| Issue 20 |
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January
2001
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| Thank
you to everyone who came to London for the Collaborators’ meeting.
The feedback confirms our judgement that the scientific speakers gave
outstanding presentations. A special thank you to our National Co-ordinators,
who came together for their first meeting prior to the main programme. For those of you who were unable to attend, here’s a brief summary of all the talks: |
| Friday
8 December 2000 .. Michael Baum discussed some of the ethical issues in the randomisation of patients with impaired consciousness. He argued that the best treatment for anyone with a life threatening condition is to be recruited into a randomised controlled trial and that the responsible doctor, in their role as the patient's "fiduciary," should take responsibility for entering patients. .. Peter Sandercock discussed the importance of large scale trials of widely practicable interventions for conditions with major public health impact, the challenges faced by the CRASH collaborative group and finding solutions to these using experience gained from previous large scale trials. .. David Menon focused on the emerging interest in the role of cerebral inflammation following acute brain injury from a variety of causes. He argued that while several anti-inflammatory agents have failed in clinical trials in head injury and stroke, studies with dexanabinol and corticosteroids provide promise of potential success. .. Jonathan Wasserberg looked at neuroprotection in head injury and the difficulties in assessing treatment interventions, as head injury is a heterogenous condition ranging from mild concussion to devastating brain injury. The use of large simple trials such as the CRASH trial for detecting small, but valuable, treatment effects using large number of patients was highlighted. .. Robert Crouch emphasised the need for nursing involvement in high quality randomised controlled trials, especially in large simple trials such as the CRASH trial. Nursing involvement in research is crucial in order for it to be successful, especially in an environment such as A&E where many clinical staff are transient but nurses remain a constant. Nurses are not merely data collectors – they are an essential part of making research a success. .. David Yates discussed the need for the CRASH trial and it’s progress so far. The trial is now well on target for recruitment and growth, with follow-up at two weeks well over 90% (the aim is to achieve 100% with reminders!). .. |
| Saturday
9 December 2000 .. Lindsay Wilson discussed outcome measures in large simple trials in head injury and presented the results of his research confirming that outcome after head injury can be reliably assessed using a simple postal version of the Glasgow Outcome Scale. .. Phil Edwards focused on how to identify methods of increasing response to postal questionnaires, and achieving this by conducting a systematic review of randomised controlled trials. The review has shown that health researchers can reduce non-response when using postal questionnaires to collect data by using identified strategies. .. The second half of the Saturday morning session was a set of wonderful presentations by Petr Svoboda – Czech Republic, Guy Mazairac – Belgium, Naren Nathoo – South Africa and Shiela Pantrini – UK. Each gave a fantastic and very varied description of how the CRASH trial is being implemented in different countries and centres around the world. They were all inspiring, motivating and very enjoyable indeed! Nin |
| Early
Outcome Data and DMEC .. The well being of trial participants is the responsibility of everyone working on the CRASH trial but the Data Monitoring and Ethics Committee (DMEC) has a special responsibility. From time to time, members of the DMEC look at unblinded trial data with the safety, rights, and well being of the trial participants being paramount. The DMEC will next look at unblinded trial data in a few months time. It is essential that we provide the DMEC with complete data so that their assessment is made on the best available information. Over the coming months we need to make a special effort to ensure that all overdue early outcome forms are completed and sent to the co-ordinating centre. The staff at the co-ordinating centre will do their best to help, but we cannot do it without your support. |
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CRASH Co-ordinating Centre, FREEPOST LON 14211, LONDON WC1N 1BR Tel: + 44 (0)20 7299 4684 Fax: + 44 (0)20 7299 4663 email: CRASH@lshtm.ac.uk |