Non-invasive assay of amino acid turnover has the potential to improve significantly the prospective selection of the most viable embryos, or single embryo, for replacement in an IVF cycle.

Although randomized trials provide the most reliable evidence of a drug's safety and efficacy, there are situations where randomized trials are not possible or ethical. In this article we discuss when and how single-arm trials can be used to support full approval of oncology drugs. These include situations in which an unprecedented effect on tumor response is observed in a setting of high unmet medical need, clinical trial patients have been well characterized, enabling a target population to be clearly defined, experience exists in a sufficient number of patients to allow adequate assessment of the risk:benefit relationship, and a proper historical context can be provided for analysis. We also discuss how response rates might be considered predictive of long-term outcomes or clinically meaningful in and of themselves in certain contexts.

Visual loss following esthetic treatment of the face is a rare but devastating iatrogenic complication. The authors report a case of a 43-year-old man with blindness and ophthalmoplegia of the left eye following a treatment of the left periorbital region with the subcutaneous filler poly-(L)-lactic acid. The patient's symptoms began immediately following one of the tunneled injections. On presentation, the patient had clear signs of ocular and orbital ischemia. Angiography and further history suggested an embolic orbital infarction as the mechanism of injury. The increased usage of subcutaneous fillers for facial rejuvenation had introduced a small but proven risk of embolization of these viscous materials to the eye and orbit.

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STUDY QUESTION How much statistical power do randomised controlled trials (RCTs) and meta-analyses have to investigate the effectiveness of interventions in reproductive medicine? SUMMARY ANSWER The largest trials in reproductive medicine are unlikely to detect plausible improvements in live birth rate (LBR), and meta-analyses do not make up for this shortcoming. WHAT IS KNOWN ALREADY Effectiveness of interventions is best evaluated using RCTs. In order to be informative, these trials should be designed to have sufficient power to detect the smallest clinically relevant effect. Similar trials can subsequently be pooled in meta-analyses to more precisely estimate treatment effects. STUDY DESIGN, SIZE, DURATION A review of power and precision in 199 RCTs and meta-analyses from 107 Cochrane Reviews was conducted. PARTICIPANTS/MATERIALS, SETTING, METHODS Systematic reviews published by Cochrane Gynaecology and Fertility with the primary outcome live birth were identified. For each live birth (or ongoing pregnancy) meta-analysis and for the largest RCT in each, we calculated the power to detect absolute improvements in LBR of varying sizes. Additionally, the 95% CIs of estimated treatment effects from each meta-analysis and RCT were recorded, as these indicate the precision of the result. MAIN RESULTS AND THE ROLE OF CHANCE Median (interquartile range) power to detect an improvement in LBR of 5 percentage points (pp) (e.g. 25–30%) was 13% (8–21%) for RCTs and 16% (9–33%) for meta-analyses. No RCTs and only 2% of meta-analyses achieved 80% power to detect an improvement of 5 pp. Median power was high (85% for trials and 93% for meta-analyses) only in relation to 20 pp absolute LBR improvement, although substantial numbers of trials and meta-analyses did not achieve 80% power even for this improbably large effect size. Median width of 95% CIs was 25 pp and 21 pp for RCTs and meta-analyses, respectively. We found that 28% of Cochrane Reviews with LBR as the primary outcome contain no live birth (or ongoing pregnancy) data. LARGE-SCALE DATA The data used in this study may be accessed at . LIMITATIONS, REASONS FOR CAUTION The design and analysis decisions used in this study are predicted to overestimate the power of trials and meta-analyses, and the size of the problem is therefore likely understated. For some interventions, it is possible that larger trials not reporting live birth or ongoing pregnancy have been conducted, which were not included in our sample. In relation to meta-analyses, we calculated power as though all participants were included in a single trial. This ignores heterogeneity between trials in a meta-analysis, and will cause us to overestimate power. WIDER IMPLICATIONS OF THE FINDINGS Trials capable of ...

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The benefits of regional anesthesia are well documented. The downsides of such techniques have been a significant failure rate and a potential for serious complications. Nearly, all regional blocks were first described as essentially 'blind' techniques. The development of high-resolution portable ultrasound (US) has made the use of US for regional anesthesia possible. Improved understanding of sonographic anatomy should lessen both the failure rate and the possibility of incurring serious complications. Natural caution has dictated that only a selection of blocks used in adults has been commonly used in pediatric practice, but with the aid of US, the repertoire of blocks for infants and children may be widened. The second part of this review will concentrate on the practice of both peripheral and central blocks.