By Susan M. Dallabrida, Ph.D., Vice President, eCOA Clinical Science & Consulting, ERT
Use of Technology Increases Patient-Site Communication and Candor
As more and more questions arise about improving patient engagement in clinical trials, many sponsors are finding that the answers may lie in the use of technology. Most pharmaceutical companies are considering methods for implementing novel technologies, e.g., activity trackers and mHealth devices in their trials, in order to maintain better, more consistent interaction with study subjects. Many of these devices are still in proof of concept testing. Whether they will find their place in clinical research will be the global regulators’ decision as consumer devices must satisfy FDA guidelines as a medical device when used to collect endpoint data within a clinical trial.
What many sponsors may not realize is they already have access to regulatory-approved technology that can address current patient engagement challenges. Researchers will find that the use of electronic clinical outcome assessments (eCOA) not only improves data quality, but also offers the potential to improve patient engagement during clinical development.
The benefits of capturing high quality clinical trial data via eCOA have been widely recognized for more than a decade. Researchers have documented significant improvements in patient protocol compliance and data quality, a reduction of missing data and data ‘noise,’ and most importantly, increased study power with fewer patients.(1)
Here we review some of the well-established literature demonstrating how eCOA can also improve patient/clinician communication and candor vs. traditional paper-based COA, helping sponsors to keep patients better engaged during clinical development.
eCOA Increases Patient/Clinician Interactions
eCOA prompts and increases patient/clinician interactions and enables subjects to think through their symptoms prior to meeting with site staff. As a result, patients are more likely to bring up clinical events in discussions with the clinical site, since the eCOA completion prompts their memory of additional details. For example,
- In a head-to-head comparison of electronic vs. paper completion using the EORTC-QLQ-C30, 48.9% of the symptoms reported electronically were addressed at the clinic visit vs. only 23.6% on paper (Taenzer, 2000).
- In a study of 660 cancer patients, patients were given touch-screen tablets to complete electronic self-report assessments, which included items on symptoms and health related quality-of-life. The results indicated that electronic patient-reported outcome (ePRO) reports to clinicians fostered discussions with patients at visits, clinicians were more likely to discuss issues flagged by the automated system at visits, and visit duration was unaffected (Berry, 2011).
- Electronic COA ensures that every patient is asked the same questions in the same order at every visit without bias, halo, error, leniency, variation, interpretation or mood. These electronic data are then available for site staff to intervene, augment and guide care.
eCOA Prompts Increase Patient Candor and Reporting of More (and More Severe) Events
eCOA has been proven to increase patient candor. Patients are more likely to report more severe and more events electronically than on paper. This principle applies across a spectrum of indications and is generally applicable to patient-reported data. Patient reporting on diverse topics such as medication compliance and blood glucose levels are common examples.
- Diabetes subjects under-report hypoglycemic and hyperglycemic events on paper COAs 67% of the time (Mazze, 1984). Further, diabetic patients using paper COA capture blood glucose values but fail to record them. A systematic review encompassing 11 diabetes studies showed that among these three categories of errors, nearly 50% of paper COA data was inaccurate (Given, 2013). Electronic COA mitigates any such errors.
- Several studies examined the impact of electronic and paper patient diaries on glycemic control and HbA1c levels. These studies found that increased monitoring in the electronic version may have encouraged positive behavioral changes and/or provided additional information on which patients could take action to improve their glycemic control. The use of a mobile electronic diary vs. conventional clinic visits were compared in patients from a diabetes clinic in a 12-week crossover design study (Tsang, 2001). In the electronic diaries, subjects recorded meals and blood glucose levels, then received immediate feedback on their nutritional intake. There was a significant improvement in HbA1c for the time that subjects were using the electronic diary vs. the control period (HbA1c levels reduced 0.83%). Overall, the authors concluded that use of eCOA improved HbA1c levels.
- In another study comparing paper vs. electronic diaries, HbA1C levels decreased more in the electronic than the paper group. Furthermore, those who reviewed their electronic screens with their healthcare providers tended toward better glycemic control than those who did not (Ralston, 2009).
- The eCOA diary has proven to be an important and better tool than paper for patients and healthcare providers to improve clinical care. Good control of blood glucose levels is well recognized as a key element to attenuating disease progression for patients with diabetes. Studies show that for each percentage point decrease in HbA1c, microvascular complications are decreased by 35% (Diabetes Control & Complications Trial Research Group, 1993).
eCOA Increases Patient Candor in Suicidal Ideation and Behavior
Self-reported electronic data capture enables increased patient candor in suicidal ideation and behavior. Patients are more likely to reveal a higher frequency and severity of symptoms than ascertained by site interviewers. These phenomena are also well documented for topics including sex, drug/alcohol abuse, obesity, HIV, and mental health.
- In major depressive disorder and bipolar disorder, self-reported questionnaires were two to four times more likely to reveal higher frequency and severity of suicidal ideation than clinician-ascertained (Gao, 2015). In an 8-year study in children and adolescents, 98 families were followed (ages 5-18). Subjects completed a youth clinical interview and youth self-report assessments on suicidal ideation. Reports of suicidality were higher for the self-report group (25% and 30% in the younger and older cohorts, respectively) than the interview version (11% and 24% in the younger and older cohorts, respectively) (Klimes Dougan, 1998).
- 68 patients admitted to a hospital or treatment facility for treatment of mood or anxiety disorders completed the Beck Depression Index (BDI) and clinician interview. Nine (18%) of the 50 participants who responded positive on the BDI were rated by clinicians as negative for suicide ideations following the face-to-face interviews (Yigletu, 2004).
- Primary care physicians reported that an online electronic monitoring tool helped with engaging their patients because their patients were more willing to share how they were feeling in terms of symptoms, side effects and their suicidal ideation online. This enabled the clinicians to better address their health issues (Hetrick, 2014).
There is a wealth of evidence demonstrating the value of eCOA in fostering better communication and increasing candor between patients and clinical site staff, as well as in improving clinical outcomes.
By providing regulatory-approved technology that enables better patient: physician communication during a trial, sponsors will reap the benefits of higher quality data collection — and also improve patient engagement during clinical development.
Taenzer, P et al. 2000. Impact of Computerized Quality of Life Screening on Physician Behaviour and Patient Satisfaction in Lung Cancer Outpatients. Psycho Oncology, 9:203-213
Berry, DL et al. 2011. Enhancing Patient-Provider Communication with the Electronic Self-Report Assessment for Cancer: A Randomized Trial. Journal of Clinical Oncology. 29:1029-1035.
Cleeland, CS et al. 2011. Automated Symptom Alerts Reduce Postoperative Symptom Severity After Cancer Surgery: A Randomized Controlled Clinical Trial. Journal of Clinical Oncology. 29:994-1000.
Mazze, RI et al. 1984. Reliability of Blood Glucose Monitoring by Patients with Diabetes Mellitus. The American Journal of Medicine. 77: 211-217.
Given, JE et al. 2013.Comparing patient-generated blood glucose diary records with meter memory in diabetes: a systematic review. Diabetic Medicine. 30:901-13
Tsang LC et al. 2001.Improvement in Diabetes Control with a Monitoring System Based on a Hand-held, Touch-screen Electronic Diary. Journal of Telemedicine and Telecare. 7:47-50
Ralston, JD et al. 2009. Web-based Collaborative Care for Type 2 Diabetes. Diabetes Care. 32(2):234-39
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Adebajo S, Obianwu O, Eluwa G, Vu L, Oginni A, Tun W, et al. 2014. Comparison of Audio Computer Assisted Self-Interview and Face-To-Face Interview Methods in Eliciting HIV-Related Risks among Men Who Have Sex with Men and Men Who Inject Drugs in Nigeria. PLoS ONE 9(1): e81981. doi:10.1371/journal.pone.0081981
Gao, K et al. 2015. Disagreement between self-reported and clinician-ascertained suicidal ideation and its correlation with depression and anxiety severity in patients with major depressive disorder or bipolar disorder. Journal Psychiatry Research. 60:117-24
Klimes-Dougan, B.1998. Screening for suicidal ideation in children and adolescents: Methodological considerations. Journal of Adolescence. 21: 435-444.
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Hetrick, S et al, 2014. Ensuring guideline-concordant monitoring of suicidal thinking and behavior after initiation of antidepressant treatment in 12- to 25-year-olds with depression
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