Kari Tikkinen, MD, provides an update on the APPEAL trial
“The great news is that we have now completed recruitment. We actually recruited more than 1700 patients,” says Kari A.O. Tikkinen, MD, PhD.
In this interview, Kari A.O. Tikkinen, MD, PhD, shares an update on the APPEAL trial (NCT03692715), which was highlighted in the recent publication, “Update on APPEAL, an International Randomized Controlled Trial Evaluating Ciprofloxacin Versus Placebo in Patients Undergoing Shockwave Lithotripsy for Urolithiasis.” Tikkinen is a professor of urology at the University of Helsinki in Finland.
Video Transcript:
First of all, thank you to the European Urology Focus [for giving us] the chance to report this. The great news is that we have now completed recruitment. We actually recruited more than 1700 patients, and now we're starting to analyze this. We have a statistical analysis plan.
It's very common in large trials, but also in smaller trials, that the recruitment is a challenge, especially in surgery. It's actually the most common reason for discontinuation of trials, and we also had problems. This trial was started in Canada as a single center trial, but it soon was clear that this recruitment was too slow. Then we expanded the trial globally, and we made it a multicenter trial with more than 10 centers in different countries. We renamed this the APPEAL trial, which is antibiotic prophylaxis before shockwave lithotripsy. Then, as we know, the COVID pandemic hit all over the world, and it also hit the APPEAL recruitment. It was also impeded because many units at that time were not able to recruit patients or even treat patients.
Then, the third thing that was a little bit of a challenge [was] that we originally planned to recruit about 1500 patients, but then we looked [at the data]. We didn't open the blinding, but we looked at the data at about 1000 patients, and we noticed that there were less events than what we had planned. That's another common problem in trials is that investigators tend to overestimate the event rate, and we underestimated it a little bit. Then we increased the sample size to a minimum of 1700 patients, and we have now recruited these 1700 patients. We are now ready for analysis and publishing papers.
This transcription has been edited for clarity.
