Objectives

Evaluate the preclinical evidence for human cell therapies for the treatment of traumatic brain injury (TBI), determine behavioral effect sizes for modified and non-modified cells, and identify variables that correlate with greater effect sizes.

Methods

A literature search identified 58 animal studies of TBI using human stem cells. Each study received a Quality Index (QI) score based on existing guidelines. Effect sizes for cell therapies were determined for the most common behavioral endpoints: Morris Water Maze (MWM) latency/correct quadrant, and modified Neurological Severity Score (mNSS).

Results

50 studies reported significant behavioral and/or histological improvement. The mean effect size for MWM latency was -1.08 for non-modified cells and -3.35 for modified cells. The mean effect size for MWM percent time in the correct quadrant was 1.66 for non-modified cells and 4.36 for modified cells. The mean effect size on the mNSS was -1.56 for non-modified cells and -4.46 for modified cells. No significant associations were found between methodological variables and effect sizes other than route of administration, where intra-lesional delivery resulted in larger effect sizes than i.v. or ventricular delivery. Studies with higher QI had smaller effect sizes; studies with larger effect sizes had greater standard errors. QI was not associated with journal impact factor.

Conclusions

Although human cell therapy studies report improved behavioral outcomes in the majority of preclinical literature, the methods are too heterogeneous to facilitate direct comparisons and bias was detected. Replication and standardization are needed to identify procedural variables to yield the best results. We encourage the use of quality criteria and rigor for future studies of human cell therapy in animal models of TBI.

Objective

The primary endpoints of this study were long-term weight loss, morbidity, and changes in comorbidities and quality of life.

Background

Bariatric surgery is an effective option for the treatment of severe obesity and its related comorbidities. However, few studies have reported on the long-term outcome (>5 yrs) of bariatric surgery.

Methods

Between 2002 and 2007, 250 patients with a body mass index (BMI) of 35 to 60 kg/m were randomly assigned to undergo laparoscopic gastric bypass or laparoscopic gastric banding. After exclusions, 111 patients underwent gastric bypass and 86 patients underwent gastric banding. Factors predictive of improved weight loss were analyzed using multiple logistic regressions.

Results

At baseline, the mean age was 43 ± 10 years and the mean BMI was 46.5 ± 5.6 kg/m. At 10-year follow-up, the mean total body weight loss for the entire cohort was -37.5 ± 19.4 kg, -42.4 ± 19.6 kg for gastric bypass versus -27.4 ± 14.5 kg for gastric banding. Late reoperation was significantly higher after gastric banding compared with the gastric bypass group (31.4% vs. 8.1%, respectively, P < 0.01). For the entire cohort, improvement or remission of diabetes occurred in 68%; 61% for hypertension; and 57% for dyslipidemia. The long-term mortality for the entire cohort was 1.0% at a mean follow-up of 9.5 ± 0.4 years. Factors predictive of improved weight loss included the type of operation (ie, gastric bypass), female sex, and the absence of diabetes at baseline. At long-term follow-up, quality of life continues to be improved from baseline for both the groups.

Conclusions

Bariatric surgery is an effective treatment for severe obesity with durable 10-year weight loss and improvement in comorbidities and quality of life. Compared with gastric banding, gastric bypass was associated with better long-term weight loss, lower rate of late reoperation, and improved remission of comorbidities.

Objective

The primary endpoints of this study were long-term weight loss, morbidity, and changes in comorbidities and quality of life.

Background

Bariatric surgery is an effective option for the treatment of severe obesity and its related comorbidities. However, few studies have reported on the long-term outcome (>5 yrs) of bariatric surgery.

Methods

Between 2002 and 2007, 250 patients with a body mass index (BMI) of 35 to 60 kg/m were randomly assigned to undergo laparoscopic gastric bypass or laparoscopic gastric banding. After exclusions, 111 patients underwent gastric bypass and 86 patients underwent gastric banding. Factors predictive of improved weight loss were analyzed using multiple logistic regressions.

Results

At baseline, the mean age was 43 ± 10 years and the mean BMI was 46.5 ± 5.6 kg/m. At 10-year follow-up, the mean total body weight loss for the entire cohort was -37.5 ± 19.4 kg, -42.4 ± 19.6 kg for gastric bypass versus -27.4 ± 14.5 kg for gastric banding. Late reoperation was significantly higher after gastric banding compared with the gastric bypass group (31.4% vs. 8.1%, respectively, P < 0.01). For the entire cohort, improvement or remission of diabetes occurred in 68%; 61% for hypertension; and 57% for dyslipidemia. The long-term mortality for the entire cohort was 1.0% at a mean follow-up of 9.5 ± 0.4 years. Factors predictive of improved weight loss included the type of operation (ie, gastric bypass), female sex, and the absence of diabetes at baseline. At long-term follow-up, quality of life continues to be improved from baseline for both the groups.

Conclusions

Bariatric surgery is an effective treatment for severe obesity with durable 10-year weight loss and improvement in comorbidities and quality of life. Compared with gastric banding, gastric bypass was associated with better long-term weight loss, lower rate of late reoperation, and improved remission of comorbidities.

Abstract Objective: To highlight the high prevalence of TDP-43 pathology, also known as limbic predominant age related TDP-43 encephalopathy (LATE), and its strong association with dementia in the oldest old. Background: The oldest old are the fastest growing segment of our population with the highest prevalence of dementia. By year 2050, more than 50% of dementia sufferers in the US will belong to this age group. TDP-43 pathology is a frequent but less studied pathology in this age. We describe findings from The 90+ Study, a longitudinal clinical and autopsy study of participants aged 90 years and older, that shows TDP-43 pathology might be as important as Alzheimer’s disease (AD) in this age. Design/Methods: 241 participants of the 90+ study with comprehensive clinical, neuropsychology, and neuropathology data were included. Dementia status, clinical syndrome, and impaired cognitive domains were determined at multi-disciplinary post-mortem conferences blind to autopsy data. AD neuropathology (ADNP) was defined as CERAD score for neuritic plaques ≥2 and Braak stage for neurofibrillary tangles ≥5. TDP-43 pathology was considered present in those with at least amygdala and hippocampal TDP-43. Logistic regression analyses adjusting for age, sex, and education, explored the association between ADNP, TDP-43, and dementia, clinical diagnosis of AD, and memory impairment. Results: 125 participants (52%) died with dementia (Mean age at death: 98.1, 75% female). Of these, 33% had TDP-43 and 40% had ADNP. TDP-43 was as important a predictor of dementia and clinical diagnosis of AD at death as ADNP (For dementia outcome: TDP-43 OR: 3.0 vs. ADNP OR: 2.6; For clinical AD outcome: TDP OR: 3.5 vs. ADNP OR: 3.4). Both pathologies independently predicted memory impairment (TDP-43 OR: 4.7; ADNP OR: 4.1). Conclusions: Our results suggest TDP-43 pathology is as important as ADNP in people over 90, the age group that will have the greatest number of dementia sufferers.

Background

There are limited available data comparing open, laparoscopic, and robotic approaches for rectal cancer surgery.

Objective

We sought to investigate outcomes of different surgical approaches to abdominoperineal resection in patients with rectal cancer.

Design

The nationwide inpatient sample database was used to examine the clinical data of patients with rectal cancer who underwent elective abdominoperineal resection between 2009 and 2012 in the United States. Multivariate regression analysis was performed to compare outcomes of different surgical approaches.

Settings

A retrospective review according to the national inpatient sample database was designed.

Patients

We included patients with rectal cancer who underwent elective abdominoperineal resection between 2009 and 2012.

Main outcome measures

Outcomes of different surgical approaches to abdominoperineal resection were investigated.

Results

We sampled 18,359 patients with rectal cancer who underwent elective abdominoperineal resections. Of these, 69.5% had open surgery, 25.8% had laparoscopic surgery, and 4.7% had robotic surgery. The rate of robotic procedures increased >4-fold, from 2.1% to 8.1%, from 2009 to 2012. The conversion rate in robotic surgery was significantly lower compared with laparoscopic surgery (5.7% vs 13.4%; p < 0.01). After risk adjustment, patients who underwent laparoscopic and robotic approaches had lower morbidity risks compared with those who underwent the open approach (adjusted OR = 0.77 (95% CI, 0.65-0.92), 0.57 (95% CI, 0.40-0.80); p < 0. 01). There were no significant differences in the morbidity rate of patients who underwent laparoscopic or robotic approaches (adjusted OR = 0.79 (95% CI, 0.55-1.14); p = 0.21). However, patients who underwent the robotic approach had significantly higher total hospital charges compared with those who underwent the laparoscopic approach (mean difference, $24,890; p < 0.01).

Limitations

We could not adjust the results with some important factors, such as the tumor stage and BMI.

Conclusions

The use of robotic and laparoscopic approaches to abdominoperineal resection have increased between 2009 and 2012. Both minimally invasive approaches decrease morbidity rates of patients undergoing abdominoperineal resection. The robotic approach has a significantly lower conversion rate compared with the laparoscopic approach. However, it had significantly higher total hospital charges compared with the laparoscopic approach.

Emerging evidence indicates that the predictability of signals early in life may influence the developing brain. This study examines links between a novel indicator of maternal mood dysregulation, mood entropy, and child neurodevelopmental outcomes. Associations between prenatal maternal mood entropy and child neurodevelopment were assessed in 2 longitudinal cohorts. Maternal mood was measured several times over pregnancy beginning as early as 15 weeks gestation. Shannons mood entropy was applied to distributions of mothers responses on mood questionnaires. Child cognitive and language development were evaluated at 2 and 6-9 years of age. Higher prenatal maternal mood entropy was associated with lower cognitive development scores at 2 years of age and lower expressive language scores at 6-9 years of age. These associations persisted after adjusting for maternal pre and postnatal mood levels and for other relevant sociodemographic factors. Our findings identify maternal mood entropy as a novel predictor of child neurodevelopment. Characterizing components of maternal mood in addition to level of severity or valence may further our understanding of specific processes by which maternal mood shapes child development. (PsycInfo Database Record (c) 2021 APA, all rights reserved).

Background

There is no published data regarding the relationship between hospital volume and outcomes in patients undergoing laparoscopic diaphragmatic hernia repair. We hypothesize that hospitals performing high case volume have improved outcomes compared to low-volume hospitals.

Materials and methods

We reviewed the National Inpatient Sample (NIS) database between 2008 and 2012 for adults with the diagnosis of diaphragmatic hernia who underwent elective laparoscopic repair of diaphragmatic Hernia and/or Nissen fundoplication. Pediatric, emergent, and open cases were excluded. Main outcome measures included logistic regression analysis of factors predictive of in-hospital mortality and outcomes according to annual hospital case volume.

Results

A total of 31,228 laparoscopic diaphragmatic hernia operations were analyzed. The overall in-hospital mortality was 0.14%. Risk factors for higher in-hospital mortality included renal failure (AOR: 6.26; 95% CI: 2.48-15.78; p < 0.001), age>60 years (AOR: 5.06; 95% CI: 2.38-10.76; p < 0.001), and CHF (AOR: 3.80; 95% CI: 1.39-10.38; p = 0.009) while an incremental increase in volume of 10 cases/year (AOR: 0.89; 95% CI: 0.81-0.98; p = 0.019) and diabetes (AOR: 0.34; 95% CI: 0.12-0.93; p = 0.036) decreases mortality. There was a small but significant inverse relationship between hospital case volume and mortality with a 10% reduction in adjusted odds of in-hospital mortality for every increase in 10 cases per year. Using 10 cases per year as the volume threshold, low-volume hospitals (≤10 cases/year) had almost a twofold higher mortality compared to high-volume hospitals (0.23 vs. 0.12%, respectively, p = 0.02).

Conclusions

There was a small but significant inverse relationship between the hospitals' case volume and mortality in laparoscopic diaphragmatic hernia repair.

Statement of problem

Conventional diagnostic aids based upon imagery and patient symptoms do not indicate whether restorative treatments have eliminated structural pathology.

Purpose

The purpose of this clinical study was to evaluate quantitative percussion diagnostics (QPD), a mechanics-based methodology that tests the structural integrity of teeth noninvasively. The study hypothesis was that QPD would provide knowledge of the structural instability of teeth after restorative work.

Material and methods

Eight participants with 60 sites needing restoration were enrolled in an IRB-approved clinical study. Each participant was examined comprehensively, including QPD testing. Each site was disassembled and microscopically video documented, and the results were recorded on a defect assessment sheet. A predictive model was developed for the pathology rating based on normalized fit error (NFE) values using data from the before treatment phase of the study published previously. Each restored site was then tested using QPD. The mean change in NFE values after restoration was evaluated by the pathology rating before treatment. The model was then used to predictively classify the rating after restoration based on the NFE values after treatment. The diagnostic potential of the rating was explored as a marker for risk of pathology after restoration.

Results

After restoration, 51 of the 60 sites fell below an NFE of 0.04, representing a greatly stabilized tooth site sample group. Several sites remained in the high-risk category and some increased in pathologic micromovement. Two models were used to determine severity with indicative cutoff points to group sites with similar values.

Conclusions

The data support the hypothesis that QPD can indicate a revised level of structural instability of teeth after restoration.

Background

In 2006, the Centers for Medicare and Medicaid Services issued a National Coverage Determination (NCD), which mandates that bariatric procedures be performed only at accredited centers. The aim of this study was to analyze outcomes of Medicare beneficiaries who underwent bariatric surgery before (2001 through 2005) vs after (2006 through 2010) implementation of the NCD.

Study design

The Nationwide Inpatient Sample database was used to analyze data on patients who underwent bariatric surgery between 2001 and 2010. Main outcomes measures were demographics, length of stay, risk-adjusted inpatient morbidity and mortality, and cost.

Results

There were 775,040 patients who underwent bariatric surgery, with 16% of the patients Medicare beneficiaries. There was an overall trend for improved in-hospital mortality during the decade (0.35% in 2001 to 0.10% in 2010). Medicare patients who underwent bariatric surgery had higher rates of comorbidities and a higher rate of in-hospital mortality than non-Medicare patients. After the NCD, there was a significant reduction of the in-hospital mortality (0.56% vs 0.23%; p < 0.01) and serious morbidity (9.92% vs 6.98%; p < 0.01) for Medicare patients and a similar reduction of the in-hospital mortality (0.18% vs 0.08%; p < 0.01) and serious morbidity (6.84% vs 5.08%; p < 0.01) for non-Medicare patients. Compared with patients who underwent stapling bariatric procedures at accredited centers, patients at nonaccredited centers had higher risk-adjusted in-hospital mortality (odds ratio = 3.53; 95% CI, 1.01-6.52) and serious morbidity (odds ratio = 1.18; 95% CI, 1.07-1.30). After the NCD, use of bariatric surgery within Medicare beneficiaries increased by 71%.

Conclusions

Outcomes of bariatric surgery in Medicare beneficiaries have improved substantially since the 2006 NCD. Facility accreditation appears to be a contributing factor to the observed improvement in outcomes.