References
All of Us Research Program Investigators. 2019. The “All of Us” research program. New England Journal of Medicine 381(7):668–676.
Bjerre-Bastos, J., A.-C. Bay-Jensen, M. Karsdal, I. Byrjalsen, J. R. Andersen, B. J. Riis, C. Christiansen, and A. R. Bihlet. 2019. THU0419 biomarkers of bone and cartilage turnover CTX-I and CTX-II predict total joint replacements in OA. Annals of the Rheumatic Diseases 78(Suppl 2):497–498.
Brummett, C. M., A. G. Urquhart, A. L. Hassett, A. Tsodikov, B. R. Hallstrom, N. I. Wood, D. A. Williams, and D. J. Clauw. 2015. Characteristics of fibromyalgia independently predict poorer long-term analgesic outcomes following total knee and hip arthroplasty. Arthritis Rheumatoly 67(5):1386–1394.
Buchbinder, R., C. Bombardier, M. Yeung, and P. Tugwell. 1995. Which outcome measures should be used in rheumatoid arthritis clinical trials? Arthritis & Rheumatism 38(11):1568–1580.
Cassidy, C. M., F. A. Zucca, R. R. Girgis, S. C. Baker, J. J. Weinstein, M. E. Sharp, C. Bellei, A. Valmadre, N. Vanegas, L. S. Kegeles, G. Brucato, U. J. Kang, D. Sulzer, L. Zecca, A. Abi-Dargham, and G. Horga. 2019. Neuromelanin-sensitive MRI as a noninvasive proxy measure of dopamine function in the human brain. Proceedings of the National Academy of Sciences 116(11):5108–5117.
CDER (Center for Drug Evaluation and Research). 2018. Biomarker qualification: Evidentiary framework. https://www.fda.gov/media/119271/download (accessed September 3, 2020).
Chou, R., R. Fu, J. A. Carrino, and R. A. Deyo. 2009. Imaging strategies for low-back pain: Systematic review and meta-analysis. Lancet 373(9662):463–472.
Collins, F. S., and H. Varmus. 2015. A new initiative on precision medicine. New England Journal of Medicine 372(9):793–795.
Davillas, A., and S. Pudney. 2020. Biomarkers as precursors of disability. Economics & Human Biology 36:100814.
Depp, C. A., J. Bashem, R. C. Moore, J. L. Holden, T. Mikhael, J. Swendsen, P. D. Harvey, and E. L. Granholm. 2019. GPS mobility as a digital biomarker of negative symptoms in schizophrenia: A case control study. NPJ Digital Medicine 2(1):108.
Eastman, P. S., W. C. Manning, F. Qureshi, D. Haney, G. Cavet, C. Alexander, and L. K. Hesterberg. 2012. Characterization of a multiplex, 12-biomarker test for rheumatoid arthritis. Journal of Pharmaceutical and Biomedical Analysis 70:415–424.
Eyles, J. P., K. Mills, B. R. Lucas, M. J. Williams, J. Makovey, L. Teoh, and D. J. Hunter. 2016. Can we predict those with osteoarthritis who will worsen following a chronic disease management program? Arthritis Care and Research 68(9):1268–1277.
FDA-NIH (Food and Drug Administration-National Institutes of Health) Biomarker Working Group. 2016 BEST (biomarkers, endpoints, and other tools) resource. Silver Spring, MD: Food and Drug Administration.
FNIH (Foundation for the National Institutes of Health). 2020. About the biomarkers consortium. https://fnih.org/what-we-do/biomarkers-consortium/about (accessed September 25, 2020).
Fonzo, G. A., A. Etkin, Y. Zhang, W. Wu, C. Cooper, C. Chin-Fatt, M. K. Jha, J. Trombello, T. Deckersbach, P. Adams, M. McInnis, P. J. McGrath, M. M. Weissman, M. Fava, and M. H. Trivedi. 2019. Brain regulation of emotional conflict predicts antidepressant treatment response for depression. Nature Human Behaviour 3(12):1319–1331.
Granholm, E., J. L. Holden, T. Mikhael, P. C. Link, J. Swendsen, C. Depp, R. C. Moore, and P. D. Harvey. 2020. What do people with schizophrenia do all day? Ecological momentary assessment of real-world functioning in schizophrenia. Schizophrenia Bulletin 46(2):242–251.
Harvey, P. D., R. K. Heaton, W. T. Carpenter, Jr., M. F. Green, J. M. Gold, and M. Schoenbaum. 2012. Functional impairment in people with schizophrenia: Focus on employability and eligibility for disability compensation. Schizophrenia Research 140(1–3):1–8.
Hunter, D. J., W. Zhang, P. G. Conaghan, K. Hirko, L. Menashe, W. M. Reichmann, and E. Losina. 2011. Responsiveness and reliability of MRI in knee osteoarthritis: A meta-analysis of published evidence. Osteoarthritis Cartilage 19(5):589–605.
Janda, A. M., S. As-Sanie, B. Rajala, A. Tsodikov, S. E. Moser, D. J. Clauw, and C. M. Brummett. 2015. Fibromyalgia survey criteria are associated with increased postoperative opioid consumption in women undergoing hysterectomy. Anesthesiology 122(5):1103–1111.
Jansen, A. L., I. van der Horst-Bruinsma, D. van Schaardenburg, R. J. van de Stadt, M. H. de Koning, and B. A. Dijkmans. 2002. Rheumatoid factor and antibodies to cyclic citrullinated peptide differentiate rheumatoid arthritis from undifferentiated polyarthritis in patients with early arthritis. Journal of Rheumatolgy 29(10):2074–2076.
Jensen, M. C., M. N. Brant-Zawadzki, N. Obuchowski, M. T. Modic, D. Malkasian, and J. S. Ross. 1994. Magnetic resonance imaging of the lumbar spine in people without back pain. New England Journal of Medicine 331(2):69–73.
Jha, M. K., A. Minhajuddin, B. S. Gadad, T. Greer, B. Grannemann, A. Soyombo, T. L. Mayes, A. J. Rush, and M. H. Trivedi. 2017. Can C-reactive protein inform antidepressant medication selection in depressed outpatients? Findings from the CO-MED trial. Psychoneuroendocrinology 78:105–113.
Jurjako, M., L. Malatesti, and I. A. Brazil. 2019. Some ethical considerations about the use of biomarkers for the classification of adult antisocial individuals. International Journal of Forensic Mental Health 18(3):228–242.
Keefe, R. S., M. Poe, T. M. Walker, J. W. Kang, and P. D. Harvey. 2006. The schizophrenia cognition rating scale: An interview-based assessment and its relationship to cognition, real-world functioning, and functional capacity. American Journal of Psychiatry 163(3):426–432.
Keren, H., G. O’Callaghan, P. Vidal-Ribas, G. A. Buzzell, M. A. Brotman, E. Leibenluft, P. M. Pan, L. Meffert, A. Kaiser, S. Wolke, D. S. Pine, and A. Stringaris. 2018. Reward processing in depression: A conceptual and meta-analytic review across FMRI and EEG studies. American Journal of Psychiatry 175(11):1111–1120.
Kraus, V. B., B. Burnett, J. Coindreau, S. Cottrell, D. Eyre, M. Gendreau, J. Gardiner, P. Garnero, J. Hardin, Y. Henrotin, D. Heinegård, A. Ko, L. S. Lohmander, G. Matthews, J. Menetski, R. Moskowitz, S. Persiani, A. R. Poole, J. C. Rousseau, M. Todman, and OARSI FDA Osteoarthritis Biomarkers Working Group. 2011. Application of biomarkers in the development of drugs intended for the treatment of osteoarthritis. Osteoarthritis and Cartilage 19(5):515–542.
Lakhan, S. E., K. Vieira, and E. Hamlat. 2010. Biomarkers in psychiatry: Drawbacks and potential for misuse. International Archives of Medicine 3:1.
Largent, E. A., M. Terrasse, K. Harkins, D. A. Sisti, P. Sankar, and J. Karlawish. 2019. Attitudes toward physician-assisted death from individuals who learn they have an Alzheimer disease biomarker. JAMA Neurology 76(7):864–866.
Largent, E. A., K. Harkins, C. H. van Dyck, S. Hachey, P. Sankar, and J. Karlawish. 2020. Cognitively unimpaired adults’ reactions to disclosure of amyloid PET scan results. PloS One 15(2):e0229137.
Laruelle, M., L. S. Kegeles, and A. Abi-Dargham. 2003. Glutamate, dopamine, and schizophrenia. Annals of the New York Academy of Sciences 1003(1):138–158.
Lehrner, A., and R. Yehuda. 2014. Biomarkers of PTSD: Military applications and considerations. European Journal of Psychotraumatology 5:10.3402/ejpt.v3405.23797.
Leptak, C., J. P. Menetski, J. A. Wagner, J. Aubrecht, L. Brady, M. Brumfield, W. W. Chin, S. Hoffmann, G. Kelloff, G. Lavezzari, R. Ranganathan, J. M. Sauer, F. D. Sistare, T. Zabka, and D. Wholley. 2017. What evidence do we need for biomarker qualification? Science Translational Medicine 9(417).
López-Solà, M., C.-W. Woo, J. Pujol, J. Deus, B. J. Harrison, J. Monfort, and T. D. Wager. 2017. Towards a neurophysiological signature for fibromyalgia. Pain 158(1):34–47.
Maixner, W., R. B. Fillingim, D. A. Williams, S. B. Smith, and G. D. Slade. 2016. Overlapping chronic pain conditions: Implications for diagnosis and classification. Journal of Pain 17(9 Suppl):T93–T107.
Menetski, J. P., S. C. Hoffmann, S. S. Cush, T. N. Kamphaus, C. P. Austin, P. L. Herrling, and J. A. Wagner. 2019. The Foundation for the National Institutes of Health Biomarkers Consortium: Past accomplishments and new strategic direction. Clinical Pharmacology & Therapeutics 105(4):829–843.
Milleville, K., R. G. Kumar, D. Disanto, and A. K. Wagner. 2019. Post-acute systemic inflammatory biomarkers and cognition after TBI: A follow-up study. Journal of Neurotrauma 36(13):A123.
Mozersky, J., P. Sankar, K. Harkins, S. Hachey, and J. Karlawish. 2018. Comprehension of an elevated amyloid positron emission tomography biomarker result by cognitively normal older adults. JAMA Neurology 75(1):44–50.
Murphy, L., T. A. Schwartz, C. G. Helmick, J. B. Renner, G. Tudor, G. Koch, A. Dragomir, W. D. Kalsbeek, G. Luta, and J. M. Jordan. 2008. Lifetime risk of symptomatic knee osteoarthritis. Arthritis Care & Research 59(9):1207–1213.
Neogi, T., D. Felson, J. Niu, M. Nevitt, C. E. Lewis, P. Aliabadi, B. Sack, J. Torner, L. Bradley, and Y. Zhang. 2009. Association between radiographic features of knee osteoarthritis and pain: Results from two cohort studies. British Journal of Management 339:b2844.
Nielen, M. M., D. van Schaardenburg, H. W. Reesink, R. J. van de Stadt, I. E. van der Horst-Bruinsma, M. H. de Koning, M. R. Habibuw, J. P. Vandenbroucke, and B. A. Dijkmans. 2004. Specific autoantibodies precede the symptoms of rheumatoid arthritis: A study of serial measurements in blood donors. Arthritis and Rheumatism 50(2):380–386.
Oliveria, S. A., D. T. Felson, J. I. Reed, P. A. Cirillo, and A. M. Walker. 1995. Incidence of symptomatic hand, hip, and knee osteoarthritis among patients in a health maintenance organization. Arthritis and Rheumatism 38(8):1134–1141.
Osimo, E. F., T. Pillinger, I. M. Rodriguez, G. M. Khandaker, C. M. Pariante, and O. D. Howes. 2020. Inflammatory markers in depression: A meta-analysis of mean differences and variability in 5,166 patients and 5,083 controls. Brain, Behavior, and Immunity 87:901–909.
Osteoarthritis Research Society International. 2016. Osteoarthritis: A serious disease. Submitted to the Food and Drug Administration.
Peterson, A., and T. Bayne. 2018. Post-comatose disorders of consciousness. In The Routledge handbook of consciousness, edited by R. J. Gennaro. New York: Taylor & Francis.
Peterson, A., D. Cruse, L. Naci, C. Weijer, and A. M. Owen. 2015. Risk, diagnostic error, and the clinical science of consciousness. NeuroImage Clinical 7:588–597.
Peterson, A., A. M. Owen, and J. Karlawish. 2020a. Alive inside. Bioethics 34(3):295–305.
Peterson, A., A. M. Owen, and J. Karlawish. 2020b. Translating the discovery of covert consciousness into clinical practice. JAMA Neurology 77(5):541–542.
Pincus, T., R. H. Brooks, and L. F. Callahan. 1994. Prediction of long-term mortality in patients with rheumatoid arthritis according to simple questionnaire and joint count measures. Annals Internal Medicine 120(1):26–34.
Raugh, I. M., S. H. James, C. M. Gonzalez, H. C. Chapman, A. S. Cohen, B. Kirkpatrick, and G. P. Strauss. 2020. Geolocation as a digital phenotyping measure of negative symptoms and functional outcome. Schizophrenia Bulletin 121.
Robinson, D. G., M. G. Woerner, M. McMeniman, A. Mendelowitz, and R. M. Bilder. 2004. Symptomatic and functional recovery from a first episode of schizophrenia or schizoaffective disorder. American Journal of Psychiatry 161(3):473–479.
Roth, M., B. E. Tomlinson, and G. Blessed. 1967. The relationship between quantitative measures of dementia and of degenerative changes in the cerebral grey matter of elderly subjects. Proceedings of the Royal Society of Medicine 60(3):254–260.
Rothenberger, A., L. A. Rhode, and L. G. Rothenberger. 2015. Biomarkers in child mental health: A bio-psycho-social perspective is needed. Behavioral and Brain Functions 11(1):31.
Sartorius, N. 2006. The meanings of health and its promotion. Croatian Medical Journal 47(4):662–664.
Schaaf, S., W. Huang, S. Perera, Y. Conley, I. Belfer, P. Jayabalan, K. Tremont, P. Coelho, S. Ernst, M. Cortazzo, D. Weiner, D., N. Vo, J. Kang, and G. Sowa. 2020. Association of protein and genetic biomarkers with response to lumbar epidural steroid injections in subjects with axial low back pain. American Journal of Physical Medicine and Rehabilitation. Online ahead of print.
Schellekens, G. A., H. Visser, B. A. de Jong, F. H. van den Hoogen, J. M. Hazes, F. C. Breedveld, and W. J. van Venrooij. 2000. The diagnostic properties of rheumatoid arthritis antibodies recognizing a cyclic citrullinated peptide. Arthritis and Rheumatism 43(1):155–163.
Sowa, G., E. Westrick, A. Rajasekhar, B. Woods, S. Leckie, N. Vo, R. Studer, and J. Kang. 2009. Identification of candidate serum biomarkers for intervertebral disk degeneration in an animal model. PM&R: The Journal of Injury, Function, and Rehabilitation 536–540.
Sowa, G. A., S. Perera, B. Bechara, V. Agarwal, J. Boardman, W. Huang, A. Camacho-Soto, N. Vo, J. Kang, and D. Weiner. 2014. Associations between serum biomarkers and pain and pain-related function in older adults with low back pain: A pilot study. Journal of American Geriatric Society 62(11):2047–2055.
SSA (Social Security Administration). 2020. Disability evaulation under Social Security. https://www.ssa.gov/disability/professionals/bluebook/general-info.htm (accessed September 1, 2020).
Stein, P. 2020. Brief overview of biomarkers: Value, limitations, and the Biomarker Qualification Program (BQP). https://fnih.org/sites/default/files/final/pdf/2-Stein-Biomarkers%20Introduction.pdf (accessed September 21, 2020).
Strassnig, M., D. Cornacchio, P. D. Harvey, R. Kotov, L. Fochtmann, and E. J. Bromet. 2017a. Health status and mobility limitations are associated with residential and employment status in schizophrenia and bipolar disorder. Journal of Psychiatric Research 94:180–185.
Strassnig, M., R. Kotov, D. Cornaccio, L. Fochtmann, P. D. Harvey, and E. J. Bromet. 2017b. Twenty-year progression of body mass index in a county-wide cohort of people with schizophrenia and bipolar disorder identified at their first episode of psychosis. Bipolar Disorder 19(5):336–343.
Sulzer, D., J. Bogulavsky, K. E. Larsen, G. Behr, E. Karatekin, M. H. Kleinman, N. Turro, D. Krantz, R. H. Edwards, L. A. Greene, and L. Zecca. 2000. Neuromelanin biosynthesis is driven by excess cytosolic catecholamines not accumulated by synaptic vesicles. Proceedings of the National Academy of Sciences 97(22):11869–11874.
Trivedi, M. H., T. L. Greer, T. S. Church, T. J. Carmody, B. D. Grannemann, D. I. Galper, A. L. Dunn, C. P. Earnest, P. Sunderajan, S. S. Henley, and S. N. Blair. 2011. Exercise as an augmentation treatment for nonremitted major depressive disorder: A randomized, parallel dose comparison. Journal of Clinical Psychiatry 72(5):677–684.
VA (Department of Veterans Affairs). 2020. Million Veteran Program. https://www.mvp.va.gov/webapp/mvp-web-participant/#/public (accessed September 24, 2020).
van Gaalen, F. A., H. Visser, and T. W. J. Huizinga. 2005. A comparison of the diagnostic accuracy and prognostic value of the first and second anti-cyclic citrullinated peptides (CCP1 and CCP2) autoantibody tests for rheumatoid arthritis. Annals of the Rheumatic Diseases 64(10):1510–1512.
Ventura, J., K. L. Subotnik, M. J. Gitlin, D. Gretchen-Doorly, A. Ered, K. F. Villa, G. S. Hellemann, and K. H. Nuechterlein. 2015. Negative symptoms and functioning during the first year after a recent onset of schizophrenia and 8 years later. Schizophrenia Research 161(2–3):407–413.
Ventura, J., K. L. Subotnik, D. Gretchen-Doorly, L. Casaus, M. Boucher, A. Medalia, M. D. Bell, G. S. Hellemann, and K. H. Nuechterlein. 2019. Cognitive remediation can improve negative symptoms and social functioning in first-episode schizophrenia: A randomized controlled trial. Schizophrenia Research 203:24–31.
Vo, N. V., R. A. Hartman, P. R. Patil, M. V. Risbud, D. Kletsas, J. C. Iatridis, J. A. Hoyland, C. L. Le Maitre, G. A. Sowa, and J. D. Kang. 2016. Molecular mechanisms of biological aging in intervertebral discs. Journal of Orthopaedic Research 34(8):1289–1306.
WHO (World Health Organization). 2001. International classification of functioning disability and health. https://www.who.int/classifications/icf/en (accessed September 8, 2020).
WHO. 2002. Towards a common language for functioning, disability and health. https://www.who.int/classifications/icf/training/icfbeginnersguide.pdf (accessed October 1, 2020).
Wolfe, F., K. Michaud, and T. Pincus. 2004. Development and validation of the health assessment questionnaire II: A revised version of the health assessment questionnaire. Arthritis & Rheumatism 50(10):3296–3305.
Wu, W., Y. Zhang, J. Jiang, M. V.Lucas, G. A. Fonzo, C. E. Rolle, C. Cooper, C. Chin-Fatt, N. Krepel, C. A. Cornelssen, R. Wright, R. T. Toll, H. M. Trivedi, K. Monuszko, T. L. Caudle, M. K. Sarhadi, J. M. Trombello, T. Deckersbach, P. Adams, P. J. McGrath, M. M. Weissman, M. Fava D. A. Pizzagalli, M. Arns, M. H, Trivedi, and A. Etkin. 2020. An electroencephalographic signature predicts antidepressant response in major depression. Nature Biotechnology 38(4):439–447.
Zhang, Y., W. Wu, R. T. Toll, S. Naparstek, A. Maron-Katz, M. Watts, J. Gordon, J. Jeong, L. Astolfi, E. Shpigel, P. Longwell, K. Sarhadi, D. El-Said, Y. Li, C. Cooper, C. Chin-Fatt, M. Arns, M. S. Goodkind, M. H. Trivedi, C. R. Marmar, and A. Etkin. 2020. Identification of psychiatric disorder subtypes from functional connectivity patterns in resting-state electroencephalography. Nature Biomedical Engineering. Epub ahead of print.
