Susan M. Dallabrida PhD

Worldwide Clinical Trials recently announced the results of a 

 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:

eCOA Decreases Post-Operative Symptom Severity:

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.	 	For detailed information on the research mentioned above, please click 

.	 	 	Susan M. Dallabrida PhD is the Vice President, eCOA Clinical Science & Consulting at ERT. She can be contacted at Susan.Dallabrida@ERT.com	 	

		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

		The Diabetes Control and Complications Trial Research Group. 1993. The Effect of Intensive Treatment of Diabetes on the Development and Progression of Long-Term Complications in Insulin-Dependent Diabetes Mellitus. NEJM 329:977-986 

		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

Screening for suicidal ideation in children and adolescents: Methodological considerations.

		Yigletu, H; Tucker, S; Harris, M; Hatlevig, J. 2004. Assessing.  Suicidal Ideation: Comparing Self-Report Versus Clinician Report.  American Psychiatric Nurses Association. 10:1. 9-15.

		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

		Khan, A et al. 2013. Assessing the sources of unreliability (rater, subject, time-point) in a failed clinical trial using items of the Positive and Negative Syndrome Scale (PANSS). Journal of Clinical Psychopharmacology.33(1):109-17

		Kobak KA; Feiger,AD; Lipsistz, JD. 2005 .Interview Quality and Signal Detection in Clinical Trials." American Journal of Psychiatry, 162(3), p. 628

		Kobak, KA. 2010. Inaccuracy in Clinical Trials: Effects and Methods to Control Inaccuracy. Current Alzheimer Research.7, 637-641.

		Modell, J. 2014. When Placebo Response Isn’t Placebo. Response: THE PERILS OF HUMAN RATERS. Rho, Inc.

http://www.rhoworld.com/rho/news/dr-jack-modell-contributes-commentary-clinical-informatics-news-placebo-response-and-human

Articles

Worldwide Clinical Trials recently announced the results of a survey that evaluated the perceptions of clinical trial site investigators who use electronic clinical outcome assessment (eCOA) technologies.

Susan M. Dallabrida PhD

Articles

eCOA Increases Patient-Site Communication and Candor