In search of evidence

This post courtesy of Anne Taylor-Vaisey: Published in the October 24 issue of the Archives of Internal Medicine are this editorial and study:

Benson AB, III. In search of evidence: Is there the will and a way? [editorial]. Arch Intern Med 2005; 165(19):2194-2195.

Excerpt: Scientifically, politically, economically and perceptually, there are growing demands by both society as a whole and the medical profession that evidence must drive clinical decision pathways. The best level of evidence as incorporated into clinical practice guidelines originates from randomized clinical trial data. For many years, the process of obtaining objective clinical data has been a path across a minefield. Even under the most optimal circumstances, obstacles confront most clinical research projects that can delay the reporting of important clinical information.

In this issue of the ARCHIVES, Embi et al present the use of the electronic health record (EHR)-based clinical trial alert (CTA) system to address the problem of rapid subject recruitment by physicians, one of the recognized obstacles that can delay successful completion of a clinical trial. Although the authors recognize the limitations of this particular CTA intervention, including a small number of physicians at a single institution, along with the use of a single EHR to test a single clinical trial, this article serves as an invitation to incorporate the evolving use of technology in the clinical practice setting to enhance all phases of the clinical research process.

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Embi PJ, Jain A, Clark J, Bizjack S, Hornung R, Harris CM. Effect of a clinical trial alert system on physician participation in trial recruitment. Arch Intern Med 2005; 165(19):2272-2277.

Background: Failure to recruit a sufficient number of eligible subjects in a timely manner represents a major impediment to the success of clinical trials. Physician participation is vital to trial recruitment but is often limited.

Methods: After 12 months of traditional recruitment to a clinical trial, we activated our electronic health record (EHR)-based clinical trial alert (CTA) system in selected outpatient clinics of a large, US academic health care system. When a patient's EHR data met selected trial criteria during the subsequent 4-month intervention period, the CTA prompted physician consideration of the patient's eligibility and facilitated secure messaging to the trial's coordinator. Subjects were the 114 physicians practicing at selected EHR-equipped clinics throughout our study. We compared differences in the number of physicians participating in recruitment and their recruitment rates before and after CTA activation.

Results: The CTA intervention was associated with significant increases in the number of physicians generating referrals (5 before and 42 after; P

Conclusions: Use of an EHR-based CTA led to significant increases in physicians' participation in and recruitment rates to an ongoing clinical trial. Given the trend toward the EHR implementation in health care centers engaged in clinical research, this approach may represent a much-needed solution to the common problem of inadequate trial recruitment.

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