Search PubMed⌕ Search

SEARCH · Search PubMed

Results for “Randomised controlled trials as topic”

Search indexed PubMed citations on genomics, clinical trials, systematic reviews and public health. Explore titles, authors and supplied subject terms, then open the PubMed record.

Quote a phrase for an exact phrase match. Source license links do not imply unrestricted reuse.

At least 829 records · Page 46Linked to original sources
PubMed2001

Limitations in randomised controlled trials evaluating drug effects in mania.

Considering the increasing number of drugs evaluated for mania in randomised controlled trials (RCTs) and the potential discrepancies between recommendations based on RCTs and the antimanic treatment given in clinical practice, this paper addresses some issues related to RCTs on drug effects in mania. One major question raised in the paper is to what extent selection prior to the point of randomisation in RCTs in mania may limit the applicability of study results to patients seen in ordinary clinical practice. Although such limitations in generalisability can be difficult to investigate empirically, it is emphasised that they should be openly discussed in the reports of RCTs. Another major focus is the issue of evaluation and interpretation of outcome, including a discussion of various response criteria based on mania rating scale scores. It is pointed out that essential criteria of dimensionality have only been sufficiently evaluated for the Bech-Rafaelsen Mania Rating Scale, although the fulfilment of such criteria are prerequisites for adding up the item scores to a total score reflecting the severity of mania. It is suggested that response defined as a decline in mania score below a certain limit may have some advantages over the commonly used 50% reduction criterion. The issues arising from the unusual high drop-out rates of around 50% are also addressed. Despite the fact that we need rigorous placebo-controlled trials to establish antimanic efficacy of new compounds, we also need large scale pragmatic studies using broad inclusion criteria, comparing the various treatments, alone or in combination, to investigate how they work in clinical practice. These studies maybe randomised but open and use simple but relevant outcome measures.

Antimanic Agents↗
PubMed2001

Lymph-node metastases in patients with melanoma: what is the optimum management?

Lymph-node metastasis is an indicator of poor prognosis for patients with melanoma. The management of regional nodes is controversial, with continuing debate about whether surgery or radiotherapy of positive lymph nodes improves long-term survival or whether nodal involvement is merely a marker of aggressive disease. However, there is general agreement that systemic chemotherapy is rarely an effective form of management. This review therefore considers surgical and radiotherapeutic aspects of lymph-node management in patients with melanoma. We discuss regional control and survival after lymph-node surgery in retrospective series, randomised trials of elective lymph-node dissection, the role of 'sentinel' lymph-node biopsy, radiobiology and radiotherapy fractionation issues in melanoma treatment, retrospective studies of adjuvant nodal radiotherapy, and finally, randomised trials of adjuvant radiotherapy after lymph-node dissection.

Combined Modality Therapy↗
PubMed2002

Mechanical ventilation for newborn infants with respiratory failure due to pulmonary disease.

BACKGROUND: Before the 1960s newborn infants with severe lung disease, usually due to respiratory distress syndrome (RDS), had a very high mortality rate. Standard treatment consisted of supportive measures including supplemental oxygen and correction of metabolic acidosis. Mechanical ventilation (MV) was introduced in the 1960s to correct hypoxaemia and respiratory acidosis in infants who were likely to die. MV is now standard treatment for infants with severe RDS but the degree to which this made a contribution to the outcome of such infants compared with standard neonatal care, is uncertain. OBJECTIVES: To evaluate the effects of the use of MV compared with no MV on mortality and morbidity in newborn infants with severe respiratory failure due to pulmonary disease. SEARCH STRATEGY: Searches were last updated in March 2002 on the Cochrane Controlled Trials Register (Cochrane Library Issue 1, 2002), MEDLINE from 1966 and EMBASE from 1980. In order to detect trials that may not have been published in full, searches carried out of the Oxford Database of Perinatal Trials and for abstracts published by the Society for Pediatric Research (1967 to 2001) and the European Society for Pediatric Research 1970 to 1977. Experts were consulted with emphasis on those who were in active neonatal practice in the 1960s and 1970s when the majority of these trials were likely to have been done. SELECTION CRITERIA: Randomised or quasi-randomised controlled trials in newborn infants with respiratory failure due to pulmonary disease evaluating the use of MV versus standard neonatal care without MV. DATA COLLECTION AND ANALYSIS: The standard methods of the Cochrane Collaboration and its Neonatal Review Group were used. Two authors independently assessed eligibility, methodological quality of each trial and extracted the data. Additional information was obtained from all trial authors on methodology or data. The data were analysed using relative risk and risk difference and their 95% confidence intervals. A fixed effect model was used for meta-analyses. MAIN RESULTS: The five trials reported on a total of 359 infants with RDS. In one study there is a higher neonatal mortality in the mechanical ventilation group [7/10 vs 1/10; RR 7.00 (1.04, 46.95)]. Overall any reported mortality is less frequent in the mechanical ventilation group with the upper 95% confidence limit on 1.00 [summary RR 0.86 (0.74, 1.00), RD -0.10 (-0.20, -0.01), NNT 10 (5, 100)]. In infants with a birth weight of 1 - 2 kg, no significant difference in mortality is found [summary RR for two trials 0.86 (0.70, 1.07)]. In infants with a birth weight of more than 2 kg, one study reports a significant reduction in mortality in the MV group compared with control [RR 0.67 (0.51, 0.86)]; overall for this birth weight group there is a significant reduction in mortality with MV in the two trials [summary RR 0.67 (0.52, 0.87), RD -0.27 (-0.45, -0.10), NNT 4 (2, 10)]. Any IVH at autopsy is not significantly different between the groups in any study or overall in four studies reporting on 202 infants who had an autopsy. Pneumothorax was reported in two studies of 275 infants and there is a non-significant trend towards an increase in the mechanical ventilation group [summary RR 2.75 (0.72, 10.45)]. REVIEWER'S CONCLUSIONS: When MV was introduced in the 1960s to treat infants with severe respiratory failure due to pulmonary disease, trials showed an overall reduction in mortality which was most marked in infants born with a birthweight of more than 2 kg. This review does not provide information to evaluate the relative benefits or harms of MV in the setting of modern perinatal care. In settings without modern neonatal care, the introduction of MV should ideally be evaluated in randomised controlled trials for its relative benefits, harms and costs.

Humans↗
PubMed2005

Ginkgo biloba for acute ischaemic stroke.

BACKGROUND: Ginkgo biloba extract is widely used in the treatment of acute ischaemic stroke in China. We aimed to assess the evidence from randomised controlled trials and quasi-randomised controlled trials on the use of Ginkgo biloba extract in acute ischaemic stroke. OBJECTIVES: The primary objective was to determine whether Ginkgo biloba extract improves functional outcome without causing undue harm in patients with acute ischaemic stroke. Secondary objectives were to assess the effect of Ginkgo biloba extract on neurological impairment and quality of life. SEARCH STRATEGY: We searched the Cochrane Stroke Group Trials Register (last searched October 2004), the Trials Register of the Cochrane Complementary Medicine Field (last searched October 2004) and the Chinese Stroke Trials Register (last searched June 2004). In addition, we searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library Issue 3, 2004), MEDLINE (1966 to August 2004), EMBASE (1980 to June 2004), AMED (1985 to May 2002) and the China Biological Medicine Database (CBM-disc, 1979 to August 2004). We searched relevant clinical trials and research registers and contacted pharmaceutical companies and researchers in an effort to identify further published and unpublished studies. SELECTION CRITERIA: Randomised controlled trials or quasi-randomised controlled clinical trials comparing Ginkgo biloba extract with placebo or open control (no placebo) in patients with acute ischaemic stroke. DATA COLLECTION AND ANALYSIS: Two reviewers independently selected trials for inclusion, assessed trial quality and extracted the data. MAIN RESULTS: Fourteen trials were identified, of which 10 trials (792 patients) were included. Four trials are awaiting assessment. In the 10 included trials follow up was performed at 14 to 35 days after stroke. In all studies neurological outcome was assessed but none of them reported on disability (activities of daily living function) or quality of life. Only three trials reported adverse events. In nine trials, all of them assessed to be of inferior quality, significant improvement in neurological deficit at the end of the treatment was used as the outcome measure. When analysing these trials together, Ginkgo biloba extract was associated with a significant increase in the number of improved patients (Peto odds ratio (OR) 2.66; 95% confidence interval (CI) 1.79 to 3.94). One placebo-controlled trial, assessed to be of good quality, reported neurological outcome as a continuous variable. It failed to show an improvement of neurological deficit at the end of treatment (weighted mean difference (fixed) 0.81; 95% CI -8.9 to 10.52). No deaths or major adverse events were reported during the follow-up period. AUTHORS' CONCLUSIONS: There was no convincing evidence from trials of sufficient methodological quality to support the routine use of Ginkgo biloba extract to promote recovery after stroke. High-quality and large-scale randomised controlled trials are needed to test its efficacy.

Ginkgo biloba↗
PubMed2004

Rehabilitation after surgery for flexor tendon injuries in the hand.

BACKGROUND: Postoperative rehabilitation of the flexor tendons in the hand consists of a short period of immobilisation while pain and swelling diminish, followed by progressive mobilisation to maximize the range of motion of the affected fingers. By altering the time of immobilisation and the manner of subsequent mobilisation different rehabilitation regimes are created. OBJECTIVES: To determine, with evidence from randomised controlled trials, the optimal rehabilitation strategy after surgery for flexor tendon injuries in the hand. SEARCH STRATEGY: We searched the Cochrane Musculoskeletal Injuries Group specialised register (November 2002), the Cochrane Central Register of Controlled Trials (The Cochrane Library, issue 4, 2002), MEDLINE (1966 to November 2002), EMBASE (1988 to November 2002), CINAHL (1982 to October 2002), CURRENT CONTENTS (1993 to October 2002), PEDro - The Physiotherapy Evidence Database (http://ptwww.cchs.usyd.edu.au/pedro/ accessed 30/10/2002) and reference lists of articles. SELECTION CRITERIA: All randomised and quasi-randomised controlled trials of interventions for rehabilitation after surgery of flexor tendon injuries in the hand after surgery. DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed trial quality, using a 10 item scale, and extracted data where possible. Additional information was sought from trialists when required. Due to the lack of extractable data and the variety of interventions used, pooling was not attempted. Where possible relative risks and 95 per cent confidence intervals were calculated for dichotomous outcomes, and mean differences and 95 per cent confidence intervals calculated for continuous outcomes. MAIN RESULTS: Six trials, including three reported only in abstracts, with a total of 464 participants were included. Data were not pooled. One trial compared continuous passive motion (CPM) with controlled intermittent passive motion (CIPM) and found a significant difference in mean active motion favouring CPM (WMD 19.00 degrees, 95% CI 15.11 to 22.89). One trial compared a shortened passive flexion/active extension programme with a normal passive flexion/active extension mobilisation programme, and reported (without data) a significant reduction in absence from work of 2.1 weeks in favour of the shortened programme. Other trials compared active flexion with rubber band traction, early controlled active mobilisation with early controlled passive mobilisation and dynamic splintage versus static splintage. No trials found significant differences in overall functioning or complication rate. REVIEWERS' CONCLUSIONS: Controlled mobilisation regimens are widely employed in rehabilitation after flexor tendon repair in the hand. This review found insufficient evidence from randomised controlled trials to define the best mobilisation strategy.

Finger Injuries↗