Nu Beta, Professor and Independence Foundation Chair in Nursing Education, Johns Hopkins University School of Nursing, Baltimore, MD, USA.
Alpha Epsilon, Professor and Associate Dean for Research, Nell Hodgson Woodruff School of Nursing, Emory University, Atlanta, GA, USA.
J Nurs Scholarsh. 2018 May;50(3):276-286. doi: 10.1111/jnu.12378. Epub 2018 Mar 25.
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.
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.
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.
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.
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.
生物标志物作为通用数据元素（CDEs）对于生物行为症状的特征化非常重要，因为一旦确定了生物学调节剂或介质，就可以针对治疗效果进行基于生物学的策略研究。正如症状清单反映了症状体验一样，生物标志物也是症状的指标，尽管不是症状本身。本立场文件的目的是：（a）确定一个“最小集合”的生物标志物，以作为症状和自我管理科学中的 CDE 进行考虑，特别是生化生物标志物；（b）评估此类有限生物标志物阵列对症状科学的影响的益处和局限性；（c）提出一种收集已认可的生物学样本最小集合的策略，以作为症状科学的 CDE 进行使用；（d）根据国家护理研究所（NINR）的疲劳、抑郁、认知、疼痛和睡眠障碍症状，将这个最小集合的生物标志物概念化。
2016 年 5 月至 2017 年 1 月，由 NINR 中心主任的一部分组成的工作组，这些中心由 P20 或 P30 机制资助的卓越中心主任组成，通过电话每两个月开会一次，制定了这项建议将生物标志物作为 CDE 加入的立场文件。所有主任都审查了草稿，提出了批评和建议，推荐了最小集合的生物标志物，并批准了完成的文件。本文描述了选择、识别和使用生物 CDE 的最佳实践，以及在症状和自我管理科学中使用生物 CDE 的挑战。介绍了当前的样本结果共享平台。最后，提出了症状和自我管理科学的生物 CDE，并对这些领域未来的研究和 CDE 使用提出了影响。
建议的生物标志物 CDE 最小集合包括促炎和抗炎细胞因子、下丘脑-垂体-肾上腺轴标志物、皮质醇、神经肽脑源性神经营养因子和 DNA 多态性。
预计随着症状和自我管理科学的生物学机制的进一步发展，这一最小集合的生物标志物 CDE 将得到进一步完善。生物 CDE 的加入可以深入了解症状的机制、拟议干预措施的有效性以及所选理论框架的适用性。同样，对于之前建议的用于行为症状和慢性疾病自我管理的 NINR CDE，生物 CDE 为加强症状和自我管理科学的合作努力提供了潜力。
在生物行为症状研究中使用生物标志物 CDE 将促进研究结果的可重复性和普遍性，并有益于症状和自我管理科学。
