Posted by Peter Morris on October 22, 2011
There were a number of corporate symposia at the ESOT Congress, which is accepted practice these days at most large meetings. However I did hear a lot of criticism about the biased presentations made at some of these symposia, which I had not heard before! Certainly I went to one sponsored by Astellas which was really a quite clever advertisement for the long acting formulation of tacrolimus, Advagraf. The speakers, all distinguished, did present valid data but in my opinion were very selective in their presentations all directed at eventually building up an argument in favour of the prolonged-release formulation of tacrolimus, Advagraft (it should be noted that Prograf, the immediate-release formulation of tacrolimus is about to come off patent!).
This is not without precedent, but I am becoming increasingly concerned as corporate symposia in the past tended to be much more educational than appears to be the case now. I also feel strongly in this age of transparency that speakers should declare up front how much they are being paid for giving their talk. I think this would help the audience to put their presentations in perspective.. The support of industry is important for our congresses, but I do think we need to carefully look at the impact of big pharma on our practice as there is no question that immunosuppression in transplantation is driven to a very considerable extent by industry, not always based on the soundest evidence. This is a plea for transparency at all levels.
Posted by Peter Morris on October 8, 2011
I have just returned from the ESOT 2011 Congress in Glasgow. It was held in the very large congress centre (SECC) on the banks of the Clyde River in Glasgow. The SECC is a very impressive centre with one building containing the major auditoria and which resembles from the outside a mini edition of the Sydney Opera House, while a second connecting building has space for all the other activities such as the exhibition hall, mini lecture theatres and meeting rooms.
The meeting itself was absolutely first class and I felt it was the best ESOT Congress ever, with over 3,500 participants. Of note was the large number of participants from outside Europe, confirming the increasing international stature of ESOT. Many innovations were introduced. These included poster sessions on an electronic screen at which the authors spoke, giving a brief 3 minute presentation and then there were a number of mini theatres which hold about 20-30 people and where short presentations took place. You could even download the scientific programme as an app on your smartphone. There was also streaming of many of the key plenary sessions, even to members of the AST in the USA.
The local organising committee comprised Professors John Forsythe and Alan Jardine as co chairmen backed up by Professors Peter Friend, Keith Rigg, Anthony Warrens and Chris Watson. They had put an enormous amount of work into organising the scientific programme, and indeed fulfilled their advance notice that this was to be a new meeting! Furthermore the Chief Executive officer, Annalisa Ponchia, and her team, Chiara and Kate, had done a tremendous job with the administrative and social side of the congress. All in all this was a great success and a great occasion for the President, Professor Rutger Ploeg.
Posted by Liset Pengel on September 22, 2011
Last week, Liang Liu presented a paper entitled ‘Reporting Quality of Randomized Controlled Trials (RCTs) in solid organ transplantation’ at the ESOT congress which was held in Glasgow, UK.
Randomized Controlled Trials (RCTs) can provide Level 1 evidence to guide treatment. Previously, we reviewed RCTs in solid organ transplantation that were published between 2004 and 2006. The results indicated that the reporting quality of RCTs was quite poor, showing that only one-third of RCT reports were of acceptable reporting quality according to the Jadad scale. In order to find out whether there has been any improvement since our last review1 we conducted another review to evaluate the methodological quality of reports of RCTs in the solid organ transplantation published in 2007 and 2008. Additionally, we explored some factors that are associated with the reporting quality of RCTs and examined adherence to the CONSORT statement. The CONSORT statement describes criteria for reporting RCTs and is a universally accepted guideline to report clinical trials.
The quality assessment included a composite quality score assessing allocation concealment, intention to treat (ITT) analysis and the Jadad scale. The Jadad scale assesses whether the report included an adequate description of randomization, double blinding and withdrawals/drop outs. The Jadad score ranges from 0 to 5 with trials scoring 3 or greater considered as reasonable good quality trials. The quality was independently assessed by two reviewers. Disagreements were resolved by discussion or a third reviewer. In total, 206 RCTs were included in the analysis. Forty-one percent of RCTs had a Jadad score of 3 or greater and approximately one-third (35%) of the trials adequately described concealed allocation. Only 16% of reports analysed the data on the basis of ITT. Of the 206 trials, 62 trials were described as single centre trials and 105 trials as multicentre trials. For 39 trials it could not be determined whether these were single or multi centre trials. The percentage of RCTs with a Jadad score of 3 or greater was higher among multicentre trials than single centre trials (45% vs. 28%). In addition, more multicentre trials compared with single centre trials used concealed allocation (48% vs. 32%). Trials receiving commercial or commercial and non-commercial (mixed) funding were of better quality than trials receiving non-commercial funding. For example, 55% of trials funded by commercial companies and 75% of trials that received mixed funding had a Jadad score of 3 or greater versus 42% of non-commercial trials.
To review the relationship between the reporting quality and CONSORT endorsement by journals, we selected 153 RCTs in 19 journals that published at least 2 RCTs in organ transplantation. RCTs published in journals that endorse the CONSORT statement in their author instructions were on average of better quality. There was a higher number of RCTs with a Jadad score of 3 or greater, using concealed allocation and ITT analysis in journals endorsing the CONSORT statement compared with journals that did not endorse the CONSORT statement (60% vs. 28% for the Jadad score, 41% vs. 26% for allocation concealment, 28% vs. 14% for ITT, respectively).
When analysing adherence of RCT reports to the CONSORT statement we found that on average 12 out 25 CONSORT items were addressed in RCT reports. Items that were generally poorly reported were for example estimated effect sizes and its precision for primary and secondary outcomes. But also trial registration that has been a mandatory requirement by many journals was only included in 14% of reports. A flow diagram demonstrating patients flow throughout the study that has been strongly recommended by the CONSORT statement, was only included in 28% of reports.
In conclusion, the methodological quality of reports of most RCTs in organ transplantation is unsatisfactory and has not improved since 2006. Despite the development of guidelines to improve the reporting of RCTs and their endorsement by medical journal, both authors and journals show insufficient compliance with these standardised guidelines. It appears that there is a strong need to educate the transplant community about the importance of adequate methodology and reporting of RCTs. We strongly advocate the consultation of the CONSORT statement during the design and reporting of a trial. To this end, the Centre for Evidence in Transplantation and the European Society for Organ Transplantation have initiated a collaboration to help with the design and reporting of RCTs in Europe (www.esot.org). The collaboration hopes to improve the quality of RCTs in organ transplantation in Europe by advising investigators in the early stages of trial design and planning. In this way a strong evidence base for the best possible patient care can be built.
1 Pengel L, Barcena L and Morris PJ. Quality of reporting of randomised controlled trials in organ transplantation. Transplant International 2009; 22(4):377-84
Posted by Simon Knight on September 4, 2011
We would like to invite ESOT members to come and visit us at the ESOT congress in Glasgow from Sunday 4th September to Wednesday 6th September. We will have a stand in the ESOT Village in the SECC where you can come and chat to us and learn more about what we do and how we can help you in your research.
Various members of the CET staff will be talking at the congress. Liset Pengel will be giving a talk on how to search the Transplant Library at 1pm on Monday in Mini-Theatre 1. John O’Callaghan will be giving a mini-oral presentation at 1:12pm on Tuesday, followed by Liang Liu who is speaking at 4:40pm.
See you there!
Posted by Simon Knight on September 2, 2009
The CET had its own stand at the ESOT congress in Paris (August 2009). Computers were available for live demonstrations of the Transplant Library. There was also information on the other activities of the CET.
Work from the Centre was also presented, including a paper by Liset Pengel and Peter Morris entitled “Do wound complications or lymphoceles occur more often in patients receiving mTOR inhibitors? A systematic review”.