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PubMed2005

The reporting quality of abstracts of randomised controlled trials submitted to the ICS meeting in Heidelberg.

AIMS: The quality of randomised controlled trials (RCTs) is associated with bias. Thus, reports of RCTs must have enough detail of key elements of quality to enable them to be interpreted properly. This study examines the quality of abstracts of RCTs reported at the ICS meeting in Heidelberg in 2002, using the CONSORT statement as the gold standard. MATERIALS AND METHODS: All of the abstracts accepted for the meeting at Heidelberg were read to identify reports of RCTs. Copies of these were printed and examined to see whether they complied with the 22 items in the CONSORT statement. As these were all abstracts the first CONSORT item was changed so that to comply the title had to say it was a randomised trial. Each item was scored as not met, partially met, met. RESULTS: Fifty-three reports of RCTs were found. Five of these were podium presentations, 14 discussion posters, and 34 non-discussion posters. Most reports did not comply with many of the items in the CONSORT statement, lacking particularly in technical details of the methods (only one study clearly reported hidden allocation to groups), and how the results were presented (only two studies fully reported results). Only 2/53 of the abstracts complied fully with more than 10 of the items, and 30/53 did not comply at all with 10 or more. CONCLUSIONS: The quality of reporting of studies at ICS is so poor that it is difficult to interpret the results. Reporting was particularly poor on the details of the randomisation and the numeric results.

Abstracting and Indexing↗
PubMed2004

Pediatric middle ear infections and gastroesophageal reflux.

OBJECTIVES: The pathogenesis of middle ear infections in children is multifactorial and includes infection, anatomical factors, impaired immunologic status, allergy, familial predisposition, male sex, method of feeding and environmental factors. Glue ear remains the commonest cause of deafness in childhood. Gastroesophageal reflux (GOR) is a common problem in the newborn and preschool periods. Recent research suggests that it may be related to eustachian tube dysfunction and otitis media. METHODS: We review the literature and discuss the possible relationship between Gastroesophageal reflux and otitis media in children. CONCLUSIONS: The current data are not enough to support antireflux treatment in children with refractory middle ear infections. More prospective randomised placebo-controlled studies are needed.

Animals↗
PubMed2001

Neurocardiogenic syncope: aetiology and management.

Neurocardiogenic syncope is the most common cause of syncope presenting in the outpatient setting. It is usually encountered among individuals without an underlying heart disease, but not uncommonly participates in the syncope mechanism of patients with an obstructive or an arrhythmic cardiac cause for syncope as well. The vasovagal event is caused by a transient profound hypotensive reaction most commonly associated with inappropriate bradycardia resulting from activation of a complex autonomic reflex. The pathophysiology of neurocardiogenic syncope has been elucidated by tilt table testing, a noninvasive and well-tolerated method for reproducing the event in susceptible individuals. Although the majority of people with vasovagal fainting need no specific treatment, treatment is required for those presenting with problematic features such as frequent events accompanied by trauma or accidents, and occasionally by a severe cardioinhibitory pattern response. A number of different drugs have been proposed to favourably act on different aspects of the neurocardiogenic reflex but only a few randomised, placebo-controlled, drug-specific trials are currently available. Alternatively, cardiac pacing has also been introduced for patients who have symptoms that are drug-refractory or for those with a severe cardioinhibitory hypotensive response. The selection of the appropriate treatment plan should be individualised after consideration of patient history, clinical characteristics and preference, results of the baseline tilting study, and the existing evidence from the few randomised, controlled studies performed so far.

Accidents↗
PubMed2003

[Systematic treatment of tinea pedis--evidence for treatment? A result of a Cochrane review].

BACKGROUND: About 15% of the population have fungal infections of the feet (tinea pedis or athlete's foot). Whilst there are many clinical presentations of tinea pedis the most common are between the toes (interdigital) and on the soles, heels and sides of the foot (plantar) which is known as moccasin foot. Once acquired the infection can spread to other sites including the nails, which can be a source of reinfection. Oral therapy is usually used for chronic conditions or when topical treatment has failed. OBJECTIVES: To assess the effects and costs of oral treatments for fungal infections of the skin of the foot (tinea pedis). SEARCH STRATEGY: Randomised controlled trials were identified from MEDLINE, EMBASE and CINAHL from the beginning of these databases to January 2000. We also searched the Cochrane Controlled trials Register (Cochrane Library issue 1, 2000) the Science Citation Index, BIOSIS, CAB-Health, Health star and Economic databases. Bibliographies were searched, podiatry journals hand searched and the pharmaceutical industry and schools of podiatry contacted. SELECTION CRITERIA: Randomised controlled trials including participants who have a clinically diagnosed tinea pedis, confirmed by microscopy and growth of dermatophytes in culture. DATA COLLECTION AND ANALYSIS: Study selection was done by two independent reviewers. Methodological quality assessment and data collection was also assessed by two independent reviewers. MAIN RESULTS: Twelve trials, involving 700 participants, were included. The two trials comparing terbinafine and griseofulvin produced a pooled risk difference of 52% (95% confidence intervals 33% to 71%) in favour of terbinafine's ability to cure infection. No significant difference was detected between terbinafine and itraconazole; fluconazole and either itraconazole and ketoconazole; or between griseofulvin and ketoconazole, although the trials were generally small. Two trials showed that terbinafine and itraconazole were effective compared with placebo. Adverse effects were reported for all drugs, with gastrointestinal effects most commonly reported. REVIEWERS' CONCLUSIONS: The evidence suggests that terbinafine is more effective than griseofulvin and that terbinafine and itraconazole are more effective than no treatment.

Antifungal Agents↗
PubMed2005

[The CONSORT statement for cluster randomised trials].

With the publication of the CONSORT statement there is now increased awareness of the need to adequately report the findings of randomised controlled trials. The CONSORT statement includes a checklist of items that should be addressed in the trial report. The original CONSORT statement was developed to ensure the appropriate reporting of parallel group randomised controlled trials in which individual participants are allocated to different intervention groups. In cluster randomised trials, however, groups of participants, rather than individuals, are randomly allocated to study groups. The process of allocating groups of participants raises additional reporting considerations and led to the publication of an extension to the CONSORT statement specifically for cluster randomised trials. In this paper we review the CONSORT extension to cluster randomised trials, outlining the special features of the cluster randomised trial which must be considered.

Authorship↗
PubMed1996

A controlled clinical trial of dorzolamide: a single-centre subset of a multicentre study.

PURPOSE: To assess the safety and intraocular pressure (IOP)-lowering activity of 2% dorzolamide (topical carbonic anhydrase inhibitor), compared to 0.5% timolol and 0.5% betaxolol eyedrops. METHODS: A parallel, masked, randomised one-year clinical trial was conducted in 16 patients with open-angle glaucoma or ocular hypertension, being a subset of a multicentre study which enrolled 523 subjects. Patients had IOP > 22 mmHg in one eye at baseline following washout of ocular hypotensive medications and were then randomised in a 3:1:1 ratio to receive 2% dorzolamide thrice daily, 0.5% timolol twice daily or 0.5% betaxolol twice daily respectively. IOP was measured at Hour 2 (morning peak), Hour 5 and Hour 8 (afternoon trough for dorzolamide) at baseline, Weeks 2 and 4 and Months 2, 3, 6, 9 and 12. RESULTS: Topical dorzolamide 2% solution was well tolerated and safe. Mean IOP for dorzolamide at Hour 2 was 29.1 mmHg at baseline and 20.8 mmHg on treatment at one year, a 28.5% change. Mean IOP for dorzolamide at Hour 8 was 24.5 mmHg at baseline and 20.2 mmHg on treatment at one year, a 17.6% change. Comparable percent changes for timolol and betaxolol were 43.2/25.7 mmHg at Hour 2 and 21.9/13.5 mmHg at Hour 8 respectively. CONCLUSIONS: Dozolamide 2% given thrice daily was well tolerated and safe, with a clinically significant effect on IOP comparable to betaxolol 0.5% twice daily, but not as great as timolol 0.5% twice daily.

Adrenergic beta-Antagonists↗
PubMed2006

Supported housing for people with severe mental disorders.

BACKGROUND: There has been a significant reduction in the number of people with severe mental illness who spend extended periods in long-stay hospitals. District health authorities, local authorities, housing associations and voluntary organisations are jointly expected to provide support for people with severe mental disorder/s. This 'support' may well involve some kind of special housing. OBJECTIVES: To determine the effects of supported housing schemes compared with outreach support schemes or 'standard care' for people with severe mental disorder/s living in the community. SEARCH STRATEGY: For the 2006 update we searched the Cochrane Schizophrenia Group Trials Register (April 2006) and the Cochrane Central Register of Controlled Trials (CENTRAL, 2006 Issue 2). SELECTION CRITERIA: We included all relevant randomised, or quasi-randomised, trials dealing with people with 'severe mental disorder/s' allocated to supported housing, compared with outreach support schemes or standard care. We focused on outcomes of service utilisation, mental state, satisfaction with care, social functioning, quality of life and economic data. DATA COLLECTION AND ANALYSIS: We reliably selected studies, quality rated them and undertook data extraction. For dichotomous data, we would have estimated relative risks (RR), with the 95% confidence intervals (CI). Where possible, we would have calculated the number needed to treat statistic (NNT). We would have carried out analysis by intention-to-treat and would have summated normal continuous data using the weighted mean difference (WMD). We would have presented scale data for only those tools that had attained pre-specified levels of quality and undertaken tests for heterogeneity and publication bias. MAIN RESULTS: Although 139 citations were acquired from the searches, no study met the inclusion criteria. AUTHORS' CONCLUSIONS: Dedicated schemes whereby people with severe mental illness are located within one site or building with assistance from professional workers have potential for great benefit as they provide a 'safe haven' for people in need of stability and support. This, however, may be at the risk of increasing dependence on professionals and prolonging exclusion from the community. Whether or not the benefits outweigh the risks can only be a matter of opinion in the absence of reliable evidence. There is an urgent need to investigate the effects of supported housing on people with severe mental illness within a randomised trial.

Group Homes↗
PubMed2006

The SITS-MOST registry.

In September 2002 the European Medicines Evaluation Agency (EMEA) approved a licence for alteplase (rt-PA) in the treatment of ischaemic stroke within 3 h of symptom onset. One of the conditions required by the EU regulatory authorities for the official definitive approval of thrombolytic therapy was that treatment safety should be monitored over a period of three years by entering all treated patients in the SITS-ISTR (Safe Implementation of Thrombolysis in Stroke -Thrombolysis Register) web register, in accordance with a study protocol, the SITS Monitoring Study - SITS-MOST. The aims of this study are to evaluate the efficacy (in terms of functional independence for activities of daily living at three months after treatment) and safety (in terms of symptomatic intracerebral haemorrhage and death) of the thrombolytic treatment in real routine clinical practice, outside the ideal conditions of an experimental setting, and to compare the results with a systematic review from the randomised clinical trials.

Databases, Factual↗