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 1,153 records · Page 64Linked to original sources
PubMed2002

Psychostimulants for hypersomnia (excessive daytime sleepiness) in myotonic dystrophy.

BACKGROUND: Excessive daytime sleepiness is a common symptom of myotonic dystrophy. Psychostimulants are drugs increasingly used to treat hypersomnia in myotonic dystrophy. OBJECTIVES: To search systematically for, and combine all evidence from, randomised trials relating to the effects of psychostimulants in myotonic dystrophy patients with hypersomnia. SEARCH STRATEGY: We searched the Cochrane Neuromuscular Disease Trial Register (searched May 2001) for randomised trials concerning psychostimulants in myotonic dystrophy, we searched of the bibliographies of identified papers and we contacted the authors of the papers. SELECTION CRITERIA: We considered all randomised or quasi randomised trials that have evaluated any type of psychostimulants (versus a placebo or no treatment) in children or adults with proven myotonic dystrophy and hypersomnia. DATA COLLECTION AND ANALYSIS: Potentially relevant papers were scrutinised by two reviewers and the selection of eligible studies was agreed by them and a third reviewer. Data were extracted by one reviewer and checked by a second reviewer. MAIN RESULTS: Primary outcome We found no trial that assessed the effect of a psychostimulant on the results of the maintenance of wakefulness tests. Secondary outcomes Only one eligible trial was found. In this crossover double blind study of 10 patients with myotonic dystrophy, the efficacy of selegiline was evaluated against a placebo on the multiple sleep latency test. There was no difference between the selegiline and placebo periods in mean improvement in the multiple sleep latency test scale. REVIEWER'S CONCLUSIONS: There is no evidence to support the use of a psychostimulant to treat hypersomnia in myotonic dystrophy. Randomised trials are needed to evaluate the efficacy and safety of psychostimulants.

Disorders of Excessive Somnolence↗
PubMed2006

Study protocol: SPARCLE--a multi-centre European study of the relationship of environment to participation and quality of life in children with cerebral palsy.

BACKGROUND: SPARCLE is a nine-centre European epidemiological research study examining the relationship of participation and quality of life to impairment and environment (physical, social and attitudinal) in 8-12 year old children with cerebral palsy. Concepts are adopted from the International Classification of Functioning, Disability and Health which bridges the medical and social models of disability. METHODS/DESIGN: A cross sectional study of children with cerebral palsy sampled from total population databases in 9 European regions. Children were visited by research associates in each country who had been trained together. The main instruments used were KIDSCREEN, Life-H, Strength and Difficulties Questionnaire, Parenting Stress Index. A measure of environment was developed within the study. All instruments were translated according to international guidelines. The potential for bias due to non response and missing data will be examined. After initial analysis using multivariate regression of how the data captured by each instrument relate to impairment and socio-economic characteristics, relationships between the latent traits captured by the instruments will then be analysed using structural equation modelling. DISCUSSION: This study is original in its methods by directly engaging children themselves, ensuring those with learning or communication difficulty are not excluded, and by studying in quantitative terms the crucial outcomes of participation and quality of life. Specification and publication of this protocol prior to analysis, which is not common in epidemiology but well established for randomised controlled trials and systematic reviews, should avoid the pitfalls of data dredging and post hoc analyses.

Cerebral Palsy↗
PubMed2003

Cognitive behaviour therapy for primary insomnia: can we rest yet?

Cognitive behaviour therapy (CBT) for chronic insomnia has been a topic of interest to researchers and clinicians for over forty years. Investment in this area has paid off. Two meta-analyses and one major review by the Standards of Practice Committee of the American Academy of Sleep Medicine have concluded, beyond doubt, that CBT is effective in the treatment of primary insomnia. In this paper we argue that it is timely to raise new questions of CBT for insomnia: namely, is there still room for improvement? and can we rest yet? Whilst significant progress has been made we argue that the field is not, as yet, at a point where patients can be offered a maximally effective psychological treatment. Two lines of argument are developed to support this conclusion. First, it is noted that whilst the effect size for CBT for insomnia is moderate, it is lower than the effect sizes reported for CBT for a range of other psychological disorders. Second, it is suggested that the large literature outlining optimal procedures for conducting randomised controlled trials (RCTs) need to be more fully adopted by research workers in this field. Directions for future research are outlined including (1) guidelines for improved RCT methodology and (2) suggestions for developing empirically grounded treatments.

Cognitive Behavioral Therapy↗
PubMedDate not supplied

Insulin and normal eating.

Sarah Bloor critiques a research paper about a randomised control trial, which examined the use of training in flexible, intensive insulin management to enable dietary freedom for people with type 1 diabetes. (Dose Adjustment for Normal Eating Study Group, 2002).

Blood Glucose↗
PubMedDate not supplied

The effectiveness of transdermal fentanyl in palliative care.

Current literature suggests that transdermal fentanyl is efficacious in relieving cancer-related pain with less opioid-related constipation than morphine for patients in the palliative care setting. However, randomised controlled trials are needed to study the drug's efficacy compared with other level-three opioids that are used to manage cancer-related pain in palliative care.

Administration, Cutaneous↗
PubMed2000

Electrical stimulation for preventing and treating post-stroke shoulder pain.

BACKGROUND: Shoulder pain after stroke is common and disabling. The optimal management is uncertain, but electrical stimulation (ES) is often used to treat and prevent pain. OBJECTIVES: The objective of this review was to determine the efficacy of any form of surface ES in the prevention and / or treatment of pain around the shoulder at any time after stroke. SEARCH STRATEGY: We searched the Cochrane Stroke Review Group trials register and undertook further searches of MEDLINE, EMBASE and CINAHL. Contact was established with equipment manufacturers and centres that have published on the topic of ES. SELECTION CRITERIA: We considered all randomised trials that assessed any surface ES technique (functional electrical stimulation (FES), transcutaneous electrical nerve stimulation (TENS) or other), applied at any time since stroke for the purpose of prevention or treatment of shoulder pain. DATA COLLECTION AND ANALYSIS: Two reviewers independently selected trials for inclusion, assessed trial quality and extracted the data. MAIN RESULTS: Four trials (a total of 170 subjects) fitted the inclusion criteria. Study design and ES technique varied considerably, often precluding the combination of studies. Population numbers were small. There was no significant change in pain incidence (Odds Ratio (OR) 0.64; 95% CI 0.19 to 2.14) or change in pain intensity (Standardised Mean Difference (SMD) 0.13; 95% CI -1.0 to 1.25) after ES treatment compared to control. There was a significant treatment effect in favour of ES for improvement in pain-free range of passive humeral lateral rotation (Weighted Mean Difference (WMD) 9.17; 95% CI 1.43 to 16.91). In these studies ES reduced the severity of glenohumeral subluxation (SMD -1.13; 95% CI -1.66 to -0.60), but there was no significant effect on upper limb motor recovery (SMD 0.24; 95% CI -0.14 to 0.62) or upper limb spasticity (WMD 0.05; 95% CI -0.28 to 0.37). There did not appear to be any negative effects of electrical stimulation at the shoulder. REVIEWER'S CONCLUSIONS: The evidence from randomised controlled trials so far does not confirm or refute that ES around the shoulder after stroke influences reports of pain, but there do appear to be benefits for passive humeral lateral rotation. A possible mechanism is through the reduction of glenohumeral subluxation. Further studies are required.

Electric Stimulation Therapy↗
PubMed2006

Topical treatments for cutaneous warts.

BACKGROUND: Viral warts are common and usually harmless but very troublesome. A very wide range of local treatments are used. OBJECTIVES: To assess the effects of different local treatments for cutaneous, non-genital warts in healthy people. SEARCH STRATEGY: We searched the Cochrane Skin Group Specialised Register (March 2005), the Cochrane Central Register of Controlled Trials (The Cochrane Library Issue 1, 2005), MEDLINE (1966 to March 2005), EMBASE (1980 to March 2005) and a number of other biomedical databases. The references of all trials and selected review articles were also searched. In addition, we contacted pharmaceutical companies involved in local treatments for warts and experts in the field SELECTION CRITERIA: Randomised controlled trials of local treatments for cutaneous non-genital viral warts in immunocompetent (healthy) people. DATA COLLECTION AND ANALYSIS: Data was extracted and two authors independently selected the trials and assessed methodological quality. MAIN RESULTS: Sixty trials were identified that fulfilled the criteria for inclusion. The evidence provided by these studies was generally weak due to poor methodology and reporting. In 21 trials with placebo groups that used participants as the unit of analysis, the average cure rate of placebo preparations was 27% (range 0 to 73%) after an average period of 15 weeks (range 4 to 24 weeks). The best available evidence was for simple topical treatments containing salicylic acid, which were clearly better than placebo. Data pooled from five placebo-controlled trials showed a cure rate of 117/160 (73%) compared with 78/162 (48%) in controls, which translates to a risk ratio of 1.60 (95% confidence interval 1.16 to 2.23), using a random effects model. Evidence for the absolute efficacy of cryotherapy was surprisingly lacking. Two trials comparing cryotherapy with salicylic acid and one comparing duct tape with cryotherapy showed no significant difference in efficacy. Evidence for the efficacy of the remaining treatments reviewed was limited. AUTHORS' CONCLUSIONS: There is a considerable lack of evidence on which to base the rational use of topical treatments for common warts. The reviewed trials are highly variable in method and quality. Cure rates with placebo preparations are variable but nevertheless considerable. There is certainly evidence that simple topical treatments containing salicylic acid have a therapeutic effect. There is less evidence for the efficacy of cryotherapy, but reasonable evidence that it is only of equivalent efficacy to simpler and safer treatments. The benefits and risks of topical dinitrochlorobenzene and 5-fluorouracil, intralesional bleomycin and interferons, photodynamic therapy and other miscellaneous treatments remain to be determined.

Administration, Topical↗
PubMed2001

Enhancing causal interpretations of quality improvement interventions.

In an era of chronic resource scarcity it is critical that quality improvement professionals have confidence that their project activities cause measured change. A commonly used research design, the single group pre-test/post-test design, provides little insight into whether quality improvement interventions cause measured outcomes. A re-evaluation of a quality improvement programme designed to reduce the percentage of bilateral cardiac catheterisations for the period from January 1991 to October 1996 in three catheterisation laboratories in a north eastern state in the USA was performed using an interrupted time series design with switching replications. The accuracy and causal interpretability of the findings were considerably improved compared with the original evaluation design. Moreover, the re-evaluation provided tangible evidence in support of the suggestion that more rigorous designs can and should be more widely employed to improve the causal interpretability of quality improvement efforts. Evaluation designs for quality improvement projects should be constructed to provide a reasonable opportunity, given available time and resources, for causal interpretation of the results. Evaluators of quality improvement initiatives may infrequently have access to randomised designs. Nonetheless, as shown here, other very rigorous research designs are available for improving causal interpretability. Unilateral methodological surrender need not be the only alternative to randomised experiments.

Cardiac Catheterization↗
PubMed2004

WF 10: Macrokine, TCDO, tetrachlorodecaoxide.

WF 10 [TCDO, Oxoferin, Immunokine, Macrokine] is a 1:10 dilution of tetrachlorodecaoxide formulated for IV delivery. It was developed by Oxo Chemie in Switzerland as an adjunctive therapy to combination antiretroviral and opportunistic infection prophylaxis regimens in AIDS patients. WF 10 specifically targets macrophages. Oxo Chemie has worldwide patent rights to WF 10 and Dimethaid Research has an exclusive licence for marketing and distribution in Canada. In May 2002, Oxo Chemie was acquired by Dimethaid Research. Oxo completed a trial in 72 cervical cancer patients undergoing radiation therapy in 1989. Results from this trial demonstrated complete remission in 75% of patients receiving WF 10. A follow-up placebo controlled trial in 1996 produced similar results. WF 10 has received regulatory approval in Thailand for postradiation cystitis following a trial completed in 1998 in 20 patients following radiation treatment for cervical carcinoma. This authorisation also allows limited availability of WF 10 at the physician's request in Germany. WF 10 is also available under Health Canada's Special Access Program. Oxo Chemie has completed a controlled randomised, crossover study in France in 1991 that examined the effects of 103 patients with acute radiation dermatitis and radiation- or chemotherapy-induced mucositis. Results demonstrated that WF 10 significantly improved lesions and accelerated recovery without side effects. Topical tetrachlorodecaoxide in a less concentrated formulation (1:55) is marketed in many countries as Oxoferin for wound healing. WF 10 is approved for use in Thailand under the name IMMUNOKINE in patients with postradiation chronic inflammatory disease including cystitis, proctitis and mucositis. In July 2003, the European examiners informed Oxo Chemie that they intend to grant the company additional patents to the technology platform that supports WF 10, extending the European protection granted in 1992 to cover a much broader range of diseases. The patents will be granted in Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Liechtenstein, Luxembourg, Monaco, the Netherlands, Portugal, Spain, Sweden, Switzerland and the UK. Patent claims cover potential treatment for autoimmune disease, organ transplant or graft rejection, lymphoma and inflammation manifested as hepatitis or chronic obstructive pulmonary disease.

Adjuvants, Immunologic↗
PubMed2002

Association between competing interests and authors' conclusions: epidemiological study of randomised clinical trials published in the BMJ.

OBJECTIVE: To assess the association between competing interests and authors' conclusions in randomised clinical trials. DESIGN: Epidemiological study of randomised clinical trials published in the BMJ from January 1997 to June 2001. Financial competing interests were defined as funding by for profit organisations and other competing interests as personal, academic, or political. STUDIES: 159 trials from 12 medical specialties. MAIN OUTCOME MEASURES: Authors' conclusions defined as interpretation of extent to which overall results favoured experimental intervention. Conclusions appraised on 6 point scale; higher scores favour experimental intervention. RESULTS: Authors' conclusions were significantly more positive towards the experimental intervention in trials funded by for profit organisations alone compared with trials without competing interests (mean difference 0.48 (SE 0.13), P=0.014), trials funded by both for profit and non-profit organisations (0.30 (SE 0.10), P=0.003), and trials with other competing interests (0.45 (SE 0.13), P=0.006). Other competing interests and funding from both for profit and non-profit organisations were not significantly associated with authors' conclusions. The association between financial competing interests and authors' conclusions was not explained by methodological quality, statistical power, type of experimental intervention (pharmacological or non-pharmacological), type of control intervention (for example, placebo or active drug), or medical specialty. CONCLUSIONS: Authors' conclusions in randomised clinical trials significantly favoured experimental interventions if financial competing interests were declared. Other competing interests were not significantly associated with authors' conclusions.

Analysis of Variance↗
PubMed2006

[Interactions between radiation and hormonal therapy in breast cancer: simultaneous or sequential treatment].

BACKGROUND: Combining radiation and hormone therapy (administration of selective estrogen receptor modulators) has become common clinical practice in recent years for receptor positive breast cancer. Little is known about a possible interaction of both treatment modalities if they are given simultaneously. Tamoxifen (antiestrogen molecule, triphenylethylene derivative) may theoretically render cancer cells less responsive to radiotherapy arresting hormone-receptor-positive cells in G0/G1 phase and increase the risk of breast and lung fibrosis stimulating the secretion of transforming growth factor beta in human fibroblasts. PURPOSE: This article reviews the published data to assess the impact of sequencing of hormonal and radiation therapy on outcomes in breast cancer. METHODS: Computerised searches for publications debating the sequencing of hormonal therapy relative to radiation therapy were done using MEDLINE data. RESULTS: Results of tamoxifen experiments with cell culture regarding radioprotection of tumour clonogens are conflicting. In contrast to in vitro results, in animal studies no protective effect of tamoxifen was observed. In one in vitro study, letrozole (non-steroid selective aromatase inhibitor) had a radiosensitizing effect on breast-cancer lines. No randomised clinical trials to date have studied sequencing of tamoxifen or other selective estrogen receptor modulators and radiotherapy. Results from retrospective clinical studies which included treatment arms with and without tamoxifen showed reduction in tumour recurrence with tamoxifen. Some of these studies have noted increased risk of lung and breast fibrosis with tamoxifen with radiotherapy. Results of three articles examined the effect of tamoxifen sequence showed no adverse effect on local control or survival in sequential versus concurrent tamoxifen and radiation patients. One of the three studies also assessed the risk of complications with respect to the timing of tamoxifen with radiotherapy. There was no difference in the rates of complications between the two groups. The association of radiation and selective aromatase inhibitors or aromatase inactivators has not been addressed in clinical studies. CONCLUSIONS: Combined application of tamoxifen and radiotherapy improves survival and local control in breast cancer. Available clinical studies do not indicate that the simultaneous application of tamoxifen and radiotherapy is disadvantageous, as was suggested by some of the in vitro studies. The risk of subcutaneous breast and lung fibrosis might be slightly increased if tamoxifen is given simultaneously with radiotherapy. Both treatment modalities should be started early after surgery. There is no sufficient evidence to withhold tamoxifen administration during irradiation of breast cancer. The issue of optimal sequencing of hormonal and radiotherapy should be addressed in randomised clinical trials.

Animals↗