2005 Scientific Session Abstracts
Supporting Collaborative Clinical Trial Protocol Writing through an Annotation Design
Chunhua Weng, Jackie Benedetti, Dana Sparks, Jason McCoy, John H Gennari
Context
Clinical trial protocols are important documents that guide clinical research. Modern protocol development requires collective expertise from a group of Loosely-Coupled protocol writers, who often work across distances and time zones. Email has been the primary communication tool of protocol writers. Unfortunately it inadequately supports collaborative writing tasks. To date, there has been insufficient study of the group work of protocol writing. Tools that support this process are even rarer.
Technology
We utilized and extended Computer-supported Cooperative Work (CSCW) theories to identify the problems in protocol development and integrate research in collaborative writing, annotation, and design rationale capture to support this collaborative writing process. We developed a protocol collaborative writing tool (PCAT) using ASP.NET, SQL Server, and JavaScripts.
Design
To understand the protocol writing process, w e interviewed 15 protocol writers spanning 5 roles, collected and analyzed 1140 protocol review comments and 70 email samples from some protocol writers, and observed protocol review committee meetings for more than three months. Informed by the field knowledge, we designed an annotation model in PCAT that facilitates in-context communication around evolving documents during the iterative reviewing and revising process. We evaluated their usefulness through formative evaluations and one field trial.
Results
Many aspects of the current PCAT design have received positive user feedback, including (1) sharing annotations as threaded discussions (2) collaborative writing over the web (3) group awareness support through shared feedback for group activities and (4) highlighting comments in different colors for multiple reviewers. Our evaluation results also reveal some impact of groupware technology on multidisciplinary clinical researchers, such as changing the work load among users in different roles and increasing the formalism of work after digitizing information.
Conclusion
Our work provides a basis for future research to address possible social-technical challenges for group work support in various fields of medicine.