protokollakohtaisen

Protokollakohtaisen is a Finnish term that translates to "protocol-specific" or "per protocol" in English. It is commonly used in the context of clinical trials and scientific research to describe data analysis or adherence that is based on the original treatment assignment, regardless of whether the patient actually received the assigned treatment.

In clinical trials, the "per protocol" analysis is a method of evaluating the efficacy and safety of an intervention. It includes only those participants who adhered to the study protocol throughout the trial. This means that patients who deviated from the protocol, such as by not taking the assigned medication, receiving a prohibited concomitant treatment, or withdrawing consent, are excluded from the analysis. The rationale behind this approach is to assess the effect of the intervention under ideal conditions, as if all participants had followed the treatment plan perfectly.

However, per protocol analysis has its limitations. Excluding participants who deviate can introduce bias, especially if the reasons for deviation are related to the treatment's effectiveness or side effects. For instance, if patients stop taking a medication because of severe side effects, excluding them from the per protocol analysis might underestimate the drug's adverse event profile. Therefore, it is often recommended to conduct both per protocol analyses and intention-to-treat (ITT) analyses, which include all randomized participants regardless of their adherence to the protocol. Comparing the results of these two analyses can provide a more comprehensive understanding of the intervention's effects and potential biases.