This administrative supplement to the Roybal Coordinating Center is a demonstration project to develop a special online authoring tool to support the writing of NIH Stage pilot research reports in the field of Alzheimer?s disease and its related dementias (AD/ADRD). This new electronic tool will facilitate the efficiency, accuracy, and timeliness of creating public protocols and results manuscripts for pilot studies, in the face of barriers to open and transparent reporting of pilot studies often cited by researchers. A paper authoring tool (PAT) originally created for the field of addictions research for 2-arm randomized controlled trials will be adapted for NIH Stages AD/ ADRD pilot designs. The currently functioning PAT will be adapted and tested to include research designs from the NIH Stages IA and IB pilot designs (e.g., feasibility, acceptability, refinement, and modification designs). The new online tool will prompt authors for design and study quality information required to transparently and openly report their Stage design, hypothesis, measures, and outcomes. It provides guidance and structure to ensure that the information provided in the manuscript is clear, consistent, comprehensive and structured. This tool allows deposit of the design meta- data, and so can be searched by future pilot investigators to determine which Stage design is optimal for their planned pilot study. The research team, including authoring tool experts, will (a) Adapt P.A.T. to AD/ADRD research and to multiple research designs, consistent with the NIH Stage Model Phase IA and IB study designs; (b) Conduct beta-testing with the modified tool to inform improvement; (c) Release the Paper Authoring Tool as an online version with an online manual. In summary, this administrative supplement seeks to support Open Science movement and Roybal AD/ADRD center by creating and hosting an electronic Paper Authoring Tool that enables more transparent, open, efficient, and timely dissemination of pilot protocols, reports, and results manuscripts from these crucial pilot studies.
Facilitating more timely, accurate, and efficient dissemination of manuscripts, protocols, and reports from critical pilot studies can be accomplished by developing an online authoring tool for writing NIH Stage Model pilot research reports applicable to the Roybal pilot studies in the area of Alzheimer?s disease and its related dementias (AD/ADRD). Enhancing the quality and timeliness of such research reports has the potential to inform the generation, conduct, and interpretation of next NIH Stage research studies by the Roybal Centers and the broader medical community to improve the health of AD/ADRD patients and their caregivers.
