Kari Tikkinen, MD, provides an update on the APPEAL process

In this interview Kari AO Tikkinen, MD, PhDannounces an update on the APPEAL trial (NCT03692715), highlighted in the recent publication “Update on APPEAL, an international randomized control trial evaluating ciprofloxacin versus placebo in patients undergoing shock wave lithotripsy for urolithiasis.” Tikkinen is Professor of Urology at the University of Helsinki in Finland.

Video transcript:

First of all, many thanks to the European focus on urology [for giving us] the chance to report on it. The good news is that we have now completed recruitment. We have actually recruited more than 1700 patients and are now starting the analysis. We have a statistical analysis plan.

It is common in large trials, but also in smaller ones, that recruitment is a challenge, especially in surgery. In fact, it is the most common reason for trials to be stopped, and we had problems too. This trial was started in Canada as a single center trial, but it soon became clear that recruitment was too slow. Then we expanded the trial globally and made it a multicenter trial with more than 10 centers in different countries. We renamed it the APPEAL trial, a trial of antibiotic prophylaxis before shock wave lithotripsy. Then, as we know, the COVID pandemic hit around the world, and it also affected APPEAL recruitment. It was also hampered by the fact that many units were not able to recruit or even treat patients at that time.

Then the third thing, which was a little challenging [was] that we had originally planned to recruit about 1500 patients, but then we saw [at the data]. We didn't open the blinding, but we looked at the data from about 1,000 patients and found that there were fewer events than planned. That's another common problem in trials: researchers tend to overestimate the event rate, and we underestimated it a little. Then we increased the sample size to at least 1,700 patients, and we've now recruited those 1,700 patients. We're now ready to do the analysis and publish the articles.

This transcription has been edited for clarity.