Protocol - Sex Assigned at Birth

Personnel and Training Required

None

Equipment Needs

The PhenX Steering Committee acknowledges these questions can be administered in a computerized or noncomputerized format (i.e., paper-and-pencil instrument). Computer software is necessary to develop computer-assisted instruments. The interviewer will require a laptop computer/handheld computer to administer a computer-assisted questionnaire.

Requirements

Requirement Category	Required
Major equipment	No
Specialized training	No
Specialized requirements for biospecimen collection	No
Average time of greater than 15 minutes in an unaffected individual	No

Mode of Administration

Self-administered or interviewer-administered questionnaire

Lifestage

Adult, Senior

Participants

Adults 18 years and older

Selection Rationale

This protocol was selected because it is both the most up-to-date and in use by the national All of Us research program.

Language

English, Other languages available at source

Standards

Standard	Name	ID	Source

Derived Variables

None

Process and Review

The NIH Sexual and Gender Minority Research Office (SGMRO) reviewed this protocol in August 2023.

• Changed Biological Sex Assigned at Birth protocol name to Sex Assigned at Birth
• Made Gender Identity and Sex Assigned at Birth protocols “essential” to one another
• Added NASEM report reference
• Removed The Precision Medicine Initiative Cohort Program, Collins, F.S. and Varmus, H., and National Research Council references
• Updated Specific Instructions
• Updated Protocol Definition
• Updated Purpose
• Updated Keywords

Protocol Name from Source

All of Us Research Program, Participant Provided Information (PPI), 2018

Source

All of Us Research Program Participant Provided Information (PPI) Version: December 17, 2018

General References

National Academies of Sciences, Engineering, and Medicine; Division of Behavioral and Social Sciences and Education; Committee on National Statistics; Committee on Measuring Sex, Gender Identity, and Sexual Orientation. Measuring Sex, Gender Identity, and Sexual Orientation. Becker T, Chin M, Bates N, editors. Washington (DC): National Academies Press (US); 2022 Mar 9. PMID: 35286054.

The GenIUSS Group. (2014). Best Practices for Asking Questions to Identify Transgender and Other Gender Minority Respondents on Population-Based Surveys. J.L. Herman (Ed.). Los Angeles, CA: The Williams Institute.

Protocol ID

11601

Variables

Export Variables

Variable Name	Variable ID	Variable Description	dbGaP Mapping
PX011601_Biological_Sex_Assigned_Birth
	PX011601010100	What was your biological sex assigned at birth?	N/A
PX011601_Biological_Sex_Assigned_Birth_Other
	PX011601010200	What was your biological sex assigned at more birth? Other show less	N/A

Demographics

Measure Name

Sex Assigned at Birth

Release Date

June 4, 2019

Definition

The indication of the sex assigned to an individual at the time of birth, typically assigned based on visual inspection of infant anatomy. If sex assigned at birth and gender identity are different, it may indicate that a person is transgender.

Purpose

Sex assigned at birth is intended to record sex at birth, often based on visual inspection of an infant. Sex assigned at birth is intended to be used in conjunction with the Gender Identity protocol.

Keywords

sex, gender identity, female, male, intersex, LGBTQ, LGBTQIA

Measure Protocols

Protocol ID	Protocol Name
11601	Sex Assigned at Birth

Publications

Levites Strekalova, Y. A., et al. (2024) Application of the Delphi method to the development of common data elements for social drivers of health: A systematic scoping review. Translational Behavioral Medicine. 2024 June; 14(7): 426-433. doi: 10.1093/tbm/ibae020

Klein, E. G., et al. (2024) A Randomized Clinical Trial of a Quitline Vaping Cessation Intervention: Baseline Characteristics of Young Adult Exclusive E-Cigarette Users Seeking Treatment. International Journal of Environmental Research and Public Health. 2024 June; 21(6): 809. doi: 10.3390/ijerph21060809

McCurry, K., et al. (2024) Data-driven, generalizable prediction of adolescent sleep disturbances in the multisite Adolescent Brain Cognitive Development Study. Sleep. 2024 June; 47(6). doi: 10.1093/sleep/zsae048

Burnett-Bowie, S. A. M., et al. (2024) The American Society for Bone and Mineral Research Task Force on clinical algorithms for fracture risk report. Journal of Bone and Mineral Research. 2024 May; 39(5): 517-530. doi: 10.1093/jbmr/zjae048

Kosyluk, K., et al. (2024) Mental Distress, Label Avoidance, and Use of a Mental Health Chatbot: Results From a US Survey. JMIR Formative Research. 2024 April; 8(17). doi: 10.2196/45959

Murley, W. D., et al. (2024) Anxiety connects social media use to food and alcohol disturbance and disordered eating when social support is low. Eating Behaviors. 2024 April; 53(7). doi: 10.1016/j.eatbeh.2024.101879

Hatch, M. A., et al. (2024) PrEP for people who use opioids: A NIDA clinical trials network survey study in Southern US cities where HIV incidence is high. Drug and Alcohol Dependence. 2024 April; 257(9). doi: 10.1016/j.drugalcdep.2024.111133

Bartholomew, T. S., et al. (2024) Project CHARIOT: study protocol for a hybrid type 1 effectiveness-implementation study of comprehensive tele-harm reduction for engagement of people who inject drugs in HIV prevention services Addiction Science & Clinical Practice. 2024 March; 19(1). doi: 10.1186/s13722-024-00447-9

Cleverley, K., et al. (2024) The Toronto Adolescent and Youth Cohort Study: Study Design and Early Data Related to Psychosis Spectrum Symptoms, Functioning, and Suicidality. Biological Psychiatry-Cognitive Neuroscience and Neuroimaging. 2024 March; 9(3): 253-264. doi: 10.1016/j.bpsc.2023.10.011

Byer, L., et al. (2024) Limitations and Future Directions in Sex, Sexuality and Gender Diverse Research in Neurology. Annals of Neurology. 2024 March; 95(3): 421-431. doi: 10.1002/ana.26863

Leiker, E., et al. (2024) Recall of Autobiographical Memories Following Odor vs Verbal Cues Among Adults With Major Depressive Disorder. JAMA Network Open. 2024 February; 7(2): e2355958-e2355958. doi: 10.1001/jamanetworkopen.2023.55958

Cuca, Y. P., et al. (2024) The Social, Mental, and Physical Health Impacts of the COVID-19 Pandemic on People With HIV: Protocol of an Observational International Multisite Study Journal of the Association of Nurses in AIDS Care. 2024 January; 35(1): 60-74. doi: 10.1097/JNC.0000000000000444

Crusan, A., et al. (2023) Using Community-Based Participatory Research Methods to Inform the Development of Medically Tailored Food Kits for Hispanic/Latine Adults with Hypertension: A Qualitative Study. Nutrients. 2023 August; 15(16): 3600. doi: https://doi.org/10.3390/nu15163600

Olfson, M., et al. (2023) Prevalence and Correlates of Mental Disorders in Children Aged 9 and 10 Years: Results From the ABCD Study. Journal of the American Academy of Child & Adolescent Psychiatry. 2023 August; 62(8): 908-919. doi: 10.1016/j.jaac.2023.04.005

Olfson, M., et al. (2023) Treatment of US Children With Attention-Deficit/Hyperactivity Disorder in the Adolescent Brain Cognitive Development Study. JAMA Network Open. 2023 April; 6(4). doi: 10.1001/jamanetworkopen.2023.10999

Chan, N. W., et al. (2022) Social determinants of health data in solid organ transplantation: National data sources and future directions. Am J Transplant. 2022 October; 22(10): 2293-2301. doi: 10.1111/ajt.17096

Aguinaldo, L. D., et al. (2022) Application of the RDoC Framework to Predict Alcohol Use and Suicidal Thoughts and Behaviors among Early Adolescents in the Adolescent Brain and Cognitive Development (ABCD) Study. Brain Sciences. 2022 July; 12(7): 15.

Pomeroy, A., et al. (2022) Protocol for a Longitudinal Study of the Determinants of Metabolic Syndrome Risk in Young Adults. Translational Journal of the American College of Sports Medicine. 2022 April; 7(2): 8. doi: 10.1249/tjx.0000000000000197

Loring, D. W., et al. (2022) Rationale and Design of the National Neuropsychology Network. Journal of the International Neuropsychological Society. 2022 January; 28(1): 11-Jan. doi: 10.1017/S1355617721000199

Schettini, E., et al. (2021) Internalizing-externalizing comorbidity and regional brain volumes in the ABCD study. Development and Psychopathology. 2021 December; 33(5): 1620-1633.

Young Hye, K., et al. (2021) Predicting multilingual effects on executive function and individual connectomes in children: An ABCD study. Proceedings of the National Academy of Sciences of the United States of America. 2021 December; 118(49): 1-11. doi: 10.1073/pnas.2110811118

Barch, D. M., et al. (2021) Demographic and mental health assessments in the adolescent brain and cognitive development study: Updates and age-related trajectories. Developmental Cognitive Neuroscience. 2021 December; 52: 101031. doi: 10.1016/j.dcn.2021.101031

Aguinaldo, L. D., et al. (2021) Preliminary analysis of low-level alcohol use and suicidality with children in the adolescent brain and cognitive development (ABCD) baseline cohort. Psychiatry Research. 2021 May; 299: 5. doi: 10.1016/j.psychres.2021.113825

Roth, A. R., et al. (2021) Network recall among older adults with cognitive impairments. Social Networks. 2021 January; 64: 99-108. doi: 10.1016/j.socnet.2020.08.005

Barbirou, M., et al. (2020) Western influenced lifestyle and Kv2.1 association as predicted biomarkers for Tunisian colorectal cancer. BMC Cancer. 2020 November; 20: Article Number: 1086. doi: 10.1186/s12885-020-07605-7

Omodior, O. and W. D. Ramos (2020) Social Determinants of Health-Related Quality of Life: A Recreation Setting Analysis. Health Promotion Practice. 2020 November; 21(6): 952-961. doi: 10.1177/1524839919827572

Harker, J. L. and J. A. Jensen. (2020) Adding insult to rivalry: Exploring the discord communicated between rivals. International Journal of Sports Marketing & Sponsorship. 2020 January; 21(4): 633-649. doi: 10.1108/IJSMS-12-2019-0141

Hankins, J. S., et al. (2018) Sickle Cell Clinical Research and Intervention Program (SCCRIP): A lifespan cohort study for sickle cell disease progression from the pediatric stage into adulthood. Pediatr Blood Cancer. 2018 September; 65(9): 27228. doi: 10.1002/pbc.27228

Barch, D. M., et al. (2018) Demographic, physical and mental health assessments in the adolescent brain and cognitive development study: Rationale and description. Dev Cogn Neurosci. 2018 August; 32: 55-66. doi: 10.1016/j.dcn.2017.10.010

Unger, J. B. (2018) Perceived Discrimination as a Risk Factor for Use of Emerging Tobacco Products: More Similarities Than Differences Across Demographic Groups and Attributions for Discrimination. Subst Use Misuse. 2018 August; 53(10): 1638-1644. doi: 10.1080/10826084.2017.1421226

Juan, J., et al. (2017) Joint Effects of PON1 Polymorphisms and Vegetable Intake on Ischemic Stroke: A Family-Based Case Control Study. Int J Mol Sci. 2017 December; 18(12): E2652. doi: 10.3390/ijms18122652