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Training for the clinical research workforce does not sufficiently prepare workers for today’s scientific complexity; deficiencies may be ameliorated with training. The Enhancing Clinical Research Professionals’ Training and Qualifications developed competency standards for principal investigators and clinical research coordinators.
Clinical and Translational Science Awards representatives refined competency statements. Working groups developed assessments, identified training, and highlighted gaps.
Forty-eight competency statements in 8 domains were developed.
Training is primarily investigator focused with few programs for clinical research coordinators. Lack of training is felt in new technologies and data management. There are no standardized assessments of competence.
The translation of discoveries to drugs, devices, and behavioral interventions requires well-prepared study teams. Execution of clinical trials remains suboptimal due to varied quality in design, execution, analysis, and reporting. A critical impediment is inconsistent, or even absent, competency-based training for clinical trial personnel.
In 2014, the National Center for Advancing Translational Science (NCATS) funded the project, Enhancing Clinical Research Professionals’ Training and Qualifications (ECRPTQ), aimed at addressing this deficit. The goal was to ensure all personnel are competent to execute clinical trials. A phased structure was utilized.
This paper focuses on training recommendations in Good Clinical Practice (GCP). Leveraging input from all Clinical and Translational Science Award hubs, the following was recommended to NCATS: all investigators and study coordinators executing a clinical trial should understand GCP principles and undergo training every 3 years, with the training method meeting the minimum criteria identified by the International Conference on Harmonisation GCP.
We anticipate that industry sponsors will acknowledge such training, eliminating redundant training requests. We proposed metrics to be tracked that required further study. A separate task force was composed to define recommendations for metrics to be reported to NCATS.
We present four cases of confirmed anti-NMDA receptor encephalitis; three presented initially with serious psychiatric symptoms and the other developed significant psychiatric symptoms during the initial phase of illness. Brain biopsy findings of one patient are also described. Psychiatrists should consider anti-NMDA receptor encephalitis in patients presenting with psychosis and additional features of dyskinesias, seizures and catatonia, particularly where there is no previous history of psychiatric disorder.
Patients presenting with acute onset of focal neurological deficits must be evaluated for intracerebral hemorrhage (ICH). Digital subtraction angiography (DSA) is the most definitive method of identifying the aneurysmal source. While cerebral DSA offers advantages over CT angiography (CTA) and magnetic resonance angiography (MRA), it does so at the expense of greater risk. It carries a 1. 3-1. 8% risk of neurological complication and 0. 2-0. 3% risk of permanent deficit. Although DSA remains the most accurate technique for the diagnosis of cerebral vascular disorders, CT and MRI now play a significant part in the diagnosis and management of cerebral arteriovenous malformation (AVM). DSA is the gold standard in the detection and evaluation of intracranial vascular abnormalities when patients present with spontaneous ICH. Aneurysms and AVM are the typical causes of ICH uncovered by DSA. The procedure is invasive and carries a small but real amount of risk.
Computerized tomography scans are rapid, readily available, and relatively inexpensive. Volume of hemorrhage on computerized tomography (CT) is an important predictor of mortality and functional ability after intracerebral hemorrhage (ICH). Computerized tomography angiography (CTA) offers many clinical advantages over cerebral digital subtraction angiography (DSA) for the evaluation of intracranial vascular abnormalities in cases of ICH. CTA must be shown to have similar sensitivity and specificity as DSA in the detection of secondary causes of ICH. The use of non-contrast CT in the initial evaluation of patients presenting with suspected ICH is well established and universally accepted. Recently, advances in CTA have enabled this modality to gain wide acceptance in evaluating possible secondary causes of ICH, such as aneurysm or vascular malformation. As scanner technology and software rendering capabilities continue to improve, CTA appears poised to replace DSA and become the new gold standard for such evaluations.
Autistic spectrum disorders (ASD), are a group of disorders characterised by qualitative abnormalities in social and emotional behaviour and are associated with restricted, stereotyped and repetitive interests and activities. There has been considerable understanding of ASD in recent years. This educational review paper focuses on four areas of interest and relevance to trainees preparing for the membership examination of the Royal College of Psychiatrists (MRCPsych): (a) diagnosing ASD; (b) epidemiology of ASD; (c) aetiology, including genetic, cognitive and neurochemical/neuropathological theories in ASD; and (d) treatment of ASD. Relevant papers are discussed and recommendations for further reading are provided.
We present a rare presentation of myasthenia gravis as acute inspiratory stridor in a 16-year-old girl. Prompt diagnosis and medical treatment avoided the need for tracheostomy. Although an uncommon cause, myasthenia gravis should be included in the differential daignosis of stridor.
Schizophrenia is associated with expanded CAG/CTG trinucleotide repeats. We wished to determine whether the presence of such expansions correlated with specific subsyndromes or other clinical features of schizophrenia.
Seventy patients from England and Wales and 44 patients from Portugal with a DSM–III–R diagnosis of schizophrenia were rated on the opcrit checklist Patients' maximum CAG/CTG repeat length was measured using repeat expansion detection (RED). Significant differences were sought for repeat lengths in subjects categorised according to dimensional and categorical schizophrenia subsyndromes, affective episodes, individual symptoms, and a range of demographic variables.
Maximum CAG/CTG repeat length did not differ significantly for any of the clinical or demographic variables studied.
There are no subsyndromes or other clinical features of schizophrenia associated with CAG/CTG repeat expansion. Therefore, the identification of the gene(s) that contain expanded CAG/CTG repeats and which are associated with schizophrenia is unlikely to be facilitated at present by using any subsyndromes of schizophrenia as phenotypes.
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