Supporting collaborative clinical trial protocol writing through an annotation design

Abstract

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 work across distances and time zones. Email has been the primary communication tool for these protocol writers. Unfortunately, it inadequately supports collaborative writing tasks. Without appropriate groupware technology, these protocol writers often compromise work efficiency and the degree of collaboration to complete their tasks. This situation is exhibited at the Southwest Oncology Group (SWOG), one of the Cooperative Group Programs under the direction of NCI. While it is clear that its current work practices do not support optimal collaboration, it is unclear how to improve the collaboration and communication in such group work because the complexities of collaborative protocol development has rarely been studied. This research utilizes and extends Computer-supported Cooperative Work (CSCW) theories to identify the problems in protocol development and to design groupware technology for supporting this group work. This dissertation consists of four parts: (1) qualitative fieldwork of the collaborative protocol writing process at SWOG; (2) a design of an annotation model that facilitates in-context communication around evolving documents during the iterative reviewing and revising process; (3) a design and an implementation of a protocol collaborative authoring tool (PCAT) that embodies the annotation model from #2 to address group work problems identified in #1; and (4) a validation of the usability of the annotation model and the PCAT prototype. In addition, this dissertation implements a grounded design process and contributes a socio-technical design of groupware technology in a healthcare setting to the literature of socio-technical approaches for system design.