The Data and Resources Core has dual missions:
- To develop and share resources and provide supports that will advance research on deprescribing, and
- To spearhead initiatives to develop new science and consensus projects around measurement and data
In the beginning years of the network, we will be developing and disseminating resources that will be valuable to investigators conducting deprescribing research, and providing targeted consultations to investigators.
A Repository of IRB and DSMB Materials for Deprescribing Studies
Deprescribing studies may encounter some unique challenges related to human subjects protections and plans for safety monitoring. Institutional Review Boards (IRBs) may have questions about potential risks to patients, and researchers and IRBs may question which safety outcomes should be monitored. To help researchers navigate these challenges, we have gathered materials to share from several ongoing deprescribing studies, to serve as resources for the larger research community.
The materials available here include: portions of grant applications addressing Human Subjects issues; study consent forms; portions of IRB applications; examples of Data Safety & Monitoring Plans (DSMPs); and examples of reports you might provide to your Data Safety and Monitoring Board (DSMB). While there is no single right way to construct IRB applications, DSMPs, or related documents, these examples show how some thoughtful investigators have navigated these issues successfully in their own research.
Literature Search Strategy Guidance
The field of deprescribing has evolved over the past thirty years, and investigators conducting deprescribing research need to know what other studies are in their area to gain insights, facilitate collaborations, harmonize measures across studies, and to avoid duplication of efforts. To further support these efforts, we have developed a literature search strategy guidance tool that can use broad and narrow search parameters tailored to an investigator’s purpose for the literature search.
Ongoing mentorship is essential for junior investigators. However, sometimes both junior and senior investigators can benefit greatly from a targeted conversation with a content expert. Therefore, we have established a one-on-one consulting service.
A Repository of Measures Relevant to Older Adults
Our network is focusing on measures particularly relevant to deprescribing. The Older Americans Independence Centers (OAIC) Geriatric Research Instrument Library (GRIL) has been working hard to develop a repository of measures that are applicable to older adults in general many of which will be useful to investigators doing deprescribing research.
Geriatric Research Algorithms & Statistical Programs (GRASP)
The Older Americans Independence Centers (OAIC) GRASP provides a list of statistical analysis programs useful for biostatisticians studying aging.
Resources for Researchers
Deprescribing research requires many types of methods, ranging from selecting valid and meaningful outcome measures to identifying optimal intervention strategies to supporting effective recruitment and retention of older adults for clinical trials of deprescribing. USDeN has created an annotated list of resources that may be useful to investigators seeking ideas, best practices, and inspiration for their own research.
Defining Key Deprescribing Measures from Electronic Health Data: A Multisite Data Harmonization Project
Electronic health records (EHR) offer support for deprescribing research, but the absence of standardized measures for essential variables poses a challenge. As part of a case study on benzodiazepines and other sedative-hypnotics (Z-drugs), Dr. Sascha Dublin and her team established and evaluated EHR-based criteria for chronic medication usage and discontinuation.
Resources (Under Development) Include:
A compendium of measures
Investigators designing deprescribing studies need information about measures, including their definition, operationalization, and validity, as well as which ones are most important to patients and which ones can be compared across studies. As described in the Working Group Description below, we will develop a compendium of measures commonly used in deprescribing studies, including how they were defined in past studies of deprescribing and information on the validity and test characteristics of these variables. The Measures Working Group will substantially contribute to this compendium.
As of June 2022, a manuscript summarizing results of the scoping literature review and expert panel engagement, Recommendations for Outcome Measurement for Deprescribing Intervention Studies, was published in the Journal of the American Geriatrics Society.
Guide for data development, harmonization and management
Many single- and multi-site trials, particularly pragmatic trials, depend on electronic health record data to determine study eligibility and outcomes in a valid and consistent manner. This includes using these data to measure key markers of prevalent medication use and deprescribing. Using learnings from the Data Harmonization Working Group, the Data and Resources Core will develop and disseminate a ‘users guide’ to essential data infrastructure for deprescribing studies that use electronic health data. Development will be led by Core leaders Drs. Bayliss and Dublin with input from the Data Harmonization Working Group.