The randomised controlled trial in the evaluation of new technology: a case study.
Explore the source record for details and available documents.
SEARCH · PubMed Health
Explore indexed PubMed citations for clinical trials, systematic reviews and public health research. Read source abstracts and follow each citation to its original PubMed record.
Quote a phrase for an exact phrase match. Source license links do not imply unrestricted reuse.
Explore the source record for details and available documents.
Explore the source record for details and available documents.
Explore the source record for details and available documents.
Explore the source record for details and available documents.
Both systemic and topical application of ketoconazole (CAS 65277-42-1) have been found effective in seborrhoeic dermatitis. The topical application of 2% ketoconazole in a cream base in particular has so far only once been compared to the application of the vehicle. Statistical analysis, however, has only been descriptive. In the present trial including 60 patients 2% ketoconazole cream (Nizoral) and a bland cream have been compared in a randomised, controlled fashion. Both erythema and scaling were found markedly more reduced in the verum group (p = 0.003 and p = 0.006, resp.). Hence the topical application of 2% ketoconazole cream can be considered as rational treatment of seborrhoeic dermatitis the more so as the application of the drug was well tolerated.
BACKGROUND: The timing of surgery to secure a ruptured aneurysm after a subarachnoid haemorrhage is an important issue. Early clipping of an aneurysm prevents rebleeding, a major cause of death after a subarachnoid haemorrhage. However, concerns about the possible deleterious effects of early surgery raise questions about the safety and efficacy of this approach. This review examines the randomised controlled evidence addressing the effect of surgery at different time intervals on the outcome after a subarachnoid haemorrhage. OBJECTIVES: To determine whether the timing of surgery after a subarachnoid haemorrhage significantly influences overall management outcome. SEARCH STRATEGY: We searched the Cochrane Stroke Review Group Trials Register and in addition searched MEDLINE, EMBASE and the Cochrane Controlled Trials Register (CENTRAL/CCTR). Colleagues were contacted to identify further studies and unpublished trials. SELECTION CRITERIA: All completed, unconfounded, truly randomised trials comparing "best medical treatment plus early surgery" with "best medical treatment plus delayed surgery". DATA COLLECTION AND ANALYSIS: The authors selected trials for inclusion, or exclusion, according to the above criteria. An "intention to treat" analysis strategy was utilised. MAIN RESULTS: Only one randomised controlled trial addressing the timing of surgery after aneurysmal subarachnoid haemorrhage was identified. Patients undergoing early surgery tended to fare better than those undergoing late surgery (death or dependency at 3 months OR 0.37 95% CI 0.13,1.02). Patients undergoing surgery in the intermediate time period appeared to fare worse than those undergoing early surgery although confidence intervals were wide (death or dependency at 3 months OR 0.34 95% CI 0.12, 0.93). REVIEWER'S CONCLUSIONS: Based upon the limited randomised controlled evidence available, the timing of surgery was not a critical factor in determining outcome following a subarachnoid haemorrhage. Since the publication of the only randomised controlled study in 1989, techniques for the treatment of subarachnoid haemorrhage have progressed, questioning the validity of the conclusions in the modern era. Currently, most neurovascular surgeons elect to operate within 3 or 4 days of the bleed in good grade patients to minimise the chances of a devastating rebleed. However, the treatment of patients in poorer grades warrants further scrutiny in a randomised controlled trial.
Explore the source record for details and available documents.
Explore the source record for details and available documents.
Explore the source record for details and available documents.
The use of placebos as reference agents in randomised controlled trials for psychiatric disorders has come under question for ethical reasons. Alternative methods for validating the efficacy of new treatments exist, but may not be as reliable as placebo. In this paper we examine arguments for and against the ongoing use of placebo agents in the development of new treatments for obsessive compulsive disorder in the context of evidence from randomised controlled trials.
Explore the source record for details and available documents.
Explore the source record for details and available documents.
Explore the source record for details and available documents.
Explore the source record for details and available documents.
Explore the source record for details and available documents.
AIMS: To evaluate the effects of promotion of residential smoke alarms. METHODS: Electronic databases, conference proceedings, and bibliographies were systematically searched, and investigators and organisations were contacted, in order to identify controlled trials evaluating interventions designed to promote residential smoke alarms. The following were assessed: smoke alarm acquisition, ownership, and function; fires; burns; and fire related injuries. Odds ratios (OR) were estimated by meta analysis of randomised trials. RESULTS: A total of 26 trials were identified, of which 13 were randomised. Overall, counselling and educational interventions had only a modest effect on the likelihood of owning an alarm (OR = 1.26; 95% confidence interval (CI): 0.87 to 1.81) or having a functional alarm (OR = 1.19; 95% CI: 0.85 to 1.66). Counselling as part of primary care child health surveillance had greater effects on ownership (OR = 1.93; 95% CI: 1.04 to 3.58) and function (OR = 1. 72; 95% CI: 0.78 to 3.78). Results were sensitive to trial quality, however, and effects on fire related injuries were not reported. In two non-randomised trials, direct provision of free alarms significantly increased functioning alarms and reduced fire related injuries. Media and community education showed little benefit in non-randomised trials. CONCLUSION: Counselling as part of child health surveillance may increase smoke alarm ownership and function, but its effects on injuries are unevaluated. Community smoke alarm give away programmes apparently reduce fire related injuries, but these trials were not randomised and results must be interpreted cautiously. Further efforts to promote smoke alarms in primary care or through give away programmes should be evaluated by adequately designed randomised controlled trials measuring injury outcomes.
Explore the source record for details and available documents.
Explore the source record for details and available documents.