Electronic Patient-reported Outcome (ePRO) are questionnaires for patients to report how they are feeling. Today, the go-to-method for collecting that information is with a ePRO Mobile App: a mobile application that patients can install of their own device to easily keep track of their symptoms.
How are you feeling today?
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Use automatic mobile reminders to keep patients engage.
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Invite your patients with a QR code, a link or an email invitation.
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Visualise your data in real-time.
Electronic PRO are mostly used in clinical trials, but recently they are also used in patient registries. With new innovations, patients can now efficiently complete surveys through user-friendly platforms that take into account the efficiency and accuracy of the data collected.
The number of clinical trials using ePRO is rapidly growing in the past 15 years. Studies show that electronic patient reporting yields higher quality data than paper-based diaries and that ePRO elicits significantly greater subject compliance, sometimes as high as 97% (Applied Clinical Trials).
Evidence from recent years shows that unsupervised paper-based self-reports are a long way from optimal compared to data collected electronically (Shields A. L et al.). Ganser et al. stated that paper-based patient-reported data collection can “result in untimely, unreadable, missing, illogical or otherwise faulty data.”
Using ePRO improves compliance which in turn, enhances the quality of data.
It is almost impossible to collect high-quality data from paper. Subjects might enter data that are incomplete, unreadable or inappropriate. Such errors can drive the research team to spend endless hours inspecting surveys, transcribing information, and looking for follow-up data.
It very well may be a long time before mistakes on a paper survey are found and, at that point, it is not possible to recover the missing information. This is not only inconvenient and exasperating but also adds to the overall costs.
Because ePRO data are collected and validated in real time, the possibility for lost, missing, and non-compliant data is altogether decreased. Also, ePRO defines specific time frames for data entries, and their timestamps document those entries (Tiplady B).
The accessibility of new technologies has empowered clinical preliminary conventions to be planned in manners that take into account all the more opportune and patient-accommodating methodologies. iPhone and Android devices have made patient data collection convenient while providing privacy and confidentiality.
Enrolment is difficult in clinical studies, but ePRO has the potential to increase patient enrollment by making it easier to participate no matter where you live. This also promotes retention.
Merck Research Laboratories conducted a ‘multicenter, parallel group and unblinded’ study for 90 patients recruited in the US. The eligibility criteria included patients who met the DSM-IV diagnosis for chronic primary insomnia and had been in treatment with FDA-approved prescription hypnotics for at least three months. Patients completed daily diaries that captured the Total Sleep Time from the previous night.
The endpoint data were used to calculate the primary outcome measure. The yielded superior data quality was faster to analyze, a 41% reduction in standard deviation, and 95% study power achieved with less than half the sample size than previous studies that used paper diaries.
It is evident that ePRO is a better tool than paper diaries in self-reported patient outcomes.
Teamscope, an offline mobile app allows researchers and clinicians to collect data from their patients in real-time.
By simply inviting your patients to your study account, patients can complete forms from anywhere and at any time without having to travel to the doctor’s office unless instructed otherwise by the doctor. Using user permissions restrictions to protect the patient data, the patient can only view their forms while the doctor has visibility of all his patient data.
Keeping patients engaged is the biggest challenge of capturing high-quality longitudinal data.
With the help of Teamscope automatic reminders patients can be reminded with a push notification when to complete a form. Reminders work offline which means that patients don't need an internet connection to be reminded nor complete forms. Once the patient connects their smartphone or tablet to the internet all data is securely synced with the cloud.
The feeling patients often have when answering an ediary survey is that once their data is submitted its locked in a silo.
This opens up ethical questions that at Teamscope we feel very strongly about. If as a patient I answer a form about my personal life and health, who owns that day, myself or the researcher? Legally, patients own their data, but in practice their ability to exercise those rights (like the right for data deletion) depends on bureaucratic processes.
At Teamscope we think our ePRO solution should work just like a personal diary.
Patients can at any moment view directly from the mobile app the data they have submitted in the past and edit it if they would like. Patients can also archive data if they feel they made a mistake and if they feel inclined to, they can even permanently delete it.
On the other hand, we reflect all those changes in a transparent Activity log, where the researcher can track data creation, updates and deletion.
Unfortunately patients might not have internet access at all moments. This means that valuable data may be lost or patients will be forced to write down their symptoms to later transcribe them to a web-based solutions.
Luckily with Teamscope, patients can access their forms when they are offline. Once the patient regains internet access the app sync all data with the server, becoming instantly visible to the research team.
Teamscope also allows the researchers to set up warning messages for specific data ranges which are crucial in ensuring data validity and giving further knowledge to patients.
If the patient enters data that matches with particular criteria, a notification is immediately sent to the doctor for necessary action. For example, a Type 2 diabetic patient checks their glucose levels at home daily. When the results are out of the normal range, the doctor gets notified immediately and can timely contact the patient for necessary actions.
Data visualization is simplified on Teamscope making your data easily actionable. Through our online dashboard, researchers may analyze the data of their patients in real-time. How? Teamscope allows you to automate calculations and perform real-time statistical analyses, such as standard deviation, build dynamic graphs and export your patient data for further analysis.
This leads to improved patient experience, reduced clinical errors, and faster insights.
The shift from paper-based to ePRO data collection has enhanced the integrity and accuracy of PRO data in clinical trials (Coons S. J. et al.). Electronic PRO offers various advantages contrasted with paper PRO or diaries including higher patient consistency, data accuracy, and better data quality. It also decreases data errors, and since the information can be entered in real time, it provides accurate time-stamped information and allows real-time monitoring of the data and quicker insights. Additionally, memory recall is reduced or eliminated, plus improved compliance and potential cost savings.
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