Extract

Sir,

I completely agree with the comment on our article1 by Cals2 on the need to standardize and make uniform the presentation of the data derived from studies on compliance carried out with electronic monitoring. Nonetheless, I would like to indicate a few points that I also consider to be important.

First, compliance studies published in the literature present different results depending on how they are analysed. With indirect methods, there is great variability. Although electronic monitoring seems to be the best method to evaluate the real compliance of the patients, the information we give the patients in these studies is also important. In our study, we did not explain the real objective of the study until the patient returned the container, in contrast to the studies by Cals et al.3 and Kardas,4 in which, being clinical trials, it was necessary to explain the real objective on the first visit. The reality of including a patient in a clinical trial and explaining that treatment compliance will be monitored makes the patients feel more controlled, which can modify their behaviour. In our study, this explanation was given when the patient returned the bottle and the patient was then asked to provide informed consent to use their data on compliance. Similar to what happened in the study by Cals et al.,3 none of the patients refused to give consent. In our study, we feel that we replicated normal practice more reliably and our results on compliance are probably closer to reality. This difference may largely explain why the data on compliance were worse in our study.

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