Biomarkers as Common Data Elements for Symptom and Self-Management Science

Gayle G Page, Elizabeth J. Corwin, Susan G. Dorsey, Nancy S. Redeker, Donna Jo McCloskey, Joan K. Austin, Barbara J. Guthrie, Shirley M. Moore, Debra Barton, Miyong T. Kim, Sharron L. Docherty, Drenna Waldrop-Valverde, Donald E. Bailey, Rachel F. Schiffman, Angela Starkweather, Teresa M. Ward, Suzanne Bakken, Kathleen T. Hickey, Cynthia L. Renn, Patricia Grady

Research output: Contribution to journalArticle

Abstract

Purpose: Biomarkers as common data elements (CDEs) are important for the characterization of biobehavioral symptoms given that once a biologic moderator or mediator is identified, biologically based strategies can be investigated for treatment efforts. Just as a symptom inventory reflects a symptom experience, a biomarker is an indicator of the symptom, though not the symptom per se. The purposes of this position paper are to (a) identify a “minimum set” of biomarkers for consideration as CDEs in symptom and self-management science, specifically biochemical biomarkers; (b) evaluate the benefits and limitations of such a limited array of biomarkers with implications for symptom science; (c) propose a strategy for the collection of the endorsed minimum set of biologic samples to be employed as CDEs for symptom science; and (d) conceptualize this minimum set of biomarkers consistent with National Institute of Nursing Research (NINR) symptoms of fatigue, depression, cognition, pain, and sleep disturbance. Design and Methods: From May 2016 through January 2017, a working group consisting of a subset of the Directors of the NINR Centers of Excellence funded by P20 or P30 mechanisms and NINR staff met bimonthly via telephone to develop this position paper suggesting the addition of biomarkers as CDEs. The full group of Directors reviewed drafts, provided critiques and suggestions, recommended the minimum set of biomarkers, and approved the completed document. Best practices for selecting, identifying, and using biological CDEs as well as challenges to the use of biological CDEs for symptom and self-management science are described. Current platforms for sample outcome sharing are presented. Finally, biological CDEs for symptom and self-management science are proposed along with implications for future research and use of CDEs in these areas. Findings: The recommended minimum set of biomarker CDEs include pro- and anti-inflammatory cytokines, a hypothalamic-pituitary-adrenal axis marker, cortisol, the neuropeptide brain-derived neurotrophic factor, and DNA polymorphisms. Conclusions: It is anticipated that this minimum set of biomarker CDEs will be refined as knowledge regarding biologic mechanisms underlying symptom and self-management science further develop. The incorporation of biological CDEs may provide insights into mechanisms of symptoms, effectiveness of proposed interventions, and applicability of chosen theoretical frameworks. Similarly, as for the previously suggested NINR CDEs for behavioral symptoms and self-management of chronic conditions, biological CDEs offer the potential for collaborative efforts that will strengthen symptom and self-management science. Clinical Relevance: The use of biomarker CDEs in biobehavioral symptoms research will facilitate the reproducibility and generalizability of research findings and benefit symptom and self-management science.

Original languageEnglish (US)
Pages (from-to)276-286
Number of pages11
JournalJournal of Nursing Scholarship
Volume50
Issue number3
DOIs
StatePublished - May 1 2018

Fingerprint

Self Care
Biomarkers
National Institute of Nursing Research (U.S.)
Common Data Elements
Behavioral Symptoms
Nursing Staff
Brain-Derived Neurotrophic Factor
Neuropeptides
Practice Guidelines
Research
Telephone
Cognition
Fatigue
Hydrocortisone
Sleep
Anti-Inflammatory Agents

Keywords

  • Biomarker
  • common data elements
  • self-management
  • symptoms

ASJC Scopus subject areas

  • Nursing(all)

Cite this

Page, G. G., Corwin, E. J., Dorsey, S. G., Redeker, N. S., McCloskey, D. J., Austin, J. K., ... Grady, P. (2018). Biomarkers as Common Data Elements for Symptom and Self-Management Science. Journal of Nursing Scholarship, 50(3), 276-286. https://doi.org/10.1111/jnu.12378

Biomarkers as Common Data Elements for Symptom and Self-Management Science. / Page, Gayle G; Corwin, Elizabeth J.; Dorsey, Susan G.; Redeker, Nancy S.; McCloskey, Donna Jo; Austin, Joan K.; Guthrie, Barbara J.; Moore, Shirley M.; Barton, Debra; Kim, Miyong T.; Docherty, Sharron L.; Waldrop-Valverde, Drenna; Bailey, Donald E.; Schiffman, Rachel F.; Starkweather, Angela; Ward, Teresa M.; Bakken, Suzanne; Hickey, Kathleen T.; Renn, Cynthia L.; Grady, Patricia.

In: Journal of Nursing Scholarship, Vol. 50, No. 3, 01.05.2018, p. 276-286.

Research output: Contribution to journalArticle

Page, GG, Corwin, EJ, Dorsey, SG, Redeker, NS, McCloskey, DJ, Austin, JK, Guthrie, BJ, Moore, SM, Barton, D, Kim, MT, Docherty, SL, Waldrop-Valverde, D, Bailey, DE, Schiffman, RF, Starkweather, A, Ward, TM, Bakken, S, Hickey, KT, Renn, CL & Grady, P 2018, 'Biomarkers as Common Data Elements for Symptom and Self-Management Science', Journal of Nursing Scholarship, vol. 50, no. 3, pp. 276-286. https://doi.org/10.1111/jnu.12378
Page GG, Corwin EJ, Dorsey SG, Redeker NS, McCloskey DJ, Austin JK et al. Biomarkers as Common Data Elements for Symptom and Self-Management Science. Journal of Nursing Scholarship. 2018 May 1;50(3):276-286. https://doi.org/10.1111/jnu.12378
Page, Gayle G ; Corwin, Elizabeth J. ; Dorsey, Susan G. ; Redeker, Nancy S. ; McCloskey, Donna Jo ; Austin, Joan K. ; Guthrie, Barbara J. ; Moore, Shirley M. ; Barton, Debra ; Kim, Miyong T. ; Docherty, Sharron L. ; Waldrop-Valverde, Drenna ; Bailey, Donald E. ; Schiffman, Rachel F. ; Starkweather, Angela ; Ward, Teresa M. ; Bakken, Suzanne ; Hickey, Kathleen T. ; Renn, Cynthia L. ; Grady, Patricia. / Biomarkers as Common Data Elements for Symptom and Self-Management Science. In: Journal of Nursing Scholarship. 2018 ; Vol. 50, No. 3. pp. 276-286.
@article{3a83fc81f28b499bbd08ce7667e2ee00,
title = "Biomarkers as Common Data Elements for Symptom and Self-Management Science",
abstract = "Purpose: Biomarkers as common data elements (CDEs) are important for the characterization of biobehavioral symptoms given that once a biologic moderator or mediator is identified, biologically based strategies can be investigated for treatment efforts. Just as a symptom inventory reflects a symptom experience, a biomarker is an indicator of the symptom, though not the symptom per se. The purposes of this position paper are to (a) identify a “minimum set” of biomarkers for consideration as CDEs in symptom and self-management science, specifically biochemical biomarkers; (b) evaluate the benefits and limitations of such a limited array of biomarkers with implications for symptom science; (c) propose a strategy for the collection of the endorsed minimum set of biologic samples to be employed as CDEs for symptom science; and (d) conceptualize this minimum set of biomarkers consistent with National Institute of Nursing Research (NINR) symptoms of fatigue, depression, cognition, pain, and sleep disturbance. Design and Methods: From May 2016 through January 2017, a working group consisting of a subset of the Directors of the NINR Centers of Excellence funded by P20 or P30 mechanisms and NINR staff met bimonthly via telephone to develop this position paper suggesting the addition of biomarkers as CDEs. The full group of Directors reviewed drafts, provided critiques and suggestions, recommended the minimum set of biomarkers, and approved the completed document. Best practices for selecting, identifying, and using biological CDEs as well as challenges to the use of biological CDEs for symptom and self-management science are described. Current platforms for sample outcome sharing are presented. Finally, biological CDEs for symptom and self-management science are proposed along with implications for future research and use of CDEs in these areas. Findings: The recommended minimum set of biomarker CDEs include pro- and anti-inflammatory cytokines, a hypothalamic-pituitary-adrenal axis marker, cortisol, the neuropeptide brain-derived neurotrophic factor, and DNA polymorphisms. Conclusions: It is anticipated that this minimum set of biomarker CDEs will be refined as knowledge regarding biologic mechanisms underlying symptom and self-management science further develop. The incorporation of biological CDEs may provide insights into mechanisms of symptoms, effectiveness of proposed interventions, and applicability of chosen theoretical frameworks. Similarly, as for the previously suggested NINR CDEs for behavioral symptoms and self-management of chronic conditions, biological CDEs offer the potential for collaborative efforts that will strengthen symptom and self-management science. Clinical Relevance: The use of biomarker CDEs in biobehavioral symptoms research will facilitate the reproducibility and generalizability of research findings and benefit symptom and self-management science.",
keywords = "Biomarker, common data elements, self-management, symptoms",
author = "Page, {Gayle G} and Corwin, {Elizabeth J.} and Dorsey, {Susan G.} and Redeker, {Nancy S.} and McCloskey, {Donna Jo} and Austin, {Joan K.} and Guthrie, {Barbara J.} and Moore, {Shirley M.} and Debra Barton and Kim, {Miyong T.} and Docherty, {Sharron L.} and Drenna Waldrop-Valverde and Bailey, {Donald E.} and Schiffman, {Rachel F.} and Angela Starkweather and Ward, {Teresa M.} and Suzanne Bakken and Hickey, {Kathleen T.} and Renn, {Cynthia L.} and Patricia Grady",
year = "2018",
month = "5",
day = "1",
doi = "10.1111/jnu.12378",
language = "English (US)",
volume = "50",
pages = "276--286",
journal = "Journal of Nursing Scholarship",
issn = "1527-6546",
publisher = "Wiley-Blackwell",
number = "3",

}

TY - JOUR

T1 - Biomarkers as Common Data Elements for Symptom and Self-Management Science

AU - Page, Gayle G

AU - Corwin, Elizabeth J.

AU - Dorsey, Susan G.

AU - Redeker, Nancy S.

AU - McCloskey, Donna Jo

AU - Austin, Joan K.

AU - Guthrie, Barbara J.

AU - Moore, Shirley M.

AU - Barton, Debra

AU - Kim, Miyong T.

AU - Docherty, Sharron L.

AU - Waldrop-Valverde, Drenna

AU - Bailey, Donald E.

AU - Schiffman, Rachel F.

AU - Starkweather, Angela

AU - Ward, Teresa M.

AU - Bakken, Suzanne

AU - Hickey, Kathleen T.

AU - Renn, Cynthia L.

AU - Grady, Patricia

PY - 2018/5/1

Y1 - 2018/5/1

N2 - Purpose: Biomarkers as common data elements (CDEs) are important for the characterization of biobehavioral symptoms given that once a biologic moderator or mediator is identified, biologically based strategies can be investigated for treatment efforts. Just as a symptom inventory reflects a symptom experience, a biomarker is an indicator of the symptom, though not the symptom per se. The purposes of this position paper are to (a) identify a “minimum set” of biomarkers for consideration as CDEs in symptom and self-management science, specifically biochemical biomarkers; (b) evaluate the benefits and limitations of such a limited array of biomarkers with implications for symptom science; (c) propose a strategy for the collection of the endorsed minimum set of biologic samples to be employed as CDEs for symptom science; and (d) conceptualize this minimum set of biomarkers consistent with National Institute of Nursing Research (NINR) symptoms of fatigue, depression, cognition, pain, and sleep disturbance. Design and Methods: From May 2016 through January 2017, a working group consisting of a subset of the Directors of the NINR Centers of Excellence funded by P20 or P30 mechanisms and NINR staff met bimonthly via telephone to develop this position paper suggesting the addition of biomarkers as CDEs. The full group of Directors reviewed drafts, provided critiques and suggestions, recommended the minimum set of biomarkers, and approved the completed document. Best practices for selecting, identifying, and using biological CDEs as well as challenges to the use of biological CDEs for symptom and self-management science are described. Current platforms for sample outcome sharing are presented. Finally, biological CDEs for symptom and self-management science are proposed along with implications for future research and use of CDEs in these areas. Findings: The recommended minimum set of biomarker CDEs include pro- and anti-inflammatory cytokines, a hypothalamic-pituitary-adrenal axis marker, cortisol, the neuropeptide brain-derived neurotrophic factor, and DNA polymorphisms. Conclusions: It is anticipated that this minimum set of biomarker CDEs will be refined as knowledge regarding biologic mechanisms underlying symptom and self-management science further develop. The incorporation of biological CDEs may provide insights into mechanisms of symptoms, effectiveness of proposed interventions, and applicability of chosen theoretical frameworks. Similarly, as for the previously suggested NINR CDEs for behavioral symptoms and self-management of chronic conditions, biological CDEs offer the potential for collaborative efforts that will strengthen symptom and self-management science. Clinical Relevance: The use of biomarker CDEs in biobehavioral symptoms research will facilitate the reproducibility and generalizability of research findings and benefit symptom and self-management science.

AB - Purpose: Biomarkers as common data elements (CDEs) are important for the characterization of biobehavioral symptoms given that once a biologic moderator or mediator is identified, biologically based strategies can be investigated for treatment efforts. Just as a symptom inventory reflects a symptom experience, a biomarker is an indicator of the symptom, though not the symptom per se. The purposes of this position paper are to (a) identify a “minimum set” of biomarkers for consideration as CDEs in symptom and self-management science, specifically biochemical biomarkers; (b) evaluate the benefits and limitations of such a limited array of biomarkers with implications for symptom science; (c) propose a strategy for the collection of the endorsed minimum set of biologic samples to be employed as CDEs for symptom science; and (d) conceptualize this minimum set of biomarkers consistent with National Institute of Nursing Research (NINR) symptoms of fatigue, depression, cognition, pain, and sleep disturbance. Design and Methods: From May 2016 through January 2017, a working group consisting of a subset of the Directors of the NINR Centers of Excellence funded by P20 or P30 mechanisms and NINR staff met bimonthly via telephone to develop this position paper suggesting the addition of biomarkers as CDEs. The full group of Directors reviewed drafts, provided critiques and suggestions, recommended the minimum set of biomarkers, and approved the completed document. Best practices for selecting, identifying, and using biological CDEs as well as challenges to the use of biological CDEs for symptom and self-management science are described. Current platforms for sample outcome sharing are presented. Finally, biological CDEs for symptom and self-management science are proposed along with implications for future research and use of CDEs in these areas. Findings: The recommended minimum set of biomarker CDEs include pro- and anti-inflammatory cytokines, a hypothalamic-pituitary-adrenal axis marker, cortisol, the neuropeptide brain-derived neurotrophic factor, and DNA polymorphisms. Conclusions: It is anticipated that this minimum set of biomarker CDEs will be refined as knowledge regarding biologic mechanisms underlying symptom and self-management science further develop. The incorporation of biological CDEs may provide insights into mechanisms of symptoms, effectiveness of proposed interventions, and applicability of chosen theoretical frameworks. Similarly, as for the previously suggested NINR CDEs for behavioral symptoms and self-management of chronic conditions, biological CDEs offer the potential for collaborative efforts that will strengthen symptom and self-management science. Clinical Relevance: The use of biomarker CDEs in biobehavioral symptoms research will facilitate the reproducibility and generalizability of research findings and benefit symptom and self-management science.

KW - Biomarker

KW - common data elements

KW - self-management

KW - symptoms

UR - http://www.scopus.com/inward/record.url?scp=85044343245&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85044343245&partnerID=8YFLogxK

U2 - 10.1111/jnu.12378

DO - 10.1111/jnu.12378

M3 - Article

VL - 50

SP - 276

EP - 286

JO - Journal of Nursing Scholarship

JF - Journal of Nursing Scholarship

SN - 1527-6546

IS - 3

ER -