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Your patients have something to say: An intro to Electronic Patient-Reported Outcomes

Patient-reported outcome (PRO) are frequently essential to adequately evaluate the treatment benefit of new medical products in clinical trials (Coons S.J. et al.). It is perceived that PRO measures ought to be utilized while evaluating ideas best known by the patient or best estimated from the patient's point of view. Paper patient diaries have been used for years to capture data from the patient's perspective. However, with the rise of technological innovations, clinical research is now replacing paper patient diaries with electronic platforms known as electronic patient-reported outcomes. A PRO tool gathers treatment benefit data directly from patients, without translation by clinicians or others (U.S. Department of Health and Human Services).

Electronic patient-reported outcome (ePRO), as the name suggests are patient-reported outcomes that are collected electronically.  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.”

Electronic PROs are beneficial to both researchers and patients. Here’s how.

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.

It is almost certain that the costs to buy and program electronic gadgets can be substantial. Labor costs for a paper-based study can overshadow the initially anticipated ePRO costs and eradicate the savings expected for the use of paper (Applied Clinical Trials).

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).

ePRO allows patients to complete eCRFs while on the go.



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. Light, portable smartphones and tablets 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.

Case study

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.

Some one in our team is doing this now, thank you.💖
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Unlock the power of ePRO with Teamscope

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.

Image showing the difference between Researcher and Patients access to data



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.

Blood glucose graph per patient


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.

Conclusion

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.

Reference

  1. Coons, S. J., Eremenco, S., Lundy, J. J., O'Donohoe, P., O'Gorman, H., & Malizia, W. (2014). Capturing Patient-Reported Outcome (PRO) Data Electronically: The Past, Present, and Promise of ePRO Measurement in Clinical Trials. The patient, 8(4), 301-9.
  1. Applied Clinical Trials http://www.appliedclinicaltrialsonline.com/epro-vs-paper?pageID=4
  1. U.S. Department of Health and Human Services FDA Center for Drug Evaluation and Research., U.S. Department of Health and Human Services FDA Center for Biologics Evaluation and Research., U.S. Department of Health and Human Services FDA Center for Devices and Radiological Health. Health Qual Life Outcomes. 2006 Oct 11; 4():79.
  1. Shields AL, Shiffman S, Stone A. Patient compliance in an ePRO environment: methods for consistent compliance management, measurement, and reporting. In: Byrom B, Tiplady B, editors. ePRO: electronic solutions for patient-reported data. Surrey: Gower; 2010. pp. 127–142.
  1. Ganser AL, Raymond SA, Pearson JD. Data quality and power in clinical trials: a comparison of ePRO and paper in a randomized trial. In: Byrom B, Tiplady B, editors. ePRO: electronic solutions for patient-reported data. Surray: Gower; 2010. pp. 49–78
  1. Tiplady B. Electronic patient diaries and questionnaires—ePRO now delivering on promise? Patient. 2010;3:179–183. doi: 10.2165/11537600-000000000-00000.

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Deborah Maufi

I'm a business development specialist Teamscope. I enjoy helping our users do more and better clinical research. I'm a non-typical medical doctor and an above average board game fanatic.

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