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Random Allocation (random + allocation)
Selected AbstractsIron plus folate is more effective than iron alone in the treatment of iron deficiency anaemia in pregnancy: a randomised, double blind clinical trialBJOG : AN INTERNATIONAL JOURNAL OF OBSTETRICS & GYNAECOLOGY, Issue 9 2002Jorge Juarez-Vazquez Objective To evaluate whether folate supplementation to iron is able to accelerate solving of iron deficiency anaemia in pregnancy. Design Multicentre, double blind, randomised clinical trial. Setting Nine hospital gynaecologic units located in Mexico. Population Three hundred seventy-one women with iron deficiency anaemia between 14 and 27 weeks of pregnancy. Methods Random allocation of the study population to receive 80 mg iron proteinsuccinylate, with or without 0.370 mg folinic acid daily for 60 days. Main outcome measure Haemoglobin concentration increase. Results Combined iron and folate therapy showed a better therapeutic response: the increase in haemoglobin levels from baseline was 1.42 (0.14) g/dL for women treated with both compounds vs 0.80 (0.125) g/dL for those given iron only (P < 0.001). A multivariable regression analysis showed that this effect was independent of basal levels of blood iron, ferritine and serum folate and was more evident in women with more severe anaemia. In the 64 women belonging to the subgroup defined by the per-protocol (PP) population and the lowest quartile of baseline haemoglobin values (mean 8.96, range 5.9,9.8 g/dL), the increase at day 60 was estimated 2.3 (0.53) g/dL for the combined therapy vs 0.5 (0.5) g/dL for iron only (P= 0.07). No significant differences in tolerability were observed between the two groups. Conclusion Folate supplementation is recommended in pregnant women with iron deficiency anaemia irrespective of the serum levels of folate. [source] Early Functional Loading of Unsplinted Roughened Surface Implants with Mandibular Overdentures 2 Weeks after SurgeryCLINICAL IMPLANT DENTISTRY AND RELATED RESEARCH, Issue 3 2003Alan G.T. Payne BDS, FCD (SA), MDent ABSTRACT Background: Before early functional loading of unsplinted implants with mandibular overdentures can become widespread, more clinical studies are needed to investigate the success of the approach. Purpose: To evaluate the success rates of two types of roughened titanium surface implants with early 2-week functional loading of paired mandibular interforaminal implants with overdentures. Materials and Methods: Random allocation divided 24 strictly selected edentulous participants into two groups, with each group to receive a different implant system (ITI Dental Implant System, Straumann AG, Waldenburg, Switzerland; or Southern Implant System, Southern Implants, Irene, South Africa). Two implants were placed in the anterior mandible of all participants using one-stage standardized surgical procedures. Previously constructed conventional mandibular dentures (opposing maxillary complete dentures) were temporarily relined and worn by the participants for the first 2 weeks; participants used a soft diet. Two weeks after implant surgery and following some mucosal healing, the mandibular dentures had the tissue conditioner removed and the appropriate matrices included for an unsplinted prosthodontic design. Results: No implant from either group was lost. Resonance frequency analysis (RFA) indicated higher primary stability at surgery for the Southern group than for the ITI group, with a statistically significant difference between the groups throughout the study period. The drop in RF values between surgery and 6 weeks was significant and was greater for the Southern group. RFA also indicated stabilized osseointegration between 6 to 12 and 12 to 52 weeks, with no participant showing any decrease in those values over time. Participants with type 3 bone showed a significant improvement in RF values between 12 and 52 weeks, eventually matching those of participants with type 2 bone. There were no significant differences in marginal bone loss, periimplant parameters, or prosthodontic maintenance between the groups over the study period. Conclusions: Using only strict patient selection criteria, 1-year follow-up data indicate that early functional loading of ITI and Southern implants with mandibular two-implant overdentures is possible as early as 2 weeks after implant surgery. [source] Promoting acute thrombolysis for ischaemic stroke (PRACTISE)INTERNATIONAL JOURNAL OF STROKE, Issue 2 2007Protocol for a cluster randomised controlled trial to assess the effect of implementation strategies on the rate, effects of thrombolysis for acute ischaemic stroke (ISRCTN 20405426) Rationale Thrombolysis with intravenous rtPA is an effective treatment for patients with ischaemic stroke if given within 3 h from onset. Generally, more than 20% of stroke patients arrive in time to be treated with thrombolysis. Nevertheless, in most hospitals, only 1,8% of all stroke patients are actually treated. Interorganisational, intraorganisational, medical and psychological barriers are hampering broad implementation of thrombolysis for acute ischaemic stroke. Aims To evaluate the effect of a high-intensity implementation strategy for intravenous thrombolysis in acute ischaemic stroke, compared with regular implementation; to identify success factors and obstacles for implementation and to assess its cost-effectiveness, taking into account the costs of implementation. Design The PRACTISE study is a national cluster-randomised-controlled trial. Twelve hospitals have been assigned to the regular or high-intensity intervention by random allocation after pair-wise matching. The high-intensity implementation consists of training sessions in conformity with the Breakthrough model, and a tool kit. All patients who are admitted with acute stroke and onset of symptoms not longer than 24 h are registered. Study outcomes The primary outcome measure is treatment with thrombolysis. Secondary outcomes are admission within 4 h after onset of symptoms, death or disability at 3 months, the rate of haemorrhagic complications in patients treated with thrombolysis, and costs of implementation and stroke care in the acute setting. Tertiary outcomes are derived from detailed criteria for the organisational characteristics, such as door-to-needle time and protocol violations. These can be used to monitor the implementation process and study the effectiveness of specific interventions. Discussion This study will provide important information on the effectiveness and cost-effectiveness of actively implementing an established treatment for acute ischaemic stroke. The multifaceted aspect of the intervention will make it difficult to attribute a difference in the primary outcome measure to a specific aspect of the intervention. However, careful monitoring of intermediate parameters as well as monitoring of accomplished SMART tasks can be expected to provide useful insights into the nature and role of factors associated with implementation of thrombolysis for acute ischaemic stroke, and of effective acute interventions in general. [source] The Role of Benzodiazepines in the Treatment of InsomniaJOURNAL OF AMERICAN GERIATRICS SOCIETY, Issue 6 2001Meta-Analysis of Benzodiazepine Use in the Treatment of Insomnia PURPOSE: To obtain a precise estimate of the efficacy and common adverse effects of benzodiazepines for the treatment of insomnia compared with those of placebo and other treatments. BACKGROUND: Insomnia, also referred to as disorder of initiating or maintaining sleep, is a common problem and its prevalence among older people is estimated to be 23% to 34%.1 The total direct cost in the United States for insomnia in 1995 was estimated to be $13.9 billion.2 The complaint of insomnia in older people is associated with chronic medical conditions; psychiatric problems, mainly depression, chronic pain, and poor perceived general condition;1,3,4 and use of sleep medications.5 Thus in most cases, insomnia is due to some other underlying problem and is not just a consequence of aging.6 Accordingly, the management of insomnia should focus on addressing the primary problem and not just short-term treatment of the insomnia. Benzodiazepines belong to the drug class of choice for the symptomatic treatment of primary insomnia.7 This abstract will appraise a meta-analysis that compared the effect of benzodiazepines for short-term treatment of primary insomnia with placebo or other treatment. DATA SOURCES: Data sources included articles listed in Medline from 1966 to December 1998 and the Cochrane Controlled Trials Registry. The medical subject heading (MeSH) search terms used were "benzodiazepine" (exploded) or "benzodiazepine tranquillizers" (exploded) or "clonazepam,""drug therapy,""randomized controlled trial" or "random allocation" or "all random,""human," and "English language." In addition, bibliographies of retrieved articles were scanned for additional articles and manufacturers of brand-name benzodiazepines were asked for reports of early trials not published in the literature. STUDY SELECTION CRITERIA: Reports of randomized controlled trials of benzodiazepine therapy for primary insomnia were considered for the meta-analysis if they compared a benzodiazepine with a placebo or an alternative active drug. DATA EXTRACTION: Data were abstracted from 45 randomized controlled trials representing 2,672 patients, 47% of whom were women. Fifteen studies included patients age 65 and older and four studies involved exclusively older patients. Twenty-five studies were based in the community and nine involved inpatients. The duration of the studies ranged from 1 day to 6 weeks, with a mean of 12.2 days and median of 7.5 days. The primary outcome measures analyzed were sleep latency and total sleep duration after a sleep study, subjects' estimates of sleep latency and sleep duration, and subjects' report of adverse effects. Interrater reliability was checked through duplicate, independent abstraction of the first 21 articles. Overall agreement was between 95% and 98% (kappa value of 0.90 and 0.95 accordingly) for classification of the studies and validity of therapy, and 76% (kappa value of 0.51) for study of harmful effects. A scale of 0 to 5 was used to rate the individual reports, taking into account the quality of randomization, blinding, follow-up, and control for baseline differences between groups. Tests for homogeneity were applied across the individual studies and, when studies were found to be heterogeneous, subgroup analysis according to a predefined group was performed. MAIN RESULTS: The drugs used in the meta-analysis included triazolam in 16 studies; flurazepam in 14 studies; temazepam in 13 studies; midazolam in five studies; nitrazepam in four studies; and estazolam, lorazepam, and diazepam in two studies each. Alternative drug therapies included zopiclone in 13 studies and diphenhydramine, glutethimide, and promethazine in one study each. Only one article reported on a nonpharmacological treatment (behavioral therapy). The mean age of patients was reported in 33 of the 45 studies and ranged between 29 and 82. SLEEP LATENCY: In four studies involving 159 subjects, there was sleep-record latency (time to fall asleep) data for analysis. The pooled difference indicated that the latency to sleep for patients receiving a benzodiazepine was 4.2 minutes (95% CI = (,0.7) (,9.2)) shorter than for those receiving placebo. Patient's estimates of sleep latency examined in eight studies showed a difference of 14.3 minutes (95% CI = 10.6,18.0) in favor of benzodiazepines over placebo. TOTAL SLEEP DURATION: Analysis of two studies involving 35 patients in which total sleep duration using sleep-record results was compared indicated that patients in the benzodiazepine groups slept for an average of 61.8 minutes (95% CI = 37.4,86.2) longer than those in the placebo groups. Patient's estimates of sleep duration from eight studies (566 points) showed total sleep duration to be 48.4 minutes (95% CI = 39.6,57.1) longer for patients taking benzodiazepines than for those on placebo. ADVERSE EFFECTS: Analysis of eight studies (889 subjects) showed that those in the benzodiazepine groups were more likely than those in the placebo groups to complain of daytime drowsiness (odds ratio (OR) 2.4, 95% confidence interval (CI) = 1.8,3.4). Analysis of four studies (326 subjects) also showed that subjects in the benzodiazepine groups were more likely to complain of dizziness or lightheadedness than the placebo groups. (OR 2.6, 95% CI = 0.7,10.3). Despite the increased reported side effects in the benzodiazepine groups, drop-out rates were similar in the benzodiazepine and placebo groups. For patient reported outcome, there was no strong correlation found for sleep latency data, (r = 0.4, 95% CI = (,0.3) (,0.9)) or for sleep duration (r = 0.2, 95% CI = ,0.8,0.4) between benzodiazepine dose and outcome. COMPARISON WITH OTHER DRUGS AND TREATMENTS: In three trials with 96 subjects, meta-analysis of the results comparing benzodiazepines with zopiclone, did not show significant difference in sleep latency in the benzodiazepine and placebo groups, but the benzodiazepine groups had increased total sleep duration (23.1 min. 95% CI = 5.6,40.6). In four trials with 252 subjects, the side effect profile did not show a statistically significant difference (OR 1.5, CI 0.8,2.9). There was only one study comparing the effect of behavioral therapy with triazolam. The result showed that triazolam was more effective than behavioral therapy in decreasing sleep latency, but its efficacy declined by the second week of treatment. Behavioral therapy remained effective throughout the 9-week follow-up period. There were four small trials that involved older patients exclusively, with three of the studies having less than 2 weeks of follow-up. The results were mixed regarding benefits and adverse effects were poorly reported. CONCLUSION: The result of the meta-analysis shows that the use of benzodiazepines results in a decrease in sleep latency and a significant increase in total sleep time as compared with placebo. There was also a report of significantly increased side effects, but this did not result in increased discontinuation rate. There was no dose-response relationship for beneficial effect seen with the use of benzodiazepines, although the data are scant. Zopiclone was the only alternative pharmacological therapy that could be studied with any precision. There was no significant difference in the outcome when benzodiazepines were compared with zopiclone. There was only one study that compared the effect of benzodiazepines with nonpharmacological therapy; thus available data are insufficient to comment. [source] Bonding characteristics of newly developed all-in-one adhesivesJOURNAL OF BIOMEDICAL MATERIALS RESEARCH, Issue 2 2007S. K. Sidhu Abstract This study evaluated the microtensile bond strength and the interfacial morphology of newer adhesives. The occlusal surfaces of extracted teeth were ground flat for random allocation to four equal groups. Resin composite was bonded to each surface using either Clearfil SE Bond [SEB], Clearfil Protect Bond [PB], G-Bond [GB], or an experimental adhesive, SSB-200 [SSB]. After storage for 24 h in water at 37°C, they were sectioned into beams (cross-sectional area 1 mm2) for microtensile bond strength testing (,TBS) at a crosshead speed of 1 mm/min. The load at failure of each was recorded; the data were analyzed by one-way ANOVA and Games Howell tests. The surfaces of the fractured specimens were observed using SEM. For the ultra-morphology of the interface, the occlusal surfaces of four more teeth were prepared as before and a thin layer of flowable resin composite was bonded to each surface using one of the four adhesives. The mean ,TBS ranged from 39.68 MPa (GB) to 64.97 MPa (SEB). There were no statistical differences between SEB and SSB, or between PB and GB (p > 0.05). The ,TBS of SEB and SSB were significantly greater than that of PB and GB (p < 0.05). SEMs of the fractured surfaces revealed a mixed (cohesive/interfacial) failure. TEM examination highlighted differences in the hybrid layer; SEB had a thicker layer than the others. In conclusion, the newer all-in-one adhesives produced a thin hybrid layer but varied in their bond strengths. The 2-step self-etching adhesives do not necessarily produce higher bond strengths than that of the all-in-one systems. © 2006 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 2007 [source] An interactive education session and follow-up support as a strategy to improve clinicians' goal-writing skills: a randomized controlled trialJOURNAL OF EVALUATION IN CLINICAL PRACTICE, Issue 1 2010Elisabeth Marsland BAppSc(OT)Hons Abstract Background, Recent research indicates that allied health clinicians have difficulty articulating client needs and priorities into specific and measurable goals. As a result, a number of strategies to facilitate improvement in allied health clinicians' goal-setting skills have been recommended in the literature. In order to assist clinicians develop the skills required to set SMART goals, it is necessary that the strategies are rigorously tested. Aim, To determine if a 50-minute education session and 3-month email and telephone support programme improves clinicians' SMART goal-writing skill and accurately predicts improved goal-writing behaviour. Methods, Concealed random allocation of participants (n = 120) into two parallel groups: (1) intervention group received education on writing goals using the SMART Goal Evaluation Method as part of a workshop on outcome measurement and received 3 months of follow-up support (n = 60); and (2) control group attended a workshop on evidence-based practice (n = 60). Results, Education and follow-up support improved clinicians' SMART goal-writing skills at both the 3- and 6-month review (Yates ,2 = 4.324, d.f. = 1, P = 0.0375). Structural equation modelling revealed education and follow-up support is an accurate predictor of SMART goal-setting behaviour change at both 3 months (standardized regression weights = 0.21; P = 0.014) and 6 months (standardized regression weights = 0.19; P = 0.02) post intervention. Changes were modest and developed over a 6-month period. Conclusion, This study provides empirical evidence that a programme of educating clinicians in a standardized method of goal setting and providing follow-up support improves allied health clinicians' SMART goal-writing skills. [source] A systematic review and meta-analysis of randomised controlled trials evaluating interventions in adult literacy and numeracyJOURNAL OF RESEARCH IN READING, Issue 3 2003Carole J. Torgerson This paper reports a systematic review of the trial literature in the field of adult literacy and numeracy. The review was undertaken to investigate the effectiveness of teaching strategies and pedagogies designed to increase adult literacy and numeracy. The objectives were to search for and locate, synthesise and quality appraise all the randomised controlled trials aiming to evaluate interventions in adult literacy and/or numeracy, published between 1980 and 2002. Fifty-nine papers were included in the descriptive map. Twelve papers were included that contained nine randomised controlled trials. All of the trials included in the review were of high quality in the sense that they had adopted an appropriate study design for assessing effectiveness. However, within that study design many of the studies had methodological problems, for example: small sample size and lack of justification of sample size calculation; unclear method of random allocation; high attrition rate and lack of ,intention to teach' analysis. There was evidence of publication bias. Pooling three studies that compared teaching against no teaching showed a strong, positive and statistically significant effect on outcome. Two other studies examined the use of computer-assisted instruction (CAI) on literacy among imprisoned adults. Pooling these two studies showed a modest but not statistically significant benefit. There is a dearth of rigorous RCTs in the field of adult literacy and numeracy. The evidence is suggestive of a benefit of adult literacy and numeracy interventions; however, because of the heterogeneity of studies, the precise role of any intervention is uncertain and this finding may be undermined by the presence of substantial publication bias. We recommend that a series of large, well-designed and well-conducted randomised trials should be undertaken in the field of adult literacy and numeracy. [source] The stability of maternal ratings of medical student interviewsMEDICAL EDUCATION, Issue 9 2005Maree O'Keefe Introduction, Little information is available on the intrarater reliability of parent ratings of medical student interview skills. The aim of this study was to compare maternal ratings of a videotaped medical student interview, with ratings by the same mother of the same interview seen a month later. Method, Thirty mothers rated 1 of 2 ,medical student' interview videotapes (random allocation). An actor played the role of the student and demonstrated different student skill levels in each interview. Mothers rated the same interview again a month later (mean ± SD 34 ± 13 days). Maternal satisfaction was measured using the Medical Interview Satisfaction Scale (MISS, maximum score 203) and the Interpersonal Skills Rating Scale (IPS, maximum score 91) with higher scores indicating higher satisfaction. Results, No significant differences in mean maternal ratings were observed following the first and second viewings of each interview. The average percentage difference in first and second viewing scores was MISS 4%, IPS 8% with correlation coefficients MISS 0.96, IPS 0.87 (P < 0.05). Conclusions, The high levels of stability in maternal evaluations of simulated medical student interviews supports the use of maternal evaluations for longitudinal monitoring of medical student performance. [source] Randomised controlled trial of two antenatal care models in rural ZimbabweBJOG : AN INTERNATIONAL JOURNAL OF OBSTETRICS & GYNAECOLOGY, Issue 7 2007F Majoko Objective, To compare a five-visit antenatal care (ANC) model with specified goals with the standard model in a rural area in Zimbabwe. Design, Cluster randomised controlled trial with the clinic as the randomisation unit. Setting, Primary care setting in a developing country where care was provided by nurse-midwives. Population, Women booking for ANC in the clinics were eligible. Main outcome measures, Number of antenatal visits, antepartum and intrapartum referrals, utilization of health centre for delivery and perinatal outcomes. Methods, Twenty-three rural health centres were stratified prior to random allocation to the new (n= 11) or standard (n= 12) model of care. Results, We recruited 13 517 women (new, n= 6897 and standard, n= 6620) in the study, and 78% (10 572) of their pregnancy records were retrieved. There was no difference in median maternal age, parity and gestational age at booking between women in the standard model and those in the new model. The median number of visits was four for both models. The proportion of women with five or less visits was 77% in the new and 69% in the standard model (OR 1.5; 95% CI 1.08,2.2). The likelihood of haemoglobin testing was higher in the new model (OR 2.4; 95% CI 1.0,5.7) but unchanged for syphilis testing. There were fewer intrapartum transfers (5.4 versus 7.9% [OR 0.66; 95% CI 0.44,0.98]) in the new model but no difference in antepartum or postpartum transfers. There was no difference in rates of preterm delivery or low birthweight. The perinatal mortality was 25/1000 in standard model and 28/1000 in new model. Conclusion, In Gutu district, a focused five-visit schedule did not change the number of contacts but was more effective as expressed by increased adherence to procedures and better use of institutional health care. [source] Transcutaneous bilirubinometry reduces the need for blood sampling in neonates with visible jaundiceACTA PAEDIATRICA, Issue 12 2009S Mishra Abstract Objectives:, We determined usefulness of transcutaneous bilirubinometry to decrease the need for blood sampling to assay serum total bilirubin (STB) in the management of jaundiced healthy Indian neonates. Methods:, Newborns, ,35 weeks' gestation, with clinical evidence of jaundice were enrolled in an institutional approved randomized clinical trial. The severity of hyperbilirubinaemia was determined by two non-invasive methods: i) protocol-based visual assessment of bilirubin (VaB) and ii) transcutaneous bilirubin (TcB) determination (BiliCheck®). By a random allocation, either method was used to decide the need for blood sampling, which was defined to be present if assessed STB by allocated method exceeded 80% of hour-specific threshold values for phototherapy (2004 AAP Guidelines). Results:, A total of 617 neonates were randomized to either TcB (n = 314) or VaB (n = 303) groups with comparable gestation, birth weight and postnatal age. Need for blood sampling to assay STB was 34% lower (95% CI: 10% to 51%) in the TcB group compared with VaB group (17.5% vs 26.4% assessments; risk difference: ,8.9%, 95% CI: ,2.4% to ,15.4%; p = 0.008). Conclusion:, Routine use of transcutaneous bilirubinometry compared with systematic visual assessment of bilirubin significantly reduced the need for blood sampling to assay STB in jaundiced term and late-preterm neonates. (ClinicalTrials.gov number, NCT00653874) [source] | ||||||||||