BACKGROUND

Serum-sodium reporting tolerates a total allowable error (TEa) of only ±4 mmol/L, yet many laboratories continue to operate at the marginal three-sigma level because the quantitative benefit of additional sigma capability is poorly characterized.

The study aims to translate sigma metrics into clinically intuitive risk estimates by (1) quantifying the proportion of QC results that exceed the TEa at five sigma levels (2 – 6 σ) and (2) determining whether successive sigma gains produce statistically significant reductions in error.

Five (5) hypothetical assays were parameterized with a common mean of 140 mmol/L and CVs corresponding to 2-, 3-, 4-, 5- and 6-sigma performance. For each assay, 1,000 Monte-Carlo iterations were run, each iteration simulating 36,500 QC results (assuming 100 runs/day for 365 days) drawn from N(μ = 140, σ = μ × CV). The error rate (the proportion of results outside ±4 mmol/L) was recorded per iteration. Distributions were summarized (mean, range, SD); differences were evaluated with one-way ANOVA followed by Tukey’s HSD.

Mean (±SD) error rates declined significantly with increasing sigma: Assay A (2 σ): 0.0456 ± 0.0011; Assay B (3 σ): 0.00270 ± 0.00027;Assay C (4 σ): 6.3 × 10-5 ± 4.1 × 10-5; Assay D (5 σ): 5.8 × 10-7 ± 8.0 × 10-7; and Assay E (6 σ): 2.0 × 10-7 ± 3.1 × 10-7. The maximum single-iteration error rate fell from 0.0505 at 2 σ to 1.1 × 10-4 at 4 σ. The 5 σ and 6 σ processes produced zero TEa violations in ≥96 % of iterations. ANOVA confirmed a global difference (p < 0.001); all pairwise contrasts were significant (p < 0.001) except between 5 σ vs 6 σ (p = 0.62).

Each one-sigma gain yields an order-of-magnitude reduction in TEa violations until a plateau is reached at ≥5 σ, where residual analytical risk is negligible. These simulations support the recommendation that laboratories operating serum-sodium assays below 4 σ should prioritize precision improvements or enhanced QC strategies, whereas ≥5 σ assays may safely adopt less intensive QC without compromising patient safety.

OBJECTIVE: To investigate the clinical efficacy of artificial cervical disc replacement for cervical disc herniation. METHODS: Retrospective analysis of 24 patients with cervical disc herniation with 24 segments admitted from July 2016 to July 2022, including 12 males and 12 females, with an average age of (50±2) years old ranging from 36 to 68 years old. The intervertebral space height of the lesion segment before replacement was 4.3 to 7.2 mm with an average of (5.6±1.6) mm, the range of motion of anterior flexion and posterior extension was 5.6° to 7.2° with an average of (6.4±1.3)°, the range of motion for the left and right lateral flexion was 10.2° to 11.4° with an average of (10.7±1.8)°, and the Japanese Orthopaedic Association (JOA) score was 8 to 13 scores with an average of (8.0±0.3) scores. Through anterior incision, artificial cervical disc replacement surgery was performed after cervical discectomy and decompression. RESULTS: After surgery, all patients'incisions healed well. All patients were followed up from 12 to 60 months with an average of (33±12) months. At the final follow-up, the intervertebral space height of replacement segment was 4.0 to 6.8 mm with an average of (5.4±1.3) mm, the range of motion of anterior flexion and posterior extension was 4.6° to 6.4°with an average of (5.6±1.2)°, the range of motion of left and right lateral flexion was 8.7°to 10.3°with an average of (9.5±1.5)°. The prosthesis did not shift or sink, slight heterotopic ossification occurred within the operative segment(ⅠorⅡgrade). The height of adjacent intervertebral spaces was not lost, there was no vertebral degeneration, no significant change in the comparison of adjacent segment mobility before and after surgery. The JOA score increased from (8.0±0.3) scores before replacement operation to (15.0±0.2) scores after operation. CONCLUSION Artificial cervical disc replacement surgery can not only obtain the same efficacy as the anterior cervical disc fusion surgery, but also avoid the increase of compensatory stress of adjacent segments, maintain the stability of the biomechanical environment, thereby reducing the incidence of degeneration of adjacent segments, and can be used as an effective method for the treatment of cervical disc herniation, , but the long-term efficacy and the existing problems of replacement surgery need to be further studied and solved in the future.
Humans ; Male ; Female ; Middle Aged ; Intervertebral Disc Displacement/surgery* ; Adult ; Cervical Vertebrae/surgery* ; Total Disc Replacement/methods* ; Aged ; Retrospective Studies

Anterior cervical discectomy and fusion (ACDF) has achieved good clinical results since it was used in clinic, and is considered as the gold standard for the treatment of cervical spondylosis. However, more and more attention has been paid to adjacent segment degeneration(ASDeg) after fusion, and the debate about its pathogenesis is mainly focused on the bio-machanical stress changes of adjacent segments caused by fusion and the result of the natural aging process. The occurrence of ASDeg after fusion seriously affect the med-and long-term outcome of surgery, and some patients even need secondary surgery. In order to reduce or even avoid the occurrence of ASDeg, many new techniques have emerged in clinic, such as artificial disc replacement with preservation of motor segments, emerging cell transplantation technology and so on, but the clinical effect still needs to be confirmed by a large number of studies. Therefore, finding the risk factors of ASDeg after fusion is of great significance for fusion surgery on the clinical work. At present, there is still no unified overview of the research on the risk factors of ASDeg. This article will review the research progress and corresponding countermeasures of the risk factors of ASDeg after ACDF, in order to guide the clinical application.
Humans ; Risk Factors ; Diskectomy/adverse effects* ; Total Disc Replacement ; Spondylosis/surgery*

The modern surgical treatment of cervical degenerative disc disease can be traced back to the advent of anterior cervical decompression and fusion.With the emergence of fusion-related complications,different scholars have promoted the gradual transformation of cervical degenerative disc diseases from "fusion fixation" to "non-fusion reconstruction" through in-depth fusion with materials science,engineering mechanics and other disciplines.The innovation of this treatment concept is consistent with the original intention of "structural remodeling,functional reconstruction,maximum repair and reconstruction of the morphology and function of skeletal muscle system" in orthopedic bionic treatment,which is essentially in line with the "bionic alternative therapy" in orthopedic bionic therapy.This paper focuses on the surgical treatment of cervical degenerative disc diseases,reviews the development history of artificial cervical disc replacement,analyzes the evolution from orthopedic biomimetic therapy,and explores a new direction for the design of artificial cervical disc prostheses and the treatment of cervical degenerative disc diseases in the future.
Bionics ; Cervical Vertebrae/surgery* ; Diskectomy ; Follow-Up Studies ; Humans ; Intervertebral Disc/surgery* ; Intervertebral Disc Degeneration/surgery* ; Spinal Fusion ; Total Disc Replacement ; Treatment Outcome

Objective: To investigate the efficacy and safety of a new cervical artificial disc prosthesis in the treatment of cervical degenerative diseases. Methods: The clinical data of 18 patients with single-level cervical degenerative diseases who underwent three dimensional printed anatomical bionic cervical disc replacement at Department of Spinal Surgery,Honghui Hospital,Xi'an Jiaotong University from May 2019 to July 2020 were analyzed retrospectively. There were 7 males and 11 females,aged (45±8) years old(range:28 to 58 years).The surgical segment was located at C_3－4 level in 2 cases, C_4－5 level in 5 cases, C_5－6 level in 9 cases, and C_6－7 level in 2 cases.The clinical and radiographic outcomes were recorded and compared at preoperative,postoperative times of one month and twelve months.The clinical assessments contained Japanese orthopedic association (JOA) score,neck disability index (NDI) and visual analogue scale (VAS).Imaging assessments included range of motion (ROM) of cervical spine, prosthesis subsidence and prosthesis anteroposterior migration.Repeated measurement variance analysis was used for comparison between groups,and paired t test was used for pairwise comparison. Results: All patients underwent the operation successfully and were followed up for more than 12 months.Compared with preoperative score,the JOA score,NDI and VAS were significantly improved after surgery (all P<0.01).There was no significant difference in postoperative ROM compared with 1-and 12-month preoperative ROM (t=1.570,P=0.135;t=1.744,P=0.099). The prosthesis subsidence was (0.29±0.13) mm (range: 0.18 to 0.50 mm) at 12-month postoperatively.The migration of prosthesis at 12-months postoperatively were (0.71±0.20) mm (range: 0.44 to 1.08 mm).There was no prosthesis subsidence or migration>2 mm at 12-month postoperatively. Conclusion: Three dimensional printed anatomical biomimetic cervical artificial disc replacement has a good early clinical effect in the treatment of cervical degenerative diseases, good mobility can be obtained while maintaining stability.
Adult ; Biomimetics ; Cervical Vertebrae/surgery* ; Female ; Follow-Up Studies ; Humans ; Intervertebral Disc/surgery* ; Intervertebral Disc Degeneration/surgery* ; Male ; Middle Aged ; Range of Motion, Articular ; Retrospective Studies ; Total Disc Replacement/methods* ; Treatment Outcome

OBJECTIVES: To study the long-term effect of active parenteral nutrition support regimen in preterm infants with a gestational age of <34 weeks. METHODS: According to the different doses of fat emulsion and amino acids used in the early stage, the preterm infants with a gestational age of <34 weeks, who were admitted to the hospital within 24 hours after birth from May to December 2019, were divided into an active parenteral nutrition group and a conventional parenteral nutrition group ( RESULTS: At the age of 6 months, the active parenteral nutrition group ( CONCLUSIONS For preterm infants with a gestational age of <34 weeks, an active parenteral nutrition support strategy with high doses of fat emulsion and amino acids within 24 hours after birth can improve their long-term neurodevelopment.
Amino Acids ; Gestational Age ; Humans ; Infant ; Infant, Newborn ; Infant, Premature ; Parenteral Nutrition ; Parenteral Nutrition, Total

OBJECTIVE: To investigate the clinical effect of anterior cervical Hybrid surgery in the treatment of cervical degenerative diseases (CDD) and observe the incidence of heterotopic ossification of disc replacement segment at 1 year after surgery. METHODS: From January 2015 to April 2018, 35 patients who received anterior cervical hybrid surgery met the inclusion and exclusion criteria and the complete clinical follow up data were analyzed retrospectively. Complete imaging follow-up data were obtained from 24 patients. There were 15 males and 20 females, aged from 39 to 70(55.57±7.73) years old. The amount of bleeding was for 20 to 100 (40.29±18.39) ml, and the hospitalstay was for 4 to 28(11.03±4.63) days, and the follow-up time was(12.97±1.36) months. Clinical outcomes were assessed by the Tanaka Yasushi cervical spondylitis symptom scale 20 score (YT20), and Japanese Orthopaedic Association (JOA) score. The occurrence of heterotopic ossification after Hybrid surgery was evaluated by X-ray according to McAfee standard one year after operation. Patients with or without heterotopic ossificationwere divided into two groups and their clinical effects were compared. RESULTS: At the final follow up, the mean YT20 score and JOA score were significantly higher than those before operation (P <0.05), and the average improvement rate of JOA was (70.66 ±0.44)%. One year after operation, the heterotopic ossification occurred in 10 of 24 segments, with incidence of 41.70%(10/24), including 29.20% in gradeⅠand 12.50% in gradeⅡ. The results of clinical efficacy comparison between patients with and without heterotopic ossification were as follows:there was no significant difference in JOA score before and after operation ( CONCLUSION The short-term clinical effect of Hybrid surgery is satisfactory for cervical degenerative diseases, and the cause of heterotopic ossification still needs tobe further explored.
Adult ; Aged ; Cervical Vertebrae/surgery* ; Female ; Follow-Up Studies ; Humans ; Intervertebral Disc Degeneration/surgery* ; Male ; Middle Aged ; Range of Motion, Articular ; Retrospective Studies ; Total Disc Replacement ; Treatment Outcome

OBJECTIVE: To compare the clinical effects of different anterior surgical methods in treating single segment cervical disc herniation. METHODS: The clinical data of 46 patients with single-segment cervical disc herniation underwent surgical treatment from September 2013 to September 2018 were retrospectively analyzed. The patients were divided into three groups according to different surgical methods. Among them, 23 patients in the anterior percutanousendomic cervical dissection (APECD) group, there were 8 males and 15 females, aged (47±3) years old, prominent segments were C RESULTS: All 46 patients were followed up for 12 to 24 (17.57±3.15)months. The follow-up time of APECD, CDR, ACDF groups were (17.30±3.25), (17.80±3.16), (17.85±2.88) months, and operation time were (95.48 ±13.85), (58.50±7.09), (76.00±15.72) min, respectively, there were no significant differences in follow-up time and operation time between two groups( CONCLUSION The three anterior surgical approaches can achieve satisfactory clinical results for the treatment of single-segment cervical disc herniation. However, the improvement rate of the CDR group and the activity of the retained responsibility segment are better than those of the other two groups. APECD surgery may have recurrence.
Adult ; Cervical Vertebrae/surgery* ; Diskectomy ; Female ; Follow-Up Studies ; Humans ; Intervertebral Disc Degeneration/surgery* ; Male ; Middle Aged ; Retrospective Studies ; Spinal Fusion ; Total Disc Replacement ; Treatment Outcome

Bone Resorption ; Cervical Vertebrae/surgery* ; Humans ; Incidence ; Intervertebral Disc/surgery* ; Intervertebral Disc Degeneration/surgery* ; Total Disc Replacement ; Treatment Outcome

PURPOSE: Newborn screening (NBS) programs are important for appropriate management of susceptible neonates to prevent serious clinical problems. Neonates admitted to neonatal intensive care units (NICU) are at a potentially high risk of false-positive results, and repetitive NBS after total parenteral nutrition is completely off results in delayed diagnosis. Here, we present the usefulness of a targeted next-generation sequencing (TNGS) panel to complement NBS for early diagnosis in high-risk neonates. MATERIALS AND METHODS: The TNGS panel covered 198 genes associated with actionable genetic and metabolic diseases that are typically included in NBS programs in Korea using tandem mass spectrometry. The panel was applied to 48 infants admitted to the NICU of Severance Children's Hospital between May 2017 and September 2017. The infants were not selected for suspected metabolic disorders. RESULTS: A total of 13 variants classified as likely pathogenic or pathogenic were detected in 11 (22.9%) neonates, including six genes (DHCR7, PCBD1, GAA, ALDOB, ATP7B, and GBA) associated with metabolic diseases not covered in NBS. One of the 48 infants was diagnosed with an isobutyl-CoA dehydrogenase deficiency, and false positive results of tandem mass screening were confirmed in two infants using the TNGS panel. CONCLUSION: The implementation of TNGS in conjunction with conventional NBS can allow for better management of and earlier diagnosis in susceptible infants, thus preventing the development of critical conditions in these sick infants.
Complement System Proteins ; Delayed Diagnosis ; Diagnosis ; Early Diagnosis ; Humans ; Infant ; Infant, Newborn ; Intensive Care Units, Neonatal ; Korea ; Mass Screening ; Metabolic Diseases ; Metabolism, Inborn Errors ; Oxidoreductases ; Parenteral Nutrition, Total ; Tandem Mass Spectrometry