CME Spotlight: Raising the quality of published research
pharmafile | January 13, 2010 | Feature | Medical Communications | CME, CME Spotlight, Eugene Pozniak, ethics
A few years ago I met someone who worked at a car factory and he described in detail how the management had adorned the factory with motivational statements; one that stood out was: “We aim to be the Rolls Royce of the motor industry”.
It was a not unreasonable aspiration for a car manufacturer to work towards, but interesting to consider that this statement was hanging in the Rolls Royce factory in Derby. We know the story: an iconic brand from a great era of British car manufacturing was losing its eminence and ‘engineered in Germany’ became a stronger statement of quality.
Quality is one of these things we value, and we know it when we have it, but is it possible to legislate for it or employ practices to make it happen?
The International Committee of Medical Journal Editors is about to publish its new guidelines tightening regulations for disclosure of information, a move which it hopes will help raise the quality of published research.
The new rules are understood to require far fuller disclosure, and across a number of areas of private life which are considered to be a potential source of bias or conflict of interest. These include financial relationships involving spouses, partners or children. Declaration of non-financial interests, such as religious and political affiliations will also be required.
The current system isn’t working well, but will disclosing ever more information about an author increase the quality or credibility of their research or written word? Do we really need to know the religion of the author, or indeed their political affiliations? Admittedly, some studies have examined attitudes of doctors in ‘end of life’ scenarios and how their religious convictions affect their clinical practice, but to extrapolate these data, taken from very specific ethical situations often with deep moral considerations, is dubious. To draw conclusions about the behaviour of a group in wider aspects of medical publishing may well be a nonsense.
Moreover, the new rules don’t tackle existing failings. The NEJM recently published a study on the declaration of conflict of interest: 79.3% (165 of 208) of doctors studied were found to have correctly disclosed direct financial relationships, and half omitted to mention any indirect relationships deemed to be inappropriate under existing rules. Developing ever stricter rules when existing standards are not being met or enforced indicates the enlargement of the paper tiger, rather than giving it a set of much needed teeth. It will be interesting to see how Good Publication Practice 2 (GPP 2) will address this topic, which is also due for publication about now. On a related topic, the US body the ACCME will shortly publish a name-and-shame list of accredited CME Providers who have transgressed their quality criteria, much of this is expected to be around flawed practice regarding disclosures and the management of bias.
Disclosure doesn’t equal quality
Disclosure of interests, however, seems to get a disproportionate level of attention as a surrogate marker of quality; surely quality refers to an end product and how it is made, and is not just about its authors or architects. Returning to Rolls Royce and their heritage of quality, I’d like to recall their beautifully crystallised mission statement: “To be trusted to deliver excellence”. ‘Trust’ as scrutinised in the publishing world is also an important factor in CME, but it is the ‘delivery of excellence’ that is attracting increased attention in Europe. We can identify these themes among the three stakeholder groups in European CME.
For the pharmaceutical company as financial supporter of CME/CPD, there have been developments following the initial internal consultation carried out by the ABPI under its “Trust Imperative”: it looks like the moves to place responsibility for CME/CPD within medical affairs rather than marketing departments is being received enthusiastically, and I am sure will become a cornerstone of trust in this area. However, plans to adopt the ‘Swedish Model’ whereby pharma and doctors go 50-50 on funding CME/CPD in the UK has been rejected. There is pre-existing resistance from the healthcare professionals to pay for their own education, but a shared responsibility for developing programmes may require additional channels of communication leading to the potential for mistakes to happen; I wonder whether there was the perceived risk of pharma being associated with poor quality education.
A public consultation phase is now starting to fine tune ideas and explore further options.
For the CME bodies and accreditation processes, I can describe a unique setting that will be taking place at the upcoming European CME Forum meeting in London (of which I am one of the organisers), where Professor Robin Stevenson (Chair, European Board for Accreditation in Pneumology) will be chairing a session on the subject of quality in CME. Stevenson, with an expert panel of representatives from two differing CME accreditation bodies, a pharma company, and an accredited CME provider from Germany, will lead a discussion about the pros and cons of various concepts. This will include examination of the two main systems of CME accreditation: event accreditation – where accreditation is based on a detailed review of a set of information and documentation from a single programme in one snapshot in time, and provider accreditation – where the education provider is made responsible for maintaining standards and following agreed processes, with the accreditation awarded following a less intensive review by the CME body, a half-way point to the system in the US.
Good CME Practice
In parallel to this, the education provider (agency), will now need to take more solid steps to become skilled in delivering this new style of educational programme. The launch of the Good CME group at the European CME Forum will help this third CME stakeholder be able to demonstrate competence and knowledge through transparent relationships and appropriate standards.
The aim of the group will be to look beyond minimum standards and work together to draw up effective working practices in CME, based on both trust and delivery of education that improves clinical practice.
European CME developments such as these will lead to further shifts in relationships. For pharma, there will be a loss of control, but a related increase in credibility of the educational messages. From an agency perspective the pharma company will no longer be a traditional client, educational messages will be judged more on the principles of EBM and outcomes, rather than eminence and an absence of financial relationships, and in the spirit of Good CME Practice, the learner will have more of a voice, with the ultimate ‘client’ being the better-treated patient.
Eugene Pozniak is managing director of Siyemi and learning and programme director of European CME Forum. Email: epozniak@siyemi.org
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