PhenX Protocols for COVID-19 Research

On April 2, 2020, the PhenX team met with Erin Ramos (NHGRI, PhenX Project Scientist) and William Riley (OBSSR) to discuss how PhenX could contribute to the NIH response to COVID-19, recognizing a need to fulfill a rapid demand for recommended measurement protocols for COVID-19 research. The next day, the PhenX team sent a COVID-19 response plan to the PhenX Steering Committee for review and comment. This plan included a page or library for current COVID-19 protocols, supporting OBSSR in vetting submitted protocols, and development of COVID-19 related collections intended for use in longitudinal studies. The plan received enthusiastic support from the PhenX Steering Committee (SC).

Step 1: COVID-19 Protocol Library

The first step was to establish a library COVID-19 measurement protocols, that were already in NIH had requested that COVID-19 protocols, which were in use, be submitted to the NIH Office of the Director via a web portal. These COVID-19 measurement protocols were shared with the scientific community via a collaboration of PhenX and the NIH Public Health Emergency and Disaster Research Response (DR2). The NIH DR2 provides a wide array of data collection tools and resources for use in public health emergencies and disasters, including the COVID-19 pandemic.

The PhenX COVID-19 library provides COVID-19 related measurement protocols (CRFs, DCFs, instruments, surveys, questionnaires) that are currently in use. Full measurement protocols consist of the full-length item. Full measurement protocols are also broken down into modules, or subsets of the full instrument. To view the full list of COVID-19 protocols in the DR2 click here; to view the full list of COVID-19 protocols on the PhenX COVID-19 Protocol Library page click here.

Step 2: COVID-19 Research Collection

In addition to establishing the PhenX COVID-19 Protocol Library, the PhenX SC thought it was important to recommend use of a subset of the protocols in the Library, and to release them in the PhenX Toolkit as a COVID-19 Research Collection. Typically, PhenX measurement protocols are required to be well-established and broadly validated, but for the COVID-19 related protocols, this was not possible. Accordingly, the PhenX SC introduced the concept of “rapid release”, a status indicating our effort to make these cutting-edge data collection protocols quickly available to the research community. The SC agreed that final selected protocols could be included in the Toolkit not using the standard process and selection criteria.

Due to the vast number of full instruments and topics in the COVID-19 Library, crowdsourcing was used to help prioritize topic areas and protocols for the PhenX Toolkit, informing the first six COVID-19 Research Collections (Krzyzanowski, et al. 2021). The goal of these collections is to help investigators better understand:

  • the symptoms and treatments of COVID-19 in the context of social determinants of health,
  • the impact of the COVID-19 pandemic on mental health and behavior, and
  • the long-term effects of COVID-19 infection on health and daily living.

As the pandemic evolved, two new areas emerged that the SC sought to address: lasting impacts after infection (Long COVID), and vaccination. PhenX worked with the Steering Committee throughout 2022 to add a seventh collection, the Long COVID Specialty Collection, to assess symptoms and impact of Long COVID or Post-COVID conditions. Protocols assessing COVID vaccination were also included in Ver 45.0, released March 17, 2023. More information on the collections can be found here.

Criteria for Selecting Protocols for the COVID-19 Research Collection

Primary considerations for selection of the recommended COVID-19 protocols included:

  • Crowdsourcing results
  • From a reputable source
  • Broadly applicable to both research and clinical assessment

Other considerations

  • Available in other languages
  • Applicable to various lifestages
  • Publicly available
  • Addresses health disparities

Social Determinants of Health: Core Collection

The Social Determinants of Health: Core Collection is included on the COVID-19 Research Collections page.