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On this site you will find practical help when trying to meet the requirements of the UK Medicines for Human Use (Clinical Trials) Regulations 2004. These regulations implement the EU Clinical Trials Directive in the UK. In light of amendments to these regulations in 2006, we are currently working to update this site. This will be finalised following publication of the specific modality for non-commercial trials.

"WHAT TO DO WHEN A PATIENT LACKS CAPACITY - The degree and urgency with which to act on findings of impaired capacity depends on multiple factors, including the expected duration of impairment, the severity of the impairment, and the seriousness of the decision. Unless the urgency of a patient's medical condition requires that a substituted decision be made immediately, efforts should be made to identify and correct any reversible causes of the impairment [26]. This is particularly relevant in hospitalized patients with impaired capacity due to delirium. Treatment of the underlying causes of delirium may restore decision-making capacity. Patients with mild to moderate cognitive impairment that is not expected to fluctuate may benefit from more intensive efforts at education to improve understanding of the relevant facts, followed by reassessment of decision-making abilities. A randomized trial found that a memory and organizational aid given to patients with mild stage Alzheimer disease dementia (n = 80) improved performance on understanding, which in turn increased the likelihood of being judged capable of providing informed consent to enroll in a clinical trial [34]. This enhancement was also effective in a randomized trial with middle-aged and older adults with schizophrenia [35]. For patients whose impairments are severe enough that they are judged to lack the capacity to make a decision, there is a clear ethical obligation to seek out a substitute decision maker. Substitute or surrogate decision makers should ideally have been chosen by the patient in advance. In the absence of a designated surrogate, laws may vary in terms of which people can serve in this proxy role and their hierarchy; in general, the order is the spouse, adult children, parents, siblings, and other relatives. (See "Legal aspects in palliative and end of life care", section on 'Surrogate decision makers'.) When making a substituted decision, the proxy should take into consideration

"These findings suggest that educational interventions can be effective in maintaining and enhancing empathy in undergraduate medical students. In addition, they highlight the need for multicenter, randomized controlled trials, reporting long-term data to evaluate the longevity of intervention effects. Defining empathy remains problematic, and the authors call for conceptual clarity to aid future research."

"Empathy Training for Resident Physicians: A Randomized Controlled Trial of a Neuroscience-Informed Curriculum"

Mind-mapping.org has a good capability for selecting software by map type and operating system (click on the 'Refine software list' tab at the top right of its web page), and shows the price. Unfortunately, it doesn't allow you to filter on price or choose to see only the free ones. This article is therefore a quick list to current software that is free or has a free option. It excludes applications that have a time limit on their operation, for example, free trial software or web applications.

CECEM, Cochrane, Conference/Meeting, EHR, Health, intermittent claudication, Physiotherapy, Randomized Controlled Trial, RCT, study type, Systematic Review

"It was observed that each institutional context formed a complex educational ecology. The intervention became interwoven with different educational ecologies so that it could no longer be considered a stable variable across the study. We suggest that researchers should conduct implementation-profiling studies in advance of any intervention-based research to account for the constructing nature of educational ecologies on their interventions and in doing so to more clearly differentiate between efficacy and effectiveness studies."

Using problem-based learning to allow students to explore the connections between science and the law