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Thyroidectomies involve meticulous dissection of a highly vascularized organ and complications may develop, such as hematoma, hypocalcemia, and even hypoparathyroidism. Because some of these complications may be fatal, we sought to identify the differences in postthyroidectomy outcomes when the use of a vessel sealant device (VSD) such, as LigaSure or Harmonic scalpel, is compared with more traditional techniques, such as ligatures and clips.Using the 2016 American College of Surgeons National Surgical Quality Improvement Program Targeted Thyroidectomy database, we compared patients who underwent a thyroidectomy using a VSD with patients without a VSD for differences in postoperative complications.A total of 5146 cases were identified and 3452 of those cases used a VSD, whose use was associated with significantly lower rates of hematoma, deep vein thrombosis, and hypocalcemia before discharge, as well as a shorter length of stay and longer operation time. Multivariate logistic regression showed that VSD was associated with 32.27% and 39.15% lower odds of hypocalcemia and hematoma, respectively. VSDs also were used more frequently in cases that had multinodular, severe, or substernal goiter or Graves disease as the primary indication for surgery and in patients with a higher body mass index. There was no significant difference in the incidence of recurrent laryngeal nerve injury between the two groups.Analysis of the American College of Surgeons National Surgical Quality Improvement Program data indicates that VSDs are associated with a lower risk of complications, such as hypocalcemia, hematoma, and deep vein thrombosis, suggesting that VSDs may be a more effective method of hemostasis than traditional techniques.

This study explores how to use smart contract technology to implement accounting principles for public use. To illustrate its feasibility, this study develops a design model of decentralized accounting contracts (DACs) and uses revenue recognition to demonstrate how to apply the proposed model. Considering various scenarios of revenue recognition, this study adopts Solidity to program smart contracts for five use cases: (1) regular sale, (2) installment sale, (3) gift card sale, (4) a contracted sale with multiple performance obligations, and (5) a contracted sale with variable considerations over the contract price. The results show that smart contracts can be created to fully address complex revenue recognition scenarios according to the Generally Accepted Accounting Principles (GAAPs). In conclusion, we discuss the implications of the study for business organizations, regulatory agencies, and the accounting profession. JEL Classifications: M40.

This study examines whether market participants react to the announcements of corporate governance ranking exercises. As a regulatory innovation, the Financial Supervisory Commission in Taiwan initiated and administered two ranking exercises, one in 2015 and the other in 2016, on all publicly listed companies. Adopting anchoring-and-adjustment theory, the study predicts that market participants will react strongly to the second announcement if the ranking obtained in the second exercise turns out to be better than the ranking in the first round. Employing an event study methodology, the study shows that market participants react positively and significantly to firms ranked in the top 50% in the second corporate governance exercise. Their reactions to the announcement are even stronger among those that did not list in the top 20% in the first exercise, but made it into the top 50% in the second one. Overall, our analyses support that anchoring-and-adjustment theory effectively explains market participants? behaviour. Since the monitoring of the board of directors and investors may not effectively mitigate the potential moral hazard committed by family owners/executives, our empirical evidence demonstrates that a ranking exercise probably can be employed to supplement routine corporate governance disclosures made in annual reports, in order to strengthen the check-and-balance mechanism and reduce the risk of principal?principal conflicts. In conclusion, we discuss the implications of the research findings and propose directions for future studies.

PurposeThis paper aims to discuss the study by Warne (2020), which investigates whether disclosure or recognition of fair value information for nonfinancial assets influences commercial lenders’ judgment on interest rates and the dollar amounts of business loans.Design/methodology/approachProvides a discussion of research design and general issues related to behavioral/experimental studies.FindingsIdentifies issues that should be carefully thought out and properly addressed by behavioral researchers in order to improve the robustness of the empirical evidence.Originality/valueThis discussion highlights issues that should be carefully thought out and properly addressed by behavioral researchers in order to improve the robustness of the empirical evidence.

Aims We aimed to examine the long-term mechanical survivorship, describe the modes of all-cause failure, and identify risk factors for mechanical failure of all-polyethylene tibial components in endoprosthetic reconstruction. Methods This is a retrospective database review of consecutive endoprosthetic reconstructions performed for oncological indications between 1980 and 2019. Patients with all-polyethylene tibial components were isolated and analyzed for revision for mechanical failure. Outcomes included survival of the all-polyethylene tibial component, revision surgery categorized according to the Henderson Failure Mode Classification, and complications and functional outcome, as assessed by the Musculoskeletal Tumor Society (MSTS) score at the final follow-up. Results A total of 278 patients were identified with 289 all-polyethylene tibial components. Mechanical survival was 98.4%, 91.1%, and 85.2% at five, ten and 15 years, respectively. A total of 15 mechanical failures were identified at the final follow-up. Of the 13 all-polyethylene tibial components used for revision of a previous tibial component, five (38.5%) failed mechanically. Younger patients (< 18 years vs > 18 years; p = 0.005) and those used as revision components (p < 0.001) had significantly increased rates of failure. Multivariate logistic regression modelling showed revision status to be a positive risk factor for failure (odds ratio (OR) 19.498, 95% confidence interval (CI) 4.598 to 82.676) and increasing age was a negative risk factor for failure (OR 0.927, 95% CI 0.872 to 0.987). Age-stratified risk analysis showed that age > 24 years was no longer a statistically significant risk factor for failure. The final mean MSTS score for all patients was 89% (8.5% to 100.0%). Conclusion The long-term mechanical survivorship of all-polyethylene tibial components when used for tumour endoprostheses was excellent. Tumour surgeons should consider using these components for their durability and the secondary benefits of reduced cost and ease of removal and revision. However, caution should be taken when using all-polyethylene tibial components in the revision setting as a significantly higher rate of mechanical failure was seen in this group of patients. Cite this article: Bone Joint J. 2020;102-B(2):170–176

A 16-year-old boy with a history of Down syndrome presented with right knee pain and swelling. He was diagnosed with isolated septic arthritis of the knee due to Fusobacterium necrophorum in the absence of current or recent oropharyngeal infection. He was successfully treated with arthroscopic irrigation and debridement and 12 weeks of oral antibiotics.Fusobacterium necrophorum is a part of the normal oral flora and a rare cause of septic arthritis, typically associated with recent oropharyngeal infection. However, patients with immune dysregulation such as those with Down syndrome may develop isolated septic arthritis due to transient hematogenous seeding.

Orthopedic sports medicine surgeons are especially vulnerable to litigation, largely because of high patient expectations in the setting of complex surgeries. Understanding the factors associated with litigation may reduce physician risk as well as optimize patient satisfaction and outcomes. We used a national medicolegal database to search for medical malpractice verdicts and out-of-court settlements involving common sports injuries and their surgical management between January 1, 2000, and January 1, 2018. Univariate analysis was performed to identify predictors of case outcome and monetary awards. We identified 777 cases, but only 328 met the inclusion criteria. Of the 328 cases included in our study, 231 (70.4%) resulted in a defendant verdict, 75 (22.9%) resulted in a plaintiff verdict, and 22 (6.7%) resulted in a settlement. The most common reason for litigation was intraoperative error (183 cases, 55.8%). No statistically significant difference was found between monetary awards for plaintiff verdicts vs settlements (mean award of $1.29 million and $0.72 million, respectively, P =.07). Cases in which the plaintiff claimed neurovascular injury were significantly more likely to result in a higher monetary award (mean award of $2.37 million, P =.02). Cases involving an incorrect surgical site were significantly less likely to result in a defendant outcome, with 7 of 12 cases (58.3%) leading to a plaintiff outcome ( P =.047). With more than two-thirds of cases resulting in a defendant verdict, many suits result in a favorable outcome for practitioners. Intraoperative error is the most common reason for litigation, and neurovascular injury resulted in the highest monetary payouts. Vigilance to avoid these events may improve patient outcomes and decrease liability to practitioners. [ Orthopedics . 2022;45(1):e47–e52.]

Hip dislocations can occur through various mechanisms. Although native hip dislocations are uncommon, increasing rates of total hip arthroplasty has translated to prosthetic hip dislocations being encountered more frequently, especially after revision surgery. Emergency room physicians employ a myriad of techniques to reduce these dislocations with success rates ranging from 60-92% prior to subsequent surgical reduction in the operating room.

PurposeThe purpose of this paper is to postulate that market participants’ views on the nature of discretionary accruals as earnings management or earnings manipulation could relate to a rise or a fall in a firm’s stock prices.Design/methodology/approachApplying the quantile regression and measuring gains and losses according to the stock returns, this study shows that the relation between earnings manipulation and stock returns is non-uniform and it varies significantly across various quantiles of the latter.FindingsThe empirical results imply a positive (negative) |DA|-RETURN relation for stocks experiencing a rise (fall) in stock prices. This finding is consistent with the notion that market participants lean towards (become) trend followers (fundamentalists) when their stocks price rise (fall) and, thus, positively reward (negatively punish) discretionary accruals.Originality/valueUsing the behavioural heterogeneity of market participants as a research framework, this paper contributes to the literature by demonstrating that market participants’ decisions to positively reward (negatively punish) earning management behaviour depend on their perceptions on nature of discretionary accruals (earnings management vs earnings manipulation).

Background Immunotherapy has emerged as an effective and durable treatment modality for solid cancers. However, its use in colorectal cancer (CRC) is limited to deficient mismatch repair (dMMR) tumors. As such, assessing immune regulatory proteins from the B7-CD28 family, other than PD-1, PD-L1, and CTLA-4, is critical. This study aimed to evaluate the expression of novel protein regulators in a racially diverse population of patients with CRC. Methods A tumor microarray was created for 214 samples from a multiracial patient population with metastatic CRC, and expression of HHLA2, B7-H3, PD-L1, CK7, CK20, and CDX2 was determined. The expression pattern was scored as 0 to 12, based on tumor tissue prevalence and the intensity. Clinical information was obtained by chart review and vital statistics from the National Death Index. Associations between low and high expression groups for each protein by race/ethnic groups were assessed, and Kaplan–Meier curves were plotted to evaluate association with survival. Results The median age at diagnosis was 61 years, with a female predominance. The majority of the patients were diagnosed with de novo metastatic disease with left-sided, moderately differentiated tumors. There were no racial disparities in the expression of any protein. Overall, a high frequency of tumors had no expression of B7-H3 (62.5%) or PD-L1 (43.5%). Low expression of both PD-L1 and B7-H3 was a significant prognostic biomarker associated with better survival (median overall survival, 43.3 months vs. 24.6 months; P Conclusion In this multiracial tumor microarray of CRC samples, low PD-L1 and B7-H3 expression was associated with an improved prognosis. There was no significant variation among races with respect to the relevant CRC protein markers.

STUDY DESIGN Retrospective review of spine surgery malpractice cases. OBJECTIVES The aim was to compare medical malpractice outcomes among different types of spine surgery and identify predictors of litigation outcomes. SUMMARY OF BACKGROUND DATA Spine surgery is highly litigious in the United States with data suggesting favorable outcomes for defendant surgeons. However, factor specific data and explanations for plaintiff verdicts are lacking. METHODS Westlaw legal database was queried for spine surgery malpractice outcomes from 2010 to 2019. Clinical data, reasons for litigation, and legal outcomes were tabulated. Statistical analysis was performed to identify factors associated with litigation outcomes. RESULTS A total of 257 cases were identified for inclusion. There were 98 noninstrumented and 148 instrumented cases; 110 single-level and 99 multilevel; 83 decompressions, 95 decompression and fusions, and 47 fusion only. In all, 182 (71%) resulted in a defendant verdict, 44 (17%) plaintiff verdict, and 31 (12%) settlement. Plaintiff verdicts resulted in payouts of $2.03 million, while settlements resulted in $1.11 million (P=0.34). Common reasons for litigation were intraoperative error, hardware complication, and improper postoperative management. Cases were more likely to result for the plaintiff if postoperative cauda equina syndrome (55% vs. 26%, P

Author(s): Hwang, Richard; Park, Howard Y; Sheppard, William; Bernthal, Nicholas M | Abstract: BackgroundSarcoma care is highly litigated in medical malpractice claims. Understanding the reasons for litigation and legal outcomes in sarcoma care may help physicians deliver more effective and satisfying care to patients while limiting their legal exposure. However, few studies have described malpractice litigation in sarcoma care.Questions/purposes(1) What percentage of sarcoma malpractice cases result in a defendant verdict? (2) What is the median indemnity payment for cases that result in a plaintiff verdict or settlement? (3) What are the most common reasons for litigation, injuries sustained, and medical specialties of the defendant physicians? (4) What are the factors associated with plaintiff verdicts or settlements and higher indemnity payments?MethodsThe national medicolegal database Westlaw was queried for medical malpractice cases pertaining to sarcomas that reached verdicts or settlements. Cases from 1982 to 2018 in the United States were included in the study to evaluate for trends in sarcoma litigation. Demographic and clinical data, tumor characteristics, reasons for litigation, injuries, and legal outcomes were recorded for each case. A univariate analysis was performed to identify factors associated with plaintiff verdicts or settlements and higher indemnity payments, such as tumor characteristics, defendant's medical or surgical specialty, reason for litigation, and injuries sustained. A total of 92 cases related to sarcomas were included in the study, of which 40 were related to bone sarcomas and 52 were related to soft-tissue sarcomas. Eighty-five percent (78 of 92) of cases involved adult patients (mean age ± SD: 40 ± 15 years) while 15% (14 of 92) of cases involved pediatric patients (mean age ± SD: 12.5 ± 5 years).ResultsThirty-eight percent (35 of 92) of the included cases resulted in a defendant verdict, 30% (28 of 92) resulted in a plaintiff verdict, and 32% (29 of 92) resulted in a settlement. The median (interquartile range [IQR]) indemnity payment for plaintiff verdicts and settlements was USD 1.9 million (USD 0.5 to USD 3.5 million). Median (IQR) indemnity payments were higher for cases resulting in a plaintiff verdict than for cases that resulted in a settlement (USD 3.3 million [1.1 to 5.7 million] versus USD 1.2 million [0.4 to 2.4 million]; difference of medians = USD 2.2 million; p = 0.008). The most common reason for litigation was delayed diagnosis of sarcoma (91%; 84 of 92) while the most common injuries cited were progression to metastatic disease (51%; 47 of 92) and wrongful death (41%; 38 of 92). Malpractice claims were most commonly filed against primary care physicians (26%; 28 of 109 defendants), nononcology-trained orthopaedic surgeons (23%; 25 of 109), and radiologists (15%; 16 of 109). Cases were more likely to result in a ruling in favor of the plaintiff or settlement if a delay in diagnosis occurred despite suspicious findings on imaging or pathologic findings (80% versus 51%; odds ratio 3.84 [95% CI 1.34 to 11.03]; p = 0.02). There were no differences in indemnity payments with the numbers available in terms of tumor type, tumor location, defendant specialty, reason for litigation, and resulting injuries.ConclusionsMany lawsuits were made against primary care physicians, nononcology-trained orthopaedic surgeons, or radiologists for a delayed diagnosis of sarcoma despite the presence of imaging or histologic findings suspicious for malignancy. Although previous studies of bone and soft-tissue sarcomas have not shown a consistent association between time to diagnosis and decreased survival, our study suggests that physicians are still likely to lose these lawsuits because of the perceived benefits of an early diagnosis.Clinical relevancePhysicians can mitigate their malpractice risk while reducing delays in diagnosis of sarcomas by carefully reviewing all existing diagnostic studies, establishing closed-loop communication protocols to communicate critical findings from diagnostic studies, and developing policies to facilitate second-opinion consultation, particularly for imaging studies, with an experienced sarcoma specialist. Musculoskeletal oncologists may be able to help further reduce the rates of malpractice litigation in sarcoma care by helping patients understand that delays in diagnosis do not necessarily constitute medical malpractice.

Background Reduced creatinine clearance is an indication for surgery in asymptomatic primary hyperparathyroidism, and a significant proportion of patients undergoing parathyroidectomy have chronic kidney disease. The purpose of this study was to evaluate the kinetics of intraoperative parathyroid hormone decline during parathyroidectomy in patients who have chronic kidney disease compared with those with who have normal renal function. Methods This is a single-center, retrospective study of patients with primary hyperparathyroidism undergoing parathyroidectomy (n = 646). Patients were grouped based on estimated glomerular filtration rate greater than (normal renal function) or less than (chronic kidney disease) 60 mL/min/1.73m2. All patients had intraoperative parathyroid hormone monitoring and ≥6-month postoperative serum studies to confirm surgical cure. Intraoperative parathyroid hormone kinetic curves were analyzed using a linear mixed model. Results Despite similar pre-excision values, patients with chronic kidney disease had significantly higher intraoperative parathyroid hormone values at 5 minutes (76 vs 58 pg/mL, P = .02) and 10 minutes (54 vs 37 pg/mL, P = .004) postexcision. No significant difference was observed in whether patients met Miami criterion by 5 minutes (chronic kidney disease 71%, normal renal function 78%, P = .255) or by 10 minutes (chronic kidney disease 95%, normal renal function 96%, P = .751) postexcision. Using a linear mixed model, glomerular filtration rate did not have a significant effect on the change in intraoperative parathyroid hormone over time. Conclusion Patients with chronic kidney disease had significantly higher postexcision intraoperative parathyroid hormone levels. However, renal function did not affect the change in intraoperative parathyroid hormone over time, nor did renal function ultimately affect the likelihood of meeting the Miami criterion. Intraoperative parathyroid hormone monitoring remains useful in this population, although additional time points may be needed to observe normalization of values.

Author(s): Bernthal, Nicholas M; Upfill-Brown, Alexander; Burke, Zachary DC; Greig, Danielle; Hwang, Richard; Crawford, Brooke; Eckardt, Jeffrey J | Abstract: BackgroundThere is a paucity of data on long-term survivorship and outcomes for total humerus replacements (THR) with only two series reporting 10-year survival.Patients and methodsA review of 769 consecutive, prospectively collected endoprosthetic reconstructions for oncological diagnoses at a single-center between 1980 and 2019 was performed. Patients with THRs were isolated and analyzed for outcomes, complications, and modes of failure.ResultsEighteen patients with 20 THR implants were identified. The median follow-up for surviving patients was 148 months (interquartile range [IQR] = 74-194) and 60 months (IQR = 17-155 months) for all patients. Two prostheses required revision for failure, both for symptomatic shoulder dislocation. There were three local recurrences. Revision-free survival at 5, 10, and 15 years was 100%, 86% and 86%, respectively. There were no cases of ulnar component failure, radial nerve palsy, or periprosthetic infection.ConclusionsTHR prosthesis survivorship is comparable to the previous series, with a longer follow-up than has previously been reported. Symptomatic shoulder instability was common (25%), and was the only cause of revision. Reverse total shoulder could be an important way to address this in the future. Local recurrence rates were high, as has been reported elsewhere for THR.

We aimed to examine the long-term mechanical survivorship, describe the modes of all-cause failure, and identify risk factors for mechanical failure of all-polyethylene tibial components in endoprosthetic reconstruction.This is a retrospective database review of consecutive endoprosthetic reconstructions performed for oncological indications between 1980 and 2019. Patients with all-polyethylene tibial components were isolated and analyzed for revision for mechanical failure. Outcomes included survival of the all-polyethylene tibial component, revision surgery categorized according to the Henderson Failure Mode Classification, and complications and functional outcome, as assessed by the Musculoskeletal Tumor Society (MSTS) score at the final follow-up.A total of 278 patients were identified with 289 all-polyethylene tibial components. Mechanical survival was 98.4%, 91.1%, and 85.2% at five, ten and 15 years, respectively. A total of 15 mechanical failures were identified at the final follow-up. Of the 13 all-polyethylene tibial components used for revision of a previous tibial component, five (38.5%) failed mechanically. Younger patients (18 years vs18 years; p = 0.005) and those used as revision components (p0.001) had significantly increased rates of failure. Multivariate logistic regression modelling showed revision status to be a positive risk factor for failure (odds ratio (OR) 19.498, 95% confidence interval (CI) 4.598 to 82.676) and increasing age was a negative risk factor for failure (OR 0.927, 95% CI 0.872 to 0.987). Age-stratified risk analysis showed that age24 years was no longer a statistically significant risk factor for failure. The final mean MSTS score for all patients was 89% (8.5% to 100.0%).The long-term mechanical survivorship of all-polyethylene tibial components when used for tumour endoprostheses was excellent. Tumour surgeons should consider using these components for their durability and the secondary benefits of reduced cost and ease of removal and revision. However, caution should be taken when using all-polyethylene tibial components in the revision setting as a significantly higher rate of mechanical failure was seen in this group of patients. Cite this article

This paper proposes the Topical Link Model (TLM), which can be used as a framework to integrate information of a specific decision topic in financial reports formatted in the eXtensible Business Reporting Language (XBRL). Building on link analysis and Topic Maps concepts, this study demonstrates that the TLM allows users and preparers of XBRL-formatted financial reports to operationalize the Generic Linkbase, an existing XLink semantic tool embedded in XBRL, to integrate topic-centric information. To validate the merits of integrating information in financial reports based on TLM, this study implements a preliminary evaluation exercise that integrates quantitative and qualitative information in XBRL-formatted financial reports. The results from the exercise demonstrates that XLink, as a semantic tool, can have broader applications because it provides detailed and insightful “links” among elements in financial reports.

Introduction: Tibial shaft fractures are a relatively common injury in orthopaedic surgery, with management options including intramedullary nail (IMN) fixation or open reduction internal fixation (ORIF) with plate osteosynthesis. Using a large national database, we sought to compare the prevalence and timing of short-term complications following either IMN or ORIF for tibial shaft fractures. Methods: The American College of Surgeons National Surgical Quality Improvement Program was used to identify patients undergoing IMN or ORIF for the treatment of tibial shaft fracture between 2012 and 2018. Multivariate Poisson hurdle regression models were utilized to determine predictors of postoperative complications as well as the timing of postoperative complications. Results: A total of 4963 tibial shaft fracture were identified, with 3601 patients undergoing IMN (72.6%) and 1362 undergoing ORIF (27.4%). Patients undergoing IMN had a lower mean age of 48.8 compared with 53.9 for plate osteosynthesis (P

Lumbar herniated disc is a "preference-sensitive" condition, in which the optimal treatment choice is crucially dependent on an informed patient's goals and values. Little is known about decisional conflict, defined as an individual's level of uncertainty regarding a decision, in patients considering treatment for lumbar herniated discs. Our work aims to identify factors associated with decisional conflict and areas for improved shared decision making.We prospectively surveyed patients seeking treatment for a lumbar herniated disc at L4-L5 and/or L5-S1 with a physician at the UCLA Spine Center. Decisional conflict was measured using the validated SURE questionnaire. We performed univariate and multivariate logistic analysis to identify predictors of decisional conflict.Among the 174 participants surveyed, 47% reported experiencing decisional conflict and 44% changed their treatment preference after the visit, with 61% of these opting for more invasive treatment. Participants with decisional conflict were less satisfied with their treatment decision (P0.001) and less willing to recommend their physician (P = 0.003) and physician's medical group to others (P = 0.003). Multivariate analysis revealed that participants were more likely to experience decisional conflict if they consulted with a physiatrist compared with a surgeon (odds ratio [OR], 2.6; P = 0.019) and if they did not feel able to discuss the various treatment options with the doctor during the visit (OR, 8.5; P0.001).Many patients with a lumbar herniated disc experience decisional conflict when choosing a treatment option. Our results highlight the need to implement tools and strategies to improve decisional quality, such as decision aids before consultation.

The impact of long-term tamoxifen therapy on ovarian function is not known. Understanding these effects will help reproductive-aged patients who desire future pregnancy make more informed decisions regarding their treatment. This is a retrospective cohort study in patients identified through the UCSF Cancer Registry and SPORE database. We enrolled women with a history of ductal carcinoma in situ (DCIS) or early stage invasive breast cancer who were premenopausal at diagnosis and did not receive chemotherapy. Menstrual histories were obtained through electronic and paper surveys. We compared the age of menopause onset and menstrual pattern changes between women who received tamoxifen (TAM) and those who did not receive tamoxifen (control). Neither group received chemotherapy. 250 subjects were included in this study (125 TAM, 125 control). Mean age of menopause onset was 51.0 for both the groups and was not associated with duration of tamoxifen use or the age at tamoxifen initiation. Menstrual pattern changes, including amenorrhea, were more frequent in the TAM group than control group (any change: 48 % TAM vs. 15 % control, p

By constructing a novel proprietary pharmaceutical database, we assessed whether the corporate transparency of Korean exchange-listed pharmaceutical...

e15127 Background: In CRC, utility of immunotherapy (IT) remains limited to persons with microsatellite instability–high (MSI-H) status. Immunotyping of CRC patients is critical towards further establishing IT's potential. Both incidence and survival rates for CRC in the United States vary between races due to multiple factors including genetic heterogeneity. In this study, we have profiled tumor samples in a racially diverse population for the expression of four different members of the B7 family of immune check point regulators. Methods: Tissue microarray (TMA) was generated from 208 CRC patients. Formalin fixed paraffin embedded (FFPE) tissues were utilized for immunohistochemistry (IHC) post- antigen retrieval. Antibodies specific for IHC staining were used for B7-H3 (D9M2L), PD-L1(E1L3N), B7-H4/B7x(D1M81) and HHLA2(566.1). Each specimen was scored for percent staining of tumor tissue (4 quartile groups) and for intensity (1-4x), and then an overall score (1-16) was calculated. The clinical outcome of interest was overall survival (OS), measured as time from diagnosis of metastatic cancer to death. Analysis for differences in OS was by log rank test, while differences between mean staining was by t test. Race was designated as non-Hispanic white (NHW, n = 41), non-Hispanic black (NHB, n = 84), Hispanic (n = 75), and others (8). Results: B7-H3 protein expression showed strong cytoplasmic distribution. NHB patients had a mean lower expression than NHW patients (0.19 vs 0.41, p = 0.02). Correspondingly, NHB patients had a worse OS than NHW patients (606 vs 759 days). No discernible differences were found in Hispanic patients. PD-L1 showed membranous distribution with 17% expression without significant difference among patients of different racial origin. HHLA2 was more widely expressed with about 35% staining but without statistical significance. B7-H4/B7x failed to show any expression. Conclusions: Expression of B7H3 varies among patients with differential racial backgrounds. It has the potential to be a prognostic biomarker and may be a reason for worse outcome among NHB patients in our population. Other B7 immune checkpoint markers failed to show clinical relevance.

This study examines the effect of disclosure regulation on earnings management using Taiwanese companies conducting transactions with China as the institutional setting. Measuring earnings management by the amount of discretionary accruals (DACCs), the study shows that disclosure regulation mitigates DACCs of Taiwanese firms engaging in related-party transactions with Chinese entities. Following enactment of the disclosure regulation in November 2000, DACCs among Taiwanese enterprises conducting transactions via offshore affiliates dropped. While the disclosure regulation helps to reduce earnings management, this study reports that such effect is asymmetric between high-tech firms and non–high-tech firms. Specifically, the disclosure regulation is effective in reducing earnings management among firms in non–high-tech sectors. However, such effect is not significant among firms in high-tech sectors. This study discusses the implications of empirical findings for corporate management, regulatory agencies, and firm stakeholders.

As documented in the literature, the effects of firm size, financial leverage, and R&D expenditures on firm earnings are inclusive. Our hypothesis is that the inconsistent empirical results of such effects may be driven by the regression models implemented in data analysis. Using the quantile regression (QR) approach developed by Koenker and Basset (1978), this study analyses S&P 500 firms from 1996 to 2005. We find that the effects of firm size, financial leverage and R&D expenditures on firm earnings differ considerably across earnings quantiles. Comparing the results from the QR approach with those from the ordinary least squares (OLS) and least absolute deviation (LAD) methods, this study further explains the puzzling relationship between firm size, financial leverage, R&D expenditures and firm earnings.

This study contributes to accounting and auditing literature by addressing two empirical questions: (1) whether litigation environment affects auditors’ decisions to accept clients’ aggressive reporting and (2) whether litigation environment, client business risk, and client retention pressure interact and jointly affect auditors’ decisions to go along with clients’ preferred accounting choices. Fifty-nine (59) US and sixty-one (61) Hong Kong auditors employed by the Big-4 accounting firms participated in this study. The result shows that litigation environment has a significant effect on auditors’ decisions. Auditors who practice in more litigious environments tend to be less willing to go along with clients’ aggressive reporting than those who practice in less litigious environments. This study also confirms that there is a significant interactive effect between litigation environment, client business risk, and client retention pressure on auditors’ decisions to accept clients’ aggressive reporting choices. Implications of the empirical findings for policymakers, standard-setting organizations, and international accounting firms, as well as directions for future studies, are discussed.

This study replicates Hwang et al. (2005) with a different cohort of accounting majors. This study also extends Hwang et al.'s (2005) article by exploring the effectiveness of employing cooperative learning pedagogy to enhance students' learning outcomes at both the application level and analysis level of knowledge (Bloom 1956). Different from the original paper, this study evaluates participants' learning outcomes using cases with supporting calculations, instead of multiple-choice questions. Overall, this study finds that cooperative learning is a more effective pedagogy than traditional lecture for students who were raised and educated in a passive learning environment. Limitations and possible directions for future research are also discussed.

Flow cytometry is a ubiquitous, multiparametric method for characterizing cellular populations. However, this method can grow increasingly complex with the number of proteins that need to be screened simultaneously: spectral emission overlap of fluorophores and the subsequent need for compensation, lengthy sample preparation, and multiple control tests that need to be performed separately must all be considered. These factors lead to increased costs, and consequently, flow cytometry is performed in core facilities with a dedicated technician operating the instrument. Here, we describe a low-cost, label-free microfluidic method that can determine the phenotypic profiles of single cells. Our method employs Node-Pore Sensing to measure the transit times of cells as they interact with a series of different antibodies, each corresponding to a specific cell-surface antigen, that have been functionalized in a single microfluidic channel. We demonstrate the capabilities of our method not only by screening two acute promyelocytic leukemia human cells lines (NB4 and AP-1060) for myeloid antigens, CD13, CD14, CD15, and CD33, simultaneously, but also by distinguishing a mixture of cells of similar size—AP-1060 and NALM-1—based on surface markers CD13 and HLA-DR. Furthermore, we show that our method can screen complex subpopulations in clinical samples: we successfully identified the blast population in primary human bone marrow samples from patients with acute myeloid leukemia and screened these cells for CD13, CD34, and HLA-DR. We show that our label-free method is an affordable, highly sensitive, and user-friendly technology that has the potential to transform cellular screening at the benchside.

This paper examines two issues. The first issue is the degree of relative isolation of managerial accounting research (MAR) from related disciplines. Using citations collected from the Web of Science, the study shows that MAR published during 1986–2000 in the four leading accounting journals is cited in journals in fields as diverse as economics, operations research, psychology, sociology, organizational behavior, and strategic management. Our findings support Kinney's (2001) observation that accounting researchers have a competitive advantage in areas relating to alternative business measurement structures. The second issue the paper addresses is whether economics-based MAR papers make a greater contribution than papers based on other disciplines, as perceived from their respective citation rates. Our citation analysis finds no evidence that economicsbased papers are cited by non-accounting researchers at a higher rate than MAR based on other disciplines. Extending the comparison to accounting journals covered in the Web of Science did not change this conclusion. We interpret this as a refutation of the contention by Zimmerman (2001) that economics-based MAR papers are more likely to make significant contributions to knowledge. We also report some preliminary evidence that the relevance of MAR to researchers publishing in non-accounting journals is waning. Although this finding is tentative, it may be an early warning signal that should be monitored in future research.

Rapid developments in information technology (IT) have posed many challenges to the accounting profession. In this study we examined what has been done in US colleges by polling auditors' perceptions to investigate whether US accounting firms provide their auditors with more information on current IT topics than colleges do. Also educators in the USA are surveyed to find out what they are planning to do in college courses to ensure that accounting graduates acquire necessary IT knowledge/skills. The results indicate that the entry-level auditors have had significantly more exposure to IT topics while in college than the senior auditors had, which suggests that educators have modified their curricula by incorporating more IT topics into accounting programmes. According to the findings, educators recognize the importance of IT topics, but only a few IT topics can/will be covered in accounting curricula. Implications, limitations, and future research directions of this study are also discussed. 1Currently vi...

This research examines the individual and interactive effects of client retention incentive and client business risks on auditors' decisions regarding whether to accept clients' aggressive reporting practices. Fifty-five audit seniors and managers from all of the Big 5 accounting firms participated in this experimental study. We find a significant main effect of client business risks and an interactive effect between client retention incentives and client business risks on auditors' decisions. Specifically, the results indicate that, when a client's business risks are high, auditors tend to scrutinize such risks and carefully evaluate a client's proposed accounting practices. However, when there is less concern over a client's business risks, auditors may be willing to accept the client's aggressive reporting proposal if retention incentives are high.

Human resource planning has always been a key issue to professional companies. To help professional firms cope with demands, a dynamic approach for planning human resources in a continuous time frame is proposed. We analytically determine an exact and globally optimal solution to a firm's human resources by explicitly considering its hierarchical structure, costs of recruiting and hiring, workload, contract delays, loss of revenues, and an over-capacity issue. Managerial implications of this study are also discussed.

This study provides evidence based on data collected from 65 US and 34 Hong Kong companies regarding current implementation of value chain cost analysis. The findings indicate significant differences in cost systems of companies in these two regions under value chain framework. The US manufacturing firms have invested more of their resources in upstream activities than have their Hong Kong counterparts, but this observation did not hold in the service industry. Overall, however, the results support a positive link between the percentages of cost and degrees of cost tracing, particularly for upstream activities, for firms in both regions. Implications of this study in cost management for the US and Hong Kong companies are also discussed.

To manage resources effectively in multinational environments, financial managers must understand the current financial management research and apply the findings to their daily practice. In this study, we develop an agenda for researchers who are interested in emerging Asian-Pacific markets. A total of 73 of Taiwan's top financial managers participated in our study. These managers completed assessments of research needs, which then were compared with the results of the Ramirez et al. study (Ramirez, G., Waldman, D., Lasser, D., 1991. Fin. Manag. 20, 17–29) that was done in the USA. While there was moderate agreement on the research needs between the two countries' top financial professionals, noticeable differences were observed regarding some specific areas.

During the past decade, rapid economic development and extensive international trade in the Asia Pacific have significantly shifted business practices in the region. Multinational investments have fostered a high demand for CPA firms in this area, making the CPA environment more competitive than ever before. This shift in operating environments has made professionals more cost- and client-sensitive. To address these concerns, this study extends the work of Chan and Dodin by proposing an audit scheduling approach which can assist the CPA firm management to better retain their audit staff and enhance audit quality and thus to increase client satisfaction. By using a systematic and easy-to-use auditor scheduling approach, it helps the CPA firm not only in handling the complexity of audit operation but also in reducing audit-related operational costs. In addition, this study explicitly considers auditor preferences and the audit team's hierarchical structure. These features make the scheduling approa...

By constructing a novel proprietary pharmaceutical database, we assess whether the corporate transparency of Korean exchange-listed pharmaceutical companies affects event-study returns upon Korea Food and Drug Agency approvals of new drugs. The empirical findings are as follows: First, we report evidence that new drugs are priced in the announcement returns. Second, product innovation is appraised higher by the investors the better the firm is governed, controlled for trading venue, R&D intensity, balance sheet variables, payout policy, valuation, and years of operation. Lastly, additionally considering analyst-coverage, patent-listing, and technological alliance reveals that the shareholders are wealthier with innovative new products promised by trustworthy managers.

Publisher Summary The drug substance—active pharmaceutical ingredient (API)—is the most important component in a drug product. During the early phase of development, the number of API batches is relatively limited, the batch size is usually very small, and manufacturing experience is beginning to evolve. The primary emphasis in setting specifications for a new drug substance is on safety, based on the purposes of clinical studies at this stage. In each phase of a clinical investigational program, sufficient information is required to be submitted to the FDA to ensure the proper safety, identification, strength, quality, purity, and potency of the investigational candidate. However, the amount of information to provide varies with the phase and the proposed duration of investigation, and the amount of information previously available. Specification for clinical trial materials is developed based on several factors: compendial standards, process development studies, and stability of batches used for toxicological/in vivo studies. Specifications for commercial drug products, also known as regulatory specifications, are generally documented in a regulatory submission or in a compendial monograph. Commercial drug product must conform to the regulatory specifications throughout its shelf life. Full compliance with the ICH guideline Q6A is expected for specifications for commercial drug products.

Publisher Summary Pharmaceutical manufacturers often rely on various strategies to help keep their new drug pipeline flowing freely. Effective management of clinical supplies delivery prevents it from becoming a rate-limiting step in product development, reduces the time for a new drug going through clinical trials, and ultimately increases the speed to bring a new drug to market. An implementation of clinical plan, clinical supplies liaison, a lean manufacturing approach, a cross-functional training program for workers, outsourcing, the use of new technology including modern computer technology and new methodologies in drug discovery and development, and process analytical technology (PAT) are among various strategies that can be used to improve clinical trial management. This chapter discusses the current good manufacturing process (cGMP) considerations to ensure the quality of the clinical materials during the clinical supplies manufacture. The comprehensive clinical supply manufacture strategy and cGMP controls prevent clinical supplies manufacture from becoming the bottleneck of a clinical trial program, and consequently reduce the total cycle time of introducing a new drug to the market. There are certain components involved in any method validation activity are outlined in the International Conference on Harmonization (ICH) guidelines on Analytical methods Q2A. For a quantitative impurity test, validation is required for specificity, limits of detection and quantitation, linearity, accuracy, precision, and range.

To succeed in todays competitive business environment, corporations need to undertake value chain analysis and select an optimal mix of value chain activities. Based on the data collected from 73 small- to medium-sized companies, this study provides evidence regarding current practices in value chain cost tracing and cost system obsolescence. The research findings indicate that companies do a better job of linking value chain costs to products/product lines than to customers/customer classes. Overall, however, the proportion of each value chain cost attributed to either cost object tends to be low. This indicates that firms management may be rather slow in adopting new management tools. Furthermore, most companies are still using value-based cost allocations, which suggests cost system obsolescence. Implications of this study and future research directions are also discussed.

The pharmaceutical industry has come under immense pressure from shareholders and consumers to continuously improve product quality, reduce manufacturing costs and increase speed to develop new medicines. One area that impacts all of these quality, cost, and speed attributes is formulation development. The formulation of a pharmaceutical product includes the active pharmaceutical ingredient (API) and inactive ingredients that enable manufacturability and help the medicine achieve its effectiveness. Formulation scientists need to develop robust formulations while meeting aggressive timelines with limited amount of API. In order to achieve these challenging goals, formulation scientists must utilise proper experimental designs to develop formulations effectively. This article will provide a background on the formulation development process and explore one approach to use design of experiments (DOE) in the development of a tablet formulation. When the formulation and manufacturing process of a pharmaceutical product are optimised by a systematic approach using DOE, the product quality and cost can be effectively optimised.