Risch Martin, Nydegger Urs, Risch Lorenz
Kantonsspital Graubünden, Chur Labormedizinisches Zentrum Dr. Risch, Liebefeld bei Bern, Bern, Switzerland Private University Triesen, Liechtenstein University of Bern, University Institute of Clinical Chemistry, Bern, Switzerland.
Medicine (Baltimore). 2017 Jan;96(1):e5726. doi: 10.1097/MD.0000000000005726.
In clinical practice, laboratory results are often important for making diagnostic, therapeutic, and prognostic decisions. Interpreting individual results relies on accurate reference intervals and decision limits. Despite the considerable amount of resources in clinical medicine spent on elderly patients, accurate reference intervals for the elderly are rarely available. The SENIORLAB study set out to determine reference intervals in the elderly by investigating a large variety of laboratory parameters in clinical chemistry, hematology, and immunology.
METHODS/DESIGN: The SENIORLAB study is an observational, prospective cohort study. Subjectively healthy residents of Switzerland aged 60 years and older were included for baseline examination (n = 1467), where anthropometric measurements were taken, medical history was reviewed, and a fasting blood sample was drawn under optimal preanalytical conditions. More than 110 laboratory parameters were measured, and a biobank was set up. The study participants are followed up every 3 to 5 years for quality of life, morbidity, and mortality. The primary aim is to evaluate different laboratory parameters at age-related reference intervals. The secondary aims of this study include the following: identify associations between different parameters, identify diagnostic characteristics to diagnose different circumstances, identify the prevalence of occult disease in subjectively healthy individuals, and identify the prognostic factors for the investigated outcomes, including mortality.
To obtain better grounds to justify clinical decisions, specific reference intervals for laboratory parameters of the elderly are needed. Reference intervals are obtained from healthy individuals. A major obstacle when obtaining reference intervals in the elderly is the definition of health in seniors because individuals without any medical condition and any medication are rare in older adulthood. Reference intervals obtained from such individuals cannot be considered representative for seniors in a status of age-specific normal health. In addition to the established methods for determining reference intervals, this longitudinal study utilizes a unique approach, in that survival and long-term well-being are taken as indicators of health in seniors. This approach is expected to provide robust and representative reference intervals that are obtained from an adequate reference population and not a collective of highly selected individuals.
The present study was registered under International Standard Randomized Controlled Trial Number registry: ISRCTN53778569.
在临床实践中，实验室检查结果对于做出诊断、治疗及预后判断通常至关重要。解读个体检查结果依赖于准确的参考区间和决策界限。尽管临床医学在老年患者身上投入了大量资源，但针对老年人的准确参考区间却很少能获得。SENIORLAB研究旨在通过调查临床化学、血液学和免疫学中的多种实验室参数来确定老年人的参考区间。
方法/设计：SENIORLAB研究是一项观察性前瞻性队列研究。纳入了瑞士60岁及以上主观健康的居民进行基线检查（n = 1467），在此期间进行人体测量、回顾病史，并在最佳分析前条件下采集空腹血样。测量了110多项实验室参数，并建立了生物样本库。研究参与者每3至5年随访一次生活质量、发病率和死亡率。主要目的是评估与年龄相关参考区间下的不同实验室参数。本研究的次要目的包括：确定不同参数之间的关联，确定诊断不同情况的诊断特征，确定主观健康个体中隐匿性疾病的患病率，以及确定所研究结局（包括死亡率）的预后因素。
为了有更好的依据来证明临床决策的合理性，需要针对老年人实验室参数的特定参考区间。参考区间是从健康个体中获得的。在老年人中获取参考区间时的一个主要障碍是老年人健康的定义，因为在老年人群中没有任何疾病和未服用任何药物的个体很少见。从这类个体获得的参考区间不能被视为代表处于特定年龄正常健康状态的老年人。除了既定的确定参考区间的方法外，这项纵向研究采用了一种独特的方法，即将生存和长期健康状况作为老年人健康的指标。这种方法有望提供从足够的参考人群而非高度挑选个体的集合中获得的可靠且具有代表性的参考区间。
本研究已在国际标准随机对照试验编号注册库注册：ISRCTN53778569。
