A multi-centre evaluation of the test strip analyser, Rapimat, was performed by four laboratories following the ECCLS 2nd draft guidelines for the evaluation of analysers in clinical chemistry. Using the Rapignost urine test strip with the test fields for bilirubin, urobilinogen, acetoacetate, ascorbic acid, glucose, protein, nitrite, pH and haemoglobin, the Rapimat was found to be analytically reliable in comparison with other, in most cases quantitative procedures. During the observation period of about 6 months no breakdown occurred in any laboratory. Interferences and sensitivity as discussed for the bilirubin and urobilinogen test field are more related to the test strip than to the instrument. Several improvements for further developments are suggested. This multi-centre study has shown that the ECCLS protocol is applicable to analytical procedures leading to discrete results. PMID:4056663
ObjectiveTo investigate possible differences in operative delivery rate among low-risk women, randomised to an alongside midwifery-led unit or to standard obstetric units within...Full Text Available
Objective To compare the efficacy and safety of three polyspecific antivenoms for bites by pit vipers.Design Randomised double blind comparative trial of three antivenoms.Setting...Full Text Available
A Prospective randomised controlled study was done to determine statistical difference between the standard microsurgical discotomy (MC) and a minimally invasive microscopic procedure for disc prolapse...Full Text Available
Transplantation has emerged as the therapy of choice for many patients with end organ failure. One of the major goals is to tailor immunosuppressive therapy to the individual needs of every patient to balance the risk for rejection and over-immunosuppression. This will require diagnostic tools that can detect harmful processes in the allograft early, and that can be measured repeatedly. This review will consider recent advances in our understanding of the molecular nature of these processes and how this information is being utilized to design novel diagnostic assays to non-invasively monitor allografts. Highlighted is the need for large-scale prospective multi-centre studies to validate assays that show early promise in single centre studies.
This randomised study aimed to compare the biochemical tolerance of three parenteral regimens administered during the first 48 hours of life. Twenty nine infants were randomised to either: (a) glucose...Full Text Available
Summary Background There is a need for new artemisinin-based combination therapies that are convenient, effective, and safe. We compared the efficacy and safety of pyronaridine-artesunate with that of artemether-lumefantrine for treatment of uncomplicated P falciparum malaria. Methods This phase 3, parallel-group, double-blind, randomised, non-inferiority trial was undertaken in seven sites in Africa and three sites in southeast Asia. In a double-dummy design, patients aged 3-60 years with uncomplicated P falciparum malaria were randomly assigned in a 2:1 ratio to receive pyronaridine-artesunate once a day or artemether-lumefantrine twice a day, orally for 3 days, plus respective placebo. Randomisation was done by computer-generated randomisation sequence in blocks of nine by study centre....
Summary Objective- To evaluate the role of prophylactic trimethoprim-sulfamethoxazole (co-trimoxazole) antibacterial prophylaxis in reducing morbidity and mortality in HIV-infected post-natal women in southern Africa. Methods- Double-blind placebo-controlled trial. HIV-infected women with WHO stage 2 or 3 HIV disease who had recently delivered in the Department of Obstetrics and Gynaecology at the University Teaching Hospital, Lusaka, Zambia were randomised to receive daily co-trimoxazole (cotox) or matched placebo daily for the duration of the trial. Participants were followed up for a minimum of 1-year. Primary outcome measures were mortality from any cause or hospital admission and serious adverse events. Results- Of 600 women randomised, follow-up information was available from 355 (18...
Background: Ecchymosis, oedema, haematoma and pain after SMAS-based facelift surgery are all the direct result of the physical trauma of surgery and subsequent inflammatory response. Hilotherapy is a novel form of cryotherapy that purports to minimise these events through single-use face masks circulating cooled, sterile water. This study was performed to assess the validity of Hilotherapy in this population of patients. Methods: Over 14 weeks fifty consecutive patients were randomised to post-operative facial cooling with Hilotherapy or management with standard dressings alone, while fifteen subsequent, consecutive patients were randomised to cooling of one side of the face but not the other. Assessment of ecchymosis, oedema, haematoma and pain was performed independently by clinical staf...
Background: Chloroquine has in-vitro activity against influenza and could be an ideal candidate for worldwide prevention of influenza in the period between onset of a pandemic with a virulent influenza strain and the development and widespread dissemination of an effective vaccine. We aimed to assess the efficacy of such an intervention. Methods: In this randomised, double-blind, placebo-controlled trial done at a single centre in Singapore, we randomly assigned (1:1) healthy adults to receive chloroquine phosphate (500 mg/day for 1 week, then once a week to complete 12 weeks) or matching placebo by use of a computer-generated randomisation list. Participants filled an online symptom diary every week, supplemented by daily diaries and self-administered nasal swabs when unwell. Haemagglutin...
Over 30 months 9292 consecutive patients admitted to nine coronary care units with suspected myocardial infarction were considered for admission to a randomised double blind study comparing the effect...Full Text Available
Objectives:The supermarket industry now services many customers through online food shopping over the Internet. The Internet shopping process offers a novel opportunity...Full Text Available
BackgroundCaesarean section is one of the most commonly performed operations on women throughout the world. Rates have increased in recent years – about 20–25% in...Full Text Available
BackgroundAdhesive capsulitis is a common, painful, and disabling condition that has been managed with corticosteroid injections for over 50 years. There is debate over the use of...Full Text Available
ObjectivesTo investigate the effect of group cognitive behavioural therapy (CBT) for fatigue self-management, compared with groups receiving fatigue information alone, on fatigue...Full Text Available
OBJECTIVE--To examine the effect of a reduced sodium and increased potassium and magnesium intake on blood pressure. DESIGN--Randomised double blind placebo controlled trial. SETTING--General population...Full Text Available
Objective To determine whether a centralised telephone intervention reduces the incidence of death or admission for worsening heart failure in outpatients with chronic heart failure.Design...Full Text Available
ObjectiveTo test whether a disclosure intervention improves subjective health and reduces medical consumption and sick leave in somatising patients in general practice.DesignNon-blind...Full Text Available
A double-blind, placebo-controlled clinical trial of a homeopathic treatment of neonatal calf diarrhoea was performed using 44 calves in 12 dairy herds. Calves with spontaneously derived diarrhoea were...Full Text Available
ObjectiveTo assess the efficacy and safety of low dose adrenaline injected subcutaneously to prevent acute adverse reactions to polyspecific antivenom serum in patients admitted...Full Text Available
BackgroundHerpes simplex virus (HSV) suppressive therapy reduces genital and plasma HIV-1 RNA over periods up to three months but the longer-term effect is unknown.Full Text Available
BackgroundCompared to healthy controls, cancer patients have a higher risk of unemployment, which has negative social and economic impacts on the patients and on society at large....Full Text Available
BackgroundChronic rotator cuff pathology (CRCP) is a common shoulder condition causing pain and disability. Physiotherapy is often the first line of management for CRCP yet there...Full Text Available
Objectives To assess the effectiveness of calcium supplementation for improving bone mineral density in healthy children and to determine if any effect is modified by other factors and...Full Text Available
SummaryBackgroundPatients undergoing dialysis have a substantially increased risk of cardiovascular mortality and morbidity. Although several trials have shown the...Full Text Available
Seventy seven patients with soft tissue shoulder lesions including adhesive capsulitis and disorders of the rotator cuff and acromioclavicular joint were admitted to a trial comparing two different...Full Text Available
The effect of potential risk factors for chronic lymphatic leukaemia was evaluated in a case-referent study encompassing 111 cases and 431 randomised referents, all alive. Information on exposure was...Full Text Available
BackgroundThis study examines the prevalence and nature of bereavement help-seeking among the population who experienced an "expected" death in the five years before their survey...Full Text Available
BackgroundIntrapartum fetal hypoxia remains an important cause of death and permanent handicap and in a significant proportion of cases there is evidence of suboptimal care related...Full Text Available
The existence and importance of an accelerated adjacent segment disc degeneration (ASD) after lumbar fusion have previously not been demonstrated by RCTs. The objectives of this study were, to determine...Full Text Available
BackgroundImproving nutrition knowledge among children may help them to make healthier food choices. The aim of this study was to assess the effectiveness and acceptability of a...Full Text Available
BackgroundMost traditional Chinese herbal formulas consist of at least four herbs. Four-Agents-Decoction (Si Wu Tang) is a documented eight hundred year old formula containing four...Full Text Available
INTRODUCTIONCutiplast (absorbent perforated dressing with adhesive border; Smith & Nephew) is commonly used following orthopaedic operation, but complications of its use...Full Text Available
Abuzakuk T, Coward P, Shenava Y, Kumar VS, Skinner JA. The management of wounds following primary lower limb arthroplasty: a prospective, randomised study comparing hydrofibre and central pad dressings. Abstract Wound care following lower limb arthroplasty has not been subject to in-depth clinical research, primarily because such wounds usually heal without complication. However, when prosthetic implants are used, serious wound problems can be disastrous (Whitehouse et al. Infect Control Hosp Epidemiol 2002;23:183-9; Lindwell OM. Clin Orthop Relat Res 1986;211:91-103). We report the results of a prospective, randomised, controlled trial comparing a hydrofibre (Aquacel) and central pad (Mepore) dressing in the management of acute wounds following primary total hip or knee arthroplasty left ...
Summary Objective To evaluate the cost-effectiveness of an educational outreach intervention to improve primary respiratory care by South African nurses. Methods Cost-effectiveness analysis alongside a pragmatic cluster randomised controlled trial, with individual patient data. The intervention, the Practical Approach to Lung Health in South Africa (PALSA), comprised educational outreach based on syndromic clinical practice guidelines for tuberculosis, asthma, chronic obstructive pulmonary disease, pneumonia and other respiratory diseases. The study included 1999 patients aged 15 or over with cough or difficult breathing, attending 40 primary care clinics staffed by nurses in the Free State province. They were interviewed at first presentation, and 1856 (93%) were interviewed 3 months late...
Summary Background- Treatments that achieve sustainable steroid-free clinical remission in Crohn-s disease are needed; however, long-term steroid-sparing efficacy data are limited. Aim- To evaluate steroid-sparing efficacy and the impact of steroid discontinuation on adverse events during treatment of Crohn's disease with adalimumab in the phase III randomised, double-blind 1-year CHARM trial and for an additional 2-years in its open-label extension ADHERE. Methods- Steroid-free remission and response and steroid-sparing (-50% steroid dose reduction) remission rates were evaluated over 3-years in patients who were taking corticosteroids at CHARM baseline. Results- Of 778 patients randomised in CHARM (including those who did not achieve clinical response to open-label induction therapy), 31...
The extent measurement error on CT colonography influences polyp categorisation according to established management guidelines is studied using twenty-eight observers of varying experience to classify polyps seen at CT colonography as either 'medium' (maximal diameter 6-9 mm) or 'large' (maximal diameter 10 mm or larger). Comparison was then made with the reference diameter obtained in each patient via colonoscopy. The Bland-Altman method was used to assess agreement between observer measurements and colonoscopy, and differences in measurement and categorisation was assessed using Kruskal-Wallis and Chi-squared test statistics respectively. Observer measurements on average underestimated the diameter of polyps when compared to the reference value, by approximately 2-3 mm, irrespective of observer experience. Ninety-five percent limits of agreement were relatively wide for all observer groups, and had sufficient span to encompass different size ...
BackgroundDue to improvements in cancer survival the number of people of working age living with cancer across Europe is likely to increase. UK governments have made commitments...Full Text Available
BackgroundMany emergency ambulance calls are for older people who have fallen. As half of them are left at home, a community-based response may often be more appropriate than hospital...Full Text Available
BackgroundChildren aged between one and five years are particularly vulnerable to disease caused by soil-transmitted helminths (STH). Periodic deworming has been shown to improve...Full Text Available
SummaryBackgroundInnovative prevention strategies for HIV-1 transmission are urgently needed. PRO2000 vaginal gel was efficacious against HIV-1 transmission in studies...Full Text Available
BackgroundIn an effort to promote healthy ageing and preserve health and function, the government of Chile has formulated a package of actions into the Programme for Complementary...Full Text Available
The efficacy of a heat inactivated hepatitis B virus vaccine, containing 3 micrograms hepatitis B surface antigen (HBsAg), was studied in a high risk group of 800 susceptible homosexual men by a randomised...Full Text Available
1. The acute haemodynamic effects of intravenous nisoldipine (1, 2, 4 microg kg(-1)) and nifedipine (2.5, 5, 10 microg kg(-1)) were compared in a randomised, within-patient crossover study. Fifteen...Full Text Available
Abuzakuk T, Coward P, Shenava Y, Kumar VS, Skinner JA. The management of wounds following primary lower limb arthroplasty: a prospective, randomised study comparing hydrofibre and central pad dressings. Pris en charge des plaies apres arthroplastie primaire du member inferieur: une etude randomisee prospective comparant hydrofibre et pansements central pad La prise en charge des plaies apres arthroplastie du member inferieur n'a pas fait l'objet de recherches approfondies, essentiellement car ces plaies cicatrisent habituellement sans complications. Cependant, lorsque des implants prothetiques sont utilizes, les serieux problemes de plaies peuvent devenir desastreux. Nous rapportons les resultants d'une etude prospective, randomisee, controlee comparant un hydrofibre et un pasnement centra...
This is an independent reanalysis of a randomised, placebo-controlled parallel-group study on the efficacy and tolerability of a special butterbur root extract (Petadolex) for the prophylaxis of migraine. The original protocol and analysis had a number of major shortcomings. In order to follow regulatory requirements, an independent reanalysis of the original data was performed. Following a 4-week baseline phase, 33 patients were randomised to treatment with two capsules 25 mg butterbur twice a day and 27 to placebo. The mean attack frequency per month decreased from 3.4 at baseline to 1.8 after 3 months (p = 0.0024) in the verum group and from 2.9 to 2.6 in the placebo group (n.s.). The responder rate (improvement of migraine frequency > or =50%) was 45% in the verum group and 15% in the placebo group. Butterbur was well tolerated. This small trial indicates that butterbur may be effective in the prophylaxis of migraine. PMID:14752215
ResumeObjectif determiner dans une etude randomisee l'impact d'un enregistrement continu du glucose sous-cutane pendant 48 heures sur le controle glycemique trois mois plus tard chez des patients presentant un diabete de type 1 (DT1) ou de type 2 (DT2). Methodes Quarante-huit patients avec un mauvais equilibre glycemique (HbA1c : 8-10,5 %) ont beneficie d'un enregistrement continu du glucose sous-cutane pendant 48 heures avec le systeme GlucoDay (A. Menarini Diagnostics) et ont ete randomises en deux groupes : ajustement de traitement en fonction de l'autosurveillance glycemique capillaire (groupe ASG) ou du profil d'enregistrement continu du glucose sous-cutane (groupe CGM). Le dosage d'HbA1c et le port du GlucoDay ont ete renouveles trois mois plus tard. Resultats Trente-quatre patients ...
Summary Background Treatment of localised renal cell carcinoma consists of partial or radical nephrectomy. A substantial proportion of patients are at risk for recurrence because no effective adjuvant therapy exists. We investigated the use of an autologous, tumour-derived heat-shock protein (glycoprotein 96)-peptide complex (HSPPC-96; vitespen) as adjuvant treatment in patients at high risk of recurrence after resection of locally advanced renal cell carcinoma. Methods In this open-label trial, patients were randomly assigned to receive either vitespen (n=409) or observation alone (n=409) after nephrectomy. Randomisation was done in a one to one ratio by a computer-generated pseudo-random number generator, with a block size of four, and was stratified by performance score, lymph node stat...
Carpal tunnel syndrome (CTS) is a common disorder, for which various conservative treatment options are available. The objective of this study is to determine the efficacy of the various conservative treatment options for relieving the symptoms of CTS. Computer-aided searches of MEDLINE (1/1966 to 3/2000), EMBASE (1/1988 to 2/2000) and the Cochrane Controlled Trials Register (2000, issue 1) were conducted, together with reference checking. Included were randomised controlled trials evaluating the efficacy of conservative treatment options in a study population of CTS patients, with a full report published in English, German, French or Dutch. Two reviewers independently selected the studies. Fourteen randomised controlled trials were included in the review. Assessment of methodological quality and data-extraction was independently performed by two reviewers. A rating system, based on the number of studies and their methodological quality and ...
Patients with acute myocardial infarction (AMI) and diabetes mellitus, as well as patients admitted with elevated blood glucose without known diabetes, have impaired outcome. Therefore intensive glucose-lowering therapy with insulin (IGL) has been proposed in diabetic or hyperglycaemic patients and has been shown to improve survival and reduce incidence of adverse events. The current manuscript provides an overview of randomised controlled trials investigating the effect of IGL. Furthermore, systematic glucose?insulin?potassium infusion (GIK) has been studied to improve outcome after AMI. In spite of positive findings in some early studies, GIK did not show any beneficial effects in recent clinical trials and thus this concept has been abandoned. While IGL targeted to achieve normoglycaemi...
Purpose. To compare erectile function (EF) recovery of patients treated by early penile rehabilitation therapy (PRT) with sildenafil and with control group. Method. Forty men treated by bilateral nerve sparing radical prostatectomy (NSRP) and with a normal pre-operative EF were enrolled. Fourteen days after surgery, they were randomised to a flexible-dose sildenafil group and to a control group. The International Index of Erectile Function (IIEF) questionnaire was completed before surgery and at 3, 6, 12 and 24 weeks after NSRP. Results. In the group treated, the mean IIEF score before surgery was 26.2 and 14.1, 16.2, 22.5 and 25.2 at 3, 6, 12 and 24 weeks after NSRP, respectively. In the control group, the respective scores were 26.5 and 12.4, 15.8, 15.3 and 17.4. There was a significant ...
AbstractBackground Randomised controlled trials (RCTs) in the 1970s and early 1980s showed the polysaccharide serogroup A vaccine (SgAV) prevented serogroup A meningococcal meningitis (SGAMM). Subsequent non-RCTs suggested significant variations in the age-specific duration of protection among children. Objectives To determine the protective effect, duration of protection, age-specific effects and the effect of booster doses in children of the SgAV against SGAMM. Search strategy We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2010, issue 2) which contains the Acute Respiratory Infections Group's Specialised Register, MEDLINE (January 1950 to May Week 3, 2010) and EMBASE (January 1974 to May 2010). Selection criteria We included RCTs. Non-RCTs ...
The aim of this study was to observe both the clinical signs and symptoms of wounds at risk of infection, that is critically colonised (biofilm infected) and antimicrobial-performance of an ionic silver alginate/carboxymethylcellulose (SACMC) dressing, in comparison with a non silver calcium alginate fibre (AF) dressing, on chronic venous leg and pressure ulcers. Thirty-six patients with venous or pressure ulcers, considered clinically to be critically colonised (biofilm infected), were randomly chosen to receive either an SACMC dressing or a non silver calcium AF dressing. The efficacy of each wound dressing was evaluated over a 4-week period. The primary study endpoints were prevention of infection and progression to wound healing. The SACMC group showed a statistically significant (P = ...
Background and purpose: To assess the effectiveness of radiotherapy in preventing tumour seeding after chest drain or pleural biopsy in patients with malignant mesothelioma and to determine, if tract metastases appear, whether they are tender or troublesome to patients. Patients and methods: Patients with a histological diagnosis of pleural mesothelioma and an invasive procedure within the preceding 21 days were stratified by age, performance status and treatment centre. Randomisation was performed between immediate drain site radiotherapy 21 Gy in three fractions (XRT arm) or best supportive care (BSC) with follow-up to 12 months. Patients were asked to complete questionnaires on treatment toxicity and on symptoms from any tract metastases detected. Results: Sixty-one patients were recruited from two centres between 1998 and 2004; 56 men, 5 women, median age 70. 31 were allocated to drain site radiotherapy. Seven patients developed tract metastases associated with ...
The aim of this study was to observe both the clinical signs and symptoms of wounds at risk of infection, that is critically colonised (biofilm infected) and antimicrobial-performance of an ionic silver alginate/carboxymethylcellulose (SACMC) dressing, in comparison with a non silver calcium alginate fibre (AF) dressing, on chronic venous leg and pressure ulcers. Thirty-six patients with venous or pressure ulcers, considered clinically to be critically colonised (biofilm infected), were randomly chosen to receive either an SACMC dressing or a non silver calcium AF dressing. The efficacy of each wound dressing was evaluated over a 4-week period. The primary study endpoints were prevention of infection and progression to wound healing. The SACMC group showed a statistically significant (P = 0.017) improvement to healing as indicated by a reduction in the surface area of the wound, over the 4-week study period, compared with AF controls. In conclusion, the SACMC dressing showed a greater ...
This study examined whether cognitive behavioural therapy (CBT) could prevent the development or worsening of panic-spectrum psychopathology and anxiety symptoms in chronic obstructive pulmonary disease (COPD). 41 patients with COPD, who had undergone pulmonary rehabilitation, were randomised to either a four-session CBT intervention condition (n = 21) or a routine care condition (n = 20). Assessments were at baseline, post-intervention, and at 6-, 12- and 18-month follow-ups. Primary outcomes were the rates of panic attacks, panic disorder and anxiety symptoms. Secondary outcomes were depressive symptoms, catastrophic cognitions about breathing difficulties, disease-specific quality of life and hospital admission rates. There were no significant differences between the groups on outcome measures at baseline. By the 18-month follow-up assessment, 12 (60%) routine care group participants had experienced at least one panic attack in the previous 6 months, with two ...
Parenting programmes are effective interventions for preventing and treating conduct problems in young children. Up to 20% of children in disadvantaged areas have conduct disorder. Recent government initiatives such as targeting early years services to designated disadvantaged Flying Start areas in Wales have resulted in increased nursery-care provision for pre-schoolers, yet little has been done to equip nursery staff with effective child behaviour management strategies. The purpose of this non-randomised trial platform study was to establish the feasibility of delivery and the effectiveness of the new Incredible Years Toddler Parent Programme in supporting nursery staff in managing difficult behaviour in the nursery. The Parent Programme is a 12-session (a two-hour session/week) course for carers/parents of children aged one to three years old, which encourages carers to: establish positive relationships with children through play and child-centred activities; ...
A prospective pilot trial was performed in 20 patients randomised to receive either {sup 131}I-Lipiodol therapy alone (n=10) or {sup 131}I-Lipiodol combined with a short low-dose cisplatin infusion (n=10), the aim being to evaluate the possible positive influence of a radiosensitiser on toxicity and tumour response. An activity of 1,354-2,128 MBq (mean 1,824 MBq) [36.6-57.5 mCi (mean 49.3 mCi)] {sup 131}I-labelled Lipiodol was administered by selective instillation in the hepatic artery. Cisplatin was given in a dose of 30 mg/m{sup 2} at day -1 and day +6 (day 0: {sup 131}I-Lipiodol). The primary endpoint of this trial was toxicity of therapy; points of secondary interest were tumour response and survival at 6 months. With the use of cisplatin we found a higher percentage of stable or diminished tumour size (90%, vs 40% without). A benefit in group survival at 6 months was not evident. Low-grade stomatitis in one patient and minor changes in peripheral blood count ...
To establish the optimum barium-based reduced-laxative tagging regimen prior to CT colonography (CTC). Ninety-five subjects underwent reduced-laxative (13 g senna/18 g magnesium citrate) CTC prior to same-day colonoscopy and were randomised to one of four tagging regimens using 20 ml 40%w/v barium sulphate: regimen A: four doses, B: three doses, C: three doses plus 220 ml 2.1% barium sulphate, or D: three doses plus 15 ml diatriazoate megluamine. Patient experience was assessed immediately after CTC and 1 week later. Two radiologists graded residual stool (1: none/scattered to 4: >50% circumference) and tagging efficacy for stool (1: untagged to 5: 100% tagged) and fluid (1: untagged, 2: layered, 3: tagged), noting the HU of tagged fluid. Preparation was good (76-94% segments graded 1), although best for regimen D (P = 0.02). Across all regimens, stool tagging quality was high (mean 3.7-4.5) and not significantly different among regimens. The HU of layered ...