Kristensen Gunn B B, Nerhus Kari, Thue Geir, Sandberg Sverre
NOKLUS, Norwegian Quality Improvement of Primary Care Laboratories, Laboratory of Clinical Biochemistry, Haukeland University Hospital, Bergen, Norway.
Clin Chem. 2006 Jul;52(7):1311-7. doi: 10.1373/clinchem.2006.068114. Epub 2006 May 11.
The analytical quality of self-monitoring of blood glucose (SMBG) is not satisfactory, and the need for standardized control routines for SMBG has been underscored. The objective of this study was to investigate whether an external quality assessment scheme (EQAS) designed for office laboratories could improve the quality of SMBG measurements.
From October 2001 through March 2004, we conducted 6 glucose surveys for diabetes patients and coordinated them with an EQAS for office laboratories. Patients received 2 control samples by post twice a year. They measured each control sample in duplicate in accordance with written instructions, returned the results, and received an assessment of their analytical performance. Participants who got a poor evaluation were followed up by phone and were offered guidance.
Participating in an EQA program over a period of 3 years decreased the percentage of poor results among diabetes patients significantly, from 11.2% to 1.9% in the first and last surveys, respectively. Between-participant CVs improved from 5.5% to 3.7% and were comparable to results from office laboratories. It was difficult to sort out factors contributing to quality improvement.
Implementing a traditional EQAS among diabetes patients may improve the analytical quality of SMBG and could be convenient for motivated patients. Further evaluation of the clinical usefulness of implementing such a program is needed, however, and costs as well as limitations of current EQAS for glucose in general should be taken into account.
血糖自我监测(SMBG)的分析质量不尽人意,强调了对SMBG标准化控制程序的需求。本研究的目的是调查专为门诊实验室设计的外部质量评估计划(EQAS)是否能提高SMBG测量的质量。
从2001年10月至2004年3月,我们为糖尿病患者进行了6次血糖调查,并与门诊实验室的EQAS进行协调。患者每年两次通过邮寄收到2个对照样本。他们按照书面说明对每个对照样本进行双份测量,返回结果,并得到其分析性能的评估。评估结果较差的参与者通过电话进行随访并获得指导。
在3年期间参与EQA计划显著降低了糖尿病患者中不良结果的百分比,在第一次和最后一次调查中分别从11.2%降至1.9%。参与者之间的变异系数从5.5%提高到3.7%,与门诊实验室的结果相当。难以梳理出有助于质量改进的因素。
在糖尿病患者中实施传统的EQAS可能会提高SMBG的分析质量,并且对有积极性的患者可能很方便。然而,需要进一步评估实施该计划的临床实用性,并且应考虑成本以及当前一般血糖EQAS的局限性。