Search

Background: Occipitocervical fusion (OCF) procedures are increasing due to an aging population and the prevalence of trauma, rheumatoid arthritis, and tumors. Reoperation rates and readmission risk factors for cervical fusions have been established, but in relation to OCF they have not been explored. This study investigates the patterns of readmissions and complications following OCF using a national database., Methods: The 2016 U.S. Nationwide Readmissions Database was used for sample collection. Adults (>18 years) who underwent OCF were identified using the 2016 ICD-10 coding system, and we examined the readmission rates (30-day and 90-day) and reoperation rates., Results: Between January and September 2016, a total of 477 patients underwent OCF; the 30-day and 90-day readmission rates were 10.4% and 22.4%, respectively. The 90-day reoperation rate related to the index surgery was 5.7%. Mean age (68.58 years) was significantly greater in the readmitted group versus nonreadmitted group (61.76 years) (P < 0.001). The readmitted group had a significantly higher Charlson Comorbidity Index and Elixhauser Comorbidity Index (5.00 and 2.41, respectively) than the nonreadmitted group (3.25 and 1.15, respectively; P < 0.001). Nonelective OCF showed a higher readmission rate (29.18%) versus elective OCF (12.23%) (P < 0.001). Medicare and Medicaid patients showed the highest rates of readmission (27.27% and 20.41%, respectively). Readmitted patients had higher total health care costs., Conclusions: Nonelective OCF was found to have a readmission rate of almost 2½× that of elective OCF. Understanding risk factors associated with OCF will help with operative planning and patient optimization., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Background: While considered a safe operation, deep brain stimulation (DBS) has been associated with various morbidities. We assessed differences in postsurgical complication rates in patients undergoing the most common types of neurostimulation surgery., Methods: The National Readmission Database (NRD) was queried to identify patients undergoing neurostimulation placement with the diagnosis of Parkinson disease (PD), epilepsy, dystonia, or essential tremor (ET). Demographics and complications, including infection, pneumonia, and neurostimulator revision, were queried for each cohort and compiled. Readmissions were assessed in 30-, 90-, and 180-day intervals. We implemented nearest-neighbor propensity score matching to control for demographic and sample size differences between groups., Results: We identified 3230 patients with Parkinson disease, 1289 with essential tremor, 965 with epilepsy, and 221 with dystonia. Following propensity score matching, 221 patients remained in each cohort. Readmission rates 30-days after hospital discharge for PD patients (15.5 %) were significantly greater than those for ET (7.8 %) and seizure patients (4.4 %). Pneumonia was reported for PD (1.6 %), seizure (3.3 %) and dystonia (1.7 %) patients but not individuals ET. No PD patients were readmitted at 30-days due to dysphagia while individuals treated for ET (6.5 %), seizure (1.6 %) and dystonia (5.2 %) were. DBS-revision surgery was performed for 11.48 % of PD, 6.52 % of ET, 1.64 % of seizure and 6.90 % of dystonia patients within 30-days of hospital discharge., Conclusion: 30-day readmission rates vary significantly between indications, with patients receiving DBS for PD having the highest rates. Further longitudinal studies are required to describe drivers of variation in postoperative outcomes following DBS surgery for different indications., (Copyright © 2020 Elsevier B.V. All rights reserved.)

Objectives: The objective of the study is to review the literature for studies that assessed the concordance of financial conflicts of interest disclosures with payments' databases and evaluate their methods., Study Design and Setting: We conducted a systematic survey of the health literature to identify eligible studies. We searched both Medline and EMBASE up to February 2017. We conducted study selection, data abstraction, and methodological quality assessment in duplicate and independently using standardized forms. We subcategorized 'nonconcordant disclosures' as either 'partially nonconcordant' or 'completely nonconcordant'. The main outcome was the percentage of authors with 'nonconcordant' disclosures. We summarized results by three levels of analysis: authors, companies, and studies., Results: We identified 27 eligible journal articles. The top two types of documents assessed were published articles (n = 13) and published guidelines (n = 9). The most commonly used payment database was the Open Payments Database (n = 16). The median percentage of authors with 'nonconcordant' disclosures was 81%; the median percentage was 43% for 'completely nonconcordant' disclosures. The percentage of 'nonconcordant' conflict of interest (COI) reporting by companies varied between 23% and 85%. The methods of concordance assessment, as well as the labeling and definitions of assessed outcomes varied widely across the included studies. We judged three of the included studies as high-quality studies., Conclusion: Underreporting of health science researchers' financial COIs is pervasive. Studies assessing COI underreporting suffer from a number of limitations that could have overestimated their findings., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Background: Every year, there are an estimated 22.6 million new neurosurgical consultative cases worldwide, of which 13.8 million require surgery. In 2016, the global neurosurgical workforce was estimated and mapped as open-access information to guide neurosurgeons, affiliates, and policy makers. We present a subsequent investigation for mapping the global neurosurgical workforce for 2018 to show the replicability of previous data collection methods as well as to show any changes in workforce density., Methods: We extracted data on the absolute number of neurosurgeons per low and middle-income countries (LMICs) in 2016 from the database of the global neurosurgical workforce mapping project. The estimated number of neurosurgeons in each LMIC during 2018 was obtained from collaborators. The median workforce densities were calculated for 2016 and 2018. Neurosurgical workforce density heat maps were generated., Results: We received data from 119 countries (response rate 86.2%) and imputed data for 19 countries (13.8%). Seventy-eight (56.5%, N = 138) countries had an increase in their number of neurosurgeons, 9 (6.5%) showed a decrease, whereas 51 (37.0%) had the same number of neurosurgeons in both years. The pooled median increased from 0.17 (interquartile range, 0.54) in 2016 to 0.18 (interquartile range, 0.59) in 2018., Conclusions: Overall, the density of the neurosurgical workforce has increased from 2016 to 2018. However, at the current rate, 80 LMICs (58.0%) will not meet the neurosurgical workforce density target by 2030., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Objectives: Surgical site infections (SSIs) result in significant negative clinical and economic outcomes. The objective of this study is to estimate annual health expenditures associated with spinal cord stimulation (SCS)-related infections., Materials and Methods: Data from the Truven MarketScan® databases were used to identify patients with an SCS implant (2009-2014) and a continuous health plan enrollment for at least 12-months before and after implant (index date). Annual expenditures were estimated for patients with a device-related infection vs. those without infection since index date. A generalized linear model estimated annual expenditures attributable to device-related infection. Multivariable expenditure models were conducted separately for patients in initial and replacement groups, controlling for demographics, comorbidities, and clinical characteristics., Results: The study included 6615 patients. Multivariable expenditure models revealed that patients with infection have higher annual expenditures than patients without infection. Estimated incremental annual healthcare expenditures for patients with an infection were $59,716 (95% CI: $48,965-$69,480) for initial implanted patients and $64,833 (95% CI: $37,377-$86,519) for replacement patients. Only 26% of patients who were explanted for infection underwent a reimplant., Conclusions: These results show the substantial expenditure burden associated with an SCS-related infection. Management of SCS-related infection is important from both clinical and economic standpoints. The economic and clinical data presented here reinforce the need for additional research and strategies for healthcare providers to minimize SCS infections. Future economic research is needed to further define the specific economic cost drivers associated with the extensive expenditure burden., (© 2019 International Neuromodulation Society.)

Objectives: To describe all published articles that have conducted comparisons of model-based effectiveness and cost-effectiveness results in the field of vaccination. Specific objectives were to 1) describe the methodologies used and 2) identify the strengths and limitations of the studies., Methods: We systematically searched MEDLINE and Embase databases for studies that compared predictions of effectiveness and cost-effectiveness of vaccination of two or more mathematical models. We categorized studies into two groups on the basis of their data source for comparison (previously published results or new simulation results) and performed a qualitative synthesis of study conclusions., Results: We identified 115 eligible articles (only 5% generated new simulations from the reviewed models) examining the effectiveness and cost-effectiveness of vaccination against 14 pathogens (69% of studies examined human papillomavirus, influenza, and/or pneumococcal vaccines). The goal of most of studies was to summarize evidence for vaccination policy decisions, and cost-effectiveness was the most frequent outcome examined. Only 33%, 25%, and 3% of studies followed a systematic approach to identify eligible studies, assessed the quality of studies, and performed a quantitative synthesis of results, respectively. A greater proportion of model comparisons using published studies followed a systematic approach to identify eligible studies and to assess their quality, whereas more studies using new simulations performed quantitative synthesis of results and identified drivers of model conclusions. Most comparative modeling studies concluded that vaccination was cost-effective., Conclusions: Given the variability in methods used to conduct/report comparative modeling studies, guidelines are required to enhance their quality and transparency and to provide better tools for decision making., (Copyright © 2018 ISPOR--The Professional Society for Health Economics and Outcomes Research. Published by Elsevier Inc. All rights reserved.)

Background: To assess whether implementation of the Mental Health Parity and Addiction Equity Act (MHPAEA) was associated with: 1. Reduced differences in financial requirements (i.e., copayments and coinsurance) for substance use disorder (SUD) versus specialty mental health (MH) care and 2. Reductions in the level of cost-sharing for SUD-specific services., Methods: MH and SUD copayments and coinsurance, 2008-2013, were obtained from benefits databases for carve-in and carve-out plans from Optum ® . Linear regression was used to estimate the association of MHPAEA with differences between MH and SUD care financial requirements among carve-in and carve-out plans. A two-part regression model investigated whether MHPAEA was associated with changes in the use or level of financial requirements for SUD-specific services among carve-out plans., Results: MHPAEA was not associated with significant changes in the difference between SUD and MH copayments or coinsurance levels among either carve-in or carve-out plans. MHPAEA was associated with decreases in the levels of inpatient (in-network: -$51.17; out-of-network: -$34.39) and outpatient (in-network: -$10.26) detox copayments, but increases in the levels of in-network outpatient detox coinsurance (6 percentage points) among all carve-out plans., Conclusion: Even if SUD benefits had been historically less generous than MH benefits, SUD financial requirements were already at parity with MH financial requirements by the time MHPAEA was passed, among Optum ® plans. MHPAEA's SUD parity mandate reduced cost-sharing for detox services via copayments, but, for outpatient detox, the law simultaneously increased cost-sharing via coinsurance., (Copyright © 2018. Published by Elsevier B.V.)

Objective: The 2013 Physician Payments Sunshine Act mandates that all U.S. drug and device manufacturers disclose payments to physicians. All payments are made available annually in the Open Payments Database (OPD). Our aim was to determine prevalence, magnitude, and nature of these payments to physicians performing neurologic surgery in 2015 and to discuss the role that financial conflicts of interest play in neurosurgery., Methods: All records of industry financial relationships with physicians identified by the neurological surgery taxonomy code in 2015 were accessed via the OPD. Data were analyzed in terms of type and amounts of payments, companies making payments, and comparison with previous studies., Results: In 2015, 83,690 payments (totaling $99,048,607) were made to 7613 physicians by 330 companies. Of these, 0.01% were >$1 million, and 73.2% were <$100. The mean payment ($13,010) was substantially greater than the median ($114). Royalties and licensing accounted for the largest monetary value of payments (74.2%) but only 1.7% of the total number. Food and beverage payments were the most commonly reported transaction (75%) but accounted for only 2.5% of total reported monetary value. Neurologic surgery had the second highest average total payment per physician of any specialty., Conclusions: The neurological surgery specialty receives substantial annual payments from industry in the United States. The overall value is driven by a small number of payments of high monetary value. The OPD provides a unique opportunity for increased transparency in industry-physician relationships facilitating disclosure of financial conflicts of interest., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Background: Many pharmacoepidemiologic studies using large-scale databases have recently been utilized to evaluate the safety and effectiveness of drugs in Western countries. In Japan, however, conventional methodology has been applied to postmarketing surveillance (PMS) to collect safety and effectiveness information on new drugs to meet regulatory requirements. Conventional PMS entails enormous costs and resources despite being an uncontrolled observational study method. This study is aimed at examining the possibility of database research as a more efficient pharmacovigilance approach by comparing a health care claims database and PMS with regard to the characteristics and safety profiles of sertraline-prescribed patients., Methods: The characteristics of sertraline-prescribed patients recorded in a large-scale Japanese health insurance claims database developed by MinaCare Co. Ltd. were scanned and compared with the PMS results. We also explored the possibility of detecting signals indicative of adverse reactions based on the claims database by using sequence symmetry analysis. Diabetes mellitus, hyperlipidemia, and hyperthyroidism served as exploratory events, and their detection criteria for the claims database were reported by the Pharmaceuticals and Medical Devices Agency in Japan., Results: Most of the characteristics of sertraline-prescribed patients in the claims database did not differ markedly from those in the PMS. There was no tendency for higher risks of the exploratory events after exposure to sertraline, and this was consistent with sertraline's known safety profile., Conclusions: Our results support the concept of using database research as a cost-effective pharmacovigilance tool that is free of selection bias . Further investigation using database research is required to confirm our preliminary observations., (Copyright © 2018. Published by Elsevier Inc.)

Background: Appropriate dissemination of clinical data is crucial for minimising bias. Despite this, high rates of study discontinuation and non-publication have been reported among clinical trials. Cardiovascular medicine receives a substantial proportion of academic funding; however, predictors of non-publication among cardiovascular trials are not well-established., Methods: The National Clinical Trials database was searched for cardiovascular trials completed between January 2010 and January 2014. Associated publications were identified in Medline or Embase. Relevant variables were extracted and subject to chi-squared and logistic regression to identify predictors of discontinuation and non-publication., Results: After reviewing 2035 trials, 431 trials were included, of which 82.1% (n=354; 119,233 participants) were completed. Among completed trials, 70.3% (n=249; 99,095 participants) were published. Industry funding was associated with increased likelihood of non-publication (odds ratio [OR] 2.84; 95% confidence interval [CI] 1.47-5.51; P=0.002), while non-randomised studies were more likely to remain unpublished than randomised counterparts. Industry-funded studies were over three times more likely to be discontinued than those sponsored by academic institutions (OR 3.89; CI 1.54-9.83; P=0.004). Trials studying heart failure and atrial fibrillation were more likely to be discontinued compared to trials studying coronary artery disease (OR 2.83; CI 1.23-6.51; and OR 3.10; CI 1.21-7.96, respectively). Of the total 135,714 participants, 25,565 were recruited into unpublished studies., Conclusions: Discontinuation and non-publication of cardiovascular trials are common, resulting in data from thousands of participants remaining unpublished. Funding source and randomisation are strong predictors of non-publication, while sponsor type, phase and blinding status are key predictors of discontinuation., (Copyright © 2017 Elsevier B.V. All rights reserved.)

The Open Payments Program (OPP) was recently implemented to publicly disclose industry payments to physicians, with the goal of enabling patient awareness of potential conflicts of interests. Awareness of OPP, its data, and its implications for transplantation are critical. We used the first wave of OPP data to describe industry payments made to transplant surgeons. Transplant surgeons (N = 297) received a total of $759 654. The median (interquartile range [IQR]) payment to a transplant surgeon was $125 ($39-1018), and the highest payment to an individual surgeon was $83 520; 122 surgeons received <$100, and 17 received >$10 000. A higher h-index was associated with 30% higher chance of receiving >$1000 (relative risk/10 unit h-index increase = 1.18 1.301.44 , p < 0.001). The highest payment category was consulting fees, with a total of $314 448 paid in this reported category. Recipients of consulting fees had higher h-indices, median (IQR) of 20 (10-35) versus nine (3-17) (p < 0.001). Ten of 122 companies accounted for 62% of all payments. Kidney transplant and liver transplant (LT) centers that received >$1000 had higher center volumes (p < 0.001). LT centers that received payments of >$1000 had a higher percentage of private-insurance/self-pay patients (p < 0.01). Continued surveillance of industry payments may further elucidate the relationship between industry payments and physician practices., (© Copyright 2015 The American Society of Transplantation and the American Society of Transplant Surgeons.)

Purpose: To examine whether neighborhood deprivation increases the odds of hospital registration for childhood and adolescent epilepsy, after accounting for family- and individual-level sociodemographic characteristics., Methods: An open cohort of all children aged 2-17 years was followed between January 1, 2000 and December 31, 2010. Children's residential addresses were geocoded and classified according to neighborhood deprivation. Data were analyzed by multilevel logistic regression, with family- and individual-level characteristics at the first level and level of neighborhood deprivation at the second level., Results: During the study period, among a total of 1,020,766 children, 9309 (0.9%) were registered with childhood and adolescent epilepsy. Age-adjusted cumulative hospital rates of childhood and adolescent epilepsy increased with increasing neighborhood-level deprivation across all family- and individual-level sociodemographic categories. The odds ratio (OR) for hospital registration for childhood and adolescent epilepsy for those living in high-deprivation neighborhoods versus those living in low-deprivation neighborhoods was 1.15. High level deprivation remained significantly associated with higher odds of childhood and adolescent epilepsy after adjustment for family- and individual-level sociodemographic characteristics (OR=1.12, 95% CI=1.04-1.21, p=0.003)., Conclusions: Our results suggest that neighborhood characteristics modestly affect the odds of hospital registration for childhood and adolescent epilepsy independently of family- and individual-level sociodemographic characteristics., (Copyright © 2013 British Epilepsy Association. Published by Elsevier Ltd. All rights reserved.)

Background: Infected necrotizing pancreatitis is a major burden for both the patient and the health care system. Little is known about how hospital costs break down and how they may have shifted with the increasing use of minimally invasive techniques. The aim of this study was to analyse inpatient hospital costs associated with pancreatic necrosectomy., Methods: A prospective database was used to identify all patients who underwent an intervention for necrotizing pancreatitis. Costs of treatment were calculated using detailed information from the Decision Support Department. Costs for open and minimally invasive surgical modalities were compared., Results: Twelve open and 13 minimally invasive necrosectomies were performed in a cohort of 577 patients presenting over a 50-month period. One patient in each group died in hospital. Overall median stay was 3.8 days in the intensive care unit (ICU) and 44 days on the ward. The median overall treatment cost was US$ 56,674. The median largest contributors to this total were ward (26.3%), surgical personnel (22.3%) and ICU (17.0%) costs. These did not differ statistically between the two treatment modalities., Conclusions: Pancreatic necrosectomy uses considerable health care resources. Minimally invasive techniques have not been shown to reduce costs. Any intervention that can reduce the length of hospital and, in particular, ICU stay by reducing the incidence of organ failure or by preventing secondary infection is likely to be cost-effective., (© 2011 International Hepato-Pancreato-Biliary Association.)

We examine the association between education and smoking by women in the population, including smoking during pregnancy, and identify risk factors for smoking and the consequences of smoking in pregnancy for children's smoking and behavioral problems. Secondary analyses of four national data sets were implemented: The National Survey of Drug Use and Health (2006), the National Longitudinal Survey of Youth (1979-2004); the National Longitudinal Survey of Adolescent Health (Wave III); National Health and Nutrition Examination Survey (2005-2006). The lower the level of education, the greater the risk of being a current smoker, smoking daily, smoking heavily, being nicotine dependent, starting to smoke at an early age, having higher levels of circulating cotinine per cigarettes smoked, and continuing to smoke in pregnancy. The educational gradient is especially strong in pregnancy. Educational level and smoking in pregnancy independently increase the risk of offspring smoking and antisocial and anxious/depressed behavior problems. These effects persist with control for other covariates, except maternal age at child's birth, which accounts for the impact of education on offspring smoking and anxious/depressed behavior problems. Women with low education should be the target of public health efforts toward reducing tobacco use. These efforts need to focus as much on social conditions that affect women's lives as on individual level interventions. These interventions would have beneficial effects not only for the women themselves but also for their offspring.

The purpose of this study was to evaluate the limits and benefits of a visualization system based on public-domain software for contemporary three-dimensional (3-D) endodontic research purposes. Three-dimensional bio-models of six human teeth and of one bone-implant specimen were generated using cross-sectional imaging. To evaluate the overall performance in processing large data sets and in reproducing accurate 3-D morphology, slices with a thickness varying from 100 microm to 10 microm were cut. Auto-outlining and segmenting techniques were tested. The 3-D bio-models represented in accurate detail the different morphological aspects of the specimen. Voxel volumes of 0.116 x 10(-5) mm3 could be realized and were only restricted by the computer hardware limitations. The system is not limited to dental hard tissues. Hypomineralized material and soft tissues as well as bone- and allogeneic-implant material could be visualized. The method presented is valid and meets current requirements applying to endodontic research. The broad-based use of high-quality, public-domain software and the resulting exchange of experience help to manage resources and may contribute to enhancing the in-process quality of research.

The routine acquisition and archiving of microbiological data is undertaken for two reasons. The first is the development of historical microbiological profiles of foods, ingredients, or processes in order to determine or verify that microorganisms of concern are being controlled to the level desired. The second reason is data concerning the pathogenicity or virulence of foodborne pathogens and their behavior in foods in order to develop strategies and criteria for assuring microbiological safety. Both types of microbiological data are essential to effective food safety programs. A firm understanding of the uses and limitations of both is essential to correct acquisition, interpretation, and use of such data.

Background: The Society of Thoracic Surgeons (STS) established the National Database (NDB) for Cardiac Surgery in 1989. Since then it has grown to be the largest database of its kind in medicine. The NDB has been one of the pioneers in the analysis and reporting of risk-adjusted outcomes in cardiothoracic surgery., Methods and Results: This report explains the numerous changes in the NDB and its structure that have occurred over the past 2 years. It highlights the benefits of these changes, both to the individual member participants and to the STS overall. Additionally, the vision changes to the NDB and reporting structure are identified. The individuals who have participated in this effort since 1989 are acknowledged, and the STS owes an enormous debt of gratitude to each of them., Conclusions: Because of their collective efforts, the goal to establish the STS NDB as a "gold standard" worldwide for process and outcomes analysis related to cardiothoracic surgery is becoming a reality.