Objective:To develop a tool that would make it easier for researchers, especially those in low- and middle-income countries, to write research protocols for pragmatic randomized controlled trials.
Study Design and Setting: A series of focus groups was held at the inaugural meeting of the Pragmatic RAndomized Controlled Trials in Health Care (PRACTIHC) project in 2001 to develop a desired specification for the Trial Protocol Tool. A working group of five individuals from the PRACTIHC group was formed to develop content for the tool.
Results: The Trial Protocol Tool was developed in English and Spanish as a Microsoft Windows HTML help system. A Web-based version is also available. This main body of the tool provides information, advice, and resources about the major headings that should be part of every research protocol. Illustrative examples are used throughout and are taken directly from the tool's protocol library. Additional resources include checklists, programs (e.g., a sample size calculator), and example documents (e.g., patient information leaflets). Conclusion: The Trial Protocol Tool packages all the key requirements for the development of a research protocol into one resource. We believe that the use of the tool will help researchers to design effective trials and to write high-quality protocols.