Quantitative Evaluation of the Real-World Harmonization Status of Laboratory Test Items Using External Quality Assessment Data.

Background: In recent decades, the analytical quality of clinical laboratory results has substantially increased because of collaborative efforts. To effectively utilize laboratory results in applications, such as machine learning through big data, understanding the level of harmonization for each test would be beneficial. We aimed to develop a quantitative harmonization index that reflects the harmonization status of real-world laboratory tests. Methods: We collected 2021-2022 external quality assessment (EQA) results for eight tests (HbA1c, creatinine, total cholesterol, HDL-cholesterol, triglyceride, alpha-fetoprotein [AFP], carcinoembryonic antigen [CEA], and prostate-specific antigen [PSA]). This EQA was conducted by the Korean Association of External Quality Assessment Service, using commutable materials. The total analytical error of each test was determined according to the bias% and CV% within peer groups. The values were divided by the total allowable error from biological variation (minimum, desirable, and optimal) to establish a real-world harmonization index (RWHI) at each level (minimum, desirable, and optimal). Good harmonization was arbitrarily defined as an RWHI value ≤ 1 for the three levels. Results: Total cholesterol, triglyceride, and CEA had an optimal RWHI of ≤ 1, indicating an optimal harmonization level. Tests with a desirable harmonization level included HDL-cholesterol, AFP, and PSA. Creatinine had a minimum harmonization level, and HbA1c did not reach the minimum harmonization level. Conclusions: We developed a quantitative RWHI using regional EQA data. This index may help reflect the actual harmonization level of laboratory tests in the field.

Comparative assessment of sacral screw loosening augmented with PMMA versus a calcium triglyceride bone cement.

STUDY DESIGN: A calcium triglyceride bone cement (CTBC) was compared with the gold-standard polymethylmethacrylate (PMMA) to assess the stability of augmented sacral screw fixation under cyclic loading. OBJECTIVE: To determine whether CTBC augmentation of a pedicle screw would provide a similar level of fixation in the S1 pedicles compared with PMMA augmentation. SUMMARY OF BACKGROUND DATA: Numerous studies have shown the advantages of using PMMA to augment screw fixation; however, its biomechanical properties are not ideal. CTBC offers potential benefits such as being low exothermic, a modulus of elasticity closer to bone, and the potential for osteoconductivity, but its comparative performance in this situation has not been previously evaluated. METHODS: Six cadaveric sacra were used in this study; 3.0 mL volumes of PMMA (Simplex P) and CTBC (Kryptonite™ Bone Cement) were injected into contralateral screw tracts, with the screw immediately inserted after cement injection. After a 12-hour setting period, the sacrum was potted in a custom fixture and mounted to the frame of a materials testing machine. Alternating flexion and extension bending moments were applied at 1 Hz. Flexion moments were applied starting at 0.5 Nm and increased by 1 Nm after every 1000 cycles until the screw had reached 6° of rotation relative to its starting position. Extension moments were maintained at 0.5 Nm. Screw rotation relative to bone was determined in real time by a custom optical tracking system and was analyzed using two-way repeated-measures analyses of variance (ANOVAs) and post hoc Student-Newman-Keuls tests (α = 0.05). RESULTS: To reach 6° of screw rotation, the PMMA-augmented screw required more loading cycles (15,464 ± 2526 vs. 10,277 ± 1762 cycles; P = 0.006) and a larger applied moment (15.3 ± 2.2 vs. 10.5 ± 1.7 Nm; P = 0.010) than CTBC-augmented screw. CONCLUSION: The PMMA augmentation provided increased resistance to cyclic loading compared with the CTBC augmentation for sacral pedicle screw fixation, but both augmentations well exceeded previously published findings for nonaugmented screws.

What combination therapy with a statin, if any, would you recommend?

The latest recommended goals for blood lipid levels may require multiple lipid drugs. Lower doses in combination may render more efficacy and safety than highest doses of single agents. Except for isolated hypoalphalipoproteinemia (a low level of high-density lipoprotein cholesterol), therapies will start with a statin. All marketed statins are acceptable. The choice may be based on dose- efficacy and patient's tolerability. High-potency statins (eg, atorvastatin, simvastatin, or rosuvastatin) are often chosen. Currently, generic statins, such as simvastatin, lovastatin, pravastatin, and fluvastatin, offer cost benefits. The choice of added agent depends on the "residual lipoprotein abnormalities" after statin therapy, efficacy, compliance issues, and cost. Approved "combined" preparations improve cost and compliance. To further lower low-density lipoprotein cholesterol, ezetimibe is a safe, efficacious choice, pending resolution of a controversial trial's results. Colesevelam is moderately effective and the best tolerated bile acids sequestrant. In combined dyslipidemias, extended-release niacin is the best tolerated niacin preparation; other quality-controlled immediate-release preparations have similar safety and efficacy but produce more flushing of the skin. Niacin or fenofibrate is effective in normalizing high-density lipoprotein and triglyceride levels persisting after statin therapy. Agents approved by the US Food and Drug Administration and the latest guidelines of the National Cholesterol Education Program, American Heart Association/American College of Cardiology provide choices and indications of drug combinations.

Lipid external quality assessment: commutability between external quality assessment and clinical specimens.

BACKGROUND: Targets for cholesterol reduction are part of the Quality Outcomes Framework and general practitioners have to meet these targets to fulfil their remuneration package. By contrast, there are no targets for the accuracy of cholesterol or other lipid measurements and no recent surveys on performance of these assays. We have assessed the performance of lipid measurement of the available methods in the UK. METHODS: Serum samples collected from individual donors attending the national blood service were distributed after values were obtained from a secondary reference laboratory. Samples were sent to participant laboratories to assess different methods' analytical performance on single donation specimens, on routine external quality assessment pooled specimens, on specimens subjected to a range of freeze-thaw cycles and on frozen-stored specimens. RESULTS: Differences in measured cholesterol were found that were method-dependent and related to triglyceride content. HDL-cholesterol (HDL-C) showed significant positive bias in all assays. Individual donor specimens showed no significant changes with differing numbers of freeze-thaw cycles. Pooled serum was stable for up to six months. CONCLUSIONS: Most cholesterol measurements are accurate but some methods are affected by triglyceride interference. HDL-C methods show significant positive bias. Although there are potential matrix effects introduced as a result of specimen preparation, additional work is needed to show if these effects are present in fresh patient samples.