Do information systems improve the quality of clinical research? Results of a randomized trial in a cooperative multi-institutional cancer group

✍ Scribed by David D. Wirtschafter; Margaret Scalise; Connie Henke; Richard A. Gams

• Publisher: Elsevier Science
• Year: 1981
• Tongue: English
• Weight: 902 KB
• Volume: 14
• Category: Article
• ISSN: 0010-4809
• DOI: 10.1016/0010-4809(81)90042-2

✦ Synopsis

A facsimile communications network was established to serve eight randomly selected medical centers belonging to the Southeastern Cancer Study Group (SEG) to test whether clinical algorithms could augment protocol compliance and patient safety. An SEG protocol (75HDO103) for testing alternative chemotherapy regimens in Advanced Hodgkin's Disease was rewritten as a clinical algorithm. The algorithm generates treatment advice rules, emulating how the clinical researcher would accurately and appropriately apply the general protocol to an individual patient's specific visit, considering his prior response to therapy. The visit-specific advice rules were typed onto general encounter forms and sent to the oncologists over the facsimile equipment prior to each therapy visit. A facsimile of the completed form was transmitted back. Protocol compliance, as judged by explicit criteria on a visit-by-visit basis, was 94% in the algorithm user group and 64% in the nonuser group (p < 0.001). Two measures of hematologic toxicity, "low" counts and "toxic" nadirs, were associated more often with protocol noncompliance. We conclude that prospective information management can improve the "control" in cooperative controlled clinical trials.