By Susan M. Dallabrida, Ph.D. VP, Clinical Science & Consulting Services, ERT
Worldwide Clinical Trials announced the results of a survey that evaluated the perceptions of clinical trial site investigators who use electronic clinical outcome assessment (eCOA) technologies. The survey results may shed light on some factors industry needs to consider regarding the importance of simple user interfaces, systems and quality training in order to improve the use and uptake of these technologies at the site level.
The announcement mentions that many respondents cited ‘…concerns that these electronic solutions may interfere with the normal patient rapport that is required during the clinical assessment process and eCOA may present a physical barrier to the clinical interview process.’ However, a well-established literature shows that eCOA improves patient/clinician communication and candor, while mitigating site rater variability.
The digital field has been largely successful in disseminating awareness of the value of eCOA systems to improve data quality/completeness. This survey highlights an important additional finding, namely that the perception that an electronic device represents a physical barrier between the site and patient remains prevalent. This is concerning because the opposite is true, the use of electronic devices promotes patient/clinicians in interactions and enables better care, as evidenced by:
- eCOA Increases Patient/Clinician Interactions: Taenzer, 2000 and Berry 2001
- eCOA Decreases Post-Operative Symptom Severity: Cleeland, 2011
- eCOA Prompts Increase Patient Candor and Reporting of More Events and More Severe Events: Mazze, 1984, Tsang, 2001, Ralston, 2009, and Diabetes Control & Complications Trial Research Group, 1993
- eCOA Increases Patient Candor in Suicidal Ideation and Behavior: Gao, 2015, Klimes Dougan, 1998, Yigletu, 2004, and Hetrick, 2014
- Site Staff Bias and Variability Compromise Clinical Trial Data Quality: Khan, 2013, Kobak, 2010, and Modell, 2016)
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. Thus, eCOA is a proven and better method than paper for increasing patient communication and candor while mitigating rater variability among clinical site staff.
We concur with Worldwide Clinical Trials on the importance of developing well-defined eCOA strategies at the study design stage and that these strategies should take into account the perceptions and capabilities of all key stakeholders, including investigative site staff. The wealth of evidence demonstrating the value of eCOA in promoting communication between patients and clinical site staff, as well as in improving patient care point to the importance of education and effective change management as these technologies are adopted more regularly in clinical development.
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