Health Care Utilization for Common Shoulder Disorders: Analysis of the 2010-2019 National Patient Sample Data from the Health Insurance Review and Assessment Service in Korea.

Background and Objective: The aim of this study was to analyze trends in surgical and non-surgical service utilization for common shoulder disorders in Korea from 2010 to 2019. Methods and Materials: This retrospective, cross-sectional, descriptive study utilized National Patient Sample data from the Health Insurance and Review Assessment Service (HIRA) of Korea. These data constitute a 2% sample out of the entire Korean population and include data for a variety of parameters instrumental for health care research. Patients with at least one medical service use for rotator cuff syndrome or tear, impingement syndrome, or adhesive capsulitis between January 2010 and December 2019 were included. Trends in healthcare utilization by disorder type, patient demographics, seasonal service use, and treatment details were examined. Results: There was an upward trend in the total number of patients and costs for shoulder disorders, from 35,798 patients and USD 5,485,196 in 2010 to 42,558 and USD 11,522,543 in 2019, respectively. The number of patients aged ≥60 and hospital visits increased. March had the highest number of claims. Physical therapy was the most common non-surgical procedure, while nerve block claims more than doubled. Opioid prescription rates also tripled. Surgical treatments were dominated by shoulder rotator cuff repair and acromioplasty. Conclusions: There was a significant increase in healthcare utilization for shoulder disorders, marked by rising costs and patient numbers. The use of nerve blocks and opioids notably increased. These data are valuable for clinicians, researchers, and policymakers.

Systemic sclerosis is associated with increased in-patient mortality in patients hospitalized for heart failure.

AIMS: We aimed to analyse the characteristics and in-hospital outcomes of patients hospitalized for heart failure (HF) with co-morbid systemic sclerosis (SSc) and compare them to those without SSc, using data from the National Inpatient Sample from years 2016 to 2019. METHODS AND RESULTS: International Classification of Diseases, Tenth Revision diagnosis codes were used to identify hospitalized patients with a primary diagnosis of HF and secondary diagnoses of SSc from the National Inpatient Sample database from 2016 to 2019. Patients were divided into two groups: those with and without a secondary diagnosis of SSc. Baseline characteristics including demographics and co-morbidities, outcomes of mortality, length of stay (LOS), and costs were compared between the two groups. Multivariable logistic regression analysis was performed to adjust for confounders and assess the impact of SSc on in-hospital mortality, cost, and LOS. A total of 4 709 724 hospitalizations for HF were identified, with 8150 (0.17%) having a secondary diagnosis of SSc. These patients were predominantly female (82.3% vs. 47.8%; P = 0.01), younger (mean age of 67.4 vs. 71.4; P < 0.01), and had significantly lower rates of traditional cardiovascular risk factors such as coronary artery disease (35.8% vs. 50.6%; P < 0.01), hyperlipidaemia (39.1% vs. 52.9%; P < 0.01), diabetes (22.5% vs. 49.1%; P < 0.01), obesity (13.2% vs. 25.0%; P < 0.01), and hypertension (20.2% vs. 23.8%; P < 0.01). Higher rates of co-morbid pulmonary disease in the form of interstitial lung disease (23.1% vs. 2.0%; P < 0.01) and pulmonary hypertension (36.6% vs. 12.7%; P < 0.01) were noted in the SSc cohort. Unadjusted in-hospital mortality was significantly higher in the HF with SSc group [5.1% vs. 2.6%; odds ratio: 1.99; 95% confidence interval (CI): 1.60-2.48; P < 0.001]. Unadjusted mortality was also higher among female (86.7% vs. 47.0%; P < 0.01), Black (15.7% vs. 13.0%; P < 0.01), and Hispanic (13.3% vs. 6.9%; P < 0.01) patients in the SSc cohort. After adjusting for potential confounders, SSc remained independently associated with higher in-hospital mortality (adjusted odds ratio: 1.81; 95% CI: 1.44-2.28; P < 0.001). Patients with HF and SSc also had longer LOS (6.4 vs. 5.4; adjusted mean difference [AMD]: 0.37, 95% CI: 0.05-0.68; P = 0.02) and higher hospitalization costs ($67 363 vs. $57 128; AMD: 198.9; 95% CI: -4780 to 5178; P = 0.93). CONCLUSIONS: In patients hospitalized for HF, those with SSc were noted to have higher odds of in-hospital mortality than those without SSc. Patients with HF and SSc were more likely to be younger, female, and have higher rates of co-morbid interstitial lung disease and pulmonary hypertension at baseline with fewer traditional cardiovascular risk factors.

Quantitative Detection of Thyroid-Stimulating Hormone in Patient Samples with a Nanomechanical Single-Antibody Spectro-Immunoassay.

Functional disorders of the thyroid remain a global challenge and have profound impacts on human health. Serving as the barometer for thyroid function, thyroid-stimulating hormone (TSH) is considered the single most useful test of thyroid function. However, the prevailing TSH immunoassays rely on two types of antibodies in a sandwich format. The requirement of repeated incubation and washing further complicates the issue, making it unable to meet the requirements of the shifting public health landscape that demands rapid, sensitive, and low-cost TSH tests. Herein, a systematic study is performed to investigate the clinical translational potential of a single antibody-based biosensing platform for the TSH test. The biosensing platform leverages Raman spectral variations induced by the interaction between a TSH antigen and a Raman molecule-conjugated TSH antibody. In conjunction with machine learning, it allows TSH concentrations in various patient samples to be predicted with high accuracy and precision, which is robust against substrate-to-substrate, intra-substrate, and day-to-day variations. It is envisioned that the simplicity and generalizability of this single-antibody immunoassay coupled with the demonstrated performance in patient samples pave the way for it to be widely applied in clinical settings for low-cost detection of hormones, other molecular biomarkers, DNA, RNA, and pathogens.

Trends of Surgical Service Utilization for Lumbar Spinal Stenosis in South Korea: A 10-Year (2010-2019) Cross-Sectional Analysis of the Health Insurance Review and Assessment Service-National Patient Sample Data.

Background and Objectives: This retrospective, cross-sectional, and descriptive study used claims data from the Korean Health Insurance Review and Assessment Service (HIRA) between 2010 and 2019 to analyze the trend of surgical service utilization in patients with lumbar spinal stenosis (LSS). Materials and Methods: The national patient sample data provided by the HIRA, which consisted of a 2% sample of the entire Korean population, was used to assess all patients who underwent decompression or fusion surgery at least once in Korea, with LSS as the main diagnosis from January 2010 to December 2019. An in-depth analysis was conducted to examine the utilization of surgical services, taking into account various demographic characteristics of patients, the frequency of claims for different types of surgeries, reoperation rates, the specific types of inpatient care associated with each surgery type, prescribed medications, and the overall expense of healthcare services. Results: A total of 6194 claims and 6074 patients were analyzed. The number of HIRA claims for patients increased from 393 (2010) to 417 (2019) for decompression, and from 230 (2010) to 244 (2019) for fusion. As for the medical expenses of surgery, there was an increase from United States dollar (USD) 867,549.31 (2010) to USD 1,153,078.94 (2019) for decompression and from USD 1,330,440.37 (2010) to USD 1,780,026.48 (2019) for fusion. Decompression accounted for the highest proportion (65.8%) of the first surgeries, but more patients underwent fusion (50.6%) than decompression (49.4%) in the second surgery. Across all sex and age groups, patients who underwent fusion procedures experienced longer hospital stays and incurred higher medical expenses for their inpatient care. Conclusion: The surgical service utilization of patients with LSS and the prescribing rate of opioids and non-opioid analgesics for surgical patients increased in 2019 compared to 2010. From mid-2010 onward, claims for fusion showed a gradual decrease, whereas those for decompression showed a continuously increasing trend. The findings of this study are expected to provide basic research data for clinicians, researchers, and policymakers.

Trends and Predictors of Short Length of Stay Following Transcatheter Aortic Valve Replacement.

BACKGROUND: Minimalist approaches to Transcatheter aortic valve replacement (TAVR) have allowed for improved efficiency in care of patients. We hypothesized that improved efficiencies in care process may have led to increased adoption of a one night length of stay (LOS) in this patient group. OBJECTIVES: The authors aimed to study temporal trends in short length of stay following TAVR. METHODS: This is a nationwide temporal trends study using the 2016-2019 National In Patient Sample (NIS) registry. Short stay was defined as LOS of one night or less. Trends in proportion of patients with short stay were obtained. A multivariate model to identify predictors of short stay was built after adjusting for confounders. Secondary analysis of temporal trends was stratified by presence or absence of major complications (major bleeding requiring transfusion or pacemaker implantation [PPMI]). RESULTS: A total of 217,110 patients were included in the weighted sample. The proportion of patients with short stay significantly increased for those with and without complications (Ptrend < 0.001). The morbidity burden, as defined by the proportion of patients with a Charlson comorbidity index (CCI) score of ≥2 and rate of major complications decreased significantly. On multivariate analysis short stay was predicted by male sex, white ethnicity, Southern/Western regions and lower CCI score. Patients with major bleeding requiring transfusion or PPMI were less likely to have short stay (aOR 0.23 and aOR 0.12, p < 0.001 respectively). CONCLUSION: There is a national trend towards shorter LOS following TAVR. There is a decrease in major post procedural complication rates from 2016 to 2019.

At risk of reproductive disadvantage? Exploring fertility awareness among migrant women in Germany.

This study examined awareness about fertility among immigrant women and non-migrants in Germany. The social relevance of infertility and fertility treatment is increasing in Western countries due to continually low overall birth rates, a high rate of childlessness, and a gap between the desired and actual numbers of children. While there is growing interest in infertility and reproductive medicine in general, previous studies have rarely included immigrant or ethnic minorities in Europe. This study investigated whether knowledge on the age-related fertility decline (ARFD) varies between migrant groups and the majority group, and the role of education. Working hypotheses were drawn from theoretical considerations on frameworks of migrant assimilation. The analysis was based on data collected in a social science pilot study on reproductive medicine, representative of the general population ('NeWiRe' 2014-2015). The sample included 962 women aged 18-50 years living in Germany. Approximately 81% of the sample were immigrants who originated from Turkey, Poland, the Balkan countries or countries of the (post-Soviet) Commonwealth of Independent States. While rather poor overall, knowledge on ARFD was found to be significantly lower in the migrant groups compared with the majority group. This minority-group disadvantage cannot be explained by sociodemographic or cultural variables. Future research should include minority groups in empirical studies on awareness about fertility in order to better understand the causes of this disadvantage, and the potential reproductive needs of migrants.

Analysis of medical services provided to patients with peripheral facial palsy in Korea: a descriptive, cross-sectional study of the health insurance review and assessment service national patient sample database.

BACKGROUND: This cross-sectional, retrospective, observational study analyzed the demographics of patients with peripheral facial palsy in South Korea and their use of healthcare services. METHODS: The 2016 Korean Health Insurance Review and Assessment National Patient Sample dataset was used; a total of 4790 patients, diagnosed with facial palsy, who had used healthcare services at least once between January 2016 and December 2016 were included, and data on the use of medical services, hospitalizations, sociodemographic factors, treatments, and medications were analyzed. RESULTS: Overall, 326 patients per 100,000 individuals used healthcare services at least once because of peripheral facial palsy in 2016, with higher numbers for women and those aged 50-59 years. The percentage of patients who used Korean traditional medicine (KM), Western medicine (WM), and both KM and WM was 54.4, 23.3, and 22.3%, respectively. Users of both WM and KM had higher per capita medical costs, more visits, and longer treatment durations. Physiotherapy was the most frequent WM treatment (44.4%), and "examinations" was the costliest (24.7%) category. "Procedures" was both the most frequent and costliest KM category (99.9 and 57.3%, respectively). "Continuous intravenous injections" (8.6%) and "superficial heat therapy" (8.3%) were the most frequent WM treatments, while acupuncture accounted for 98% of all KM treatments. CONCLUSIONS: This study analyzed the demographic characteristics and medical service use of patients with peripheral facial palsy in detail. These results can be used as basic information to improve clinical and policy strategies for the management and treatment of peripheral facial palsy.

Cytotoxic capacity of a novel glycosylated antitumor ether lipid in chemotherapy-resistant high grade serous ovarian cancer in vitro and in vivo.

Chemotherapy resistant high grade serous ovarian cancer remains a clinically intractable disease with a high rate of mortality. We tested a novel glycosylated antitumor ether lipid called l-Rham to assess the in vitro and in vivo efficacy on high grade serous ovarian cancer cell lines and patient samples. l-Rham effectively kills high grade serous ovarian cancer cells grown as 2D or 3D cultures in a dose and time dependent manner. l-Rham efficacy was tested in vivo in a chicken allantoic membrane/COV362 xenograft model, where l-Rham activity was as effective as paclitaxel in reducing tumor weight and metastasis. The efficacy of l-Rham to reduce OVCAR3 tumor xenografts in NRG mice was assessed in low and high tumor burden models. l-Rham effectively reduced tumor formation in the low tumor burden group, and blocked ascites formation in low and high tumor burden animals. l-Rham demonstrates efficacy against OVCAR3 tumor and ascites formation in vivo in NRG mice, laying the foundation for further development of this drug class for the treatment of high grade serous ovarian cancer patients.

In-patient outcomes of patients with diabetic ketoacidosis and concurrent protein energy malnutrition: A national database study from 2016 to 2017.

Introduction:Patients often present to the hospital with a well-known complication of diabetes mellitus, namely diabetic ketoacidosis (DKA). In this study, we assess the clinical outcomes of DKA hospitalizations with and without protein-energy malnutrition (PEM).Methods:This was a population-based, retrospective observational study using data gathered from the Nationwide Inpatient Sample (NIS) for 2016 and 2017. Hospitalizations of adults >/ = 18 years old with a principal diagnosis of DKA were obtained using ICD-10 codes and divided into groups based on a secondary diagnosis of PEM. The primary outcome was in-hospital mortality. Secondary outcomes included length of stay (LOS), total hospital charges (THC), and system-based complications.Results:Patients with PEM had a statistically significant difference in the adjusted odds for in-hospital mortality compared to patients without PEM (aOR 1.73, 95% CI: 1.20-2.49, p = 0.004). Patients with DKA and PEM had an increased risk of developing sepsis (aOR 2.99, 95% CI: 2.49-3.58, p < 0.001), septic shock (aOR 3.37, 95% CI: 2.31-4.91, p < 0.001), acute kidney failure (aOR 1.27, 95% CI: 1.17-1.37, p < 0.001), acute respiratory failure (aOR 2.23, 95% CI: 1.83-2.73, p < 0.001), deep vein thrombosis (aOR 1.91, 95% CI: 1.43-2.54, p < 0.001), and pulmonary embolism (aOR 2.36, 95% CI: 1.42-3.94, p = 0.001). Patients with DKA and PEM also had an increased mean THC (aOR 19,200, 95% CI 16,000-22,400, p < 0.001) in US dollars and increased LOS (aOR 2.26, 95% CI 1.96-2.57, p < 0.001) in days when compared to patients without PEM.Conclusion:Patients hospitalized for DKA with a secondary diagnosis of PEM within the same admission had a statistically significantly higher in-hospital mortality.

In-hospital outcomes of percutaneous mitral valve repair in patients with chronic obstructive pulmonary disease: insights from the national inpatient sample database.

OBJECTIVES: We aimed to assess the in-hospital outcomes in patients with mitral regurgitation treated with percutaneous mitral valve repair (PMVR) among patients with chronic obstructive pulmonary disease (COPD). BACKGROUND: There is lack of data on the outcomes of PMVR for mitral regurgitation in patients with COPD. METHODS: We analyzed the national inpatient sample (NIS) database from January 2012 to December 2016. RESULTS: A total of 9125 patients underwent PMVR in the period between January 2012 and December 2016, of whom 2,495 (27.3%) patients had concomitant COPD. Comparing COPD patients to non-COPD patients, COPD patients had higher proportion of females (48.3% vs. 46.6%, p = .16), were younger (75.8 ± 10.0 years vs. 76.4 ± 12.2 years; p = .04), had higher prevalence of peripheral vascular disease (17.4% vs. 13.5%; p < .01) and renal failure (39.3% vs. 37%; p < .01). After propensity matching, there was no significant difference in mortality among the COPD group versus non-COPD patients (2.6% vs. 2.9%; p = .6). Patients with COPD had higher proportion of in-hospital morbidities including St-segment elevation myocardial infarction (1.8% vs. 1.0%; p = .02), cardiogenic shock (1.4% vs. 0.4%; p < .01), vascular complications (2% vs. 0.8; p < .01), pneumothorax (1% vs. 0.4%; p < .01), and septic shock (1.2% vs. 0.4%; p < .01). Moreover, surrogates of severe disability (mechanical intubation and non-home discharges), cost of hospitalization, and length of stay were higher in the COPD group. CONCLUSIONS: There was no difference in mortality between the COPD and non-COPD patients after PMVR. Moreover, we observed higher rates of in-hospital morbidities, surrogates of severe disability, and higher resources utilization by the COPD group.

Contemporary Trends and Outcomes in Patients With ST-Segment Elevation Myocardial Infarction and End-Stage Renal Disease on Dialysis: Insight from the National Inpatient Sample.

BACKGROUND: Cardiovascular disease is the major cause of mortality in end stage renal disease (ESRD) patients on dialysis and myocardial infarction constitutes almost 20% of such deaths. We assessed the trends, characteristics and in-hospital outcomes in patients with ESRD. METHODS: We used national inpatient sample (NIS) to identify patients with ESRD presenting with ST-segment elevation myocardial infarction (STEMI) for calendar years 2012-2016. Multiple logistic regression analysis and propensity matched data was used to compare outcomes for the purpose of our study. RESULTS: Patients on dialysis who presented with STEMI were less likely to be treated with emergent reperfusion therapies including percutaneous coronary intervention, bypass graft surgery and thrombolytics with in first 24 h. In propensity-matched cohort, the mortality was nearly double in patients who have ESRD compared to patients without ESRD (29.7% vs. 15.9%, p < 0.01). In-patient morbidity such as utilization of tracheostomy, mechanical ventilation and feeding tubes was also more prevalent in propensity matched ESRD cohort. In multivariate regression analysis, ESRD remains a strong predictor of increased mortality in STEMI patients (OR 2.65, 95% CI, 2.57-2.75, p < 0.01). CONCLUSION: Our study showed low utilization of evidence-based prompt reperfusion therapies in ESRD patients with STEMI along with concomitant increased poor outcomes and resource utilization. Future research specifically targeting this extremely high-risk patient population is needed to identify the role of prompt reperfusion therapies in improving outcomes in these patients.

Seasonal Impacts on the Incidence of Esophageal Variceal Hemorrhage: A Nationwide Analysis across a Decade.

BACKGROUND/AIMS: Seasonal variation has previously been reported in relation to the incidence of non-variceal upper gastrointestinal bleeding; however, the impact of seasonal variation on variceal bleeding is not known. METHODS: We conducted a cross-sectional study using the Nationwide Inpatient Sample database from 2005 to 2014. International Classification of Diseases, Clinical Modification- 9th Revision codes were used to identify patients hospitalized with a primary or secondary diagnosis of esophageal variceal hemorrhage. The data were analyzed based on the month of hospitalization. Our primary aim was to assess seasonal variations in variceal bleeding-related hospitalizations. The secondary aims were to assess the impact of seasonal variation on outcomes in variceal bleeding including in-hospital mortality and healthcare resource utilization. RESULTS: A total of 348,958 patients hospitalized with esophageal variceal bleeding were included. The highest number of hospitalizations was reported in December (99.3/day) and the lowest was reported in June (90.8/day). In-hospital mortality was highest in January (11.5%) and lowest in June (9.8%). There was no significant difference in hospital length of stay or total hospitalization costs across all months in all years combined. CONCLUSION: There appears to be a seasonal variation in the incidence and mortality of variceal hemorrhage in the United States. December was the month with the highest number of daily hospitalizations while the nadir occurred in June.

Association between serum uric acid and chronic kidney disease in patients with hypertension: A multicenter nationwide cross-sectional study.

INTRODUCTION: Current data on the role of hyperuricemia as a risk factor for renal progression in patients with hypertension is inconclusive. This study aimed to assess the association of uric acid and chronic kidney disease (CKD) in hypertensive patients using a nationwide patient sample. METHODS: We conducted a nationwide cross-sectional study based on the DM/HT study of the Medical Research Network of the Consortium of Thai Medical Schools. This study evaluated adult patients with hypertension from 831 Thailand public hospitals in the year 2014. Serum uric acid (SUA) was categorized into quintiles (≤4.5, 4.6 to 5.4, 5.5 to 6.2, 6.3 to 7.4, ≥7.5 mg/dL). CKD was defined as estimated glomerular filtration rate of ≤ 60 mL/min/1.73 m2 . Multivariate logistic regression was performed to assess the association between SUA and CKD using uric acid of ≤4.5 mg/dL as the reference group. RESULTS: A total of 9776 hypertensive patients with available SUA were included in the analysis. The mean SUA was 6.1±1.8 mg/dL. The prevalence of CKD in hypertensive patients was 31.8%. SUA of 4.6 to 5.4, 5.5 to 6.2, 6.3 to 7.4, and ≥7.5 mg/dL were associated with an increased CKD with ORs of 1.57 (95% CI 1.28 to 1.92), 2.15 (95% CI 1.74 to 2.66), 3.31 (95% CI 2.72 to 4.04), and 7.11 (95% CI 5.76 to 8.78), respectively. The restricted cubic spline showed significant increased CKD prevalence when uric acid ≥4.6 mg/dL. CONCLUSION: Higher SUA was associated with increased CKD prevalence in patients with hypertension. SUA should be monitored in hypertensive patients for CKD prevention.

Safe surgery in the elderly: A review of outcomes following robotic proctectomy from the Nationwide Inpatient Sample in a cross-sectional study.

BACKGROUND: As our nation's population ages, operating on older and sicker patients occurs more frequently. Robotic operations have been thought to bridge the gap between a laparoscopic and an open approach, especially in more complex cases like proctectomy. METHODS: Our objective was to evaluate the use and outcomes of robotic proctectomy compared to open and laparoscopic approaches for rectal cancer in the elderly. A retrospective cross-sectional cohort study utilizing the Nationwide Inpatient Sample (NIS; 2006-2013) was performed. All cases were restricted to age 70 years old or greater. RESULTS: We identified 6740 admissions for rectal cancer including: 5879 open, 666 laparoscopic, and 195 robotic procedures. The median age was 77 years old. The incidence of a robotic proctectomy increased by 39%, while the open approach declined by 6% over the time period studied. Median (interquartile range) length of stay was shorter for robotic procedures at 4.3 (3-7) days, compared to laparoscopic 5.8 (4-8) and open at 6.7 (5-10) days (p < 0.01), while median total hospital charges were greater in the robotic group compared to laparoscopic and open cases ($64,743 vs. $55,813 vs. $50,355, respectively, p < 0.01). There was no significant difference in the risk of total complications between the different approaches following multivariate analysis. CONCLUSION: Robotic proctectomy was associated with a shorter LOS, and this may act as a surrogate marker for an overall improvement in adverse events. These results demonstrate that a robotic approach is a safe and feasible option, and should not be discounted solely based on age or comorbidities.

Development of a CDC-certified total testosterone assay for adult and pediatric samples using LC-MS/MS.

BACKGROUND: Highly accurate and sensitive method to measure testosterone in hypogonadal male, female and children is vital for proper diagnosis of hormone-related conditions and their treatment. OBJECTIVE: To develop an accurate and robust total testosterone ESI-LC-MS/MS quantification method with a simple sample preparation workflow and sufficient sensitivity for serum or plasma samples of all gender and age groups, via ketone functional group derivatization (using Amplifex™ Keto Reagent). METHOD: A simple sample preparation method to accommodate both low and high numbers of samples was developed using simultaneous protein precipitation and derivatization with Amplifex™ Keto reagent, followed by centrifugation and direct injection of supernatant into an LC-MS/MS system (SCIEX Topaz™ IVD LC-MS/MS, in which MS is equivalent to a SCIEX 4500MD Mass Spectrometer). Total testosterone in human serum or plasma samples was quantified using an external calibration curve generated by calibrators spanning a broad concentration range of ∼1-2000 ng/dL (10-20,000 pg/mL), traceable to NIST 971 SRM. 13C3-enriched testosterone was used as an internal standard to correct for both analyte loss during sample preparation and matrix effect during analysis (Supplementary Information: SI Fig. 4C). Two methods, one using a 96-well filter plate and another using Eppendorf tubes, were developed. Both methods were certified by the Centers for Disease Control (CDC) hormone standardization (HoSt) program for total serum testosterone. The feasibility of implementing the method for plasma and serum samples was tested via a small-scale method comparison study between matched pediatric serum and plasma samples derived from the same donor. In addition, plasma samples originating from the same donor collected in two different anticoagulant tube types (Li-heparin and K2EDTA) were compared. RESULTS: Using in-house formulated NIST 971-traceable calibrators, the method was linear (r2 > 0.999) between 1 and 2000 ng/dL (10 and 20,000 pg/mL) with a limit of detection of approximately 1 ng/dL (10 pg/mL). The testosterone concentration bias against 40 reference samples from the HoSt certification program was absolute <3% with an average %CV of ∼3-4%. More than 78% of samples passed the CDC bias criterion of ±6.4%. Comparison between pediatric matched serum and plasma samples resulted in high correlation (r2 = 0.997) and bias of <5%. The calculated % difference between matched adult serum and plasma samples was ∼1%. CONCLUSIONS: Feasibility for an accurate and streamlined method suitable for measuring total testosterone in all human samples was demonstrated with a choice of sample preparation workflow to suit low or high number of samples. The method can potentially be used for plasma matrix from different blood collection tubes (Li-Heparin and K2EDTA).

Shockwave Therapy Efficiently Cures Multispecies Chronic Periodontitis in a Humanized Rat Model.

Biofilms are ubiquitous in nature and are invariably associated with health and diseases of all living beings. Periodontal diseases & dental caries are the most prevalent conditions in which biofilm has established as a primary causative factor. Managing poly-microbial biofilm is the mainstay of periodontal therapy. Plethora of antimicrobials have been used till date to combat biofilm, but the emergence of antibiotic tolerance and resistance in biofilms is a major cause of concern. Apart from use of antimicrobials, various anti-biofilm strategies have evolved which include the use of mechanical, and chemical means to disrupt biofilms. However, none of these approaches have led to desired or optimal biofilm control and hence search for novel approach continues. Shockwaves are used in medical practice for various therapeutic purposes and in local drug delivery, gene therapy, wound healing & regeneration. With this background, a study was designed with an attempt to explore the possibility of using the shockwave for their effect on multispecies oral biofilm development from subgingival plaque samples obtained from chronic periodontitis patients. Plaque samples from 25 patients were used to derive multispecies biofilm which were used to check the efficacy of shockwaves and antibacterial efficacy of four clinically relevant antimicrobials. Biofilms were analyzed by scanning electron microscope; atomic force microscope and their biomass was quantitated by crystal violet staining. Further, a humanized rat model of periodontitis was developed. Patient derived plaque was used to establish periodontitis in healthy rats. The model was validated by performing colony forming unit (CFU) analysis of the infected tissue. The animals were subjected to low intensity shockwaves using a hand-held shockwave generator at the site of infection. Shockwave treatment was done with or without antimicrobial application. The animals were monitored for clearance of infection and for mortality. The results show that shockwave treatment in combination with antimicrobials is significantly effective in clearing a multispecies biofilm. This also brings out the possibility of application of shockwaves in the management of oral biofilms either alone or in combination with established antimicrobial agents. With further research, safety profile validation and clinical trials, shockwaves can be an effective, novel approach in management of biofilm associated periodontal disease.

Commutability and traceability in EQA programs.

OBJECTIVES: The concept of commutability of samples has focused laboratories on the importance of traceability. However, the critical role of External Quality Assurance (EQA) in achieving the primary role of traceability (i.e. facilitating comparable patient results in different laboratories) has largely been lost. The aim of this paper is to review the role of EQA in achieving traceable/commutable results. DESIGN AND METHODS: The role of commutability and traceability in EQA and Internal Quality Control (IQC) are discussed. Examples of commutable EQA samples are given to highlight the problem of assuming EQA material does not behave like patient samples. RESULTS: We provide the conventional traceability chain (top down) and the role of EQA in a "bottom up" model using conventional EQA samples. CONCLUSIONS: The quest for commutable samples has compromised the value of EQA without an understanding that some EQA materials are commutable for some measurands. EQA plays a key role in performance improvement, but laboratories need to understand the importance of using a range of values appropriate to the assay to identify areas of quality need. Traceability and EQA using conventional samples are not mutually exclusive concepts.

Establishing and Maintaining an Extensive Library of Patient-Derived Xenograft Models.

Patient-derived xenograft (PDX) models have recently emerged as a highly desirable platform in oncology and are expected to substantially broaden the way in vivo studies are designed and executed and to reshape drug discovery programs. However, acquisition of patient-derived samples, and propagation, annotation and distribution of PDXs are complex processes that require a high degree of coordination among clinic, surgery and laboratory personnel, and are fraught with challenges that are administrative, procedural and technical. Here, we examine in detail the major aspects of this complex process and relate our experience in establishing a PDX Core Laboratory within a large academic institution.

Analysis of medical service use of knee osteoarthritis and knee meniscal and ligament injuries in Korea: a cross-sectional study of national patient sample data.

BACKGROUND: Osteoarthritis (OA) and meniscal and ligament injuries of the knee are the two most common knee disorders in Korea. The aim of this study was to analyze the demographic characteristics, medical service use and related costs for these disorders, and the results are expected to help inform practitioners, researchers, and policy-makers. METHODS: The present study aimed to evaluate incidence and patient characteristics, and to assess current medical service use, usual care, and medical expenses of knee disorders by analyzing 2014 national patient sample data from the Korean Health Insurance Review and Assessment Service. Data was extracted using 3% stratified sampling from all Korea national health insurance claims submitted in 2014, and analyzed. Usual care for M17 knee osteoarthritis and S83 knee meniscal and ligament injury codes of the International Classification of Diseases, 10th revision (ICD-10) were determined by investigating total number of patients, sociodemographic characteristics, days in care, number of visits, and expenses. RESULTS: Knee OA showed the highest incidence in females aged ≥60 years, whereas meniscal and ligament injuries of the knee were most prevalent among patients aged <20 years and young adults. Total inpatient care expenses exceeded the cost of ambulatory care for both disorders. Ambulatory care was mainly provided at primary care clinics, with 90% of these visits made to orthopedic specialists. Medical expenses for knee OA and meniscal and ligament injuries were largely due to procedures/surgeries and injections, and procedures/surgeries and hospitalizations, respectively. Total replacement arthroplasty was the most commonly performed surgery for knee OA, while meniscectomy and cruciate ligament reconstruction were the most often performed surgeries for meniscal and ligament injuries. Intra-articular injection rates were 55% in knee OA patients and 3% in meniscal and ligament injury patients. Aceclofenac, diclofenac, and tramadol were the most frequently prescribed analgesics. CONCLUSIONS: The current findings may be used as basic data for establishing medical policies and can benefit researchers and clinicians in recognizing trends and patterns of treatment for knee disorders.

Drug Discovery Testing Compounds in Patient Samples by Automated Flow Cytometry.

Functional ex vivo assays that predict a patient's clinical response to anticancer drugs for guiding cancer treatment have long been a goal, but few have yet proved to be reliable. To address this, we have developed an automated flow cytometry platform for drug screening that evaluates multiple endpoints with a robust data analysis system that can capture the complex mechanisms of action across different compounds. This system, called PharmaFlow, is used to test peripheral blood or bone marrow samples from patients diagnosed with hematological malignancies. Functional assays that use the whole sample, retaining all the microenvironmental components contained in the sample, offer an approach to ex vivo testing that may give results that are clinically relevant. This new approach can help to predict the patients' response to existing treatments or to drugs under development, for hematological malignancies or other tumors. In addition, relevant biomarkers can be identified that determine the patient's sensitivity, resistance, or toxicity to a given treatment. We propose that this approach, which better recapitulates the human microenvironment, constitutes a more predictive assay for personalized medicine and preclinical drug discovery.