eDiaries: How often is too often?

Valdo Arnera, MD – eCOA Scientific Advisor

Clario began using e-diaries in clinical trials nearly 25 years ago. During this time, two fundamental
questions have continued to arise:

• How often should a questionnaire be completed by the patient?

That is, how much can we reasonably ask of a patient daily? What about weekly or monthly? Too often may lead to poor compliance; not frequently enough may result in not enough ePRO data being collected for your study.

• How many questions should we ask the patient?

While there will never be a “magic number” in response to these questions, Clario has learned a few
guiding principles along the way to help guide trials.

1 Keep questions simple and keep them to a minimum

The simpler the diary is, the easier it is for patients to understand. When appropriately designed, e-diaries can obtain very high compliance.

An example of a simple, well-designed e-diary is for medication intake, in which patients log the medications they are taking and when.

2 The frequency depends upon the indication and the patient population under study

Patients taking part in oncology studies, for example, would generally be more willing and motivated to complete questionnaires more often than those who are in a trial for a skin rash.

3 Make sure patients understand why they are being asked the questions

The third piece of advice is to ensure that patients clearly understand why they are being asked to complete the assessment and ensure the questions are relevant to them.

Let’s consider a couple of examples:

In trials for urinary incontinence or menopause, events can take place a dozen times each day. Sponsors may consider it too burdensome to ask patients to complete a diary after each event. However, Clario studies within these indications have shown high compliance rates because patients understand why it is so important to collect these data points.

Compliance can also remain very high, even when the ‘ask’ of the patient is complex and time-consuming. In a Clario study for chronic obstructive pulmonary disease (COPD), patients were asked 15 questions in the morning and evening and were required to blow into a PEF meter three times in the morning and then sync the values to an e-diary. The study was also lengthy, lasting 64 weeks. Despite all this, compliance exceeded 93% because the patients understood why they were being asked to perform these diary entries and measurements and were relevant to them and their condition.

In conclusion, when designing an eDiary, questions should be relevant and easy to understand, and questions should be kept to a minimum to gather only the necessary data points. Studies can achieve high compliance rates if eDiaries are designed with the above considerations in mind. This is true even if 1) questionnaires are long; 2) patients are asked to complete a diary several times a day; or 3) the requested action is complex or seemingly burdensome. Getting eDiary designs right is critical to patient engagement, compliance levels and data quality.

If you would like to find out more about how Clario’s eCOA Science Team can support your next study, visit our eCOA webpage.