Tools for standardized data collection: Speech, Language, and Hearing measurement protocols in the PhenX Toolkit.

The PhenX Toolkit (https://www.phenxtoolkit.org/) is an online catalog of recommended measurement protocols to facilitate cross-study analyses for biomedical research. An expert review panel (ERP) reviewed and updated the PhenX Toolkit Speech and Hearing domain to improve the precision and consistency of speech, language, and hearing disorder phenotypes. A three-member ERP convened in August 2018 to review the measurement protocols in the PhenX Speech and Hearing domain. Aided by three additional experts in voice assessment, vertigo, and stuttering, the ERP updated the 28 protocols to reflect the latest science and technology. ERP recommendations include six new protocols, five updated protocols (from the same source), and one retired protocol. New additions include two voice-related, three hearing-related, and two speech-related protocols. Additions reflect new phone/tablet applications for hearing and language, and clinical evaluations of voice. "Language" was added to the domain name, which is now "Speech, Language, and Hearing," to represent language-related protocols. These protocols can facilitate the assessment of speech, language, and hearing in clinical and population research. Common data elements (i.e., use of the same variables across studies) used by geneticists, otolaryngologists, audiologists, speech-language pathologists, and in other disciplines can lead to cross-study data integration and increased statistical power when studies are combined.

Research standardization tools: pregnancy measures in the PhenX Toolkit.

Only through concerted and well-executed research endeavors can we gain the requisite knowledge to advance pregnancy care and have a positive impact on maternal and newborn health. Yet the heterogeneity inherent in individual studies limits our ability to compare and synthesize study results, thus impeding the capacity to draw meaningful conclusions that can be trusted to inform clinical care. The PhenX Toolkit (http://www.phenxtoolkit.org), supported since 2007 by the National Institutes of Health, is a web-based catalog of standardized protocols for measuring phenotypes and exposures relevant for clinical research. In 2016, a working group of pregnancy experts recommended 15 measures for the PhenX Toolkit that are highly relevant to pregnancy research. The working group followed the established PhenX consensus process to recommend protocols that are broadly validated, well established, nonproprietary, and have a relatively low burden for investigators and participants. The working group considered input from the pregnancy experts and the broader research community and included measures addressing the mode of conception, gestational age, fetal growth assessment, prenatal care, the mode of delivery, gestational diabetes, behavioral and mental health, and environmental exposure biomarkers. These pregnancy measures complement the existing measures for other established domains in the PhenX Toolkit, including reproductive health, anthropometrics, demographic characteristics, and alcohol, tobacco, and other substances. The preceding domains influence a woman's health during pregnancy. For each measure, the PhenX Toolkit includes data dictionaries and data collection worksheets that facilitate incorporation of the protocol into new or existing studies. The measures within the pregnancy domain offer a valuable resource to investigators and clinicians and are well poised to facilitate collaborative pregnancy research with the goal to improve patient care. To achieve this aim, investigators whose work includes the perinatal population are encouraged to utilize the PhenX Toolkit in the design and implementation of their studies, thus potentially reducing heterogeneity in data measures across studies. Such an effort will enhance the overall impact of individual studies, increasing the ability to draw more meaningful conclusions that can then be translated into clinical practice.

The PhenX Toolkit: Recommended Measurement Protocols for Social Determinants of Health Research.

Health disparities are driven by unequal conditions in the environments in which people are born, live, learn, work, play, worship, and age, commonly termed the Social Determinants of Health (SDoH). The availability of recommended measurement protocols for SDoH will enable investigators to consistently collect data for SDoH constructs. The PhenX (consensus measures for Phenotypes and eXposures) Toolkit is a web-based catalog of recommended measurement protocols for use in research studies with human participants. Using standard protocols from the PhenX Toolkit makes it easier to compare and combine studies, potentially increasing the impact of individual studies, and aids in comparability across literature. In 2018, the National Institute on Minority Health and Health Disparities provided support for an initial expert Working Group to identify and recommend established SDoH protocols for inclusion in the PhenX Toolkit. In 2022, a second expert Working Group was convened to build on the work of the first SDoH Working Group and address gaps in the SDoH Toolkit Collections. The SDoH Collections consist of a Core Collection and Individual and Structural Specialty Collections. This article describes a Basic Protocol for using the PhenX Toolkit to select and implement SDoH measurement protocols for use in research studies. © 2024 The Authors. Current Protocols published by Wiley Periodicals LLC. This article has been contributed to by U.S. Government employees and their work is in the public domain in the USA. Basic Protocol: Using the PhenX Toolkit to select and implement SDoH protocols.

Application of the Delphi method to the development of common data elements for social drivers of health: A systematic scoping review.

Collaborative data science requires standardized, harmonized, interoperable, and ethically sourced data. Developing an agreed-upon set of elements requires capturing different perspectives on the importance and feasibility of the data elements through a consensus development approach. This study reports on the systematic scoping review of literature that examined the inclusion of diverse stakeholder groups and sources of social drivers of health variables in consensus-based common data element (CDE) sets. This systematic scoping review included sources from PubMed, Embase, CINAHL, WoS MEDLINE, and PsycINFO databases. Extracted data included the stakeholder groups engaged in the Delphi process, sources of CDE sets, and inclusion of social drivers data across 11 individual and 6 social domains. Of the 384 studies matching the search string, 22 were included in the final review. All studies involved experts with healthcare expertise directly relevant to the developed CDE set, and only six (27%) studies engaged health consumers. Literature reviews and expert input were the most frequent sources of CDE sets. Seven studies (32%) did not report the inclusion of any demographic variables in the CDE sets, and each demographic SDoH domain was included in at least one study with age and sex assigned at birth included in all studies, and social driver domains included only in four studies (18%). The Delphi technique engages diverse expert groups around the development of SDoH data elements. Future studies can benefit by involving health consumers as experts.

Collecting and capturing social factors that affect individuals' health is imperative. Social drivers of health data allow researchers to understand health disparities to make healthcare available, accessible, and affordable. However, collecting common health data elements has challenged researchers due to limited resources to facilitate change. Incorporating various stakeholders, such as individuals and patient advocacy groups, can effectively contribute to the research process as community advisors. This article reviews the studies that used the Delphi method and brings together experts to agree on guidelines for collecting common data elements. The article's findings reveal that experts are healthcare professionals and researchers, leaving out the crucial input from patients and caregivers. This article emphasized that developing a standard set of data elements can improve the standardization of social drivers of health. Common data elements provide the opportunity to improve patients' and social circumstances and their efforts toward health outcomes.

Trends in publication and levels of social determinants of health reporting in Journal of Clinical and Translational Science from 2017 to 2023.

Social determinants of health affect clinical and translational research processes and outcomes but remain underreported in empirical studies. This scoping review examined the rate and types of social determinants of health (SDoH) variables included in the JCTS translational research studies published between 2017 and 2023 and included 129 studies. Most papers (91.7%) reported at least one SDoH variable with age, race and ethnicity, and sex included most often. Future studies to inform the role of SDoH data in translational research and science are recommended, and a draft SDoH data checklist is provided.

Smoking cessation, harm reduction, and biomarkers protocols in the PhenX Toolkit: Tools for standardized data collection.

The use of standard protocols in studies supports consistent data collection, improves data quality, and facilitates cross-study analyses. Funded by the National Institutes of Health, the PhenX (consensus measures for Phenotypes and eXposures) Toolkit is a catalog of recommended measurement protocols that address a wide range of research topics and are suitable for inclusion in a variety of study designs. In 2020, a PhenX Working Group of smoking cessation experts followed a well-established consensus process to identify and recommend measurement protocols suitable for inclusion in smoking cessation and smoking harm reduction studies. The broader scientific community was invited to review and provide feedback on the preliminary recommendation of the Working Group. Fourteen selected protocols for measuring smoking cessation, harm reduction, and biomarkers research associated with smoking cessation were released in the PhenX Toolkit ( https://www.phenxtoolkit.org) in February 2021. These protocols complement existing PhenX Toolkit content related to tobacco regulatory research, substance use and addiction research, and other measures of smoking-related health outcomes. Adopting well-established protocols enables consistent data collection and facilitates comparing and combining data across studies, potentially increasing the scientific impact of individual studies.

The PhenX Toolkit: Establishing Standard Measures for COVID-19 Research.

The PhenX (consensus measures for Phenotypes and eXposures) Toolkit (https://www.phenxtoolkit.org/) is a publicly available, web-based catalog of recommended, well-established measurement protocols of phenotypes and exposures. The goal of PhenX is to facilitate the use of standard measures, enhance data interoperability, and promote collaborative and translational research. PhenX is driven by the scientific community and historically has depended on working groups of experts to recommend measures for release in the PhenX Toolkit. The urgent need for recommended, standard measures for COVID-19 research triggered the development of a "rapid release" process for releasing new content in the PhenX Toolkit. Initially, PhenX collaborated with the National Institutes of Health (NIH) Office of Behavioral and Social Sciences Research, the National Human Genome Research Institute, and the NIH Disaster Research Response (DR2) program to create a library of COVID-19 measurement protocols. With additional support from NIH, PhenX adapted crowdsourcing techniques to accelerate prioritization and recommendation of protocols for release in the PhenX Toolkit. Prioritized COVID-19-specific protocols were used to anchor and define specialty collections of protocols that were subject to review and approval by the PhenX Steering Committee. In addition to the COVID-19-specific protocols, the specialty collections include existing, well-established PhenX protocols, use of which will further enhance data interoperability and cross-study analysis. The COVID-19 specialty collections are Behaviors and Risks; Ethnicity, Race and Demographics; History, Treatment and Outcomes; Information Resources; Psychosocial and Mental Health; and Socioeconomic. The development and usage of PhenX COVID-19 specialty collections are described in this article. © 2021 The Authors. Basic Protocol: Selecting COVID-19 protocols.

Common Data Elements for National Institute of Mental Health-Funded Translational Early Psychosis Research.

The National Institutes of Health has established the PhenX Toolkit as a web-based resource containing consensus measures freely available to the research community. The National Institute of Mental Health (NIMH) has introduced the Mental Health Research Core Collection as part of the PhenX Toolkit and recently convened the PhenX Early Psychosis Working Group to generate the PhenX Early Psychosis Specialty Collection. The Working Group consisted of two complementary panels for clinical and translational research. We review the process, deliberations, and products of the translational research panel. The Early Psychosis Specialty Collection rationale for measure selection as well as additional information and protocols for obtaining each measure are available on the PhenX website (https://www.phenxtoolkit.org). The NIMH strongly encourages investigators to use instruments from the PhenX Mental Health Research Collections in NIMH-funded studies and discourages use of alternative measures to collect similar data without justification. We also discuss some of the potential advances that can be achieved by collecting common data elements across large-scale longitudinal studies of early psychosis.

Using the PhenX Toolkit to Add Standard Measures to a Study.

The PhenX (consensus measures for Phenotypes and eXposures) Toolkit (https://www.phenxtoolkit.org/) offers high-quality, well-established measures of phenotypes and exposures for use by the scientific community. The goal is to promote the use of standard measures, enhance data interoperability, and help investigators identify opportunities for collaborative and translational research. The Toolkit contains 395 measures drawn from 22 research domains (fields of research), along with additional collections of measures for Substance Abuse and Addiction (SAA) research, Mental Health Research (MHR), and Tobacco Regulatory Research (TRR). Additional measures for TRR that are expected to be released in 2015 include Obesity, Eating Disorders, and Sickle Cell Disease. Measures are selected by working groups of domain experts using a consensus process that includes input from the scientific community. The Toolkit provides a description of each PhenX measure, the rationale for including it in the Toolkit, protocol(s) for collecting the measure, and supporting documentation. Users can browse measures in the Toolkit or can search the Toolkit using the Smart Query Tool or a full text search. PhenX Toolkit users select measures of interest to add to their Toolkit. Registered Toolkit users can save their Toolkit and return to it later to revise or complete. They then have options to download a customized Data Collection Worksheet that specifies the data to be collected, and a Data Dictionary that describes each variable included in the Data Collection Worksheet. The Toolkit also has a Register Your Study feature that facilitates cross-study collaboration by allowing users to find other investigators using the same PhenX measures.