one of the two IVF arms

  14. A randomised, controlled clinical study on total hip arthroplasty using 4 different bearings

    DEFF Research Database (Denmark)

    Borgwardt, Arne; Zerahn, Bo; Fabricius, Sandra D

    2017-01-01

    PURPOSE: To compare 4 different bearings in total hip arthroplasty (THA) in a randomised controlled clinical study on clinical performance. METHODS: 393 patients with osteoarthritis of the hip or avascular necrosis were included and allocated to 1 of the head-and-cup couples zirconia...

  15. Multicentre randomised study of the effect and experience of an early inhome programme (PreHomeCare) for preterm infants using video consultation and smartphone applications compared with inhospital consultations

    DEFF Research Database (Denmark)

    Hägi-Pedersen, Mai-Britt; Norlyk, Annelise; Dessau, Ram B

    2017-01-01

    ) in Denmark. Parents of hospitalised premature infants who fulfil the inclusion criteria for PreHomeCare will be randomised during hospitalisation to either the intervention (n=80) or control group (n=80) using 1:1 block randomisation. During PreHomeCare, the intervention group will receive a smartphone...

  16. The PRICE study (Protection Rest Ice Compression Elevation: design of a randomised controlled trial comparing standard versus cryokinetic ice applications in the management of acute ankle sprain [ISRCTN13903946

    Directory of Open Access Journals (Sweden)

    Rocke Laurence G

    2007-12-01

    Full Text Available Abstract Background Cryotherapy (the application of ice for therapeutic purposes is one of the most common treatment modalities employed in the immediate management of acute soft tissue injury. Despite its widespread clinical use, the precise physiological responses to therapeutic cooling have not been fully elucidated, and effective evidence-based treatment protocols are yet to be established. Intermittent ice applications are thought to exert a significant analgesic effect. This could facilitate earlier therapeutic exercise after injury, potentially allowing for a quicker return to activity. The primary aim of the forthcoming study is therefore to examine the safety and effectiveness of combining intermittent ice applications with periods of therapeutic exercise in the first week after an acute ankle sprain. Methods/Design The study is a randomised controlled trial. 120 subjects with an acute grade I or grade II ankle sprain will be recruited from Accident & Emergency and a University based Sports Injury Clinic. Subjects will be randomised under strict double-blind conditions to either a standard cryotherapy (intermittent ice applications with compression or cryokinetic treatment group (intermittent ice applications with compression and therapeutic exercise. After the first week, treatment will be standardised across groups. Assessor blinding will be maintained throughout the trial. Primary outcome will be function, assessed using the Lower Extremity Functional Scale (LEFS. Additional outcomes will include pain (10 cm Visual Analogue Scale, swelling (modified figure-of-eight method and activity levels (activPAL™ physical activity monitor, PAL Technologies, Glasgow, UK. Diagnostic Ultrasound (Episcan-1-200 high frequency ultrasound scanning system, Longport International Ltd, PA will also be used to assess the degree of soft tissue injury. After baseline assessment subjects will be followed up at 1, 2, 3 & 4 weeks post injury. All data will

  17. Comparing the effects of tofacitinib, methotrexate and the combination, on bone marrow oedema, synovitis and bone erosion in methotrexate-naive, early active rheumatoid arthritis: results of an exploratory randomised MRI study incorporating semiquantitative and quantitative techniques

    DEFF Research Database (Denmark)

    Conaghan, Philip G.; Ostergaard, Mikkel; Bowes, Michael A.

    2016-01-01

    OBJECTIVES: To explore the effects of tofacitinib-an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA)-with or without methotrexate (MTX), on MRI endpoints in MTX-naive adult patients with early active RA and synovitis in an index wrist or hand. METHODS: In this exploratory......, phase 2, randomised, double-blind, parallel-group study, patients received tofacitinib 10 mg twice daily + MTX, tofacitinib 10 mg twice daily + placebo (tofacitinib monotherapy), or MTX + placebo (MTX monotherapy), for 1 year. MRI endpoints (Outcome Measures in Rheumatology Clinical Trials RA MRI score...... differences in RAMRIS bone marrow oedema (BME) at month 6 were -1.55 (90% CI -2.52 to -0.58) for tofacitinib + MTX and -1.74 (-2.72 to -0.76) for tofacitinib monotherapy (both ptofacitinib + MTX...

  18. Neck dissection with harmonic scalpel and electrocautery? A randomised study.

    Science.gov (United States)

    Verma, Roshan K; Mathiazhagan, Arulalan; Panda, Naresh K

    2017-10-01

    Is the use of harmonic scalpel for neck dissection useful? Literature search did not show a single, prospective, randomised control trial. We intended to study the role of harmonic scalpel in neck dissection and compare it with conventional electrocautery technique for oral cavity carcinoma. 40 patients undergoing selective neck dissection for primary oral cavity malignancy were enrolled in this study. The harmonic scalpel (HS) group consisted of 20 patients, and the electrocautery technique (ET) group comprised of 20 patients. The following variables were examined: intraoperative blood loss, operative time, number of ligatures used, postoperative drain, and postoperative hospital stay. Intraoperative blood loss was found to be significantly reduced in harmonic scalpel group as compared to electrocautery group. However, we found no difference in other parameters like operative time, postop drain, postoperative hospital stay and number of ligatures used between both groups. Harmonic scalpel for neck dissection is associated with significantly lesser intraoperative blood loss as compared to electrocautery. There is no effect on operative time and postoperative hospital stay in both groups. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  19. Esoteric Connective Tissue Therapy for chronic low back pain to reduce pain, and improve functionality and general well-being compared with physiotherapy: study protocol for a randomised controlled trial.

    Science.gov (United States)

    Schnelle, Christoph; Messerschmidt, Steffen; Minford, Eunice J; Greenaway-Twist, Kate; Szramka, Maxine; Masiorski, Marianna; Sheldrake, Michelle; Jones, Mark

    2017-07-17

    Low back pain causes more global disability than any other condition. Once the acute pain becomes chronic, about two-thirds of sufferers will not fully recover after 1-2 years. There is a paucity of effective treatments for non-specific, chronic low back pain. It has been noted that low back pain is associated with changes in the connective tissue in the affected area, and a very low-impact treatment, Esoteric Connective Tissue Therapy (ECTT), has been developed to restore flexibility in connective tissue. ECTT uses patterns of very small, circular movements, to the legs, arms, spine, sacrum and head, which anecdotally are effective in pain relief. In an unpublished single-arm phase I/II trial with chronic pain patients, ECTT showed a 56% reduction in pain after five treatments and 45% and 54% improvements at 6 months and 7-9 years of follow-up respectively. The aim of this randomised controlled trial is to compare ECTT with physiotherapy for reducing pain and improving physical function and physical and mental well-being in patients with chronic low back pain. The trial will be held at two hospitals in Vietnam. One hundred participants with chronic low back pain greater than or equal to 40/100 on the visual analogue scale will be recruited and randomised to either ECTT or physiotherapy. Four weekly treatments will be provided by two experienced ECTT practitioners (Treatment Group, 40 minutes each) and hospital-employed physiotherapy nurses (Control Group, 50 minutes). The primary outcomes will be changes in pain, physical function per the Quebec Pain Functionality Questionnaire and physical and mental well-being recorded by the Short Form Health Survey (SF-36), with mixed modelling used as the primary statistical tool because the data are longitudinal. Initial follow-up will be at either 4 or 8 months, with a second follow-up after 12 months. The trial design has important strengths, because it is to be conducted in hospitals under medical supervision

  20. A prospective randomised trial comparing mesh types and fixation in totally extraperitoneal inguinal hernia repairs.

    Science.gov (United States)

    Cristaudo, Adam; Nayak, Arun; Martin, Sarah; Adib, Reza; Martin, Ian

    2015-05-01

    The totally extraperitoneal (TEP) approach for surgical repair of inguinal hernias has emerged as a popular technique. We conducted a prospective randomised trial to compare patient comfort scores using different mesh types and fixation using this technique. Over a 14 month period, 146 patients underwent 232 TEP inguinal hernia repairs. We compared the comfort scores of patients who underwent these procedures using different types of mesh and fixation. A non-absorbable 15 × 10 cm anatomical mesh fixed with absorbable tacks (Control group) was compared with either a non-absorbable 15 × 10 cm folding slit mesh with absorbable tacks (Group 2), a partially-absorbable 15 × 10 cm mesh with absorbable tacks (Group 3) or a non-absorbable 15 × 10 cm anatomical mesh fixed with 2 ml fibrin sealant (Group 4). Outcomes were compared at 1, 2, 4 and 12 weeks using the Carolina Comfort Scale (CCS) scores. At 1, 2, 4 and 12 weeks, the median global CCS scores were low for all treatment groups. Statistically significant differences were seen only for median CCS scores and subscores with the use of partially-absorbable mesh with absorbable tacks (Group 3) at weeks 2 and 4. However, these were no longer significant at week 12. In this study, the TEP inguinal hernia repair with minimal fixation results in low CCS scores. There were no statistical differences in CCS scores when comparing types of mesh, configuration of the mesh or fixation methods. Copyright © 2015 IJS Publishing Group Limited. Published by Elsevier Ltd. All rights reserved.

  1. Randomised controlled trial comparing oral and intravenous paracetamol (acetaminophen) plasma levels when given as preoperative analgesia.

    Science.gov (United States)

    van der Westhuizen, J; Kuo, P Y; Reed, P W; Holder, K

    2011-03-01

    Gastric absorption of oral paracetamol (acetaminophen) may be unreliable perioperatively in the starved and stressed patient. We compared plasma concentrations of parenteral paracetamol given preoperatively and oral paracetamol when given as premedication. Patients scheduled for elective ear; nose and throat surgery or orthopaedic surgery were randomised to receive either oral or intravenous paracetamol as preoperative medication. The oral dose was given 30 minutes before induction of anaesthesia and the intravenous dose given pre-induction. All patients were given a standardised anaesthetic by the same specialist anaesthetist who took blood for paracetamol concentrations 30 minutes after the first dose and then at 30 minute intervals for 240 minutes. Therapeutic concentrations of paracetamol were reached in 96% of patients who had received the drug parenterally, and 67% of patients who had received it orally. Maximum median plasma concentrations were 19 mg.l(-1) (interquartile range 15 to 23 mg.l(-1)) and 13 mg.l(-1) (interquartile range 0 to 18 mg.l(-1)) for the intravenous and oral group respectively. The difference between intravenous and oral groups was less marked after 150 minutes but the intravenous preparation gave higher plasma concentrations throughout the study period. It can be concluded that paracetamol gives more reliable therapeutic plasma concentrations when given intravenously.

  2. Laser Acupuncture at Large Intestine 4 Compared with Oral Glucose Administration for Pain Prevention in Healthy Term Neonates Undergoing Routine Heel Lance: Study Protocol for an Observer-Blinded, Randomised Controlled Clinical Trial

    Directory of Open Access Journals (Sweden)

    Jasmin Stadler

    2018-01-01

    Full Text Available Background. Nonpharmacological strategies have actually become more important in neonatal pain management during routinely applied minor painful procedures. However, commonly used nonpharmacological strategies are inferior to orally administered sweet solutions. Therefore, we will compare laser acupuncture, as a recent nonpharmacological method, with the standard care of oral glucose solution for pain prevention. Methods. Ninety-five healthy term neonates will be allocated into one of two groups. Before routine heel lance for metabolic screening, one group will receive laser acupuncture at acupuncture point Large Intestine 4 (LI 4 bilaterally for 60 seconds per point (acupuncture group and the other will receive the standard care with orally administered glucose solution (glucose group. The complete procedure of blood sampling will be recorded on video, excluding the intervention before heel lance. A paediatric nurse, blinded with respect to the allocation, will evaluate these video recordings and determine the Premature Infant Pain Profile (PIPP for each neonate. Primary outcome will be the mean difference in PIPP scores between groups. Discussion. This observer-blinded randomised controlled trial has been designed to explore potential advantages of laser acupuncture in the management of neonatal pain because more data are required to provide information about its efficacy and safety. Trial Registration. This trial is registered with DRKS00010122.

  3. Laser Acupuncture at Large Intestine 4 Compared with Oral Glucose Administration for Pain Prevention in Healthy Term Neonates Undergoing Routine Heel Lance: Study Protocol for an Observer-Blinded, Randomised Controlled Clinical Trial.

    Science.gov (United States)

    Stadler, Jasmin; Avian, Alexander; Posch, Katrin; Urlesberger, Berndt; Raith, Wolfgang

    2018-01-01

    Nonpharmacological strategies have actually become more important in neonatal pain management during routinely applied minor painful procedures. However, commonly used nonpharmacological strategies are inferior to orally administered sweet solutions. Therefore, we will compare laser acupuncture, as a recent nonpharmacological method, with the standard care of oral glucose solution for pain prevention. Ninety-five healthy term neonates will be allocated into one of two groups. Before routine heel lance for metabolic screening, one group will receive laser acupuncture at acupuncture point Large Intestine 4 (LI 4) bilaterally for 60 seconds per point (acupuncture group) and the other will receive the standard care with orally administered glucose solution (glucose group). The complete procedure of blood sampling will be recorded on video, excluding the intervention before heel lance. A paediatric nurse, blinded with respect to the allocation, will evaluate these video recordings and determine the Premature Infant Pain Profile (PIPP) for each neonate. Primary outcome will be the mean difference in PIPP scores between groups. This observer-blinded randomised controlled trial has been designed to explore potential advantages of laser acupuncture in the management of neonatal pain because more data are required to provide information about its efficacy and safety. This trial is registered with DRKS00010122.

  4. Standardised Chinese herbal treatment delivered by GPs compared with individualised treatment administered by practitioners of Chinese herbal medicine for women with recurrent urinary tract infections (RUTI): study protocol for a randomised controlled trial.

    Science.gov (United States)

    Flower, Andrew; Harman, Kim; Lewith, George; Moore, Michael; Bishop, Felicity L; Stuart, Beth; Lampert, Nicholas

    2016-07-27

    In the UK, urinary tract infections (UTIs) are the most common bacterial infection presented by women in primary care. Recurrent urinary tract infections (RUTIs) are defined as three episodes of UTI in the last 12 months, or two episodes in the last 6 months. Between 20 and 30 % of women who have had one episode of UTI will have an RUTI, and approximately 25 % of these will develop subsequent recurrent episodes. RUTIs can have a significant negative effect on the quality of life, and have a high impact on health care costs as a result of outpatient visits, diagnostic tests and prescriptions. Chinese herbal medicine (CHM) has a recorded history of treatments for the symptoms of UTIs for more than 2000 years. More recent clinical research in China has provided some preliminary evidence that CHM can alleviate the symptoms of UTIs and reduce the rate of recurrence, but more rigorous investigation is required. The RUTI trial is a double-blind, randomised, placebo-controlled, feasibility trial. A total of 80 women will be randomised to 'individualised' herbs prescribed by a Chinese herbal practitioner or to 'standardised' herbs provided by primary care clinicians. Both arms will have herbs for prevention of UTIs and treatment of acute episodes. Treatment duration is for 16 weeks. The primary outcomes are the number of episodes of recurrent UTIs during the trial period and in the 6 months of follow-up, and the number of days of symptoms rated moderately bad or worse based on patient diaries. Secondary outcomes will assess participant expectations and beliefs, adherence to the treatment, adverse events and health economics and provide quantitative and qualitative assessments of the impact of recurrent infections on the lives of women. The RUTI trial is the first instance of CHM delivered as a clinical trial of an investigatory medicinal product in the UK. This study provides important information regarding the feasibility and acceptability of researching and using

  5. The effect of music therapy compared with general recreational activities in reducing agitation in people with dementia: a randomised controlled trial

    NARCIS (Netherlands)

    Vink, A.C.; Zuidersma, M.; Boersma, F.; Jonge, P. de; Zuidema, S.U.; Slaets, J.P.

    2013-01-01

    OBJECTIVE: This study aimed to compare the effects of music therapy with general recreational day activities in reducing agitation in people with dementia, residing in nursing home facilities. METHODS: In a randomised controlled design, residents with dementia (n = 94) were allocated to either music

  6. The effect of music therapy compared with general recreational activities in reducing agitation in people with dementia : a randomised controlled trial

    NARCIS (Netherlands)

    Vink, A. C.; Zuidersma, M.; Boersma, F.; de Jonge, P.; Zuidema, S. U.; Slaets, J. P. J.

    2013-01-01

    Objective This study aimed to compare the effects of music therapy with general recreational day activities in reducing agitation in people with dementia, residing in nursing home facilities. Methods In a randomised controlled design, residents with dementia (n=94) were allocated to either music

  7. Randomised studies of income supplementation: a lost opportunity to assess health outcomes.

    Science.gov (United States)

    Connor, J; Rodgers, A; Priest, P

    1999-11-01

    Despite the wealth of evidence linking low income to ill health, there is little information from randomised studies on how much and how quickly these risks can be reversed by improvements in income. To conduct a systematic review of randomised studies of income supplementation, with particular reference to health outcomes. Extensive searches of electronic databases and contact with previous authors. As well as searching for trials that were specifically designed to assess the effects of increased income, studies of winners and losers of lotteries were also sought: if winning is purely chance, such studies are, in effect, randomised trials of increased income. Ten relevant studies were identified, all conducted in North America, mostly in the late 1960s and 1970s. Five trials were designed to assess the effects of income supplementation on workforce participation and randomised a total of 10,000 families to 3-5 years of various combinations of minimum income guarantees and reduced tax rates. Two trials were designed to assess re-offending rates in recently released prisoners and randomised a total of 2400 people to 3-6 months of benefits. One trial was designed to assess housing allowances and randomised 3500 families to three years of income supplements. One trial assessed the health effects of 12 months of income supplementation in 54 people with severe mental illness. Finally, one study compared three groups of people who won different amounts of money in a state lottery. In all these studies the interventions resulted in increases in income of at least one fifth. However, no reliable analyses of health outcome data are available. Extensive opportunities to reliably assess the effects of increases in income on health outcomes have been missed. Such evidence might have increased the consideration of potential health effects during deliberations about policies that have major implications for income, such as taxation rates, benefit policies, and minimum wage

  8. Comparing cognitive behavioural therapy for eating disorders integrated with behavioural weight loss therapy to cognitive behavioural therapy-enhanced alone in overweight or obese people with bulimia nervosa or binge eating disorder: study protocol for a randomised controlled trial.

    Science.gov (United States)

    Palavras, Marly Amorim; Hay, Phillipa; Touyz, Stephen; Sainsbury, Amanda; da Luz, Felipe; Swinbourne, Jessica; Estella, Nara Mendes; Claudino, Angélica

    2015-12-18

    Around 40 % of individuals with eating disorders of recurrent binge eating, namely bulimia nervosa and binge eating disorder, are obese. In contrast to binge eating disorder, currently there is no evidence base for weight management or weight loss psychological therapies in the treatment of bulimia nervosa despite their efficacy in binge eating disorder. Thus, a manualised therapy called HAPIFED (Healthy APproach to weIght management and Food in Eating Disorders) has been developed. HAPIFED integrates the leading evidence-based psychological therapies, cognitive behavioural therapy-enhanced (CBT-E) and behavioural weight loss treatment (BWLT) for binge eating disorder and obesity respectively. The aim of the present study is to detail the protocol for a randomised controlled trial (RCT) of HAPIFED versus CBT-E for people with bulimia nervosa and binge eating disorder who are overweight/obese. A single-blind superiority RCT is proposed. One hundred Brazilian participants aged ≥ 18 years, with a diagnosis of bulimia nervosa or binge eating disorder, BMI > 27 to bulimia nervosa as well as with binge eating disorder. It will have the potential to improve health outcomes for the rapidly increasing number of adults with co-morbid obesity and binge eating disorder or bulimia nervosa. US National Institutes of Health clinical trial registration number NCT02464345 , date of registration 1 June 2015.

  9. Study protocol for the SMART2D adaptive implementation trial: a cluster randomised trial comparing facility-only care with integrated facility and community care to improve type 2 diabetes outcomes in Uganda, South Africa and Sweden.

    Science.gov (United States)

    Guwatudde, David; Absetz, Pilvikki; Delobelle, Peter; Östenson, Claes-Göran; Olmen Van, Josefien; Alvesson, Helle Molsted; Mayega, Roy William; Ekirapa Kiracho, Elizabeth; Kiguli, Juliet; Sundberg, Carl Johan; Sanders, David; Tomson, Göran; Puoane, Thandi; Peterson, Stefan; Daivadanam, Meena

    2018-03-17

    Type 2 diabetes (T2D) is increasingly contributing to the global burden of disease. Health systems in most parts of the world are struggling to diagnose and manage T2D, especially in low-income and middle-income countries, and among disadvantaged populations in high-income countries. The aim of this study is to determine the added benefit of community interventions onto health facility interventions, towards glycaemic control among persons with diabetes, and towards reduction in plasma glucose among persons with prediabetes. An adaptive implementation cluster randomised trial is being implemented in two rural districts in Uganda with three clusters per study arm, in an urban township in South Africa with one cluster per study arm, and in socially disadvantaged suburbs in Stockholm, Sweden with one cluster per study arm. Clusters are communities within the catchment areas of participating primary healthcare facilities. There are two study arms comprising a facility plus community interventions arm and a facility-only interventions arm. Uganda has a third arm comprising usual care. Intervention strategies focus on organisation of care, linkage between health facility and the community, and strengthening patient role in self-management, community mobilisation and a supportive environment. Among T2D participants, the primary outcome is controlled plasma glucose; whereas among prediabetes participants the primary outcome is reduction in plasma glucose. The study has received approval in Uganda from the Higher Degrees, Research and Ethics Committee of Makerere University School of Public Health and from the Uganda National Council for Science and Technology; in South Africa from the Biomedical Science Research Ethics Committee of the University of the Western Cape; and in Sweden from the Regional Ethical Board in Stockholm. Findings will be disseminated through peer-reviewed publications and scientific meetings. ISRCTN11913581; Pre-results. © Article author(s) (or their

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

    DEFF Research Database (Denmark)

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

    2011-01-01

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

  11. Comparing the effects of tofacitinib, methotrexate and the combination, on bone marrow oedema, synovitis and bone erosion in methotrexate-naive, early active rheumatoid arthritis: results of an exploratory randomised MRI study incorporating semiquantitative and quantitative techniques.

    Science.gov (United States)

    Conaghan, Philip G; Østergaard, Mikkel; Bowes, Michael A; Wu, Chunying; Fuerst, Thomas; van der Heijde, Désirée; Irazoque-Palazuelos, Fedra; Soto-Raices, Oscar; Hrycaj, Pawel; Xie, Zhiyong; Zhang, Richard; Wyman, Bradley T; Bradley, John D; Soma, Koshika; Wilkinson, Bethanie

    2016-06-01

    To explore the effects of tofacitinib-an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA)-with or without methotrexate (MTX), on MRI endpoints in MTX-naive adult patients with early active RA and synovitis in an index wrist or hand. In this exploratory, phase 2, randomised, double-blind, parallel-group study, patients received tofacitinib 10 mg twice daily + MTX, tofacitinib 10 mg twice daily + placebo (tofacitinib monotherapy), or MTX + placebo (MTX monotherapy), for 1 year. MRI endpoints (Outcome Measures in Rheumatology Clinical Trials RA MRI score (RAMRIS), quantitative RAMRIS (RAMRIQ) and dynamic contrast-enhanced (DCE) MRI) were assessed using a mixed-effect model for repeated measures. Treatment differences with ptofacitinib + MTX and -1.74 (-2.72 to -0.76) for tofacitinib monotherapy (both ptofacitinib + MTX and -0.52 (-1.46 to 0.41) for tofacitinib monotherapy (both p>0.05 vs MTX monotherapy). Treatment differences in RAMRIQ synovitis were statistically significant at month 3, consistent with DCE MRI findings. Less deterioration of RAMRIS and RAMRIQ erosive damage was seen at months 6 and 12 in both tofacitinib groups versus MTX monotherapy. These results provide consistent evidence using three different MRI technologies that tofacitinib treatment leads to early reduction of inflammation and inhibits progression of structural damage. NCT01164579. 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/

  12. [Randomised comparative study of early versus delayed surgery in hip-fracture patients on concomitant treatment with antiplatelet drugs. Determination of platelet aggregation, perioperative bleeding and a review of annual mortality].

    Science.gov (United States)

    Mas-Atance, J; Marzo-Alonso, C; Matute-Crespo, M; Trujillano-Cabello, J J; Català-Tello, N; de Miguel-Artal, M; Forcada-Calvet, P; Fernández-Martínez, J J

    2013-01-01

    A review of the perioperative management of patients with hip fractures and concomitant therapy with antiplatelet agents, and to analyse the differences in mortality and perioperative bleeding in early surgery (5 days). Platelet aggregation was measured on admission and immediately before surgery in all patients included in the study A total of 175 patients over 65 years old, with low energy hip fracture were randomised into 3 groups: Patients on antiplatelet therapy undergoing early surgery, patients on antiplatelet therapy undergoing delayed surgery, and patients not on antiplatelet therapy undergoing early surgery. The same clinical and laboratory data were collected prospectively up to 12 months for all the patients. The platelet aggregation was determined by a semi-quantitative computerised system based on impedance aggregometry in whole blood. Bleeding, transfusion requirements and analytical results showed no significant differences between groups. More than half (59.8%) of the patients not taking antiplatelet therapy had normal platelet aggregation on admission, while 13.5% of those taking antiplatelet agents did not. Multivariate analysis showed increased mortality at 12 months for the variables, low Barthel index before hip fracture (OR: 0.9-0.9) and number of transfusions (OR: 1.1-1.5). The average lenth of stay was 4.1 days greater in the delayed surgery group. Early surgery for patients receiving antiplatelet therapy has similar clinical outcomes to the delayed, but improves hospital efficiency by reducing the average length of stay. The antiplatelet drug reported by the patient showed low concordance with the determination of the platelet aggregation. Copyright © 2011 SECOT. Published by Elsevier Espana. All rights reserved.

  13. Premature Discontinuation of Prospective Clinical Studies Approved by a Research Ethics Committee - A Comparison of Randomised and Non-Randomised Studies.

    Directory of Open Access Journals (Sweden)

    Anette Blümle

    Full Text Available Premature discontinuation of clinical studies affects about 25% of randomised controlled trials (RCTs which raises concerns about waste of scarce resources for research. The risk of discontinuation of non-randomised prospective studies (NPSs is yet unclear.To compare the proportion of discontinued studies between NPSs and RCTs that received ethical approval.We systematically surveyed prospective longitudinal clinical studies that were approved by a single REC in Freiburg, Germany between 2000 and 2002. We collected study characteristics, identified subsequent publications, and surveyed investigators to elucidate whether a study was discontinued and, if so, why.Of 917 approved studies, 547 were prospective longitudinal studies (306 RCTs and 241 NPSs. NPSs were on average smaller than RCTs, more frequently single centre and pilot studies, and less frequently funded by industry. NPSs were less frequently discontinued than RCTs: 32/221 (14% versus 78/288 (27%, p<0.001, missing data excluded. Poor recruitment was the most frequent reason for discontinuation in both NPSs (36% and RCTs (37%.Compared to RCTs, NPSs were at lower risk for discontinuation. Measures to reliably predict, sustain, and stimulate recruitment could prevent discontinuation of many RCTs but also of some NPSs.

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

    Directory of Open Access Journals (Sweden)

    Grotenhuis J André

    2007-11-01

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

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

    Directory of Open Access Journals (Sweden)

    Juszczak Edmund

    2010-04-01

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

  16. A new primary dental care service compared with standard care for child and family to reduce the re-occurrence of childhood dental caries (Dental RECUR): study protocol for a randomised controlled trial.

    Science.gov (United States)

    Pine, Cynthia; Adair, Pauline; Burnside, Girvan; Robinson, Louise; Edwards, Rhiannon Tudor; Albadri, Sondos; Curnow, Morag; Ghahreman, Marjan; Henderson, Mary; Malies, Clare; Wong, Ferranti; Muirhead, Vanessa; Weston-Price, Sally; Whitehead, Hilary

    2015-11-04

    In England and Scotland, dental extraction is the single highest cause of planned admission to the hospital for children under 11 years. Traditional dental services have had limited success in reducing this disease burden. Interventions based on motivational interviewing have been shown to impact positively dental health behaviours and could facilitate the prevention of re-occurrence of dental caries in this high-risk population. The objective of the study is to evaluate whether a new, dental nurse-led service, delivered using a brief negotiated interview based on motivational interviewing, is a more cost-effective service than treatment as usual, in reducing the re-occurrence of dental decay in young children with previous dental extractions. This 2-year, two-arm, multicentre, randomised controlled trial will include 224 child participants, initially aged 5 to 7 years, who are scheduled to have one or more primary teeth extracted for dental caries under general anaesthesia (GA), relative analgesia (RA: inhalation sedation) or local anaesthesia (LA). The trial will be conducted in University Dental Hospitals, Secondary Care Centres or other providers of dental extraction services across the United Kingdom. The intervention will include a brief negotiated interview (based on the principles of motivational interviewing) delivered between enrollment and 6 weeks post-extraction, followed by directed prevention in primary dental care. Participants will be followed up for 2 years. The main outcome measure will be the dental caries experienced by 2 years post-enrollment at the level of dentine involvement on any tooth in either dentition, which had been caries-free at the baseline assessment. The participants are a hard-to-reach group in which secondary prevention is a challenge. Lack of engagement with dental care makes the children and their families scheduled for extraction particularly difficult to recruit to an RCT. Variations in service delivery between sites have

  17. Postpartum perineal reapir performed by midwives: A randomised trial comparing two suture techniques for perineal repair leaving the skin unsutured

    DEFF Research Database (Denmark)

    Kindberg, Sara; Misan, Stehouwer; Hvidman, Lone

    2008-01-01

    Postpartum perineal repair performed by midwives: A randomised trial comparing two suture techniques leaving the skin unsutured. Objective      To compare a continuous suture technique to interrupted stitches using inverted knots for postpartum perineal repair of second-degree lacerations...... and episiotomies.   Design          A double blind randomised controlled trial.   Setting          A Danish university hospital with more than 4800 deliveries annually.   Population   400 healthy primiparous women with a vaginal delivery at term.   Method         Randomisation was computer-controlled. Structured...... healing, patient satisfaction, dyspareunia or need for resuturing. The continuous suture technique was significantly faster (15 min. vs. 17 min, p=0.03) and less suture material was used (1 vs. 2 packets, pskin unsutured...

  18. Translation of randomised controlled trial findings into clinical practice: comparison of olanzapine and valproate in the EMBLEM study

    DEFF Research Database (Denmark)

    Novick, D; Gonzalez-Pinto, A; Haro, J M

    2009-01-01

    OBJECTIVES: The aim of this study was to compare the outcomes of olanzapine- and valproate-treated patients in an observational study of acute mania with the results of a randomised controlled trial (RCT) assessing the same treatments. METHODS: EMBLEM (European Mania in Bipolar Evaluation of Medi...

  19. INCITE: A randomised trial comparing constraint induced movement therapy and bimanual training in children with congenital hemiplegia

    Directory of Open Access Journals (Sweden)

    Gilmore Rose

    2010-01-01

    Full Text Available Abstract Background Congenital hemiplegia is the most common form of cerebral palsy (CP accounting for 1 in 1300 live births. These children have limitations in capacity to use the impaired upper limb and bimanual coordination deficits which impact on daily activities and participation in home, school and community life. There are currently two diverse intensive therapy approaches. Traditional therapy has adopted a bimanual approach (BIM training and recently, constraint induced movement therapy (CIMT has emerged as a promising unimanual approach. Uncertainty remains about the efficacy of these interventions and characteristics of best responders. This study aims to compare the efficacy of CIMT to BIM training to improve outcomes across the ICF for school children with congenital hemiplegia. Methods/Design A matched pairs randomised comparison design will be used with children matched by age, gender, side of hemiplegia and level of upper limb function. Based on power calculations a sample size of 52 children (26 matched pairs will be recruited. Children will be randomised within pairs to receive either CIMT or BIM training. Both interventions will use an intensive activity based day camp model, with groups receiving the same dosage of intervention delivered in the same environment (total 60 hours over 10 days. A novel circus theme will be used to enhance motivation. Groups will be compared at baseline, then at 3, 26 and 52 weeks following intervention. Severity of congenital hemiplegia will be classified according to brain structure (MRI and white matter fibre tracking, cortical excitability using Transcranial Magnetic Stimulation (TMS, functional use of the hand in everyday tasks (Manual Ability Classification System and Gross Motor Function Classification System (GMFCS. Outcomes will address neurovascular changes (functional MRI, functional connectivity, and brain (reorganisation (TMS, body structure and function (range of motion, spasticity

  20. Post-prandial reflux suppression by a raft-forming alginate (Gaviscon Advance) compared to a simple antacid documented by magnetic resonance imaging and pH-impedance monitoring: mechanistic assessment in healthy volunteers and randomised, controlled, double-blind study in reflux patients.

    Science.gov (United States)

    Sweis, R; Kaufman, E; Anggiansah, A; Wong, T; Dettmar, P; Fried, M; Schwizer, W; Avvari, R K; Pal, A; Fox, M

    2013-06-01

    Alginates form a raft above the gastric contents, which may suppress gastro-oesophageal reflux; however, inconsistent effects have been reported in mechanistic and clinical studies. To visualise reflux suppression by an alginate-antacid [Gaviscon Advance (GA), Reckitt Benckiser, UK] compared with a nonraft-forming antacid using magnetic resonance imaging (MRI), and to determine the feasibility of pH-impedance monitoring for assessment of reflux suppression by alginates. Two studies were performed: (i) GA and antacid (Alucol, Wander Ltd, Switzerland) were visualised in the stomach after ingestion in 12 healthy volunteers over 30 min after a meal by MRI, with reflux events documented by manometry. (ii) A randomised controlled, double-blind cross-over trial of post-prandial reflux suppression documented by pH-impedance in 20 patients randomised to GA or antacid (Milk of Magnesia; Boots, UK) after two meals taken 24 h apart. MRI visualized a "mass" of GA form at the oesophago-gastric junction (OGJ); simple antacid sank to the distal stomach. The number of post-prandial common cavity reflux events was less with GA than antacid [median 2 (0-5) vs. 5 (1-11); P < 0.035]. Distal reflux events and acid exposure measured by pH-impedance were similar after GA and antacid. There was a trend to reduced proximal reflux events with GA compared with antacid [10.5 (8.9) vs. 13.9 (8.3); P = 0.070]. Gaviscon Advance forms a 'mass' close to the OGJ and significantly suppresses reflux compared with a nonraft-forming antacid. Standard pH-impedance monitoring is suitable for clinical studies of GA in gastro-oesophageal reflux disease patients where proximal reflux is the primary outcome. © 2013 Blackwell Publishing Ltd.

  1. Comparative ultrasound study of acute lateral ankle ligament ...

    African Journals Online (AJOL)

    The return to competitive level of sport dates were also documented and compared. A single blind randomised control study comparing the JSFB rehabilitation programme with conventional ankle rehabilitation programmes was used. Ultrasound examinations were done on all first time lateral ankle ligament injuries 72 ...

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

    Science.gov (United States)

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

    2016-03-03

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

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

    Science.gov (United States)

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

    2007-11-01

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

  4. Comparative randomised controlled clinical trial of a herbal eye drop with artificial tear and placebo in computer vision syndrome.

    Science.gov (United States)

    Biswas, N R; Nainiwal, S K; Das, G K; Langan, U; Dadeya, S C; Mongre, P K; Ravi, A K; Baidya, P

    2003-03-01

    A comparative randomised double masked multicentric clinical trial has been conducted to find out the efficacy and safety of a herbal eye drop preparation, itone eye drops with artificial tear and placebo in 120 patients with computer vision syndrome. Patients using computer for at least 2 hours continuosly per day having symptoms of irritation, foreign body sensation, watering, redness, headache, eyeache and signs of conjunctival congestion, mucous/debris, corneal filaments, corneal staining or lacrimal lake were included in this study. Every patient was instructed to put two drops of either herbal drugs or placebo or artificial tear in the eyes regularly four times for 6 weeks. Objective and subjective findings were recorded at bi-weekly intervals up to six weeks. Side-effects, if any, were also noted. In computer vision syndrome the herbal eye drop preparation was found significantly better than artificial tear (p computer vision syndrome.

  5. Cost utility analysis of co-prescribed heroin compared with methadone maintenance treatment in heroin addicts in two randomised trials

    NARCIS (Netherlands)

    Dijkgraaf, Marcel G. W.; van der Zanden, Bart P.; de Borgie, Corianne A. J. M.; Blanken, Peter; van Ree, Jan M.; van den Brink, Wim

    2005-01-01

    Objective To determine the cost utility of medical co-prescription of heroin compared with methadone maintenance treatment for chronic, treatment resistant heroin addicts. Design Cost utility analysis of two pooled open label randomised controlled trials. Setting Methadone maintenance programmes in

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

    NARCIS (Netherlands)

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

    2015-01-01

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

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

    NARCIS (Netherlands)

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

    2015-01-01

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

  8. CONTRACT Study - CONservative TReatment of Appendicitis in Children (feasibility): study protocol for a randomised controlled Trial.

    Science.gov (United States)

    Hutchings, Natalie; Wood, Wendy; Reading, Isabel; Walker, Erin; Blazeby, Jane M; Van't Hoff, William; Young, Bridget; Crawley, Esther M; Eaton, Simon; Chorozoglou, Maria; Sherratt, Frances C; Beasant, Lucy; Corbett, Harriet; Stanton, Michael P; Grist, Simon; Dixon, Elizabeth; Hall, Nigel J

    2018-03-02

    Currently, the routine treatment for acute appendicitis in the United Kingdom is an appendicectomy. However, there is increasing scientific interest and research into non-operative treatment of appendicitis in adults and children. While a number of studies have investigated non-operative treatment of appendicitis in adults, this research cannot be applied to the paediatric population. Ultimately, we aim to perform a UK-based multicentre randomised controlled trial (RCT) to test the clinical and cost effectiveness of non-operative treatment of acute uncomplicated appendicitis in children, as compared with appendicectomy. First, we will undertake a feasibility study to assess the feasibility of performing such a trial. The study involves a feasibility RCT with a nested qualitative research to optimise recruitment as well as a health economic substudy. Children (aged 4-15 years inclusive) diagnosed with acute uncomplicated appendicitis that would normally be treated with an appendicectomy are eligible for the RCT. Exclusion criteria include clinical/radiological suspicion of perforated appendicitis, appendix mass or previous non-operative treatment of appendicitis. Participants will be randomised into one of two arms. Participants in the intervention arm are treated with antibiotics and regular clinical assessment to ensure clinical improvement. Participants in the control arm will receive appendicectomy. Randomisation will be minimised by age, sex, duration of symptoms and centre. Children and families who are approached for the RCT will be invited to participate in the embedded qualitative substudy, which includes recording of recruitment consultants and subsequent interviews with participants and non-participants and their families and recruiters. Analyses of these will inform interventions to optimise recruitment. The main study outcomes include recruitment rate (primary outcome), identification of strategies to optimise recruitment, performance of trial treatment

  9. SYSTEMS-2: A randomised phase II study of radiotherapy dose escalation for pain control in malignant pleural mesothelioma

    Directory of Open Access Journals (Sweden)

    M. Ashton

    2018-01-01

    Full Text Available SYSTEMS-2 is a randomised study of radiotherapy dose escalation for pain control in 112 patients with malignant pleural mesothelioma (MPM. Standard palliative (20 Gy/5# or dose escalated treatment (36 Gy/6# will be delivered using advanced radiotherapy techniques and pain responses will be compared at week 5. Data will guide optimal palliative radiotherapy in MPM.

  10. Evaluation of biases present in the cohort multiple randomised controlled trial design : a simulation study

    NARCIS (Netherlands)

    Candlish, Jane; Pate, Alexander; Sperrin, Matthew; Staa, Tjeerd P van

    2017-01-01

    BACKGROUND: The cohort multiple randomised controlled trial (cmRCT) design provides an opportunity to incorporate the benefits of randomisation within clinical practice; thus reducing costs, integrating electronic healthcare records, and improving external validity. This study aims to address a key

  11. Pressure RElieving Support SUrfaces: a Randomised Evaluation 2 (PRESSURE 2): study protocol for a randomised controlled trial.

    Science.gov (United States)

    Brown, Sarah; Smith, Isabelle L; Brown, Julia M; Hulme, Claire; McGinnis, Elizabeth; Stubbs, Nikki; Nelson, E Andrea; Muir, Delia; Rutherford, Claudia; Walker, Kay; Henderson, Valerie; Wilson, Lyn; Gilberts, Rachael; Collier, Howard; Fernandez, Catherine; Hartley, Suzanne; Bhogal, Moninder; Coleman, Susanne; Nixon, Jane E

    2016-12-20

    Pressure ulcers represent a major burden to patients, carers and the healthcare system, affecting approximately 1 in 17 hospital and 1 in 20 community patients. They impact greatly on an individual's functional status and health-related quality of life. The mainstay of pressure ulcer prevention practice is the provision of pressure redistribution support surfaces and patient repositioning. The aim of the PRESSURE 2 study is to compare the two main mattress types utilised within the NHS: high-specification foam and alternating pressure mattresses, in the prevention of pressure ulcers. PRESSURE 2 is a multicentre, open-label, randomised, double triangular, group sequential, parallel group trial. A maximum of 2954 'high-risk' patients with evidence of acute illness will be randomised on a 1:1 basis to receive either a high-specification foam mattress or alternating-pressure mattress in conjunction with an electric profiling bed frame. The primary objective of the trial is to compare mattresses in terms of the time to developing a new Category 2 or above pressure ulcer by 30 days post end of treatment phase. Secondary endpoints include time to developing new Category 1 and 3 or above pressure ulcers, time to healing of pre-existing Category 2 pressure ulcers, health-related quality of life, cost-effectiveness, incidence of mattress change and safety. Validation objectives are to determine the responsiveness of the Pressure Ulcer Quality of Life-Prevention instrument and the feasibility of having a blinded endpoint assessment using photography. The trial will have a maximum of three planned analyses with unequally spaced reviews at event-driven coherent cut-points. The futility boundaries are constructed as non-binding to allow a decision for stopping early to be overruled by the Data Monitoring and Ethics Committee. The double triangular, group sequential design of the PRESSURE 2 trial will provide an efficient design through the possibility of early stopping for

  12. Study protocol of the SWORD-study: a randomised controlled trial comparing combined online and face-to-face cognitive behaviour therapy versus treatment as usual in managing fear of cancer recurrence

    NARCIS (Netherlands)

    Wal, M.A. van de; Gielissen, M.F.M.; Servaes, P.; Knoop, H.; Speckens, A.E.M.; Prins, J.B.

    2015-01-01

    BACKGROUND: Fear of cancer recurrence (FCR) is one of the most frequently cited problems by cancer survivors. More than one third report high FCR, which is a clinical concern due to its association with negative health outcomes. The aim of the current study is to evaluate the efficacy of cognitive

  13. Cognitive rehabiliation for Parkinson's disease demantia: a study protocol for a pilot randomised controlled trial.

    Science.gov (United States)

    Hindle, John V; Watermeyer, Tamlyn J; Roberts, Julie; Martyr, Anthony; Lloyd-Williams, Huw; Brand, Andrew; Gutting, Petra; Hoare, Zoe; Edwards, Rhiannon Tudor; Clare, Linda

    2016-03-22

    There is growing interest in developing non-pharmacological treatments to address the cognitive deficits apparent in Parkinson's disease dementia and dementia with Lewy bodies. Cognitive rehabilitation is a goal-oriented behavioural intervention which focuses on improving everyday functioning through management of cognitive difficulties; it has been shown to be effective in Alzheimer's disease. To date, no studies have assessed its potential efficacy for addressing the impact of cognitive impairment in people with Parkinson's disease or dementia with Lewy bodies. Participants (n = 45) will be recruited from movement disorders, care for the elderly and memory clinics. Inclusion criteria include: a diagnosis of Parkinson's disease, Parkinson's disease dementia or dementia with Lewy bodies according to consensus criteria and an Addenbrooke's Cognitive Examination - III score of ≤ 82. Exclusion criteria include: a diagnosis of any other significant neurological condition; major psychiatric disorder, including depression, which is not related to the patient's Parkinson's disease and unstable medication use for their physical or cognitive symptoms. A single-blind pilot randomised controlled trial, with concurrent economic evaluation, will compare the relative efficacy of cognitive rehabilitation with that of two control conditions. Following a goal-setting interview, the participants will be randomised to one of the three study arms: cognitive rehabilitation (eight weekly sessions), relaxation therapy (eight weekly sessions) or treatment as usual. Randomisation and treatment group allocation will be carried out by a clinical trials unit using a dynamic adaptive sequential randomisation algorithm. The primary outcomes are patients' perceived goal attainment at a 2-months post-intervention assessment and a 6-months follow-up. Secondary outcomes include patients' objective cognitive performance (on tests of memory and executive function) and satisfaction with goal

  14. Personalised long-term follow-up of cochlear implant patients using remote care, compared with those on the standard care pathway: study protocol for a feasibility randomised controlled trial.

    Science.gov (United States)

    Cullington, Helen; Kitterick, Padraig; DeBold, Lisa; Weal, Mark; Clarke, Nicholas; Newberry, Eva; Aubert, Lisa

    2016-05-13

    Many resources are required to provide postoperative care to patients who receive a cochlear implant. The implant service commits to lifetime follow-up. The patient commits to regular adjustment and rehabilitation appointments in the first year and annual follow-up appointments thereafter. Offering remote follow-up may result in more stable hearing, reduced patient travel expense, time and disruption, more empowered patients, greater equality in service delivery and more freedom to optimise the allocation of clinic resources. This will be a two-arm feasibility randomised controlled trial (RCT) involving 60 adults using cochlear implants with at least 6 months device experience in a 6-month clinical trial of remote care. This project will design, implement and evaluate a person-centred long-term follow-up pathway for people using cochlear implants offering a triple approach of remote and self-monitoring, self-adjustment of device and a personalised online support tool for home speech recognition testing, information, self-rehabilitation, advice, equipment training and troubleshooting. The main outcome measure is patient activation. Secondary outcomes are stability and quality of hearing, stability of quality of life, clinic resources, patient and clinician experience, and any adverse events associated with remote care. We will examine the acceptability of remote care to service users and clinicians, the willingness of participants to be randomised, and attrition rates. We will estimate numbers required to plan a fully powered RCT. Ethical approval was received from North West-Greater Manchester South Research Ethics Committee (15/NW/0860) and the University of Southampton Research Governance Office (ERGO 15329). Results will be disseminated in the clinical and scientific communities and also to the patient population via peer-reviewed research publications both online and in print, conference and meeting presentations, posters, newsletter articles, website reports

  15. Help from home for depression: A randomised controlled trial comparing internet-delivered cognitive behaviour therapy with bibliotherapy for depression

    Directory of Open Access Journals (Sweden)

    Jessica Smith

    2017-09-01

    Full Text Available Major Depressive Disorder (MDD is a leading cause of the Global Burden of Disease. Cognitive Behavioural Therapy (CBT is an effective treatment for MDD, but access can be impaired due to numerous barriers. Internet-delivered CBT (iCBT can be utilised to overcome treatment barriers and is an effective treatment for depression, but has never been compared to bibliotherapy. This Randomised Controlled Trial (RCT included participants meeting diagnostic criteria for MDD (n = 270 being randomised to either: iCBT (n = 61, a CBT self-help book (bCBT (n = 77, a meditation self-help book (bMED (n = 64 or wait-list control (WLC (n = 68. The primary outcome was the Patient Health Questionnaire 9-item scale (PHQ-9 at 12-weeks (post-treatment. All three active interventions were significantly more effective than WLC in reducing depression at post-treatment, but there were no significant differences between the groups. All three interventions led to large within-group reductions in PHQ-9 scores at post-treatment (g = 0.88–1.69, which were maintained at 3-month follow-up, although there was some evidence of relapse in the bMED group (within-group g [post to follow-up] = 0.09–1.04. Self-help based interventions could be beneficial in treating depression, however vigilance needs to be applied when selecting from the range of materials available. Replication of this study with a larger sample is required.

  16. Results of a prospective randomised trial comparing conventional radiotherapy to split course bifractionated radiation therapy in patients with nasopharyngeal carcinoma

    International Nuclear Information System (INIS)

    Daoud, Jamel; Toumi, Nabil; Siala, Wissem; Ghorbel, Abdelmonem; Drira, Mohamed Mokthar; Frikha, Mounir

    2007-01-01

    Background and purpose: Nasopharyngeal carcinoma (NPC) is generally responsive to radiation therapy. However therapeutic results after conventional radiotherapy remain relatively poor especially for patients with locoregional advanced NPC. The aim of this study was to evaluate the impact of a split course bifractionated radiotherapy regimen in a phase III randomised trial. Patients and methods: From January 1997 to September 2003, 154 patients with M0 histologically proven NPC were treated in our institution. They were staged according to the American Joint Committee on Cancer - International Union Against Cancer (AJCC-UICC) 1986 TNM classification. Patients with locally advanced nodal disease (N2-N3) received induction chemotherapy. All patients were randomised to receive either conventional radiotherapy at 2 Gy/fraction/day, 5 days/week to 70 Gy/7 weeks or split course bifractionated radiotherapy at 1.6 Gy/fraction, twice daily, 5 days/week to 70.4 Gy/6 weeks. Response and toxicity were evaluated according to the WHO and RTOG criteria. Results: Patients were well balanced between the two arms. The complete remission rate was 91% in conventional radiotherapy arm and 93% in bifractionated radiotherapy arm (p = 0.3). There was more grade II-III skin fibrosis in experimental arm with a 5 year actuarial probability of 66% vs 52% (p = 0.04). Locoregional and distant relapses occurred in 34% of cases in conventional arm and 38% in experimental arm (p = 0.28). With a median follow-up of 56 months, the 5 year overall survival and the disease free survival rates were, respectively (71% and 61%), in conventional arm and (62% and 60%) in bifractionated arm, the difference being statistically non significant. Comments: The present trial comparing conventional radiotherapy to a split course bifractionated radiation therapy failed to demonstrate significant improvement in locoregional control and survival in experimental arm which was associated with more grade II-III skin

  17. Randomised and non-randomised studies to estimate the effect of community-level public health interventions: definitions and methodological considerations.

    Science.gov (United States)

    Schmidt, Wolf-Peter

    2017-01-01

    The preferred method to evaluate public health interventions delivered at the level of whole communities is the cluster randomised trial (CRT). The practical limitations of CRTs and the need for alternative methods continue to be debated. There is no consensus on how to classify study designs to evaluate interventions, and how different design features are related to the strength of evidence. This article proposes that most study designs for the evaluation of cluster-level interventions fall into four broad categories: the CRT, the non-randomised cluster trial (NCT), the controlled before-and-after study (CBA), and the before-and-after study without control (BA). A CRT needs to fulfil two basic criteria: (1) the intervention is allocated at random; (2) there are sufficient clusters to allow a statistical between-arm comparison. In a NCT, statistical comparison is made across trial arms as in a CRT, but treatment allocation is not random. The defining feature of a CBA is that intervention and control arms are not compared directly, usually because there are insufficient clusters in each arm to allow a statistical comparison. Rather, baseline and follow-up measures of the outcome of interest are compared in the intervention arm, and separately in the control arm. A BA is a CBA without a control group. Each design may provide useful or misleading evidence. A precise baseline measurement of the outcome of interest is critical for causal inference in all studies except CRTs. Apart from statistical considerations the exploration of pre/post trends in the outcome allows a more transparent discussion of study weaknesses than is possible in non-randomised studies without a baseline measure.

  18. The Women's international study of long-duration oestrogen after menopause (WISDOM: a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Meade Tom W

    2007-02-01

    Full Text Available Abstract Background At the time of feasibility work and final design of the trial there was no randomised control trial evidence for the long-term risks and benefits of hormone replacement therapy. Observational studies had suggested that long term use of estrogen was likely to be associated, amongst other things, with reduced risks of osteoporosis and ischaemic heart disease and increased risks of breast and endometrial cancer. Concomitant use of progestogens had been shown to protect against endometrial cancer, but there were few data showing how progestogen might affect estrogen actions on other conditions. Disease specific risks from observational studies suggested that, overall, long-term HRT was likely to be beneficial. Several studies showed that mortality from all causes was lower in HRT users than in non-users. Some secondary cardiovascular prevention trials were ongoing but evidence was also required for a range of outcomes in healthy women. The WISDOM trial was designed to compare combined estrogen and progestogen versus placebo, and estrogen alone versus combined estrogen and progestogen. During the development of WISDOM the Women's Health Initiative trial was designed, funded and started in the US. Design Randomised, placebo, controlled, trial. Methods The trial was set in general practices in the UK (384, Australia (94, and New Zealand (24. In these practices 284175 women aged 50–69 years were registered with 226282 potentially eligible. We sought to randomise 22300 postmenopausal women aged 50 – 69 and treat for ten years. The interventions were: conjugated equine estrogens, 0.625 mg orally daily; conjugated equine estrogens plus medroxyprogesterone acetate 2.5/5.0 mg orally daily; matched placebo. Primary outcome measures were: major cardiovascular disease, osteoporotic fractures, breast cancer and dementia. Secondary outcomes were: other cancers, all cause death, venous thromboembolism and cerebro-vascular disease. Results

  19. Randomised trial comparing hysterectomy with endometrial ablation for dysfunctional uterine bleeding: psychiatric and psychosocial aspects.

    Science.gov (United States)

    Alexander, D. A.; Naji, A. A.; Pinion, S. B.; Mollison, J.; Kitchener, H. C.; Parkin, D. E.; Abramovich, D. R.; Russell, I. T.

    1996-01-01

    OBJECTIVE: To compare in psychiatric and psychosocial terms the outcome of hysterectomy and endometrial ablation for the treatment of dysfunctional uterine bleeding. DESIGN: Prospective randomised controlled trial. SETTING--Obstetrics and gynaecology department of a large teaching hospital. SUBJECTS: 204 women with dysfunctional bleeding for whom hysterectomy would have been the preferred treatment were recruited over 24 months and randomly allocated to hysterectomy (99 women) or to hysteroscopic surgery (transcervical resection (52 women) or laser ablation (53 women). MAIN OUTCOME MEASURES: Mental state, martial relationship, psychosocial and sexual adjustment in assessments conducted before the operation and one month, six months, and 12 months later. RESULTS: Both treatments significantly reduced the anxiety and depression present before the operation, and there were no differences in mental health between the groups at 12 months. Hysterectomy did not lead to postoperative psychiatric illness. Sexual interest after the operation did not vary with treatment. Overall, 46 out of 185 (25%) women reported a loss sexual interest and 50 out of 185 (27%) reported increased sexual interest. Marital relationships were unaffected by surgery. Personality and duration of dysfunctional uterine bleeding played no significant part in determining outcome. CONCLUSIONS: Hysteroscopic surgery and hysterectomy have a similar effect on psychiatric and psychosocial outcomes. There is no evidence that hysterectomy leads to postoperative psychiatric illness. PMID:8611783

  20. A randomised controlled trial of benefit finding in caregivers: The Building Resources in Caregivers Study Protocol

    Directory of Open Access Journals (Sweden)

    Charles Brand

    2015-07-01

    Full Text Available Caregivers may engage in benefit finding, that is, an increase in perceived positive growth, as a cognitive strategy for coping with stress. The Building Resources in Caregivers study will compare effects of a brief benefit finding writing intervention with a control intervention. Caregivers of people with mental and physical disabilities will be randomised into either a benefit-writing group or a neutral writing group. Caregivers will complete measures relating to themselves and care-recipients (e.g. sociodemographics and illness type and psychometric measures of benefit finding, distress and quality of life at three time points. Additionally, qualitative commentary on participation experiences will be gathered.

  1. Safety and efficacy of antibiotics compared with appendicectomy for treatment of uncomplicated acute appendicitis: meta-analysis of randomised controlled trials

    Science.gov (United States)

    Varadhan, Krishna K; Neal, Keith R

    2012-01-01

    Objective To compare the safety and efficacy of antibiotic treatment versus appendicectomy for the primary treatment of uncomplicated acute appendicitis. Design Meta-analysis of randomised controlled trials. Population Randomised controlled trials of adult patients presenting with uncomplicated acute appendicitis, diagnosed by haematological and radiological investigations. Interventions Antibiotic treatment versus appendicectomy. Outcome measures The primary outcome measure was complications. The secondary outcome measures were efficacy of treatment, length of stay, and incidence of complicated appendicitis and readmissions. Results Four randomised controlled trials with a total of 900 patients (470 antibiotic treatment, 430 appendicectomy) met the inclusion criteria. Antibiotic treatment was associated with a 63% (277/438) success rate at one year. Meta-analysis of complications showed a relative risk reduction of 31% for antibiotic treatment compared with appendicectomy (risk ratio (Mantel-Haenszel, fixed) 0.69 (95% confidence interval 0.54 to 0.89); I2=0%; P=0.004). A secondary analysis, excluding the study with crossover of patients between the two interventions after randomisation, showed a significant relative risk reduction of 39% for antibiotic therapy (risk ratio 0.61 (0.40 to 0.92); I2=0%; P=0.02). Of the 65 (20%) patients who had appendicectomy after readmission, nine had perforated appendicitis and four had gangrenous appendicitis. No significant differences were seen for treatment efficacy, length of stay, or risk of developing complicated appendicitis. Conclusion Antibiotics are both effective and safe as primary treatment for patients with uncomplicated acute appendicitis. Initial antibiotic treatment merits consideration as a primary treatment option for early uncomplicated appendicitis. PMID:22491789

  2. Efficacy and safety of the partial PPARγ agonist balaglitazone compared with pioglitazone and placebo: A phase III, randomised, parallel-group study in patients with type 2 diabetes on stable insulin therapy

    DEFF Research Database (Denmark)

    Henriksen, Kim; Byrjalsen, Inger; Qvist, Per

    2011-01-01

    Treatment of patients with full PPARγ agonists is associated with weight gain, heart failure, peripheral oedema and bone loss. However, the safety of partial PPARγ agonists has not been established in a clinical trial. The BALLET trial aimed to establish the glucose-lowering effects and safety...... in all treatment arms. DXA analyses showed balaglitazone 10mg led to less fat and fluid accumulation and no change in bone mineral density, when compared to pioglitazone. In the balaglitazone 10mg treated group clinically relevant reductions in HbA(1c) and glucose levels were observed, although...... it appeared to be a little less potent that pioglitazone 45mg. On the other hand significantly less fluid and fat accumulation were observed, highlighting this treatment regimen for further studies....

  3. Randomised Controlled Trial Study of the Effect of TENS and NSAID ...

    African Journals Online (AJOL)

    Randomised Controlled Trial Study of the Effect of TENS and NSAID (Opoid) Drug in the Management of Post Operative Gynaecological Pain. AAG Jimoh, LO Omokanye, GA Salaudeen, ZA Suleiman, K Durowade, EO Adewara ...

  4. Evaluation of biases present in the cohort multiple randomised controlled trial design: a simulation study

    Directory of Open Access Journals (Sweden)

    Jane Candlish

    2017-01-01

    Full Text Available Abstract Background The cohort multiple randomised controlled trial (cmRCT design provides an opportunity to incorporate the benefits of randomisation within clinical practice; thus reducing costs, integrating electronic healthcare records, and improving external validity. This study aims to address a key concern of the cmRCT design: refusal to treatment is only present in the intervention arm, and this may lead to bias and reduce statistical power. Methods We used simulation studies to assess the effect of this refusal, both random and related to event risk, on bias of the effect estimator and statistical power. A series of simulations were undertaken that represent a cmRCT trial with time-to-event endpoint. Intention-to-treat (ITT, per protocol (PP, and instrumental variable (IV analysis methods, two stage predictor substitution and two stage residual inclusion, were compared for various refusal scenarios. Results We found the IV methods provide a less biased estimator for the causal effect when refusal is present in the intervention arm, with the two stage residual inclusion method performing best with regards to minimum bias and sufficient power. We demonstrate that sample sizes should be adapted based on expected and actual refusal rates in order to be sufficiently powered for IV analysis. Conclusion We recommend running both an IV and ITT analyses in an individually randomised cmRCT as it is expected that the effect size of interest, or the effect we would observe in clinical practice, would lie somewhere between that estimated with ITT and IV analyses. The optimum (in terms of bias and power instrumental variable method was the two stage residual inclusion method. We recommend using adaptive power calculations, updating them as refusal rates are collected in the trial recruitment phase in order to be sufficiently powered for IV analysis.

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

    Science.gov (United States)

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

    2015-06-01

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

  6. Translation of randomised controlled trial findings into clinical practice: comparison of olanzapine and valproate in the EMBLEM study

    DEFF Research Database (Denmark)

    Novick, D; Gonzalez-Pinto, A; Haro, J M

    2009-01-01

    OBJECTIVES: The aim of this study was to compare the outcomes of olanzapine- and valproate-treated patients in an observational study of acute mania with the results of a randomised controlled trial (RCT) assessing the same treatments. METHODS: EMBLEM (European Mania in Bipolar Evaluation......: The EMBLEM results support those of the RCT, which suggest that olanzapine monotherapy seems to be more effective than valproate monotherapy in the treatment of acute mania....

  7. Deviation from intention to treat analysis in randomised trials and treatment effect estimates: meta-epidemiological study.

    Science.gov (United States)

    Abraha, Iosief; Cherubini, Antonio; Cozzolino, Francesco; De Florio, Rita; Luchetta, Maria Laura; Rimland, Joseph M; Folletti, Ilenia; Marchesi, Mauro; Germani, Antonella; Orso, Massimiliano; Eusebi, Paolo; Montedori, Alessandro

    2015-05-27

    To examine whether deviation from the standard intention to treat analysis has an influence on treatment effect estimates of randomised trials. Meta-epidemiological study. Medline, via PubMed, searched between 2006 and 2010; 43 systematic reviews of interventions and 310 randomised trials were included. From each year searched, random selection of 5% of intervention reviews with a meta-analysis that included at least one trial that deviated from the standard intention to treat approach. Basic characteristics of the systematic reviews and randomised trials were extracted. Information on the reporting of intention to treat analysis, outcome data, risk of bias items, post-randomisation exclusions, and funding were extracted from each trial. Trials were classified as: ITT (reporting the standard intention to treat approach), mITT (reporting a deviation from the standard approach), and no ITT (reporting no approach). Within each meta-analysis, treatment effects were compared between mITT and ITT trials, and between mITT and no ITT trials. The ratio of odds ratios was calculated (value deviated from the intention to treat analysis showed larger intervention effects than trials that reported the standard approach. Where an intention to treat analysis is impossible to perform, authors should clearly report who is included in the analysis and attempt to perform multiple imputations. © Abraha et al 2015.

  8. Homeopathy for Perennial Asthma in Adolescents: Pilot Feasibility Study Testing a Randomised Withdrawal Design.

    Science.gov (United States)

    Mitchiguian Hotta, Livia; Cardinalli Adler, Ubiratan; de Toledo Cesar, Amarilys; Martinez, Edson Zangiacomi; Demarzo, Marcelo Marcos Piva

    2018-05-01

     Previous findings from a pragmatic trial suggest that usual care compared with usual care plus individualised homeopathy is not a feasible design to address homeopathic interventions for asthma.  The main purpose of this article was to investigate the feasibility of the randomised withdrawal design as a strategy to assess the effectiveness of a standardised clinical-pharmaceutical homeopathic protocol ( Organon.modus ) on perennial asthma in adolescents.  Randomised withdrawal, double-blind, parallel, placebo-controlled, 12-week study. 12 to 17 years old adolescents, with the diagnosis of perennial asthma, using inhalatory beclomethasone (plus fenoterol for wheezing episodes), who achieved 3 months of well-controlled asthma, after a variable period of individualised homeopathic treatment according to Organon.modus protocol. a secondary care medical specialist centre. continuation with the individualised homeopathic medicine or with indistinguishable placebo during 12 weeks of beclomethasone step-down. number of days of well-controlled asthma. Secondary measures: number of days of fenoterol use, number of visits to an emergency service (without hospitalisation) and percentage of patients excluded due to an exacerbation characterising a partly controlled asthma. Tolerability was assessed by Adverse Events, registered at every visit.  Nineteen patients were randomised to continue treatment with homeopathy and 21 with placebo. Effectiveness measures for the homeopathy and placebo groups respectively were median number of days of good clinical control: 84 versus 30 ( p  = 0.18); median number of days of fenoterol use per patient: 3 versus 5 ( p  = 0.41); visits to an emergency room: 1 versus 6 ( p  = 0.35); percentage of exclusion due to partly controlled asthma: 36.8% versus 71.4% ( p  = 0.05). Few Adverse Events were reported.  This pilot study supports the feasibility of the double-blind randomised withdrawal design in studies investigating

  9. Comparative Studies for What?

    Directory of Open Access Journals (Sweden)

    Pedro Guedes de Carvalho

    2017-12-01

    Full Text Available ISCPES stands for International Society for Comparative Physical Education and Sports and it is going to celebrate its 40th anniversary in 2018. Since the beginning (Israel 1978 the main goals of the Society were established under a worldwide mind set considering five continents and no discrimination of any kind. The founders wanted to compare Physical Education and Sports across the world, searching for the best practices deserving consideration and applied on the purpose of improving citizen quality of life. The mission still stands for “Compare to learn and improve”. As all the organizations lasting for 39 years, ISCPES experienced several vicissitudes, usually correlated with world economic cycles, social and sports changes, which are in ISS journal articles - International Sport Studies. ISS journal is Scopus indexed, aiming to improve its quality (under evaluation to reach more qualified students, experts, professionals and researchers; doing so it will raise its indexation, which we know it is nowadays a more difficult task. First, because there are more journals trying to compete on this academic fierce competitive market; secondly, because the basic requirements are getting more and more hard to gather in the publishing environment around Physical Education and Sports issues. However, we can promise this will be one of our main strategic goals. Another goal I would like to address on this Editorial is the language issue. We have this second strategic goal, which is to reach most of languages spoken in different continents; besides the English language, we will reach Chinese, Spanish and Portuguese speaking countries. For that reason, we already defined that all the abstracts in English will be translated into Chinese, Spanish and Portuguese words so people can find them on any search browser. That will expand the demand for our journal and articles, increasing the number of potential readers. Of course this opportunity, given by

  10. Operations dashboard: comparative study

    Science.gov (United States)

    Ramly, Noor Nashriq; Ismail, Ahmad Zuhairi; Aziz, Mohd Haris; Ahmad, Nurul Haszeli

    2011-10-01

    In this present days and age, there are increasing needs for companies to monitor application and infrastructure health. Apart from having proactive measures to secure their application and infrastructure, many see monitoring dashboards as crucial investment in disaster preparedness. As companies struggle to find the best solution to cater for their needs and interest for monitoring their application and infrastructure's health, this paper summarizes the studies made on several known off-the-shelf operations dashboard and in-house developed dashboard. A few criteria of good dashboard are collected from previous studies carried out by several researchers and rank them according to importance and business needs. The finalized criteria that will be discussed in later sections are data visualization, performance indicator, dashboard personalization, audit capability and alert/ notification. Comparative studies between several popular dashboards were then carried out to determine whether they met these criteria that we derived from the first exercise. The findings hopefully can be used to educate and provide an overview of selecting the best IT application and infrastructure operations dashboard that suit business needs, thus become the main contribution of this paper.

  11. Academic disintegrity among medical students: a randomised response technique study.

    Science.gov (United States)

    Mortaz Hejri, Sameh; Zendehdel, Kazem; Asghari, Fariba; Fotouhi, Akbar; Rashidian, Arash

    2013-02-01

    Medical students, as tomorrow's doctors, are responsible for their patients' health; cheating may affect their academic knowledge and clinical skills. The main purpose of this study was to investigate the frequency of and attitudes towards academic disintegrity among medical students at Tehran University of Medical Sciences (TUMS). Anonymous questionnaires including questions about various types of academic disintegrity were distributed among medical students during the clerkship and internship phases of the curriculum. Randomised response technique (RRT) was used to maintain the responders' privacy. Because the study design guaranteed the confidentiality of respondents, the TUMS Institutional Review Board declared that formal ethical approval was not required. A total of 124 students were enrolled in this study, of whom 63 were in the clerkship phase and 61 were in the internship phase. Of these respondents, 29% (n = 36) were male. The most frequently reported type of academic disintegrity was found to be 'impersonating an absent student in a class' (93%) and the least frequent to be 'legitimising absences by using bribes' (5%). Only a small number of interns considered 'buying hospital shifts', 'selling hospital shifts', 'impersonating an absent student' and 'helping others to cheat in examinations' as representing academic disintegrity. Approximately one third of participants stated that the RRT increased their confidence in anonymity and 90% of students found the use of RRT not difficult. Academic integrity is widely disrespected in different ways among medical students. Effective policies and interventions are required to control these misbehaviours in future doctors in order to optimise medical practice. Almost all respondents found it not difficult to use the RRT; the technique proved to be an effective and easily applied method of eliciting truthful responses to sensitive questions and represents an alternative to conventional anonymising techniques.

  12. Safety of a new compact catheter for men with neurogenic bladder dysfunction: a randomised, crossover and open-labelled study

    DEFF Research Database (Denmark)

    Chartier-Kastler, E; Lauge, I; Ruffion, A

    2011-01-01

    Self-catheterising males aged ≥18 years with spinal cord lesion and normal/impaired urethral sensation were enrolled in this comparative, randomised, crossover and open-labelled multicentre trial.......Self-catheterising males aged ≥18 years with spinal cord lesion and normal/impaired urethral sensation were enrolled in this comparative, randomised, crossover and open-labelled multicentre trial....

  13. Safety of a new compact catheter for men with neurogenic bladder dysfunction: a randomised, crossover and open-labelled study

    DEFF Research Database (Denmark)

    Chartier-Kastler, E; Lauge, I; Ruffion, A

    2011-01-01

    Self-catheterising males aged =18 years with spinal cord lesion and normal/impaired urethral sensation were enrolled in this comparative, randomised, crossover and open-labelled multicentre trial.......Self-catheterising males aged =18 years with spinal cord lesion and normal/impaired urethral sensation were enrolled in this comparative, randomised, crossover and open-labelled multicentre trial....

  14. Ibrutinib combined with bendamustine and rituximab compared with placebo, bendamustine, and rituximab for previously treated chronic lymphocytic leukaemia or small lymphocytic lymphoma (HELIOS): a randomised, double-blind, phase 3 study.

    Science.gov (United States)

    Chanan-Khan, Asher; Cramer, Paula; Demirkan, Fatih; Fraser, Graeme; Silva, Rodrigo Santucci; Grosicki, Sebastian; Pristupa, Aleksander; Janssens, Ann; Mayer, Jiri; Bartlett, Nancy L; Dilhuydy, Marie-Sarah; Pylypenko, Halyna; Loscertales, Javier; Avigdor, Abraham; Rule, Simon; Villa, Diego; Samoilova, Olga; Panagiotidis, Panagiots; Goy, Andre; Mato, Anthony; Pavlovsky, Miguel A; Karlsson, Claes; Mahler, Michelle; Salman, Mariya; Sun, Steven; Phelps, Charles; Balasubramanian, Sriram; Howes, Angela; Hallek, Michael

    2016-02-01

    Most patients with chronic lymphocytic leukaemia or small lymphocytic lymphoma relapse after initial therapy. Bendamustine plus rituximab is often used in the relapsed or refractory setting. We assessed the efficacy and safety of adding ibrutinib, an oral covalent inhibitor of Bruton's tyrosine kinase (BTK), to bendamustine plus rituximab in patients with previously treated chronic lymphocytic leukaemia or small lymphocytic lymphoma. The HELIOS trial was an international, double-blind, placebo-controlled, phase 3 study in adult patients (≥18 years of age) who had active chronic lymphocytic leukaemia or small lymphocytic lymphoma with measurable lymph node disease (>1·5 cm) by CT scan, and had relapsed or refractory disease following one or more previous lines of systemic therapy consisting of at least two cycles of a chemotherapy-containing regimen, an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, and adequate bone marrow, liver, and kidney function. Patients with del(17p) were excluded because of known poor response to bendamustine plus rituximab. Patients who had received previous treatment with ibrutinib or other BTK inhibitors, refractory disease or relapse within 24 months with a previous bendamustine-containing regimen, or haemopoietic stem-cell transplant were also excluded. Patients were randomly assigned (1:1) by a web-based system to receive bendamustine plus rituximab given in cycles of 4 weeks' duration (bendamustine: 70 mg/m(2) intravenously on days 2-3 in cycle 1, and days 1-2 in cycles 2-6; rituximab: 375 mg/m(2) on day 1 of cycle 1, and 500 mg/m(2) on day 1 of cycles 2-6 for a maximum of six cycles) with either ibrutinib (420 mg daily orally) or placebo until disease progression or unacceptable toxicity. Patients were stratified according to whether they were refractory to purine analogues and by number of previous lines of therapy. The primary endpoint was independent review committee (IRC)-assessed progression

  15. A Randomised Clinical Trial to Compare Coaxial and Noncoaxial Techniques in Percutaneous Core Needle Biopsy of Renal Parenchyma

    International Nuclear Information System (INIS)

    Babaei Jandaghi, Ali; Lebady, Mohammadkazem; Zamani, Athar-Alsadat; Heidarzadeh, Abtin; Monfared, Ali; Pourghorban, Ramin

    2017-01-01

    PurposeTo compare the coaxial and noncoaxial techniques of renal parenchymal core needle biopsy.Materials and MethodsThis is an institutional review board-approved randomised controlled trial comparing 83 patients (male, n = 49) who underwent renal parenchymal core biopsy with coaxial method and 83 patients (male, n = 40) with noncoaxial method. The rate of complications, the number of glomerular profiles, and the procedural time were evaluated in a comparison of the two methods. Correlation between the presence of renal parenchymal disease and the rate of complication was also evaluated.ResultsThe procedural time was significantly shorter in the coaxial technique (coaxial group, 5 ± 1 min; noncoaxial group, 14 ± 2 min; p < 0.001). The rates of complications for the coaxial method was significantly lower than the noncoaxial method (coaxial group, 10.8 %; noncoaxial group, 24.1 %; p = 0.025). There was no significant correlation between gender and the rate of complication. The number of glomerular profiles was significantly higher in patents who underwent renal biopsy with the coaxial method (coaxial group, 18.2 ± 9.1; noncoaxial group, 8.6 ± 5.5; p < 0.001). In the whole study population, the rate of complications was significantly higher in patients with a pathologic renal parenchyma compared to those with a normal parenchyma (19/71 vs. 10/95; p = 0.006).ConclusionsRenal parenchymal biopsy using a coaxial needle is a faster and safer method with a lower rate of complications.

  16. A Randomised Clinical Trial to Compare Coaxial and Noncoaxial Techniques in Percutaneous Core Needle Biopsy of Renal Parenchyma

    Energy Technology Data Exchange (ETDEWEB)

    Babaei Jandaghi, Ali [Guilan University of Medical Sciences, Department of Radiology, Poursina Hospital (Iran, Islamic Republic of); Lebady, Mohammadkazem; Zamani, Athar-Alsadat [Guilan University of Medical Sciences, Urology Research Center, Razi Hospital (Iran, Islamic Republic of); Heidarzadeh, Abtin [Guilan University of Medical Sciences, Department of Community Medicine (Iran, Islamic Republic of); Monfared, Ali [Guilan University of Medical Sciences, Urology Research Center, Razi Hospital (Iran, Islamic Republic of); Pourghorban, Ramin, E-mail: ramin-p2005@yahoo.com [Tehran University of Medical Sciences, Department of Radiology, Imam Khomeini Hospital Complex (Iran, Islamic Republic of)

    2017-01-15

    PurposeTo compare the coaxial and noncoaxial techniques of renal parenchymal core needle biopsy.Materials and MethodsThis is an institutional review board-approved randomised controlled trial comparing 83 patients (male, n = 49) who underwent renal parenchymal core biopsy with coaxial method and 83 patients (male, n = 40) with noncoaxial method. The rate of complications, the number of glomerular profiles, and the procedural time were evaluated in a comparison of the two methods. Correlation between the presence of renal parenchymal disease and the rate of complication was also evaluated.ResultsThe procedural time was significantly shorter in the coaxial technique (coaxial group, 5 ± 1 min; noncoaxial group, 14 ± 2 min; p < 0.001). The rates of complications for the coaxial method was significantly lower than the noncoaxial method (coaxial group, 10.8 %; noncoaxial group, 24.1 %; p = 0.025). There was no significant correlation between gender and the rate of complication. The number of glomerular profiles was significantly higher in patents who underwent renal biopsy with the coaxial method (coaxial group, 18.2 ± 9.1; noncoaxial group, 8.6 ± 5.5; p < 0.001). In the whole study population, the rate of complications was significantly higher in patients with a pathologic renal parenchyma compared to those with a normal parenchyma (19/71 vs. 10/95; p = 0.006).ConclusionsRenal parenchymal biopsy using a coaxial needle is a faster and safer method with a lower rate of complications.

  17. Weight loss in a UK commercial all meal provision study: a randomised controlled trial.

    Science.gov (United States)

    Mellor, D D; Whitham, C; Goodwin, S; Morris, M; Reid, M; Atkin, S L

    2014-08-01

    Effective approaches are needed to address the increasing prevalence of overweight and obesity. The present study investigated whether all meal provision was a more effective and acceptable method for weight loss than a self-directed diet. This randomised controlled trial recruited 112 men and women with a body mass index in the range 27-35 kg m(-2), who had no comorbidities, from the local area of Hull. Participants were randomised to receive either meal provision or follow a self-directed diet for a 12-week period that resulted in an estimated 2928 kJ day(-1) (700 kcal day(-1)) deficit. A dietitian supervised both dietary interventions. At 12 weeks [mean (SEM)], percentage weight loss in the meal provision group was 6.6% (0.5%) compared to 4.3% (0.6%) for those on the self-directed diet. In terms of clinically relevant weight loss, 61% of participants lost 5% or more of their body weight with meal provision compared to 22% on the self-directed diet (P meal provision withdrawing from the study compared to 41% of those following the self-directed diet (P Meal provision was a more effective and accepted method for weight loss over a 12-week period compared to a self-directed diet. This may in part represent the difference between being given the meal provision food free of charge. However, longer-term maintenance studies need to be undertaken to ascertain their effects on the maintenance of weight loss. © 2013 The Authors. Journal of Human Nutrition and Dietetics published by John Wiley & Sons Ltd on behalf of British Dietetic Association Ltd.

  18. Heartburn treatment in primary care: randomised, double blind study for 8 weeks

    Science.gov (United States)

    Hatlebakk, Jan G; Hyggen, Arild; Madsen, Per H; Walle, Per O; Schulz, Tom; Mowinckel, Petter; Bernklev, Tomm; Berstad, Arnold

    1999-01-01

    Objective To compare the effects and tolerability of omeprazole and cisapride with that of placebo for control of heartburn in primary care patients. Design Randomised, double blind, placebo controlled study. Setting 65 primary care practices in Norway. Participants 483 untreated patients with complaints of heartburn ⩾3 days a week, with at most grade 1 reflux oesophagitis. Interventions Omeprazole 20 mg once daily, cisapride 20 mg twice daily, or placebo for 8 weeks. Main outcome measures Adequate control of heartburn, defined as ⩽1 day of the past 7 days with no more than mild heartburn, after 4 weeks of treatment. Results In the all patients treated analysis, adequate control of heartburn was achieved in 71% of patients taking omeprazole, 22% taking cisapride, and 18% taking placebo after 4 weeks of treatment (omeprazole v cisapride and placebo, Pheartburn whereas cisapride 20 mg twice daily was not significantly more effective than placebo. Key messagesIn primary care patients, heartburn is commonly treated empiricallyMost randomised clinical trials of treatment for heartburn have been conducted in specialist care, and documentation for empirical treatment is limitedOmeprazole was significantly more effective than cisapride or placebo in controlling heartburn and other symptoms of gastro-oesophageal reflux after 2, 4, and 8 weeks, whereas cisapride did not differ significantly from placeboOmeprazole should be considered as a first choice for empirical treatment of heartburn in primary care PMID:10463897

  19. Immediate interruption of sedation compared with usual sedation care in critically ill postoperative patients (SOS-Ventilation): a randomised, parallel-group clinical trial.

    Science.gov (United States)

    Chanques, Gerald; Conseil, Matthieu; Roger, Claire; Constantin, Jean-Michel; Prades, Albert; Carr, Julie; Muller, Laurent; Jung, Boris; Belafia, Fouad; Cissé, Moussa; Delay, Jean-Marc; de Jong, Audrey; Lefrant, Jean-Yves; Futier, Emmanuel; Mercier, Grégoire; Molinari, Nicolas; Jaber, Samir

    2017-10-01

    Avoidance of excessive sedation and subsequent prolonged mechanical ventilation in intensive care units (ICUs) is recommended, but no data are available for critically ill postoperative patients. We hypothesised that in such patients stopping sedation immediately after admission to the ICU could reduce unnecessary sedation and improve patient outcomes. We did a randomised, parallel-group, clinical trial at three ICUs in France. Stratified randomisation with minimisation (1:1 via a restricted web platform) was used to assign eligible patients (aged ≥18 years, admitted to an ICU after abdominal surgery, and expected to require at least 12 h of mechanical ventilation because of a critical illness defined by a Sequential Organ Failure Assessment score >1 for any organ, but without severe acute respiratory distress syndrome or brain injury) to usual sedation care provided according to recommended practices (control group) or to immediate interruption of sedation (intervention group). The primary outcome was the time to successful extubation (defined as the time from randomisation to the time of extubation [or tracheotomy mask] for at least 48 h). All patients who underwent randomisation (except for those who were excluded after randomisation) were included in the intention-to-treat analysis. This study is registered with ClinicalTrials.gov, number NCT01486121. Between Dec 2, 2011, and Feb 27, 2014, 137 patients were randomly assigned to the control (n=68) or intervention groups (n=69). In the intention-to-treat analysis, time to successful extubation was significantly lower in the intervention group than in the control group (median 8 h [IQR 4-36] vs 50 h [29-93], group difference -33·6 h [95% CI -44·9 to -22·4]; p<0·0001). The adjusted hazard ratio was 5·2 (95% CI 3·1-8·8, p<0·0001). Immediate interruption of sedation in critically ill postoperative patients with organ dysfunction who were admitted to the ICU after abdominal surgery improved outcomes compared

  20. Comparative evaluation of atenolol and clonidine premedication on cardiovascular response to nasal speculum insertion during trans-sphenoid surgery for resection of pituitary adenoma: A prospective, randomised, double-blind, controlled study

    Directory of Open Access Journals (Sweden)

    Devendra Gupta

    2011-01-01

    Full Text Available Severe cardiovascular responses in the form of tachycardia and hypertension following nasal speculum insertion occur during sublabial rhinoseptal trans-sphenoid approach for resection of small pituitary tumours. We compare the effects of preoperative administration of clonidine (α-2 agonist and atenolol (α-blocker over haemodynamic response, caused by speculum insertion during trans-sphenoid pituitary resection. We enrolled 66 patients in age range 18-65 years, of ASA I-II, and of either sex undergoing elective sublabial rhinoseptal trans-sphenoidal hypophysectomy. Group I (control received placebo, group II (clonidine received tablet clonidine 5 μg/kg, and group III (atenolol received tablet atenolol 0.5 mg/kg. The heart rate increased on speculum insertion and 5 and 10 minutes following speculum insertion as compared to the pre-speculum values in the control group, while no change in the heart rate was observed in other groups (P<0.05. There was a rise in the mean arterial pressure during and 5, 10, and 15 minutes after nasal speculum insertion in the control group, whereas it was not seen in other groups (P<0.05. We therefore suggest that oral clonidine and oral atenolol (given 2 hours prior to surgery is an equally effective and safe method of attenuating haemodynamic response caused by nasal speculum insertion during trans-sphenoid pituitary resection.

  1. Comparing Intra-Arterial Chemotherapy Combined With Intravesical Chemotherapy Versus Intravesical Chemotherapy Alone: A Randomised Prospective Pilot Study for T1G3 Bladder Transitional Cell Carcinoma After Bladder-Preserving Surgery

    Energy Technology Data Exchange (ETDEWEB)

    Chen, Junxing, E-mail: Junxingchen@hotmail.com; Yao, Zhijun, E-mail: yaozhijun1985@qq.com; Qiu, Shaopeng, E-mail: qiushp@mail.sysu.edu.cn; Chen, Lingwu, E-mail: chenlingwu@hotmail.com [First Affiliated Hospital of Sun Yat-Sen University, Department of Urology (China); Wang, Yu, E-mail: zsyyjr@163.com; Yang, Jianyong, E-mail: yangjianyong_2011@163.com; Li, Jiaping, E-mail: jpli3s@126.com [First Affiliated Hospital of Sun Yat-Sen University, Department of Interventional Oncology (China)

    2013-12-15

    Purpose: To compare the efficacy of intra-arterial chemotherapy combined with intravesical chemotherapy versus intravesical chemotherapy alone for T1G3 bladder transitional cell carcinoma (BTCC) followed by bladder-preserving surgery. Materials and Methods: Sixty patients with T1G3 BTCC were randomly divided into two groups. After bladder-preserving surgery, 29 patients (age 30-80 years, 24 male and 5 female) received intra-arterial chemotherapy in combination with intravesical chemotherapy (group A), whereas 31 patients (age 29-83 years, 26 male and 5 female) were treated with intravesical chemotherapy alone (group B). Twenty-nine patients were treated with intra-arterial epirubicin (50 mg/m{sup 2}) + cisplatin (60 mg/m{sup 2}) chemotherapy 2-3 weeks after bladder-preserving surgery once every 4-6 weeks. All of the patients received the same intravesical chemotherapy: An immediate prophylactic was administered in the first 6 h. After that, therapy was administered one time per week for 8 weeks and then one time per month for 8 months. The instillation drug was epirubicin (50 mg/m{sup 2}) and lasted for 30-40 min each time. The end points were tumour recurrence (stage Ta, T1), tumour progression (to T2 or greater), and disease-specific survival. During median follow-up of 22 months, the overall survival rate, tumour-specific death rate, recurrence rate, progression rate, time to first recurrence, and adverse reactions were compared between groups. Results: The recurrence rates were 10.3 % (3 of 29) in group A and 45.2 % (14 of 31) in group B, and the progression rates were 0 % (0 of 29) in group A and 22.6 % (7 of 31) in group B. There was a significant difference between the two groups regarding recurrence (p = 0.004) and progression rates (p = 0.011). Median times to first recurrence in the two groups were 15 and 6.5 months, respectively. The overall survival rates were 96.6 and 87.1 %, and the tumour-specific death rates were 0 % (0 of 29) and 13.5 % (4 of 31

  2. Comparative waste forms study

    International Nuclear Information System (INIS)

    Wald, J.W.; Lokken, R.O.; Shade, J.W.; Rusin, J.M.

    1980-12-01

    A number of alternative process and waste form options exist for the immobilization of nuclear wastes. Although data exists on the characterization of these alternative waste forms, a straightforward comparison of product properties is difficult, due to the lack of standardized testing procedures. The characterization study described in this report involved the application of the same volatility, mechanical strength and leach tests to ten alternative waste forms, to assess product durability. Bulk property, phase analysis and microstructural examination of the simulated products, whose waste loading varied from 5% to 100% was also conducted. The specific waste forms investigated were as follows: Cold Pressed and Sintered PW-9 Calcine; Hot Pressed PW-9 Calcine; Hot Isostatic Pressed PW-9 Calcine; Cold Pressed and Sintered SPC-5B Supercalcine; Hot Isostatic pressed SPC-5B Supercalcine; Sintered PW-9 and 50% Glass Frit; Glass 76-68; Celsian Glass Ceramic; Type II Portland Cement and 10% PW-9 Calcine; and Type II Portland Cement and 10% SPC-5B Supercalcine. Bulk property data were used to calculate and compare the relative quantities of waste form volume produced at a spent fuel processing rate of 5 metric ton uranium/day. This quantity ranged from 3173 L/day (5280 Kg/day) for 10% SPC-5B supercalcine in cement to 83 L/day (294 Kg/day) for 100% calcine. Mechanical strength, volatility, and leach resistance tests provide data related to waste form durability. Glass, glass-ceramic and supercalcine ranked high in waste form durability where as the 100% PW-9 calcine ranked low. All other materials ranked between these two groupings

  3. A multicentre, randomised controlled, non-inferiority trial, comparing nasal high flow with nasal continuous positive airway pressure as primary support for newborn infants with early respiratory distress born in Australian non-tertiary special care nurseries (the HUNTER trial): study protocol.

    Science.gov (United States)

    Manley, Brett J; Roberts, Calum T; Arnolda, Gaston R B; Wright, Ian M R; Owen, Louise S; Dalziel, Kim M; Foster, Jann P; Davis, Peter G; Buckmaster, Adam G

    2017-06-23

    Nasal high-flow (nHF) therapy is a popular mode of respiratory support for newborn infants. Evidence for nHF use is predominantly from neonatal intensive care units (NICUs). There are no randomised trials of nHF use in non-tertiary special care nurseries (SCNs). We hypothesise that nHF is non-inferior to nasal continuous positive airway pressure (CPAP) as primary support for newborn infants with respiratory distress, in the population cared for in non-tertiary SCNs. The HUNTER trial is an unblinded Australian multicentre, randomised, non-inferiority trial. Infants are eligible if born at a gestational age ≥31 weeks with birth weight ≥1200 g and admitted to a participating non-tertiary SCN, are 1 hour. Infants are randomised to treatment with either nHF or CPAP. The primary outcome is treatment failure within 72 hours of randomisation, as determined by objective oxygenation, apnoea or blood gas criteria or by a clinical decision that urgent intubation and mechanical ventilation, or transfer to a tertiary NICU, is required. Secondary outcomes include incidence of pneumothorax requiring drainage, duration of respiratory support, supplemental oxygen and hospitalisation, costs associated with hospital care, cost-effectiveness, parental stress and satisfaction and nursing workload. Multisite ethical approval for the study has been granted by The Royal Children's Hospital, Melbourne, Australia (Trial Reference No. 34222), and by each participating site. The trial is currently recruiting in eight centres in Victoria and New South Wales, Australia, with one previous site no longer recruiting. The trial results will be published in a peer-reviewed journal and will be presented at national and international conferences. Australian and New Zealand Clinical Trials Registry (ANZCTR): ACTRN12614001203640; pre-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted

  4. Influence of room heating on ambulatory blood pressure in winter: a randomised controlled study.

    Science.gov (United States)

    Saeki, Keigo; Obayashi, Kenji; Iwamoto, Junko; Tanaka, Yuu; Tanaka, Noriyuki; Takata, Shota; Kubo, Hiroko; Okamoto, Nozomi; Tomioka, Kimiko; Nezu, Satoko; Kurumatani, Norio

    2013-06-01

    Previous studies have proposed that higher blood pressure (BP) in winter is an important cause of increased mortality from cardiovascular disease during the winter. Some observational and physiological studies have shown that cold exposure increases BP, but evidence from a randomised controlled study assessing the effectiveness of intensive room heating for lowering BP was lacking. The present study aimed to determine whether intensive room heating in winter decreases ambulatory BP as compared with weak room heating resulting in a 10°C lower target room temperature when sufficient clothing and bedclothes are available. We conducted a parallel group, assessor blinded, simple randomised controlled study with 1:1 allocation among 146 healthy participants in Japan from November 2009 to March 2010. Ambulatory BP was measured while the participants stayed in single experimental rooms from 21:00 to 8:00. During the session, participants could adjust the amount of clothing and bedclothes as required. Compared with the weak room heating group (mean temperature ± SD: 13.9 ± 3.3°C), systolic morning BP (mean BP 2 h after getting out of bed) of the intensive room heating group (24.2 ± 1.7°C) was significantly lower by 5.8 mm Hg (95% CI 2.4 to 9.3). Sleep-trough morning BP surges (morning BP minus lowest night-time BP) in the intensive room heating group were significantly suppressed to about two thirds of the values in the weak room heating group (14.3 vs 21.9 mm Hg; pheating decreased morning BP and the morning BP surge in winter.

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

    Science.gov (United States)

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

    2015-12-24

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

  6. The RAPID-CTCA trial (Rapid Assessment of Potential Ischaemic Heart Disease with CTCA) - a multicentre parallel-group randomised trial to compare early computerised tomography coronary angiography versus standard care in patients presenting with suspected or confirmed acute coronary syndrome: study protocol for a randomised controlled trial.

    Science.gov (United States)

    Gray, Alasdair J; Roobottom, Carl; Smith, Jason E; Goodacre, Steve; Oatey, Katherine; O'Brien, Rachel; Storey, Robert F; Na, Lumine; Lewis, Steff C; Thokala, Praveen; Newby, David E

    2016-12-07

    Emergency department attendances with chest pain requiring assessment for acute coronary syndrome (ACS) are a major global health issue. Standard assessment includes history, examination, electrocardiogram (ECG) and serial troponin testing. Computerised tomography coronary angiography (CTCA) enables additional anatomical assessment of patients for coronary artery disease (CAD) but has only been studied in very low-risk patients. This trial aims to investigate the effect of early CTCA upon interventions, event rates and health care costs in patients with suspected/confirmed ACS who are at intermediate risk. Participants will be recruited in about 35 tertiary and district general hospitals in the UK. Patients ≥18 years old with symptoms with suspected/confirmed ACS with at least one of the following will be included: (1) ECG abnormalities, e.g. ST-segment depression >0.5 mm; (2) history of ischaemic heart disease; (3) troponin elevation above the 99 th centile of the normal reference range or increase in high-sensitivity troponin meeting European Society of Cardiology criteria for 'rule-in' of myocardial infarction (MI). The early use of ≥64-slice CTCA as part of routine assessment will be compared to standard care. The primary endpoint will be 1-year all-cause death or recurrent type 1 or type 4b MI at 1 year, measured as the time to such event. A number of secondary clinical, process and safety endpoints will be collected and analysed. Cost effectiveness will be estimated in terms of the lifetime incremental cost per quality-adjusted life year gained. We plan to recruit 2424 (2500 with ~3% drop-out) evaluable patients (1212 per arm) to have 90% power to detect a 20% versus 15% difference in 1-year death or recurrent type 1 MI or type 4b MI, two-sided p Acute Coronary Events score, previous CAD and baseline troponin level. The results will be expressed as a hazard ratio with the corresponding 95% confidence intervals and p value. The Rapid Assessment of

  7. A comparative study of tranexamic acid and ethamsylate in menorrhagia

    OpenAIRE

    Nita K. Patel; Manish R. Pandya

    2012-01-01

    Background: Menorrhagia interferes with the woman's physical, social, emotional, and/or material quality of life. Antifibrinolytic drugs are effective in decreasing excessive menstrual bleeding. The objective of this study was to compare the effects of tranexamic acid and ethamsylate on quality of life in women with menorrhagia. Methods: The 50 women with menorrhagia were randomised to receive either tranexamic acid or ethamsylate. Twenty five patients were allocated to receive tranexamic aci...

  8. Auricular Acupuncture and Cognitive Behavioural Therapy for Insomnia: A Randomised Controlled Study

    Directory of Open Access Journals (Sweden)

    L. Bergdahl

    2016-01-01

    Full Text Available Objective. The most effective nonpharmacological treatment for insomnia disorder is cognitive behavioural therapy-insomnia (CBT-i. However CBT-i may not suit everyone. Auricular acupuncture (AA is a complementary treatment. Studies show that it may alleviate insomnia symptoms. The aim of this randomised controlled study was to compare treatment effects of AA with CBT-i and evaluate symptoms of insomnia severity, anxiety, and depression. Method. Fifty-nine participants, mean age 60.5 years (SD 9.4, with insomnia disorder were randomised to group treatment with AA or CBT-i. Self-report questionnaires, the Insomnia Severity Index (ISI, Dysfunctional Beliefs and Attitudes about Sleep scale (DBAS-16, Epworth Sleepiness Scale (ESS, and Hospital Anxiety and Depression scale (HAD, were collected at baseline, after treatment, and at 6-month follow-up. A series of linear mixed models were performed to examine treatment effect over time between and within the groups. Results. Significant between-group improvements were seen in favour of CBT-i in ISI after treatment and at the 6-month follow-up and in DBAS-16 after treatment. Both groups showed significant within-group postintervention improvements in ISI, and these changes were maintained six months later. The CBT-i group also showed a significant reduction in DBAS-16 after treatment and six months later. Conclusions. Compared to CBT-i, AA, as offered in this study, cannot be considered an effective stand-alone treatment for insomnia disorder. The trial is registered with ClinicalTrials.gov NCT01765959.

  9. [Randomised study on histaminelike side-effects of 5 common plasmasubstitutes in orthopedic surgery (author's transl)].

    Science.gov (United States)

    Schöning, B; Koch, H

    1975-12-01

    Preceding anaesthesia 750 randomised patients, sub-divided into 5 different age groups, were given 500 ml of a standard plasma-substitute at a flow rate of 25-30 ml/min. There was direct correlation (p=0.1%) of the frequency of side-effects to the substance used; none, however, to the age or general surgical risk. Side-effects were observed in 21.3% with derivates of gelatin as compared to 3.7% with Macrodex and Plasmasteril combined. The rate of more serious anaphylactoid reactions was 6% with Haemaccel, 1.3% with Gelifundol-S, 0.67% with Macrodex and less than 0.67% with Neo-Plasmagel. The study reveals that serious side-effects may be expected in orthopaedictic patients after application of plasma substitutes. As a prophylactic procedure for those patients we recommend, therefore, the application of these substances only after careful consideration of the indications for their use.

  10. Minocycline versus co-trimoxazole in chancroid : A double-blind randomised study

    Directory of Open Access Journals (Sweden)

    Oberoi C

    1994-01-01

    Full Text Available This double-blind randomised parallel-group study comparing the efficacy and side effects of minocycline with that of cotrimoxazole in chancroid, had 56 analysable cases, 28 in each group. All admissible cases were assessed clinically on a scale of 0 to 3 for number and size of ulcers, pain, discharge, surrounding erythema and bubo. Each drug individually showed significant improvement in all clinical parameters. Minocycline showed significantly better improvement than cotrimoxazole in all parameters. Minocycline had 43% cure rate, and no failures, against 36% cure and 25% failure for cotrimoxazole. Both the drug were well tolerated. We conclude that minocycline is a superior alternative to cotrimoxazole in the therapy of chancroid.

  11. 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.

  12. No effect of forearm band and extensor strengthening exercises for the treatment of tennis elbow: a prospective randomised study.

    Science.gov (United States)

    Luginbühl, Rolf; Brunner, Florian; Schneeberger, Alberto G

    2008-01-01

    The objective of this prospective randomised study was to analyse the effect of the forearm support band and of strengthening exercises for the treatment of tennis elbow. Twenty-nine patients with 30 tennis elbows were randomised into 3 groups of treatment: (I) forearm support band, (II) strengthening exercises and (III) both methods. The patients had a standardised examination at their first visit, and then after 6 weeks, 3 months and 1 year. At the latest follow-up, there was a significant improvement of the symptoms compared to before treatment (p<0.0001), considering all patients independently of the methods of treatment. However, no differences in the scores were found between the 3 groups of treatment (p=0.27), indicating that no beneficial influence was found either for the strengthening exercises or for the forearm support band. Improvement seems to occur with time, independent of the method of treatment used.

  13. Mobile OS Comparative Study

    OpenAIRE

    Joseph, Jyothy; K, Shinto Kurian

    2013-01-01

    In the fast growing mobile revolutionary era, many operating systems are playing vital role in present market. This study is intending to identify the apt and secure mobile based on mobile operating systems capability and user requirements.

  14. 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

  15. A randomised, double-masked phase III/IV study of the efficacy and safety of Avastin® (Bevacizumab intravitreal injections compared to standard therapy in subjects with choroidal neovascularisation secondary to age-related macular degeneration: clinical trial design

    Directory of Open Access Journals (Sweden)

    Bunce Catey

    2008-10-01

    Full Text Available Abstract Background The management of neovascular age-related macular degeneration (nAMD has been transformed by the introduction of agents delivered by intravitreal injection which block the action of vascular endothelial growth factor-A (anti-VEGF agents. One such agent in widespread use is bevacizumab which was initially developed for use in oncology. Most of the evidence supporting the use of bevacizumab for nAMD has come from interventional case series and this clinical trial was initiated because of the increasing and widespread use of this agent in the treatment of nAMD (an off-label indication despite a lack of definitive unbiased safety and efficacy data. Methods and design The Avastin® (bevacizumab for choroidal neovascularisation (ABC trial is a double-masked randomised controlled trial comparing intravitreal bevacizumab injections to standard therapy in the treatment of nAMD. Patients are randomised to intravitreal bevacizumab or standard therapy available at the time of trial initiation (verteporfin photodynamic therapy, intravitreal pegaptanib or sham treatment. Ranibizumab treatment was not included in the control arm as it had not been licensed for use at the start of recruitment for this trial. The primary outcome is the proportion of patients gaining ≥ 15 letters of visual acuity at 1 year and secondary outcomes include the proportion of patients with stable vision and mean visual acuity change. Discussion The ABC Trial is the first double-masked randomised control trial to investigate the efficacy and safety of intravitreal bevacizumab in the treatment of nAMD. This trial fully recruited in November 2007 and results should be available in early 2009. Important design issues for this clinical trial include (a defining the control group (b use of gain in vision as primary efficacy end-point and (c use of pro re nata treatment using intravitreal bevacizumab rather than continuous therapy. Trial registration Current controlled

  16. Smoking cessation at the workplace. Results of a randomised controlled intervention study

    Science.gov (United States)

    Lang, T; Nicaud, V; Slama, K; Hirsch, A; Imbernon, E; Goldberg, M; Calvel, L; Desobry, P; Favre-Trosson, J; Lhopital, C; Mathevon, P; Miara, D; Miliani, A; Panthier, F; Pons, G; Roitg, C; Thoores, M; the, w

    2000-01-01

    OBJECTIVES—To compare the effects of a worksite intervention by the occupational physician offering simple advice of smoking cessation with a more active strategy of advice including a "quit date" and extra support.
POPULATION—Employees of an electrical and gas company seen at the annual visit by their occupational physicians.
CRITERIA END POINTS—Smoking point prevalence defined as the percentage of smokers who were non-smokers at one year. Secondary criteria were the percentage of smokers who stopped smoking for more than six months and the difference in prevalence of smoking in both groups.
METHODS—Randomised controlled trial. The unit of randomisation was the work site physician and a random sample of the employees of whom he or she was in charge. The length of the follow up was one year. Each of 30 work site physicians included in the study 100 to 150 employees.
RESULTS—Among 504 subjects classified as smokers at baseline receiving simple advice (group A) and 591 the more active programme (group B), 68 (13.5%) in group A and 109 (18.4%) were non-smokers one year later (p=0.03; p=0.01 taking the occupational physician as the statistical unit and using a non-parametric test). Twenty three subjects (4.6%) in group A and 36 (6.1%) in group B (p=0.26) declared abstinence of six months or more. Among non-smokers at baseline, 3.4% in both groups were smokers after one year follow up. The prevalence of smokers did not differ significantly at baseline (32.9% and 32.4%, p=0.75). After the intervention the prevalence of smoking was 30.8% in group A and 28.7% in group B (p=0.19). An increase of the mean symptoms score for depression in those who quit was observed during this period.
CONCLUSIONS—A simple cessation intervention strategy during a mandatory annual examination, targeting a population of smokers independently of their motivation to stop smoking or their health status, showed a 36% relative increase of the proportion of smokers who

  17. Use of the learning conversation improves instructor confidence in life support training: An open randomised controlled cross-over trial comparing teaching feedback mechanisms.

    Science.gov (United States)

    Baldwin, Lydia J L; Jones, Christopher M; Hulme, Jonathan; Owen, Andrew

    2015-11-01

    Feedback is vital for the effective delivery of skills-based education. We sought to compare the sandwich technique and learning conversation structured methods of feedback delivery in competency-based basic life support (BLS) training. Open randomised crossover study undertaken between October 2014 and March 2015 at the University of Birmingham, United Kingdom. Six-hundred and forty healthcare students undertaking a European Resuscitation Council (ERC) BLS course were enrolled, each of whom was randomised to receive teaching using either the sandwich technique or the learning conversation. Fifty-eight instructors were randomised to initially teach using either the learning conversation or sandwich technique, prior to crossing-over and teaching with the alternative technique after a pre-defined time period. Outcome measures included skill acquisition as measured by an end-of-course competency assessment, instructors' perception of teaching with each feedback technique and candidates' perception of the feedback they were provided with. Scores assigned to use of the learning conversation by instructors were significantly more favourable than for the sandwich technique across all but two assessed domains relating to instructor perception of the feedback technique, including all skills-based domains. No difference was seen in either assessment pass rates (80.9% sandwich technique vs. 77.2% learning conversation; OR 1.2, 95% CI 0.85-1.84; p=0.29) or any domain relating to candidates' perception of their teaching technique. This is the first direct comparison of two feedback techniques in clinical medical education using both quantitative and qualitative methodology. The learning conversation is preferred by instructors providing competency-based life support training and is perceived to favour skills acquisition. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  18. The Head Injury Retrieval Trial (HIRT): a single-centre randomised controlled trial of physician prehospital management of severe blunt head injury compared with management by paramedics only.

    Science.gov (United States)

    Garner, Alan A; Mann, Kristy P; Fearnside, Michael; Poynter, Elwyn; Gebski, Val

    2015-11-01

    Advanced prehospital interventions for severe brain injury remains controversial. No previous randomised trial has been conducted to evaluate additional physician intervention compared with paramedic only care. Participants in this prospective, randomised controlled trial were adult patients with blunt trauma with either a scene GCS score definition), or GCSdefinition). Patients were randomised to either standard ground paramedic treatment or standard treatment plus a physician arriving by helicopter. Patients were evaluated by 30-day mortality and 6-month Glasgow Outcome Scale (GOS) scores. Due to high non-compliance rates, both intention-to-treat and as-treated analyses were preplanned. 375 patients met the original definition, of which 197 was allocated to physician care. Differences in the 6-month GOS scores were not significant on intention-to-treat analysis (OR 1.11, 95% CI 0.74 to 1.66, p=0.62) nor was the 30-day mortality (OR 0.91, 95% CI 0.60 to 1.38, p=0.66). As-treated analysis showed a 16% reduction in 30-day mortality in those receiving additional physician care; 60/195 (29%) versus 81/180 (45%), pdefinition, of which 182 were allocated to physician care. The 6-month GOS scores were not significantly different on intention-to-treat analysis (OR 1.14, 95% CI 0.73 to 1.75, p=0.56) nor was the 30-day mortality (OR 1.05, 95% CI 0.66 to 1.66, p=0.84). As-treated analyses were also not significantly different. This trial suggests a potential mortality reduction in patients with blunt trauma with GCSdefinition only). Confirmatory studies which also address non-compliance issues are needed. NCT00112398. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  19. The effect of targeted treatment on people with patellofemoral pain: a pragmatic, randomised controlled feasibility study.

    Science.gov (United States)

    Drew, Benjamin T; Conaghan, Philip G; Smith, Toby O; Selfe, James; Redmond, Anthony C

    2017-08-04

    Targeted treatment, matched according to specific clinical criteria e.g. hip muscle weakness, may result in better outcomes for people with patellofemoral pain (PFP). However, to ensure the success of future trials, a number of questions on the feasibility of a targeted treatment need clarification. The aim of the study was to explore the feasibility of matched treatment (MT) compared to usual care (UC) management for a subgroup of people with PFP determined to have hip weakness and to explore the mechanism of effect for hip strengthening. In a pragmatic, randomised controlled feasibility study, 24 participants with PFP (58% female; mean age 29 years) were randomly allocated to receive either MT aimed specifically at hip strengthening, or UC over an eight-week period. The primary outcomes were feasibility outcomes, which included rates of adherence, attrition, eligibility, missing data and treatment efficacy. Secondary outcomes focused on the mechanistic outcomes of the intervention, which included hip kinematics. Conversion to consent (100%), missing data (0%), attrition rate (8%) and adherence to both treatment and appointments (>90%) were deemed successful endpoints. The analysis of treatment efficacy showed that the MT group reported a greater improvement for the Global Rating of Change Scale (62% vs. 9%) and the Anterior Knee Pain Scale (-5.23 vs. 1.18) but no between-group differences for either average or worst pain. Mechanistic outcomes showed a greatest reduction in peak hip internal rotation angle for the MT group (13.1% vs. -2.7%). This feasibility study indicates that a definitive randomised controlled trial investigating a targeted treatment approach is achievable. Findings suggest the mechanism of effect of hip strengthening may be to influence kinematic changes in hip function in the transverse plane. This study was registered retrospectively. ISRCTN74560952 . Registration date: 2017-02-06.

  20. Comparative Packaging Study

    Science.gov (United States)

    Perchonok, Michele H.; Oziomek, Thomas V.

    2009-01-01

    Future long duration manned space flights beyond low earth orbit will require the food system to remain safe, acceptable and nutritious. Development of high barrier food packaging will enable this requirement by preventing the ingress and egress of gases and moisture. New high barrier food packaging materials have been identified through a trade study. Practical application of this packaging material within a shelf life test will allow for better determination of whether this material will allow the food system to meet given requirements after the package has undergone processing. The reason to conduct shelf life testing, using a variety of packaging materials, stems from the need to preserve food used for mission durations of several years. Chemical reactions that take place during longer durations may decrease food quality to a point where crew physical or psychological well-being is compromised. This can result in a reduction or loss of mission success. The rate of chemical reactions, including oxidative rancidity and staling, can be controlled by limiting the reactants, reducing the amount of energy available to drive the reaction, and minimizing the amount of water available. Water not only acts as a media for microbial growth, but also as a reactant and means by which two reactants may come into contact with each other. The objective of this study is to evaluate three packaging materials for potential use in long duration space exploration missions.

  1. A smartphone application for treating depressive symptoms: study protocol for a randomised controlled trial.

    Science.gov (United States)

    Deady, M; Johnston, D A; Glozier, N; Milne, D; Choi, I; Mackinnon, A; Mykletun, A; Calvo, R A; Gayed, A; Bryant, R; Christensen, H; Harvey, S B

    2018-06-01

    Depression is a commonly occurring disorder linked to diminished role functioning and quality of life. The development of treatments that overcome barriers to accessing treatment remains an important area of clinical research as most people delay or do not receive treatment at an appropriate time. The workplace is an ideal setting to roll-out an intervention, particularly given the substantial psychological benefits associated with remaining in the workforce. Mobile health (mhealth) interventions utilising smartphone applications (apps) offer novel solutions to disseminating evidence based programs, however few apps have undergone rigorous testing. The present study aims to evaluate the effectiveness of a smartphone app designed to treat depressive symptoms in workers. The present study is a multicentre randomised controlled trial (RCT), comparing the effectiveness of the intervention to that of an attention control. The primary outcome measured will be reduced depressive symptoms at 3 months. Secondary outcomes such as wellbeing and work performance will also be measured. Employees from a range of industries will be recruited via a mixture of targeted social media advertising and Industry partners. Participants will be included if they present with likely current depression at baseline. Following baseline assessment (administered within the app), participants will be randomised to receive one of two versions of the Headgear application: 1) Intervention (a 30-day mental health intervention focusing on behavioural activation and mindfulness), or 2) attention control app (mood monitoring for 30 days). Participants will be blinded to their allocation. Analyses will be conducted within an intention to treat framework using mixed modelling. The results of this trial will provide valuable information about the effectiveness of mhealth interventions in the treatment of depressive symptoms in a workplace context. The current trial is registered with the Australian and

  2. 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

  3. A pilot randomised controlled study of the mental health first aid eLearning course with UK medical students.

    Science.gov (United States)

    Davies, E Bethan; Beever, Emmeline; Glazebrook, Cris

    2018-03-21

    Medical students face many barriers to seeking out professional help for their mental health, including stigma relating to mental illness, and often prefer to seek support and advice from fellow students. Improving medical students' mental health literacy and abilities to support someone experiencing a mental health problem could reduce barriers to help seeking and improve mental health in this population. Mental Health First Aid (MHFA) is an evidence-based intervention designed to improve mental health literacy and ability to respond to someone with a mental health problem. This pilot randomised controlled trial aims to evaluate the MHFA eLearning course in UK medical students. Fifty-five medical students were randomised to receive six weeks access to the MHFA eLearning course (n = 27) or to a no-access control group (n = 28). Both groups completed baseline (pre-randomisation) and follow-up (six weeks post-randomisation) online questionnaires measuring recognition of a mental health problem, mental health first aid intentions, confidence to help a friend experiencing a mental health problem, and stigmatising attitudes. Course feedback was gathered at follow-up. More participants were lost follow-up in the MHFA group (51.9%) compared to control (21.4%). Both intention-to-treat (ITT) and non-ITT analyses showed that the MHFA intervention improved mental health first aid intentions (p = first aid actions at follow-up (p = .006). Feedback about the MHFA course was generally positive, with participants stating it helped improve their knowledge and confidence to help someone. This pilot study demonstrated the potential for the MHFA eLearning course to improve UK medical students' mental health first aid skills, confidence to help a friend and stigmatising attitudes. It could be useful in supporting their own and others' mental health while studying and in their future healthcare careers. Retrospectively registered ( ISRCTN11219848 ).

  4. randomised trial of alternative malaria chemoprophylaxis strategies

    African Journals Online (AJOL)

    hi-tech

    2000-02-02

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

  5. Skeletal effects and functional outcome with olpadronate in children with osteogenesis imperfecta: a 2-year randomised placebo-controlled study

    NARCIS (Netherlands)

    Sakkers, Ralph; Kok, Dieke; Engelbert, Raoul; van Dongen, Alice; Jansen, Maarten; Pruijs, Hans; Verbout, Ab; Schweitzer, Dave; Uiterwaal, Cuno

    2004-01-01

    Non-randomised studies have suggested beneficial effects of bisphosphonates in osteogenesis imperfecta. We assessed the effects of oral olpadronate in children with this disorder in a randomised double-blind placebo-controlled trial. 34 children recruited from the Dutch national centre for

  6. Brief Cognitive Behavioural Therapy compared to optimised general practitioners’ care for depression : A randomised trial

    NARCIS (Netherlands)

    Schene, A.H.; Baas, K.D.; Koeter, M.W.J.; Lucassen, P.; Bockting, C.L.H.; Wittkampf, K.A.; Huyser, J.; van Weert, H.C.

    2014-01-01

    Background: How to treat Major Depressive Disorder (MDD) in primary care? Studies that compared (brief) Cognitive Behavioural Therapy (CBT) with care as usual by the General Practitioner (GP) found the first to be more effective. However, to make a fair comparison GP care should be optimised and

  7. Brief Cognitive Behavioural Therapy Compared to Optimised General Practitioners? Care for Depression: A Randomised Trial

    NARCIS (Netherlands)

    Schene, A. H.; Baas, K. D.; Koeter, M.; Lucassen, P.; Bockting, C. L. H.|info:eu-repo/dai/nl/258267992; Wittkampf, K. F.; van Weert, H. C.; Huyser, J.

    2014-01-01

    Background: How to treat Major Depressive Disorder (MDD) in primary care? Studies that compared (brief) Cognitive Behavioural Therapy (CBT) with care as usual by the General Practitioner (GP) found the first to be more effective. However, to make a fair comparison GP care should be optimised and

  8. Ciprofloxacin DPI: a randomised, placebo-controlled, phase IIb efficacy and safety study on cystic fibrosis.

    Science.gov (United States)

    Dorkin, Henry L; Staab, Doris; Operschall, Elisabeth; Alder, Jeff; Criollo, Margarita

    2015-01-01

    Treatment of infective bronchitis involving Pseudomonas aeruginosa is a cornerstone of care in patients with cystic fibrosis (CF). This phase IIb, randomised, double-blind, placebo-controlled study assessed the efficacy and safety of ciprofloxacin dry powder for inhalation (DPI) in this population. Patients with CF, ≥12 years of age (N=286), were randomised to ciprofloxacin DPI (32.5 mg (n=93) or 48.75 mg (n=93)), or corresponding placebo (32.5 mg, n=65; 48.75 mg, n=35) twice daily for 28 days. The primary objective was the change in forced expiratory volume in 1 s (FEV1) from baseline (day 0) to end of treatment (day 29) in the intent-to-treat population for ciprofloxacin DPI compared with the corresponding placebo group. The primary effectiveness objective was not met; there were no significant differences in change in FEV1 between ciprofloxacin DPI and the corresponding placebo group for either dose (p=0.154). However, in pooled analyses, FEV1 decline from baseline to treatment end was significantly lower with ciprofloxacin DPI than with placebo (pooled data; p=0.02). Ciprofloxacin DPI showed positive effects on sputum bacterial load and quality of life, but these effects were not maintained at the 4-week follow-up. Ciprofloxacin DPI was well tolerated and there were no significant differences in type/incidence of treatment-emergent adverse events by treatment group (p=0.115). Further investigations are needed to determine the full scope of the beneficial effects of ciprofloxacin DPI for patients with CF. Clinicaltrials.gov NCT00645788; EudraCT 2008-008314-40.

  9. BTS randomised feasibility study of active symptom control with or without chemotherapy in malignant pleural mesothelioma: ISRCTN 54469112.

    Science.gov (United States)

    Muers, M F; Rudd, R M; O'Brien, M E R; Qian, W; Hodson, A; Parmar, M K B; Girling, D J

    2004-02-01

    The incidence of mesothelioma is rising rapidly in the UK. There is no generally accepted standard treatment. The BTS recommends active symptom control (ASC). It is not known whether chemotherapy in addition prolongs survival or provides worthwhile palliation with acceptable toxicity. Palliation as recorded by patients has been fully reported for only two regimens: mitomycin, vinblastine, and cisplatin (MVP), and vinorelbine (N). The BTS and collaborators planned to conduct a phase III randomised trial comparing ASC only, ASC+MVP, and ASC+N in 840 patients with survival as the primary outcome measure. The aim of the present study was to assess the acceptability of the trial design to patients and the suitability of two standard quality of life (QL) questionnaires for mesothelioma. Collaborating centres registered all new patients with mesothelioma. Those eligible and giving informed consent completed EORTC QLQ-C30+LC13 and FACT-L QL questionnaires and were randomised between all three or any two of (1) ASC only, (2) ASC+4 cycles of MVP, and (3) ASC+12 weekly doses of N. During 1 year, 242 patients were registered of whom 109 (45%) were randomised (55% of the 197 eligible patients). Fifty two patients from 20 centres were randomised to an option including ASC only. This translates into a rate of 312 per year from 60 centres interested in collaborating in the phase III trial. The EORTC QL questionnaire was superior to FACT-L in terms of completeness of data and patient preference. Clinically relevant palliation was achieved with ASC. The planned phase III trial is feasible.

  10. Cost effectiveness of home ultraviolet B phototherapy for psoriasis : economic evaluation of a randomised controlled trial (PLUTO study)

    NARCIS (Netherlands)

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

    2010-01-01

    Objective To assess the costs and cost effectiveness of phototherapy with ultraviolet B light provided at home compared with outpatient ultraviolet B phototherapy for psoriasis. Design Cost utility, cost effectiveness, and cost minimisation analyses performed alongside a pragmatic randomised

  11. 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…

  12. 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,…

  13. 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

  14. Informed consent, parental awareness, and reasons for participating in a randomised controlled study

    NARCIS (Netherlands)

    M. van Stuijvenberg (Margriet); M.H. Suur (Marja); S. de Vos (Sandra); G.C.H. Tjiang (Gilbert); E.W. Steyerberg (Ewout); G. Derksen-Lubsen (Gerarda); H.A. Moll (Henriëtte)

    1998-01-01

    textabstractBACKGROUND: The informed consent procedure plays a central role in randomised controlled trials but has only been explored in a few studies on children. AIM: To assess the quality of the informed consent process in a paediatric setting. METHODS: A

  15. A randomised trial comparing the effect of exercise training and weight loss on microvascular function in coronary artery disease

    DEFF Research Database (Denmark)

    Olsen, Rasmus Huan; Pedersen, Lene Rørholm; Jürs, Anders

    2015-01-01

    BACKGROUND: Coronary microvascular function is associated with outcome and is reduced in coronary artery disease (CAD) and obesity. We compared the effect of aerobic interval training (AIT) and weight loss on coronary flow reserve (CFR) and peripheral vascular function in revascularised obese CAD...... patients. METHODS AND RESULTS: Seventy non-diabetic patients (BMI 28-40 kg × m(-2), age 45-75 years) were randomised to 12 weeks' AIT (three weekly sessions lasting 38 min with ≈ 16 min at 85-90% of VO2peak) or low energy diet (LED, 800-1000 kcal/day). Per protocol adherence was defined by training......-attendance ≥ 60% and weight loss ≥ 5%, respectively. CFR was assessed by Doppler echocardiography of the LAD. Peripheral vascular function was assessed by arterial tonometry as reactive hyperaemia index (RHI) and augmentation index. Most participants had impaired CFR with a mean CFR of 2.38 (SD 0.59). Twenty...

  16. A cluster-randomised clinical trial comparing two cardiovascular health education strategies in a child population: the Savinghearts project

    Directory of Open Access Journals (Sweden)

    Sánchez-Gómez Luis

    2012-11-01

    Full Text Available Abstract Background This paper describes a methodology for comparing the effects of an eduentertainment strategy involving a music concert, and a participatory class experience involving the description and making of a healthy breakfast, as educational vehicles for delivering obesity-preventing/cardiovascular health messages to children aged 7–8 years. Methods/design This study will involve a cluster-randomised trial with blinded assessment. The study subjects will be children aged 7–8 years of both sexes attending public primary schools in the Madrid Region. The participating schools (n=30 will be randomly assigned to one of two groups: 1 Group MC, in which the children will attend a music concert that delivers obesity-preventing/cardiovascular health messages, or 2 Group HB, in which the children will attend a participatory class providing the same information but involving the description and making of a healthy breakfast. The main outcome measured will be the increase in the number of correct answers scored on a knowledge questionnaire and in an attitudes test administered before and after the above interventions. The secondary outcome recorded will be the reduction in BMI percentile among children deemed overweight/obese prior to the interventions. The required sample size (number of children was calculated for a comparison of proportions with an α of 0.05 and a β of 0.20, assuming that the Group MC subjects would show values for the measured variables at least 10% higher than those recorded for the subjects of Group HB. Corrections were made for the design effect and assuming a loss to follow-up of 10%. The maximum sample size required will be 2107 children. Data will be analysed using summary measurements for each cluster, both for making estimates and for hypothesis testing. All analyses will be made on an intention-to-treat basis. Discussion The intervention providing the best results could be recommended as part of health

  17. Born not breathing: A randomised trial comparing two self-inflating bag-masks during newborn resuscitation in Tanzania.

    Science.gov (United States)

    Thallinger, Monica; Ersdal, Hege Langli; Francis, Fortunata; Yeconia, Anita; Mduma, Estomih; Kidanto, Hussein; Linde, Jørgen Erland; Eilevstjønn, Joar; Gunnes, Nina; Størdal, Ketil

    2017-07-01

    Effective ventilation is crucial to save non-breathing newborns. We compared standard equipment for newborn resuscitation to a new Upright bag, in an area with high neonatal mortality. Newborns requiring resuscitation at Haydom Lutheran Hospital, Tanzania, were ventilated with 230ml standard or 320ml Upright bag-mask by weekly non-blinded block randomisation. A Laerdal Newborn Resuscitation Monitor collected ventilation data through a flow sensor between mask and bag and heart rate with electrocardiography electrodes. Primary outcome was expiratory tidal volume per birth weight. Of 6110 babies born, 136 randomised to standard bag-mask and 192 to Upright, both groups had similar birth weight, gestational age, Apgar scores, gender, and mode of delivery. Compared to standard bag-mask, Upright gave higher median expiratory tidal volume (8.6ml/kg (IQR: 3.5-13.8) vs. 10.0ml/kg (IQR: 4.3-16.8) difference ratio 1.29, 95%CI 1.05, 1.58, p=0.014)), increased mean airway and peak inspiratory pressures, and higher early expired CO 2 (median at 20s 4.2% vs. 3.2%, p=0.0099). Clinical outcome 30min post-delivery was normal in 44% with standard versus 57% with Upright (p=0.016), but similar at 24h. Upright provided higher expired tidal volume, MAP, PIP and early ECO 2 than the standard bag. Clinical outcome differed at 30min, but not at 24h. Larger volume of Upright than standard bag can be an important factor. The results are relevant for low- and high-income settings as ventilatory and heart rate parameters during resuscitation of newborns are rarely reported. Trial registered at www.ClinicalTrials.gov, NCT01869582. Copyright © 2017 Elsevier B.V. All rights reserved.

  18. Randomised trial of elective continuous positive airway pressure (CPAP) compared with rescue CPAP after extubation

    OpenAIRE

    Robertson, N; Hamilton, P

    1998-01-01

    AIM—To determine if a weaning regimen on flow driver continuous positive airway pressure (CPAP) would decrease the number of ventilator days but increase the number of CPAP days when compared with a rescue regimen.
METHODS—Fifty eight babies of 24-32 weeks gestation with respiratory distress syndrome (RDS) were studied prospectively. After extubation they were randomly allocated to receive CPAP for 72 hours (n=29) according to a weaning regimen, or were placed in headbox ...

  19. Are pilot trials useful for predicting randomisation and attrition rates in definitive studies: A review of publicly funded trials

    Science.gov (United States)

    Whitehead, Amy; Pottrill, Edward; Julious, Steven A; Walters, Stephen J

    2018-01-01

    Background/aims: External pilot trials are recommended for testing the feasibility of main or confirmatory trials. However, there is little evidence that progress in external pilot trials actually predicts randomisation and attrition rates in the main trial. To assess the use of external pilot trials in trial design, we compared randomisation and attrition rates in publicly funded randomised controlled trials with rates in their pilots. Methods: Randomised controlled trials for which there was an external pilot trial were identified from reports published between 2004 and 2013 in the Health Technology Assessment Journal. Data were extracted from published papers, protocols and reports. Bland–Altman plots and descriptive statistics were used to investigate the agreement of randomisation and attrition rates between the full and external pilot trials. Results: Of 561 reports, 41 were randomised controlled trials with pilot trials and 16 met criteria for a pilot trial with sufficient data. Mean attrition and randomisation rates were 21.1% and 50.4%, respectively, in the pilot trials and 16.8% and 65.2% in the main. There was minimal bias in the pilot trial when predicting the main trial attrition and randomisation rate. However, the variation was large: the mean difference in the attrition rate between the pilot and main trial was −4.4% with limits of agreement of −37.1% to 28.2%. Limits of agreement for randomisation rates were −47.8% to 77.5%. Conclusion: Results from external pilot trials to estimate randomisation and attrition rates should be used with caution as comparison of the difference in the rates between pilots and their associated full trial demonstrates high variability. We suggest using internal pilot trials wherever appropriate. PMID:29361833

  20. Comparing standard office-based follow-up with text-based remote monitoring in the management of postpartum hypertension: a randomised clinical trial.

    Science.gov (United States)

    Hirshberg, Adi; Downes, Katheryne; Srinivas, Sindhu

    2018-04-27

    Monitoring blood pressure at 72 hours and 7-10 days post partum in women with hypertensive disorders is recommended to decrease morbidity. However, there are no recommendations as to how to achieve this. To compare the effectiveness of text-based blood pressure monitoring to in-person visits for women with hypertensive disorders of pregnancy in the immediate postpartum period. Randomised clinical trial among 206 postpartum women with pregnancy-related hypertension diagnosed during the delivery admission between August 2016 and January 2017. Women were randomised to 2 weeks of text-based surveillance using a home blood pressure cuff and previously tested automated platform or usual care blood pressure check at their prenatal clinic 4-6 days following discharge. The primary study outcome was a single recorded blood pressure in the first 10 days post partum. The ability to meet American Congress of Obstetricians and Gynecologists (ACOG) guidelines, defined as having a blood pressure recorded on postpartum days 3-4 and 7-10 was evaluated in the text message group. The study was powered to detect a 1.4-fold increase in a single recorded blood pressure using text messaging. All outcomes were analysed as intention to treat. 206 women were randomised (103 in each arm). Baseline characteristics were similar. There was a statistically significant increase in a single blood pressure obtained in the texting group in the first 10 days post partum as compared with the office group (92.2% vs 43.7%; adjusted OR 58.2 (16.2-208.1), p<0.001). Eighty-four per cent of patients undergoing text-based surveillance met ACOG criteria for blood pressures at both recommended points. Text-based monitoring is more effective in obtaining blood pressures and meeting current clinical guidelines in the immediate postdischarge period in women with pregnancy-related hypertension compared with traditional office-based follow-up. NCT03185455, Remote Surveillance of Postpartum Hypertension (Text

  1. A randomised controlled trial in comparing maternal and neonatal outcomes between hands-and-knees delivery position and supine position in China.

    Science.gov (United States)

    Zhang, Hongyu; Huang, Shurong; Guo, Xiaolan; Zhao, Ningning; Lu, Yujing; Chen, Min; Li, Yingxia; Wu, Junqin; Huang, Lihua; Ma, Fenglan; Yang, Yuhong; Zhang, Xiaoli; Zhou, Xiaoyu; Guo, Renfei; Cai, Wenzhi

    2017-07-01

    the supine position is the most frequently offered for birth delivery in China and many other countries, but the hands-and-knees position is now gaining prominence with doctors in China. This study aims to examine the differences in maternal and neonatal outcomes among low-risk women who gave birth either in the hands-and-knees position or the supine position. a randomised controlled trial was conducted in 11 hospitals in China from May to December in 2012. In total, 1400 women were recruited and randomly allocated to either the experimental group (n=700, 446 completed the protocol) who delivered in hands-and-knees position and the control group (n=700, 440 completed the protocol) who delivered in supine position. Women who could not maintain the randomised position during the second stage of labour were allowed to withdraw from the study. The primary maternal outcome measured was rate of episiotomy. Secondary outcomes included degree of perineum laceration, rate of emergency caesarean section, rate of shoulder dystocia, and duration of labour, postpartum bleeding, neonatal Apgar score, and the rate of neonatal asphyxia. Because outcome data were only collected for women who gave birth in the randomised position, per-protocol analyses were used to compare groups. The primary outcome, episiotomy, was also compared between groups using logistic regression adjusting for maternal age,gestational age at birth, whether the woman was primiparous, the process of second stage of labour and birthweight. as compared with the control group, the experimental group had lower rates of episiotomy and second-degree perineum laceration (including episiotomy), and higher rates of intact perineum and first-degree perineum laceration, with a longer duration of second stage of labour. No significant differences were found in the amount of postpartum bleeding, shoulder dystocia, neonatal asphyxia and neonatal Apgar scores at 1minute and 5minutes. Adjusted for maternal age, gestational

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

    Directory of Open Access Journals (Sweden)

    Jenkins William

    2007-05-01

    Full Text Available Abstract Background Tobacco use continues to be a global public health problem. Helping patients to quit is part of the preventive role of all health professionals. There is now increasing interest in the role that the dental team can play in helping their patients to quit smoking. The aim of this study was to determine the feasibility of undertaking a randomised controlled smoking cessation intervention, utilising dental hygienists to deliver tobacco cessation advice to a cohort of periodontal patients. Methods One hundred and eighteen patients who attended consultant clinics in an outpatient dental hospital department (Periodontology were recruited into a trial. Data were available for 116 participants, 59 intervention and 57 control, and were analysed on an intention-to-treat basis. The intervention group received smoking cessation advice based on the 5As (ask, advise, assess, assist, arrange follow-up and were offered nicotine replacement therapy (NRT, whereas the control group received 'usual care'. Outcome measures included self-reported smoking cessation, verified by salivary cotinine measurement and CO measurements. Self-reported measures in those trial participants who did not quit included number and length of quit attempts and reduction in smoking. Results At 3 months, 9/59 (15% of the intervention group had quit compared to 5/57 (9% of the controls. At 6 months, 6/59 (10% of the intervention group quit compared to 3/57 (5% of the controls. At one year, there were 4/59 (7% intervention quitters, compared to 2/59 (4% control quitters. In participants who described themselves as smokers, at 3 and 6 months, a statistically higher percentage of intervention participants reported that they had had a quit attempt of at least one week in the preceding 3 months (37% and 47%, for the intervention group respectively, compared with 18% and 16% for the control group. Conclusion This study has shown the potential that trained dental hygienists

  3. 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.

  4. Comparing membranes and bone substitutes in a one-stage procedure for horizontal bone augmentation. A double-blind randomised controlled trial.

    Science.gov (United States)

    Merli, Mauro; Moscatelli, Marco; Mariotti, Giorgia; Pagliaro, Umberto; Raffaelli, Eugenia; Nieri, Michele

    2015-01-01

    The objective of this parallel randomised controlled trial is to compare two bone substitutes and collagen membranes in a one-stage procedure for horizontal bone augmentation: anorganic bovine bone (Bio-Oss) and collagen porcine membranes (Bio-Gide) (BB group) versus a synthetic resorbable bone graft substitute made of pure β-tricalcium phosphate (Ceros TCP) and porcine pericardium collagen membranes (Jason) (CJ group). Patients in need of implant treatment having at least one site with horizontal osseous defects at a private clinic in Rimini (Italy) were included in this study. Patients were randomised to receive either the BB or CJ treatment. Randomisation was computer-generated with allocation concealment by opaque sequentially numbered sealed envelopes. Patients and the outcome assessor were blinded to group assignment. The main outcome measures were implant failure, complications, clinical bone gain at augmented sites, and complete filling of the bone defect. Secondary outcome measures were chair-time, postoperative pain and peri-implant marginal bone level changes. Twenty-five patients with 32 implants were allocated to the BB group and 25 patients with 29 implants to the CJ group. All 50 randomised patients received the treatment as allocated and there were no dropouts up to 6-months post-loading (12 months post-surgery). There were no failures and there were three complications in the BB group and three complications in the CJ group (relative risk: 1.00, 95% CI from 0.22 to 4.49, P = 1.00). The estimated difference between treatments in the vertical defect bone gain was -0.15 mm (95% CI from -0.65 to 0.35, P = 0.5504) favouring the BB group, and the estimated difference between treatments in the horizontal defect bone gain was -0.27 mm (95%CI from -0.73 to 0.19, P = 0.3851) favouring the BB group. There was no difference in the complete filling of the defect (relative risk: 0.88, 95%CI from 0.58 to 1.34, P = 0.7688). No significant differences were

  5. A randomised cross-over pharmacokinetic bioavailability study of synthetic versus kiwifruit-derived vitamin C.

    Science.gov (United States)

    Carr, Anitra C; Bozonet, Stephanie M; Vissers, Margreet C M

    2013-11-11

    Kiwifruit are a rich source of vitamin C and also contain numerous phytochemicals, such as flavonoids, which may influence the bioavailability of kiwifruit-derived vitamin C. The aim of this study was to compare the relative bioavailability of synthetic versus kiwifruit-derived vitamin C using a randomised cross-over pharmacokinetic study design. Nine non-smoking males (aged 18-35 years) received either a chewable tablet (200 mg vitamin C) or the equivalent dose from gold kiwifruit (Actinidia chinensis var. Sungold). Fasting blood and urine were collected half hourly to hourly over the eight hours following intervention. The ascorbate content of the plasma and urine was determined using HPLC with electrochemical detection. Plasma ascorbate levels increased from 0.5 h after the intervention (P = 0.008). No significant differences in the plasma time-concentration curves were observed between the two interventions (P = 0.645). An estimate of the total increase in plasma ascorbate indicated complete uptake of the ingested vitamin C tablet and kiwifruit-derived vitamin C. There was an increase in urinary ascorbate excretion, relative to urinary creatinine, from two hours post intervention (P vitamin C tablet and kiwifruit arms, respectively. Overall, our pharmacokinetic study has shown comparable relative bioavailability of kiwifruit-derived vitamin C and synthetic vitamin C.

  6. Aspartame Sensitivity? A Double Blind Randomised Crossover Study

    OpenAIRE

    Sathyapalan, Thozhukat; Thatcher, Natalie J.; Hammersley, Richard; Rigby, Alan S.; Pechlivanis, Alexandros; Gooderham, Nigel J.; Holmes, Elaine; le Roux, Carel W.; Atkin, Stephen L.; Courts, Fraser

    2015-01-01

    Background Aspartame is a commonly used intense artificial sweetener, being approximately 200 times sweeter than sucrose. There have been concerns over aspartame since approval in the 1980s including a large anecdotal database reporting severe symptoms. The objective of this study was to compare the acute symptom effects of aspartame to a control preparation. Methods This was a double-blind randomized cross over study conducted in a clinical research unit in United Kingdom. Forty-eight indivi...

  7. Upscaling Participatory Action and Videos for Agriculture and Nutrition (UPAVAN) trial comparing three variants of a nutrition-sensitive agricultural extension intervention to improve maternal and child nutritional outcomes in rural Odisha, India: study protocol for a cluster randomised controlled trial.

    Science.gov (United States)

    Kadiyala, Suneetha; Prost, Audrey; Harris-Fry, Helen; O'Hearn, Meghan; Pradhan, Ronali; Pradhan, Shibananth; Mishra, Naba Kishore; Rath, Suchitra; Nair, Nirmala; Rath, Shibanand; Tripathy, Prasantha; Krishnan, Sneha; Koniz-Booher, Peggy; Danton, Heather; Elbourne, Diana; Sturgess, Joanna; Beaumont, Emma; Haghparast-Bidgoli, Hassan; Skordis-Worrall, Jolene; Mohanty, Satyanarayan; Upadhay, Avinash; Allen, Elizabeth

    2018-03-09

    Maternal and child undernutrition have adverse consequences for pregnancy outcomes and child morbidity and mortality, and they are associated with low educational attainment, economic productivity as an adult, and human wellbeing. 'Nutrition-sensitive' agriculture programs could tackle the underlying causes of undernutrition. This study is a four-arm cluster randomised controlled trial in Odisha, India. Interventions are as follows: (1) an agricultural extension platform of women's groups viewing and discussing videos on nutrition-sensitive agriculture (NSA) practices, and follow-up visits to women at home to encourage the adoption of new practices shown in the videos; (2) women's groups viewing and discussing videos on NSA and nutrition-specific practices, with follow-up visits; and (3) women's groups viewing and discussing videos on NSA and nutrition-specific practices combined with a cycle of Participatory Learning and Action meetings, with follow-up visits. All arms, including the control, receive basic nutrition training from government community frontline workers. Primary outcomes, assessed at baseline and 32 months after the start of the interventions, are (1) percentage of children aged 6-23 months consuming ≥ 4 out of 7 food groups per day and (2) mean body mass index (BMI) (kg/m 2 ) of non-pregnant, non-postpartum (gave birth > 42 days ago) mothers or female primary caregivers of children aged 0-23 months. Secondary outcomes are percentage of mothers consuming ≥ 5 out of 10 food groups per day and percentage of children's weight-for-height z-score  70%) proportion of Scheduled Tribe or Scheduled Caste (disadvantaged) households. A process evaluation will assess the quality of implementation and mechanisms behind the intervention effects. A cost-consequence analysis will compare incremental costs and outcomes of the interventions. This trial will contribute evidence on the impacts of NSA extension through participatory, low-cost, video

  8. Does hydrotherapy improve strength and physical function in patients with osteoarthritis—a randomised controlled trial comparing a gym based and a hydrotherapy based strengthening programme

    Science.gov (United States)

    Foley, A; Halbert, J; Hewitt, T; Crotty, M

    2003-01-01

    Objective: To compare the effects of a hydrotherapy resistance exercise programme with a gym based resistance exercise programme on strength and function in the treatment of osteoarthritis (OA). Design: Single blind, three arm, randomised controlled trial. Subjects: 105 community living participants aged 50 years and over with clinical OA of the hip or knee. Methods: Participants were randomised into one of three groups: hydrotherapy (n = 35), gym (n = 35), or control (n = 35). The two exercising groups had three exercise sessions a week for six weeks. At six weeks an independent physiotherapist unaware of the treatment allocation performed all outcome assessments (muscle strength dynamometry, six minute walk test, WOMAC OA Index, total drugs, SF-12 quality of life, Adelaide Activities Profile, and the Arthritis Self-Efficacy Scale). Results: In the gym group both left and right quadriceps significantly increased in strength compared with the control group, and right quadriceps strength was also significantly better than in the hydrotherapy group. The hydrotherapy group increased left quadriceps strength only at follow up, and this was significantly different from the control group. The hydrotherapy group was significantly different from the control group for distance walked and the physical component of the SF-12. The gym group was significantly different from the control group for walk speed and self efficacy satisfaction. Compliance rates were similar for both exercise groups, with 84% of hydrotherapy and 75% of gym sessions attended. There were no differences in drug use between groups over the study period. Conclusion: Functional gains were achieved with both exercise programmes compared with the control group. PMID:14644853

  9. Does hydrotherapy improve strength and physical function in patients with osteoarthritis--a randomised controlled trial comparing a gym based and a hydrotherapy based strengthening programme.

    Science.gov (United States)

    Foley, A; Halbert, J; Hewitt, T; Crotty, M

    2003-12-01

    To compare the effects of a hydrotherapy resistance exercise programme with a gym based resistance exercise programme on strength and function in the treatment of osteoarthritis (OA). Single blind, three arm, randomised controlled trial. 105 community living participants aged 50 years and over with clinical OA of the hip or knee. Participants were randomised into one of three groups: hydrotherapy (n = 35), gym (n = 35), or control (n = 35). The two exercising groups had three exercise sessions a week for six weeks. At six weeks an independent physiotherapist unaware of the treatment allocation performed all outcome assessments (muscle strength dynamometry, six minute walk test, WOMAC OA Index, total drugs, SF-12 quality of life, Adelaide Activities Profile, and the Arthritis Self-Efficacy Scale). In the gym group both left and right quadriceps significantly increased in strength compared with the control group, and right quadriceps strength was also significantly better than in the hydrotherapy group. The hydrotherapy group increased left quadriceps strength only at follow up, and this was significantly different from the control group. The hydrotherapy group was significantly different from the control group for distance walked and the physical component of the SF-12. The gym group was significantly different from the control group for walk speed and self efficacy satisfaction. Compliance rates were similar for both exercise groups, with 84% of hydrotherapy and 75% of gym sessions attended. There were no differences in drug use between groups over the study period. Functional gains were achieved with both exercise programmes compared with the control group.

  10. Acute morbidity reduction using 3DCRT for prostate carcinoma; a randomised phase III study

    International Nuclear Information System (INIS)

    Koper, P.; Putten, W. van; Stroom, J.; Korevaar, G.; Heijmen, B.; Wijnmaalen, A.; Jansen, P.; Hanssens, P.; Griep, C.; Krol, A.; Samson, M.; Levendag, P.

    1997-01-01

    Purpose: A randomised phase III toxicity study (conventional vs conformal radiotherapy) was performed for prostatic carcinoma to study the effects on the (acute) morbidity of intestinal/rectosigmoid and bladder. The observed toxicity was compared with Dose Volume Histograms to reveal possible volume (reduction) effects. Methods: In the phase III study 266 T1-4 N0M0 prostate cancer patients were entered. Patients were randomised for conventional and conformal radiotherapy (total dose 66 Gy, minimum PTV dose 95% ICRU and a CTV-PTV margin of 10 mm in both study arms). The GTV was limited to the prostate only in T1 tumors. In all other patients the GTV was defined to be prostate and seminal vesicles for the complete treatment course. The CTV-PTV margin (10mm) was created by a automated program to ensure the minimum prescribed margin. The rectosigmoid was defined to be the rectum including the sigmoid within the Treatment Volume (ICRU). Acute toxicity was evaluated using the EORTC/RTOG morbidity score and weekly quality of life questionnaires. The radiation technique comparison was done by Dose volume Histogram analysis using the Area Under The Curve (AUC) for different dose levels. In this preliminary DVH analysis we present the data for the first 100 patients. Results: Patient and tumor characteristics were evenly distributed between both study groups. The maximum toxicity is reached at 75% of the tumordose (TD) (rectal grade I 59% grade II 26%, bladder grade I 48%, grade II 16% and grade III 1% [catheter for urinary retention]). Comparing both study arms there seems to be a reduction in intestinal morbidity (grade II and higher resp. 32% vs 19% p=0.02). Further analysis revealed a marked reduction in medication for anal symptoms; this accounts for a large part of the significant difference in intestinal toxicity (grade II conventional vs conformal rectosigmoid 18% vs 14% and anal 16% vs 8%). For bladder morbidity no difference for mobidity higher than grade I is

  11. 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 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...

  12. Report of a randomised pilot study of the treatment of patients with supratentorial gliomas using neutron irradiation

    International Nuclear Information System (INIS)

    Duncan, W.; McLelland, J.; Jack, W.J.L.; Arnott, S.J.; Kerr, G.R.; Williams, J.R.; Gordon, A.

    1986-01-01

    A randomised pilot study is reported of d(15) + Be neutrons compared with 4 MV photons in the treatment of patients with astrocytoma. Sixteen patients were treated by photons and 18 by neutrons. Both treatments were well tolerated by patients. The median survival after photons was 11 months and after neutrons, 7 months. It was demonstrated that four of nine patients treated by neutrons had evidence at autopsy of radiation-induced brain damage. All had residual cancer. No patient treated by photons had signs of radiation-related morbidity. The trial was, therefore, discontinued prematurely. (author)

  13. ROPIVACAINE VERSUS LIDOCAINE FOR EPISIOTOMY-A RANDOMISED DOUBLE BLIND STUDY

    Directory of Open Access Journals (Sweden)

    Pushpalatha Nagaraj

    2017-04-01

    Full Text Available BACKGROUND Episiotomy is a most common surgical procedure for parturients during vaginal delivery. The problem encountered with episiotomy is pain, which is maximum during first 24 hours and may be severe enough to disturb the puerperium. This study aims to compare analgesic efficacy of analgesics, ropivacaine and lidocaine for perineal infiltration during episiotomy. MATERIALS AND METHODS We conducted a randomised double blind study for a period one year from August 2013 in a tertiary hospital. 100 parturients were included. RESULTS Ropivacaine 0.75% compared to lidocaine 2% did not show any statistical significant changes at suturing and after 4 hours; however, there were great statistically significant changes in VAS scores after 8 hours, 12 hours, 24 hours of episiotomy suturing. Ropivacaine group did not require systemic analgesics for 24 hours, but lidocaine group required systemic analgesics after 4 hours of suturing. Both groups (Ropivacaine and Lidocaine did not have any adverse effects. CONCLUSION Ropivacaine can be used safely for episiotomy wound infiltration thereby reducing the need for systemic analgesia.

  14. Effect of pelvic floor muscle training compared with watchful waiting in older women with symptomatic mild pelvic organ prolapse : randomised controlled trial in primary care

    NARCIS (Netherlands)

    Wiegersma, Marian; Panman, Chantal M. C. R.; Kollen, Boudewijn J.; Berger, Marjolein Y.; Lisman-Van Leeuwen, Yvonne; Dekker, Janny H.

    2014-01-01

    Objective To compare the effects of pelvic floor muscle training and watchful waiting on pelvic floor symptoms in a primary care population of women aged 55 years and over with symptomatic mild pelvic organ prolapse. Design Randomised controlled trial. Setting Dutch primary care. Participants Women

  15. The effect of souvenaid on functional brain network organisation in patients with mild Alzheimer's disease: a randomised controlled study.

    Directory of Open Access Journals (Sweden)

    Hanneke de Waal

    Full Text Available Synaptic loss is a major hallmark of Alzheimer's disease (AD. Disturbed organisation of large-scale functional brain networks in AD might reflect synaptic loss and disrupted neuronal communication. The medical food Souvenaid, containing the specific nutrient combination Fortasyn Connect, is designed to enhance synapse formation and function and has been shown to improve memory performance in patients with mild AD in two randomised controlled trials.To explore the effect of Souvenaid compared to control product on brain activity-based networks, as a derivative of underlying synaptic function, in patients with mild AD.A 24-week randomised, controlled, double-blind, parallel-group, multi-country study.179 drug-naïve mild AD patients who participated in the Souvenir II study.Patients were randomised 1∶1 to receive Souvenaid or an iso-caloric control product once daily for 24 weeks.In a secondary analysis of the Souvenir II study, electroencephalography (EEG brain networks were constructed and graph theory was used to quantify complex brain structure. Local brain network connectivity (normalised clustering coefficient gamma and global network integration (normalised characteristic path length lambda were compared between study groups, and related to memory performance.THE NETWORK MEASURES IN THE BETA BAND WERE SIGNIFICANTLY DIFFERENT BETWEEN GROUPS: they decreased in the control group, but remained relatively unchanged in the active group. No consistent relationship was found between these network measures and memory performance.The current results suggest that Souvenaid preserves the organisation of brain networks in patients with mild AD within 24 weeks, hypothetically counteracting the progressive network disruption over time in AD. The results strengthen the hypothesis that Souvenaid affects synaptic integrity and function. Secondly, we conclude that advanced EEG analysis, using the mathematical framework of graph theory, is useful and

  16. The effect of souvenaid on functional brain network organisation in patients with mild Alzheimer's disease: a randomised controlled study.

    Science.gov (United States)

    de Waal, Hanneke; Stam, Cornelis J; Lansbergen, Marieke M; Wieggers, Rico L; Kamphuis, Patrick J G H; Scheltens, Philip; Maestú, Fernando; van Straaten, Elisabeth C W

    2014-01-01

    Synaptic loss is a major hallmark of Alzheimer's disease (AD). Disturbed organisation of large-scale functional brain networks in AD might reflect synaptic loss and disrupted neuronal communication. The medical food Souvenaid, containing the specific nutrient combination Fortasyn Connect, is designed to enhance synapse formation and function and has been shown to improve memory performance in patients with mild AD in two randomised controlled trials. To explore the effect of Souvenaid compared to control product on brain activity-based networks, as a derivative of underlying synaptic function, in patients with mild AD. A 24-week randomised, controlled, double-blind, parallel-group, multi-country study. 179 drug-naïve mild AD patients who participated in the Souvenir II study. Patients were randomised 1∶1 to receive Souvenaid or an iso-caloric control product once daily for 24 weeks. In a secondary analysis of the Souvenir II study, electroencephalography (EEG) brain networks were constructed and graph theory was used to quantify complex brain structure. Local brain network connectivity (normalised clustering coefficient gamma) and global network integration (normalised characteristic path length lambda) were compared between study groups, and related to memory performance. THE NETWORK MEASURES IN THE BETA BAND WERE SIGNIFICANTLY DIFFERENT BETWEEN GROUPS: they decreased in the control group, but remained relatively unchanged in the active group. No consistent relationship was found between these network measures and memory performance. The current results suggest that Souvenaid preserves the organisation of brain networks in patients with mild AD within 24 weeks, hypothetically counteracting the progressive network disruption over time in AD. The results strengthen the hypothesis that Souvenaid affects synaptic integrity and function. Secondly, we conclude that advanced EEG analysis, using the mathematical framework of graph theory, is useful and feasible for

  17. A prospective randomised, open-labeled, trial comparing sirolimus-containing versus mTOR-inhibitor-free immunosuppression in patients undergoing liver transplantation for hepatocellular carcinoma

    International Nuclear Information System (INIS)

    Schnitzbauer, Andreas A; Adam, Rene; Bechstein, Wolf O; Becker, Thomas; Beckebaum, Susanne; Chazouillères, Olivier; Cillo, Umberto; Colledan, Michele; Fändrich, Fred; Gugenheim, Jean; Hauss, Johann P; Zuelke, Carl; Heise, Michael; Hidalgo, Ernest; Jamieson, Neville; Königsrainer, Alfred; Lamby, Philipp E; Lerut, Jan P; Mäkisalo, Heikki; Margreiter, Raimund; Mazzaferro, Vincenzo; Mutzbauer, Ingrid; Graeb, Christian; Otto, Gerd; Pageaux, Georges-Philippe; Pinna, Antonio D; Pirenne, Jacques; Rizell, Magnus; Rossi, Giorgio; Rostaing, Lionel; Roy, Andre; Turrion, Victor Sanchez; Schmidt, Jan; Rochon, Justine; Troisi, Roberto I; Hoek, Bart van; Valente, Umberto; Wolf, Philippe; Wolters, Heiner; Mirza, Darius F; Scholz, Tim; Steininger, Rudolf; Soderdahl, Gunnar; Strasser, Simone I; Bilbao, Itxarone; Jauch, Karl-Walter; Neuhaus, Peter; Schlitt, Hans J; Geissler, Edward K; Burra, Patrizia; Jong, Koert P de; Duvoux, Christophe; Kneteman, Norman M

    2010-01-01

    The potential anti-cancer effects of mammalian target of rapamycin (mTOR) inhibitors are being intensively studied. To date, however, few randomised clinical trials (RCT) have been performed to demonstrate anti-neoplastic effects in the pure oncology setting, and at present, no oncology endpoint-directed RCT has been reported in the high-malignancy risk population of immunosuppressed transplant recipients. Interestingly, since mTOR inhibitors have both immunosuppressive and anti-cancer effects, they have the potential to simultaneously protect against immunologic graft loss and tumour development. Therefore, we designed a prospective RCT to determine if the mTOR inhibitor sirolimus can improve hepatocellular carcinoma (HCC)-free patient survival in liver transplant (LT) recipients with a pre-transplant diagnosis of HCC. The study is an open-labelled, randomised, RCT comparing sirolimus-containing versus mTOR-inhibitor-free immunosuppression in patients undergoing LT for HCC. Patients with a histologically confirmed HCC diagnosis are randomised into 2 groups within 4-6 weeks after LT; one arm is maintained on a centre-specific mTOR-inhibitor-free immunosuppressive protocol and the second arm is maintained on a centre-specific mTOR-inhibitor-free immunosuppressive protocol for the first 4-6 weeks, at which time sirolimus is initiated. A 2 1/2 -year recruitment phase is planned with a 5-year follow-up, testing HCC-free survival as the primary endpoint. Our hypothesis is that sirolimus use in the second arm of the study will improve HCC-free survival. The study is a non-commercial investigator-initiated trial (IIT) sponsored by the University Hospital Regensburg and is endorsed by the European Liver and Intestine Transplant Association; 13 countries within Europe, Canada and Australia are participating. If our hypothesis is correct that mTOR inhibition can reduce HCC tumour growth while simultaneously providing immunosuppression to protect the liver allograft from

  18. A prospective randomised, open-labeled, trial comparing sirolimus-containing versus mTOR-inhibitor-free immunosuppression in patients undergoing liver transplantation for hepatocellular carcinoma

    Directory of Open Access Journals (Sweden)

    Roy Andre

    2010-05-01

    Full Text Available Abstract Background The potential anti-cancer effects of mammalian target of rapamycin (mTOR inhibitors are being intensively studied. To date, however, few randomised clinical trials (RCT have been performed to demonstrate anti-neoplastic effects in the pure oncology setting, and at present, no oncology endpoint-directed RCT has been reported in the high-malignancy risk population of immunosuppressed transplant recipients. Interestingly, since mTOR inhibitors have both immunosuppressive and anti-cancer effects, they have the potential to simultaneously protect against immunologic graft loss and tumour development. Therefore, we designed a prospective RCT to determine if the mTOR inhibitor sirolimus can improve hepatocellular carcinoma (HCC-free patient survival in liver transplant (LT recipients with a pre-transplant diagnosis of HCC. Methods/Design The study is an open-labelled, randomised, RCT comparing sirolimus-containing versus mTOR-inhibitor-free immunosuppression in patients undergoing LT for HCC. Patients with a histologically confirmed HCC diagnosis are randomised into 2 groups within 4-6 weeks after LT; one arm is maintained on a centre-specific mTOR-inhibitor-free immunosuppressive protocol and the second arm is maintained on a centre-specific mTOR-inhibitor-free immunosuppressive protocol for the first 4-6 weeks, at which time sirolimus is initiated. A 21/2 -year recruitment phase is planned with a 5-year follow-up, testing HCC-free survival as the primary endpoint. Our hypothesis is that sirolimus use in the second arm of the study will improve HCC-free survival. The study is a non-commercial investigator-initiated trial (IIT sponsored by the University Hospital Regensburg and is endorsed by the European Liver and Intestine Transplant Association; 13 countries within Europe, Canada and Australia are participating. Discussion If our hypothesis is correct that mTOR inhibition can reduce HCC tumour growth while simultaneously

  19. Dextrose gel for neonatal hypoglycaemia (the Sugar Babies Study): a randomised, double-blind, placebo-controlled trial.

    Science.gov (United States)

    Harris, Deborah L; Weston, Philip J; Signal, Matthew; Chase, J Geoffrey; Harding, Jane E

    2013-12-21

    Neonatal hypoglycaemia is common, and a preventable cause of brain damage. Dextrose gel is used to reverse hypoglycaemia in individuals with diabetes; however, little evidence exists for its use in babies. We aimed to assess whether treatment with dextrose gel was more effective than feeding alone for reversal of neonatal hypoglycaemia in at-risk babies. We undertook a randomised, double-blind, placebo-controlled trial at a tertiary centre in New Zealand between Dec 1, 2008, and Nov 31, 2010. Babies aged 35-42 weeks' gestation, younger than 48-h-old, and at risk of hypoglycaemia were randomly assigned (1:1), via computer-generated blocked randomisation, to 40% dextrose gel 200 mg/kg or placebo gel. Randomisation was stratified by maternal diabetes and birthweight. Group allocation was concealed from clinicians, families, and all study investigators. The primary outcome was treatment failure, defined as a blood glucose concentration of less than 2·6 mmol/L after two treatment attempts. Analysis was by intention to treat. The trial is registered with Australian New Zealand Clinical Trials Registry, number ACTRN12608000623392. Of 514 enrolled babies, 242 (47%) became hypoglycaemic and were randomised. Five babies were randomised in error, leaving 237 for analysis: 118 (50%) in the dextrose group and 119 (50%) in the placebo group. Dextrose gel reduced the frequency of treatment failure compared with placebo (16 [14%] vs 29 [24%]; relative risk 0·57, 95% CI 0·33-0·98; p=0·04). We noted no serious adverse events. Three (3%) babies in the placebo group each had one blood glucose concentration of 0·9 mmol/L. No other adverse events took place. Treatment with dextrose gel is inexpensive and simple to administer. Dextrose gel should be considered for first-line treatment to manage hypoglycaemia in late preterm and term babies in the first 48 h after birth. Waikato Medical Research Foundation, the Auckland Medical Research Foundation, the Maurice and Phyllis Paykel

  20. Comparative randomised active drug controlled clinical trial of a herbal eye drop in computer vision syndrome.

    Science.gov (United States)

    Chatterjee, Pranab Kr; Bairagi, Debasis; Roy, Sudipta; Majumder, Nilay Kr; Paul, Ratish Ch; Bagchi, Sunil Ch

    2005-07-01

    A comparative double-blind placebo-controlled clinical trial of a herbal eye drop (itone) was conducted to find out its efficacy and safety in 120 patients with computer vision syndrome. Patients using computers for more than 3 hours continuously per day having symptoms of watering, redness, asthenia, irritation, foreign body sensation and signs of conjunctival hyperaemia, corneal filaments and mucus were studied. One hundred and twenty patients were randomly given either placebo, tears substitute (tears plus) or itone in identical vials with specific code number and were instructed to put one drop four times daily for 6 weeks. Subjective and objective assessments were done at bi-weekly intervals. In computer vision syndrome both subjective and objective improvements were noticed with itone drops. Itone drop was found significantly better than placebo (pcomputer vision syndrome.

  1. The effect of music therapy compared with general recreational activities in reducing agitation in people with dementia: a randomised controlled trial.

    Science.gov (United States)

    Vink, A C; Zuidersma, M; Boersma, F; de Jonge, P; Zuidema, S U; Slaets, J P J

    2013-10-01

    This study aimed to compare the effects of music therapy with general recreational day activities in reducing agitation in people with dementia, residing in nursing home facilities. In a randomised controlled design, residents with dementia (n = 94) were allocated to either music therapy or recreational activities. Both music therapy and general activities were offered twice weekly for 4 months. Changes in agitation were measured with a modified Cohen-Mansfield Agitation Inventory (CMAI) at four intervals on each intervention day. A mixed model analysis was used to evaluate the effectiveness of music therapy, compared with general activities, on CMAI scores at 4 h after the intervention, controlled for CMAI scores at 1 h before the session and session number. Data were analysed for 77 residents (43 randomised to music therapy and 34 to general activities). In both groups, the intervention resulted in a decrease in agitated behaviours from 1 h before to 4 h after each session. This decrease was somewhat greater in the music therapy group than in the general activities group, but this difference was statistically not significant (F = 2.885, p = 0.090) and disappeared completely after adjustment for Global Deterioration Scale stage (F = 1.500; p = 0.222). Both music therapy and recreational activities lead to a short-term decrease in agitation, but there was no additional beneficial effect of music therapy over general activities. More research is required to provide insight in the effects of music therapy in reducing agitation in demented older people. Copyright © 2012 John Wiley & Sons, Ltd.

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

    Science.gov (United States)

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

    2016-07-01

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

  3. Prostate cancer mortality reduction by prostate-specific antigen-based screening adjusted for nonattendance and contamination in the European Randomised Study of Screening for Prostate Cancer (ERSPC).

    Science.gov (United States)

    Roobol, Monique J; Kerkhof, Melissa; Schröder, Fritz H; Cuzick, Jack; Sasieni, Peter; Hakama, Matti; Stenman, Ulf Hakan; Ciatto, Stefano; Nelen, Vera; Kwiatkowski, Maciej; Lujan, Marcos; Lilja, Hans; Zappa, Marco; Denis, Louis; Recker, Franz; Berenguer, Antonio; Ruutu, Mirja; Kujala, Paula; Bangma, Chris H; Aus, Gunnar; Tammela, Teuvo L J; Villers, Arnauld; Rebillard, Xavier; Moss, Sue M; de Koning, Harry J; Hugosson, Jonas; Auvinen, Anssi

    2009-10-01

    Prostate-specific antigen (PSA) based screening for prostate cancer (PCa) has been shown to reduce prostate specific mortality by 20% in an intention to screen (ITS) analysis in a randomised trial (European Randomised Study of Screening for Prostate Cancer [ERSPC]). This effect may be diluted by nonattendance in men randomised to the screening arm and contamination in men randomised to the control arm. To assess the magnitude of the PCa-specific mortality reduction after adjustment for nonattendance and contamination. We analysed the occurrence of PCa deaths during an average follow-up of 9 yr in 162,243 men 55-69 yr of age randomised in seven participating centres of the ERSPC. Centres were also grouped according to the type of randomisation (ie, before or after informed written consent). Nonattendance was defined as nonattending the initial screening round in ERSPC. The estimate of contamination was based on PSA use in controls in ERSPC Rotterdam. Relative risks (RRs) with 95% confidence intervals (CIs) were compared between an ITS analysis and analyses adjusting for nonattendance and contamination using a statistical method developed for this purpose. In the ITS analysis, the RR of PCa death in men allocated to the intervention arm relative to the control arm was 0.80 (95% CI, 0.68-0.96). Adjustment for nonattendance resulted in a RR of 0.73 (95% CI, 0.58-0.93), and additional adjustment for contamination using two different estimates led to estimated reductions of 0.69 (95% CI, 0.51-0.92) to 0.71 (95% CI, 0.55-0.93), respectively. Contamination data were obtained through extrapolation of single-centre data. No heterogeneity was found between the groups of centres. PSA screening reduces the risk of dying of PCa by up to 31% in men actually screened. This benefit should be weighed against a degree of overdiagnosis and overtreatment inherent in PCa screening.

  4. Vitamin D and risk of pregnancy related hypertensive disorders: mendelian randomisation study.

    Science.gov (United States)

    Magnus, Maria C; Miliku, Kozeta; Bauer, Anna; Engel, Stephanie M; Felix, Janine F; Jaddoe, Vincent W V; Lawlor, Debbie A; London, Stephanie J; Magnus, Per; McGinnis, Ralph; Nystad, Wenche; Page, Christian M; Rivadeneira, Fernando; Stene, Lars C; Tapia, German; Williams, Nicholas; Bonilla, Carolina; Fraser, Abigail

    2018-06-20

    To use mendelian randomisation to investigate whether 25-hydroxyvitamin D concentration has a causal effect on gestational hypertension or pre-eclampsia. One and two sample mendelian randomisation analyses. Two European pregnancy cohorts (Avon Longitudinal Study of Parents and Children, and Generation R Study), and two case-control studies (subgroup nested within the Norwegian Mother and Child Cohort Study, and the UK Genetics of Pre-eclampsia Study). 7389 women in a one sample mendelian randomisation analysis (751 with gestational hypertension and 135 with pre-eclampsia), and 3388 pre-eclampsia cases and 6059 controls in a two sample mendelian randomisation analysis. Single nucleotide polymorphisms in genes associated with vitamin D synthesis (rs10741657 and rs12785878) and metabolism (rs6013897 and rs2282679) were used as instrumental variables. Gestational hypertension and pre-eclampsia defined according to the International Society for the Study of Hypertension in Pregnancy. In the conventional multivariable analysis, the relative risk for pre-eclampsia was 1.03 (95% confidence interval 1.00 to 1.07) per 10% decrease in 25-hydroxyvitamin D level, and 2.04 (1.02 to 4.07) for 25-hydroxyvitamin D levels effect of 25-hydroxyvitamin D on the risk of gestational hypertension or pre-eclampsia: odds ratio 0.90 (95% confidence interval 0.78 to 1.03) and 1.19 (0.92 to 1.52) per 10% decrease, respectively. The two sample mendelian randomisation estimate gave an odds ratio for pre-eclampsia of 0.98 (0.89 to 1.07) per 10% decrease in 25-hydroxyvitamin D level, an odds ratio of 0.96 (0.80 to 1.15) per unit increase in the log(odds) of 25-hydroxyvitamin D level effect of vitamin D status on gestational hypertension or pre-eclampsia. Future mendelian randomisation studies with a larger number of women with pre-eclampsia or more genetic instruments that would increase the proportion of 25-hydroxyvitamin D levels explained by the instrument are needed. Published by the BMJ

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

    Directory of Open Access Journals (Sweden)

    Logan Pip A

    2012-06-01

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

  6. CATCH: a randomised clinical trial comparing long-term tinzaparin versus warfarin for treatment of acute venous thromboembolism in cancer patients

    International Nuclear Information System (INIS)

    Lee, Agnes YY; Bauersachs, Rupert; Janas, Mette S; Jarner, Mikala F; Kamphuisen, Pieter W; Meyer, Guy; Khorana, Alok A

    2013-01-01

    Low-molecular-weight heparin (LMWH) is recommended and commonly used for extended treatment of cancer-associated thrombosis (CAT), but its superiority over warfarin has been demonstrated in only one randomised study. We report here the rationale, design and a priori analysis plans of Comparison of Acute Treatments in Cancer Haemostasis (CATCH; NCT01130025), a multinational, Phase III, open-label, randomised controlled trial comparing tinzaparin with warfarin for extended treatment of CAT. The primary objective is to assess the efficacy of tinzaparin in preventing recurrent venous thromboembolism (VTE) in patients with active cancer and acute, symptomatic proximal deep vein thrombosis and/or pulmonary embolism. The secondary objectives are to determine: safety of tinzaparin given over 6 months; clinical and laboratory markers for recurrent VTE and/or major bleeding; 6-month overall mortality; incidence and severity of post-thrombotic syndrome; patient-reported quality of life; and healthcare resource utilisation. Nine hundred patients are randomised to receive tinzaparin 175 IU/kg once daily for 6 months or initial tinzaparin 175 IU/kg once daily for 5–10 days and dose-adjusted warfarin (target INR 2.0–3.0) for 6 months. The primary composite outcome is time to recurrent VTE, including incidental VTE and fatal pulmonary embolism. All patients are followed up to 6 months or death, whichever comes sooner. Blinded adjudication will be performed for all reported VTE, bleeding events and causes of death. Efficacy will be analysed using centrally adjudicated results of all patients according to intention-to-treat analysis. An independent Data Safety Monitoring Board is reviewing data at regular intervals and an interim analysis is planned after 450 patients have completed the study. The results will add significantly to the knowledge of the efficacy, safety and cost effectiveness of tinzaparin in the prevention of recurrent VTE in patients with cancer and thrombosis

  7. 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

  8. Promoting childbirth companions in South Africa: a randomised pilot study

    Science.gov (United States)

    Brown, Heather; Hofmeyr, G Justus; Nikodem, V Cheryl; Smith, Helen; Garner, Paul

    2007-01-01

    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 of a lay carer impacted

  9. A pilot randomised controlled trial in intensive care patients comparing 7 days' treatment with empirical antibiotics with 2 days' treatment for hospital-acquired infection of unknown origin.

    Science.gov (United States)

    Scawn, N; Saul, D; Pathak, D; Matata, B; Kemp, I; Stables, R; Lane, S; Haycox, A; Houten, R

    2012-09-01

    Management of cardiac intensive care unit (ICU) sepsis is complicated by the high incidence of systemic inflammatory response syndrome, which mimics sepsis but without an infective cause. This pilot randomised trial investigated whether or not, in the ICU, 48 hours of broad-spectrum antibiotic treatment was adequate to safely treat suspected sepsis of unknown and unproven origin and also the predictive power of newer biomarkers of sepsis. The main objective of this pilot study was to provide preliminary data on the likely safety and efficacy of a reduced course of antibiotics for the treatment of ICU infections of unknown origin. A pilot, single-centre, open-label randomised trial. This study was carried out in the ICU of a tertiary heart and chest hospital. Patients being treated within the ICU were recruited into the trial if the intensivist was planning to commence antibiotics because of evidence of systemic inflammatory response syndrome and a strong suspicion of infection but there was no actual known source for that infection. Broad-spectrum antibiotic treatment administered for 48 hours (experimental) compared with treatment for 7 days (control). The primary outcome was a composite outcome of the rate of death or initiation of antibiotic therapy after the completion of the treatment schedule allocated at randomisation. Secondary outcomes included the duration of mechanical ventilation and ICU and hospital stay; the incidence of infection with Clostridium difficile (B. S. Weeks & E. Alcamo) Jones & Bartlett International Publishers, 2008, or methicillin-resistant Staphylococcus aureus (MRSA) (B. S. Weeks & E. Alcamo) Jones & Bartlett International Publishers, 2008; resource utilisation and costs associated with each of the two pilot arms; the ratio of patients screened to patients eligible to patients randomised; the incidence of crossover between groups; and the significance of newer biomarkers for sepsis for predicting patients' need for further antibiotics

  10. Parenting for Autism, Language, And Communication Evaluation Study (PALACES): protocol for a pilot randomised controlled trial.

    Science.gov (United States)

    Williams, Margiad Elen; Hastings, Richard; Charles, Joanna Mary; Evans, Sue; Hutchings, Judy

    2017-02-16

    Children with autistic spectrum disorder (ASD) often have associated behavioural difficulties that can present a challenge for parents and parenting. There are several effective social learning theory-based parenting programmes for dealing with behavioural difficulties, including the Incredible Years (IY) parent programmes. However, these programmes typically do not specifically target parents of children with ASD. Recently, a new addition to the IY suite of programmes known as the IY Autistic Spectrum and Language Delays (IY-ASLD) parent programme was developed. The main aims of the present study are to examine the feasibility of delivering this programme within child health services and to provide initial evidence for effectiveness and economic costs. The Parenting for Autism, Language, And Communication Evaluation Study (PALACES) trial is a pragmatic, multicentre, pilot randomised controlled trial comparing the IY-ASLD programme with a wait-list control condition. 72 parents of children with ASD (aged 3-8 years) will be randomly allocated to either the intervention or control condition. Data will be collected prior to randomisation and 6 months postrandomisation for all families. Families in the intervention condition only will also be followed up at 12 and 18 months postrandomisation. This study will provide initial evidence of effectiveness for the newly developed IY-ASLD parenting programme. It will also add to the limited economic evidence for an intervention targeting parents of children with ASD and provide longer term data, an important component for evaluations of parenting programmes. Approval for the study was granted by the Research Ethics Committee at the School of Psychology, Bangor University (reference number: 2016-15768) and the North Wales Research Ethics Committee, UK (reference number: 16/WA/0224). The findings will be disseminated through research conferences and peer-reviewed journals. ISRCTN57070414; Pre-results. Published by the BMJ

  11. Acupuncture point injection treatment of primary dysmenorrhoea: a randomised, double blind, controlled study.

    Science.gov (United States)

    Wade, C; Wang, L; Zhao, W J; Cardini, F; Kronenberg, F; Gui, S Q; Ying, Z; Zhao, N Q; Chao, M T; Yu, J

    2016-01-05

    To determine if injection of vitamin K3 in an acupuncture point is optimal for the treatment of primary dysmenorrhoea, when compared with 2 other injection treatments. A Menstrual Disorder Centre at a public hospital in Shanghai, China. Chinese women aged 14-25 years with severe primary dysmenorrhoea for at least 6 months not relieved by any other treatment were recruited. Exclusion criteria were the use of oral contraceptives, intrauterine devices or anticoagulant drugs, pregnancy, history of abdominal surgery, participation in other therapies for pain and diagnosis of secondary dysmenorrhoea. Eighty patients with primary dysmenorrhoea, as defined on a 4-grade scale, completed the study. Two patients withdrew after randomisation. A double-blind, double-dummy, randomised controlled trial compared vitamin K3 acupuncture point injection to saline acupuncture point injection and vitamin K3 deep muscle injection. Patients in each group received 3 injections at a single treatment visit. The primary outcome was the difference in subjective perception of pain as measured by an 11 unit Numeric Rating Scale (NRS). Secondary measurements were Cox Pain Intensity and Duration scales and the consumption of analgesic tablets before and after treatment and during 6 following cycles. Patients in all 3 groups experienced pain relief from the injection treatments. Differences in NRS measured mean pain scores between the 2 active control groups were less than 1 unit (-0.71, CI -1.37 to -0.05) and not significant, but the differences in average scores between the treatment hypothesised to be optimal and both active control groups (1.11, CI 0.45 to 1.78) and (1.82, CI 1.45 to 2.49) were statistically significant in adjusted mixed-effects models. Menstrual distress and use of analgesics were diminished for 6 months post-treatment. Acupuncture point injection of vitamin K3 relieves menstrual pain rapidly and is a useful treatment in an urban outpatient clinic. NCT00104546; Results

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

    Science.gov (United States)

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

    2016-02-17

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

  13. 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; Fox, Matthew P; 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...

  14. OPTIMUM: a protocol for a multicentre randomised controlled trial comparing Out Patient Talc slurry via Indwelling pleural catheter for Malignant pleural effusion vs Usual inpatient Management.

    Science.gov (United States)

    Sivakumar, P; Douiri, A; West, A; Rao, D; Warwick, G; Chen, T; Ahmed, L

    2016-10-18

    The development of malignant pleural effusion (MPE) results in disabling breathlessness, pain and reduced physical capability with treatment a palliative strategy. Ambulatory management of MPE has the potential to improve quality of life (QoL). The OPTIMUM trial is designed to determine whether full outpatient management of MPE with an indwelling pleural catheter (IPC) and pleurodesis improves QoL compared with traditional inpatient care with a chest drain and talc pleurodesis. OPTIMUM is currently open for any centres interested in collaborating in this study. OPTIMUM is a multicentre non-blinded randomised controlled trial. Patients with a diagnosis of MPE will be identified and screened for eligibility. Consenting participants will be randomised 1:1 either to an outpatient ambulatory pathway using IPCs and talc pleurodesis or standard inpatient treatment with chest drain and talc pleurodesis as per British Thoracic Society guidelines. The primary outcome measure is global health-related QoL at 30 days measured using the EORTC QLQ-C30 questionnaire. Secondary outcome measures include breathlessness and pain measured using a 100 mm Visual Analogue Scale and health-related QoL at 60 and 90 days. A sample size of 142 patients is needed to demonstrate a clinically significant difference of 8 points in global health status at 30 days, for an 80% power and a 5% significance level. The study has been approved by the NRES Committee South East Coast-Brighton and Sussex (reference 15/LO/1018). The trial results will be published in peer-reviewed journals and presented at scientific conferences. UKCRN19615 and ISRCTN15503522; Pre-results. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  15. The feasibility of a pragmatic randomised controlled trial to compare usual care with usual care plus individualised homeopathy, in children requiring secondary care for asthma.

    Science.gov (United States)

    Thompson, E A; Shaw, A; Nichol, J; Hollinghurst, S; Henderson, A J; Thompson, T; Sharp, D

    2011-07-01

    To test the feasibility of a pragmatic trial design with economic evaluation and nested qualitative study, comparing usual care (UC) with UC plus individualised homeopathy, in children requiring secondary care for asthma. This included recruitment and retention, acceptability of outcome measures patients' and health professionals' views and experiences and a power calculation for a definitive trial. In a pragmatic parallel group randomised controlled trial (RCT) design, children on step 2 or above of the British Thoracic Society Asthma Guidelines (BTG) were randomly allocated to UC or UC plus a five visit package of homeopathic care (HC). Outcome measures included the Juniper Asthma Control Questionnaire, Quality of Life Questionnaire and a resource use questionnaire. Qualitative interviews were used to gain families' and health professionals' views and experiences. 226 children were identified from hospital clinics and related patient databases. 67 showed an interest in participating, 39 children were randomised, 18 to HC and 21 to UC. Evidence in favour of adjunctive homeopathic treatment was lacking. Economic evaluation suggests that the cost of additional consultations was not offset by the reduced cost of homeopathic remedies and the lower use of primary care by children in the homeopathic group. Qualitative data gave insights into the differing perspectives of families and health care professionals within the research process. A future study using this design is not feasible, further investigation of a potential role for homeopathy in asthma management might be better conducted in primary care with children with less severe asthma. Copyright © 2011 The Faculty of Homeopathy. Published by Elsevier Ltd. All rights reserved.

  16. Effect of multiple honey doses on non-specific acute cough in children. An open randomised study and literature review.

    Science.gov (United States)

    Miceli Sopo, S; Greco, M; Monaco, S; Varrasi, G; Di Lorenzo, G; Simeone, G

    2015-01-01

    Honey is recommended for non-specific acute paediatric cough by the Australian guidelines. Current available randomised clinical trials evaluated the effects of a single evening dose of honey, but multiple doses outcomes have never been studied. To evaluate the effects of wildflower honey, given for three subsequent evenings, on non-specific acute paediatric cough, compared to dextromethorphan (DM) and levodropropizine (LDP), which are the most prescribed over-the-counter (OTC) antitussives in Italy. 134 children suffering from non-specific acute cough were randomised to receive for three subsequent evenings a mixture of milk (90ml) and wildflower honey (10ml) or a dose of DM or LDP adjusted for the specific age. The effectiveness was evaluated by a cough questionnaire answered by parents. Primary end-point efficacy was therapeutic success. The latter was defined as a decrease in cough questionnaire score greater than 50% after treatment compared with baseline values. Three children were excluded from the study, as their parents did not complete the questionnaire. Therapeutic success was achieved by 80% in the honey and milk group and 87% in OTC medication group (p=0.25). Milk and honey mixture seems to be at least as effective as DM or LDP in non-specific acute cough in children. These results are in line with previous studies, which reported the health effects of honey on paediatric cough, even if placebo effect cannot be totally excluded. Copyright © 2014 SEICAP. Published by Elsevier Espana. All rights reserved.

  17. The Head Injury Retrieval Trial (HIRT): a single-centre randomised controlled trial of physician prehospital management of severe blunt head injury compared with management by paramedics only

    Science.gov (United States)

    Garner, Alan A; Mann, Kristy P; Fearnside, Michael; Poynter, Elwyn; Gebski, Val

    2015-01-01

    Background Advanced prehospital interventions for severe brain injury remains controversial. No previous randomised trial has been conducted to evaluate additional physician intervention compared with paramedic only care. Methods Participants in this prospective, randomised controlled trial were adult patients with blunt trauma with either a scene GCS score <9 (original definition), or GCS<13 and an Abbreviated Injury Scale score for the head region ≥3 (modified definition). Patients were randomised to either standard ground paramedic treatment or standard treatment plus a physician arriving by helicopter. Patients were evaluated by 30-day mortality and 6-month Glasgow Outcome Scale (GOS) scores. Due to high non-compliance rates, both intention-to-treat and as-treated analyses were preplanned. Results 375 patients met the original definition, of which 197 was allocated to physician care. Differences in the 6-month GOS scores were not significant on intention-to-treat analysis (OR 1.11, 95% CI 0.74 to 1.66, p=0.62) nor was the 30-day mortality (OR 0.91, 95% CI 0.60 to 1.38, p=0.66). As-treated analysis showed a 16% reduction in 30-day mortality in those receiving additional physician care; 60/195 (29%) versus 81/180 (45%), p<0.01, Number needed to treat =6. 338 patients met the modified definition, of which 182 were allocated to physician care. The 6-month GOS scores were not significantly different on intention-to-treat analysis (OR 1.14, 95% CI 0.73 to 1.75, p=0.56) nor was the 30-day mortality (OR 1.05, 95% CI 0.66 to 1.66, p=0.84). As-treated analyses were also not significantly different. Conclusions This trial suggests a potential mortality reduction in patients with blunt trauma with GCS<9 receiving additional physician care (original definition only). Confirmatory studies which also address non-compliance issues are needed. Trial registration number NCT00112398. PMID:25795741

  18. The Tilburg double blind randomised controlled trial comparing inguinal hernia repair according to Lichtenstein and the transinguinal preperitoneal technique

    Directory of Open Access Journals (Sweden)

    Gerritsen Pieter G

    2009-09-01

    Full Text Available Abstract Background Anterior open treatment of the inguinal hernia with a tension free mesh has reduced the incidence of recurrence and direct postoperative pain. The Lichtenstein procedure rules nowadays as reference technique for hernia treatment. Not recurrences but chronic pain is the main postoperative complication in inguinal hernia repair after Lichtenstein's technique. Preliminary experiences with a soft mesh placed in the preperitoneal space showed good results and less chronic pain. Methods The TULIP is a double-blind randomised controlled trial in which 300 patients will be randomly allocated to anterior inguinal hernia repair according to Lichtenstein or the transinguinal preperitoneal technique with soft mesh. All unilateral primary inguinal hernia patients eligible for operation who meet inclusion criteria will be invited to participate in this trial. The primary endpoint will be direct postoperative- and chronic pain. Secondary endpoints are operation time, postoperative complications, hospital stay, costs, return to daily activities (e.g. work and recurrence. Both groups will be evaluated. Success rate of hernia repair and complications will be measured as safeguard for quality. To demonstrate that inguinal hernia repair according to the transinguinal preperitoneal (TIPP technique reduces postoperative pain to Discussion The TULIP trial is aimed to show a reduction in postoperative chronic pain after anterior hernia repair according to the transinguinal preperitoneal (TIPP technique, compared to Lichtenstein. In our hypothesis the TIPP technique reduces chronic pain compared to Lichtenstein. Trial registration ISRCTN 93798494

  19. Analgesic control after hip arthroscopy: a randomised, double-blinded trial comparing portal with intra-articular infiltration of bupivacaine.

    LENUS (Irish Health Repository)

    Baker, Joseph F

    2011-06-07

    Abstract: The optimum anaesthetic and analgesic management following hip arthroscopy is yet to be determined. There is, in addition, some concern over the use of intraarticular local anaesthetic. We compared the analgesic efficacy of intra-articular infiltration compared with portal infiltration of bupivacaine following hip arthroscopy. Patients were randomised to receive either 10ml of 0.25% bupivacaine either into the joint or around the portal sites following completion of surgery. 73 patients were recruited (40 intra-articular). The portal infiltration group required significantly more rescue analgesia immediately after surgery (2.33mg vs.0.57mg, p=0.036). Visual Analogue Scale pain scores were not significantly different at 1 and 2 hours following surgery, but at 6 hours the portal group had significantly lower VAS scores (p=0.0036). We believe that the initial pain following surgery results from capsular injury and this explains the need for more rescue analgesia in the portal infiltration group. Further work is needed to establish the ideal regimen. A combination of portal and intra-articular infiltration may be the most efficacious.

  20. Effectiveness of tramadol/paracetamol compared with etoricoxib as ...

    African Journals Online (AJOL)

    paracetamol combination when compared with etoricoxib as postoperative analgesia following day care surgery. Design: This was a prospective, randomised, single-blind study. Setting and subjects: Sixty-two patients were randomised to receive ...

  1. Timing of oral anticoagulant therapy in acute ischemic stroke with atrial fibrillation: study protocol for a registry-based randomised controlled trial.

    Science.gov (United States)

    Åsberg, Signild; Hijazi, Ziad; Norrving, Bo; Terént, Andreas; Öhagen, Patrik; Oldgren, Jonas

    2017-12-02

    Oral anticoagulation therapy is recommended for the prevention of recurrent ischemic stroke in patients with atrial fibrillation (AF). Current guidelines do not provide evidence-based recommendations on optimal time-point to start anticoagulation therapy after an acute ischemic stroke. Non-vitamin K antagonist oral anticoagulants (NOACs) may offer advantages compared to warfarin because of faster and more predictable onset of action and potentially a lower risk of intracerebral haemorrhage also in the acute phase after an ischemic stroke. The TIMING study aims to establish the efficacy and safety of early vs delayed initiation of NOACs in patients with acute ischemic stroke and AF. The TIMING study is a national, investigator-led, registry-based, multicentre, open-label, randomised controlled study. The Swedish Stroke Register is used for enrolment, randomisation and follow-up of 3000 patients, who are randomised (1:1) within 72 h from ischemic stroke onset to either early (≤ 4 days) or delayed (≥ 5-10 days) start of NOAC therapy. The primary outcome is the composite of recurrent ischemic stroke, symptomatic intracerebral haemorrhage, or all-cause mortality within 90 days after randomisation. Secondary outcomes include: individual components of the primary outcome at 90 and 365 days; major haemorrhagic events; functional outcome by the modified Rankin Scale at 90 days; and health economics. In an optional biomarker sub-study, blood samples will be collected after randomisation from approximately half of the patients for central analysis of cardiovascular biomarkers after study completion. The study is funded by the Swedish Medical Research Council. Enrolment of patients started in April 2017. The TIMING study addresses the ongoing clinical dilemma of when to start NOAC after an acute ischemic stroke in patients with AF. By the inclusion of a randomisation module within the Swedish Stroke Register, the advantages of a prospective randomised study design

  2. PRECISE - pregabalin in addition to usual care for sciatica: study protocol for a randomised controlled trial.

    Science.gov (United States)

    Mathieson, Stephanie; Maher, Christopher G; McLachlan, Andrew J; Latimer, Jane; Koes, Bart W; Hancock, Mark J; Harris, Ian; Day, Richard O; Pik, Justin; Jan, Stephen; Billot, Laurent; Lin, Chung-Wei Christine

    2013-07-11

    Sciatica is a type of neuropathic pain that is characterised by pain radiating into the leg. It is often accompanied by low back pain and neurological deficits in the lower limb. While this condition may cause significant suffering for the individual, the lack of evidence supporting effective treatments for sciatica makes clinical management difficult. Our objectives are to determine the efficacy of pregabalin on reducing leg pain intensity and its cost-effectiveness in patients with sciatica. PRECISE is a prospectively registered, double-blind, randomised placebo-controlled trial of pregabalin compared to placebo, in addition to usual care. Inclusion criteria include moderate to severe leg pain below the knee with evidence of nerve root/spinal nerve involvement. Participants will be randomised to receive either pregabalin with usual care (n = 102) or placebo with usual care (n = 102) for 8 weeks. The medicine dosage will be titrated up to the participant's optimal dose, to a maximum 600 mg per day. Follow up consultations will monitor individual progress, tolerability and adverse events. Usual care, if deemed appropriate by the study doctor, may include a referral for physical or manual therapy and/or prescription of analgesic medication. Participants, doctors and researchers collecting participant data will be blinded to treatment allocation. Participants will be assessed at baseline and at weeks 2, 4, 8, 12, 26 and 52. The primary outcome will determine the efficacy of pregabalin in reducing leg pain intensity. Secondary outcomes will include back pain intensity, disability and quality of life. Data analysis will be blinded and by intention-to-treat. A parallel economic evaluation will be conducted from health sector and societal perspectives. This study will establish the efficacy of pregabalin in reducing leg pain intensity in patients with sciatica and provide important information regarding the effect of pregabalin treatment on disability and quality of life

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

    Science.gov (United States)

    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; Fox, Matthew P; Sabin, Lora; Seidenberg, Philip; Simon, Jonathon L; Hamer, Davidson H

    2011-02-03

    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. Prospective, cluster randomised and controlled effectiveness study. 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 settings. 127 traditional birth attendants and mothers and their newborns (3559 infants delivered regardless of vital status) from Lufwanyama district. Using an unblinded design, birth attendants were cluster randomised to intervention or control groups. The intervention had two components: training in a modified version of the neonatal resuscitation protocol, and single dose amoxicillin coupled with facilitated referral of infants to a health centre. Control birth attendants continued their existing standard of care (basic obstetric skills and use of clean delivery kits). The primary outcome was the proportion of liveborn infants who died by day 28 after birth, with rate ratios statistically adjusted for clustering. Secondary outcomes were mortality at different time points; and comparison of causes of death based on verbal autopsy data. Among 3497 deliveries with reliable information, mortality at day 28 after birth was 45% lower among liveborn infants delivered by intervention birth attendants than control birth attendants (rate ratio 0.55, 95% confidence interval 0.33 to 0.90). The greatest reductions in mortality were in the first 24 hours after birth: 7.8 deaths per 1000 live births for infants delivered by intervention birth attendants compared with 19.9 per 1000 for infants delivered by control birth attendants (0.40, 0.19 to 0.83). Deaths due to birth asphyxia were reduced by 63% among infants delivered by intervention birth attendants (0.37, 0.17 to 0.81) and by 81% within the first two days

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

    Science.gov (United States)

    Phiri-Mazala, Grace; Guerina, Nicholas G; Kasimba, Joshua; Mulenga, Charity; MacLeod, William B; Waitolo, Nelson; Knapp, Anna B; Mirochnick, Mark; Mazimba, Arthur; Fox, Matthew P; 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 settings. Participants 127 traditional birth attendants and mothers and their newborns (3559 infants delivered regardless of vital status) from Lufwanyama district. Interventions Using an unblinded design, birth attendants were cluster randomised to intervention or control groups. The intervention had two components: training in a modified version of the neonatal resuscitation protocol, and single dose amoxicillin coupled with facilitated referral of infants to a health centre. Control birth attendants continued their existing standard of care (basic obstetric skills and use of clean delivery kits). Main outcome measures The primary outcome was the proportion of liveborn infants who died by day 28 after birth, with rate ratios statistically adjusted for clustering. Secondary outcomes were mortality at different time points; and comparison of causes of death based on verbal autopsy data. Results Among 3497 deliveries with reliable information, mortality at day 28 after birth was 45% lower among liveborn infants delivered by intervention birth attendants than control birth attendants (rate ratio 0.55, 95% confidence interval 0.33 to 0.90). The greatest reductions in mortality were in the first 24 hours after birth: 7.8 deaths per 1000 live births for infants delivered by intervention birth attendants compared with 19.9 per 1000 for infants delivered by control birth attendants (0.40, 0.19 to 0.83). Deaths due to birth asphyxia were reduced by 63% among infants delivered by

  5. Binocular treatment of amblyopia using videogames (BRAVO): study protocol for a randomised controlled trial.

    Science.gov (United States)

    Guo, Cindy X; Babu, Raiju J; Black, Joanna M; Bobier, William R; Lam, Carly S Y; Dai, Shuan; Gao, Tina Y; Hess, Robert F; Jenkins, Michelle; Jiang, Yannan; Kowal, Lionel; Parag, Varsha; South, Jayshree; Staffieri, Sandra Elfride; Walker, Natalie; Wadham, Angela; Thompson, Benjamin

    2016-10-18

    Amblyopia is a common neurodevelopmental disorder of vision that is characterised by visual impairment in one eye and compromised binocular visual function. Existing evidence-based treatments for children include patching the nonamblyopic eye to encourage use of the amblyopic eye. Currently there are no widely accepted treatments available for adults with amblyopia. The aim of this trial is to assess the efficacy of a new binocular, videogame-based treatment for amblyopia in older children and adults. We hypothesise that binocular treatment will significantly improve amblyopic eye visual acuity relative to placebo treatment. The BRAVO study is a double-blind, randomised, placebo-controlled multicentre trial to assess the effectiveness of a novel videogame-based binocular treatment for amblyopia. One hundred and eight participants aged 7 years or older with anisometropic and/or strabismic amblyopia (defined as ≥0.2 LogMAR interocular visual acuity difference, ≥0.3 LogMAR amblyopic eye visual acuity and no ocular disease) will be recruited via ophthalmologists, optometrists, clinical record searches and public advertisements at five sites in New Zealand, Canada, Hong Kong and Australia. Eligible participants will be randomised by computer in a 1:1 ratio, with stratification by age group: 7-12, 13-17 and 18 years and older. Participants will be randomised to receive 6 weeks of active or placebo home-based binocular treatment. Treatment will be in the form of a modified interactive falling-blocks game, implemented on a 5th generation iPod touch device viewed through red/green anaglyphic glasses. Participants and those assessing outcomes will be blinded to group assignment. The primary outcome is the change in best-corrected distance visual acuity in the amblyopic eye from baseline to 6 weeks post randomisation. Secondary outcomes include distance and near visual acuity, stereopsis, interocular suppression, angle of strabismus (where applicable) measured at

  6. Randomised controlled trial comparing early home biofeedback physiotherapy with pelvic floor exercises for the treatment of third-degree tears (EBAPT Trial).

    Science.gov (United States)

    Peirce, C; Murphy, C; Fitzpatrick, M; Cassidy, M; Daly, L; O'Connell, P R; O'Herlihy, C

    2013-09-01

    To compare early home biofeedback physiotherapy with pelvic floor exercises (PFEs) for the initial management of women sustaining a primary third-degree tear. Single centre, randomised trial. National Maternity Hospital, Dublin, Ireland. A total of 120 women sustaining a primary third-degree tear. Women were randomised in a one to three ratio: 30 to early postpartum home biofeedback physiotherapy and 90 to PFEs. Differences in anorectal manometry results, Cleveland Clinic continence scores and Rockwood faecal incontinence quality of life scale scores after 3 months of postpartum treatment. The mean anal resting pressure was 39 ± 13 mmHg in the early biofeedback physiotherapy group and 43 ± 17 mmHg in the PFE group. The mean anal squeeze pressure was 64 ± 17 mmHg in the biofeedback group and 62 ± 23 mmHg in the PFE group. There was no significant difference in anal resting and squeeze pressure values between the groups (P = 0.123 and P = 0.68, respectively). There were no differences in symptom score and quality of life measurements between the groups. This study demonstrates no added value in using early home biofeedback physiotherapy in the management of women sustaining third-degree tears. Poor compliance may have contributed because women found it difficult to designate time to using biofeedback. © 2013 The Authors BJOG An International Journal of Obstetrics and Gynaecology © 2013 RCOG.

  7. Methylphenidate for attention deficit hyperactivity disorder (ADHD) in children and adolescents - assessment of harmful effects in non-randomised studies

    DEFF Research Database (Denmark)

    Jakob, Storebø Ole; Nadia, Pedersen; Erica, Ramstad

    2016-01-01

    This is the protocol for a review and there is no abstract. The objectives are as follows:To assess the harmful effects of methylphenidate treatment for children and adolescents with attention deficit hyperactivity disorder (ADHD) in non-randomised studies.......This is the protocol for a review and there is no abstract. The objectives are as follows:To assess the harmful effects of methylphenidate treatment for children and adolescents with attention deficit hyperactivity disorder (ADHD) in non-randomised studies....

  8. Increasing work-place healthiness with the probiotic Lactobacillus reuteri: A randomised, double-blind placebo-controlled study

    Directory of Open Access Journals (Sweden)

    Stan Vlaicu

    2005-11-01

    Full Text Available Abstract Background Short term illnesses, usually caused by respiratory or gastrointestinal diseases are disruptive to productivity and there is relatively little focus on preventative measures. This study examined the effect of the probiotic Lactobacillus reuteri protectis (ATCC55730 on its ability to improve work-place healthiness by reducing short term sick-leave caused by respiratory or gastrointestinal infections. Methods 262 employees at TetraPak in Sweden (day-workers and three-shift-workers that were healthy at study start were randomised in a double-blind fashion to receive either a daily dose of 108 Colony Forming Units of L. reuteri or placebo for 80 days. The study products were administered with a drinking straw. 181 subjects complied with the study protocol, 94 were randomised to receive L. reuteri and 87 received placebo. Results In the placebo group 26.4% reported sick-leave for the defined causes during the study as compared with 10.6% in the L. reuteri group (p L. reuteri group (p L. reuteri group(p

  9. A Mediterranean Diet to Improve Cardiovascular and Cognitive Health: Protocol for a Randomised Controlled Intervention Study.

    Science.gov (United States)

    Wade, Alexandra T; Davis, Courtney R; Dyer, Kathryn A; Hodgson, Jonathan M; Woodman, Richard J; Keage, Hannah A D; Murphy, Karen J

    2017-02-16

    The Mediterranean diet has demonstrated efficacy for improving cardiovascular and cognitive health. However, a traditional Mediterranean diet delivers fewer serves of dairy and less dietary calcium than is currently recommended in Australia, which may limit long-term sustainability. The present study aims to evaluate whether a Mediterranean diet with adequate dairy and calcium can improve cardiovascular and cognitive function in an at-risk population, and thereby reduce risk of cardiovascular disease (CVD) and cognitive decline. A randomised, controlled, parallel, crossover design trial will compare a Mediterranean diet supplemented with dairy foods against a low-fat control diet. Forty participants with systolic blood pressure above 120 mmHg and at least two other risk factors of CVD will undertake each dietary intervention for eight weeks, with an eight-week washout period between interventions. Systolic blood pressure will be the primary measure of interest. Secondary outcomes will include measures of cardiometabolic health, dietary compliance, cognitive function, assessed using the Cambridge Neuropsychological Test Automated Battery (CANTAB), psychological well-being and dementia risk. This research will provide empirical evidence as to whether the Mediterranean diet can be modified to provide recommended dairy and calcium intakes while continuing to deliver positive effects for cardiovascular and cognitive health. The findings will hold relevance for the field of preventative healthcare and may contribute to revisions of national dietary guidelines.

  10. Adding a PECS II block for proximal arm arteriovenous access - a randomised study.

    Science.gov (United States)

    Quek, K H; Low, E Y; Tan, Y R; Ong, A S C; Tang, T Y; Kam, J W; Kiew, A S C

    2018-05-01

    Brachial plexus block is often utilised for proximal arm arteriovenous access creation. However, the medial upper arm and axilla are often inadequately anaesthetised, requiring repeated, intraoperative local anaesthetic supplementation, or conversion into general anaesthesia. We hypothesised that the addition of a PECS II block would improve anaesthesia and analgesia for proximal arm arteriovenous access surgery. In this prospective, double-blinded, randomised proof-of-concept study, 36 consenting adults with end-stage renal disease aged between 21 and 90 years received either a combined supraclavicular and PECS II block (Group PECS, n = 18), or combined supraclavicular and sham block (Group SCB, n = 18) for proximal arm arteriovenous access surgery. Primary outcome was whether patients required intraoperative local anaesthetic supplementation by the surgeon. In Group PECS, 33.3% (6/18) needed local anaesthetic supplementation vs. 100% (18/18) in Group SCB. Group SCB had three times (RR 3.0, 95% CI 1.6-5.8; P PECS required lower volume of supplemental local anaesthetic compared to Group SCB (0.0 ml, IQR 0.0-6.3 ml vs. 15.0 ml, IQR 7.4-17.8 ml; P PECS II block to a supraclavicular block improves regional anaesthesia for patients with end-stage renal disease undergoing proximal arm arteriovenous access surgery. © 2018 The Acta Anaesthesiologica Scandinavica Foundation. Published by John Wiley & Sons Ltd.

  11. Erythropoietin in traumatic brain injury: study protocol for a randomised controlled trial.

    LENUS (Irish Health Repository)

    Nichol, Alistair

    2015-02-08

    Traumatic brain injury is a leading cause of death and disability worldwide. Laboratory and clinical studies demonstrate a possible beneficial effect of erythropoietin in improving outcomes in the traumatic brain injury cohort. However, there are concerns regarding the association of erythropoietin and thrombosis in the critically ill. A large-scale, multi-centre, blinded, parallel-group, placebo-controlled, randomised trial is currently underway to address this hypothesis.

  12. Psychosocial therapy for Parkinson's-related dementia: study protocol for the INVEST randomised controlled trial.

    Science.gov (United States)

    McCormick, Sheree A; McDonald, Kathryn R; Vatter, Sabina; Orgeta, Vasiliki; Poliakoff, Ellen; Smith, Sarah; Silverdale, Monty A; Fu, Bo; Leroi, Iracema

    2017-06-19

    Parkinson's disease (PD) with mild cognitive impairment (MCI-PD) or dementia (PDD) and dementia with Lewy bodies (DLB) are characterised by motor and 'non-motor' symptoms which impact on quality of life. Treatment options are generally limited to pharmacological approaches. We developed a psychosocial intervention to improve cognition, quality of life and companion burden for people with MCI-PD, PDD or DLB. Here, we describe the protocol for a single-blind randomised controlled trial to assess feasibility, acceptability and tolerability of the intervention and to evaluate treatment implementation. The interaction among the intervention and selected outcome measures and the efficacy of this intervention in improving cognition for people with MCI-PD, PDD or DLB will also be explored. Dyads will be randomised into two treatment arms to receive either 'treatment as usual' (TAU) or cognitive stimulation therapy specifically adapted for Parkinson's-related dementias (CST-PD), involving 30 min sessions delivered at home by the study companion three times per week over 10 weeks. A mixed-methods approach will be used to collect data on the operational aspects of the trial and treatment implementation. This will involve diary keeping, telephone follow-ups, dyad checklists and researcher ratings. Analysis will include descriptive statistics summarising recruitment, acceptability and tolerance of the intervention, and treatment implementation. To pilot an outcome measure of efficacy, we will undertake an inferential analysis to test our hypothesis that compared with TAU, CST-PD improves cognition. Qualitative approaches using thematic analysis will also be applied. Our findings will inform a larger definitive trial. Ethical opinion was granted (REC reference: 15/YH/0531). Findings will be published in peer-reviewed journals and at conferences. We will prepare reports for dissemination by organisations involved with PD and dementia. ISRCTN (ISRCTN11455062). © Article author

  13. Antiseptic mouthwash against pharyngeal Neisseria gonorrhoeae: a randomised controlled trial and an in vitro study.

    Science.gov (United States)

    Chow, Eric Pf; Howden, Benjamin P; Walker, Sandra; Lee, David; Bradshaw, Catriona S; Chen, Marcus Y; Snow, Anthony; Cook, Stuart; Fehler, Glenda; Fairley, Christopher K

    2017-03-01

    Gonorrhoea is increasing among men who have sex with men (MSM). We aimed to determine whether Listerine, a commercial mouthwash product, has an inhibitory effect against Neisseria gonorrhoeae in a randomised controlled trial (RCT) and an in vitro study, and therefore may be a potentially useful agent for gonorrhoea control. In vitro: a suspension of ∼10 8 colony forming units per mL (CFU/mL) of N. gonorrhoeae was added to a serial of dilutions (up to 1:32) of alcohol-containing Listerine mouthwashes (Cool Mint and Total Care) for 1 min. A 10 µL aliquot was spread over the surface of a gonococcal agar plate and the number of N. gonorrhoeae colonies present at each dilution was calculated. The phosphate buffered saline (PBS) was used as a control. RCT: we recruited MSM with pharyngeal gonorrhoea who returned for treatment at the Melbourne Sexual Health Centre between May 2015 and February 2016. Untreated men were randomised to rinse and gargle either Listerine Cool Mint or saline for 1 min. Pharyngeal swabs were taken before and after rinsing and gargling for culture of N. gonorrhoeae . The analysis included only men who were culture positive for N. gonorrhoeae before using the allocated solution on the day of recruitment. In vitro: Listerine mouthwashes at dilutions of up to 1:4 for 1 min resulted in significant reduction of total N. gonorrhoeae counts but PBS has no inhibitory effect against N. gonorrhoeae . RCT: a total of 196 MSM were recruited, 58 (30%) were culture positive before using the solution. After gargling the allocated solution, men in the Listerine group were significantly less likely to be culture positive on the pharyngeal surface (52%) compared with men in the saline group (84%) (p=0.013). This data suggest Listerine, significantly reduces the amount of N. gonorrhoeae on the pharyngeal surface. With daily use it may increase gonococcal clearance and have important implications for prevention strategies. ACTRN12615000716561. Published by

  14. A randomised controlled trial comparing TVT, Pelvicol and autologous fascial slings for the treatment of stress urinary incontinence in women.

    Science.gov (United States)

    Guerrero, K L; Emery, S J; Wareham, K; Ismail, S; Watkins, A; Lucas, M G

    2010-11-01

    To compare TVT(TM) , Pelvicol(TM) and autologous fascial slings (AFSs). A multicentre randomised control trial. Four units in the UK. Women requiring primary surgery for stress urinary incontinence (SUI). A total of 201 women with urodynamically proven stress incontinence were randomised into three groups and assessed at baseline, 6 weeks, 6 months and 1 year. The primary outcome was patient-reported improvement rates. Secondary outcomes included operative complications/time, intermittent self-catheterisation (ISC) and re-operation rates. The quality-of-life tools used were the Bristol Female Lower Urinary Tract Symptoms (BFLUTS) and EuroQoL. Fifty women had a Pelvicol(TM) sling, 79 had AFSs and 72 had TVT(TM). At 6 months the Pelvicol(TM) arm had poorer improvement rates (73%) than TVT(TM) (92%)/AFS (95%); P=0.003. At 1 year only 61% of the Pelvicol(TM) slings remained as improved, versus 93% of TVTs and 90% of AFSs (PTVT(TM) (55%)/AFS (48%) (P=0.001) at 1 year; hence, the Pelvicol(TM) arm was suspended following interim analysis. There is no difference in the success rates between TVT(TM) and AFS. One in five women in the Pelvicol(TM) arm had further surgery for SUI by 1 year, but none required further surgery in the other arms. AFS took longer to do (54 minutes versus 35 minutes for TVT(TM) /36 minutes for Pelvicol(TM) ) and had higher ISC rates (9.9 versus 0% Pelvicol(TM) /TVT(TM) 1.5%). Hospital stay was shortest for TVT(TM) (2 days). Most BFLUTS domains showed improvement in all three arms. The improvement for women in the Pelvicol(TM) arm, however, was less than for women in the other arms in several key domains. Pelvicol(TM) cannot be recommended for the management of SUI. TVT(TM) does not have greater efficacy than AFS, but does utilise fewer resources. © 2010 The Authors Journal compilation © RCOG 2010 BJOG An International Journal of Obstetrics and Gynaecology.

  15. Respiratory and cardiovascular responses to walking down a traffic-polluted road compared with walking in a traffic-free area in participants aged 60 years and older with chronic lung or heart disease and age-matched healthy controls: a randomised, crossover study.

    Science.gov (United States)

    Sinharay, Rudy; Gong, Jicheng; Barratt, Benjamin; Ohman-Strickland, Pamela; Ernst, Sabine; Kelly, Frank J; Zhang, Junfeng Jim; Collins, Peter; Cullinan, Paul; Chung, Kian Fan

    2018-01-27

    Long-term exposure to pollution can lead to an increase in the rate of decline of lung function, especially in older individuals and in those with chronic obstructive pulmonary disease (COPD), whereas shorter-term exposure at higher pollution levels has been implicated in causing excess deaths from ischaemic heart disease and exacerbations of COPD. We aimed to assess the effects on respiratory and cardiovascular responses of walking down a busy street with high levels of pollution compared with walking in a traffic-free area with lower pollution levels in older adults. In this randomised, crossover study, we recruited men and women aged 60 years and older with angiographically proven stable ischaemic heart disease or stage 2 Global initiative for Obstructive Lung Disease (GOLD) COPD who had been clinically stable for 6 months, and age-matched healthy volunteers. Individuals with ischaemic heart disease or COPD were recruited from existing databases or outpatient respiratory and cardiology clinics at the Royal Brompton & Harefield NHS Foundation Trust and age-matched healthy volunteers using advertising and existing databases. All participants had abstained from smoking for at least 12 months and medications were taken as recommended by participants' doctors during the study. Participants were randomly assigned by drawing numbered disks at random from a bag to do a 2 h walk either along a commercial street in London (Oxford Street) or in an urban park (Hyde Park). Baseline measurements of participants were taken before the walk in the hospital laboratory. During each walk session, black carbon, particulate matter (PM) concentrations, ultrafine particles, and nitrogen dioxide (NO 2 ) concentrations were measured. Between October, 2012, and June, 2014, we screened 135 participants, of whom 40 healthy volunteers, 40 individuals with COPD, and 39 with ischaemic heart disease were recruited. Concentrations of black carbon, NO 2 , PM 10 , PM 2.5 , and ultrafine particles

  16. Aspartame sensitivity? A double blind randomised crossover study.

    Directory of Open Access Journals (Sweden)

    Thozhukat Sathyapalan

    Full Text Available Aspartame is a commonly used intense artificial sweetener, being approximately 200 times sweeter than sucrose. There have been concerns over aspartame since approval in the 1980s including a large anecdotal database reporting severe symptoms. The objective of this study was to compare the acute symptom effects of aspartame to a control preparation.This was a double-blind randomized cross over study conducted in a clinical research unit in United Kingdom. Forty-eight individual who has self reported sensitivity to aspartame were compared to 48 age and gender matched aspartame non-sensitive individuals. They were given aspartame (100mg-containing or control snack bars randomly at least 7 days apart. The main outcome measures were acute effects of aspartame measured using repeated ratings of 14 symptoms, biochemistry and metabonomics.Aspartame sensitive and non-sensitive participants differed psychologically at baseline in handling feelings and perceived stress. Sensitive participants had higher triglycerides (2.05 ± 1.44 vs. 1.26 ± 0.84mmol/L; p value 0.008 and lower HDL-C (1.16 ± 0.34 vs. 1.35 ± 0.54 mmol/L; p value 0.04, reflected in 1H NMR serum analysis that showed differences in the baseline lipid content between the two groups. Urine metabonomic studies showed no significant differences. None of the rated symptoms differed between aspartame and control bars, or between sensitive and control participants. However, aspartame sensitive participants rated more symptoms particularly in the first test session, whether this was placebo or control. Aspartame and control bars affected GLP-1, GIP, tyrosine and phenylalanine levels equally in both aspartame sensitive and non-sensitive subjects.Using a comprehensive battery of psychological tests, biochemistry and state of the art metabonomics there was no evidence of any acute adverse responses to aspartame. This independent study gives reassurance to both regulatory bodies and the public that

  17. Aspartame sensitivity? A double blind randomised crossover study.

    Science.gov (United States)

    Sathyapalan, Thozhukat; Thatcher, Natalie J; Hammersley, Richard; Rigby, Alan S; Courts, Fraser L; Pechlivanis, Alexandros; Gooderham, Nigel J; Holmes, Elaine; le Roux, Carel W; Atkin, Stephen L

    2015-01-01

    Aspartame is a commonly used intense artificial sweetener, being approximately 200 times sweeter than sucrose. There have been concerns over aspartame since approval in the 1980s including a large anecdotal database reporting severe symptoms. The objective of this study was to compare the acute symptom effects of aspartame to a control preparation. This was a double-blind randomized cross over study conducted in a clinical research unit in United Kingdom. Forty-eight individual who has self reported sensitivity to aspartame were compared to 48 age and gender matched aspartame non-sensitive individuals. They were given aspartame (100mg)-containing or control snack bars randomly at least 7 days apart. The main outcome measures were acute effects of aspartame measured using repeated ratings of 14 symptoms, biochemistry and metabonomics. Aspartame sensitive and non-sensitive participants differed psychologically at baseline in handling feelings and perceived stress. Sensitive participants had higher triglycerides (2.05 ± 1.44 vs. 1.26 ± 0.84mmol/L; p value 0.008) and lower HDL-C (1.16 ± 0.34 vs. 1.35 ± 0.54 mmol/L; p value 0.04), reflected in 1H NMR serum analysis that showed differences in the baseline lipid content between the two groups. Urine metabonomic studies showed no significant differences. None of the rated symptoms differed between aspartame and control bars, or between sensitive and control participants. However, aspartame sensitive participants rated more symptoms particularly in the first test session, whether this was placebo or control. Aspartame and control bars affected GLP-1, GIP, tyrosine and phenylalanine levels equally in both aspartame sensitive and non-sensitive subjects. Using a comprehensive battery of psychological tests, biochemistry and state of the art metabonomics there was no evidence of any acute adverse responses to aspartame. This independent study gives reassurance to both regulatory bodies and the public that acute ingestion of

  18. 360° Operative Videos: A Randomised Cross-Over Study Evaluating Attentiveness and Information Retention.

    Science.gov (United States)

    Harrington, Cuan M; Kavanagh, Dara O; Wright Ballester, Gemma; Wright Ballester, Athena; Dicker, Patrick; Traynor, Oscar; Hill, Arnold; Tierney, Sean

    2017-11-06

    Although two-dimensional (2D) and three-dimensional videos have traditionally provided foundations for reviewing operative procedures, the recent 360º format may provide new dimensions to surgical education. This study sought to describe the production of a high quality 360º video for an index-operation (augmented with educational material), while evaluating for variances in attentiveness, information retention, and appraisal compared to 2D. A 6-camera synchronised array (GoPro Omni, [California, United States]) was suspended inverted and recorded an elective laparoscopic cholecystectomy in 2016. A single-blinded randomised cross-over study was performed to evaluate this video in 360º vs 2D formats. Group A experienced the 360º video using Samsung (Suwon, South-Korea) GearVR virtual-reality headsets, followed by the 2D experience on a 75-inch television. Group B were reversed. Each video was probed at designated time points for engagement levels and task-unrelated images or thoughts. Alternating question banks were administered following each video experience. Feedback was obtained via a short survey at study completion. The New Academic and Education Building (NAEB) in Dublin, Royal College of Surgeons in Ireland, July 2017. Preclinical undergraduate students from a medical university in Ireland. Forty students participated with a mean age of 23.2 ± 4.5 years and equal sex involvement. The 360º video demonstrated significantly higher engagement (p video as their learning platform of choice. Mean appraisal levels for the 360º platform were positive with mean responses of >8/10 for the platform for learning, immersion, and entertainment. This study describes the successful development and evaluation of a 360º operative video. This new video format demonstrated significant engagement and attentiveness benefits compared to traditional 2D formats. This requires further evaluation in the field of technology enhanced learning. Copyright © 2017 Association of

  19. One-year outcomes of a bilateral randomised prospective clinical trial comparing PRK with mitomycin C and LASIK.

    Science.gov (United States)

    Wallau, A D; Campos, M

    2009-12-01

    To compare 1-year follow-up results of photorefractive keratectomy (PRK) with mitomycin C (MMC) and laser in situ keratomileusis (LASIK) for custom correction of myopia. Eighty-eight eyes of 44 patients with moderate myopia were randomised to PRK with 0.002% MMC for 1 min in one eye and LASIK in the fellow eye. The 1-year follow-up was evaluated. There were no differences between LASIK and MMC-PRK eyes preoperatively. Forty-two patients completed the 1-year follow-up. MMC-PRK eyes achieved better uncorrected visual acuity (p = 0.03) and better best-spectacle-corrected visual acuity (pPRK eyes postoperatively. Excellent vision was reported in 64% of LASIK and 74% of MMC-PRK eyes 1 year after surgery. The corneal resistance factor and corneal hysteresis (ORA, Reichert) were higher in LASIK than in MMC-PRK eyes (pPRK with 0.002% MMC was more effective than wavefront-guided LASIK for correction of moderate myopia. Further research is necessary to determine the optimal concentration, exposure time and long-term corneal side effect of MMC.

  20. Translation of randomised controlled trial findings into clinical practice: comparison of olanzapine and valproate in the EMBLEM study.

    Science.gov (United States)

    Novick, D; Gonzalez-Pinto, A; Haro, J M; Bertsch, J; Reed, C; Perrin, E; Tohen, M

    2009-07-01

    The aim of this study was to compare the outcomes of olanzapine- and valproate-treated patients in an observational study of acute mania with the results of a randomised controlled trial (RCT) assessing the same treatments. EMBLEM (European Mania in Bipolar Evaluation of Medication) was a 2-year, prospective, observational study of health outcomes associated with the treatment of mania. Severity of mania and depression were assessed at baseline and 6 weeks using the YMRS and the 5-item version of the HAMD, respectively. 621 patients were analysed (n=107 valproate, n=514 olanzapine). Both groups improved from baseline to 6 weeks in mean YMRS and HAMD-5 total scores, with greater mean improvements in the olanzapine compared with the valproate group. Olanzapine was associated with more weight gain and less gastrointestinal difficulties than valproate. The EMBLEM results support those of the RCT, which suggest that olanzapine monotherapy seems to be more effective than valproate monotherapy in the treatment of acute mania.

  1. 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

  2. Adolescent standing postural response to backpack loads: a randomised controlled experimental study

    Directory of Open Access Journals (Sweden)

    Pirunsan Ubon

    2002-04-01

    Full Text Available Abstract Background Backpack loads produce changes in standing posture when compared with unloaded posture. Although 'poor' unloaded standing posture has been related to spinal pain, there is little evidence of whether, and how much, exposure to posterior load produces injurious effects on spinal tissue. The objective of this study was to describe the effect on adolescent sagittal plane standing posture of different loads and positions of a common design of school backpack. The underlying study aim was to test the appropriateness of two adult 'rules-of-thumb'-that for postural efficiency, backpacks should be worn high on the spine, and loads should be limited to 10% of body weight. Method A randomised controlled experimental study was conducted on 250 adolescents (12–18 years, randomly selected from five South Australian metropolitan high schools. Sagittal view anatomical points were marked on head, neck, shoulder, hip, thigh, knee and ankle. There were nine experimental conditions: combinations of backpack loads (3, 5 or 10% of body weight and positions (backpack centred at T7, T12 or L3. Sagittal plane photographs were taken of unloaded standing posture (baseline, and standing posture under the experimental conditions. Posture was quantified from the x (horizontal coordinate of each anatomical point under each experimental condition. Differences in postural response were described, and differences between conditions were determined using Analysis of Variance models. Results Neither age nor gender was a significant factor when comparing postural response to backpack loads or conditions. Backpacks positioned at T7 produced the largest forward (horizontal displacement at all the anatomical points. The horizontal position of all anatomical points increased linearly with load. Conclusion There is evidence refuting the 'rule-of-thumb' to carry the backpack high on the back. Typical school backpacks should be positioned with the centre at waist or

  3. Modelling variable dropout in randomised controlled trials with longitudinal outcomes: application to the MAGNETIC study.

    Science.gov (United States)

    Kolamunnage-Dona, Ruwanthi; Powell, Colin; Williamson, Paula Ruth

    2016-04-28

    Clinical trials with longitudinally measured outcomes are often plagued by missing data due to patients withdrawing or dropping out from the trial before completing the measurement schedule. The reasons for dropout are sometimes clearly known and recorded during the trial, but in many instances these reasons are unknown or unclear. Often such reasons for dropout are non-ignorable. However, the standard methods for analysing longitudinal outcome data assume that missingness is non-informative and ignore the reasons for dropout, which could result in a biased comparison between the treatment groups. In this article, as a post hoc analysis, we explore the impact of informative dropout due to competing reasons on the evaluation of treatment effect in the MAGNETIC trial, the largest randomised placebo-controlled study to date comparing the addition of nebulised magnesium sulphate to standard treatment in acute severe asthma in children. We jointly model longitudinal outcome and informative dropout process to incorporate the information regarding the reasons for dropout by treatment group. The effect of nebulised magnesium sulphate compared with standard treatment is evaluated more accurately using a joint longitudinal-competing risk model by taking account of such complexities. The corresponding estimates indicate that the rate of dropout due to good prognosis is about twice as high in the magnesium group compared with standard treatment. We emphasise the importance of identifying reasons for dropout and undertaking an appropriate statistical analysis accounting for such dropout. The joint modelling approach accounting for competing reasons for dropout is proposed as a general approach for evaluating the sensitivity of conclusions to assumptions regarding missing data in clinical trials with longitudinal outcomes. EudraCT number 2007-006227-12 . Registration date 18 Mar 2008.

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

    Science.gov (United States)

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

    2018-05-02

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

  5. Comparative Study on the Efficacy of Two Regimens of Single-Shot ...

    African Journals Online (AJOL)

    Objective: To assess and compare the satisfaction and efficacy of two regimens of single-shot spinal blocks for the relief of labor pain in women who present in active phase of labour. Design: A prospective randomised single-blind observational study. Setting: Labour ward of Kenyatta National Hospital, Nairobi. Subjects: All ...

  6. Weight Loss Maintenance for 2 Years after a 6-Month Randomised Controlled Trial Comparing Education-Only and Group-Based Support in Japanese Adults

    Directory of Open Access Journals (Sweden)

    Yoshio Nakata

    2014-11-01

    Full Text Available Objective: Our previous study, a 6-month randomised controlled trial, demonstrated that a group-based support promoted weight loss as compared to an education-only intervention. The purpose of this study was to examine weight loss maintenance for 2 years. Methods: Originally, 188 overweight Japanese adults, aged 40-65 years, were randomly assigned to 3 groups: control, education-only or group-based support. After the 6-month intervention, 125 participants in the education-only and the group-based support groups were followed up for 2 years. The primary outcome was the amount of weight lost. The participants were retrospectively grouped into quartiles of percent weight loss for secondary analyses. Results: At the end of follow-up, the amount of weight lost in the education-only and the group-based support groups was the same (3.3 kg. Secondary analyses using data of those who completed the study (n = 100 revealed that the participants in the highest quartile of percent weight loss significantly increased their step counts and moderate-to-vigorous physical activity compared with the lowest quartile. No significant differences were observed in the energy intake among the four groups. Conclusion: The effects of group-based support disappear within 2 years. Increasing physical activity may be a crucial factor for successful maintenance of weight loss.

  7. Comparing the effects of chlorhexidine and persica on alveolar bone healing following tooth extraction in rats, a randomised controlled trial.

    Science.gov (United States)

    Dorri, Mojtaba; Shahrabi, Shokufeh; Navabazam, Alireza

    2012-02-01

    Chlorhexidine is broadly prescribed by clinicians for treating extraction socket wounds; however, studies have reported adverse effects for chlorhexidine. Persica, a herbal antibacterial agent, could be an alternative for chlorhexidine. The aim of this randomised controlled trial was to investigate the effects of persica and chlorhexidine on alveolar bone healing following tooth extraction in rats. Eighteen Wistar rats were randomly allocated to three study groups: 0.2% chlorhexidine, 10% persica and controls (tap water). The rats were mouth-rinsed for 14 days. On day 8, the mandibular right first molars of all the rats were extracted. On day 21, the rats were euthanized and histological slides of their extraction sockets were prepared. The amount of new bone formation and the number of inflammatory cells in the extraction socket for each rat were recorded. Data were analysed using linear regression and Mann-Whitney tests. There was no significant difference between the control group and the intervention groups in terms of new bone formation and inflammatory cell count. The mean new bone formation was significantly higher in the persica group than in the chlorhexidine group. There was a significant association between new bone formation and inflammatory cell count in the entire sample. In conclusion, there were no significant differences between rinsing with tap water and rinsing with 0.2% chlorhexidine and 10% persica in enhancing extraction socket wound healing in rats. Extraction socket wound healing in rats was better enhanced with 10% persica than 0.2% chlorhexidine.

  8. Effect of aggregation form on bioavailability of zeaxanthin in humans: a randomised cross-over study.

    Science.gov (United States)

    Hempel, Judith; Fischer, Anja; Fischer, Monique; Högel, Josef; Bosy-Westphal, Anja; Carle, Reinhold; Schweiggert, Ralf M

    2017-11-01

    Carotenoid bioavailability from plant and animal food is highly variable depending on numerous factors such as the physical deposition form of carotenoids. As the carotenoid zeaxanthin is believed to play an important role in eye and brain health, we sought to compare the human bioavailability of an H-aggregated with that of a J-aggregated deposition form of zeaxanthin encapsulated into identical formulation matrices. A randomised two-way cross-over study with sixteen participants was designed to compare the post-prandial bioavailability of an H-aggregated zeaxanthin and a J-aggregated zeaxanthin dipalmitate formulation, both delivering 10 mg of free zeaxanthin. Carotenoid levels in TAG-rich lipoprotein fractions were analysed over 9·5 h after test meal consumption. Bioavailability from the J-aggregated formulation (AUC=55·9 nmol h/l) was 23 % higher than from the H-aggregated one (AUC=45·5 nmol h/l), although being only marginally significant (P=0·064). Furthermore, the same formulations were subjected to an internationally recognised in vitro digestion protocol to reveal potential strengths and weaknesses of simulated digestions. In agreement with our human study, liberation of zeaxanthin from the J-aggregated formulation into the simulated duodenal fluids was superior to that from the H-aggregated form. However, micellization rate (bioaccessibility) of the J-aggregated zeaxanthin dipalmitate was lower than that of the H-aggregated zeaxanthin, being contradictory to our in vivo results. An insufficient ester cleavage during simulated digestion was suggested to be the root cause for these observations. In brief, combining our in vitro and in vivo observations, the effect of the different aggregation forms on human bioavailability was lower than expected.

  9. A randomised, double-masked comparison study of diquafosol versus sodium hyaluronate ophthalmic solutions in dry eye patients.

    Science.gov (United States)

    Takamura, Etsuko; Tsubota, Kazuo; Watanabe, Hitoshi; Ohashi, Yuichi

    2012-10-01

    To compare the efficacy and safety of 3% diquafosol ophthalmic solution with those of 0.1% sodium hyaluronate ophthalmic solution in dry eye patients, using mean changes in fluorescein and rose bengal staining scores as endpoints. TRIAL DESIGN AND METHODS: In this multicenter, randomised, double-masked, parallel study of 286 dry eye patients with fluorescein and rose bengal staining scores of ≥3 were randomised to the treatment groups in a 1 : 1 ratio. Efficacy and safety were evaluated after drop-wise instillation of the study drug, six times daily for 4 weeks. After 4 weeks, the intergroup difference in the mean change from baseline in fluorescein staining score was -0.03; this verified the non-inferiority of diquafosol. The mean change from baseline in rose bengal staining score was significantly lower in the diquafosol group (p=0.010), thus verifying its superiority. The incidence of adverse events was 26.4% and 18.9% in the diquafosol and sodium hyaluronate groups, respectively, with no significant difference. Diquafosol (3%) and sodium hyaluronate (0.1%) exhibit similar efficacy in improving fluorescein staining scores of dry eye patients, whereas, diquafosol exhibits superior efficacy in improving rose bengal staining scores. Diquafosol has high clinical efficacy and is well tolerated with a good safety profile.

  10. Subcutaneous Injection of Adalimumab Trial compared with Control (SCIATiC): a randomised controlled trial of adalimumab injection compared with placebo for patients receiving physiotherapy treatment for sciatica.

    Science.gov (United States)

    Williams, Nefyn H; Jenkins, Alison; Goulden, Nia; Hoare, Zoe; Hughes, Dyfrig A; Wood, Eifiona; Foster, Nadine E; Walsh, David A; Carnes, Dawn; Sparkes, Valerie; Hay, Elaine M; Isaacs, John; Konstantinou, Kika; Morrissey, Dylan; Karppinen, Jaro; Genevay, Stephane; Wilkinson, Clare

    2017-10-01

    Biological treatments such as adalimumab (Humira ® ; AbbVie Ltd, Maidenhead, UK) are antibodies targeting tumour necrosis factor alpha, released from ruptured intervertebral discs, which might be useful in sciatica. Recent systematic reviews concluded that they might be effective, but that a definitive randomised controlled trial was needed. Usual care in the NHS typically includes a physiotherapy intervention. To test whether or not injections of adalimumab plus physiotherapy are more clinically effective and cost-effective than injections of saline plus physiotherapy for patients with sciatica. Pragmatic, parallel-group, randomised controlled trial with blinded participants and clinicians, and an outcome assessment and statistical analysis with concurrent economic evaluation and internal pilot. Participants were referred from primary care and musculoskeletal services to outpatient physiotherapy clinics. Adults with persistent symptoms of sciatica of 1-6 months' duration and with moderate to high levels of disability. Eligibility was assessed by research physiotherapists according to clinical criteria for diagnosing sciatica. After a second eligibility check, trial participants were randomised to receive two doses of adalimumab (80 mg and then 40 mg 2 weeks later) or saline injections. Both groups were referred for a course of physiotherapy. Outcomes were measured at the start, and after 6 weeks' and 6 months' follow-up. The main outcome measure was the Oswestry Disability Index (ODI). Other outcomes: leg pain version of the Roland-Morris Disability Questionnaire, Sciatica Bothersomeness Index, EuroQol-5 Dimensions, 5-level version, Hospital Anxiety and Depression Scale, resource use, risk of persistent disabling pain, pain trajectory based on a single question, Pain Self-Efficacy Questionnaire, Tampa Scale of Kinesiophobia and adverse effects. To detect an effect size of 0.4 with 90% power, a 5% significance level for a two-tailed t -test and 80% retention

  11. Effect of lactic acid suppositories compared with oral metronidazole and placebo in bacterial vaginosis: a randomised clinical trial.

    Science.gov (United States)

    Boeke, A J; Dekker, J H; van Eijk, J T; Kostense, P J; Bezemer, P D

    1993-01-01

    OBJECTIVE--To compare the effect of lactic acid locally, metronidazole orally and placebo in women with bacterial vaginosis. DESIGN--Randomised clinical trial. SETTING--30 general practices in the Netherlands. PATIENTS--125 women consulting the general practitioner for symptomatic bacterial vaginosis. MAIN OUTCOME MEASURES--Duration of subjective symptoms, recurrence of symptoms, clinically diagnosed cure, adverse events. RESULTS--Survival analysis showed a significantly faster disappearance of symptoms in the metronidazole category compared with both lactic acid and placebo (p = 0.0005 metronidazole v placebo, p = 0.0002 metronidazole v lactic acid p = 0.6521 lactic acid v placebo [The stratified Mantel Cox test]). The median duration until absence of symptoms was 21 days for metronidazole and 80 days for placebo. Disappearance of symptoms did not occur in 50% of the lactic acid group in 90 days. Recurrence rates of symptoms were similar over the treatment categories (p = 0.13 metronidazole v placebo and p = 0.12 lactic acid v placebo). After 2 weeks cure rates (cure defined as less than three of four clinical criteria present) were 83%, 49% and 47% for metronidazole, lactic acid and placebo category respectively. At that time cure rates (cure defined as none of three clinical criteria present) were 10%, 0% and 3%. After four weeks and three months these figures were: 55%, 20%, 20% and 64%, 28%, 28%. No differences in adverse events were found between the three interventions. CONCLUSIONS--Lactic acid suppositories are ineffective, metronidazole capsules are effective on signs and symptoms in bacterial vaginosis. A considerable proportion of the patients recover without active medication. PMID:8244360

  12. A Randomised Controlled Trial Comparing the Effect of E-learning, with a Taught Workshop, on the Knowledge and Search Skills of Health Professionals

    Directory of Open Access Journals (Sweden)

    Nicola Pearce‐Smith

    2006-09-01

    Full Text Available Objective The aim of the trial was to establish whether there is a significant difference in terms of knowledge and skills, between self-directed learning using a web-based resource, compared with a classroom based interactive workshop, for teaching health professionals how to search. The outcomes measured were knowledge of databases and study designs, and search skills. Methods The study design was a randomised controlled trial (RCT. 17 health professionals were randomised into one of two groups – one group (EG received access to a search-skills web resource, and the other group received a search workshop (WG taught by a librarian. Participants completed pre- and post-intervention tests involving multiple choice questions and practical searching using clinical scenarios. Results 9 WG and 6 EG participants completed both pre- and post-intervention tests. The test results were blindly marked using a score chart developed with two other librarians. For question formulation and devising a search strategy, all participants obtained a score that was the same or better after receiving the intervention (both WG and EG, but statistical analysis showed that the only significant outcomes were for the WG devising a search strategy (p=0.01 and preferring to search using MeSH after receiving the taught workshop (p=0.02. The Mann‐Whitney test showed there were no significant differences in any of the outcomes (p>0.05, between the WG and the EG. The statistical analyses must be viewed with caution due to the small sample size. Conclusion There were no significant differences in knowledge of databases and study design, or search skills, when the WG and the EG were compared. Although many participants obtained a score that was higher post‐intervention, only devising a search strategy and preferring to search using MeSH were statistically significant for the WG. The question of whether a taught workshop and an e-learning module are of equal effectiveness in

  13. Comparative efficacy of selective serotonin reuptake inhibitors (SSRI) in treating major depressive disorder: a protocol for network meta-analysis of randomised controlled trials.

    Science.gov (United States)

    Jia, Yongliang; Zhu, Hongmei; Leung, Siu-Wai

    2016-06-07

    There have been inconsistent findings from randomised controlled trials (RCTs) and systematic reviews on the efficacies of selective serotonin reuptake inhibitors (SSRIs) as the first-line treatment of major depressive disorder (MDD). Besides inconsistencies among randomised controlled trials (RCTs), their risks of bias and evidence grading have seldom been evaluated in meta-analysis. This study aims to compare the efficacy of SSRIs by conducting a Bayesian network meta-analysis, which will be the most comprehensive evaluation of evidence to resolve the inconsistency among previous studies. SSRIs including citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline and vilazodone have been selected. Systematic database searching and screening will be conducted for the RCTs on drug treatment of patients with MDD according to pre-specified search strategies and selection criteria. PubMed, the Cochrane Library, EMBASE, ScienceDirect, the US Food and Drug Administration Website, ClinicalTrial.gov and WHO Clinical Trials will be searched. Outcome data including Hamilton Depression Rating Scale (HDRS), Montgomery-Åsberg Depression Rating Scale (MADRS) and Clinical Global Impression (CGI) from eligible RCTs will be extracted. The outcomes will be analysed as ORs and mean differences under a random-effects model. A Bayesian network meta-analysis will be conducted with WinBUGS software, to compare the efficacies of SSRIs. Subgroup and sensitivity analysis will be performed to explain the study heterogeneity and evaluate the robustness of the results. Meta-regression analysis will be conducted to determine the possible factors affecting the efficacy outcomes. The Cochrane risk of bias assessment tool will be used to assess the RCT quality, and the Grading of Recommendation, Assessment, Development and Evaluation will be used to assess the strength of evidence from the meta-analysis. No ethical approval is required because this study includes neither

  14. A randomised controlled trial of a lifestyle behavioural intervention for patients with low back pain, who are overweight or obese: study protocol.

    Science.gov (United States)

    Williams, Amanda; Wiggers, John; O'Brien, Kate M; Wolfenden, Luke; Yoong, Serene; Campbell, Elizabeth; Robson, Emma; McAuley, James; Haskins, Robin; Kamper, Steven J; Williams, Christopher M

    2016-02-11

    Low back pain is a highly prevalent condition with a significant global burden. Management of lifestyle factors such as overweight and obesity may improve low back pain patient outcomes. Currently there are no randomised controlled trials that have been conducted to assess the effectiveness of lifestyle behavioural interventions in managing low back pain. The aim of this trial is to determine if a telephone-based lifestyle behavioural intervention is effective in reducing pain intensity in overweight or obese patients with low back pain, compared to usual care. A randomised controlled trial will be conducted with patients waiting for an outpatient consultation with an orthopaedic surgeon at a public tertiary referral hospital within New South Wales, Australia for chronic low back pain. Patients will be randomly allocated in a 1:1 ratio to receive a lifestyle behavioural intervention (intervention group) or continue with usual care (control group). After baseline data collection, patients in the intervention group will receive a clinical consultation followed by a 6-month telephone-based lifestyle behavioural intervention (10 individually tailored sessions over a 6-month period) and patients in the control group will continue with usual care. Participants will be followed for 26 weeks and asked to undertake three self-reported questionnaires at baseline (pre-randomisation), week 6 and 26 post randomisation to collect primary and secondary outcome data. The study requires a sample of 80 participants per group to detect a 1.5 point difference in pain intensity (primary outcome) 26 weeks post randomisation. The primary outcome, pain intensity, will be measured using a 0-10 numerical rating scale. The study will provide robust evidence regarding the effectiveness of a lifestyle behavioural intervention in reducing pain intensity in overweight or obese patients with low back pain and inform management of these patients. Australian New Zealand Clinical Trials Registry

  15. Surgery versus Active Monitoring in Intermittent Exotropia (SamExo: study protocol for a pilot randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Buck Deborah

    2012-10-01

    Full Text Available Abstract Background Childhood intermittent exotropia [X(T] is a type of strabismus (squint in which one eye deviates outward at times, usually when the child is tired. It may progress to a permanent squint, loss of stereovision and/or amblyopia (reduced vision. Treatment options for X(T include eye patches, glasses, surgery and active monitoring. There is no consensus regarding how this condition should be managed, and even when surgery is the preferred option clinicians disagree as to the optimal timing. Reports on the natural history of X(T are limited, and there is no randomised controlled trial (RCT evidence on the effectiveness or efficiency of surgery compared with active monitoring. The SamExo (Surgery versus Active Monitoring in Intermittent Exotropia pilot study has been designed to test the feasibility of such a trial in the UK. Methods Design: an external pilot patient randomised controlled trial. Setting: four UK secondary ophthalmology care facilities at Newcastle NHS Hospitals Foundation Trust, Sunderland Eye Infirmary, Moorfields Eye Hospital and York NHS Trust. Participants: children aged between 6 months and 16 years referred with suspected and subsequently diagnosed X(T. Recruitment target is a total of 144 children over a 9-month period, with 120 retained by 9-month outcome visit. Randomisation: permuted blocks stratified by collaborating centre, age and severity of X(T. Interventions: initial clinical assessment; randomisation (eye muscle surgery or active monitoring; 3-, 6- and 9-month (primary outcome clinical assessments; participant/proxy completed questionnaire covering time and travel costs, health services use and quality of life (Intermittent Exotropia Questionnaire; qualitative interviews with parents to establish reasons for agreeing or declining participation in the pilot trial. Outcomes: recruitment and retention rates; nature and extent of participation bias; nature and extent of biases arising from crossover or

  16. Veterinary homeopathy: systematic review of medical conditions studied by randomised trials controlled by other than placebo.

    Science.gov (United States)

    Mathie, Robert T; Clausen, Jürgen

    2015-09-15

    No systematic review has previously been carried out on randomised controlled trials (RCTs) of veterinary homeopathy in which the control group was an intervention other than placebo (OTP). For eligible peer-reviewed RCTs, the objectives of this study were to assess the risk of bias (RoB) and to quantify the effect size of homeopathic intervention compared with an active comparator or with no treatment. Our systematic review approach complied fully with the PRISMA 2009 Checklist. Cochrane methods were applied to assess RoB and to derive effect size using standard meta-analysis methods. Based on a thorough and systematic literature search, the following key attributes of the published research were distinguished: individualised homeopathy (n = 1 RCT)/non-individualised homeopathy (n = 19); treatment (n = 14)/prophylaxis (n = 6); active controls (n = 18)/untreated controls (n = 2). The trials were highly diverse, representing 12 different medical conditions in 6 different species. No trial had sufficiently low RoB to be judged as reliable evidence: 16 of the 20 RCTs had high RoB; the remaining four had uncertain RoB in several domains of assessment. For three trials with uncertain RoB and without overt vested interest, it was inconclusive whether homeopathy combined with conventional intervention was more or was less effective than conventional intervention alone for modulation of immune response in calves, or in the prophylaxis of cattle tick or of diarrhoea in piglets. Due to the poor reliability of their data, OTP-controlled trials do not currently provide useful insight into the effectiveness of homeopathy in animals.

  17. Comparing motivational, self-regulatory and habitual processes in a computer-tailored physical activity intervention in hospital employees - protocol for the PATHS randomised controlled trial.

    Science.gov (United States)

    Kwasnicka, Dominika; Vandelanotte, Corneel; Rebar, Amanda; Gardner, Benjamin; Short, Camille; Duncan, Mitch; Crook, Dawn; Hagger, Martin S

    2017-05-26

    Most people do not engage in sufficient physical activity to confer health benefits and to reduce risk of chronic disease. Healthcare professionals frequently provide guidance on physical activity, but often do not meet guideline levels of physical activity themselves. The main objective of this study is to develop and test the efficacy of a tailored intervention to increase healthcare professionals' physical activity participation and quality of life, and to reduce work-related stress and absenteeism. This is the first study to compare the additive effects of three forms of a tailored intervention using different techniques from behavioural theory, which differ according to their focus on motivational, self-regulatory and/or habitual processes. Healthcare professionals (N = 192) will be recruited from four hospitals in Perth, Western Australia, via email lists, leaflets, and posters to participate in the four group randomised controlled trial. Participants will be randomised to one of four conditions: (1) education only (non-tailored information only), (2) education plus intervention components to enhance motivation, (3) education plus components to enhance motivation and self-regulation, and (4) education plus components to enhance motivation, self-regulation and habit formation. All intervention groups will receive a computer-tailored intervention administered via a web-based platform and will receive supporting text-messages containing tailored information, prompts and feedback relevant to each condition. All outcomes will be assessed at baseline, and at 3-month follow-up. The primary outcome assessed in this study is physical activity measured using activity monitors. Secondary outcomes include: quality of life, stress, anxiety, sleep, and absenteeism. Website engagement, retention, preferences and intervention fidelity will also be evaluated as well as potential mediators and moderators of intervention effect. This is the first study to examine a tailored

  18. Comparing motivational, self-regulatory and habitual processes in a computer-tailored physical activity intervention in hospital employees - protocol for the PATHS randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Dominika Kwasnicka

    2017-05-01

    Full Text Available Abstract Background Most people do not engage in sufficient physical activity to confer health benefits and to reduce risk of chronic disease. Healthcare professionals frequently provide guidance on physical activity, but often do not meet guideline levels of physical activity themselves. The main objective of this study is to develop and test the efficacy of a tailored intervention to increase healthcare professionals’ physical activity participation and quality of life, and to reduce work-related stress and absenteeism. This is the first study to compare the additive effects of three forms of a tailored intervention using different techniques from behavioural theory, which differ according to their focus on motivational, self-regulatory and/or habitual processes. Methods/Design Healthcare professionals (N = 192 will be recruited from four hospitals in Perth, Western Australia, via email lists, leaflets, and posters to participate in the four group randomised controlled trial. Participants will be randomised to one of four conditions: (1 education only (non-tailored information only, (2 education plus intervention components to enhance motivation, (3 education plus components to enhance motivation and self-regulation, and (4 education plus components to enhance motivation, self-regulation and habit formation. All intervention groups will receive a computer-tailored intervention administered via a web-based platform and will receive supporting text-messages containing tailored information, prompts and feedback relevant to each condition. All outcomes will be assessed at baseline, and at 3-month follow-up. The primary outcome assessed in this study is physical activity measured using activity monitors. Secondary outcomes include: quality of life, stress, anxiety, sleep, and absenteeism. Website engagement, retention, preferences and intervention fidelity will also be evaluated as well as potential mediators and moderators of intervention

  19. Parent-focused treatment for adolescent anorexia nervosa: a study protocol of a randomised controlled trial.

    Science.gov (United States)

    Hughes, Elizabeth K; Le Grange, Daniel; Court, Andrew; Yeo, Michele S M; Campbell, Stephanie; Allan, Erica; Crosby, Ross D; Loeb, Katharine L; Sawyer, Susan M

    2014-04-08

    Family-based treatment is an efficacious outpatient intervention for medically stable adolescents with anorexia nervosa. Previous research suggests family-based treatment may be more effective for some families when parents and adolescents attend separate therapy sessions compared to conjoint sessions. Our service developed a novel separated model of family-based treatment, parent-focused treatment, and is undertaking a randomised controlled trial to compare parent-focused treatment to conjoint family-based treatment. This randomised controlled trial will recruit 100 adolescents aged 12-18 years with DSM-IV anorexia nervosa or eating disorder not otherwise specified (anorexia nervosa type). The trial commenced in 2010 and is expected to be completed in 2015. Participants are recruited from the Royal Children's Hospital Eating Disorders Program, Melbourne, Australia. Following a multidisciplinary intake assessment, eligible families who provide written informed consent are randomly allocated to either parent-focused treatment or conjoint family-based treatment. In parent-focused treatment, the adolescent sees a clinical nurse consultant and the parents see a trained mental health clinician. In conjoint family-based treatment, the whole family attends sessions with the mental health clinician. Both groups receive 18 treatment sessions over 6 months and regular medical monitoring by a paediatrician. The primary outcome is remission at end of treatment and 6 and 12 month follow up, with remission defined as being ≥ 95% expected body weight and having an eating disorder symptom score within one standard deviation of community norms. The secondary outcomes include partial remission and changes in eating pathology, depressive symptoms and self-esteem. Moderating and mediating factors will also be explored. This will be first randomised controlled trial of a parent-focused model of family-based treatment of adolescent anorexia nervosa. If found to be efficacious, parent

  20. Developing an Australian-first recovery model for parents in Victorian mental health and family services: a study protocol for a randomised controlled trial.

    Science.gov (United States)

    Maybery, Darryl; Goodyear, Melinda; Reupert, Andrea; Sheen, Jade; Cann, Warren; Dalziel, Kim; Tchernagovski, Phillip; O'Hanlon, Brendan; von Doussa, Henry

    2017-05-26

    A considerable number of people with a mental illness are parents caring for dependent children. For those with a mental illness, parenting can provide a sense of competence, belonging, identity and hope and hence is well aligned to the concept of personal recovery. However, little research has focused on the recovery journey of those who are parents and have a mental illness. This randomised controlled trial aims to (i) evaluate the effectiveness of an intervention model of recovery for parents (Let's Talk about Children) in three different mental health service sectors and (ii) examine the economic value of a larger roll out (longer term) of the parent recovery model. A two arm parallel randomised controlled trial will be used with participants, who are being treated for their mental illness in adult mental health, non-government community mental health or family welfare services. The study will involve 192 parents, who are considered by their treating practitioner to be sufficiently well to provide informed consent and participate in an intervention (Let's Talk about Children) or control group (treatment as usual). Participant randomisation will occur at the level of the treating practitioner and will be based on whether the randomised practitioner is trained in the intervention. Outcomes are compared at pre, post intervention and six-month follow-up. Recovery, parenting and family functioning, and quality of life questionnaires will be used to measure parent wellbeing and the economic benefits of the intervention. This is the first randomised controlled trial to investigate the efficacy of a parenting intervention on recovery outcomes and the first to provide an economic evaluation of an intervention for parents with a mental illness. An implementation model is required to embed the intervention in different sectors. The trial was retrospectively registered: ACTRN12616000460404 on the 8/4/2016.

  1. Comparative efficacy of simultaneous versus sequential multiple health behavior change interventions among adults: A systematic review of randomised trials.

    Science.gov (United States)

    James, Erica; Freund, Megan; Booth, Angela; Duncan, Mitch J; Johnson, Natalie; Short, Camille E; Wolfenden, Luke; Stacey, Fiona G; Kay-Lambkin, Frances; Vandelanotte, Corneel

    2016-08-01

    Growing evidence points to the benefits of addressing multiple health behaviors rather than single behaviors. This review evaluates the relative effectiveness of simultaneous and sequentially delivered multiple health behavior change (MHBC) interventions. Secondary aims were to identify: a) the most effective spacing of sequentially delivered components; b) differences in efficacy of MHBC interventions for adoption/cessation behaviors and lifestyle/addictive behaviors, and; c) differences in trial retention between simultaneously and sequentially delivered interventions. MHBC intervention trials published up to October 2015 were identified through a systematic search. Eligible trials were randomised controlled trials that directly compared simultaneous and sequential delivery of a MHBC intervention. A narrative synthesis was undertaken. Six trials met the inclusion criteria and across these trials the behaviors targeted were smoking, diet, physical activity, and alcohol consumption. Three trials reported a difference in intervention effect between a sequential and simultaneous approach in at least one behavioral outcome. Of these, two trials favoured a sequential approach on smoking. One trial favoured a simultaneous approach on fat intake. There was no difference in retention between sequential and simultaneous approaches. There is limited evidence regarding the relative effectiveness of sequential and simultaneous approaches. Given only three of the six trials observed a difference in intervention effectiveness for one health behavior outcome, and the relatively consistent finding that the sequential and simultaneous approaches were more effective than a usual/minimal care control condition, it appears that both approaches should be considered equally efficacious. PROSPERO registration number: CRD42015027876. Copyright © 2016 Elsevier Inc. All rights reserved.

  2. Comparative cost-effectiveness of two interventions to promote work functioning by targeting mental health complaints among nurses: pragmatic cluster randomised trial.

    Science.gov (United States)

    Noben, Cindy; Smit, Filip; Nieuwenhuijsen, Karen; Ketelaar, Sarah; Gärtner, Fania; Boon, Brigitte; Sluiter, Judith; Evers, Silvia

    2014-10-01

    The specific job demands of working in a hospital may place nurses at elevated risk for developing distress, anxiety and depression. Screening followed by referral to early interventions may reduce the incidence of these health problems and promote work functioning. To evaluate the comparative cost-effectiveness of two strategies to promote work functioning among nurses by reducing symptoms of mental health complaints. Three conditions were compared: the control condition consisted of online screening for mental health problems without feedback about the screening results. The occupational physician condition consisted of screening, feedback and referral to the occupational physician for screen-positive nurses. The third condition included screening, feedback, and referral to e-mental health. The study was designed as an economic evaluation alongside a pragmatic cluster randomised controlled trial with randomisation at hospital-ward level. The study included 617 nurses in one academic medical centre in the Netherlands. Treatment response was defined as an improvement on the Nurses Work Functioning Questionnaire of at least 40% between baseline and follow-up. Total per-participant costs encompassed intervention costs, direct medical and non-medical costs, and indirect costs stemming from lost productivity due to absenteeism and presenteeism. All costs were indexed for the year 2011. At 6 months follow-up, significant improvement in work functioning occurred in 20%, 24% and 16% of the participating nurses in the control condition, the occupational physician condition and the e-mental health condition, respectively. In these conditions the total average annualised costs were €1752, €1266 and €1375 per nurse. The median incremental cost-effectiveness ratio for the occupational physician condition versus the control condition was dominant, suggesting cost savings of €5049 per treatment responder. The incremental cost-effectiveness ratio for the e-mental health

  3. Comparative efficacy of active and passive distraction during restorative treatment in children using an iPad versus audiovisual eyeglasses: a randomised controlled trial.

    Science.gov (United States)

    Attar, R H; Baghdadi, Z D

    2015-02-01

    This study aimed to compare the effects of two types of distraction techniques: passive, using audiovisual glasses (AV glasses), versus active, using an iPad, as an adjunct to local analgesia during vital pulp therapy in children. Pain behaviour, and heart rates from an exposure group (treatment with the aid of an iPad) and control group (treatment with the aid of AV glasses) were compared in a randomised, split-mouth design using the Wilcoxon signed rank test (pain and behaviour) and paired t test for heart rate scores at p 0.05. Children (39) (mean age 6.27 years) received the two treatment sessions. Generally, AV glasses had higher pain and behaviour scores than iPad. Pain results demonstrated marginal significant differences between the two distraction techniques during local analgesia administration (p 0.076) and caries removal (p 0.071). A significant difference between the two techniques during local analgesia administration only (p 0.017), in favour of an iPad. Average heart rates over the treatment intervals were lower among iPad group than those using AV glasses group. Patients preferred an iPad more than AV glasses (24 versus 15). Treatment sessions were significantly shorter for iPad. Active distraction using an iPad demonstrated better performance than passive distraction using AV glasses.

  4. 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.

  5. Risk factors for low vision related functioning in the Mycotic Ulcer Treatment Trial: a randomised trial comparing natamycin with voriconazole.

    Science.gov (United States)

    Rose-Nussbaumer, Jennifer; Prajna, N Venkatesh; Krishnan, Tiruvengada; Mascarenhas, Jeena; Rajaraman, Revathi; Srinivasan, Muthiah; Raghavan, Anita; Oldenburg, Catherine E; O'Brien, Kieran S; Ray, Kathryn J; Porco, Travis C; McLeod, Stephen D; Acharya, Nisha R; Keenan, Jeremy D; Lietman, Thomas M

    2016-07-01

    The Mycotic Ulcer Treatment Trial I (MUTT I) was a double-masked, multicentre, randomised controlled trial, which found that topical natamycin is superior to voriconazole for the treatment of filamentous fungal corneal ulcers. In this study, we determine risk factors for low vision-related quality of life in patients with fungal keratitis. The Indian visual function questionnaire (IND-VFQ) was administered to MUTT I study participants at 3 months. Associations between patient and ulcer characteristics and IND-VFQ subscale score were assessed using generalised estimating equations. 323 patients were enrolled in the trial, and 292 (90.4%) completed the IND-VFQ at 3 months. Out of a total possible score of 100, the average VFQ score for all participants was 81.3 (range 0-100, SD 23.6). After correcting for treatment arm, each logMAR line of worse baseline visual acuity in the affected eye resulted in an average 1.2 points decrease on VFQ at 3 months (95% CI -1.8 to 0.6, p<0.001). Those who required therapeutic penetrating keratoplasty had an average of 25.2 points decrease on VFQ after correcting for treatment arm (95% CI -31.8 to -18.5, p<0.001). Study participants who were unemployed had on average 28.5 points decrease on VFQ (95% CI -46.9 to -10.2, p=0.002) after correcting for treatment arm. Monocular vision loss from corneal opacity due to fungal keratitis reduced vision-related quality of life. Given the relatively high worldwide burden of corneal opacity, improving treatment outcomes of corneal infections should be a public health priority. Clinicaltrials.gov Identifier: NCT00996736. 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/.

  6. Comparing multidisciplinary and brief intervention in employees with different job relations on sick leave due to low back pain: protocol of a randomised controlled trial.

    Science.gov (United States)

    Pedersen, Pernille; Nielsen, Claus Vinther; Andersen, Morten Hovgaard; Langagergaard, Vivian; Boes, Anders; Jensen, Ole Kudsk; Jensen, Chris; Labriola, Merete

    2017-12-16

    Low back pain (LBP) is a common problem that affects the lives of many individuals and is a frequent cause of sickness absence. To help this group of individuals resume work, several interventions have been studied. However, not all individuals may profit from the same intervention and the effect of a given intervention on return to work (RTW) may depend on their work situation. The aim of this study is to evaluate whether employees on sick leave due to LBP and with poor job relations will benefit more from a multidisciplinary intervention, while patients with strong job relations will benefit more from a brief intervention. The study is designed as a randomised controlled trial with up to five years of follow-up comparing brief intervention with brief intervention plus multidisciplinary intervention. Employees, aged 18-60 years, are included in the study from March 2011 to August 2016 if they have been on sick leave for 4-12 weeks due to LBP with or without radiculopathy. They are divided into two groups, a group with poor job relations and a group with strong job relations based on their answers in the baseline questionnaire. Each group is randomised 1:1 to receive the brief intervention or brief intervention plus multidisciplinary intervention. The brief intervention comprises a clinical examination and advice offered by a rheumatologist and a physiotherapist, whereas the supplementary multidisciplinary intervention comprises the assignment of a case manager who draws up a rehabilitation plan in collaboration with the participant and the multidisciplinary team. The primary outcome is duration of sickness absence measured by register data. Secondary outcomes include sustainable RTW and questionnaire-based measures of functional capacity. Outcomes will be assessed at one, two and five years of follow-up. This trial will evaluate the effect of brief and multidisciplinary intervention on RTW and functional capacity among employees on sick leave due to LBP with

  7. Employment status five years after a randomised controlled trial comparing multidisciplinary and brief intervention in employees on sick leave due to low back pain.

    Science.gov (United States)

    Pedersen, Pernille; Nielsen, Claus Vinther; Jensen, Ole Kudsk; Jensen, Chris; Labriola, Merete

    2018-05-01

    To evaluate differences in employment status, during a five-year follow-up period in patients on sick leave due to low back pain who had participated in a trial comparing a brief and a multidisciplinary intervention. From 2004 to 2008, 535 patients were referred to the Spine Centre at the Regional Hospital in Silkeborg if they had been on sick leave for 3-16 weeks due to low back pain. All patients underwent a clinical examination by a rehabilitation physician and a physiotherapist, and were randomised to either the brief intervention or the multidisciplinary intervention. The outcome was employment status from randomisation to five years of follow-up and was measured by the mean number of weeks in four different groups of employment status (sequence analysis) and a fraction of the number of weeks working (work participation score) that were accumulated over the years. A total of 231 patients were randomised to the brief intervention and 233 patients to the multidisciplinary intervention. No statistically significant differences in the mean weeks spent within the different employment statuses were found between the two intervention groups. After five years of follow-up, participants in the multidisciplinary intervention had a 19% higher risk of not having a work participation score above 75% compared to participants in the brief intervention. After five years of follow-up no differences in employment status were found between participants in the brief and the multidisciplinary intervention.

  8. The acute (immediate) effects of reflexology on arterial compliance in healthy volunteers: A randomised study.

    OpenAIRE

    Rollinson, K; Jones, J; Scott, N; Megson, IL; Leslie, SJ

    2016-01-01

    BACKGROUND: Reflexology is a widely used complementary therapy. The effects of reflexology on the cardiovascular system are not well characterised. Arterial stiffness (compliance) is a marker of vascular health. This study aimed to evaluate the effects of reflexology on arterial compliance in healthy volunteers. METHODS: 12 healthy volunteers (1 male; 11 female; mean age 44.8 ± 10.8 yrs) received 10 min of reflexology on each foot in a single-blind randomised study. The main outcome measures ...

  9. Ten year results of a randomised trial comparing two conservative treatment strategies for small size breast cancer

    International Nuclear Information System (INIS)

    Mariani, L.; Salvadori, B.; Marubini, E.; Conti, A.R.; Rovini, D.; Cusumano, F.; Rosolin, T.; Andreola, S.; Zucali, R.; Rilke, F.; Veronesi, U.

    1998-01-01

    We report the 10-year results of a randomised clinical trial in which two different breast conservation treatment strategies were compared in women with small, non-metastatic primary breast cancer: quadrantectomy, axillary dissection and radiotherapy (QUART) versus tumorectomy and axillary dissection followed by external radiotherapy and a boost with 192 Ir implantation (TART). No second surgery was given to women with affected surgical margins. Axillary node positive women received adjuvant medical therapy. From 1985-1987, this trial accrued 705 patients, 360 in the QUART and 345 in the TART arm. Crude cumulative incidence curves for intrabreast tumour recurrence (IBTR) and metastases as first events and mortality curves in each of the two treatment arms were computed. A crude cumulative incidence curve of IBTR as a second event (in women who had already had a local recurrence) was also computed. The two groups were compared in terms of hazard for IBTR, metastases or death occurrence by using Cox regression models, both with and without adjustment for patient age, tumour size, number of metastatic axillary nodes and histology. Possible interactions between the aforementioned prognostic factors and the type of surgery were also investigated. The two groups were well matched for baseline patient and tumour characteristics, the only exception being resection margins, which were more often positive in the TART group. At the Cox model, a significant difference between groups was detected for IBTR (P<0.0001), but not for distant metastases and overall survival. In particular, 5- and 10-year estimates of crude cumulative incidence of IBTR were 4.7 and 7.4% in the QUART group, and 11.6 and 18.6% in the TART group. The difference was not substantially affected by patient or disease characteristics. Likewise, the status of resection margins in women who underwent TART treatment did not significantly influence the risk of occurrence of IBTRs. Finally, the rate of second IBTR

  10. Comparative effectiveness of individualised homeopathy and antibiotics in the treatment of bovine clinical mastitis: randomised controlled trial.

    Science.gov (United States)

    Keller, Diana; Sundrum, Albert

    2018-04-07

    Based on the widespread use of homeopathy in dairy farm practice when treating mastitis, a blind randomised controlled trial (RCT) was conducted to assess the effectiveness of homeopathic treatment of clinical mastitis on four dairy farms. The study considered specific guidelines for RCTs as well as the basic principles of individualised homeopathy and involved 180 lactating dairy cows. Evaluation of cure rates was based on clinical investigation of the udder and on laboratory analysis of milk samples. In culture-positive cases, the antibiotic treatment provided suboptimal bacteriological cures (60-81 per cent) but was more effective than individualised homeopathy (33-43 per cent) whose effects appeared little different to those of placebos (45-47 per cent) (P≤0.05). On the cytological cure level, all three treatment methods were similarly ineffective: antibiotic being 2-21 per cent, individualised homeopathy 0-8 per cent and placebo 3-13 per cent (P≤0.05; P=0.13). Antibiotics, individualised homeopathy and placebo had similar effects on bacteriological and cytological cure in cases of culture-negative milk samples (P>0.4) and Escherichia coli infections (P=1.0). The study results implied that the effectiveness of individualised homeopathy does not go beyond a placebo effect and successful treatment is highly dependent on the specific mastitis pathogen. Thus, antimicrobial or alternative remedies used should be based on the bacterial culture of the milk sample. NTP-ID: 00008011-1-9, Pre-results. © British Veterinary Association (unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  11. Treatment of trauma-affected refugees with Venlafaxine versus Sertraline combined with psychotherapy – a randomised study

    DEFF Research Database (Denmark)

    Sonne, Charlotte Kærgaard; Carlsson, Jessica; Bech, P

    2016-01-01

    Background: The prevalence of trauma-related psychiatric disorders is high among refugees. Despite this, little is known about the effect of pharmacological treatment for this patient group. The objective of the present study was therefore to examine differences in the effects of venlafaxine...... and sertraline on Post-Traumatic Stress Disorder (PTSD), depression and functional impairment in trauma-affected refugees. Methods: The study was a randomised pragmatic trial comparing venlafaxine and sertraline in combination with psychotherapy and social counselling. PTSD symptoms were measured on the Harvard......: Two hundred seven adult refugee patients were included in the trial (98 in the venlafaxine and 109 in the sertraline group). Of these, 195 patients were eligible for intention-to-treat analyses. Small but significant pre-treatment to post-treatment differences were found on the Harvard Trauma...

  12. Pressure ulcers prevention efficacy of an alternating pressure air mattress in elderly patients: E²MAO a randomised study.

    Science.gov (United States)

    Sauvage, P; Touflet, M; Pradere, C; Portalier, F; Michel, J-M; Charru, P; Passadori, Y; Fevrier, R; Hallet-Lezy, A-M; Beauchêne, F; Scherrer, B

    2017-06-02

    Our aim was to compare Axtair One, an alternating pressure air mattress (APAM), with a viscoelastic foam mattress (VFM) in elderly patients at moderate to high risk of developing pressure ulcers (PUs). A randomised, controlled, superiority, parallel-group, open-label, multicentre study, was conducted, between February 2012 and March 2015, in nine French, medium- and long-term stay facilities. Eligible patients were aged 70 and over, had no PUs on enrolment, were bedridden for at least 15 hours per day, had reduced mobility, an absent or minimal positioning capability, a Braden score 12 and a Karnofsky score elderly patients, bedridden for more than 15 hours per day, severely dependent, at moderate-to high-risk of PUs, with an instantaneous risk for the appearance of PUs 7.57 times greater in the VFM group than in the APAM group. This study provides descriptive information and evidence for practice.

  13. Radiotherapy enhances laser palliation of malignant dysphagia: a randomised study

    Energy Technology Data Exchange (ETDEWEB)

    Sargeant, I.R.; Thorpe, S.; Glover, J.R.; Bown, S.G. [National Medical Laser Centre, London (United Kingdom); Tobias, J.S.; Blackman, G. [University Coll., London (United Kingdom). Meyerstein Inst. of Oncology

    1997-03-01

    A major drawback of laser endoscopy in the palliation of malignant dysphagia is the need for repeated treatments. This study was designed to test whether external beam radiotherapy would reduce the necessity for repeated laser therapy. (author).

  14. Radiotherapy enhances laser palliation of malignant dysphagia: a randomised study

    International Nuclear Information System (INIS)

    Sargeant, I.R.; Thorpe, S.; Glover, J.R.; Bown, S.G.; Tobias, J.S.; Blackman, G.

    1997-01-01

    A major drawback of laser endoscopy in the palliation of malignant dysphagia is the need for repeated treatments. This study was designed to test whether external beam radiotherapy would reduce the necessity for repeated laser therapy. (author)

  15. A randomised trial comparing low-fat diets differing in carbohydrate and protein ratio, combined with regular moderate intensity exercise, on glycaemic control, cardiometabolic risk factors, food cravings, cognitive function and psychological wellbeing in adults with type 2 diabetes: Study protocol.

    Science.gov (United States)

    Watson, Nerylee Ann; Dyer, Kathryn Ann; Buckley, Jonathan David; Brinkworth, Grant David; Coates, Alison Mary; Parfitt, Gaynor; Howe, Peter Ranald Charles; Noakes, Manny; Dye, Louise; Chadwick, Helen; Murphy, Karen Joy

    2015-11-01

    Hypocaloric low-fat diets, high in protein with moderate carbohydrate (HP) can enhance weight loss, improve glycaemic control and improve cardiometabolic health risk factors in type 2 diabetes mellitus (T2DM). However, it is unclear whether the metabolic benefits observed during weight loss are sustained during energy-balance and weight maintenance. Furthermore, there is a lack of evidence regarding the effect of HP diets on food cravings, cognitive function and psychological wellbeing in T2DM, despite carbohydrate food cravings, cognitive impairment and depression being associated with hyperglycaemia. Overweight/obese adults with T2DM were randomised to consume either a HP diet (n=32, ~32% protein, 33% carbohydrate, 30% fat) or a higher-carbohydrate diet (HC, n=29, ~22% protein, 51% carbohydrate, 22% fat) for 24 weeks with 30 min of moderate intensity exercise five days/week for the study duration. There were 2 phases: a 12 week weight loss phase followed by a 12 week weight maintenance phase. Primary outcome was glycaemic control (glycosylated haemoglobin; HbA1c). Secondary outcomes were cardiometabolic risk factors (body composition, fasting blood pressure, blood lipids, glucose, insulin and C-reactive protein), food cravings, cognitive function (memory; psychomotor and executive function and psychological well-being. Outcomes were measured at baseline and the end of each 12-week intervention phase. Data will be analysed as intention-to-treat using linear mixed effects models. This study will examine the effects of two dietary interventions on health outcomes in T2DM during weight loss and notably following weight maintenance where there is a paucity of evidence. Copyright © 2015. Published by Elsevier Inc.

  16. Argentine tango dance compared to mindfulness meditation and a waiting-list control: a randomised trial for treating depression.

    Science.gov (United States)

    Pinniger, Rosa; Brown, Rhonda F; Thorsteinsson, Einar B; McKinley, Patricia

    2012-12-01

    To determine whether tango dancing is as effective as mindfulness meditation in reducing symptoms of psychological stress, anxiety and depression, and in promoting well-being. This study employed analysis of covariance (ANCOVA) and multiple regression analysis. Ninety-seven people with self-declared depression were randomised into tango dance or mindfulness meditation classes, or to control/waiting-list. classes were conducted in a venue suitable for both activities in the metropolitan area of Sydney, Australia. Participants completed six-week programmes (1½h/week of tango or meditation). The outcome measures were assessed at pre-test and post-test. Depression, Anxiety and Stress Scale; The Self Esteem Scale; Satisfaction with Life Scale, and Mindful Attention Awareness Scale. Sixty-six participants completed the program and were included in the statistical analysis. Depression levels were significantly reduced in the tango (effect size d=0.50, p=.010), and meditation groups (effect size d=0.54, p=.025), relative to waiting-list controls. Stress levels were significantly reduced only in the tango group (effect size d=0.45, p=.022). Attending tango classes was a significant predictor for the increased levels of mindfulness R(2)=.10, adjusted R(2)=.07, F (2,59)=3.42, p=.039. Mindfulness-meditation and tango dance could be effective complementary adjuncts for the treatment of depression and/or inclusion in stress management programmes. Subsequent trials are called to explore the therapeutic mechanisms involved. Crown Copyright © 2012. Published by Elsevier Ltd. All rights reserved.

  17. Acupuncture and rehabilitation of the painful shoulder: study protocol of an ongoing multicentre randomised controlled clinical trial [ISRCTN28687220

    Directory of Open Access Journals (Sweden)

    Jimenez Carmen

    2005-10-01

    Full Text Available Abstract Background Although the painful shoulder is one of the most common dysfunctions of the locomotor apparatus, and is frequently treated both at primary healthcare centres and by specialists, little evidence has been reported to support or refute the effectiveness of the treatments most commonly applied. According to the bibliography reviewed, physiotherapy, which is the most common action taken to alleviate this problem, has not yet been proven to be effective, because of the small size of sample groups and the lack of methodological rigor in the papers published on the subject. No reviews have been made to assess the effectiveness of acupuncture in treating this complaint, but in recent years controlled randomised studies have been made and these demonstrate an increasing use of acupuncture to treat pathologies of the soft tissues of the shoulder. In this study, we seek to evaluate the effectiveness of physiotherapy applied jointly with acupuncture, compared with physiotherapy applied with a TENS-placebo, in the treatment of painful shoulder caused by subacromial syndrome (rotator cuff tendinitis and subacromial bursitis. Methods/design Randomised controlled multicentre study with blind evaluation by an independent observer and blind, independent analysis. A study will be made of 465 patients referred to the rehabilitation services at participating healthcare centres, belonging to the regional public health systems of Andalusia and Murcia, these patients presenting symptoms of painful shoulder and a diagnosis of subacromial syndrome (rotator cuff tendinitis and subacromial bursitis. The patients will be randomised into two groups: 1 experimental (acupuncture + physiotherapy; 2 control (TENS-placebo + physiotherapy; the administration of rescue medication will also be allowed. The treatment period will have a duration of three weeks. The main result variable will be the change produced on Constant's Shoulder Function Assessment (SFA Scale

  18. Children, parents, and pets exercising together (CPET randomised controlled trial: study rationale, design, and methods

    Directory of Open Access Journals (Sweden)

    Yam Philippa S

    2012-03-01

    Full Text Available Abstract Background Objectively measured physical activity is low in British children, and declines as childhood progresses. Observational studies suggest that dog-walking might be a useful approach to physical activity promotion in children and adults, but there are no published public health interventions based on dog-walking with children. The Children, Parents, and Pets Exercising Together Study aims to develop and evaluate a theory driven, generalisable, family-based, dog walking intervention for 9-11 year olds. Methods/design The Children, Parents, and Pets Exercising Together Study is an exploratory, assessor-blinded, randomised controlled trial as defined in the UK MRC Framework on the development and evaluation of complex interventions in public health. The trial will follow CONSORT guidance. Approximately 40 dog-owning families will be allocated randomly in a ratio of 1.5:1 to receive a simple behavioural intervention lasting for 10 weeks or to a 'waiting list' control group. The primary outcome is change in objectively measured child physical activity using Actigraph accelerometry. Secondary outcomes in the child, included in part to shape a future more definitive randomised controlled trial, are: total time spent sedentary and patterning of sedentary behaviour (Actigraph accelerometry; body composition and bone health from dual energy x-ray absorptiometry; body weight, height and BMI; and finally, health-related quality of life using the PedsQL. Secondary outcomes in parents and dogs are: changes in body weight; changes in Actigraph accelerometry measured physical activity and sedentary behaviour. Process evaluation will consist of assessment of simultaneous child, parent, and dog accelerometry data and brief interviews with participating families. Discussion The Children, Parents, and Pets Exercising Together trial should be the first randomised controlled study to establish and evaluate an intervention aimed at dog-based physical

  19. Children, parents, and pets exercising together (CPET) randomised controlled trial: study rationale, design, and methods.

    Science.gov (United States)

    Yam, Philippa S; Morrison, Ryan; Penpraze, Viki; Westgarth, Carri; Ward, Dianne S; Mutrie, Nanette; Hutchison, Pippa; Young, David; Reilly, John J

    2012-03-19

    Objectively measured physical activity is low in British children, and declines as childhood progresses. Observational studies suggest that dog-walking might be a useful approach to physical activity promotion in children and adults, but there are no published public health interventions based on dog-walking with children. The Children, Parents, and Pets Exercising Together Study aims to develop and evaluate a theory driven, generalisable, family-based, dog walking intervention for 9-11 year olds. The Children, Parents, and Pets Exercising Together Study is an exploratory, assessor-blinded, randomised controlled trial as defined in the UK MRC Framework on the development and evaluation of complex interventions in public health. The trial will follow CONSORT guidance. Approximately 40 dog-owning families will be allocated randomly in a ratio of 1.5:1 to receive a simple behavioural intervention lasting for 10 weeks or to a 'waiting list' control group. The primary outcome is change in objectively measured child physical activity using Actigraph accelerometry. Secondary outcomes in the child, included in part to shape a future more definitive randomised controlled trial, are: total time spent sedentary and patterning of sedentary behaviour (Actigraph accelerometry); body composition and bone health from dual energy x-ray absorptiometry; body weight, height and BMI; and finally, health-related quality of life using the PedsQL. Secondary outcomes in parents and dogs are: changes in body weight; changes in Actigraph accelerometry measured physical activity and sedentary behaviour. Process evaluation will consist of assessment of simultaneous child, parent, and dog accelerometry data and brief interviews with participating families. The Children, Parents, and Pets Exercising Together trial should be the first randomised controlled study to establish and evaluate an intervention aimed at dog-based physical activity promotion in families. It should advance our

  20. International multicentre randomised controlled trial of improvisational music therapy for children with autism spectrum disorder: TIME-A study.

    Science.gov (United States)

    Crawford, Mike J; Gold, Christian; Odell-Miller, Helen; Thana, Lavanya; Faber, Sarah; Assmus, Jörg; Bieleninik, Łucja; Geretsegger, Monika; Grant, Claire; Maratos, Anna; Sandford, Stephan; Claringbold, Amy; McConachie, Helen; Maskey, Morag; Mössler, Karin Antonia; Ramchandani, Paul; Hassiotis, Angela

    2017-10-01

    Preliminary studies have indicated that music therapy may benefit children with autism spectrum disorders (ASD). To examine the effects of improvisational music therapy (IMT) on social affect and responsiveness of children with ASD. International, multicentre, three-arm, single-masked randomised controlled trial, including a National Institute for Health Research (NIHR)-funded centre that recruited in London and the east of England. Randomisation was via a remote service using permuted blocks, stratified by study site. Schools and private, voluntary and state-funded health-care services. Children aged between 4 and 7 years with a confirmed diagnosis of ASD and a parent or guardian who provided written informed consent. We excluded children with serious sensory disorder and those who had received music therapy within the past 12 months. All parents and children received enhanced standard care (ESC), which involved three 60-minute sessions of advice and support in addition to treatment as usual. In addition, they were randomised to either one (low-frequency) or three (high-frequency) sessions of IMT per week, or to ESC alone, over 5 months in a ratio of 1 : 1 : 2. The primary outcome was measured using the social affect score derived from the Autism Diagnostic Observation Schedule (ADOS) at 5 months: higher scores indicated greater impairment. Secondary outcomes included social affect at 12 months and parent-rated social responsiveness at 5 and 12 months (higher scores indicated greater impairment). A total of 364 participants were randomised between 2011 and 2015. A total of 182 children were allocated to IMT (90 to high-frequency sessions and 92 to low-frequency sessions), and 182 were allocated to ESC alone. A total of 314 (86.3%) of the total sample were followed up at 5 months [165 (90.7%) in the intervention group and 149 (81.9%) in the control group]. Among those randomised to IMT, 171 (94.0%) received it. From baseline to 5 months, mean scores of ADOS

  1. The IDvIP Trial: A two-centre randomised double-blind controlled trial comparing intramuscular diamorphine and intramuscular pethidine for labour analgesia

    Directory of Open Access Journals (Sweden)

    Thomas Peter

    2011-07-01

    Full Text Available Abstract Background Intramuscular pethidine is routinely used throughout the UK for labour analgesia. Studies have suggested that pethidine provides little pain relief in labour and has a number of side effects affecting mother and neonate. It can cause nausea, vomiting and dysphoria in mothers and can cause reduced fetal heart rate variability and accelerations. Neonatal effects include respiratory depression and impaired feeding. There are few large studies comparing the relative side effects and efficacy of different opioids in labour. A small trial comparing intramuscular pethidine with diamorphine, showed diamorphine to have some benefits over pethidine when used for labour analgesia but the study did not investigate the adverse effects of either opioid. Methods The Intramuscular Diamorphine versus Intramuscular Pethidine (IDvIP trial is a randomised double-blind two centre controlled trial comparing intramuscular diamorphine and pethidine regarding their analgesic efficacy in labour and their side effects in mother, fetus and neonate. Information about the trial will be provided to women in the antenatal period or in early labour. Consent and recruitment to the trial will be obtained when the mother requests opioid analgesia. The sample size requirement is 406 women with data on primary outcomes. The maternal primary outcomes are pain relief during the first 3 hours after trial analgesia and specifically pain relief after 60 minutes. The neonatal primary outcomes are need for resuscitation and Apgar Score Discussion If the trial demonstrates that diamorphine provides better analgesia with fewer side effects in mother and neonate this could lead to a change in national practice and result in diamorphine becoming the preferred intramuscular opioid for analgesia in labour. Trial Registration ISRCTN14898678 Eudra No: 2006-003250-18, REC Reference No: 06/Q1702/95, MHRA Authorisation No: 1443/0001/001-0001, NIHR UKCRN reference 6895, RfPB grant

  2. Treatment of trauma-affected refugees with venlafaxine versus sertraline combined with psychotherapy - a randomised study.

    Science.gov (United States)

    Sonne, Charlotte; Carlsson, Jessica; Bech, Per; Elklit, Ask; Mortensen, Erik Lykke

    2016-11-08

    The prevalence of trauma-related psychiatric disorders is high among refugees. Despite this, little is known about the effect of pharmacological treatment for this patient group. The objective of the present study was therefore to examine differences in the effects of venlafaxine and sertraline on Post-Traumatic Stress Disorder (PTSD), depression and functional impairment in trauma-affected refugees. The study was a randomised pragmatic trial comparing venlafaxine and sertraline in combination with psychotherapy and social counselling. PTSD symptoms were measured on the Harvard Trauma Questionnaire - part IV, which was the primary outcome measure. Other outcome measures included: Hopkins Symptom Check List-25 (depression and anxiety), Social Adjustment Scale - short version (social functioning), WHO-5 Well-being Index (quality of life), Crisis Support Scale (support from social network), Sheehan Disability Scale (disability in three areas of functioning), Hamilton Depression and Anxiety scale, the somatisation items of the Symptoms Checklist-90, Global Assessment of Functioning scales and the summarised score of pain in four body areas rated on visual analogue scales. Two hundred seven adult refugee patients were included in the trial (98 in the venlafaxine and 109 in the sertraline group). Of these, 195 patients were eligible for intention-to-treat analyses. Small but significant pre-treatment to post-treatment differences were found on the Harvard Trauma Questionnaire and a number of other ratings in both groups. On the primary outcome measure, no difference was found in treatment effect between the sertraline and venlafaxine group. A significant group difference was found in favour of sertraline on the Sheehan Disability Scale. Sertraline had a slightly better outcome than venlafaxine on some of the secondary outcome measures, but not on the primary outcome measure. Furthermore, a higher percentage of dropouts was found in the venlafaxine group compared to the

  3. [Comparative studies of face recognition].

    Science.gov (United States)

    Kawai, Nobuyuki

    2012-07-01

    Every human being is proficient in face recognition. However, the reason for and the manner in which humans have attained such an ability remain unknown. These questions can be best answered-through comparative studies of face recognition in non-human animals. Studies in both primates and non-primates show that not only primates, but also non-primates possess the ability to extract information from their conspecifics and from human experimenters. Neural specialization for face recognition is shared with mammals in distant taxa, suggesting that face recognition evolved earlier than the emergence of mammals. A recent study indicated that a social insect, the golden paper wasp, can distinguish their conspecific faces, whereas a closely related species, which has a less complex social lifestyle with just one queen ruling a nest of underlings, did not show strong face recognition for their conspecifics. Social complexity and the need to differentiate between one another likely led humans to evolve their face recognition abilities.

  4. The influence of high-intensity compared with moderate-intensity exercise training on cardiorespiratory fitness and body composition in colorectal cancer survivors: a randomised controlled trial.

    Science.gov (United States)

    Devin, James L; Sax, Andrew T; Hughes, Gareth I; Jenkins, David G; Aitken, Joanne F; Chambers, Suzanne K; Dunn, Jeffrey C; Bolam, Kate A; Skinner, Tina L

    2016-06-01

    Following colorectal cancer diagnosis and anti-cancer therapy, declines in cardiorespiratory fitness and body composition lead to significant increases in morbidity and mortality. There is increasing interest within the field of exercise oncology surrounding potential strategies to remediate these adverse outcomes. This study compared 4 weeks of moderate-intensity exercise (MIE) and high-intensity exercise (HIE) training on peak oxygen consumption (V̇O2peak) and body composition in colorectal cancer survivors. Forty seven post-treatment colorectal cancer survivors (HIE = 27 months post-treatment; MIE = 38 months post-treatment) were randomised to either HIE [85-95 % peak heart rate (HRpeak)] or MIE (70 % HRpeak) in equivalence with current physical activity guidelines and completed 12 training sessions over 4 weeks. HIE was superior to MIE in improving absolute (p = 0.016) and relative (p = 0.021) V̇O2peak. Absolute (+0.28 L.min(-1), p body composition for colorectal cancer survivors. HIE appears to offer superior improvements in cardiorespiratory fitness and body composition in comparison to current physical activity recommendations for colorectal cancer survivors and therefore may be an effective clinical utility following treatment.

  5. Provision of mental health services in resource-poor settings: a randomised trial comparing counselling with routine medical treatment in North Afghanistan (Mazar-e-Sharif

    Directory of Open Access Journals (Sweden)

    Ayoughi Sarah

    2012-02-01

    Full Text Available Abstract Background Psychosocial stress caused by war, ongoing conflict, lack of security, and restricted access to resources promotes mental suffering and diseases in many resource-poor countries. In an exemplary setting, the present study compares the efficacy of psychosocial counselling with routine pharmacological treatment in a randomised trial in Mazar-e-Sharif (Afghanistan. Methods Help seeking Afghan women (N = 61, who were diagnosed with mental health symptoms by local physicians either received routine medical treatment(treatment as usual or psychosocial counselling (5-8 sessions following a specifically developed manualised treatment protocol. Primary outcome measures were symptoms of depression and anxiety assessed before treatment and at follow-up using the Hopkins Symptom Checklist and the Mini-International Neuropsychiatric Interview. Secondary outcome measures were psychosocial stressors and coping mechanisms. Results At 3-month follow-up, psychosocial counselling patients showed high improvements with respect to the severity of symptoms of depression and anxiety. In addition, they reported a reduction of psychosocial stressors and showed an enhancement of coping strategies. At the same time, the severity of symptoms, the quantity of psychosocial stressors and coping mechanisms did not improve in patients receiving routine medical treatment. Conclusion These results indicate that psychosocial counselling can be an effective treatment for mental illnesses even for those living in ongoing unsafe environments. Trial registration NCT01155687

  6. Evaluation of eLearning for the teaching of undergraduate ophthalmology at medical school: a randomised controlled crossover study.

    Science.gov (United States)

    Petrarca, Caroline A; Warner, Julia; Simpson, Andrew; Petrarca, Robert; Douiri, Abdel; Byrne, David; Jackson, Timothy L

    2018-05-25

    To compare ophthalmology teaching delivered by eLearning with traditional lectures, in terms of undergraduate performance and satisfaction. Randomised controlled crossover study at King's College London Medical School with 245 third year medical students. The ophthalmology syllabus was divided into ten topics. Five topics were randomised to be taught by traditional lectures and five by electronic learning (eLearning). For the second rotation of students the topics were crossed over, so that those topics taught by traditional lectures were taught by eLearning and vice versa. At the end of each rotation the students sat an optional online mock examination containing 100 questions (ten on each topic). Students' examination performance was compared between the two teaching methods. Student satisfaction was assessed using an online satisfaction survey. Outcome measures were the mean percentage of correct answers across all ten topics, student satisfaction and self-assessed knowledge. The mean examination score for questions taught by eLearning was 58% (95% CI, 55.7-59.6), versus 55% (95% CI 53.1-56.8) for traditional lectures (P = 0.047). Across all topics students were more satisfied with eLearning than traditional lectures, with 87% (95% CI 84.5-88.4) rating eLearning as 'excellent' or 'good' versus 65% (95% CI 62.0-67.4) for lectures (p eLearning compared to traditional lectures, with 166 (69.7%) rating eLearning 'much better' or 'better,' 61 (25.6%) 'neutral' and 11 (4.6%) 'worse' or 'much worse.' Student satisfaction and examination performance are both enhanced by ophthalmology eLearning. Similar eLearning modules may be suitable for other specialties and postgraduate learning.

  7. Routine resite of peripheral intravenous devices every 3 days did not reduce complications compared with clinically indicated resite: a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Rickard Claire M

    2010-09-01

    Full Text Available Abstract Background Peripheral intravenous device (IVD complications were traditionally thought to be reduced by limiting dwell time. Current recommendations are to resite IVDs by 96 hours with the exception of children and patients with poor veins. Recent evidence suggests routine resite is unnecessary, at least if devices are inserted by a specialised IV team. The aim of this study was to compare the impact of peripheral IVD 'routine resite' with 'removal on clinical indication' on IVD complications in a general hospital without an IV team. Methods A randomised, controlled trial was conducted in a regional teaching hospital. After ethics approval, 362 patients (603 IVDs were randomised to have IVDs replaced on clinical indication (185 patients or routine change every 3 days (177 patients. IVDs were inserted and managed by the general hospital medical and nursing staff; there was no IV team. The primary endpoint was a composite of IVD complications: phlebitis, infiltration, occlusion, accidental removal, local infection, and device-related bloodstream infection. Results IVD complication rates were 68 per 1,000 IVD days (clinically indicated and 66 per 1,000 IVD days (routine replacement (P = 0.86; HR 1.03; 95% CI, 0.74-1.43. Time to first complication per patient did not differ between groups (KM with log rank, P = 0.53. There were no local infections or IVD-related bloodstream infections in either group. IV therapy duration did not differ between groups (P = 0.22, but more (P = 0.004 IVDs were placed per patient in the routine replacement (mean, 1.8 than the clinical indication group (mean, 1.5, with significantly higher hospital costs per patient (P Conclusions Resite on clinical indication would allow one in two patients to have a single cannula per course of IV treatment, as opposed to one in five patients managed with routine resite; overall complication rates appear similar. Clinically indicated resite would achieve savings in equipment

  8. Transitional care for the highest risk patients: findings of a randomised control study

    Directory of Open Access Journals (Sweden)

    Kheng Hock Lee

    2015-10-01

    Full Text Available Background: Interventions to prevent readmissions of patients at highest risk have not been rigorously evaluated. We conducted a randomised controlled trial to determine if a post-discharge transitional care programme can reduce readmissions of such patients in Singapore. Methods: We randomised 840 patients with two or more unscheduled readmissions in the prior 90 days and Length of stay, Acuity of admission, Comorbidity of patient, Emergency department utilisation score ≥10 to the intervention programme (n = 419 or control (n = 421. Patients allocated to the intervention group received post-discharge surveillance by a multidisciplinary integrated care team and early review in the clinic. The primary outcome was the proportion of patients with at least one unscheduled readmission within 30 days after discharge. Results: We found no statistically significant reduction in readmissions or emergency department visits in patients on the intervention group compared to usual care. However, patients in the intervention group reported greater patient satisfaction (p < 0.001. Conclusion: Any beneficial effect of interventions initiated after discharge is small for high-risk patients with multiple comorbidity and complex care needs. Future transitional care interventions should focus on providing the entire cycle of care for such patients starting from time of admission to final transition to the primary care setting. Trial Registration: Clinicaltrials.gov, no NCT02325752

  9. Transitional care for the highest risk patients: findings of a randomised control study

    Directory of Open Access Journals (Sweden)

    Kheng Hock Lee

    2015-10-01

    Full Text Available Background: Interventions to prevent readmissions of patients at highest risk have not been rigorously evaluated. We conducted a randomised controlled trial to determine if a post-discharge transitional care programme can reduce readmissions of such patients in Singapore.Methods: We randomised 840 patients with two or more unscheduled readmissions in the prior 90 days and Length of stay, Acuity of admission, Comorbidity of patient, Emergency department utilisation score ≥10 to the intervention programme (n = 419 or control (n = 421. Patients allocated to the intervention group received post-discharge surveillance by a multidisciplinary integrated care team and early review in the clinic. The primary outcome was the proportion of patients with at least one unscheduled readmission within 30 days after discharge.Results: We found no statistically significant reduction in readmissions or emergency department visits in patients on the intervention group compared to usual care. However, patients in the intervention group reported greater patient satisfaction (p < 0.001.Conclusion: Any beneficial effect of interventions initiated after discharge is small for high-risk patients with multiple comorbidity and complex care needs. Future transitional care interventions should focus on providing the entire cycle of care for such patients starting from time of admission to final transition to the primary care setting.Trial Registration: Clinicaltrials.gov, no NCT02325752

  10. The effectiveness of fermented turmeric powder in subjects with elevated alanine transaminase levels: a randomised controlled study

    Science.gov (United States)

    2013-01-01

    Background Previous animal studies have shown that Curcuma longa (turmeric) improves liver function. Turmeric may thus be a promising ingredient in functional foods aimed at improving liver function. The purpose of the study is to investigate the hepatoprotective effect of fermented turmeric powder (FTP) on liver function in subjects with elevated alanine transaminase (ALT) levels. Methods A randomised, double-blind, placebo-controlled trial was conducted between November 2010 and April 2012 at the clinical trial center for functional foods of the Chonbuk National University Hospital. The trial included 60 subjects, 20 years old and above, who were diagnosed mild to moderate elevated ALT levels between 40 IU/L and 200 IU/L. Sixty subjects were randomised to receive FTP 3.0 g per day or placebo 3.0 g per day for 12 weeks. The treatment group received two capsules of FTP three times a day after meals, for 12 weeks. The primary efficacy endpoint was change in the ALT levels in the two groups. The secondary efficacy endpoints included its effect on aspartate aminotransferase (AST), gamma-glutamyl transferase (GGT), total bilirubin (TB), and lipid profiles. Safety was assessed throughout the study using ongoing laboratory tests. Adverse events (AEs) were also recorded. Results Sixty subjects were randomised in the study (30 into the FTP group, 30 into the placebo group), and among them, twelve subjects were excluded from the analysis for protocol violation, adverse events or consent withdrawal. The two groups did not differ in baseline characteristics. After 12 weeks of treatment, 48 subjects were evaluated. Of the 48 subjects, 26 randomly received FTP capsules and 22 received placebo. The FTP group showed a significant reduction in ALT levels after 12 weeks of treatment compared with the placebo group (p = 0.019). There was also observed that the serum AST levels were significantly reduce in the FTP group than placebo group (p = 0.02). The GGT levels

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

    OpenAIRE

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

    2012-01-01

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

  12. 'Putting Life in Years' (PLINY) telephone friendship groups research study: pilot randomised controlled trial.

    Science.gov (United States)

    Mountain, Gail A; Hind, Daniel; Gossage-Worrall, Rebecca; Walters, Stephen J; Duncan, Rosie; Newbould, Louise; Rex, Saleema; Jones, Carys; Bowling, Ann; Cattan, Mima; Cairns, Angela; Cooper, Cindy; Edwards, Rhiannon Tudor; Goyder, Elizabeth C

    2014-04-24

    Loneliness in older people is associated with poor health-related quality of life (HRQoL). We undertook a parallel-group randomised controlled trial to evaluate the effectiveness and cost-effectiveness of telephone befriending for the maintenance of HRQoL in older people. An internal pilot tested the feasibility of the trial and intervention. Participants aged >74 years, with good cognitive function, living independently in one UK city were recruited through general practices and other sources, then randomised to: (1) 6 weeks of short one-to-one telephone calls, followed by 12 weeks of group telephone calls with up to six participants, led by a trained volunteer facilitator; or (2) a control group. The main trial required the recruitment of 248 participants in a 1-year accrual window, of whom 124 were to receive telephone befriending. The pilot specified three success criteria which had to be met in order to progress the main trial to completion: recruitment of 68 participants in 95 days; retention of 80% participants at 6 months; successful delivery of telephone befriending by local franchise of national charity. The primary clinical outcome was the Short Form (36) Health Instrument (SF-36) Mental Health (MH) dimension score collected by telephone 6 months following randomisation. We informed 9,579 older people about the study. Seventy consenting participants were randomised to the pilot in 95 days, with 56 (80%) providing valid primary outcome data (26 intervention, 30 control). Twenty-four participants randomly allocated to the research arm actually received telephone befriending due to poor recruitment and retention of volunteer facilitators. The trial was closed early as a result. The mean 6-month SF-36 MH scores were 78 (SD 18) and 71 (SD 21) for the intervention and control groups, respectively (mean difference, 7; 95% CI, -3 to 16). Recruitment and retention of participants to a definitive trial with a recruitment window of 1 year is feasible. For

  13. ‘Putting Life in Years’ (PLINY) telephone friendship groups research study: pilot randomised controlled trial

    Science.gov (United States)

    2014-01-01

    Background Loneliness in older people is associated with poor health-related quality of life (HRQoL). We undertook a parallel-group randomised controlled trial to evaluate the effectiveness and cost-effectiveness of telephone befriending for the maintenance of HRQoL in older people. An internal pilot tested the feasibility of the trial and intervention. Methods Participants aged >74 years, with good cognitive function, living independently in one UK city were recruited through general practices and other sources, then randomised to: (1) 6 weeks of short one-to-one telephone calls, followed by 12 weeks of group telephone calls with up to six participants, led by a trained volunteer facilitator; or (2) a control group. The main trial required the recruitment of 248 participants in a 1-year accrual window, of whom 124 were to receive telephone befriending. The pilot specified three success criteria which had to be met in order to progress the main trial to completion: recruitment of 68 participants in 95 days; retention of 80% participants at 6 months; successful delivery of telephone befriending by local franchise of national charity. The primary clinical outcome was the Short Form (36) Health Instrument (SF-36) Mental Health (MH) dimension score collected by telephone 6 months following randomisation. Results We informed 9,579 older people about the study. Seventy consenting participants were randomised to the pilot in 95 days, with 56 (80%) providing valid primary outcome data (26 intervention, 30 control). Twenty-four participants randomly allocated to the research arm actually received telephone befriending due to poor recruitment and retention of volunteer facilitators. The trial was closed early as a result. The mean 6-month SF-36 MH scores were 78 (SD 18) and 71 (SD 21) for the intervention and control groups, respectively (mean difference, 7; 95% CI, -3 to 16). Conclusions Recruitment and retention of participants to a definitive trial with a

  14. The serious mental illness health improvement profile [HIP]: study protocol for a cluster randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Swift Louise

    2011-07-01

    Full Text Available Abstract Background The serious mental illness Health Improvement Profile [HIP] is a brief pragmatic tool, which enables mental health nurses to work together with patients to screen physical health and take evidence-based action when variables are identified to be at risk. Piloting has demonstrated clinical utility and acceptability. Methods/Design A single blind parallel group cluster randomised controlled trial with secondary economic analysis and process observation. Unit of randomisation: mental health nurses [MHNs] working in adult community mental health teams across two NHS Trusts. Subjects: Patients over 18 years with a diagnosis of schizophrenia, schizoaffective or bipolar disorder on the caseload of participating MHNs. Primary objective: To determine the effects of the HIP programme on patients' physical wellbeing assessed by the physical component score of the Medical Outcome Study (MOS 36 Item Short Form Health Survey version 2 [SF-36v2]. Secondary objectives: To determine the effects of the HIP programme on: cost effectiveness, mental wellbeing, cardiovascular risk, physical health care attitudes and knowledge of MHNs and to determine the acceptability of the HIP Programme in the NHS. Consented nurses (and patients will be randomised to receive the HIP Programme or treatment as usual. Outcomes will be measured at baseline and 12 months with a process observation after 12 months to include evaluation of patients' and professionals' experience and observation of any effect on care plans and primary-secondary care interface communication. Outcomes will be analysed on an intention-to-treat (ITT basis. Discussion The results of the trial and process observation will provide information about the effectiveness of the HIP Programme in supporting MHNs to address physical comorbidity in serious mental illness. Given the current unacceptable prevalence of physical comorbidity and mortality in the serious mental illness population, it is

  15. Cervical auscultation in the diagnosis of oropharyngeal aspiration in children: a study protocol for a randomised controlled trial.

    Science.gov (United States)

    Frakking, Thuy T; Chang, Anne B; O'Grady, Kerry-Ann F; Walker-Smith, Katie; Weir, Kelly A

    2013-11-07

    Oropharyngeal aspiration (OPA) can lead to recurrent respiratory illnesses and chronic lung disease in children. Current clinical feeding evaluations performed by speech pathologists have poor reliability in detecting OPA when compared to radiological procedures such as the modified barium swallow (MBS). Improved ability to diagnose OPA accurately via clinical evaluation potentially reduces reliance on expensive, less readily available radiological procedures. Our study investigates the utility of adding cervical auscultation (CA), a technique of listening to swallowing sounds, in improving the diagnostic accuracy of a clinical evaluation for the detection of OPA. We plan an open, unblinded, randomised controlled trial at a paediatric tertiary teaching hospital. Two hundred and sixteen children fulfilling the inclusion criteria will be randomised to one of the two clinical assessment techniques for the clinical detection of OPA: (1) clinical feeding evaluation only (CFE) group or (2) clinical feeding evaluation with cervical auscultation (CFE + CA) group. All children will then undergo an MBS to determine radiologically assessed OPA. The primary outcome is the presence or absence of OPA, as determined on MBS using the Penetration-Aspiration Scale. Our main objective is to determine the sensitivity, specificity, negative and positive predictive values of 'CFE + CA' versus 'CFE' only compared to MBS-identified OPA. Early detection and appropriate management of OPA is important to prevent chronic pulmonary disease and poor growth in children. As the reliability of CFE to detect OPA is low, a technique that can improve the diagnostic accuracy of the CFE will help minimise consequences to the paediatric respiratory system. Cervical auscultation is a technique that has previously been documented as a clinical adjunct to the CFE; however, no published RCTs addressing the reliability of this technique in children exist. Our study will be the first to establish the utility

  16. WELLFOCUS PPT - modified positive psychotherapy to improve well-being in psychosis: study protocol for a pilot randomised controlled trial.

    Science.gov (United States)

    Schrank, Beate; Riches, Simon; Coggins, Tony; Rashid, Tayyab; Tylee, Andre; Slade, Mike

    2014-06-03

    The promotion of well-being is an important goal of recovery oriented mental health services. No structured, evidence-based intervention exists that aims to increase the well-being in people with severe mental illness such as psychosis. Positive psychotherapy (PPT) is a promising intervention for this goal. Standard PPT was adapted for use with people with psychosis in the UK following the Medical Research Council framework for developing and testing complex interventions, resulting in the WELLFOCUS Model describing the intended impact of WELLFOCUS PPT. This study aims to test the WELLFOCUS Model, by piloting the intervention, trial processes, and evaluation strategy. This study is a non-blinded pragmatic pilot RCT comparing WELLFOCUS PPT provided as an 11-session group therapy in addition to treatment as usual to treatment as usual alone. Inclusion criteria are adults (aged 18-65 years) with a main diagnosis of psychosis who use mental health services. A target sample of 80 service users with psychosis are recruited from mental health services across the South London and Maudsley NHS Foundation Trust. Participants are randomised in blocks to the intervention and control group. WELLFOCUS PPT is provided to groups by specifically trained and supervised local therapists and members of the research team. Assessments are conducted before randomisation and after the group intervention. The primary outcome measure is well-being assessed by the Warwick-Edinburgh Mental Well-being Scale. Secondary outcomes include good feelings, symptom relief, connectedness, hope, self-worth, empowerment, and meaning. Process evaluation using data collected during the group intervention, post-intervention individual interviews and focus groups with participants, and interviews with trial therapists will complement quantitative outcome data. This study will provide data on the feasibility of the intervention and identify necessary adaptations. It will allow optimisation of trial processes

  17. The OPTIMIST study: optimisation of cost effectiveness through individualised FSH stimulation dosages for IVF treatment. A randomised controlled trial.

    Science.gov (United States)

    van Tilborg, Theodora C; Eijkemans, Marinus J C; Laven, Joop S E; Koks, Carolien A M; de Bruin, Jan Peter; Scheffer, Gabrielle J; van Golde, Ron J T; Fleischer, Kathrin; Hoek, Annemieke; Nap, Annemiek W; Kuchenbecker, Walter K H; Manger, Petra A; Brinkhuis, Egbert A; van Heusden, Arne M; Sluijmer, Alexander V; Verhoeff, Arie; van Hooff, Marcel H A; Friederich, Jaap; Smeenk, Jesper M J; Kwee, Janet; Verhoeve, Harold R; Lambalk, Cornelis B; Helmerhorst, Frans M; van der Veen, Fulco; Mol, Ben Willem J; Torrance, Helen L; Broekmans, Frank J M

    2012-09-18

    Costs of in vitro fertilisation (IVF) are high, which is partly due to the use of follicle stimulating hormone (FSH). FSH is usually administered in a standard dose. However, due to differences in ovarian reserve between women, ovarian response also differs with potential negative consequences on pregnancy rates. A Markov decision-analytic model showed that FSH dose individualisation according to ovarian reserve is likely to be cost-effective in women who are eligible for IVF. However, this has never been confirmed in a large randomised controlled trial (RCT). The aim of the present study is to assess whether an individualised FSH dose regime based on an ovarian reserve test (ORT) is more cost-effective than a standard dose regime. Multicentre RCT in subfertile women indicated for a first IVF or intracytoplasmic sperm injection cycle, who are aged IVF with oocyte donation, will not be included. Ovarian reserve will be assessed by measuring the antral follicle count. Women with a predicted poor response or hyperresponse will be randomised for a standard versus an individualised FSH regime (150 IU/day, 225-450 IU/day and 100 IU/day, respectively). Participants will undergo a maximum of three stimulation cycles during maximally 18 months. The primary study outcome is the cumulative ongoing pregnancy rate resulting in live birth achieved within 18 months after randomisation. Secondary outcomes are parameters for ovarian response, multiple pregnancies, number of cycles needed per live birth, total IU of FSH per stimulation cycle, and costs. All data will be analysed according to the intention-to-treat principle. Cost-effectiveness analysis will be performed to assess whether the health and associated economic benefits of individualised treatment of subfertile women outweigh the additional costs of an ORT. The results of this study will be integrated into a decision model that compares cost-effectiveness of the three dose-adjustment strategies to a standard dose strategy

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

    Science.gov (United States)

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

    2018-01-18

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

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

    Science.gov (United States)

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

    2005-04-01

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

  20. Study Protocol: Screening and Treatment of Alcohol-Related Trauma (START – a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Jayaraj Rama

    2012-10-01

    Full Text Available Abstract Background The incidence of mandibular fractures in the Northern Territory of Australia is very high, especially among Indigenous people. Alcohol intoxication is implicated in the majority of facial injuries, and substance use is therefore an important target for secondary prevention. The current study tests the efficacy of a brief therapy, Motivational Care Planning, in improving wellbeing and substance misuse in youth and adults hospitalised with alcohol-related facial trauma. Methods and design The study is a randomised controlled trial with 6 months of follow-up, to examine the effectiveness of a brief and culturally adapted intervention in improving outcomes for trauma patients with at-risk drinking admitted to the Royal Darwin Hospital maxillofacial surgery unit. Potential participants are identified using AUDIT-C questionnaire. Eligible participants are randomised to either Motivational Care Planning (MCP or Treatment as Usual (TAU. The outcome measures will include quantity and frequency of alcohol and other substance use by Timeline Followback. The recruitment target is 154 participants, which with 20% dropout, is hoped to provide 124 people receiving treatment and follow-up. Discussion This project introduces screening and brief interventions for high-risk drinkers admitted to the hospital with facial trauma. It introduces a practical approach to integrating brief interventions in the hospital setting, and has potential to demonstrate significant benefits for at-risk drinkers with facial trauma. Trial Registration The trial has been registered in Australian New Zealand Clinical Trials Registry (ANZCTR and Trial Registration: ACTRN12611000135910.

  1. Brachytherapy and percutaneous stenting in the treatment of cholangiocarcinoma: A prospective randomised study

    International Nuclear Information System (INIS)

    Valek, Vlastimil; Kysela, Petr; Kala, Zdenek; Kiss, Igor; Tomasek, Jiri; Petera, Jiri

    2007-01-01

    Purpose: To evaluate the effect of radiation therapy including intraluminal brachyterapy with iridium-192 on survival of patients with malignant biliary strictures (cholangiocarcinoma, histologically improved) treated with metallic stent in a prospective randomised study. Method and materials: In the prospective randomised study, 21 patients with cholangiocarcinoma were treated with implantation of percutaneous stents followed with intraluminal Ir-192 brachytherapy (mean dose 30 Gy) and external radiotherapy (mean dose 50 Gy) and 21 patients were treated only with stents insertion. We did not find any statistically significant differences in age and tumor localization between these two groups of patients. Results: All the patients died. In the group of patients treated with brachytherapy and with stent implantation, the mean survival time was 387.9 days. In the group of patients treated only with stent insertion the mean survival was 298 days. In effort to eliminate possible effect of external radiotherapy we treated the control group of eight patients with cholangiocarcinoma by stent insertion and brachyterapy only. Conclusion: Our results show that combined radiation therapy could extend the survival in the patients with cholangiocarcinoma obstruction

  2. A randomised controlled study of reflexology for the management of chronic low back pain.

    Science.gov (United States)

    Poole, Helen; Glenn, Sheila; Murphy, Peter

    2007-11-01

    The use of complementary and alternative medicine (CAM) for the management of chronic low back pain (CLBP) continues to rise. However, questions regarding the efficacy of many CAM therapies for CLBP remain unresolved. The present study investigated the effectiveness of reflexology for CLBP. A pragmatic randomised controlled trial was conducted. N=243 patients were randomised to one of three groups: reflexology, relaxation, or non-intervention (usual care). All completed a questionnaire booklet before and after the treatment phase, and at six months follow up. This measured their general health status, pain, functioning, coping strategies and mood. After adjusting for pre-treatment scores repeated measures ANCOVA found no significant differences between the groups pre and post treatment on the primary outcome measures of pain and functioning. There was a main effect of pain reduction, irrespective of group. Trends in the data illustrated the pain reduction was greatest in the reflexology group. Thus, the current study does not indicate that adding reflexology to usual GP care for the management of CLBP is any more effective than usual GP care alone.

  3. Defining Feasibility and Pilot Studies in Preparation for Randomised Controlled Trials: Development of a Conceptual Framework.

    Directory of Open Access Journals (Sweden)

    Sandra M Eldridge

    Full Text Available We describe a framework for defining pilot and feasibility studies focusing on studies conducted in preparation for a randomised controlled trial. To develop the framework, we undertook a Delphi survey; ran an open meeting at a trial methodology conference; conducted a review of definitions outside the health research context; consulted experts at an international consensus meeting; and reviewed 27 empirical pilot or feasibility studies. We initially adopted mutually exclusive definitions of pilot and feasibility studies. However, some Delphi survey respondents and the majority of open meeting attendees disagreed with the idea of mutually exclusive definitions. Their viewpoint was supported by definitions outside the health research context, the use of the terms 'pilot' and 'feasibility' in the literature, and participants at the international consensus meeting. In our framework, pilot studies are a subset of feasibility studies, rather than the two being mutually exclusive. A feasibility study asks whether something can be done, should we proceed with it, and if so, how. A pilot study asks the same questions but also has a specific design feature: in a pilot study a future study, or part of a future study, is conducted on a smaller scale. We suggest that to facilitate their identification, these studies should be clearly identified using the terms 'feasibility' or 'pilot' as appropriate. This should include feasibility studies that are largely qualitative; we found these difficult to identify in electronic searches because researchers rarely used the term 'feasibility' in the title or abstract of such studies. Investigators should also report appropriate objectives and methods related to feasibility; and give clear confirmation that their study is in preparation for a future randomised controlled trial designed to assess the effect of an intervention.

  4. Defining Feasibility and Pilot Studies in Preparation for Randomised Controlled Trials: Development of a Conceptual Framework.

    Science.gov (United States)

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

    2016-01-01

    We describe a framework for defining pilot and feasibility studies focusing on studies conducted in preparation for a randomised controlled trial. To develop the framework, we undertook a Delphi survey; ran an open meeting at a trial methodology conference; conducted a review of definitions outside the health research context; consulted experts at an international consensus meeting; and reviewed 27 empirical pilot or feasibility studies. We initially adopted mutually exclusive definitions of pilot and feasibility studies. However, some Delphi survey respondents and the majority of open meeting attendees disagreed with the idea of mutually exclusive definitions. Their viewpoint was supported by definitions outside the health research context, the use of the terms 'pilot' and 'feasibility' in the literature, and participants at the international consensus meeting. In our framework, pilot studies are a subset of feasibility studies, rather than the two being mutually exclusive. A feasibility study asks whether something can be done, should we proceed with it, and if so, how. A pilot study asks the same questions but also has a specific design feature: in a pilot study a future study, or part of a future study, is conducted on a smaller scale. We suggest that to facilitate their identification, these studies should be clearly identified using the terms 'feasibility' or 'pilot' as appropriate. This should include feasibility studies that are largely qualitative; we found these difficult to identify in electronic searches because researchers rarely used the term 'feasibility' in the title or abstract of such studies. Investigators should also report appropriate objectives and methods related to feasibility; and give clear confirmation that their study is in preparation for a future randomised controlled trial designed to assess the effect of an intervention.

  5. Protocol for the Electroencephalography Guidance of Anesthesia to Alleviate Geriatric Syndromes (ENGAGES) study: a pragmatic, randomised clinical trial

    Science.gov (United States)

    Wildes, T S; Winter, A C; Maybrier, H R; Mickle, A M; Lenze, E J; Stark, S; Lin, N; Inouye, S K; Schmitt, E M; McKinnon, S L; Muench, M R; Murphy, M R; Upadhyayula, R T; Fritz, B A; Escallier, K E; Apakama, G P; Emmert, D A; Graetz, T J; Stevens, T W; Palanca, B J; Hueneke, R L; Melby, S; Torres, B; Leung, J; Jacobsohn, E; Avidan, M S

    2016-01-01

    Introduction Postoperative delirium, arbitrarily defined as occurring within 5 days of surgery, affects up to 50% of patients older than 60 after a major operation. This geriatric syndrome is associated with longer intensive care unit and hospital stay, readmission, persistent cognitive deterioration and mortality. No effective preventive methods have been identified, but preliminary evidence suggests that EEG monitoring during general anaesthesia, by facilitating reduced anaesthetic exposure and EEG suppression, might decrease incident postoperative delirium. This study hypothesises that EEG-guidance of anaesthetic administration prevents postoperative delirium and downstream sequelae, including falls and decreased quality of life. Methods and analysis This is a 1232 patient, block-randomised, double-blinded, comparative effectiveness trial. Patients older than 60, undergoing volatile agent-based general anaesthesia for major surgery, are eligible. Patients are randomised to 1 of 2 anaesthetic approaches. One group receives general anaesthesia with clinicians blinded to EEG monitoring. The other group receives EEG-guidance of anaesthetic agent administration. The outcomes of postoperative delirium (≤5 days), falls at 1 and 12 months and health-related quality of life at 1 and 12 months will be compared between groups. Postoperative delirium is assessed with the confusion assessment method, falls with ProFaNE consensus questions and quality of life with the Veteran's RAND 12-item Health Survey. The intention-to-treat principle will be followed for all analyses. Differences between groups will be presented with 95% CIs and will be considered statistically significant at a two-sided pAnesthesia to Alleviate Geriatric Syndromes (ENGAGES) is approved by the ethics board at Washington University. Recruitment began in January 2015. Dissemination plans include presentations at scientific conferences, scientific publications, internet-based educational materials and

  6. USG-guided injection of corticosteroid for lateral epicondylitis does not improve clinical outcomes: a prospective randomised study.

    Science.gov (United States)

    Gulabi, Deniz; Uysal, Mehmet Ali; Akça, Ahmet; Colak, Ilker; Çeçen, Gultekin Sıtkı; Gumustas, Seyitali

    2017-05-01

    Corticosteroid injection used to be the treatment of choice for lateral epicondylitis. Most injections are performed blindly. In the blinded technique, it could be difficult to determine the exact pathological localisation. The purpose of this single-blinded, randomised controlled clinical study was to compare the clinical therapeutic effects of blinded and USG-guided corticosteroid injection therapy in lateral epicondylitis. Forty patients with chronic lateral epicondylitis were included in this clinical trial. The patients were randomly allocated to blinded group or USG-guided injection group according to a computer-generated randomisation list. All blinded injections were administered by an orthopaedic surgeon and all ultrasound-guided injections were made by a radiologist experienced in this technique. All patients were injected under aseptic conditions using 40 mg/2 mL methylprednisolone acetate. The outcomes of both treatments were assessed by an independent assessor at pre-injection, then at 6-week and 3- and 6-month follow-up assessments. The assessor evaluated the q-DASH, VAS, and grip strength scores. No statistically significant difference was determined between the groups in respect of the Q-DASH and grip strength scores preoperatively and at 6 weeks and 3 and 6 months post-injection. No statistically significant difference was determined between the groups in respect of the VAS scores preoperatively and at 6 weeks and 6 months. No systemic or local complications were reported during the treatment. There was no statistically significant difference compared to the blinded injection technique, and the mean score differences between the groups are of no clinical relevance.

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

    Science.gov (United States)

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

    2012-08-01

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

  8. Comparative electrocardiographic effects of intravenous ondansetron and granisetron in patients undergoing surgery for carcinoma breast: A prospective single-blind randomised trial

    Directory of Open Access Journals (Sweden)

    Ashish Ganjare

    2013-01-01

    Full Text Available Background: Postoperative nausea and vomiting (PONV are common and distressing symptoms after surgery performed under general anaesthesia. 5-hydroxytryptamine 3 antagonists are routinely used for prevention and treatment of PONV. The aim of our study was to compare the incidence of QTc prolongation and quantify the amount of QTc prolongation with ondansetron and granisetron. Methods: This prospective, randomised, single-blind study was carried out in the OT and Recovery Room (RR of a tertiary referral cancer centre. After obtaining Institutional Review Board approval and written informed consent from the patients, 70 patients undergoing elective surgery for carcinoma breast were included. In the RR, patients randomly received 8 mg of ondansetron or 1 mg of granisetron intravenously. Serial ECGs were recorded at various intervals, Non-invasive blood pressure and SpO 2 were also recorded. Chi-square test and Mann-Whiteny test were used for statistical analysis. Results: The demographics were similar in both groups. The incidence of significant QTc prolongation was significantly higher in the ondansetron group (22 of 37 (59.4% vs. 11 of 33 patients (33.33% ( P<0.05. There was an increase in the QTc interval in both the groups as compared to the baseline. The median prolongation in QTc interval from baseline was much more in the ondansetron group; this was statistically significant only at 5 and 15 min. Conclusion: Granisetron may be a safer option than ondanasetron for prevention and treatment of PONV due to lesser prolongation QTc interval. (ClinicalTrials.gov ID: NCT01352130

  9. 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 .

  10. Evaluation of homoeopathic treatment in polycystic ovary syndrome: A single-blind, randomised, placebo-controlled pilot study

    Directory of Open Access Journals (Sweden)

    Chetna Deep Lamba

    2018-01-01

    Full Text Available Background and Objectives: This study was conducted with the primary objective of evaluating efficacy of Homoeopathy in establishing the menstrual regularity with improvement in either ultrasonological findings or hirsutism/acne. The quality of life was also assessed using polycystic ovary syndrome questionnaire (PCOSQ. Materials and Methods: A single-blind, randomised, placebo-controlled pilot study was conducted from February 2014 to May 2015 at two research centres. The cases fulfilling the eligibility criteria were enrolled (n = 60 and randomised to either the homoeopathic intervention (HI (n = 30 or identical placebo (P (n = 30 with uniform lifestyle modification (LSM for 6 months. Results: The menstrual regularity with improvement in other signs/symptoms was observed in 60% of the cases (n = 18 in HI + LSM group and none (n = 0 in control group (P = 0.001. Statistically significant difference (P = 0.016 was observed in reduction of intermenstrual duration (from 76.1 ± 37.7 to 46.6 ± 38.7 days in HI + LSM in comparison to placebo + LSM group (from 93.0 ± 65.2 to 93.9 ± 96.2 days. In PCOSQ, also, significant improvement was observed in HI group in domains of weight, fertility, emotions and menstrual problems (P < 0.05 with no difference in body hair (P = 0.708. No change was observed in respect of improvement in the ultrasound findings. Pulsatilla was the most frequently indicated medicine (n = 12, 40%. Conclusion: HI along with LSM has shown promising outcome; further comparative study with standard conventional treatment on adequate sample size is desirable.

  11. Initiating change locally in bullying and aggression through the school environment (INCLUSIVE): study protocol for a cluster randomised controlled trial.

    Science.gov (United States)

    Bonell, Chris; Allen, Elizabeth; Christie, Deborah; Elbourne, Diana; Fletcher, Adam; Grieve, Richard; LeGood, Rosa; Mathiot, Anne; Scott, Stephen; Wiggins, Meg; Viner, Russell M

    2014-09-30

    Systematic reviews suggest that interventions that address school organisation are effective in reducing victimisation and bullying. We successfully piloted a school environment intervention modified from international studies to incorporate 'restorative justice' approaches. This trial aims to establish the effectiveness and cost-effectiveness of the INCLUSIVE intervention in reducing aggression and bullying in English secondary schools. cluster randomised trial. 40 state-supported secondary schools. OUTCOMES assessed among the cohort of students in year 8 (n = approximately 6,000) in intervention year 1. INCLUSIVE is a school-led intervention which combines changes to the school environment with the promotion of social and emotional skills and restorative practices through: the formation of a school action group involving students and staff supported by an external facilitator to review local data on needs, determine priorities, and develop and implement an action plan for revising relevant school policies/rules and other actions to improve relationships at school and reduce aggression; staff training in restorative practices; and a new social and emotional skills curriculum. The intervention will be delivered by schools supported in the first two years by educational facilitators independent of the research team, with a third locally facilitated intervention year.Comparator: normal practice. primary: 2 primary outcomes at student level assessed at baseline and at 36 months:1. Aggressive behaviours in school: Edinburgh Study of Youth Transitions and Crime school misbehaviour subscale (ESYTC)2. Bullying and victimisation: Gatehouse Bullying Scale (GBS)Secondary outcomes assessed at baseline, 24 and 36 months will include measures relating to the economic evaluation, psychosocial outcomes in students and staff and school-level truancy and exclusion rates. 20 schools per arm will provide 90% power to identify an effect size of 0.25 SD with a 5% significance level.Randomisation

  12. Utilising advance care planning videos to empower perioperative cancer patients and families: a study protocol of a randomised controlled trial.

    Science.gov (United States)

    Aslakson, Rebecca A; Isenberg, Sarina R; Crossnohere, Norah L; Conca-Cheng, Alison M; Yang, Ting; Weiss, Matthew; Volandes, Angelo E; Bridges, John F P; Roter, Debra L

    2017-06-06

    Despite positive health outcomes associated with advance care planning (ACP), little research has investigated the impact of ACP in surgical populations. Our goal is to evaluate how an ACP intervention video impacts the patient centredness and ACP of the patient-surgeon conversation during the presurgical consent visit. We hypothesise that patients who view the intervention will engage in a more patient-centred communication with their surgeons compared with patients who view a control video. Randomised controlled superiority trial of an ACP video with two study arms (intervention ACP video and control video) and four visits (baseline, presurgical consent, postoperative 1 week and postoperative 1 month). Surgeons, patients, principal investigator and analysts are blinded to the randomisation assignment. Single, academic, inner city and tertiary care hospital. Data collection began July 16, 2015 and continues to March 2017. Patients recruited from nine surgical oncology clinics who are undergoing major cancer surgery. In the intervention arm, patients view a patient preparedness video developed through extensive engagement with patients, surgeons and other stakeholders. Patients randomised to the control arm viewed an informational video about the hospital surgical programme. Primary Outcome: Patient centredness and ACP of patient-surgeon conversations during the presurgical consent visit as measured through the Roter Interaction Analysis System. patient Hospital Anxiety and Depression Scale score; patient goals of care; patient, companion and surgeon satisfaction; video helpfulness; medical decision maker designation; and the frequency patients watch the video. Intent-to-treat analysis will be used to assess the impact of video assignment on outcomes. Sensitivity analyses will assess whether there are differential effects contingent on patient or surgeon characteristics. This study has been approved by the Johns Hopkins School of Medicine institutional review

  13. Antibiotics for bronchiectasis exacerbations in children: rationale and study protocol for a randomised placebo-controlled trial

    Directory of Open Access Journals (Sweden)

    Chang Anne B

    2012-08-01

    Full Text Available Abstract Background Despite bronchiectasis being increasingly recognised as an important cause of chronic respiratory morbidity in both indigenous and non-indigenous settings globally, high quality evidence to inform management is scarce. It is assumed that antibiotics are efficacious for all bronchiectasis exacerbations, but not all practitioners agree. Inadequately treated exacerbations may risk lung function deterioration. Our study tests the hypothesis that both oral azithromycin and amoxicillin-clavulanic acid are superior to placebo at improving resolution rates of respiratory exacerbations by day 14 in children with bronchiectasis unrelated to cystic fibrosis. Methods We are conducting a bronchiectasis exacerbation study (BEST, which is a multicentre, randomised, double-blind, double-dummy, placebo-controlled, parallel group trial, in five centres (Brisbane, Perth, Darwin, Melbourne, Auckland. In the component of BEST presented here, 189 children fulfilling inclusion criteria are randomised (allocation-concealed to receive amoxicillin-clavulanic acid (22.5 mg/kg twice daily with placebo-azithromycin; azithromycin (5 mg/kg daily with placebo-amoxicillin-clavulanic acid; or placebo-azithromycin with placebo-amoxicillin-clavulanic acid for 14 days. Clinical data and a paediatric cough-specific quality of life score are obtained at baseline, at the start and resolution of exacerbations, and at day 14. In most children, blood and deep nasal swabs are also collected at the same time points. The primary outcome is the proportion of children whose exacerbations have resolved at day 14. The main secondary outcome is the paediatric cough-specific quality of life score. Other outcomes are time to next exacerbation; requirement for hospitalisation; duration of exacerbation; and spirometry data. Descriptive viral and bacteriological data from nasal samples and blood markers will also be reported. Discussion Effective, evidence-based management

  14. Clinical and biometrological efficacy of a hyaluronic acid-based mesotherapy product: a randomised controlled study.

    Science.gov (United States)

    Baspeyras, Martine; Rouvrais, Céline; Liégard, Laetitia; Delalleau, Alexandre; Letellier, Sandrine; Bacle, Irène; Courrech, Laetitia; Murat, Pascale; Mengeaud, Valérie; Schmitt, Anne-Marie

    2013-10-01

    Data demonstrating the efficacy of hyaluronic acid (HA)-based mesotherapy for skin rejuvenation are scarce. The aim of the study is to assess the efficacy of non-reticulated HA-based mesotherapy on skin elasticity and complexion radiance. 55 women with cutaneous ageing signs included in the Full Analysis Set (FAS) population blindly received intradermal micro-injections (50 × 0.02 mL) of non-cross-linked HA filler with mannitol (Glytone 1, HA concentration: 14 mg/g) in one cheek and saline physiological solution in the other according to hemifacial randomisation in 3 monthly sessions. Elasticity (E1 and E2 stiffness parameters) and dermis thickness were measured by cutometry and 20 MHz echography, before (D0) treatment and 1 (1M) and 3 months (3M) after the last injection. A trained panel blindly scored skin complexion radiance from standardised and calibrated photographs, using 100 mm analogue scales. In the FAS population, only HA filler significantly decreased E1 at 1M (-10.9 %, p = 0.026) and 3M (-10.5 %, p = 0.035) compared with D0; its effect versus the control tended to be more persistent, with a difference between treatments at 3M close to significance (p = 0.063). E2 also decreased at 1M (-8.2 %, p = 0.027 in the per protocol population, n = 53) and 3M after HA-treatment only. Dermis thickness significantly increased after HA-treatment at 1M (+3.4 %, p = 0.028) and 3M (+4 %, p = 0.008), and after control-treatment at 1M only (+2.5 %, p = 0.015). The HA filler significantly improved complexion radiance at 3M compared with the control (p = 0.012) and for 51 % of subjects, their skin status. Non-reticulated HA-based mesotherapy significantly and sustainably improves skin elasticity and complexion radiance.

  15. 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

  16. The Diabetes Care Project: an Australian multicentre, cluster randomised controlled trial [study protocol].

    Science.gov (United States)

    Leach, Matthew J; Segal, Leonie; Esterman, Adrian; Armour, Caroline; McDermott, Robyn; Fountaine, Tim

    2013-12-20

    Diabetes mellitus is an increasingly prevalent metabolic disorder that is associated with substantial disease burden. Australia has an opportunity to improve ways of caring for the growing number of people with diabetes, but this may require changes to the way care is funded, organised and delivered. To inform how best to care for people with diabetes, and to identify the extent of change that is required to achieve this, the Diabetes Care Project (DCP) will evaluate the impact of two different, evidence-based models of care (compared to usual care) on clinical quality, patient and provider experience, and cost. The DCP uses a pragmatic, cluster randomised controlled trial design. Accredited general practices that are situated within any of the seven Australian Medicare Locals/Divisions of General Practice that have agreed to take part in the study were invited to participate. Consenting practices will be randomly assigned to one of three treatment groups for approximately 18 to 22 months: (a) control group (usual care); (b) Intervention 1 (which tests improvements that could be made within the current funding model, facilitated through the use of an online chronic disease management network); or (c) Intervention 2 (which includes the same components as Intervention 1, as well as altered funding to support voluntary patient registration with their practice, incentive payments and a care facilitator). Adult patients who attend the enrolled practices and have established (≥12 month's duration) type 1 diabetes mellitus or newly diagnosed or established type 2 diabetes mellitus are invited to participate. Multiple outcomes will be studied, including changes in glycosylated haemoglobin (primary outcome), changes in other biochemical and clinical metrics, incidence of diabetes-related complications, quality of life, clinical depression, success of tailored care, patient and practitioner satisfaction, and budget sustainability. This project responds to a need for robust

  17. Collaborative care for depression in general practice: study protocol for a randomised controlled trial.

    Science.gov (United States)

    Brinck-Claussen, Ursula Ødum; Curth, Nadja Kehler; Davidsen, Annette Sofie; Mikkelsen, John Hagel; Lau, Marianne Engelbrecht; Lundsteen, Merete; Csillag, Claudio; Christensen, Kaj Sparle; Hjorthøj, Carsten; Nordentoft, Merete; Eplov, Lene Falgaard

    2017-07-21

    Depression is a common illness with great human costs and a significant burden on the public economy. Previous studies have indicated that collaborative care (CC) has a positive effect on symptoms when provided to people with depression, but CC has not yet been applied in a Danish context. We therefore developed a model for CC (the Collabri model) to treat people with depression in general practice in Denmark. Since systematic identification of patients is an "active ingredient" in CC and some literature suggests case finding as the best alternative to standard detection, the two detection methods are examined as part of the study. The aim is to investigate if treatment according to the Collabri model has an effect on depression symptoms when provided to people with depression in general practice in Denmark, and to examine if case finding is a better method to detect depression in general practice than standard detection. The trial is a cluster-randomised, clinical superiority trial investigating the effect of treatment according to the Collabri model for CC, compared to treatment as usual for 480 participants diagnosed with depression in general practice in the Capital Region of Denmark. The primary outcome is depression symptoms (Beck's Depression Inventory (BDI-II)) after 6 months. Secondary outcomes include depression symptoms (BDI-II) after 15 months, anxiety symptoms (Beck's Anxiety Inventory (BAI)), level of functioning (Global Assessment of Function (GAF)) and psychological stress (Symptom Checklist-90-Revised (SCL-90-R)). In addition, case finding (with the recommended screening tool Major Depression Inventory (MDI)) and standard detection of depression is examined in a cluster-randomized controlled design. Here, the primary outcome is the positive predictive value of referral diagnosis. If the Collabri model is shown to be superior to treatment as usual, the study will contribute with important knowledge on how to improve treatment of depression in

  18. Sex work: a comparative study.

    Science.gov (United States)

    McCarthy, Bill; Benoit, Cecilia; Jansson, Mikael

    2014-10-01

    Explanations of adult involvement in sex work typically adopt one of two approaches. One perspective highlights a variety of negative experiences in childhood and adolescence, including physical and sexual abuse, family instability, poverty, associations with "pimps" and other exploiters, homelessness, and drug use. An alternative account recognizes that some of these factors may be involved, but underscores the contribution of more immediate circumstances, such as current economic needs, human capital, and employment opportunities. Prior research offers a limited assessment of these contrasting claims: most studies have focused exclusively on people working in the sex industry and they have not assessed the independent effects of life course variables central to these two perspectives. We add to this literature with an analysis that drew on insights from life course and life-span development theories and considered the contributions of factors from childhood, adolescence, and adulthood. Our comparative approach examined predictors of employment in sex work relative to two other low-income service or care work occupations: food and beverage serving and barbering and hairstyling. Using data from a study of almost 600 workers from two cities, one in Canada and the other in the United States, we found that both immediate circumstances and negative experiences from early life are related to current sex work involvement: childhood poverty, abuse, and family instability were independently associated with adult sex work, as were limited education and employment experience, adult drug use, and marital status.

  19. Randomised Controlled Trial to determine the appropriate time to initiate peritoneal dialysis after insertion of catheter to minimise complications (Timely PD study

    Directory of Open Access Journals (Sweden)

    Fassett Robert G

    2010-06-01

    Full Text Available Abstract Background The most appropriate time to initiate dialysis after surgical insertion of Tenckhoff catheters is not clear in the literature. There is the possibility of peritoneal dialysis (PD complications such as leakage and infection if dialysis is started too soon after insertion. However, much morbidity and expense could be saved by reducing dependency on haemodialysis (HD by earlier initiation of PD post catheter insertion. Previous studies are observational and mostly compare immediate with delayed use. The primary objective is to determine the safest and shortest time interval between surgical placement of a Tenckhoff catheter and starting PD. Methods/Design This is a randomised controlled trial of patients who will start PD after insertion of Tenckhoff catheter at Royal Brisbane and Women's Hospital (RBWH or Rockhampton Base Hospital (RBH who meet the inclusion criteria. Patients will be stratified by site and diabetic status. The patients will be randomised to one of three treatment groups. Group 1 will start PD one week after Tenckhoff catheter insertion, group 2 at two weeks and group 3 at four weeks. Nurses and physicians will be blinded to the randomised allocation. The primary end point is the complication rate (leaks and infection after initiation of PD. Discussion The study will determine the most appropriate time to initiate PD after placement of a Tenckhoff catheter. Trial Registration ACTRN12610000076077

  20. Hepatitis C - Assessment to Treatment Trial (HepCATT) in primary care: study protocol for a cluster randomised controlled trial.

    Science.gov (United States)

    Roberts, Kirsty; Macleod, John; Metcalfe, Chris; Simon, Joanne; Horwood, Jeremy; Hollingworth, William; Marlowe, Sharon; Gordon, Fiona H; Muir, Peter; Coleman, Barbara; Vickerman, Peter; Harrison, Graham I; Waldron, Cherry-Ann; Irving, William; Hickman, Matthew

    2016-07-29

    Public Health England (PHE) estimates that there are upwards of 160,000 individuals in England and Wales with chronic hepatitis C virus (HCV) infection, but until now only around 100,000 laboratory diagnoses have been reported to PHE and of these 28,000 have been treated. Targeted case-finding in primary care is estimated to be cost-effective; however, there has been no robust randomised controlled trial evidence available of specific interventions. Therefore, this study aims to develop and conduct a complex intervention within primary care and to evaluate this approach using a cluster randomised controlled trial. A total of 46 general practices in South West England will be randomised in a 1:1 ratio to receive either a complex intervention comprising: educational training on HCV for the practice; poster and leaflet display in the practice waiting rooms to raise awareness and encourage opportunistic testing; a HCV risk prediction algorithm based on information on possible risk markers in the electronic patient record run using Audit + software (BMJ Informatica). The audit will then be used to recall and offer patients a HCV test. Control practices will follow usual care. The effectiveness of the intervention will be measured by comparing number and rates of HCV testing, the number and proportion of patients testing positive, onward referral, rates of specialist assessment and treatment in control and intervention practices. Intervention costs and health service utilisation will be recorded to estimate the NHS cost per new HCV diagnosis and new HCV patient initiating treatment. Longer-term cost-effectiveness of the intervention in improving quality-adjusted life years (QALYs) will be extrapolated using a pre-existing dynamic health economic model. Patients' and health care workers' experiences and acceptability of the intervention will be explored through semi-structured qualitative interviews. This trial has the potential to make an important impact on patient

  1. Impact of a deferred recruitment model in a randomised controlled trial in primary care (CREAM study).

    Science.gov (United States)

    Shepherd, Victoria; Thomas-Jones, Emma; Ridd, Matthew J; Hood, Kerenza; Addison, Katy; Francis, Nick A

    2017-11-10

    Recruitment of participants is particularly challenging in primary care, with less than a third of randomised controlled trials (RCT) achieving their target within the original time frame. Participant identification, consent, randomisation and data collection can all be time-consuming. Trials recruiting an incident, as opposed to a prevalent, population may be particularly affected. This paper describes the impact of a deferred recruitment model in a RCT of antibiotics for children with infected eczema in primary care, which required the recruitment of cases presenting acutely. Eligible children were identified by participating general practitioners (GPs) and referred to a study research nurse, who then visited them at home. This allowed the consent and recruitment processes to take place outside the general practice setting. Information was recorded about patients who were referred and recruited, or if not, the reasons for non-recruitment. Data on recruitment challenges were collected through semi-structured interviews and questionnaires with a sample of participating GPs. Data were thematically analysed to identify key themes. Of the children referred to the study 34% (58/171) were not recruited - 48% (28/58) because of difficulties arranging a baseline visit within the defined time frame, 31% (18/58) did not meet the study inclusion criteria at the time of nurse assessment, and 21% (12/58) declined participation. GPs had positive views about the recruitment process, reporting that parents valued and benefitted from additional contact with a nurse. GPs felt that the deferred recruitment model did not negatively impact on the study. GPs and parents recognised the benefits of deferred recruitment, but these did not translate into enhanced recruitment of participants. The model resulted in the loss of a third of children who were identified by the GP as eligible, but not subsequently recruited to the study. If the potential for improving outcomes in primary care

  2. Randomised trial of neonatal hypoglycaemia prevention with oral dextrose gel (hPOD): study protocol.

    Science.gov (United States)

    Harding, Jane E; Hegarty, Joanne E; Crowther, Caroline A; Edlin, Richard; Gamble, Greg; Alsweiler, Jane M

    2015-09-16

    Neonatal hypoglycaemia is common, affecting up to 15% of newborn babies and 50% of those with risk factors (preterm, infant of a diabetic, high or low birthweight). Hypoglycaemia can cause brain damage and death, and babies born at risk have an increased risk of developmental delay in later life. Treatment of hypoglycaemia usually involves additional feeding, often with infant formula, and admission to Neonatal Intensive Care for intravenous dextrose. This can be costly and inhibit the establishment of breast feeding. Prevention of neonatal hypoglycaemia would be desirable, but there are currently no strategies, beyond early feeding, for prevention of neonatal hypoglycaemia. Buccal dextrose gel is safe and effective in treatment of hypoglycaemia. The aim of this trial is to determine whether 40% dextrose gel given to babies at risk prevents neonatal hypoglycaemia and hence reduces admission to Neonatal Intensive Care. Randomised, multicentre, placebo controlled trial. Babies at risk of hypoglycaemia (preterm, infant of a diabetic, small or large), less than 1 h old, with no apparent indication for Neonatal Intensive Care Unit admission and mother intends to breastfeed. Trial entry & randomisation: Eligible babies of consenting parents will be allocated by online randomisation to the dextrose gel group or placebo group, using a study number and corresponding trial intervention pack. Babies will receive a single dose of 0.5 ml/kg study gel at 1 h after birth; either 40% dextrose gel (200 mg/kg) or 2% hydroxymethylcellulose placebo. Gel will be massaged into the buccal mucosal and followed by a breast feed. Primary study outcome: Admission to Neonatal Intensive Care. 2,129 babies are required to detect a decrease in admission to Neonatal Intensive Care from 10-6% (two-sided alpha 0.05, 90% power, 5% drop-out rate). This study will investigate whether admission to Neonatal Intensive Care can be prevented by prophylactic oral dextrose gel; a simple, cheap and painless

  3. Draining after breast reduction: a randomised controlled inter-patient study

    NARCIS (Netherlands)

    Corion, Leonard U. M.; Smeulders, Mark J. C.; van Zuijlen, Paul P. M.; van der Horst, Chantal M. A. M.

    2009-01-01

    One hundred and seven bilateral breast reductions were prospectively randomised during surgery to receive or not receive wound drains. Fifty-five patients were randomised to have a drain and 52 to not have a drain. There was no statistical difference in the number of complications between the

  4. A comparative analysis of costs of single and dual rapid HIV and syphilis diagnostics: results from a randomised controlled trial in Colombia.

    Science.gov (United States)

    Obure, Carol Dayo; Gaitan-Duarte, Hernando; Losada Saenz, Ricardo; Gonzalez, Lina; Angel-Muller, Edith; Laverty, Maura; Perez, Freddy

    2017-11-01

    HIV and congenital syphilis are major public health burdens contributing to substantial perinatal morbidity and mortality globally. Although studies have reported on the costs and cost-effectiveness of rapid diagnostic tests (RDTs) for syphilis screening within antenatal care in a number of resource-constrained settings, empirical evidence on country-specific cost and estimates of single RDTs compared with dual RDTs for HIV and syphilis are limited. A cluster randomised controlled study design was used to compare the incremental costs of two testing algorithms: (1) single RDTs for HIV and syphilis and (2) dual RDTs for HIV and syphilis, in 12 health facilities in Bogota and Cali, Colombia. The costs of single HIV and syphilis RDTs and dual HIV and syphilis RDTs were collected from each of the health facilities. The economic costs per woman tested for HIV and syphilis and costs per woman treated for syphilis defined as the total costs required to test and treat one woman for syphilis were estimated. A total of 2214 women were tested in the study facilities. Cost per pregnant woman tested and cost per woman treated for syphilis were US$10.26 and US$607.99, respectively in the single RDT arm. For the dual RDTs, the cost per pregnant woman tested for HIV and syphilis and cost per woman treated for syphilis were US$15.89 and US$1859.26, respectively. Overall costs per woman tested for HIV and syphilis and cost per woman treated for syphilis were lower in Cali compared with Bogota across both intervention arms. Staff costs accounted for the largest proportion of costs while treatment costs comprised <1% of the preventive programme. Findings show lower average costs for single RDTs compared with dual RDTs with costs sensitive to personnel costs and the scale of output at the health facilities. NCT02454816; 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/.

  5. Healthy Foundations Study: a randomised controlled trial to evaluate biological embedding of early-life experiences.

    Science.gov (United States)

    Gonzalez, Andrea; Catherine, Nicole; Boyle, Michael; Jack, Susan M; Atkinson, Leslie; Kobor, Michael; Sheehan, Debbie; Tonmyr, Lil; Waddell, Charlotte; MacMillan, Harriet L

    2018-01-26

    Adverse early experiences are associated with long-lasting disruptions in physiology, development and health. These experiences may be 'biologically embedded' into molecular and genomic systems that determine later expressions of vulnerability. Most studies to date have not examined whether preventive interventions can potentially reverse biological embedding. The Nurse-Family Partnership (NFP) is an evidence-based intervention with demonstrated efficacy in improving prenatal health, parenting and child functioning. The Healthy Foundations Study is an innovative birth cohort which will evaluate the impact of the NFP on biological outcomes of mothers and their infants. Starting in 2013, up to 400 pregnant mothers and their newborns were recruited from the British Columbia Healthy Connections Project-a randomised controlled trial of the NFP, and will be followed to child aged 2 years. Women were recruited prior to 28 weeks' gestation and then individually randomised to receive existing services (comparison group) or NFP plus existing services (intervention group). Hair samples are collected from mothers at baseline and 2 months post partum to measure physiological stress. Saliva samples are collected from infants during all visits for analyses of stress and immune function. Buccal swabs are collected from infants at 2 and 24 months to assess DNA methylation. Biological samples will be related to child outcome measures at age 2 years. The study received ethical approval from seven research ethics boards. Findings from this study will be shared broadly with the research community through peer-reviewed publications, and conference presentations, as well as seminars with our policy partners and relevant healthcare providers. The outcomes of this study will provide all stakeholders with important information regarding how early adversity may lead to health and behavioural disparities and how these may be altered through early interventions. NCT01672060; Pre-results.

  6. In type 2 diabetes, randomisation to advice to follow a low-carbohydrate diet transiently improves glycaemic control compared with advice to follow a low-fat diet producing a similar weight loss.

    Science.gov (United States)

    Guldbrand, H; Dizdar, B; Bunjaku, B; Lindström, T; Bachrach-Lindström, M; Fredrikson, M; Ostgren, C J; Nystrom, F H

    2012-08-01

    The study aimed to compare the effects of a 2 year intervention with a low-fat diet (LFD) or a low-carbohydrate diet (LCD), based on four group meetings to achieve compliance. This was a prospective randomised parallel trial involving 61 adults with type 2 diabetes consecutively recruited in primary care and randomised by drawing ballots. Patients that did not speak Swedish could not be recruited. The primary outcomes in this non-blinded study were weight and HbA(1c). Patients on the LFD aimed for 55-60 energy per cent (E%) and those on LCD for 20 E% from carbohydrate. The mean BMI and HbA(1c) of the participants were 32.7 ± 5.4 kg/m(2) and 57.0 ± 9.2 mmol/mol, respectively. No patients were lost to follow-up. Weight loss did not differ between groups and was maximal at 6 months: LFD -3.99 ± 4.1 kg (n=31); LCD -4.31 ± 3.6 kg (n=30); p carbohydrates is safe with respect to cardiovascular risk compared with the traditional LFD and this approach could constitute a treatment alternative. ClinicalTrials.gov NCT01005498 University Hospital of Linköping Research Funds, Linköping University, the County Council of Östergötland, and the Diabetes Research Centre of Linköping University.

  7. 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

    2008-01-01

    CONTEXT: The impact of clinical experience on learning outcome from a resuscitation course has not been systematically investigated. AIM: To determine whether half a year of clinical experience before participation in an Advanced Life Support (ALS) course increases the immediate learning outcome...... 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...... immediately following graduation. RESULTS: Invitation to participate was accepted by 154/240 (64%) graduates and 117/154 (76%) completed the study. There was no difference between the intervention and control groups with regard to the immediate learning outcome. The intervention group had significantly higher...

  8. Cognitive behavioural therapy for the management of inflammatory bowel disease-fatigue with a nested qualitative element: study protocol for a randomised controlled trial.

    Science.gov (United States)

    Artom, Micol; Czuber-Dochan, Wladyslawa; Sturt, Jackie; Norton, Christine

    2017-05-11

    Fatigue is one of the most prevalent and burdensome symptoms for patients with inflammatory bowel disease (IBD). Although fatigue increases during periods of inflammation, for some patients it persists when disease is in remission. Compared to other long-term conditions where fatigue has been extensively researched, optimal management of fatigue in patients with IBD is unknown and fatigue has rarely been the primary outcome in intervention studies. To date, interventions for the management of IBD-fatigue are sparse, have short-term effects and have not been implemented within the existing health system. There is a need to integrate current best evidence across different conditions, patient experience and clinical expertise in order to develop interventions for IBD-fatigue management that are feasible and effective. Modifying an existing intervention for patients with multiple sclerosis, this study aims to assess the feasibility and initial estimates of efficacy of a cognitive behavioural therapy (CBT) intervention for the management of fatigue in patients with IBD. The study will be a two-arm pilot randomised controlled trial. Patients will be recruited from one outpatient IBD clinic and randomised individually to either: Group 1 (CBT manual for the management of fatigue, one 60-min session and seven 30-min telephone/Skype sessions with a therapist over an eight-week period); or Group 2 (fatigue information sheet to use without therapist help). Self-reported IBD-fatigue (Inflammatory Bowel Disease-Fatigue Scale) and IBD-quality of life (United Kingdom Inflammatory Bowel Disease Questionnaire) and self-reported disease activity will be collected at baseline, three, six and 12 months post randomisation. Illness perceptions, daytime sleepiness, anxiety and depression explanatory variables will be collected only at three months post randomisation. Clinical and sociodemographic data will be retrieved from the patients' medical notes. A nested qualitative study will

  9. Short structured feedback training is equivalent to a mechanical feedback device in two-rescuer BLS: a randomised simulation study.

    Science.gov (United States)

    Pavo, Noemi; Goliasch, Georg; Nierscher, Franz Josef; Stumpf, Dominik; Haugk, Moritz; Breckwoldt, Jan; Ruetzler, Kurt; Greif, Robert; Fischer, Henrik

    2016-05-13

    Resuscitation guidelines encourage the use of cardiopulmonary resuscitation (CPR) feedback devices implying better outcomes after sudden cardiac arrest. Whether effective continuous feedback could also be given verbally by a second rescuer ("human feedback") has not been investigated yet. We, therefore, compared the effect of human feedback to a CPR feedback device. In an open, prospective, randomised, controlled trial, we compared CPR performance of three groups of medical students in a two-rescuer scenario. Group "sCPR" was taught standard BLS without continuous feedback, serving as control. Group "mfCPR" was taught BLS with mechanical audio-visual feedback (HeartStart MRx with Q-CPR-Technology™). Group "hfCPR" was taught standard BLS with human feedback. Afterwards, 326 medical students performed two-rescuer BLS on a manikin for 8 min. CPR quality parameters, such as "effective compression ratio" (ECR: compressions with correct hand position, depth and complete decompression multiplied by flow-time fraction), and other compression, ventilation and time-related parameters were assessed for all groups. ECR was comparable between the hfCPR and the mfCPR group (0.33 vs. 0.35, p = 0.435). The hfCPR group needed less time until starting chest compressions (2 vs. 8 s, p feedback or by using a mechanical audio-visual feedback device was similar. Further studies should investigate whether extended human feedback training could further increase CPR quality at comparable costs for training.

  10. A double blind, randomised, parallel group study on the efficacy and safety of treating acute lateral ankle sprain with oral hydrolytic enzymes

    NARCIS (Netherlands)

    Kerkhoffs, G. M. M. J.; Struijs, P. A. A.; de Wit, C.; Rahlfs, V. W.; Zwipp, H.; van Dijk, C. N.

    2004-01-01

    Objective: To compare the effectiveness and safety of the triple combination Phlogenzym ( rutoside, bromelain, and trypsin) with double combinations, the single substances, and placebo. Design: Multinational, multicentre, double blind, randomised, parallel group design with eight groups structured

  11. A cluster-randomised quality improvement study to improve two inpatient stroke quality indicators.

    Science.gov (United States)

    Williams, Linda; Daggett, Virginia; Slaven, James E; Yu, Zhangsheng; Sager, Danielle; Myers, Jennifer; Plue, Laurie; Woodward-Hagg, Heather; Damush, Teresa M

    2016-04-01

    Quality indicator collection and feedback improves stroke care. We sought to determine whether quality improvement training plus indicator feedback was more effective than indicator feedback alone in improving inpatient stroke indicators. We conducted a cluster-randomised quality improvement trial, randomising hospitals to quality improvement training plus indicator feedback versus indicator feedback alone to improve deep vein thrombosis (DVT) prophylaxis and dysphagia screening. Intervention sites received collaborative-based quality improvement training, external facilitation and indicator feedback. Control sites received only indicator feedback. We compared indicators pre-implementation (pre-I) to active implementation (active-I) and post-implementation (post-I) periods. We constructed mixed-effect logistic models of the two indicators with a random intercept for hospital effect, adjusting for patient, time, intervention and hospital variables. Patients at intervention sites (1147 admissions), had similar race, gender and National Institutes of Health Stroke Scale scores to control sites (1017 admissions). DVT prophylaxis improved more in intervention sites during active-I period (ratio of ORs 4.90, pimproved similarly in both groups during active-I, but control sites improved more in post-I period (ratio of ORs 0.67, p=0.04). In logistic models, the intervention was independently positively associated with DVT performance during active-I period, and negatively associated with dysphagia performance post-I period. Quality improvement training was associated with early DVT improvement, but the effect was not sustained over time and was not seen with dysphagia screening. External quality improvement programmes may quickly boost performance but their effect may vary by indicator and may not sustain over time. 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/

  12. Intracameral bevacizumab as an adjunct to trabeculectomy: a 1-year prospective, randomised study.

    Science.gov (United States)

    Vandewalle, Evelien; Abegão Pinto, Luís; Van Bergen, Tine; Spielberg, Leigh; Fieuws, Steffen; Moons, Lieve; Spileers, Werner; Zeyen, Thierry; Stalmans, Ingeborg

    2014-01-01

    To investigate the efficacy and safety of a single intracameral bevacizumab injection to improve the outcome of trabeculectomy. A 12-month, prospective, randomised, double-masked, placebo-controlled trial. Patients with medically uncontrolled open-angle glaucoma scheduled for a primary trabeculectomy were recruited and randomised to receive 50 µL of either bevacizumab (1.25 mg) or placebo (balanced salt solution) peroperatively. Absolute success was defined as intraocular pressure (IOP) ≤18 mm Hg and >5 mm Hg with at least 30% reduction from baseline and no loss of light perception. Success through the use of additional medical and/or surgical IOP-lowering treatments was defined as qualified success. 138 patients completed a 12-month follow-up, 69 of whom were in the bevacizumab treated group. IOP at 1 year postoperatively was significantly lower than baseline (placebo: 25.6±9.9 mm Hg vs 11.5±3.9 mm Hg, p<0.01; bevacizumab: 24.8±8.1 mm Hg vs 11.9±3.8 mm Hg, p<0.01), with no difference between treatment groups (p=0.69). However, absolute success was higher in the bevacizumab group (71% vs 51%, p=0.02), with the need for IOP-lowering interventions (needlings) being lower in this group (12% vs 33%, p=0.003). Complication rates were low and comparable between groups. Peroperative administration of intracameral bevacizumab significantly reduces the need for additional interventions during the follow-up of patients undergoing trabeculectomy.

  13. Comparison between treatment effects in a randomised controlled trial and an observational study using propensity scores in primary care

    NARCIS (Netherlands)

    Stuart, Beth L.; Grebel, Louise E.N.; Butler, Christopher C.; Hood, Kerenza; Verheij, Theo J.M.; Little, Paul

    2017-01-01

    Background  Although randomised controlled trials (RCTs) are considered 'gold standard' evidence, they are not always feasible or appropriate, and may represent a select population. Observational studies provide a useful alternative to enhance applicability, but results can be biased due to

  14. Herbst appliance with skeletal anchorage versus dental anchorage in adolescents with Class II malocclusion: study protocol for a randomised controlled trial.

    Science.gov (United States)

    Batista, Klaus Barretto Dos Santos Lopes; Lima, Tatiana; Palomares, Nathália; Carvalho, Felipe de Assis; Quintão, Cátia; Miguel, José Augusto Mendes; Lin, Yin-Ling; Su, Ting-Li; O'Brien, Kevin

    2017-11-25

    The Herbst appliance is an orthodontic appliance that is used for the correction of class II malocclusion with skeletal discrepancies. Research has shown that this is effective. However, a potential harm is excessive protrusion of the lower front teeth. This is associated with gingival recession, loss of tooth support, and root resorption. This trial evaluates a method of reducing this problem. The study is a single-center, randomised, assessor-blinded, superiority clinical trial with parallel 1:1 allocation. Male and female young people (10-14 years old) with prominent front teeth (class II, division 1) will be treated in one orthodontic clinic. Group 1 will be treated with the conventional Herbst appliance with dental anchorage and group 2 with the Herbst appliance with indirect skeletal anchorage for 12 months. The primary objective will be to compare the proclination of the lower incisors between the Herbst appliance with dental anchorage and skeletal anchorage. Secondary objectives will be to evaluate the changes occurring between the groups in the mandible, maxilla, lower and upper molars, and in gingival recession and root resorption at the end of the treatment. Additionally, the young patient's experience using the appliances will be assessed. The primary outcome measure will be the amount of lower incisor proclination at the end of treatment. This will be assessed by cone-beam computed tomography (CBCT) superimposition. Secondary outcome measures will be the changes in the mandible, maxilla, lower and upper molars at the end of treatment assessed by tomography superimposition and the young patient's experience using the appliances assessed by self-reported questionnaires and semi-structured interviews. The randomisation method will be blocked randomisation, using software to generate a randomised list. The allocation concealment will be done in opaque envelopes numbered from 1 to 40 containing the treatment modality. The randomisation will be

  15. A Placebo-Controlled, Blinded and Randomised Study on the Effects of Recombinant Human Thyrotropin on Quality of Life in the Treatment of Thyroid Cancer

    DEFF Research Database (Denmark)

    Nygaard, Birte; Bastholt, Lars; Bennedbæk, Finn Noe

    2013-01-01

    BACKGROUND: It is well known that thyroid hormone withdrawal (THW) in thyroid cancer patients can induce a decrease in quality of life (QOL). Recombinant human thyrotropin (rh-TSH) has been used to avoid this; however, no blinded studies have ever documented the effect. OBJECTIVE: To compare QOL...... in patients with differentiated thyroid cancer (DTC) treated with either rh-TSH or liothyronine (L-T3) THW for 10 days. STUDY DESIGN: Double-blind, randomised cross-over. PATIENTS: Fifty-six patients with DTC treated by total thyroidectomy and indication for postsurgery radioiodine (RI) ablation therapy...

  16. Comparative study Beamnrc VS Pinnacle

    International Nuclear Information System (INIS)

    Moreno Reyes, J. C.; Macias Jaen, J.; Jimenez Ortega, E.

    2013-01-01

    Has been developed in JAVA a software application called JJGAMMA, capable of manipulating the environment BEAMNRC and Pinnacle output formats 3 , comfortable, fast and accurately. As particular application you can use to compare dose distributions (plans for treatments, checking fields for modeling and clinical accelerators Commissioner) using, as objective criteria, function or Gamma index. (Author)

  17. Paracetamol suppositories: a comparative study.

    Science.gov (United States)

    Cullen, S; Kenny, D; Ward, O C; Sabra, K

    1989-01-01

    Paracetamol suppositories in two different bases were given to children who had fever after operations. Plasma concentrations and the effect on temperature were compared. There was a significant correlation between peak plasma concentrations and maximum drop in temperature. A lipophilic base produced better results than a hydrophilic base. PMID:2817936

  18. Paracetamol suppositories: a comparative study.

    OpenAIRE

    Cullen, S; Kenny, D; Ward, O C; Sabra, K

    1989-01-01

    Paracetamol suppositories in two different bases were given to children who had fever after operations. Plasma concentrations and the effect on temperature were compared. There was a significant correlation between peak plasma concentrations and maximum drop in temperature. A lipophilic base produced better results than a hydrophilic base.

  19. A prospective, randomised trial comparing closed intramedullary nailing with percutaneous plating in the treatment of distal metaphyseal fractures of the tibia.

    Science.gov (United States)

    Guo, J J; Tang, N; Yang, H L; Tang, T S

    2010-07-01

    We compared the outcome of closed intramedullary nailing with minimally invasive plate osteosynthesis using a percutaneous locked compression plate in patients with a distal metaphyseal fracture in a prospective study. A total of 85 patients were randomised to operative stabilisation either by a closed intramedullary nail (44) or by minimally invasive osteosynthesis with a compression plate (41). Pre-operative variables included the patients' age and the side and pattern of the fracture. Peri-operative variables were the operating time and the radiation time. Postoperative variables were wound problems, the time to union of the fracture, the functional American Orthopaedic Foot and Ankle surgery score and removal of hardware. We found no significant difference in the pre-operative variables or in the time to union in the two groups. However, the mean radiation time and operating time were significantly longer in the locked compression plate group (3.0 vs 2.12 minutes, p fractures had united. Patients who had intramedullary nailing had a higher mean pain score (40 = no pain, 0 = severe pain), [corrected] but better function, alignment and total American Orthopaedic Foot and Ankle surgery scores, although the differences were not statistically significant (p = 0.234, p = 0.157, p = 0.897, p = 0.177 respectively). Three (6.8%) patients in the intramedullary nailing group and six (14.6%) in the locked compression plate group showed delayed wound healing, and 37 (84.1%) in the former group and 38 (92.7%) in the latter group expressed a wish to have the implant removed. We conclude that both closed intramedullary nailing and a percutaneous locked compression plate can be used safely to treat Orthopaedic Trauma Association type-43A distal metaphyseal fractures of the tibia. However, closed intramedullary nailing has the advantage of a shorter operating and radiation time and easier removal of the implant. We therefore prefer closed intramedullary nailing for patients with

  20. The Value of Audio Devices in the Endoscopy Room (VADER) study: a randomised controlled trial.

    Science.gov (United States)

    Ardalan, Zaid Sm; Vasudevan, Abhinav; Hew, Simon; Schulberg, Julien; Lontos, Steve

    2015-12-14

    To evaluate the effect of Star Wars music (SWM) compared with endoscopist-selected popular music (PM) on quality outcomes in colonoscopy. A single-centre, prospective, randomised controlled trial conducted in an endoscopy suite within a quaternary-centre gastroenterology unit, Melbourne, Australia. The primary outcome measures were procedure time, polyp detection rate (PDR) and adenoma detection rate (ADR). The secondary outcome measure was adenomas per colonoscopy (APC). 103 colonoscopies were analysed: 58 in the SWM group and 45 in the PM group. Bowel preparation was assessed as good or excellent in 57% of the SWM group compared with 69% of the PM group (P < 0.01). The PDR was significantly higher in the SWM group than in the PM group (60% v 35%; P = 0.006). Similarly, the ADR was significantly higher in the SWM group than in the PM group (48% v 27%; P = 0.01). The APC in the SWM group was 84% compared with 35% in the PM group (P = 0.01). SWM compared with PM improves key quality outcomes in colonoscopy, despite poorer bowel preparation.

  1. Randomised controlled trial of extraarticular gold bead implantation for treatment of knee osteoarthritis: a pilot study

    DEFF Research Database (Denmark)

    Nejrup, Kirsten; Olivarius, Niels de Fine; Jacobsen, Judith L.

    2008-01-01

    The primary objective of this double-blind, randomised, controlled trial was to determine if implanting gold beads at five acupuncture points around the knee joint improves 1-year outcomes for patients with osteoarthritis (OA) of the knee. Participants were 43 adults aged 18-80 years with pain...... and stiffness from non-specific OA of the knee for over a year. The intervention was blinded implantation of gold beads at five acupuncture points around the affected knee through a hypodermic needle, or needle insertion alone. Primary outcome measures were knee pain, stiffness and function assessed...... acupuncture had greater relative improvements in self-assessed outcomes. The treatment was well tolerated. This 1-year pilot study indicates that extraarticular gold bead implantation is a promising treatment modality for patients with OA of the knee. The new treatment should be tested in a larger trial...

  2. The IDvIP trial: a two-centre randomised double-blind controlled trial comparing intramuscular diamorphine and intramuscular pethidine for labour analgesia.

    Science.gov (United States)

    Wee, Michael Y K; Tuckey, Jenny P; Thomas, Peter; Burnard, Sara

    2011-07-08

    Intramuscular pethidine is routinely used throughout the UK for labour analgesia. Studies have suggested that pethidine provides little pain relief in labour and has a number of side effects affecting mother and neonate. It can cause nausea, vomiting and dysphoria in mothers and can cause reduced fetal heart rate variability and accelerations. Neonatal effects include respiratory depression and impaired feeding. There are few large studies comparing the relative side effects and efficacy of different opioids in labour. A small trial comparing intramuscular pethidine with diamorphine, showed diamorphine to have some benefits over pethidine when used for labour analgesia but the study did not investigate the adverse effects of either opioid. The Intramuscular Diamorphine versus Intramuscular Pethidine (IDvIP) trial is a randomised double-blind two centre controlled trial comparing intramuscular diamorphine and pethidine regarding their analgesic efficacy in labour and their side effects in mother, fetus and neonate. Information about the trial will be provided to women in the antenatal period or in early labour. Consent and recruitment to the trial will be obtained when the mother requests opioid analgesia. The sample size requirement is 406 women with data on primary outcomes. The maternal primary outcomes are pain relief during the first 3 hours after trial analgesia and specifically pain relief after 60 minutes. The neonatal primary outcomes are need for resuscitation and Apgar Score analgesia, whether method of analgesia would be used again, use of Entonox, umbilical arterial and venous pH, fetal heart rate, meconium staining, time from delivery to first breath, Apgar scores at 5 mins, naloxone requirement, transfer to neonatal intensive care unit, neonatal haemoglobin oxygen saturation at 30, 60, 90, and 120 mins after delivery, and neonatal sedation and feeding behaviour during first 2 hours. If the trial demonstrates that diamorphine provides better analgesia

  3. Low back pain : a comparative study on the value of core training versus traditional strengthening exercises

    OpenAIRE

    Schembri, Laura; Fenech, Pauline; Sacco, Mark

    2014-01-01

    This randomised controlled trial (RCT) employed a pre-test/post-test design to compare the effects of core training (Pilates method) and traditional back exercises on a population with low back pain (LBP). Therapeutic intervention related to the Pilates method has recently become popular, but there is little evidence to prove it works. In this study, 120 individuals with LBP were allocated to three different groups. Group A was the control group, Group B was given modifie...

  4. Trial Protocol: Cognitive functional therapy compared with combined manual therapy and motor control exercise for people with non-specific chronic low back pain: protocol for a randomised, controlled trial.

    Science.gov (United States)

    Belache, Fabiana Terra Cunha; Souza, Cíntia Pereira de; Fernandez, Jessica; Castro, Julia; Ferreira, Paula Dos Santos; Rosa, Elizana Rodrigues de Sousa; Araújo, Nathalia Cristina Gimenez de; Reis, Felipe José Jandre; Almeida, Renato Santos de; Nogueira, Leandro Alberto Calazans; Correia, Luís Cláudio Lemos; Meziat-Filho, Ney

    2018-06-11

    Chronic low back pain is a public health problem, and there is strong evidence that it is associated with a complex interaction of biopsychosocial factors. Cognitive functional therapy is an intervention that deals with potentially modifiable multidimensional aspects of pain (eg, provocative cognitive, movement and lifestyle behaviours). There is evidence (from a single randomised, controlled trial) that cognitive functional therapy is better than combined manual therapy and motor control exercise. However, this study had significant methodological shortcomings including the failure to carry out an intention-to-treat analysis and a considerable loss of follow-up of participants. It is important to replicate this study in another domain through a randomised clinical trial with similar objectives but correcting these methodological shortcomings. To investigate the efficacy of cognitive functional therapy compared to combined manual therapy and exercise on pain and disability at 3 months in patients with chronic non-specific low back pain. Two-group, randomised, multicentre controlled trial with blinded assessors. One hundred and forty-eight participants with chronic low back pain that has persisted for >3months and no specific spinal pathology will be recruited from the school clinic of the Centro Universitário Augusto Motta and a private clinic in the city of Rio de Janeiro, Brazil. Four to 10 sessions of cognitive functional therapy. The physiotherapists who will treat the participants in the cognitive functional therapy group have previously attended 2 workshops with two different tutors of the method. Such physiotherapists have completed 106 hours of training, including workshops and patient examinations, as well as conducting a pilot study under the supervision of another physiotherapist with>3 years of clinical experience in cognitive functional therapy. Four to 10 sessions of combined manual therapy and motor control exercises. Participants in the combined

  5. Effects of umeclidinium/vilanterol on exercise endurance in COPD: a randomised study

    Directory of Open Access Journals (Sweden)

    John H. Riley

    2018-01-01

    Full Text Available This multicentre, randomised, double-blind, placebo-controlled, two-period crossover study assessed the effect of umeclidinium/vilanterol (UMEC/VI on exercise capacity in patients with chronic obstructive pulmonary disease (COPD using the endurance shuttle walk test (ESWT. Patients were randomised 1:1 to one of two treatment sequences: 1 UMEC/VI 62.5/25 µg followed by placebo or 2 placebo followed by UMEC/VI 62.5/25 µg. Each treatment was taken once daily for 12 weeks. The primary end-point was 3-h post-dose exercise endurance time (EET at week 12. Secondary end-points included trough forced expiratory volume in 1 s (FEV1 and 3-h post-dose functional residual capacity (FRC, both at week 12. COPD Assessment Test (CAT score at week 12 was also assessed. UMEC/VI treatment did not result in a statistically significant improvement in EET change from baseline at week 12 versus placebo (p=0.790. However, improvements were observed in trough FEV1 (206 mL, 95% CI 167–246, 3-h post-dose FRC (−346 mL, 95% CI −487 to −204 and CAT score (−1.07 units, 95% CI −2.09 to −0.05 versus placebo at week 12. UMEC/VI did not result in improvements in EET at week 12 versus placebo, despite improvements in measures of lung function, hyperinflation and health status.

  6. Comparative Efficacy of Aloe vera and Benzydamine Mouthwashes on Radiation-induced Oral Mucositis: A Triple-blind, Randomised, Controlled Clinical Trial.

    Science.gov (United States)

    Sahebjamee, Mahnaz; Mansourian, Arash; Hajimirzamohammad, Mohammad; Mohammad, Haji Mirza Mohammad; Zadeh, Mohsen Taghi; Bekhradi, Reza; Kazemian, Ali; Manifar, Soheila; Ashnagar, Sajjad; Doroudgar, Kiavash

    2015-01-01

    To compare the efficacy of an Aloe vera mouthwash with a benzydamine mouthwash in the alleviation of radiation- induced mucositis in head and neck cancer patients using a triple-blind, randomised controlled trial. Twenty-six eligible head and neck cancer patients who were to receive conventional radiation therapy at the radiation oncology department were randomised to receive an Aloe vera mouthwash or a benzydamine mouthwash. Mucositis severity was assessed during the course of radiation therapy using the WHO grading system. At baseline, there was no difference in the distribution of mucositis severity between the two groups. The mean interval between radiation therapy and onset of mucositis was similar for both groups (Aloe vera 15.69±7.77 days, benzydamine 15.85±12.96 days). The mean interval between the start of radiation therapy and the maximum severity of mucositis were was also similar in both the Aloe vera and benzydamine groups (Aloe vera 23.38±10.75 days, benzydamine 23.54±15.45 days). Mean changes of mucositis severity over time in both groups were statistically similar and the effect of both treatments did not change signficantly with time (p=0.09). Aloe vera mouthwash was as beneficial as benzydamine mouthwash in alleviating the severity of radiation-induced mucositis and showed no side effects. The Aloe vera mouthwash could be an alternative agent in the treatment of radiation-induced mucositis in patients with head and neck cancers.

  7. Randomised study of Casodex 50 MG monotherapy vs orchidectomy in the treatment of metastatic prostate cancer. The Scandinavian Casodex Cooperative Group

    DEFF Research Database (Denmark)

    Iversen, P; Tveter, K; Varenhorst, E

    1996-01-01

    The effect of Casodex (ICI 176,334), a new, once-daily, selective antiandrogen, given as 50 mg monotherapy, was compared with orchidectomy in a randomised, multicentre, open study in 376 patients with metastatic prostate cancer. At 3 months, PSA was reduced by 86% in the Casodex group and by 96......% in the orchidectomy group. Treatment failed in 51 patients in the orchidectomy group and 66 showed a subjective response. Treatment failed in 86 patients treated with Casodex and 40 patients showed a subjective response. Patients treated with Casodex maintained their sexual interest better than those...

  8. Study protocol: a phase III randomised, double-blind, parallel arm, stratified, block randomised, placebo-controlled trial investigating the clinical effect and cost-effectiveness of sertraline for the palliative relief of breathlessness in people with chronic breathlessness.

    Science.gov (United States)

    Watts, Gareth J; Clark, Katherine; Agar, Meera; Davidson, Patricia M; McDonald, Christine; Lam, Lawrence T; Sajkov, Dimitar; McCaffrey, Nicola; Doogue, Matthew; Abernethy, Amy P; Currow, David C

    2016-11-29

    Breathlessness remains a highly prevalent and distressing symptom for many patients with progressive life-limiting illnesses. Evidence-based interventions for chronic breathlessness are limited, and there is an ongoing need for high-quality research into developing management strategies for optimal palliation of this complex symptom. Previous studies have suggested that selective serotonin reuptake inhibitors such as sertraline may have a role in reducing breathlessness. This paper presents the protocol for a large, adequately powered randomised study evaluating the use of sertraline for chronic breathlessness in people with progressive life-limiting illnesses. A total of 240 participants with modified Medical Research Council Dyspnoea Scale breathlessness of level 2 or higher will be randomised to receive either sertraline or placebo for 28 days in this multisite, double-blind study. The dose will be titrated up every 3 days to a maximum of 100 mg daily. The primary outcome will be to compare the efficacy of sertraline with placebo in relieving the intensity of worst breathlessness as assessed by a 0-100 mm Visual Analogue Scale. A number of other outcome measures and descriptors of breathlessness as well as caregiver assessments will also be recorded to ensure adequate analysis of participant breathlessness and to allow an economic analysis to be performed. Participants will also be given the option of continuing blinded treatment until either study data collection is complete or net benefit ceases. Appropriate statistical analysis of primary and secondary outcomes will be used to describe the wealth of data obtained. Ethics approval was obtained at all participating sites. Results of the study will be submitted for publication in peer-reviewed journals and the key findings presented at national and international conferences. ACTRN12610000464066. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a

  9. A randomised study on the effects of fish protein supplement on glucose tolerance, lipids and body composition in overweight adults.

    Science.gov (United States)

    Vikøren, Linn A; Nygård, Ottar K; Lied, Einar; Rostrup, Espen; Gudbrandsen, Oddrun A

    2013-02-28

    The popularity of high-protein diets for weight reduction is immense. However, the potential benefits from altering the source of dietary protein rather than the amount is scarcely investigated. In the present study, we examined the effects of fish protein supplement on glucose and lipid metabolism in overweight adults. A total of thirty-four overweight adults were randomised to 8 weeks' supplementation with fish protein or placebo tablets (controls). The intake of fish protein supplement was 3 g/d for the first 4 weeks and 6 g/d for the last 4 weeks. In this study, 8 weeks of fish protein supplementation resulted in lower values of fasting glucose (Pfish protein supplementation compared to controls. Glucose-AUC was decreased after 8 weeks with fish protein supplement compared to baseline (Pfish protein may have beneficial effects on blood levels of glucose and LDL-cholesterol as well as glucose tolerance and body composition in overweight adults. The long-term effects of fish protein supplementation is of interest in the context of using more fish as a protein source in the diet, and the effects of inclusion of fish in the diet of individuals with low glucose tolerance should be evaluated.

  10. The Effect of Souvenaid on Functional Brain Network Organisation in Patients with Mild Alzheimer’s Disease: A Randomised Controlled Study

    Science.gov (United States)

    de Waal, Hanneke; Stam, Cornelis J.; Lansbergen, Marieke M.; Wieggers, Rico L.; Kamphuis, Patrick J. G. H.; Scheltens, Philip; Maestú, Fernando; van Straaten, Elisabeth C. W.

    2014-01-01

    Background Synaptic loss is a major hallmark of Alzheimer’s disease (AD). Disturbed organisation of large-scale functional brain networks in AD might reflect synaptic loss and disrupted neuronal communication. The medical food Souvenaid, containing the specific nutrient combination Fortasyn Connect, is designed to enhance synapse formation and function and has been shown to improve memory performance in patients with mild AD in two randomised controlled trials. Objective To explore the effect of Souvenaid compared to control product on brain activity-based networks, as a derivative of underlying synaptic function, in patients with mild AD. Design A 24-week randomised, controlled, double-blind, parallel-group, multi-country study. Participants 179 drug-naïve mild AD patients who participated in the Souvenir II study. Intervention Patients were randomised 1∶1 to receive Souvenaid or an iso-caloric control product once daily for 24 weeks. Outcome In a secondary analysis of the Souvenir II study, electroencephalography (EEG) brain networks were constructed and graph theory was used to quantify complex brain structure. Local brain network connectivity (normalised clustering coefficient gamma) and global network integration (normalised characteristic path length lambda) were compared between study groups, and related to memory performance. Results The network measures in the beta band were significantly different between groups: they decreased in the control group, but remained relatively unchanged in the active group. No consistent relationship was found between these network measures and memory performance. Conclusions The current results suggest that Souvenaid preserves the organisation of brain networks in patients with mild AD within 24 weeks, hypothetically counteracting the progressive network disruption over time in AD. The results strengthen the hypothesis that Souvenaid affects synaptic integrity and function. Secondly, we conclude that advanced EEG

  11. Benchmarked Library Websites Comparative Study

    KAUST Repository

    Ramli, Rindra M.; Tyhurst, Janis

    2015-01-01

    This presentation provides an analysis of services provided by the benchmarked library websites. The exploratory study includes comparison of these websites against a list of criterion and presents a list of services that are most commonly deployed by the selected websites. In addition to that, the investigators proposed a list of services that could be provided via the KAUST library website.

  12. A Comparative Randomised Controlled Trial of the Effects of Brain Wave Vibration Training, Iyengar Yoga, and Mindfulness on Mood, Well-Being, and Salivary Cortisol

    Directory of Open Access Journals (Sweden)

    Deborah Bowden

    2012-01-01

    Full Text Available This randomised trial compared the effects of Brain Wave Vibration (BWV training, which involves rhythmic yoga-like meditative exercises, with Iyengar yoga and Mindfulness. Iyengar provided a contrast for the physical components and mindfulness for the “mental” components of BWV. 35 healthy adults completed 10 75-minute classes of BWV, Iyengar, or Mindfulness over five weeks. Participants were assessed at pre- and postintervention for mood, sleep, mindfulness, absorption, health, memory, and salivary cortisol. Better overall mood and vitality followed both BWV and Iyengar training, while the BWV group alone had improved depression and sleep latency. Mindfulness produced a comparatively greater increase in absorption. All interventions improved stress and mindfulness, while no changes occurred in health, memory, or salivary cortisol. In conclusion, increased well-being followed training in all three practices, increased absorption was specific to Mindfulness, while BWV was unique in its benefits to depression and sleep latency, warranting further research.

  13. COMPARATIVE STUDY ON CORPORATE GOVERNANCE

    Directory of Open Access Journals (Sweden)

    Gavrea Corina

    2011-12-01

    Full Text Available Corporate governance is a key element of today’s economic reality being more and more present in many countries around the world. This paper has two main objectives. The first one is to offer more insight into the concept of corporate governance by a thorough literature review and by presenting and analyzing a framework of corporate governance. The second objective of this paper is to investigate the corporate governance situation in three developing economies (Romania, Bulgaria and Hungary. The World Bank and the European Bank for Reconstruction and Development published a series of reports on corporate governance. The present study uses data from these reports in order to illustrate how these developing economies are dealing with corporate governance. Based on ROSC Reports a corporate governance score was calculated. As this score shows, there is room for improvement for all three developing economies. This study is important because it shows the differences in corporate governance among developing economies and the need to study these nations at the individual country level. Corporate governance has many benefits for developing economies. It helps developing economies to register sustainable growth rates, to increases investors’ confidence in the national economy, and to increase the ability of capital markets to mobilize savings.

  14. Tailored care for somatoform vertigo/dizziness: study protocol for a randomised controlled trial evaluating integrative group psychotherapy.

    Science.gov (United States)

    Lahmann, Claas; Henningsen, P; Dieterich, M; Radziej, K; Schmid, G

    2015-08-01

    Vertigo/dizziness (VD) ranks high in lifetime prevalence and clinical relevance. Nearly half of the complex VD disorders presenting at specialised units for vertigo or otoneurological disorders are not fully explained by an identifiable medical illness, but instead are related to anxiety, depressive, or somatoform disorders. Although there is some evidence that psychotherapy may be effective for these patients, therapeutic options remain unsatisfactory. This report describes the objectives, design and methods of a randomised, controlled clinical trial, evaluating the efficacy of manualised, multimodal group psychotherapy, based on integrative psychotherapy (IPT) and tailored to subgroups of mental disorders in medically unexplained VD. This psychotherapeutic approach will be compared to self-help groups (n = 172; n = 86 per study arm). Improvements with regard to handicap due to VD at 12 months follow-up will serve as primary outcome. Additionally, measures of generic quality of life, severity of vertigo, depression, anxiety, somatisation as well as Head Impulse Test and Computerized Static Posturography will be applied. We will also analyse the cost-effectiveness of this trial. The study aims to improve treatment of this therapeutically underserved population who are often severely impaired in their working and daily lives. ClinicalTrials.gov Identifier: NCT02320851. This is an on-going study; recruitment for the study is about to start.

  15. Treatment for the premenstrual syndrome with agnus castus fruit extract: prospective, randomised, placebo controlled study.

    Science.gov (United States)

    Schellenberg, R

    2001-01-20

    To compare the efficacy and tolerability of agnus castus fruit (Vitex agnus castus L extract Ze 440) with placebo for women with the premenstrual syndrome. Randomised, double blind, placebo controlled, parallel group comparison over three menstrual cycles. General medicine community clinics. 178 women were screened and 170 were evaluated (active 86; placebo 84). Mean age was 36 years, mean cycle length was 28 days, mean duration of menses was 4.5 days. Agnus castus (dry extract tablets) one tablet daily or matching placebo, given for three consecutive cycles. Main efficacy variable: change from baseline to end point (end of third cycle) in women's self assessment of irritability, mood alteration, anger, headache, breast fullness, and other menstrual symptoms including bloating. Secondary efficacy variables: changes in clinical global impression (severity of condition, global improvement, and risk or benefit) and responder rate (50% reduction in symptoms). Improvement in the main variable was greater in the active group compared with placebo group (Pagnus castus fruit is an effective and well tolerated treatment for the relief of symptoms of the premenstrual syndrome.

  16. Effects of exercise intensity and nutrition advice on myocardial function in obese children and adolescents: a multicentre randomised controlled trial study protocol

    Science.gov (United States)

    Dias, Katrin A; Coombes, Jeff S; Green, Daniel J; Gomersall, Sjaan R; Keating, Shelley E; Tjonna, Arnt Erik; Hollekim-Strand, Siri Marte; Hosseini, Mansoureh Sadat; Ro, Torstein Baade; Haram, Margrete; Huuse, Else Marie; Davies, Peter S W; Cain, Peter A; Leong, Gary M; Ingul, Charlotte B

    2016-01-01

    Introduction The prevalence of paediatric obesity is increasing, and with it, lifestyle-related diseases in children and adolescents. High-intensity interval training (HIIT) has recently been explored as an alternate to traditional moderate-intensity continuous training (MICT) in adults with chronic disease and has been shown to induce a rapid reversal of subclinical disease markers in obese children and adolescents. The primary aim of this study is to compare the effects of HIIT with MICT on myocardial function in obese children and adolescents. Methods and analysis Multicentre randomised controlled trial of 100 obese children and adolescents in the cities of Trondheim (Norway) and Brisbane (Australia). The trial will examine the efficacy of HIIT to improve cardiometabolic outcomes in obese children and adolescents. Participants will be randomised to (1) HIIT and nutrition advice, (2) MICT and nutrition advice or (3) nutrition advice. Participants will partake in supervised exercise training and/or nutrition sessions for 3 months. Measurements for study end points will occur at baseline, 3 months (postintervention) and 12 months (follow-up). The primary end point is myocardial function (peak systolic tissue velocity). Secondary end points include vascular function (flow-mediated dilation assessment), quantity of visceral and subcutaneous adipose tissue, myocardial structure and function, body composition, cardiorespiratory fitness, autonomic function, blood biochemistry, physical activity and nutrition. Lean, healthy children and adolescents will complete measurements for all study end points at one time point for comparative cross-sectional analyses. Ethics and dissemination This randomised controlled trial will generate substantial information regarding the effects of exercise intensity on paediatric obesity, specifically the cardiometabolic health of this at-risk population. It is expected that communication of results will allow for the development of

  17. Comparative study of Butterfly valves

    International Nuclear Information System (INIS)

    Galmes Belmonte, F.B.

    1998-01-01

    This work tries to justify the hydrodynamic butterfly valves performance, using the EPRI tests, results carried out in laboratory and in situ. This justification will be possible if: - The valves to study are similar - Their performance is calculated using EPRI's methodology Looking for this objective, the elements of the present work are: 1. Brief EPRI butterfly valve description it wild provide the factors which are necessary to define the butterfly valves similarity. 2. EPRI tests description and range of validation against test data definition. 3. Description of the spanish butterfly analyzed valves, and comparison with the EPRI performance results, to prove that this valves are similar to the EPRI test valves. In this way, it will not be necessary to carry out particular dynamic tests on the spanish valves to describe their hydrodynamic performance. (Author)

  18. Smartphone application for women with gestational diabetes mellitus: a study protocol for a multicentre randomised controlled trial.

    Science.gov (United States)

    Borgen, Iren; Garnweidner-Holme, Lisa Maria; Jacobsen, Anne Flem; Bjerkan, Kirsti; Fayyad, Seraj; Joranger, Pål; Lilleengen, Anne Marie; Mosdøl, Annhild; Noll, Josef; Småstuen, Milada Cvancarova; Terragni, Laura; Torheim, Liv Elin; Lukasse, Mirjam

    2017-03-27

    The promotion of a healthy diet, physical activity and measurement of blood glucose levels are essential components in the care for women with gestational diabetes mellitus (GDM). Smartphones offer a new way to promote health behaviour. The main aim is to investigate if the use of the Pregnant+ app, in addition to standard care, results in better blood glucose levels compared with current standard care only, for women with GDM. This randomised controlled trial will include 230 pregnant women with GDM followed up at 5 outpatient departments (OPD) in the greater Oslo Region. Women with a 2-hour oral glucose tolerance test (OGTT) ≥9 mmol/L, who own a smartphone, understand Norwegian, Urdu or Somali and are <33 weeks pregnant, are invited. The intervention group receives the Pregnant+ app and standard care. The control group receives standard care only. Block randomisation is performed electronically. Data are collected using self-reported questionnaires and hospital records. Data will be analysed according to the intention-to-treat principle. Groups will be compared using linear regression for the main outcome and χ 2 test for categorical data and Student's t-test or Mann-Whitney-Wilcoxon test for skewed distribution. The main outcome is the glucose level measured at the 2-hour OGTT 3 months postpartum. Secondary outcomes are a change in health behaviour and knowledge about GDM, quality of life, birth weight, mode of delivery and complications for mother and child. The study is exempt from regional ethics review due to its nature of quality improvement in patient care. Our study has been approved by the Norwegian Social Science Data Services and the patient privacy protections boards governing over the recruitment sites. Findings will be presented in peer-reviewed journals and at conferences. NCT02588729, Post-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/.

  19. Cost-effectiveness of an intensive group training protocol compared to physiotherapy guideline care for sub-acute and chronic low back pain: design of a randomised controlled trial with an economic evaluation. [ISRCTN45641649

    Directory of Open Access Journals (Sweden)

    Franken Willemien K

    2004-11-01

    Full Text Available Abstract Background Low back pain is a common disorder in western industrialised countries and the type of treatments for low back pain vary considerably. Methods In a randomised controlled trial the cost-effectiveness and cost-utility of an intensive group training protocol versus physiotherapy guideline care for sub-acute and chronic low back pain patients is evaluated. Patients with back pain for longer than 6 weeks who are referred to physiotherapy care by their general practitioner or medical specialist are included in the study. The intensive group training protocol combines exercise therapy with principles of behavioural therapy ("graded activity" and back school. This training protocol is compared to physiotherapy care according to the recently published Low Back Pain Guidelines of the Royal Dutch College for Physiotherapy. Primary outcome measures are general improvement, pain intensity, functional status, work absenteeism and quality of life. The direct and indirect costs will be assessed using cost diaries. Patients will complete questionnaires at baseline and 6, 13, 26 and 52 weeks after randomisation. Discussion No trials are yet available that have evaluated the effect of an intensive group training protocol including behavioural principles and back school in a primary physiotherapy care setting and no data on cost-effectiveness and cost-utility are available.

  20. Comparison of foam swabs and toothbrushes as oral hygiene interventions in mechanically ventilated patients: a randomised split mouth study.

    Science.gov (United States)

    Marino, Paola J; Hannigan, Ailish; Haywood, Sean; Cole, Jade M; Palmer, Nicki; Emanuel, Charlotte; Kinsella, Tracey; Lewis, Michael A O; Wise, Matt P; Williams, David W

    2016-01-01

    During critical illness, dental plaque may serve as a reservoir of respiratory pathogens. This study compared the effectiveness of toothbrushing with a small-headed toothbrush or a foam-headed swab in mechanically ventilated patients. This was a randomised, assessor-blinded, split-mouth trial, performed at a single critical care unit. Adult, orally intubated patients with >20 teeth, where >24 hours of mechanical ventilation was expected were included. Teeth were cleaned 12-hourly using a foam swab or toothbrush (each randomly assigned to one side of the mouth). Cleaning efficacy was based on plaque scores, gingival index and microbial plaque counts. High initial plaque (mean=2.1 (SD 0.45)) and gingival (mean=2.0 (SD 0.54)) scores were recorded for 21 patients. A significant reduction compared with initial plaque index occurred using both toothbrushes (mean change=-1.26, 95% CI -1.57 to -0.95; poral health, which improved after brushing with a toothbrush or foam swab. Both interventions were equally effective at removing plaque and reducing gingival inflammation. NCT01154257; Pre-results.

  1. Effects of kinesiotaping on foot posture in participants with pronated foot: a quasi-randomised, double-blind study.

    Science.gov (United States)

    Luque-Suarez, Alejandro; Gijon-Nogueron, Gabriel; Baron-Lopez, Francisco Javier; Labajos-Manzanares, Maria Teresa; Hush, Julia; Hancock, Mark Jonathan

    2014-03-01

    To investigate whether kinesiotaping improves excessive foot pronation compared with sham kinesiotaping. Quasi-randomised, double-blind study. One primary care centre. One hundred and thirty participants were screened for inclusion. Sixty-eight participants with pronated feet [Foot Posture Index (FPI)≥ 6] were enrolled, and the follow-up rate was 100%. Participants were allocated into one of two groups: an experimental kinesiotaping group (KT1) and a sham taping group (KT2). Measures were collected by a blinded assessor at baseline, and 1 minute, 10 minutes, 60 minutes and 24 hours after taping. The primary outcome was total FPI score, and the secondary outcome was rear-foot FPI score. There were no significant differences in total FPI score between kinesiotaping and sham taping at any time point. Similarly, there were no significant differences in rear-foot FPI score, apart from at 60-minute follow-up when the difference between groups was significant (P=0.04) but the effect size was very small (0.85 points on the rear-foot FPI score between -6 and +6). Kinesiotaping does not correct foot pronation compared with sham kinesiotaping in people with pronated feet. Copyright © 2013 Chartered Society of Physiotherapy. All rights reserved.

  2. Randomised trial of biofeedback training for encopresis

    NARCIS (Netherlands)

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

    1996-01-01

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

  3. A cluster-randomised, controlled trial to assess the impact of a workplace osteoporosis prevention intervention on the dietary and physical activity behaviours of working women: study protocol

    OpenAIRE

    Tan, Ai May; LaMontagne, Anthony D; Sarmugam, Rani; Howard, Peter

    2013-01-01

    Background Osteoporosis is a debilitating disease and its risk can be reduced through adequate calcium consumption and physical activity. This protocol paper describes a workplace-based intervention targeting behaviour change in premenopausal women working in sedentary occupations. Method/Design A cluster-randomised design was used, comparing the efficacy of a tailored intervention to standard care. Workplaces were the clusters and units of randomisation and intervention. Sample size calculat...

  4. Day care bipolar transurethral resection vs photoselective vaporisation under sedoanalgesia: A prospective, randomised study of the management of benign prostatic hyperplasia.

    Science.gov (United States)

    Sood, Rajeev; Manasa, T; Goel, Hemant; Singh, Ritesh Kumar; Singh, Rajpal; Khattar, Nikhil; Pandey, Praveen

    2017-12-01

    To conduct a prospective randomised study comparing the safety, effectiveness and treatment outcomes in patients undergoing bipolar transurethral resection of the prostate (bTURP) and photoselective vaporisation of the prostate (PVP) under sedoanalgesia, as sedoanalgesia is a safe and effective technique suitable for minimally invasive endourological procedures and although studies have confirmed that both TURP and PVP are feasible under sedoanalgesia there are none comparing the two. Between November 2014 and April 2016, all patients satisfying the eligibility criteria underwent either bTURP or PVP under sedoanalgesia after randomisation. The groups were compared for functional outcomes, visual analogue scale (VAS) pain scores (range 0-10), perioperative variables and complications, with a follow-up of 3 months. In all, 42 and 36 patients underwent bTURP and PVP under sedoanalgesia, respectively. The mean VAS pain score was operating time [mean (SD) 55.64 (12.8) vs 61.79 (14.2) min, P  = 0.035], shorter duration of hospitalisation [mean (SD) 14.58 (2.81) vs 19.21 (2.82) h, P  post-void residual urine volume at 3 months were similar in both groups. None of our patients required re-admission or re-operation. Both PVP and bTURP can be carried out safely under sedoanalgesia with excellent treatment outcomes.

  5. The OPTIMIST study: optimisation of cost effectiveness through individualised FSH stimulation dosages for IVF treatment. A randomised controlled trial

    Directory of Open Access Journals (Sweden)

    van Tilborg Theodora C

    2012-09-01

    Full Text Available Abstract Background Costs of in vitro fertilisation (IVF are high, which is partly due to the use of follicle stimulating hormone (FSH. FSH is usually administered in a standard dose. However, due to differences in ovarian reserve between women, ovarian response also differs with potential negative consequences on pregnancy rates. A Markov decision-analytic model showed that FSH dose individualisation according to ovarian reserve is likely to be cost-effective in women who are eligible for IVF. However, this has never been confirmed in a large randomised controlled trial (RCT. The aim of the present study is to assess whether an individualised FSH dose regime based on an ovarian reserve test (ORT is more cost-effective than a standard dose regime. Methods/Design Multicentre RCT in subfertile women indicated for a first IVF or intracytoplasmic sperm injection cycle, who are aged  Discussion The results of this study will be integrated into a decision model that compares cost-effectiveness of the three dose-adjustment strategies to a standard dose strategy. The study outcomes will provide scientific foundation for national and international guidelines. Trial registration NTR2657

  6. Pathways: patient-centred decision counselling for women at risk of cancer-related infertility: a protocol for a comparative effectiveness cluster randomised trial.

    Science.gov (United States)

    Woodard, Terri Lynn; Hoffman, Aubri S; Crocker, Laura C; Holman, Deborah A; Hoffman, Derek B; Ma, Jusheng; Bassett, Roland L; Leal, Viola B; Volk, Robert J

    2018-02-21

    National guidelines recommend that all reproductive-age women with cancer be informed of their fertility risks and offered referral to fertility specialists to discuss fertility preservation options. However, reports indicate that only 5% of patients have consultations, and rates of long-term infertility-related distress remain high. Previous studies report several barriers to fertility preservation; however, initial success has been reported using provider education, patient decision aids and navigation support. This protocol will test effects of a multicomponent intervention compared with usual care on women's fertility preservation knowledge and decision-making outcomes. This cluster-randomised trial will compare the multicomponent intervention (provider education, patient decision aid and navigation support) with usual care (consultation and referral, if requested). One hundred newly diagnosed English-speaking women of reproductive age who are at risk of cancer-related infertility will be recruited from four regional oncology clinics.The Pathways patient decision aid website provides (1) up-to-date evidence and descriptions of fertility preservation and other family-building options, tailored to cancer type; (2) structured guidance to support personalising the information and informed decision-making; and (3) a printable summary to help women prepare for discussions with their oncologist and/or fertility specialist. Four sites will be randomly assigned to intervention or control groups. Participants will be recruited after their oncology consultation and asked to complete online questionnaires at baseline, 1 week and 2 months to assess their demographics, fertility preservation knowledge, and decision-making process and quality. The primary outcome (decisional conflict) will be tested using Fisher's exact test. Secondary outcomes will be assessed using generalised linear mixed models, and sensitivity analyses will be conducted, as appropriate. The University of

  7. The Preservation of Cued Recall in the Acute Mentally Fatigued State: A Randomised Crossover Study.

    Science.gov (United States)

    Flindall, Ian Richard; Leff, Daniel Richard; Pucks, Neysan; Sugden, Colin; Darzi, Ara

    2016-01-01

    The objective of this study is to investigate the impact of acute mental fatigue on the recall of clinical information in the non-sleep-deprived state. Acute mental fatigue in the non-sleep-deprived subject is rarely studied in the medical workforce. Patient handover has been highlighted as an area of high risk especially in fatigued subjects. This study evaluates the deterioration in recall of clinical information over 2 h with cognitively demanding work in non-sleep-deprived subjects. A randomised crossover study involving twenty medical students assessed free (presentation) and cued (MCQ) recall of clinical case histories at 0 and 2 h under low and high cognitive load using the N-Back task. Acute mental fatigue was assessed through the Visual Analogue Scale, Stanford Scale and NASA-TLX Mental Workload Rating Scale. Free recall is significantly impaired by increased cognitive load (p cued recall under high and low cognitive load conditions (p = 1). This study demonstrates the loss of clinical information over a short time period involving a mentally fatiguing, high cognitive load task. Free recall for the handover of clinical information is unreliable. Memory cues maintain recall of clinical information. This study provides evidence towards the requirement for standardisation of a structured patient handover. The use of memory cues (involving recognition memory and cued recall methodology) would be beneficial in a handover checklist to aid recall of clinical information and supports evidence for their adoption into clinical practice.

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

    Science.gov (United States)

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

    2017-01-26

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

  9. Physical Activity during Cancer Treatment (PACT Study: design of a randomised clinical trial

    Directory of Open Access Journals (Sweden)

    de Wit G Ardine

    2010-06-01

    Full Text Available Abstract Background Fatigue is a major problem of cancer patients. Thirty percent of cancer survivors report serious fatigue three years after finishing treatment. There is evidence that physical exercise during cancer treatment reduces fatigue. This may also lead to an improvement of quality of life. Such findings may result in a decrease of healthcare related expenditures and societal costs due to sick leave. However, no studies are known that investigated these hypotheses. Therefore, the primary aim of our study is to assess the effect of exercise during cancer treatment on reducing complaints of fatigue and on reducing health service utilisation and sick leave. Methods/Design The Physical Activity during Cancer Treatment study is a multicentre randomised controlled trial in 150 breast and 150 colon cancer patients undergoing cancer treatment. Participants will be randomised to an exercise or a control group. In addition to the usual care, the exercise group will participate in an 18-week supervised group exercise programme. The control group will be asked to maintain their habitual physical activity pattern. Study endpoints will be assessed after 18 weeks (short term and after 9 months (long term. Validated questionnaires will be used. Primary outcome: fatigue (Multidimensional Fatigue Inventory and Fatigue Quality List and cost-effectiveness, health service utilisation and sick leave. Secondary outcome: health related quality of life (European Organisation Research and Treatment of Cancer-Quality of Life questionnaire-C30, Short Form 36 healthy survey, impact on functioning and autonomy (Impact on functioning and autonomy questionnaire, anxiety and depression (Hospital Anxiety and Depression Scale, physical fitness (aerobic peak capacity, muscle strength, body composition and cognitive-behavioural aspects. To register health service utilisation and sick leave, participants will keep diaries including the EuroQuol-5D. Physical activity level

  10. Hand sanitisers for reducing illness absences in primary school children in New Zealand: a cluster randomised controlled trial study protocol

    Directory of Open Access Journals (Sweden)

    Poore Marion R

    2010-01-01

    Full Text Available Abstract Background New Zealand has relatively high rates of morbidity and mortality from infectious disease compared with other OECD countries, with infectious disease being more prevalent in children compared with others in the population. Consequences of infectious disease in children may have significant economic and social impact beyond the direct effects of the disease on the health of the child; including absence from school, transmission of infectious disease to other pupils, staff, and family members, and time off work for parents/guardians. Reduction of the transmission of infectious disease between children at schools could be an effective way of reducing the community incidence of infectious disease. Alcohol based no-rinse hand sanitisers provide an alternative hand cleaning technology, for which there is some evidence that they may be effective in achieving this. However, very few studies have investigated the effectiveness of hand sanitisers, and importantly, the potential wider economic implications of this intervention have not been established. Aims The primary objective of this trial is to establish if the provision of hand sanitisers in primary schools in the South Island of New Zealand, in addition to an education session on hand hygiene, reduces the incidence rate of absence episodes due to illness in children. In addition, the trial will establish the cost-effectiveness and conduct a cost-benefit analysis of the intervention in this setting. Methods/Design A cluster randomised controlled trial will be undertaken to establish the effectiveness and cost-effectiveness of hand sanitisers. Sixty-eight primary schools will be recruited from three regions in the South Island of New Zealand. The schools will be randomised, within region, to receive hand sanitisers and an education session on hand hygiene, or an education session on hand hygiene alone. Fifty pupils from each school in years 1 to 6 (generally aged from 5 to 11 years

  11. Smoking cessation at the workplace. Results of a randomised controlled intervention study. Worksite physicians from the AIREL group.

    Science.gov (United States)

    Lang, T; Nicaud, V; Slama, K; Hirsch, A; Imbernon, E; Goldberg, M; Calvel, L; Desobry, P; Favre-Trosson, J P; Lhopital, C; Mathevon, P; Miara, D; Miliani, A; Panthier, F; Pons, G; Roitg, C; Thoores, M

    2000-05-01

    To compare the effects of a worksite intervention by the occupational physician offering simple advice of smoking cessation with a more active strategy of advice including a "quit date" and extra support. Employees of an electrical and gas company seen at the annual visit by their occupational physicians. CRITERIA END POINTS: Smoking point prevalence defined as the percentage of smokers who were non-smokers at one year. Secondary criteria were the percentage of smokers who stopped smoking for more than six months and the difference in prevalence of smoking in both groups. Randomised controlled trial. The unit of randomisation was the work site physician and a random sample of the employees of whom he or she was in charge. The length of the follow up was one year. Each of 30 work site physicians included in the study 100 to 150 employees. Among 504 subjects classified as smokers at baseline receiving simple advice (group A) and 591 the more active programme (group B), 68 (13.5%) in group A and 109 (18. 4%) were non-smokers one year later (p=0.03; p=0.01 taking the occupational physician as the statistical unit and using a non-parametric test). Twenty three subjects (4.6%) in group A and 36 (6.1%) in group B (p=0.26) declared abstinence of six months or more. Among non-smokers at baseline, 3.4% in both groups were smokers after one year follow up. The prevalence of smokers did not differ significantly at baseline (32.9% and 32.4%, p=0.75). After the intervention the prevalence of smoking was 30.8% in group A and 28. 7% in group B (p=0.19). An increase of the mean symptoms score for depression in those who quit was observed during this period. A simple cessation intervention strategy during a mandatory annual examination, targeting a population of smokers independently of their motivation to stop smoking or their health status, showed a 36% relative increase of the proportion of smokers who quit smoking as compared with what can be achieved through simple advice.

  12. Telerehabilitation to improve outcomes for people with stroke: study protocol for a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Saywell Nicola

    2012-12-01

    Full Text Available Abstract Background In New Zealand, around 45,000 people live with stroke and many studies have reported that benefits gained during initial rehabilitation are not sustained. Evidence indicates that participation in physical interventions can prevent the functional decline that frequently occurs after discharge from acute care facilities. However, on-going stroke services provision following discharge from acute care is often related to non-medical factors such as availability of resources and geographical location. Currently most people receive no treatment beyond three months post stroke. The study aims to determine if the Augmented Community Telerehabilitation Intervention (ACTIV results in better physical function for people with stroke than usual care, as measured by the Stroke Impact Scale, physical subcomponent. Methods/design This study will use a multi-site, two-arm, assessor blinded, parallel randomised controlled trial design. People will be eligible if they have had their first ever stroke, are over 20 and have some physical impairment in either arm or leg, or both. Following discharge from formal physiotherapy services (inpatient, outpatient or community, participants will be randomised into ACTIV or usual care. ACTIV uses readily available technology, telephone and mobile phones, combined with face-to-face visits from a physiotherapist over a six-month period, to help people with stroke resume activities they enjoyed before the stroke. The impact of stroke on physical function and quality of life will be assessed, measures of cost will be collected and a discrete choice survey will be used to measure preferences for rehabilitation options. These outcomes will be collected at baseline, six months and 12 months. In-depth interviews will be used to explore the experiences of people participating in the intervention arm of the study. Discussion The lack of on-going rehabilitation for people with stroke diminishes the chance of their

  13. Using new technologies to promote weight management: a randomised controlled trial study protocol.

    Science.gov (United States)

    Jane, Monica; Foster, Jonathan; Hagger, Martin; Pal, Sebely

    2015-05-27

    Over the last three decades, overweight and obesity and the associated health consequences have become global public health priorities. Methods that have been tried to address this problem have not had the desired impact, suggesting that other approaches need to be considered. One of the lessons learned throughout these attempts is that permanent weight loss requires sustained dietary and lifestyle changes, yet adherence to weight management programs has often been noted as one of the biggest challenges. This trial aims to address this issue by examining whether social media, as a potential health promotion tool, will improve adherence to a weight management program. To test the effectiveness of this measure, the designated program will be delivered via the popular social networking site Facebook, and compared to a standard delivery method that provides exactly the same content but which is communicated through a pamphlet. The trial will be conducted over a period of twelve weeks, with a twelve week follow-up. Although weight loss is expected, this study will specifically investigate the effectiveness of social media as a program delivery method. The program utilised will be one that has already been proven to achieve weight loss, namely The CSIRO Total Wellbeing Diet. This project will be conducted as a 3-arm randomised controlled trial. One hundred and twenty participants will be recruited from the Perth community, and will be randomly assigned to one of the following three groups: the Facebook group, the pamphlet group, or a control group. The Facebook Group will receive the weight management program delivered via a closed group in Facebook, the Pamphlet Group will be given the same weight management program presented in a booklet, and the Control Group will follow the Australian Dietary Guidelines and the National Physical Activity Guidelines for Adults as usual care. Change in weight, body composition and waist circumference will be initial indicators of

  14. Single vs. multiple fraction regimens for palliative radiotherapy treatment of multiple myeloma. A prospective randomised study

    Energy Technology Data Exchange (ETDEWEB)

    Rudzianskiene, Milda; Inciura, Arturas; Gerbutavicius, Rolandas; Rudzianskas, Viktoras; Dambrauskiene, Ruta; Juozaityte, Elona [Lithuanian University of Health Sciences, Oncology Institute, Kaunas (Lithuania); Macas, Andrius [Lithuanian University of Health Sciences, Anaesthesiology Department, Kaunas (Lithuania); Simoliuniene, Renata [Lithuanian University of Health Sciences, Department of Physics, Mathematics and Biophysics, Kaunas (Lithuania); Kiavialaitis, Greta Emilia [University Hospital Zurich, Intitute of Anesthesiology, Zurich (Switzerland)

    2017-09-15

    To compare the impact of a single fraction (8 Gy x 1 fraction) and multifraction (3 Gy x 10 fractions) radiotherapy regimens on pain relief, recalcification and the quality of life (QoL) in patients with bone destructions due to multiple myeloma (MM). In all, 101 patients were included in a randomised prospective clinical trial: 58 patients were included in the control arm (3 Gy x 10 fractions) and 43 patients into the experimental arm (8 Gy x 1 frac