Sciacovelli Laura, Zardo Lorena, Secchiero Sandra, Zaninotto Martina, Plebani Mario
Centro di Ricerca Biomedica, Via Ospedale, 18, Castelfranco Veneto (TV) 31033, Italy.
Clin Chim Acta. 2003 Jul 15;333(2):209-19. doi: 10.1016/s0009-8981(03)00188-8.
Laboratory information is generated when a meaning is given to certain data. This is usually achieved by comparing a laboratory test result with the reference range/decisional limit (RL), and by providing consultation for the interpretation of data, advice, and follow-up testing.
In this paper, we investigate factors affecting the conversion of data into useful information with regard to biochemical markers of myocardial damage (CK-MB mass, myoglobin, and troponins), in view of their importance in detecting myocardial necrosis. Our aim was to report results obtained in order to verify the consensus between laboratories with reference to interpretative comments and the reference ranges/decisional limits added to clinical reports.
A questionnaire and simulated medical reports on three different patients were distributed to participants (94 laboratories) in the 2001 cycle of the External Quality Assessment (EQA). Moreover, we analysed 113 medical reports sent by laboratories during the most recent EQA cycle 2002, and checked the number of different RLs used, both independent and within the diagnostic system used. We also compared each laboratory result of a control sample, obtained in the 2002 cycle, with declared RL in order to verify the clinical significance of results ("normal" or "pathological") for troponin I and CK-MB.
Our findings show that few laboratories regularly add interpretative comments to medical reports. On the contrary, they cooperate with clinicians who require consultation, advice, and information for the appropriate use of biochemical markers. There is a general consensus among participants regarding probable syndromes suggested by the interpretation of the same result and most laboratories also agree on further investigations to be carried out for several diseases. Concerning RL, the data demonstrate that numerous different RLs are used to report the results of the biochemical markers evaluated, both when considered independent of the diagnostic system used and within the diagnostic system used.
The biochemist does not have the opportunity to verify the efficacy of the interpretation that he/she provided. An audit of this activity is therefore required to allow the laboratory to monitor its own performance and to assure good practice. The evaluation of interpretative comments, through specific surveys, should be a prime objective of EQA organisers. Well-designed EQA programs can, moreover, support laboratories in establishing appropriate RL and in verifying the clinical significance of their results with respect to that of other laboratories. Our survey on interpretative comments and the analysis of the RLs further demonstrate how laboratory medicine can contribute to the objective evaluation of the patients' health status.
当赋予某些数据意义时，实验室信息便得以产生。这通常是通过将实验室检测结果与参考范围/判定限（RL）进行比较，并为数据解读、建议及后续检测提供咨询来实现的。
鉴于心肌损伤生化标志物（肌酸激酶同工酶质量、肌红蛋白和肌钙蛋白）在检测心肌坏死方面的重要性，本文我们研究了影响将这些数据转化为有用信息的因素。我们的目的是报告所获得的结果，以验证各实验室在解释性评论以及临床报告中所添加的参考范围/判定限方面的共识。
在2001年外部质量评估（EQA）周期中，向参与者（94个实验室）分发了一份问卷以及关于三名不同患者的模拟医学报告。此外，我们分析了实验室在最近的2002年EQA周期中发送的113份医学报告，并检查了所使用的不同RL的数量，包括独立使用的以及在所用诊断系统内使用的。我们还将2002年周期中获得的对照样本的每个实验室结果与公布的RL进行比较，以验证肌钙蛋白I和肌酸激酶同工酶结果（“正常”或“病理性”）的临床意义。
我们的研究结果表明，很少有实验室会定期在医学报告中添加解释性评论。相反，它们与需要咨询、建议以及关于生化标志物恰当使用信息的临床医生进行合作。对于同一结果解读所提示的可能综合征，参与者之间存在普遍共识，并且大多数实验室对于针对几种疾病应进行的进一步检查也达成了一致。关于RL，数据表明，无论是独立于所用诊断系统还是在所用诊断系统内考虑，在报告所评估的生化标志物结果时都使用了众多不同的RL。
生物化学家没有机会验证其提供的解读的有效性。因此，需要对此活动进行审核，以便实验室监控自身表现并确保良好操作规范。通过特定调查对解释性评论进行评估，应成为EQA组织者的首要目标。此外，精心设计的EQA计划可以支持实验室确定合适的RL，并验证其结果相对于其他实验室结果的临床意义。我们关于解释性评论的调查以及对RL的分析进一步证明了检验医学如何能够为客观评估患者健康状况做出贡献。
