Patient retention in virtual cognitive debriefing interviews

Patient retention

Patient retention is a key element in clinical trials: It is a fundamental prerequisite of a successful and valid study to have samples and results from as many patients as possible. During linguistic validation, when the translations of the study documentation are verified by patients from the target population, it is equally important to have the patients complete the debriefing interviews – even if this type of engagement is not as long as the participation in a trial, which can last for years.

Patient withdrawal can happen at two stages. Firstly, they can change their mind after applying, and refuse to participate. Secondly, they can resign even during the debriefing if it is not appropriately prepared.

These situations can be frustrating and, moreover, they can also slow down the validation process, and therefore the study as a whole. So, we have compiled some useful advice that can help avoid such cases.

Digital transition

Digital transition

As in all areas of our lives, the global pandemic that started in 2020 has accelerated the digital transition in clinical studies and linguistic validation too. Trials have either stopped or suspended recruitment, and as we wrote in an earlier blog post, the US has implemented new regulations that have allowed some types and parts of the visits to be held online.

But this forced change has caused a considerable dropout rate, partly because the traditional doctor-patient relationship, which is built on trust and personal relations, has been transformed completely with this transition into the online world.

According to the data published by 2020 onsite, at least 30% of patients dropped out of clinical trials in the year 2020. However, it is important to note in the same article that most patients withdrew due to the stress caused by the visits, or because they considered that traveling to the site took too much time and effort. Considering these factors, the transition into the online world can even be beneficial, as it reduces the traveling time and probably the stress as well.

The same applies to cognitive debriefing: while in-person interviews used to involve the patient travelling, video interviews do not take more time than what is needed for the debriefing itself. Moreover, an online interview carried out at home, provided the technical requirements are met, means less stress than replying to an interviewer’s questions in person and in an unknown place.

Maintaining the personal relationship

As we mentioned, the doctor-patient relationship is more than a simple working relationship: during a clinical trial, patients put their trust in the physician. For some of them, the doctor’s instruction is one of the reasons they even enroll in the trial (according to statista.com, for 16% of patients this is the main reason for participating).

In the case of a cognitive debriefing, mostly there is no doctor-patient relationship between the interviewer and the interviewee. Still, on one side of the table there is a patient who sees the other party as a “person of science”. An interviewer working for the success of the study is simultaneously representing the company that conducts the study and the company that is providing the translation.

If the cognitive interview is conducted among real patients suffering from the condition that the study is targeting (and not healthy volunteers), it is equally important that they have trust, and that they take on the interview, consider it important and do not quit it. Therefore, it is paramount that the patients have a relationship based on trust with the interviewer, but they also need to understand that a cognitive debriefing is not a clinical study, only its preparatory phase.

Experience shows that patients tend to answer the questions of the translated questionnaire even if their task is only to tell if they understood the questions; they also tend to speak about their condition and share sensitive health information. Thus, the interviewer unintentionally finds themselves in a situation where the patient might feel vulnerable.

So, a good interviewer should not only be aware of the linguistic and professional aspects of the validation process; they also have to show great interpersonal skills, empathy and trustworthiness.

Preliminary measures

Preliminary measures

Although a cognitive debriefing is only a short, one-hour engagement, it is important to see it as a crucial milestone in finalizing the translations of the study documentation, and thus in the success of the whole trial.

It is useful to provide the participant with all the necessary details about the aim of the study and the linguistic validation, and to underline the importance of their participation in the finalization of the translations. Even if cognitive debriefing is compensated with a participation fee (unlike in clinical trials in Hungary), this is not a huge amount, so the financial factor alone might not be enough to convince someone to participate.

What will the future bring?

Patient retention strategies are currently undergoing a necessary change: while not long ago their main aspect was reducing the expenses and time effort for the patient, these factors seem to have automatically found a solution due to online interviews.

However, new challenges seem to have appeared: web-based debriefing is less personal, and is a short, ad-hoc task that makes it hard to build the sense of engagement and importance in the patient. This must be compensated for with more preparation, care and the simplest possible process, so that online interviews are not a technical challenge and a burden to the participant, but a quick way of earning money while being part of the success of an important future clinical trial.

It is not clear whether in-person interviews will return, therefore strategies have to be optimized to the online world. However, personal engagement has to be retained, as the key to success is always an adequate number of loyal participants.

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