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Results for “Randomised Controlled Trial”

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At least 865 records · Page 48Linked to original sources

PubMed1998

Reactions of participants to the results of a randomised controlled trial: exploratory study.

OBJECTIVES: To assess views of parents of babies who participated in a neonatal trial, about feedback of trial results. DESIGN: Qualitative analysis of interviews. SETTING: Parents' homes. SUBJECTS: Parents of 24 surviving babies enrolled in a UK randomised controlled trial comparing ventilatory support by extracorporeal membrane oxygenation with conventional management. MAIN OUTCOME MEASURES: Views about contents of results, reactions to results, effect of hindsight, and importance of feedback. RESULTS: Information about mortality was well understood by the parents but morbidity was less clearly reported. Even when the content was emotionally exacting, the information was still wanted as it removed uncertainty; provided an endpoint to difficult events; promoted further discussion within couples; and acknowledged their contribution to answering an important clinical question. CONCLUSIONS: Feedback of trial results to participants should be a consideration of researchers, but a careful approach is required. This study was based on a highly selective group of parents within a particularly sensitive trial. More research is needed to assess the extent to which these results can be generalised to other trials or to groups such as bereaved parents.

Adult↗

PubMed2006

Is inferior dissection of the rectus sheath necessary during Pfannenstiel incision for lower segment Caesarean section? A randomised controlled trial.

OBJECTIVE: The objective was to determine the benefit of non-dissection of the rectus sheath inferiorly in a Pfannenstiel incision during an elective Caesarean section with regard to operative blood loss and post-operative pain. DESIGN: A randomised controlled trial. SETTING: The Royal Free Teaching Hospital in London. POPULATION: One hundred and twenty women who underwent elective Caesarean section delivery. METHOD: Women were randomised to have dissection or non-dissection of the rectus sheath inferiorly during an elective Caesarean section. MAIN OUTCOME MEASURES: Estimated blood loss during the operation, as well as the difference between pre- and post-operative haemoglobin levels. Post-operative pain was assessed by the visual analogue scale, a verbal rating scale and the use of post-operative analgesia. Patient satisfaction was assessed by a verbal rating scale. RESULTS: There was no significant difference in the estimated blood loss during the procedure between the two groups; however, the mean difference between the pre-operative and post-operative haemoglobin was significantly smaller in the study group (p=0.05). There was a statistically significant difference in both the visual analogue scale (p-value=0.03) and the verbal rating scale scores (p-value=0.02) for pain between the two groups, with lower scores for the study group. There was no overall difference in the verbal rating scale scores for patient satisfaction. CONCLUSION: Non-dissection of the rectus sheath inferiorly in Pfannenstiel incisions during Caesarean section procedures is associated with a significant reduction in the post-operative pain as well as a smaller drop in post-operative haemoglobin.

Adult↗

PubMed1998

Randomised controlled trial to examine the effects of a GP exercise referral programme in Hailsham, East Sussex, on modifiable coronary heart disease risk factors.

OBJECTIVE: To examine the effects of a GP exercise referral programme on modifiable coronary heart disease risk factors. DESIGN: Randomised controlled trial. A battery of validated measures were carried out at 0, 8, 16, 26, and 37 weeks. SETTING: Two community health centres and a leisure centre in Hailsham, East Sussex. SUBJECTS: 389 patients (smokers, hypertensive or overweight) were selected from medical records, screened for contraindications to exercise and 345 were invited into the study. Of 142 patients randomly allocated, 40 (41%) completed the study in the exercise group and 31 (69%) in the control group. Sixty (35%) invited smokers (48% of non-smokers), 71 (38%) invited hypertensive patients (45% of non-hypertensive patients), and 107 (45%) overweight patients (33% of non-overweight patients) were randomised. Of those randomised, 27 (45%) smokers, 52 (48%) overweight, and 43 (61%) hypertensive patients completed the study. INTERVENTION: The exercise group was offered 20, half price sessions over 10 weeks at a leisure centre. Patients engaged in moderate and vigorous aerobic type activity on various exercise machines, in a semi-supervised, informal environment. RESULTS: 87% of those referred used the prescription and 28% (high adherers)(45% of obese patients) did at least 15 sessions. The exercise group reduced sum of skinfolds by 8.1% (2.9 to 13.3, 95% confidence intervals) more than the control group, up to 16 weeks after baseline. High adherers reduced sum of skinfolds by 9.2% (0.9 to 17.5) more than the control group, up to 26 weeks. High adherers reduced systolic blood pressure by 7.2% (-0.7 to 14.9) (that is, 9 mm Hg) more than low adherers, up to 37 weeks. Non-smokers and obese patients attended more prescribed sessions than smokers and non-overweight patients. CONCLUSIONS: Reduction in sum of skinfolds was maintained up to 26 weeks, among high adherers compared with controls. Reduction in systolic blood pressure was evident up to 37 weeks among high adherers, but only in comparison with low adherers. Selection of appropriate referees and use of other strategies to improve exercise adherence will help to maximise the benefits from GP exercise prescription schemes.

Coronary Disease↗

PubMed1997

A randomised controlled trial of Doppler ultrasound velocimetry of the umbilical artery in low risk pregnancies. Doppler French Study Group.

OBJECTIVE: To evaluate the effect on management and outcome of pregnancy of routine umbilical Doppler examination in low risk populations. DESIGN: Pragmatic randomised controlled trial. SETTING: Twenty centres caring for low risk pregnant women. PARTICIPANTS: 4187 women were randomly assigned to umbilical Doppler between 28 and 34 weeks of gestation or no routine umbilical Doppler. The women included were at low risk at 28 weeks of gestation defined by a normal ultrasonographic examination at the time of randomisation and no obstetric or medical complications during the first two trimesters of the pregnancy. RESULTS: The general characteristics at inclusion were comparable for the two groups. Performance of umbilical Doppler led to a significant increase in the number of ultrasonographic and Doppler examinations subsequently conducted; there were no other effects on the management of the pregnancy. There was no significant difference in fetal distress during labour (odds ratio [OR] 0.96; 95% confidence interval [CI] 0.70-1.33). There were three times fewer perinatal deaths in the Doppler group (three versus nine), but this difference was not significant (OR 0.33; 95% CI 0.06-1.33). CONCLUSION: Based on this trial routine use of umbilical doppler for low risk pregnancy cannot be recommended. More data are needed to reach a definite conclusion of the value of routine Doppler.

Adult↗

PubMed1998

Randomised controlled trial of the use of a modified postal reminder card on the uptake of measles vaccination.

OBJECTIVE: To determine whether rewording postal reminder cards according to the "health belief model", a theory about preventive health behaviour, would help to improve measles vaccination rates. DESIGN: A randomised controlled trial, with blind assessment of outcome status. Parents of children due for their first measles vaccination were randomised to one of two groups, one receiving the health belief model reminder card, the other receiving the usual, neutrally worded card. The proportion of children subsequently vaccinated in each group over a five week period was ascertained from clinical (provider based) records. SETTING: A local government operated public vaccination clinic. PARTICIPANTS: Parents of 259 children due for measles vaccination. MAIN RESULTS: The proportion of children vaccinated in the health belief model card group was 79% compared with 67% of those sent the usual card (95% CI, 2% to 23%), a modest but important improvement. CONCLUSION: This study illustrates how the effectiveness of a minimal and widely practised intervention to promote vaccination compliance can be improved with negligible additional effort.

Adult↗

PubMed2006

A randomised-controlled trial evaluating a fetal monitoring education programme.

OBJECTIVE: to evaluate the effectiveness of a fetal monitoring education programme on midwives' fetal monitoring knowledge and intrapartum cardiotocograph interpretation skills. DESIGN: two group, before-after, randomised-controlled trial. SETTING: two maternity hospitals in the Republic of Ireland. PARTICIPANTS: 55 midwives were randomly assigned to either the experimental group (n=27) or the control group (n=28). INTERVENTIONS: the experimental group participated in a 1.5 hr fetal monitoring education programme, whereas the control group attended an alternative education programme consisting of a non-fetal-monitoring-related video presentation. MEASUREMENTS: the primary outcomes of interest were fetal monitoring knowledge and intrapartum cardiotocograph interpretation skills test. FINDINGS: in the fetal monitoring knowledge post-test, the median percentage correct responses for the control and experimental groups were 56% (IQR 18.75) and 88% (IQR 12.5), respectively. This difference, 31.2%, was statistically significant (U=78.5, 95.1% CI -31.25 to -18.75, p<0.001). In the intrapartum cardiotocograph interpretation skills post-test, the median percentage correct responses for the control and experimental groups were 55.6% (IQR 16.7) and 66.7% (IQR 22.2), respectively. This difference, of 11.1%, was statistically significant (U=186, 95.2% CI -16.67 to -5.56, p<0.001). KEY CONCLUSIONS AND IMPLICATIONS FOR PRACTICE: attendance at a short (1.5 hr), in-service fetal monitoring education programme can increase midwives' fetal monitoring knowledge and cardiotocograph interpretation skills. The availability of in-service fetal monitoring education programmes is sporadic, often less than recommended, and is a cause for concern.

Adult↗

PubMedDate not supplied

Safety and efficacy of buccal midazolam versus rectal diazepam for emergency treatment of seizures in children: a randomised controlled trial.

BACKGROUND: Rectal diazepam and buccal midazolam are used for emergency treatment of acute febrile and afebrile (epileptic) seizures in children. We aimed to compare the safety and efficacy of these drugs. METHODS: A multicentre, randomised controlled trial was undertaken to compare buccal midazolam with rectal diazepam for emergency-room treatment of children aged 6 months and older presenting to hospital with active seizures and without intravenous access. The dose varied according to age from 2.5 to 10 mg. The primary endpoint was therapeutic success: cessation of seizures within 10 min and for at least 1 hour, without respiratory depression requiring intervention. Analysis was per protocol. FINDINGS: Consent was obtained for 219 separate episodes involving 177 patients, who had a median age of 3 years (IQR 1-5) at initial episode. Therapeutic success was 56% (61 of 109) for buccal midazolam and 27% (30 of 110) for rectal diazepam (percentage difference 29%, 95% CI 16-41). Analysing only initial episodes revealed a similar result. The rate of respiratory depression did not differ between groups. When centre, age, known diagnosis of epilepsy, use of antiepileptic drugs, prior treatment, and length of seizure before treatment were adjusted for with logistic regression, buccal midazolam was more effective than rectal diazepam. INTERPRETATION: Buccal midazolam was more effective than rectal diazepam for children presenting to hospital with acute seizures and was not associated with an increased incidence of respiratory depression.

Acute Disease↗

PubMed1999

Ex-vivo gene therapy of human vascular bypass grafts with E2F decoy: the PREVENT single-centre, randomised, controlled trial.

BACKGROUND: Cell-cycle blockade by ex-vivo gene therapy of experimental vein grafts inhibits the neointimal hyperplasia and subsequent accelerated atherosclerosis that lead to human bypass-graft failure. In a prospective, randomised, controlled trial, we investigated the safety and biological efficacy of intraoperative gene therapy in patients receiving bypass vein grafts. METHODS: We studied gene therapy that uses decoy oligodeoxynucleotide, which binds and inactivates the pivotal cell-cycle transcription factor E2F. 41 patients were randomly assigned untreated (16), E2F-decoy-treated (17), or scrambled-oligodeoxynucleotide-treated (eight) human infrainguinal vein grafts. Oligonucleotide was delivered to grafts intraoperatively by ex-vivo pressure-mediated transfection. The primary endpoints were safety and inhibition of target cell-cycle regulatory genes and of DNA synthesis in the grafts. Analysis was by intention to treat. FINDINGS: Mean transfection efficiency was 89.0% (SD 1.9). Proliferating-cell nuclear antigen and c-myc mRNA concentrations and bromodeoxyuridine incorporation were decreased in the EF2-decoy group by medians of 73% [IQR 53-84], 70% [50-79], and 74% [56-83], respectively) but not in the scrambled-oligodeoxynucleotide group (p<0.0001). Groups did not differ for postoperative complication rates. At 12 months, fewer graft occlusions, revisions, or critical stenoses were seen in the E2F-decoy group than in the untreated group (hazard ratio 0.34 [95% CI 0.12-0.99]). INTERPRETATION: Intraoperative transfection of human bypass vein grafts with E2F-decoy oligodeoxynucleotide is safe, feasible, and can achieve sequence-specific inhibition of cell-cycle gene expression and DNA replication. Application of this genetic-engineering strategy may lower failure rates of human primary bypass vein grafting.

Adult↗

PubMed1995

The efficacy of audiotapes in promoting psychological well-being in cancer patients: a randomised, controlled trial.

Open or uncontrolled studies have suggested that providing cancer patients with audiotapes of their clinical interviews can improve information recall and reduce psychological distress. We tested these hypotheses in a 'clinician-blind', prospective, randomised controlled trial. A total of 117 patients newly referred to a medical oncology clinic who were to be given 'bad news' had their consultations audiotaped. Blind to the clinician, patients were randomly allocated to receive a copy of the tape to play at home or not (control group). At 6 months follow-up, tape group patients reported positive attitudes to the audiotape and were shown to recall significantly more information about their illness than did controls. Overall improvement in psychological distress at 1 and 6 months follow-up, as measured with the 30-item General Health Questionnaire and the Hospital Anxiety and Depression Scale was no different in the two groups. However, a second-order interaction suggested that poor-prognosis patients were disadvantaged specifically by access to the audiotape, with less improvement in psychological distress at 6 months follow-up than non-tape controls. Patient access to audiotapes of clinical interviews promotes factual retention but does not reliably reduce psychological distress and may be actively unhelpful in some subgroups of patients.

Adult↗

PubMed2004

A randomised controlled trial of a care home rehabilitation service to reduce long-term institutionalisation for elderly people.

OBJECTIVES: to evaluate the effect of a care home rehabilitation service on institutionalisation, health outcomes and service use. DESIGN: randomised controlled trial, stratified by Barthel ADL index, social service sector and whether living alone. The intervention was a rehabilitation service based in Social Services old people's homes in Nottingham, UK. The control group received usual health and social care. PARTICIPANTS: 165 elderly and disabled hospitalised patients who wished to go home but were at high risk of institutionalisation (81 intervention, 84 control). MAIN OUTCOME MEASURES: institutionalisation rates, Barthel ADL index, Nottingham Extended ADL score, General Health Questionnaire (12 item version) at 3 and 12 months, Health and Social Service resource use. RESULTS: the number of participants institutionalised was similar at 3 months (relative risk 1.04, 95% confidence intervals 0.65-1.65) and 12 months (relative risk 1.23, 95% confidence intervals 0.75-2.02). Barthel ADL Index, Nottingham Extended ADL score and General Health Questionnaire scores were similar at 3 and 12 months. The intervention group spent significantly fewer days in hospital over 3 and 12 months (mean reduction 12.1 and 27.6 days respectively, P < 0.01), but spent a mean of 36 days in a care home rehabilitation service facility. CONCLUSIONS: this service did not reduce institutionalisation, but diverted patients from the hospital to social services sector without major effects on activity levels or well-being.

Activities of Daily Living↗

PubMed2004

Realism in evidence based medicine: interpreting the randomised controlled trial.

Realism is emerging as a paradigm for research and explanation in the natural and social sciences. A realist framework is elaborated and applied to the four possible situations that may generate the observations of randomised, controlled trials. It is demonstrated that by using two realist concepts "mechanism" and "context" a number of misinterpretations of such trials from within the dominant empiricist paradigm may be rectified. Evidence based medicine should adopt realism to temper a misleading empiricism, this will involve relegating statistical arguments to their proper subsidiary place and adopting an adequate theory of causation.

Causality↗

PubMed1990

Randomised controlled trial of recombinant human interferon -alpha A for chronic active hepatitis B.

The efficacy of interferon treatment for Australian patients with chronic active hepatitis B (CAH-B) was assessed by a three-centre randomised controlled trial in Sydney and Brisbane. Thirty patients (29 with histologically-proven CAH-B with and without cirrhosis and one with chronic persistent hepatitis) were allocated to receive either thrice weekly intramuscular injections of recombinant human leucocyte interferon -alpha A (either 2.5, 5.0 or 10.0 million units/m2) for six months followed by 12 months of observation, or to be observed for 18 months without active treatment. Three of 23 treated patients but none of seven controls underwent clinical, biochemical and histological resolution of their disease with loss of HBsAg, HBeAg and HBV-DNA from serum. An additional six treated and two control patients underwent a sustained partial remission of their disease. This was characterised by resolution of symptoms and serum aminotransferase abnormalities in association with seroconversion from HBeAg positive to negative, loss of HBV-DNA from serum but persistent hepatitis B surface antigenaemia. In such patients, there was significant improvement in histological appearances but some necroinflammatory activity remained and fibrosis was unchanged. Although total response rates were similar in treated and control subjects, they appeared to occur earlier after interferon treatment. Treatment with interferon was associated with predictable but minor side effects that usually did not necessitate dose reduction and rarely compromised the patient's life style. Interferon is thus a feasible treatment for CAH-B. Complete responses occurred only in treated patients and partial responses appeared to occur earlier in treated than in untreated patients. However, differences in the partial response rate at 18 months were not significant and seroconversion from HBeAg positive to negative was not associated with complete histological resolution of disease activity. Hence, while interferon is a promising agent for treatment of CAH-B, efforts must continue to define more optimal treatment regimes and to identify those patients most likely to respond to this agent.

Adult↗

PubMed2002

A two-centred pragmatic randomised controlled trial of two interventions of postnatal support.

OBJECTIVES: To establish whether providing additional postnatal support during the early postnatal months influences women's physical and psychological health and to identify health service benefits. DESIGN: Pragmatic randomised controlled trial with a 2 x 2 factorial design with two interventions. SETTING: Community centres, Ayrshire and Grampian, Scotland. POPULATION: One thousand and four primiparous women, 83% completed the baseline questionnaire, 71% at six months. METHODS: (1) An invitation to a local postnatal support group run weekly with a facilitator, starting two weeks postpartum. (2) A postnatal support manual, posted two weeks postpartum. MAIN OUTCOME MEASURES: Data regarding primary outcome postnatal depression (Edinburgh Postnatal Depression Scale, EPDS), secondary outcomes, general health measures (SF-36), social support (SSQ6), use of health services and women's views of interventions were collected at two weeks postpartum and at three and six months. RESULTS: There were no significant differences in EPDS scores between the control and trial arms at three and six months, nor were there differences in the SF-36 and the SSQ6 scores. The 95% CI for the difference in EPDS effectively excluded a change in mean score of more than 10% with either intervention. There were no differences in health service attendances in primary or secondary care between the control and trial arms. Of those women who attended the groups, 40% attended six or more. Women reported favourably on the 'pack' with the majority reading it a few times and feeling that it was aimed at them. CONCLUSIONS: Wide-scale provision by the National Health Service of either support groups or self-help manuals is not appropriate if the aim is to improve measurable health outcomes.

Adult↗

PubMed2005

Randomised controlled trial of community debriefing following operative delivery.

OBJECTIVE: The aim of this study was to determine if two debriefing sessions following an operative delivery could reduce a woman's fear of future childbirth. DESIGN: Prospective randomised controlled trial (RCT) with two arms comparing debriefing, aimed to reduce fear of future childbirth, with standard care after birth. SETTING: District General Hospital with 2500 deliveries per year. SAMPLE: Three hundred and nineteen mothers who delivered a first child by operative delivery (i.e. forceps, vacuum or emergency caesarean section). The study took place at Huddersfield Royal Infirmary, from January 2002 to July 2003. METHODS: Debriefing by community midwives specifically trained in postpartum debriefing at 10 days and 10 weeks. MAIN OUTCOME MEASURE: Fear of childbirth was assessed using the Wijma Delivery Expectancy Scale (WDEQ). WDEQ scores were measured 10 days, 10 weeks and 20 weeks following delivery. RESULTS: Fear of childbirth as measured by the WDEQ was lower throughout the study for the debriefing group. However, it never reached statistical significance in the short term [10 days debriefing = 94.5, control = 97.5 (P= 0.295), 10 weeks debriefing = 92.0, control = 97.9 (P= 0.076), 20 weeks debriefing = 90.9, control = 97.4 (P= 0.057)]. CONCLUSION: This study shows in the short term there was no significant difference in the WDEQ fear of childbirth scores. The debriefing group were showing a tendency for lower scores. Long term follow up of these cases may be more relevant.

Adult↗

PubMed1996

Double blind randomised controlled trial of effect of metoprolol on myocardial ischaemia during endoscopic cholangiopancreatography.

OBJECTIVE: To evaluate the effect of metoprolol, a beta adrenergic blocking drug, on the occurrence of myocardial ischaemia during endoscopic cholangiopancreatography. DESIGN: Double blind, randomised, controlled trial. SETTING: University Hospital. SUBJECTS: 38 (two groups of 19) patients scheduled for endoscopic cholangiopancreatography. INTERVENTIONS: Metoprolol 100 mg or placebo as premedication two hours before endoscopy. MAIN OUTCOME MEASURES: Heart rate, arterial oxygen saturation by continuous pulse oximetry, ST segment changes during endoscopic cholangiopancreatography (an ST segment deviation > 1 mV was defined as myocardial ischaemia), electrocardiogram monitored continuously with a Holter tape recorder. RESULTS: All patients had increased heart rate during endoscopy compared with rate before endoscopy, but heart rate during endoscopy was significantly lower in the metoprolol group compared with the placebo group (P = 0.0002). Twenty one patients (16 placebo, 5 metoprolol; P = 0.0008) developed tachycardia (heart rate > 100/min) during the procedure, and 11 patients (10 placebo, 1 metoprolol; P = 0.003) developed myocardial ischaemia. One patient in the placebo group had an acute inferolateral myocardial infarction. In the 10 other patients with signs of myocardial ischaemia during endoscopy the ST deviation disappeared when the endoscope was retracted. In all patients myocardial ischaemia was related to increases in heart rate, and 10 of the 11 patients had tachycardia coherent with myocardial ischaemia. CONCLUSIONS: Metoprolol prevented myocardial ischaemia during endoscopic cholangiopancreatography, probably through lowering the heart rate. Thus, tachycardia seems to be a key pathogenic factor in the development of myocardial ischaemia during endoscopy.

Adrenergic beta-Agonists↗

PubMed1998

Randomised controlled trial comparing hospital at home care with inpatient hospital care. I: three month follow up of health outcomes.

OBJECTIVES: To compare hospital at home care with inpatient hospital care in terms of patient outcomes. DESIGN: Randomised controlled trial with three month follow up. SETTING: District general hospital and catchment area of neighbouring community trust. SUBJECTS: Patients recovering from hip replacement (n=86), knee replacement (n=86), and hysterectomy (n=238); elderly medical patients (n=96); and patients with chronic obstructive airways disease (n=32). INTERVENTIONS: Hospital at home care or inpatient hospital care. MAIN OUTCOME MEASURES: Dartmouth COOP chart to measure patients' general health status; SF-36 to measure possible limitations in physical functioning of patients with hysterectomy; disease specific measures-chronic respiratory disease questionnaire, Barthel index for elderly medical patients, Oxford hip score, and Bristol knee score; hospital readmission and mortality data; carer strain index to measure burden on carers; patients' and carers' preferred form of care. RESULTS: At follow up, there were no major differences in outcome between hospital at home care and hospital care for any of the patient groups except that those recovering from hip replacement reported a significantly greater improvement in quality of life with hospital at home care (difference in change from baseline value 0.50, 95% confidence interval 0.13 to 0.88). Hospital at home did not seem suitable for patients recovering from a knee replacement, as 14 (30%) of patients allocated to hospital at home remained in hospital. Patients in all groups preferred hospital at home care except those with chronic obstructive airways disease. No differences were detected for carer burden. Carers of patients recovering from knee replacement preferred hospital at home care, while carers of patients recovering from a hysterectomy preferred hospital care. CONCLUSIONS: Few differences in outcome were detected. Thus, the cost of hospital at home compared with hospital care becomes a primary concern.

Adult↗

PubMed2000

Randomised controlled trial of community based speech and language therapy in preschool children.

OBJECTIVE: To compare routine speech and language therapy in preschool children with delayed speech and language against 12 months of "watchful waiting." DESIGN: Pragmatic randomised controlled trial. SETTING: 16 community clinics in Bristol. PARTICIPANTS: 159 preschool children with appreciable speech or language difficulties who fulfilled criteria for admission to speech and language therapy. MAIN OUTCOME MEASURES: Four quantitative measures of speech and language, assessed at 6 and 12 months; a binary variable indicating improvement, by 12 months, on the trial entry criterion. RESULTS: Improvement in auditory comprehension was significant in favour of therapy (adjusted difference in means 4.1, 95% confidence interval 0.5 to 7.6; P=0.025). No significant differences were observed for expressive language (1.4, -2.1 to 4.8; P=0.44); phonology error rate (-4.4, -12.0 to 3.3; P=0.26); language development (0.1, -0.4 to 0.6; P=0.73); or improvement on entry criterion (odds ratio 1.3, 0.67 to 2.4; P=0.46). At the end of the trial, 70% of all children still had substantial speech and language deficits. CONCLUSIONS: This study provides little evidence for the effectiveness of speech and language therapy compared with watchful waiting over 12 months. Providers of speech and language therapy should reconsider the appropriateness, timing, nature, and intensity of such therapy in preschool children. Continued research into more specific provision to subgroups of children is also needed to identify better treatment methods. The lack of resolution of difficulties for most of the children suggests that further research is needed to identify effective ways of helping this population of children.

Analysis of Variance↗

PubMed2004

Delivering interventions for depression by using the internet: randomised controlled trial.

OBJECTIVE: To evaluate the efficacy of two internet interventions for community-dwelling individuals with symptoms of depression--a psychoeducation website offering information about depression and an interactive website offering cognitive behaviour therapy. DESIGN: Randomised controlled trial. SETTING: Internet users in the community, in Canberra, Australia. PARTICIPANTS: 525 individuals with increased depressive symptoms recruited by survey and randomly allocated to a website offering information about depression (n = 166) or a cognitive behaviour therapy website (n = 182), or a control intervention using an attention placebo (n = 178). MAIN OUTCOME MEASURES: Change in depression, dysfunctional thoughts; knowledge of medical, psychological, and lifestyle treatments; and knowledge of cognitive behaviour therapy. RESULTS: Intention to treat analyses indicated that information about depression and interventions that used cognitive behaviour therapy and were delivered via the internet were more effective than a credible control intervention in reducing symptoms of depression in a community sample. For the intervention that delivered cognitive behaviour therapy the reduction in score on the depression scale of the Center for Epidemiologic Studies was 3.2 (95% confidence interval 0.9 to 5.4). For the "depression literacy" site (BluePages), the reduction was 3.0 (95% confidence interval 0.6 to 5.2). Cognitive behaviour therapy (MoodGYM) reduced dysfunctional thinking and increased knowledge of cognitive behaviour therapy. Depression literacy (BluePages) significantly improved participants' understanding of effective evidence based treatments for depression (P < 0.05). CONCLUSIONS: Both cognitive behaviour therapy and psychoeducation delivered via the internet are effective in reducing symptoms of depression.

Adolescent↗