2 February 2012
Survey finds public support for randomised medicine studies
Studies of the effectiveness and safety of prescription medicines in Scotland that randomise prescribing policy in different GP practices are broadly supported by the general public, a survey carried out for the University of Dundee has found.
The survey showed that 97% of the general public participants agreed that the NHS has a duty to determine the safety and effectiveness of the medicines its doctors prescribe. A majority were willing to participate in studies which would make changes to their prescription medicines and use subsequent follow-up medical data to measure effectiveness and safety.
There was, however, a spread of opinion among GPs on the use of such studies, largely related to concerns about the workload involved - 45% were in favour of the studies, 19% were undecided and 36% not in favour.
Findings of the study have been published by the British Journal of Clinical Pharmacology.
Obtaining data on the comparative effectiveness and safety of different drug therapies within the NHS is essential to make correct and cost-effective decisions regarding treatment recommendations. One way of collecting data is to introduce policy changes that randomise groups of patients (eg whole General Practices or Health Centres) to different treatments and then compare outcomes using routinely collected data - so-called 'randomised policy design' or cluster randomised studies.
'While we believe that randomised policy design studies would be ideal for studying the comparative effectiveness and safety of drug therapies within the UK NHS system, we felt that it was important to gather the opinions of the general public and general practitioners on this subject,' said Dr Isla Mackenzie, of the Medicines Monitoring Unit (MEMO) at the University of Dundee.
Participants in the survey were asked questions about their views on randomised policy design studies and changes being made to their prescribed medicines. General Practitioners in Scotland were also surveyed to ascertain their attitudes towards the concept of randomised policy design studies to improve understanding of comparative effectiveness and safety of medicines.
A sample of 1040 adults was surveyed. 30% of people said they would be happy to receive a letter about randomised policy changes to their therapy, 31% would not mind or had no opinion and 39% would be unhappy. This view was sensitive to the reason for change; effectiveness and safety reasons were most acceptable (96%) and costsaving least acceptable (39%). Only 19% thought randomised policy change was not an acceptable method of determining the best treatments. 81% of respondents were willing for their medical data to be followed up to compare drug treatments (a further 10% were undecided). Participants reporting long-term medical conditions and those reporting previous changes to drug therapy were more in favour of randomised policy design studies than other participants.
Over 300 GPs responded to the survey. The main concerns from GPs were around the potential additional workload involved in helping carry out randomised policy design studies. The results of this survey are broadly in keeping with other experience of involving GP practices in formal randomised controlled trials.
'These results suggest that the general population within Scotland is broadly supportive of the concept of randomised policy design studies to determine the effectiveness and safety of drug treatments within the NHS, while there is a spread of opinion among general practitioners,' said Professor Tom MacDonald, Director of MEMO.
'The next step may be to perform one of these types of study, to answer an important and widely relevant question in clinical practice, then further determine the acceptability of this method of studying drug effectiveness and safety with both the public and health professionals.'
Professor Ken Paterson, of the University of Glasgow, commented, 'Use of data collected in these studies within routine clinical practice in the NHS could often be a quick, powerful and relatively inexpensive tool to answer questions of real relevance to patients, independent of the possible influence of the pharmaceutical industry.'
The survey was commissioned by the Medicines Monitoring Unit (MEMO) at the University of Dundee and carried out by mruk research as part of the Scottish Consumer Omnibus.
For media enquiries contact:
Roddy Isles
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University of Dundee
Nethergate, Dundee, DD1 4HN
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E-MAIL: r.isles@dundee.ac.uk
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