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Results for “Randomised Controlled Trial”

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PubMed2006

A randomised controlled trial of omega-3 fatty acid supplementation for the treatment of hypertriglyceridemia in HIV-infected males on highly active antiretroviral therapy.

BACKGROUND: Hypertriglyceridaemia is a recognised metabolic abnormality in HIV-infected people, increasing in severity in people treated with highly active antiretroviral therapy (HAART). An alternative treatment for hypertriglyceridaemia in non-HIV-infected populations is omega-3 fatty acid supplementation. This study aimed to compare the effectiveness of omega-3 fatty acid supplementation and placebo in lowering fasting triglyceride levels in HIV-infected patients on HAART. METHODS: A placebo-controlled, randomised, double-blind trial in participants on stable HAART with fasting triglycerides of >3.5 mm to 10.0 mm using 9 g of omega-3 fatty acids versus placebo (olive oil) after a 6-week lead in on dietary therapy. RESULTS: Eleven patients were enrolled. The mean triglyceride level for the population decreased from 5.02 mm at baseline to 4.44 mm (-11.6%) after dietary intervention and 3.37 mm (-32.9%) after the 8-week treatment period. In the omega-3 fatty acid arm of the study, triglycerides fell from 5.34 mm to 5.02 mm (-6%) after dietary intervention and to 2.30 mm (-56.9%) after the treatment period. In the placebo arm of the study, triglycerides fell from 4.77 mm to 4.05 mm (-15.1%) after dietary intervention and to 4.08 mm (-14.5%) after the treatment period. Using the random effects model, a statistically significant effect on triglycerides of omega-3 fatty acid versus placebo was found (chi(2) = 6.04, P = 0.0487). The estimated difference between groups for change in mean triglycerides over 8 weeks was -2.32 mm (95% CI -4.52, -0.12 mm). CONCLUSIONS: Omega-3 fatty acids are likely to be an effective treatment for hypertriglyceridaemia in HIV-infected males on HAART.

Adult↗

PubMed1997

A randomised controlled trial evaluating a novel cytotoxic drug delivery system for the treatment of cervical intraepithelial neoplasia.

OBJECTIVE: To investigate the efficacy of a novel method for the treatment of cervical intraepithelial neoplasia. A cytotoxic drug delivery system using a bilaminar bioadhesive polymeric film was applied directly to the cervix. This cytotoxic drug delivery system allowed the dose, the site and the duration of application of the cytotoxic drug (5-fluorouracil) to be controlled. DESIGN: A prospective, double-blind randomised controlled trial. SETTING: The Departments of Obstetrics and Gynaecology and Pathology of Belfast City Hospital and The Queen's University of Belfast, and the Department of Pharmacy of The Queen's University of Belfast. PARTICIPANTS: One hundred and four patients who had been referred to the colposcopy outpatient clinic because of abnormal cervical cytology were recruited into the trial. They were assessed colposcopically and biopsies for histopathology were obtained. Only patients with cervical intraepithelial neoplasia lesions Grades 1 and 2 were recruited. INTERVENTIONS: All patients were re-assessed one, three, and six months after application of the cytotoxic drug delivery system by colposcopy. Clinical endpoints were noted. MAIN OUTCOME MEASURES: Pre-treatment histopathological biopsy results were compared with those obtained after treatment. RESULTS: The cytotoxic drug delivery system fulfilled the requirements for treatment of cervical intraepithelial neoplasia without causing any architechtural damage, but the chemotherapeutic agent, 5-fluorouracil, did not provide effective treatment of disease. CONCLUSIONS: This study showed that the delivery system was effective, and further studies using this mechanism are now possible.

Administration, Topical↗

PubMed2004

Enhanced low vision rehabilitation for people with age related macular degeneration: a randomised controlled trial.

AIM: To compare the effectiveness of three models of low vision rehabilitation for people with age related macular degeneration (AMD) referred for low vision rehabilitation (LVR): (a) an enhanced low vision rehabilitation model (ELVR) including supplementary home based low vision rehabilitation; (b) conventional low vision rehabilitation (CLVR) based in a hospital clinic; (c) CLVR with home visits that did not include rehabilitation (CELVR), intended to act as a control for the additional contact time with ELVR. METHOD: A single centre parallel group randomised controlled trial in participants' homes and the low vision clinic, Manchester Royal Eye Hospital. People referred for LVR with a primary diagnosis of AMD and visual acuity worse than 6/18 in both eyes and equal to or better than 1/60 in the better eye. The main outcome measures were vision specific quality of life (QoL) (primary outcome, VCM1) and generic health related QoL (SF-36); psychological adjustment to vision loss; measured task performance; restriction in everyday activities; use of low vision aids (LVAs). RESULTS: 226 participants were recruited (median age 82 years); 194 completed the trial (86%). Except for SF-36 physical and mental component summary scores, arms did not differ significantly for any of the outcomes. Differences for the VCM1 were ELVR v CLVR, 0.06 (95% CI to 0.17 to 0.30, p = 0.60); ELVR v CELVR, 0.12 (95% CI to 0.11 to 0.34, p = 0.31); CELVR v CLVR, -0.05 (95% CI -0.29 to 0.18, p = 0.64). Differences for the SF-36 favoured CLVR compared to ELVR (ELVR v CLVR: physical = -6.05, 95% CI -10.2 to -1.91, p = 0.004; mental = -4.04, 95% CI -7.44 to -0.65, p = 0.02). At 12 months, 94% of participants reported using at least one LVA. CONCLUSION: ELVR was no more effective than CLVR. Researchers should be wary of proposing new LVR interventions without preliminary evidence of effectiveness, given the manifest lack of effectiveness of the model of enhanced LVR evaluated in the trial.

Activities of Daily Living↗

PubMed1983

Treatment of hyperlipidaemia retards progression of symptomatic femoral atherosclerosis. A randomised controlled trial.

The effect of plasma lipid reduction on the progression of femoral atherosclerosis was studied in hyperlipidaemic patients with stable intermittent claudication. 24 patients were randomly assigned to treatment and usual-care groups, the former receiving dietary advice and cholestyramine, nicotinic acid, or clofibrate depending on their lipoprotein phenotype. Biplanar arteriography was performed when the study began and after a mean period of 19 months. Angiograms were assessed visually, with blinding, and by computerised image analysis. Therapy reduced mean plasma total cholesterol by 25%, mean low density lipoprotein (LDL) cholesterol by 28%, and mean plasma triglycerides by 45%. Significantly fewer arterial segments showed detectable progression of atherosclerosis in the treatment group. The mean increase in plaque area (mm2/segment/year) in the treatment group was only one third of that in the usual-care group. The mean increase in edge irregularity index (a measure of the severity of disease) in the treatment group was only 40% of that in the usual care group. Twice as many arterial segments showed improvement in the treatment group. In both groups changes in edge irregularity index were directly related to plasma LDL cholesterol concentration. This study, the first randomised controlled trial of its type, provides evidence that effective treatment of hyperlipidaemia favourably influences the natural history of symptomatic peripheral atherosclerosis.

Angiography↗

PubMed2004

Protocol for a randomised controlled trial of a decision aid for the management of pain in labour and childbirth [ISRCTN52287533].

BACKGROUND: Women report fear of pain in childbirth and often lack complete information on analgesic options prior to labour. Preferences for pain relief should be discussed before labour begins. A woman's antepartum decision to use pain relief is likely influenced by her cultural background, friends, family, the media, literature and her antenatal caregivers. Pregnant women report that information about analgesia was most commonly derived from hearsay and least commonly from health professionals. Decision aids are emerging as a promising tool to assist practitioners and their patients in evidence-based decision making.Decision aids are designed to assist patients and their doctors in making informed decisions using information that is unbiased and based on high quality research evidence. Decision aids are non-directive in the sense that they do not aim to steer the user towards any one option, but rather to support decision making which is informed and consistent with personal values. METHODS/DESIGN: We aim to evaluate the effectiveness of a Pain Relief for Labour decision aid, with and without an audio-component, compared to a pamphlet in a three-arm randomised controlled trial. Approximately 600 women expecting their first baby and planning a vaginal birth will be recruited for the trial.The primary outcomes of the study are decisional conflict (uncertainty about a course of action), knowledge, anxiety and satisfaction with decision-making and will be assessed using self-administered questionnaires. The decision aid is not intended to influence the type of analgesia used during labour, however we will monitor health service utilisation rates and maternal and perinatal outcomes. This study is funded by a competitive peer-reviewed grant from the Australian National Health and Medical Research Council (No. 253635). DISCUSSION: The Pain Relief for Labour decision aid was developed using the Ottawa Decision Support Framework and systematic reviews of the evidence about the benefits and risks of the non-pharmacological and pharmacological methods of pain relief for labour. It comprises a workbook and worksheet and has been developed in two forms - with and without an audio-component (compact disc). The format allows women to take the decision aid home and discuss it with their partner.

Journal Article↗

PubMed2004

The relative efficacy of two brief treatments for sleep problems in young learning disabled (mentally retarded) children: a randomised controlled trial.

BACKGROUND: Settling and night waking problems are particularly prevalent, persistent, and generally considered difficult to treat in children with a learning disability, although intervention trials are few. Scarce resources, however, limit access to proven behavioural treatments. AIMS: To investigate the efficacy of a media based brief behavioural treatment of sleep problems in such children by comparing (1) face-to-face delivered treatment versus control and (2) booklet delivered treatment versus controls. METHODS: The parents of 66 severely learning disabled children aged 2-8 years with settling and/or night waking problems took part in a randomised controlled trial with a wait-list control group. Behavioural treatments were presented either conventionally face-to-face or by means of a 14 page easy to read illustrated booklet. A composite sleep disturbance score was derived from sleep diaries kept by parents. RESULTS: Both forms of treatment were almost equally effective compared with controls. Two thirds of children who were taking over 30 minutes to settle five or more times per week and waking at night for over 30 minutes four or more times per week improved on average to having such settling or night waking problems for only a few minutes or only once or twice per week (H = 34.174, df = 2, p<0.001). These improvements were maintained after six months. CONCLUSIONS: Booklet delivered behavioural treatments for sleep problems were as effective as face-to-face treatment for most children in this population.

Behavior Control↗

PubMed1999

Efficacy of home-based peer counselling to promote exclusive breastfeeding: a randomised controlled trial.

BACKGROUND: Exclusive breastfeeding is recommended worldwide but not commonly practised. We undertook a randomised controlled study of the efficacy of home-based peer counselling to increase the proportion of exclusive breastfeeding among mothers and infants residing in periurban Mexico City. METHODS: Two intervention groups with different counselling frequencies, six visits (44) and three visits (52), were compared with a control group (34) that had no intervention. From March, 1995, to September, 1996, 170 pregnant women were identified by census and invited to participate in the study. Home visits were made during pregnancy and early post partum by peer counsellors recruited from the same community and trained by La Leche League. Data were collected by independent interview. Exclusive breastfeeding was defined by WHO criteria. FINDINGS: 130 women participated in the study. Only 12 women refused participation. Study groups did not differ in baseline factors. At 3 months post partum, exclusive breastfeeding was practised by 67% of six-visit, 50% of three-visit, and 12% of control mothers (intervention groups vs controls, p<0.001; six-visit vs three-visit, p=0.02). Duration of breastfeeding was significantly (p=0.02) longer in intervention groups than in controls, and fewer intervention than control infants had an episode of diarrhoea (12% vs 26%, p=0.03). INTERPRETATION: This is the first reported community-based randomised trial of breastfeeding promotion. Early and repeated contact with peer counsellors was associated with a significant increase in breastfeeding exclusivity and duration. The two-fold decrease in diarrhoea demonstrates the importance of breastfeeding promotion to infant health.

Breast Feeding↗

PubMed2002

A pragmatic randomised controlled trial of a prompt and reminder card in the care of people with epilepsy.

BACKGROUND: The quality of epilepsy care has often been noted to be poor and fragmentary. Most people with epilepsy are solely under the care of their general practitioner (GP). Many patients report medication side-effects and poor seizure control. Most GPs accept responsibility for epilepsy care; however, many report problems with knowledge of epilepsy and nearly all support guidance on epilepsy management. AIM: To determine whether a GP-completed prompt and reminder card is effective in improving the quality of epilepsy care when used opportunistically. DESIGN OF STUDY: Primary care-based pragmatic cluster-randomised controlled trial. SETTING: People with active epilepsy (n = 1275) from 82 practices. METHOD: Practices were randomly categorised as 'control', 'doctor-held card' (card in patient records), or 'patient-held card' practices. RESULTS: Compared with control practices, recording of seizure frequency was significantly increased in doctor-held card practices (57.4% versus 42.8%, P = 0.003) but not in patient-held card practices (44.6% versus 42.8%). No differences were found in the proportion of seizure-free patients (doctor-held card [56.0%] versus control [51.5%]; patient-held card [58.1%] versus control [51.5%]) or in the proportion on monotherapy. Patients in both intervention groups reported more medication-related side-effects and patients in doctor-held card practices were less satisfied with information provision about epilepsy. Participating GPs found the card useful. The doctor-held card was retrieved and completed more often than the patient-held card. CONCLUSIONS: A doctor-held prompt and reminder card is effective in improving the recording of key clinical information for people with epilepsy, is felt to be useful by GPs, and is completed more often than a patient-held card. However it does not improve outcomes and may result in less patient-centred care.

Attitude of Health Personnel↗

PubMed2005

Acupuncture in patients with tension-type headache: randomised controlled trial.

OBJECTIVE: To investigate the effectiveness of acupuncture compared with minimal acupuncture and with no acupuncture in patients with tension-type headache. DESIGN: Three armed randomised controlled multicentre trial. SETTING: 28 outpatient centres in Germany. PARTICIPANTS: 270 patients (74% women, mean age 43 (SD 13) years) with episodic or chronic tension-type headache. INTERVENTIONS: Acupuncture, minimal acupuncture (superficial needling at non-acupuncture points), or waiting list control. Acupuncture and minimal acupuncture were administered by specialised physicians and consisted of 12 sessions per patient over eight weeks. MAIN OUTCOME MEASURE: Difference in numbers of days with headache between the four weeks before randomisation and weeks 9-12 after randomisation, as recorded by participants in headache diaries. RESULTS: The number of days with headache decreased by 7.2 (SD 6.5) days in the acupuncture group compared with 6.6 (SD 6.0) days in the minimal acupuncture group and 1.5 (SD 3.7) days in the waiting list group (difference: acupuncture v minimal acupuncture, 0.6 days, 95% confidence interval -1.5 to 2.6 days, P = 0.58; acupuncture v waiting list, 5.7 days, 3.9 to 7.5 days, P < 0.001). The proportion of responders (at least 50% reduction in days with headache) was 46% in the acupuncture group, 35% in the minimal acupuncture group, and 4% in the waiting list group. CONCLUSIONS: The acupuncture intervention investigated in this trial was more effective than no treatment but not significantly more effective than minimal acupuncture for the treatment of tension-type headache. TRIAL REGISTRATION NUMBER: ISRCTN9737659.

Acupuncture Therapy↗

PubMed1995

The analgesic effect of sucrose in full term infants: a randomised controlled trial.

OBJECTIVE: To evaluate the effects of different sucrose concentrations on measures of neonatal pain. DESIGN: Randomised, double blind, placebo controlled trial of sterile water (control) or one of three solutions of sucrose--namely, 12.5%, 25%, and 50% wt/vol. SETTING: Postnatal ward. PATIENTS: 60 healthy infants of gestational age 37-42 weeks and postnatal age 1-6 days randomised to receive 2 ml of one of the four solutions on to the tongue two minutes before heel prick sampling for serum bilirubin concentrations. MAIN OUTCOME MEASURE: Duration of crying over the first three minutes after heel prick. RESULTS: There was a significant reduction in overall crying time and heart rate after three minutes in the babies given 50% sucrose as compared with controls. This was maximal one minute after heel prick in the 50% sucrose group and became statistically significant in the 25% sucrose group at two minutes. There was a significant trend for a reduction in crying time with increasing concentrations of sucrose over the first three minutes. CONCLUSION: Concentrated sucrose solution seems to reduce crying and the autonomic effects of a painful procedure in healthy normal babies. Sucrose may be a useful and safe analgesic for minor procedures in neonates.

Administration, Oral↗

PubMed2002

Failure of regular external ventricular drain exchange to reduce cerebrospinal fluid infection: result of a randomised controlled trial.

BACKGROUND: It is controversial whether regular changes of external ventricular drains can reduce cerebrospinal fluid (CSF) infection. OBJECTIVE: To carry out a randomised controlled clinical trial over a two year period to determine whether a regular change of ventricular catheter every five days could reduce CSF infection and improve outcome. METHODS: 103 patients requiring external ventricular drains for more than five days and with no evidence of concurrent CSF infection were studied. The patients were randomised to regular change of ventricular catheter (every five days) and no change unless clinically indicated. RESULTS: The CSF infection rates were 7.8% for the catheter change group and 3.8% for the no change group, respectively (rate ratio = 1.80, 95% confidence interval 0.33 to 9.81, p = 0.50). No significant difference was found in intensive care unit stay, ward stay, or clinical outcome between the two groups. CONCLUSIONS: Regular changes of ventricular catheter at five day intervals did not reduce the risk of CSF infection. A single external ventricular drain can be employed for as long as clinically indicated.

Acinetobacter Infections↗

PubMed1999

Prediction of successful outcome in a randomised controlled trial of the long-term efficacy of interferon alpha treatment for chronic hepatitis C.

To evaluate the efficacy of a 12-month course of recombinant interferon alpha (IFN-alpha2b), and to assess predictive factors of successful response to IFN therapy in chronic active hepatitis C (HCV CAH), 242 patients with histologically proven HCV CAH were assigned randomly to two groups, one treated with IFN-alpha2b (3 MU three times weekly, intramuscularly), the other untreated. To determine the efficacy of IFN-alpha2b 12 months after therapy, a second liver biopsy was carried out on 100 treated patients and 27 untreated patients. The biochemical, virological, and serological response of patients followed up for at least 50 months after treatment was also evaluated to confirm the efficacy of IFN-alpha2b. The genotypes of infecting HCV, anti-HCV core IgM, and HCV-RNA concentrations were also analysed and the predictors of response determined by univariate and multivariate analyses. Response was defined in terms of the normalisation of aminotransferase activities and the disappearance of HCV-RNA. The overall long-term response was 39.4%. Anti-HCV core IgM levels were significantly lower in long-term responders. Patients with increased levels of IgM anti HCV core (>3.8 sample/cut-off), infected with genotype 1b were nonresponders. Liver histology improved significantly in patients with long-term response. Multivariate analysis identified three independent predictors of the likelihood of long-term response to IFN therapy: age younger than 40 years, basal anti-HCV core IgM levels < or = 3.8, and genotypes other than 1b. These data indicate that the treatment with IFN-alpha2b used in this randomised controlled trial is effective in HCV CAH. Anti-HCV core IgM was the strongest predictor of long-term response in the present study.

Alanine Transaminase↗

PubMed2003

Randomised controlled trial of total compared with subtotal hysterectomy with one-year follow up results.

OBJECTIVE: To compare total abdominal hysterectomy and subtotal abdominal hysterectomy performed for benign uterine diseases. DESIGN: Randomised, controlled, unblinded trial with central, computer-generated randomisation. SETTING: Danish trial performed in 11 departments of gynaecology. POPULATION: Women referred for benign uterine diseases were randomised to total abdominal hysterectomy (n = 158) or subtotal abdominal hysterectomy (n = 161). One-year follow up questionnaires had a response rate of 87%. METHODS: Patients were followed by strict data collection procedures, including postal questionnaires. The results after one year of follow up were analysed by intention-to-treat analyses. MAIN OUTCOME MEASURES: (1) Primary: urinary incontinence and (2) secondary: post-operative complications, quality of life (SF-36), constipation, prolapse of the vaginal vault/cervical stump, satisfaction with sexual life, pelvic pain and vaginal bleeding. RESULTS: A significantly (P = 0.043) smaller proportion of women had urinary incontinence one year after total abdominal hysterectomy compared with subtotal abdominal hysterectomy [9% vs 18% (OR 2.08, 95% CI 1.01-4.29)]. The lower proportion of incontinent women in the total abdominal hysterectomy group was a result of a higher proportion of symptom relief (total abdominal hysterectomy: 20/140, subtotal abdominal hysterectomy: 14/136) as well as a lower proportion of women with new symptoms (total abdominal hysterectomy: 3/140, subtotal abdominal hysterectomy: 10/137). Twenty-seven women (20%) from the subtotal abdominal hysterectomy group had vaginal bleeding and two of them had to have their cervix removed. No other clinically important differences were found between the two hysterectomy methods. CONCLUSIONS: A smaller proportion of women suffered from urinary incontinence after total abdominal hysterectomy than after subtotal abdominal hysterectomy one year post-operatively.

Female↗

PubMed2001

Which treatment for low back pain? A factorial randomised controlled trial comparing intravenous analgesics with oral analgesics in the emergency department and a centrally acting muscle relaxant with placebo over three days [ISRCTN09719705].

BACKGROUND: About two thirds of adults suffer from backpain at some time during their life. In the emergency room many patients with acute back pain are treated with intravenous non-steroidal analgesics. Whether this treatment is superior to oral administration of non-steroidal analgesics is unknown. Intravenous administration, however, requires considerable amounts of resources and accounts for high workload in busy clinics. In the further course centrally acting muscle relaxants are prescribed but the effectiveness remains unclear. The objective of this study is on the one hand to compare the effectiveness of intravenous with oral non-steroidal analgesics for acute treatment and on the other hand to compare the effectiveness of a centrally active muscle relaxant with placebo given for three days after presentation to the ED (emergency department). METHODS/DESIGN: This study is intended as a randomised controlled factorial trial mainly for two reasons: (1) the sequence of treatments resembles the actual proceedings in every-day clinical practice, which is important for the generalisability of the results and (2) this design allows to take interactions between the two sequential treatment strategies into account. There is a patient preference arm included because patients preference is an important issue providing valuable information: (1) it allows to assess the interaction between desired treatment and outcome, (2) results can be extrapolated to a wider group while (3) conserving the advantages of a fully randomised controlled trial. CONCLUSION: We hope to shed more light on the effectiveness of treatment modalities available for acute low back pain.

Journal Article↗

PubMed1992

A prospective randomised controlled trial comparing the efficacy of somatostatin with injection sclerotherapy in the control of bleeding oesophageal varices.

Since previous reports have suggested that somatostatin may be of value in the control of acute variceal haemorrhage, we compared its efficacy with that of injection sclerotherapy in a randomised controlled clinical trial. Eighty consecutive patients with endoscopically-proven severe variceal bleeding were randomised to injection sclerotherapy (n = 41) or somatostatin (n = 39) given as a continuous infusion of 250 micrograms/h for 5 days plus daily bolus administration of 250 micrograms. The efficacy of injection sclerotherapy and somatostatin infusion in controlling haemorrhage and preventing rebleeding (censored at 5 days), mortality (censored at 28 days) and complications was compared. The aetiology of the portal hypertension and transfusion requirements was similar between the two groups, but there were more patients with severe liver disease (Child's C) in the somatostatin group. There was no significant difference between the two treatments in the initial (p = 1.0) or overall control of bleeding (p = 0.58). Furthermore, somatostatin was as effective as injection sclerotherapy in controlling bleeding in patients with severe liver disease or in those actively bleeding at the time of their endoscopy. The relative risk of rebleeding whilst receiving somatostatin compared to injection sclerotherapy was 1.39 [95% Confidence Interval (CI) 3.73; 0.52], but this was reduced to 0.98 (95% CI 0.37; 2.67) when readjusted for Child's grading, the only prognostic factor shown to be of significance. Mortality was not significantly different between the two groups of patients (p = 0.31). The relative risk of dying whilst receiving somatostatin compared to injection sclerotherapy was 1.6 (95% CI 3.93; 0.66) but was reduced to 1.03 (95% CI 0.47; 2.47) when adjusted for Child's grading, the only significant prognostic factor. Complications in the somatostatin group were minor and less frequent than after injection sclerotherapy. The results of this study indicate that somatostatin is a safe treatment, which is as effective an endoscopic injection sclerotherapy for acute variceal bleeding.

Adult↗

PubMed2004

The Lambeth Early Onset (LEO) Team: randomised controlled trial of the effectiveness of specialised care for early psychosis.

OBJECTIVE: To evaluate the effectiveness of a service for early psychosis. DESIGN: Randomised controlled clinical trial. SETTING: Community mental health teams in one London borough. PARTICIPANTS: 144 people aged 16-40 years presenting to mental health services for the first or second time with non-organic, non-affective psychosis. INTERVENTIONS: Assertive outreach with evidence based biopsychosocial interventions (specialised care group) and standard care (control group) delivered by community mental health teams. PRIMARY OUTCOME MEASURES: Rates of relapse and readmission to hospital. RESULTS: Compared with patients in the standard care group, those in the specialised care group were less likely to relapse (odds ratio 0.46, 95% confidence interval 0.22 to 0.97), were readmitted fewer times (beta 0.39, 0.10 to 0.68), and were less likely to drop out of the study (odds ratio 0.35, 0.15 to 0.81). When rates were adjusted for sex, previous psychotic episode, and ethnicity, the difference in relapse was no longer significant (odds ratio 0.55, 0.24 to 1.26); only total number of readmissions (beta 0.36, 0.04 to 0.66) and dropout rates (beta 0.28, 0.12 to 0.73) remained significant. CONCLUSIONS: Limited evidence shows that a team delivering specialised care for patients with early psychosis is superior to standard care for maintaining contact with professionals and for reducing readmissions to hospital. No firm conclusions can, however, be drawn owing to the modest sample size.

Adolescent↗

PubMedDate not supplied

Effect of a participatory intervention with women's groups on birth outcomes in Nepal: cluster-randomised controlled trial.

BACKGROUND: Neonatal deaths in developing countries make the largest contribution to global mortality in children younger than 5 years. 90% of deliveries in the poorest quintile of households happen at home. We postulated that a community-based participatory intervention could significantly reduce neonatal mortality rates. METHODS: We pair-matched 42 geopolitical clusters in Makwanpur district, Nepal, selected 12 pairs randomly, and randomly assigned one of each pair to intervention or control. In each intervention cluster (average population 7000), a female facilitator convened nine women's group meetings every month. The facilitator supported groups through an action-learning cycle in which they identified local perinatal problems and formulated strategies to address them. We monitored birth outcomes in a cohort of 28?931 women, of whom 8% joined the groups. The primary outcome was neonatal mortality rate. Other outcomes included stillbirths and maternal deaths, uptake of antenatal and delivery services, home care practices, infant morbidity, and health-care seeking. Analysis was by intention to treat. The study is registered as an International Standard Randomised Controlled Trial, number ISRCTN31137309. FINDINGS: From 2001 to 2003, the neonatal mortality rate was 26.2 per 1000 (76 deaths per 2899 livebirths) in intervention clusters compared with 36.9 per 1000 (119 deaths per 3226 livebirths) in controls (adjusted odds ratio 0.70 [95% CI 0.53-0.94]). Stillbirth rates were similar in both groups. The maternal mortality ratio was 69 per 100000 (two deaths per 2899 livebirths) in intervention clusters compared with 341 per 100000 (11 deaths per 3226 livebirths) in control clusters (0.22 [0.05-0.90]). Women in intervention clusters were more likely to have antenatal care, institutional delivery, trained birth attendance, and hygienic care than were controls. INTERPRETATION: Birth outcomes in a poor rural population improved greatly through a low cost, potentially sustainable and scalable, participatory intervention with women's groups.

Adolescent↗

PubMed1994

Prevention of oral mucositis in patients treated with high-dose chemotherapy and bone marrow transplantation: a randomised controlled trial comparing two protocols of dental care.

Between February 1986 and November 1989, 166 patients who were candidates for a bone marrow transplantation entered a randomised controlled clinical trial to compare limited oral hygiene care (LIM) and intensive oral hygiene care (INT) in the prevention of mucositis. Randomisation was stratified on the initial oral status (good vs. bad IOS). Intensive oral hygiene care included an initial treatment of dental lesions and tooth and gum brushing during aplasia. Limited oral hygiene care excluded preventive dental treatment and gingival and tooth brushing. Mucositis was classified as absent, mild, moderate or severe, according to the clinical aspects of the different sites in the mouth and to two scales of pain evaluation. Of the 150 evaluable patients (75 in each group), 134 developed moderate/severe mucositis (64 in the INT group and 70 in the LIM group) (log-rank test P < 0.02). The superiority of intensive oral care was observed both in patients with and without total body irradiation (TBI) and in patients with a good or bad IOS; the observed risk of mucositis was reduced by 70% in each of these four subgroups. Duration of moderate/severe mucositis was, although not significantly, lower in the INT group (17 days, S.D. = 12) than in the LIM group (19 days, S.D. = 13). The median time of mucositis occurrence was 11 days in the INT group and 9 days in the LIM group. Contrary to a widespread belief, the percentage of documented septicaemia was not higher in patients who underwent intensive oral care. We conclude that, although statistically significant, the superiority of intensive oral hygiene care is not clinically impressive.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗