Director's Update
Go Ahead Given
Sub Studies Ready
State Launches
Data
Management Centre
Committees
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Welcome to the First Edition of ANBP2 News. This newsletter will be provided to all investigators involved with the study to keep you informed of progress. Each issue will be designed to provide useful and informative information to you on various aspects of the study, keep you up to date on management issues in hypertension, to reinforce your role as an investigator in the project and to introduce you to the people who are working behind the scenes to ensure that this study is being conducted according to the highest international standards. It will also be used as a forum for your comments and experience so please do not hesitate to provide us with information which can be forwarded to the National Centre at the address shown below.
Following the provision of a report from the Study Director, Dr Christopher Reid, the Management Committee have approved the continuation of the main ANBP2 study. The pilot study has been operating in Victoria and South Australia from April 1995 and officially finished on October 9. 1995. The study was conducted in the Dandenong Division of General Practice in Victoria and the Central Easter, Eastern, Southern, Western and Riverland Divisions of General Practice in South Australia, Highlights of the findings of the pilot study were: 1. 75% of general practitioners who had the opportunity to have the study explained to them by Regional Directors (Dr Mark Nelson in Victoria, Dr Paul Beckinsale in South Australia) agreed to participate as a general practitioner investigator in ANBP2. It exceed all expectations with a total of 89 general practitioners registering during the pilot study (our initial target was 40). 2. 22% of patients who were identified through the practice records as being in the 65-84 year age group and were considered acceptable for an invitation to attend a screening program responded to a letter of invitation. 3. Almost 2000 patients from 38 participating practices were screened during the pilot study period. 4. 7% of those patients screened went on to be randomised into the study (this figure in excess of our target 5%). The successful completion of the pilot study marks the commencement of the Second Australian National Blood Pressure Study which will attempt to recruit 6000 patients across Australia over the next two years. Clearly the success of this pilot study rests with the participating practices which are all listed here.
Berwick Medical Centre
All Care Prospect
As part of ANBP2 four specific sub-studies have been approved by the Royal Australian College of General Practitioners Ethics Review Committee to be conducted in association with the main study. These four studies are: 1. Genetic determinants of cardiovascular outcome in elderly patients. 2. Ambulatory blood pressure as a predictor of cardiovascular events. 3. Left ventricular hypertrophy as a predictor of cardiovascular events. 4. Health economics and quality of life analysis. Each of these sub-studies is a major piece of research work in its own right. All of the protocols for the sub-studies have been approved and interested practitioners can obtain copies of these protocols by ringing the National Centre on 1800 670 695.
Official launches of the project in the states where the pilot study was conducted were held shortly after the announcement of the continuation of the main study. Professor John Murtagh from the Department of Community Medicine at Monash University was invited to officially launch the project in Victoria and Professor Derek Frewin from the Department of Medicine at the University of Adelaide performed the function in South Australia At both venues Professor Lindon Wing (Chairman of the Management Committee (pictured here) provided an overview of the role of diuretics in the treatment of hypertension in the elderly. Similar functions are being planned to launch the project in New South Wales, Western Australia and Queensland in mid-1996.
We began, though it was quite unclear at the time just what was beginning, in early 1994 when Kristyn Willson, a biostatistician in the Department of Community Medicine, and I, an academic medical statistician from that Department, were asked by John Marley and Lindon Wing to "have a look at some numbers for a clinical trial". A 150 page report of numbers and statistical methods (including appendices) did not have the desired effect of stopping these worthies in their tracks: the result was the establishment of the Data Management Centre for the Second Australian Blood Pressure Study in early 1995 within the new Department of General Practice of the University of Adelaide. The staff of the Centre is drawn from the Departments of Community Medicine (DCM) and General Practice (DGP) of the University of Adelaide and complemented by two full-time research staff recruited explicitly for the Study. The Staff are: Dr Philip Ryan (DCM, Head of Data Management Centre) Helen Miles (DGP, Data Manager) Sarah Kenyon (Research Officer) Kristyn Willson (DCM, Statistician) Brian McDermott (DCM, Computer Programmer) Rebecca O'Brien (Data Assistant) Mark Reynolds (DCM and DGP, Computing Officer) Georgina Binks, who ably assisted the Centre during the pilot phase of the Study, now works full-time for the South Australian Regional Centre. For those working in the Regional Centres, the usual points of contact with the Data Management Centre will be Sarah or Rebecca. With their experience of processing nearly 11,000 Study forms representing more than 6000 subject visits (so far!) it is unlikely that they will not have a solution for virtually any problem that may arise. If they do not, you can be sure Helen or I will dream up something plausible, perhaps even reasonable, so please phone, fax or e-mail us as soon as a data management issue arises. We are fortunate to be located close to the SA Regional Centre and to have easy access to John Moss of the Department of Community Medicine, who is running the Quality of Life/health Services Utilisation strand of ANBP2. These connections, and our frequent meetings with the Study Director, have contributed to the successful establishment phase of the Data Management Centre. We now look forward to the challenge of the rapid expansion of the Study beyond Victoria and South Australia. The main functions of the Data Management Centre are: Central randomisation Design and programming of the central and regional databases Management and secure storage of all primary Study data Interim and final analyses of the data (in fact, we will probably turn into a Data Management and Analysis Centre) Maintaining quality control Auditing of Regional Centre data collection and management processes Providing reports to the Study Director and Regional Medical Co-ordinators Advising on the design of data collection tools and on Study processes Assisting in the training of new staff from the Regional Centres.
MANAGEMENT COMMITTEE Professor Lindon Wing*
Dr Ian Steven*
Professor John Marley*
Professor Malcolm West*
Professor Garry Jennings*
Professor Lawrie Beilin*
Professor Jim Dickinson*
Professor Fred de Looze*
Professor Michael Kidd*
Professor Trefor Morgan*
Professor Garry Jennings*
Professor John McNeil*
Professor John Chalmers* These committee members provide their time in an honorary capacity and without their involvement the quality of the work done in the study would be severely jeopardised. * Chairperson
If you have a bright idea for a catchy
title for our newsletter, which will be distributed
nationally to all ANBP2 investigators, please drop us a line
at: National Centre ANBP2 Contacts |
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