Author: Melissa Newara, Senior Director, Subject Matter Expertise
Every clinical research professional has a story about paper diaries that they have collected and, more specifically, the pain of paper.
When I was a coordinator, it was not unusual to receive all of my adolescent participants’ 18-month follow-up assessments stuffed into one envelope written in the same pen. You could see the handwriting degrade across the 18-month follow up, since the assessments were obviously completed at the same time. There were often coffee stains or even sometimes ice cream marks all over the questionnaires. Inevitably, there would be pages with answers missing or maybe whole pages stuck together with that ice cream and unreadable. Sometimes participants would write in new response options on their rating scales that they thought were more appropriate to how they felt. These are the issues you get when using paper PRO.
But beyond the frustrations and humorous anecdotes, paper submissions also have to be manually verified and entered into the trial database – introducing time delays that could cost a sponsor or CRO the first-mover market advantage.[1]
In contrast, ePRO automatically incorporates this eCOA data into the study, improving the depth, timeliness, and accuracy of patient-reported outcomes data in the following ways:
1. Timeliness of PRO collection
ePRO collection is always timely. Participants receive notifications to complete their study according to the schedule specified in the protocol. There are no paper forms to misplace, and many patients already carry electronic devices at work and home, so it is easy. Compliance with paper survey completion may be as low as 8 to 14 percent and is usually no higher than 30%.[2] Studies have shown 90 to 97 percent compliance with electronic surveys, and some patients have noted that electronic diaries are easier to use.[3] Also, ePRO applies timestamps to when the form is completed and uses electronic reminders to encourage engagement. This helps avoid the “parking lot syndrome” – when a participant fills out all of their surveys in the parking lot immediately before a site visit.
Patient safety may also benefit from the timely reporting of ePRO. Participants in clinical trials often wait for their routine appointments to report symptoms of adverse events (AEs) rather than reporting them as experienced.[4] In contrast, ePRO makes it easy to record patient-reported outcomes when it is needed – be it at specified intervals or when the participant is experiencing symptoms.
2. Completeness of PRO collection
ePRO isn’t just timely; it tends to be more complete. Under-reporting symptoms, especially mild ones, is a frequent concern in many trials. This behavior can happen for various reasons, including forgetfulness, not realizing the importance of reporting these symptoms, and concerns about having treatment stopped.[4]
Electronic patient-reported outcomes allow participants to report symptoms as they experience them and for researchers to receive that information in real time.[4] An ePRO solution clarifies when and how participants should report symptoms by sending notifications and requiring that each field be completed before submission. In addition, researchers can set up electronic PRO systems to alert them when participants enter out-of-range responses, allowing them to take action quickly.[5]
3. Fewer Reporting Errors
Surveys completed via ePRO are less likely to contain errors[3] than surveys completed via paper. Using an ePRO can prevent missing data because the patient must answer all questions as presented. Also, with ePRO, illogical responses, such as marks outside of a visual analogue scale (VAS), are eliminated. The use of ePRO also eliminates the problem of unintelligible stray marks and illegibility. Essentially, ePRO reduces human error and helps to provide more accurate information about the patient experience.
4. Less Time Spent Cleaning Data
When paper surveys are used, data cleaning and reconciliation are more expensive and require more time at the end of the study. Someone has to enter data from paper surveys into an electronic database manually. The time it takes can be significant depending on the number of participants, the frequency of surveys, and the total number of surveys required. The use of ePRO software eliminates these steps; the data is automatically reconciled. Without the need for data transcription and review, data analysis can happen more quickly.
5. Eliminate Recall Bias
With paper surveys, patients may delay completion until after the specified time window and may even falsify the date and time on their surveys. Worse yet, they may fill in the information before the actual diary day. A study published in the British Medical Journal found that patients in a chronic pain study recorded only 11 percent of their diary entries at the specified time but claimed to have recorded 90 percent of entries at the correct time.[2]
When patients back-fill surveys and diaries, recall bias impacts data accuracy and quality. Notifications and reminders native to ePRO systems drive compliance to ensure that data are collected as intended in the study protocol. Additionally, timestamping within the ePRO surveys assures study teams that patients actually completed the survey during the proper time window resulting in data that are compliant with regulations.
Overcoming Early-phase Challenges with ePRO
With regulators and payers increasingly emphasizing the importance of including patient-reported outcomes in study designs, researchers can benefit from starting studies with a core focus on producing the highest quality data possible, as efficiently as possible.
A tool like ePRO improves data collection for studies of all phases and indications and provides a comprehensive and accurate view of any adverse events, ensuring patient safety. It also ensures accurate reporting of adverse events and reduces clinical staff workload through automated reporting and notifications. Plus, Medrio ePRO is available with seamless EDC integration to ensure data security, accuracy, and completeness across all areas of clinical trials.
Are you curious about how Medrio ePRO could work for your study? Get in touch.
References
- Bergmo T. S. (2015). How to Measure Costs and Benefits of eHealth Interventions: An Overview of Methods and Frameworks. Journal of medical Internet research, 17(11), e254.
- Hufford, M.R., Stone, A.A., Shiffman, S., Schwartz, J.E., & Broderick, J.E. (2002). Paper vs. electronic diaries: Compliance and subject evaluations. Applied Clinical Trials. 2002;(August):38–43. Retrieved September 15, 2022.
- José, N. C., & Langel, K. (2010, June 10). EPRO vs. paper. Applied Clinical Trials Online. Retrieved September 15, 2022.
- Kennedy F, Shearsmith L, Ayres M, Lindner OC, Marston L, Pass A, et al. Online monitoring of patient self-reported adverse events in early phase clinical trials: Views from patients, clinicians, and trial staff. Clin Trials. 2021;18(3):168–79.
- Hughes, S. E., McMullan, C., Rowe, A., Retzer, A., Malpass, R., Bathurst, C., Davies, E. H., Frost, C., McNamara, G., Harding, R., Price, G., Wilson, R., Walker, A., Newsome, P. N., & Calvert, M. (2022). Feasibility of a new electronic patient-reported outcome (ePRO) system for an advanced therapy clinical trial in immune-mediated inflammatory disease (PROmics): protocol for a qualitative feasibility study. BMJ Open, 12(9), e063199.
