通过ISO 15189认可实验室质量指标制定及监测情况调查

目的 了解目前我国通过ISO 15189认可的实验室质量指标制定及监测情况。 方法 设计质量指标制定及监测情况调查表并下发给185家认可实验室,要求在10月31日前以邮件形式回报结果,使用Microsoft Excel 2010软件进行统计分析。 结果 共85家（占45.95%）实验室回报结果,76家临床实验室,9家独立实验室。不同认可实验室制定的质量指标数量及分布差异较大。76家临床实验室共设置质量指标1105项,每家实验室平均14.5项。9家独立实验室设置质量指标195项,每家实验室平均21.7项。临床实验室制定了更多的检验前、检验中质量指标,独立实验室在设置质量指标时还包括了较多的检验后、支持性过程和其他质量指标。 结论 目前我国认可实验室质量指标制定及监测情况尚不理想。在推进质量指标一致化的同时,实验室应加强宣贯与教育,建议一套完整、科学和实用的质量指标体系。

     

Mass spectrometry applications in microbiology beyond microbe identification: progress and potential

Introduction: Mass spectrometry (MS), particularly MALDI-time of flight (MALDI-TOF), has become a routine tool for microorganism identification in clinical microbiology laboratories in the last five years. The use of MALDI-TOF MS has accelerated laboratory analysis, thus providing accurate species-level information with very short turnaround times.

Areas covered: Beyond microbe identification, MALDI-TOF MS offers great opportunities for fast strain typing and detection of antimicrobial susceptibility/resistance in both bacterial and fungal organisms. Drawing on evidence from PubMed literature searches, clinical microbiology laboratory experience, and the authors’ opinions, this review summarizes recent significant advances and ongoing challenges in these areas.

Expert commentary: In the near future, it is expected that the implementation of new analytical algorithms, automation of procedures, and refinement of assays will enhance the clinical and epidemiological usefulness of MALDI-TOF and other MS technologies.     

Analytical Performance Characteristics of the Cepheid GeneXpert Ebola Assay for the Detection of Ebola Virus

BackgroundThe recently developed Xpert® Ebola Assay is a novel nucleic acid amplification test for simplified detection of Ebola virus (EBOV) in whole blood and buccal swab samples. The assay targets sequences in two EBOV genes, lowering the risk for new variants to escape detection in the test. The objective of this report is to present analytical characteristics of the Xpert® Ebola Assay on whole blood samples.ConclusionIn summary, we found the Xpert® Ebola Assay to have high analytical sensitivity and specificity for the detection of EBOV in whole blood. It offers ease of use, fast turnaround time, and remote monitoring. The test has an efficient viral inactivation protocol, fulfills inclusivity and exclusivity criteria, and has specimen stability characteristics consistent with the need for decentralized testing. The simplicity of the assay should enable testing in a wide variety of laboratory settings, including remote laboratories that are not capable of performing highly complex nucleic acid amplification tests, and during outbreaks where time to detection is critical.     

Report Preparation on Result Turnaround Time and Savings in Cost,Time, and Space

ObjectiveTo evaluate whether introduction of a densitometry workflow, data-storage, and reporting software system would result in streamlined workflow with fewer expenses and quicker result turnaround time.MethodsBoneStation was implemented March 30, 2009, in a large, urban, tertiary referral center performing more than 6000 bone mineral density studies annually at 3 different geographic sites. The times of scan acquisition, report preparation, and final signature in the online medical record were recorded, and the delays from scan to report and from scan to final signature in the online medical record were calculated for each patient during 2 representative weeks before (n = 274) and 2 weeks after (n = 235) implementation of BoneStation.ResultsUse of BoneStation reduced time from scan to report from 2.11 ± 0.16 days to 0.46 ± 0.05 days (P <.001). BoneStation saved our practice $8.94 per scan, while costing only $3 per scan, resulting in net savings. Considering that the total reimbursement from Medicare in 2010 for dual-energy x-ray absorptiometry is projected to be $55.44, this constitutes cost savings of 10.7% of the total reimbursement.ConclusionThe introduction of a specialized electronic medical system for data storage and reporting reduced costs and improved result turnaround time in a densitometry practice. (Endocr Pract. 2010;16:30-35)     

Treatment planning systems dosimetry auditing project in Portugal

Background and purposeThe Medical Physics Division of the Portuguese Physics Society (DFM_SPF) in collaboration with the IAEA, carried out a national auditing project in radiotherapy, between September 2011 and April 2012. The objective of this audit was to ensure the optimal usage of treatment planning systems. The national results are presented in this paper.Material and methodsThe audit methodology simulated all steps of external beam radiotherapy workflow, from image acquisition to treatment planning and dose delivery. A thorax CIRS phantom lend by IAEA was used in 8 planning test-cases for photon beams corresponding to 15 measuring points (33 point dose results, including individual fields in multi-field test cases and 5 sum results) in different phantom materials covering a set of typical clinical delivery techniques in 3D Conformal Radiotherapy.ResultsAll 24 radiotherapy centers in Portugal have participated. 50 photon beams with energies 4–18 MV have been audited using 25 linear accelerators and 32 calculation algorithms.In general a very good consistency was observed for the same type of algorithm in all centres and for each beam quality.ConclusionsThe overall results confirmed that the national status of TPS calculations and dose delivery for 3D conformal radiotherapy is generally acceptable with no major causes for concern. This project contributed to the strengthening of the cooperation between the centres and professionals, paving the way to further national collaborations.     

Considerations for Group Testing: A Practical Approach for the Clinical Laboratory

Group testing, also known as pooled sample testing, was first proposed by Robert Dorfman in 1943. While sample pooling has been widely practiced in blood-banking, it is traditionally seen as anathema for clinical laboratories. However, the ongoing COVID-19 pandemic has re-ignited interest for group testing among clinical laboratories to mitigate supply shortages. We propose five criteria to assess the suitability of an analyte for pooled sample testing in general and outline a practical approach that a clinical laboratory may use to implement pooled testing for SARS-CoV-2 PCR testing. The five criteria we propose are: (1) the analyte concentrations in the diseased persons should be at least one order of magnitude (10 times) higher than in healthy persons; (2) sample dilution should not overly reduce clinical sensitivity; (3) the current prevalence must be sufficiently low for the number of samples pooled for the specific protocol; (4) there is no requirement for a fast turnaround time; and (5) there is an imperative need for resource rationing to maximise public health outcomes. The five key steps we suggest for a successful implementation are: (1) determination of when pooling takes place (pre-pre analytical, pre-analytical, analytical); (2) validation of the pooling protocol; (3) ensuring an adequate infrastructure and archival system; (4) configuration of the laboratory information system; and (5) staff training. While pool testing is not a panacea to overcome reagent shortage, it may allow broader access to testing but at the cost of reduction in sensitivity and increased turnaround time.     

Regional Variation in Analytical Techniques used in the Diagnosis and Monitoring of Porphyria: a Case for Harmonisation?

Background:The Royal College of Pathologists of Australasia (RCPA) Porphyrin Quality Assurance Program assesses the measurement of urine, faecal, plasma and whole blood porphyrins and their components plus urinary porphobilinogen and delta aminolaevulinic acid and has laboratories enrolled from around the world. It was observed that there was a wide scatter in results submitted to some subsections of the program.Methods:A detailed questionnaire covering the analytical techniques used in the diagnosis of porphyria was sent to all laboratories enrolled in the RCPA Porphyrin Quality Assurance Program. Additionally, self-enrolment data over a five year period was examined for trends/changes in standardisation, reagent sources and analytical technique.Results:Twenty of the 45 laboratories enrolled in the Porphyrin Quality Assurance Program completed the survey, providing a snapshot of the analytical techniques used world-wide. Post survey self enrolment data indicated only little or no noticeable changes to analytical standardisation of techniques despite the continual lack of agreement of results in subsections of the External Quality Assurance program.Conclusions:While some aspects of porphyria testing are relatively consistent between laboratories, other diagnostic techniques vary widely. A wide variety of individualised reference intervals and reporting techniques is currently in use world-wide. While most of the participants in the survey are regional reference centres specialising in the diagnosis of porphyria and, as such, their diagnostic capability is not in question, international guidelines or global harmonisation of analytical techniques should allow better inter-laboratory comparisons to be made, ultimately improving diagnostic accuracy.     

Verification of quantitative analytical methods in medical laboratories

BackgroundGlobally, all medical laboratories seeking accreditation should meet international quality standards to perform certain specific tests. Quality management program provides disciplines targeted to ensure that quality standards have been implemented by a laboratory in order to generate correct results. The hallmark of the accreditation process is method verification and quality assurance. Before introducing a new method in your laboratory, it is important to assess certain performance characteristics that reflect the concept of method verification.MethodsIn this review, we illustrated how to verify the performance characteristics of a new method according to the recent guidelines. It includes an assessment of precision, trueness, analytical sensitivity, detection limits, analytical specificity, interference, measuring range, linearity, and measurement uncertainty.ConclusionsAlthough the presence of several updated guidelines used to determine the performance characteristics of new methods in clinical chemistry laboratories, the real practice raised several concerns with the application of these guidelines which in need for further consideration in the upcoming updates of these guidelines.     

Biological rhythms of biochemical serum parameters in a Brazilian population: a three-year study

A marked decrease in analytical and post-analytical variability has been achieved in clinical laboratories by the use of automated analytical systems. Current studies are now focused on the origin of pre-analytical variability, such as that due to intra-individual differences and biological rhythms. The objective of this work was to evaluate the occurrence of biological rhythms in several biochemical serum parameters in a Brazilian population. A retrospective study (1996 to 1998) was carried out to collect the test results within the reference intervals of adults, from 21 to 50 yr of age (average age of 36 yr) attending the outpatient clinics of the Teaching Hospital at the University of Campinas, S?o Paulo, Brazil. The reference sample was 52.9% male and 47.1% female and encompassed 15,036 calcium, 7,478 phosphorus, 53,641 urea, 58,315 creatinine and 6,433 uric acid determinations (140,903 in total). Significant annual rhythms were detected in serum calcium (p相似文献   

Interferograms plotted with reference change value (RCV) may facilitate the management of hemolyzed samples

BackgroundThe European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) Working Group for Preanalytical Phase (WG-PRE) have recommended an algorithm based on the reference change value (RCV) to evaluate hemolysis. We utilized this algorithm to analyze hemolysis-sensitive parameters.MethodsTwo tubes of blood were collected from each of the 10 participants, one of which was subjected to mechanical trauma while the other was centrifuged directly. Subsequently, the samples were diluted with the participant''s hemolyzed sample to obtain the desired hemoglobin concentrations (0, 1, 2, 4, 6, 8, and 10 g/L). ALT, AST, K, LDH, T. Bil tests were performed using Beckman Coulter AU680 analyzer. The analytical and clinical cut-offs were based on the biological variation for the allowable imprecision and RCV. The algorithms could report the values directly below the analytical cut-off or those between the analytical and clinical cut-offs with comments. If the change was above the clinical cut-off, the test was rejected. The linear regression was used for interferograms, and the hemoglobin concentrations corresponding to cut-offs were calculated via the interferograms.ResultsThe RCV was calculated as 29.6% for ALT. Therefore, ALT should be rejected in samples containing >5.9 g/L hemoglobin. The RCVs for AST, K, LDH, and T. Bil were calculated as 27.9%, 12.1%, 19.2%, and 61.2%, while the samples'' hemoglobin concentrations for test rejection were 0.8, 1.6, 0.5, and 2.2 g/L, respectively.ConclusionsAlgorithms prepared with RCV could provide evidence-based results and objectively manage hemolyzed samples.     

Improving the accuracy of chloride measurements through participation in regular external quality assessment programme

BackgroundA chloride test is an integral part of a basic metabolic panel that is essential for the assessment of a patient’s acid-base and electrolyte status. While many methods are available commercially for the routine measurement of chloride, there is a need to address the accuracy and variability among the measurement results, especially with the prevalence of patients seeking treatment across different healthcare providers for alternative opinions.MethodA method based on sector field inductively coupled plasma isotope dilution mass spectrometry (SF-ICP-IDMS) was developed for the measurement of chloride in human serum. The SF-ICP-IDMS method was then used to assign the target values in the Health Sciences Authority (HSA) External Quality Assessment (EQA) Programme to evaluate the results of chloride test from participating clinical laboratories.ResultsThe accuracy of the measurements was evaluated by comparing the results with the certified values of Electrolytes in Frozen Human Serum Certified Reference Materials (SRM 956c and SRM 956d) from the National Institute of Standards and Technology (NIST) at different chloride concentration levels. Over a five-year period from 2014–2018, the number of clinical laboratories which participated in the EQA Programme increased from 23 to 33. Comparison of robust means from the laboratories’ results with our assigned target values revealed a reduction in relative deviation over time. The relationship between the deviation of each brand of clinical analysers and the chloride levels was established, where a larger deviation was uncovered at low chloride concentration. The SF-ICP-IDMS method was further demonstrated to be comparable with methods used by other metrology institutes in an international comparison organised by HSA under the auspice of the Consultative Committee for Amount of Substance – Metrology in Chemistry and Biology (CCQM).ConclusionThe use of metrologically traceable assigned target values enabled the study of method biasness from a small pool of dataset in each of the four brands of clinical analysers in HSA EQA Programme. This work underscores the need to improve the accuracy of chloride measurements by regular participation in an accuracy-based EQA Programme.     

A sensitive branched DNA HIV-1 signal amplification viral load assay with single day turnaround

Branched DNA (bDNA) is a signal amplification technology used in clinical and research laboratories to quantitatively detect nucleic acids. An overnight incubation is a significant drawback of highly sensitive bDNA assays. The VERSANT® HIV-1 RNA 3.0 Assay (bDNA) (“Versant Assay”) currently used in clinical laboratories was modified to allow shorter target incubation, enabling the viral load assay to be run in a single day. To dramatically reduce the target incubation from 16–18 h to 2.5 h, composition of only the “Lysis Diluent” solution was modified. Nucleic acid probes in the assay were unchanged. Performance of the modified assay (assay in development; not commercially available) was evaluated and compared to the Versant Assay. Dilution series replicates (>950 results) were used to demonstrate that analytical sensitivity, linearity, accuracy, and precision for the shorter modified assay are comparable to the Versant Assay. HIV RNA-positive clinical specimens (n = 135) showed no significant difference in quantification between the modified assay and the Versant Assay. Equivalent relative quantification of samples of eight genotypes was demonstrated for the two assays. Elevated levels of several potentially interfering endogenous substances had no effect on quantification or specificity of the modified assay. The modified assay with drastically improved turnaround time demonstrates the viability of signal-amplifying technology, such as bDNA, as an alternative to the PCR-based assays dominating viral load monitoring in clinical laboratories. Highly sensitive bDNA assays with a single day turnaround may be ideal for laboratories with especially stringent cost, contamination, or reliability requirements.     

Platelet lumiaggregation testing: Reference intervals and the effect of acetylsalicylic acid in healthy adults

BackgroundLight transmission aggregometry with lumiaggregometry are methods commonly recommended as a first-line test in platelet dysfunction diagnostic work-up. They are poorly standardized and usually performed in specialized laboratories. For proper interpretation, each laboratory should establish its own diagnostic approach in order to recognize abnormal aggregation patterns. The aim of this study was to measure plasma lumiaggregometry with basic agonists to establish the analyzer-reagent reference intervals (RI) for adults and to test the method response to aspirin.MethodsThe Chrono-Log Model 700 lumiaggregometer using Chrono-Par and Chrono-lume reagents (Chrono-Log Corp., Havertown, PA, USA) was used to measure the maximal aggregation and adenosine triphosphate release using adenosine diphosphate (2 μmol/L), collagen (2 μg/mL), arachidonic acid (1 μmol/L), epinephrine (5.5 μmol/L) and ristocetin (1.25 mg/mL), and thrombin (1 U/mL). The effect of aspirin on platelet aggregation and granule release was inspected.ResultsRIs derived from 40 healthy adults were calculated using the non-parametric approach. Wider intervals and low lower limits were determined for weak agonist as well as absence or impaired aggregation in up to one of 7 healthy controls. The response of platelets to aspirin shows response comparable to previously reported study.ConclusionsLocally established RI in our study enable us to investigate platelet function in patients with a high probability of bleeding disorders. Values are agonist and equipment specific. The variability of the method can be reduced by considering standardized preanalytical and analytical variables. Pathological results must be interpreted in the context of other hemostasis test results and clinical findings.     

妊娠中期孕妇血糖水平变化与新生儿体质及大脑发育的关系

摘要 目的：探讨妊娠中期孕妇血糖水平变化与新生儿体质及大脑发育的关系。方法：2018年2月到2021年1月选择在本院建档分娩的妊娠中期妊娠期糖尿病(Gestational diabetes,GDM)孕妇105例作为研究对象,根据孕妇血糖控制情况进行分组,孕妇血糖控制较好纳入良好组,其他纳入对照组。调查分娩的新生儿体质、大脑发育情况并进行相关性分析。结果：在105例孕妇中,血糖控制良好85例,控制不良20例。良好组的孕周、年龄、孕前体重指数、孕次、产次等与对照组对比差异无统计学意义(P>0.05)。良好组新生儿分娩第3个月的体重与身长都高于对照组(P<0.05)。良好组新生儿分娩第3个月的MDI与PDI评分都高于对照组(P<0.05)。在105例孕妇中,Spearsman相关分析显示血糖控制水平与新生儿的体重、身长、智力发育指数(Intelligence Development Index,MDI)评分、精神运动发育指数(Intelligence Development Index,PDI)评分等都存在相关性(P<0.05)。多因素Logistic回归分析显示血糖控制水平都为影响新生儿体重、身长、MDI评分、PDI评分的危险因素(P<0.05)。结论：妊娠中期妊娠期糖尿病孕妇血糖控制水平与新生儿体质、大脑发育存在相关性,血糖控制不佳可导致新生儿体质发育缓慢与智力水平下降。     

Association of Low Serum 25-Hydroxyvitamin D Levels in Pregnancy with Glucosehomeostasis and Obstetric And Newborn Outcomes

ObjectiveTo evaluate the association of maternal serum 25-hydroxyvitamin D (25[OH]D) status with glucose homeostasis and obstetric and newborn outcomes in women screened for gestational diabetes mellitus (GDM).MethodsConsecutive women were screened for GDM at 24 to 28 weeks’ gestation during the months of maximal sunlight exposure in Spain (June through September). Serum 25(OH)D levels and parameters of glucose homeostasis were measured. Outcomes of the delivery and newborn were collected.ResultsTwo hundred sixty-six women were screened. Vitamin D deficiency (25[OH]D < 20 ng/mL) was observed in 157 women (59%). We observed an inverse correlation between 25(OH)D levels and hemoglobin A_1c, homeostasis model assessment of insulin resistance, serum insulin, and fasting and 1-hour oral glucose tolerance test glucose levels (P <.001). With a 25(OH)D concentration less than 20 ng/mL, the odds ratios were 3.31 for premature birth (95% confidence interval, 1.52-7.19; P <.002) and 3.93 for cesarean delivery (95% confidence interval, 2.00-7.73; P <.001). A 25(OH)D concentration of 20 ng/mL had 79% sensitivity and 51% specificity for cesarean delivery and 80% sensitivity and 45% specificity for premature birth. The cutoffs with the best combination of sensitivity and specificity were 16 ng/mL for cesarean delivery (62.9% sensitivity and 61.2% specificity) and 14 ng/mL for premature birth (66.7% sensitivity and 71.0% specificity).ConclusionsIn the population we sampled, vitamin D deficiency is very common during pregnancy. Lower 25(OH)D levels are associated with disorders of glucose homeostasis and adverse obstetric and newborn outcomes.(Endocr Pract. 2012;18:676-684)     

急诊科尿源性脓毒症的临床回顾性研究

目的:回顾性研究急诊科住院患者的尿路感染及其所致脓毒症的临床及病原学特征。方法:选取2014年1月至2017年8月上海交通大学医学院附属仁济医院急诊病房及急诊ICU收治住院的106名诊断为"尿路感染"的患者,结合出院诊断及新版脓毒症诊断标准再评估,分为"尿脓毒症组"(n=45)和"非脓毒症组"(n=61),收集和比较一般临床资料、实验室指标、病原学分类及特征。结果:1)尿脓毒症组上尿路感染、泌尿系统梗阻以及上尿路梗阻并感染的发生率均显著高于非脓毒症组(P=0.042,P=0.011,P=0.035)。2)尿脓毒症组白细胞计数(P=0.002)、C反应蛋白(P0.001)、降钙素原(P=0.028)、肌酐(P0.001)、D-二聚体(P0.001)、APACHE II评分(Acute Physiology and Chronic Health Evaluation II,APACHE II)(P0.001)均明显高于非脓毒症组,而血清白蛋白(P0.001)、血小板(P0.001)计数、Glasgow评分(P0.001)均显著低于非脓毒症组;3)尿脓毒症组急性肾脏功能障碍(28/45,62.22%)发生率最高,凝血系统功能障碍发生率次之(25/45,55.56%)。中段尿培养中以屎肠球菌占比最高(11/40,27.5%),其次为大肠埃希菌(8/40,20%)。结论:上尿路感染与泌尿系统梗阻是发生尿脓毒症的危险因素,相较于非脓毒症患者,尿脓毒症患者炎症指标、肌酐、D-二聚体、APACHE II评分水平更高,白蛋白、血小板及Glasgow评分更低,肾功能障碍与凝血功能障碍在尿脓毒症患者中更多见。临床需对中段尿培养肠球菌阳性的患者引起重视。     

Clinical application of quantitative glycomics

ABSTRACT

Introduction: Aberrant glycosylation has been associated with many diseases. Decades of research activities have reported many reliable glycan biomarkers of different diseases which enable effective disease diagnostics and prognostics. However, none of the glycan markers have been approved for clinical diagnosis. Thus, a review of these studies is needed to guide the successful clinical translation.

Area covered: In this review, we describe and discuss advances in analytical methods enabling clinical glycan biomarker discovery, focusing only on studies of released glycans. This review also summarizes the different glycobiomarkers identified for cancers, Alzheimer’s disease, diabetes, hepatitis B and C, and other diseases.

Expert commentary: Along with the development of techniques in quantitative glycomics, more glycans or glycan patterns have been reported as better potential biomarkers of different diseases and proved to have greater diagnostic/diagnostic sensitivity and specificity than existing markers. However, to successfully apply glycan markers in clinical diagnosis, more studies and verifications on large biological cohorts need to be performed. In addition, faster and more efficient glycomic strategies need to be developed to shorten the turnaround time. Thus, glycan biomarkers have an immense chance to be used in clinical prognosis and diagnosis of many diseases in the near future.     

When your MR linac is down: Can an automated pipeline bail you out of trouble?

PurposeThe unique treatment delivery technique provided by magnetic resonance guided radiotherapy (MRgRT) can represent a significant drawback when system fail occurs. This retrospective study proposes and evaluates a pipeline to completely automate the workflow necessary to shift a MRgRT treatment to a traditional radiotherapy linac.Material and methodsPatients undergoing treatment during the last MRgRT system failure were retrospectively included in this study. The core of the proposed pipeline was based on a tool able to mimic the original MR linac dose distribution. The so obtained dose distribution (AUTO) has been compared with the distribution obtained in the conventional radiotherapy linac (MAN). Plan comparison has been performed in terms of time required to obtain the final dose distribution, DVH parameters, dosimetric indices and visual analogue scales scoring by radiation oncologists.ResultsAUTO plans generation has been obtained within 10 min for all the considered cases. All AUTO plans were found to be within clinical tolerance, showing a mean target coverage variation of 1.7% with a maximum value of 4.3% and a minimum of 0.6% when compared with MAN plans. The highest OARs mean variation has been found for rectum V60 (6.7%). Dosimetric indices showed no relevant differences, with smaller gradient measure in favour of AUTO plans. Visual analogue scales scoring has confirmed comparable plan quality for AUTO plans.ConclusionThe proposed workflow allows a fast and accurate generation of automatic treatment plans. AUTO plans can be considered equivalent to MAN ones, with limited clinical impact in the worst-case scenario.     

Using Meal-Based Self-Monitoring of Blood Glucose as a Tool to Improve Outcomes in Pregnancy Complicated By Diabetes

ObjectiveTo review the importance of controlling blood glucose levels and the role of self-monitoring of blood glucose (SMBG) in the management of pregnancy complicated by diabetes.MethodsThis report describes the relationship between hyperglycemia and maternal and neonatal complications, reviews the utility of meal-based SMBG in modifying food choices and adjusting insulin doses, and proposes an algorithm to achieve normoglycemia in pregnancies complicated by diabetes.ResultsThe risk of diabetes-related complications in pregnancy is more strongly associated with 1-hour post-prandial plasma glucose concentrations than with fasting plasma glucose levels. SMBG strategies that incorporate postprandial glucose testing provide better glycemic control and greater reductions in risk of complications than does preprandial glucose testing alone. Although the optimal timing and frequency of SMBG remain controversial, available clinical evidence supports testing 4 times per day (before breakfast and 1 hour after each meal) in women with gestational diabetes managed by medical nutrition therapy only and 6 times per day (before and 1 hour after each meal) in pregnant women treated with insulin.ConclusionMeal-based SMBG is a valuable tool for improving outcomes in pregnancy complicated by diabetes. The lessons learned in this setting should have relevance to the general population of patients with diabetes, in whom microvascular and macrovascular complications are the outcomes of importance. (Endocr Pract. 2008; 14:239-247)     

Risk of Postoperative Hypoglycemia In Cardiovascular Surgical Patients Receiving Computer-Based Versus Paper-Based Insulin Therapy

ObjectiveTo evaluate the safety and efficacy of replacing a paper-based protocol with a computer-guided glucose management system (CGMS) for the treatment of postoperative hyperglycemia in the cardiovascular intensive care unit (CVICU).MethodsWith use of a before-and-after analysis, adult patients (≥ 18 years) discharged from the CVICU and treated with the paper protocol were compared with patients discharged from the CVICU and treated with the CGMS. Of the 1,648 patients analyzed, 991 were in the CGMS group. Clinical end points were evaluated by using the Wilcoxon test. Unadjusted and adjusted hazard ratios (HRs) for each hypoglycemic end point were calculated from Cox models with use of the proportional hazards regression procedure, and clinical end points were adjusted for potential confounders.ResultsPatients treated with the paper protocol were6 times as likely to experience clinical hypoglycemia (blood glucose ≤ 70 mg/dL) as patients treated with the CGMS (adjusted HR = 6.06; P < .0001) and more than 7 times as likely to experience severe hypoglycemia (blood glucose ≤ 40 mg/dL) (adjusted HR = 7.59; P = .01). Despite the increased risk of hypoglycemia, no significant difference in length of stay or mortality was observed between the groups.ConclusionCGMS treatment of postoperative hyperglycemia in CVICU patients can successfully attain goal glucose levels with a significant reduction in hypoglycemia in comparison with a paper protocol. This association persists after controlling for covariates. (Endocr Pract. 2012; 18:529-537)