Dynamics of hiatal hernia recurrence: how important is a composite crural repair?

INTRODUCTION: Hiatal hernia recurrence rates vary widely. The true causes of recurrences are not fully understood but likely multifactorial. Surgical approaches and techniques have evolved over time to try and reduce recurrence rates after hiatal hernia repair. Our objective is to provide a current review on the physiology of hiatal hernias and the importance of a composite crural repair on hiatal hernia recurrence rates; more specifically, for this review, a composite repair is defined as a repair requiring more than primary closure of the crura. METHODS: A recent review of the literature was conducted to identify studies reporting on hiatal hernia pathophysiology, stress, and tension, as well as the role of composite repair. RESULTS: There is a paucity of studies focusing on the pathophysiology of hiatal hernias and recurrence rates. Articles that report on the pathophysiology of the hiatus were found to have alterations of the extracellular matrix, collagen composition, changes in metalloproteinases (MMPs), and differences in genetic composition. The role of composite repair on reducing recurrence rates is not well studied. CONCLUSIONS: Hiatal hernias remain a complex problem with no ideal surgical technique. It is likely that the pathophysiology of hiatal hernias is multifactorial, and more studies need to be done to better understand the potential underlying mechanisms for hiatal hernias so this may also further identify the ideal surgical repair.

Leveraging real-world data to predict cancer cachexia stage, quality of life, and survival in a racially and ethnically diverse multi-institutional cohort of treatment-naïve patients with pancreatic ductal adenocarcinoma.

Introduction: Cancer-associated cachexia (CC) is a progressive syndrome characterized by unintentional weight loss, muscle atrophy, fatigue, and poor outcomes that affects most patients with pancreatic ductal adenocarcinoma (PDAC). The ability to identify and classify CC stage along its continuum early in the disease process is challenging but critical for management. Objectives: The main objective of this study was to determine the prevalence of CC stage overall and by sex and race and ethnicity among treatment-naïve PDAC cases using clinical, nutritional, and functional criteria. Secondary objectives included identifying the prevalence and predictors of higher symptom burden, supportive care needs, and quality of life (QoL), and examining their influence on overall survival (OS). Materials and methods: A population-based multi-institutional prospective cohort study of patients with PDAC was conducted between 2018 and 2021 by the Florida Pancreas Collaborative. Leveraging patient-reported data and laboratory values, participants were classified at baseline into four stages [non-cachexia (NCa), pre-cachexia (PCa), cachexia (Ca), and refractory cachexia (RCa)]. Multivariate regression, Kaplan Meier analyses, and Cox regression were conducted to evaluate associations. Results: CC stage was estimated for 309 PDAC cases (156 females, 153 males). The overall prevalence of NCa, PCa, Ca, and RCa was 12.9%, 24.6%, 54.1%, and 8.4%, respectively. CC prevalence across all CC stages was highest for males and racial and ethnic minorities. Criteria differentiated NCa cases from other groups, but did not distinguish PCa from Ca. The most frequently reported symptoms included weight loss, fatigue, pain, anxiety, and depression, with pain significantly worsening over time. The greatest supportive care needs included emotional and physical domains. Males, Black people, and those with RCa had the worst OS. Conclusions: Using clinical, nutritional, and functional criteria, nearly one-quarter of the PDAC cases in our diverse, multi-institutional cohort had PCa and 62.5% had Ca or RCa at the time of diagnosis. The PCa estimate is higher than that reported in prior studies. We recommend these criteria be used to aid in CC classification, monitoring, and management of all incident PDAC cases. Findings also highlight the recommendation for continued emotional support, assistance in alleviating pain, and supportive care needs throughout the PDAC treatment journey.

Publication Bias in Clinical Trials in Cataract Therapies: Implications for Evidence-Based Decision-Making: Publication Bias in Clinical Trials in Cataract Therapies.

ABSTRACT: Evidence-based decision-making is generally based on published evidence. Therefore, if the published evidence is biased, so will the decision-making. One possible bias is the "positive-results" publication bias. This study attempts to characterize this phenomenon in cataract therapy trials. Studies were categorized as "positive" if their results were congruent with the hypothesis and "negative" if not. Secondary outcomes included the influence of funding source and differences in publication metrics between "positive" and "negative" publications. The US NLM Clinical Trials database was reviewed for cataract trials, yielding 248 trials. Trials with less than 2 treatment arms, less than 5 participants, or insufficient reporting were excluded. Data was collected on intervention, treatment arms, funding type, publication rates, citation rate, and the impact factor/H-index of journals. Of the 132 trials included, there were 69 positive and 63 negative results. Publication rate for positive results (71%) was significantly greater than negative results (17%), (p<0.01), with no significant difference in the other publication metrics. In conclusion, "negative" result trials are published less frequently, but are equally valued, if published. There are implications for evidence-based medicine with these findings.

Evaluation of body mass index, ponderal index, visceral cross-sectional area, subcutaneous fat cross-sectional area, and liver volume as predictive factors for obesity-related comorbidities: a retrospective cohort study.

BACKGROUND: The body mass index (BMI) is an imperfect clinical measure of obesity that should be used in conjunction with other valid measures of weight-related risk. We studied whether there is a superior measure of obesity-related comorbidities. METHODS: Records of bariatric clinic patients who had an abdominal computed tomography (CT) within 1 year of visit were reviewed. The presence of obesity-related comorbidities was determined at the time of the scan. BMI and ponderal index (PI) were calculated, and CT scans were reviewed to determine the visceral cross-sectional area (VCSA), subcutaneous fat cross-sectional area (SFCSA), and liver volume (LV). Data were analyzed using the Kruskal-Wallis test and Mann-Whitney U test. RESULTS: A higher number of comorbidities were found to be associated with a larger BMI (P = .011), VCSA (P = .014), SFCSA (P = .007), and LV (P = .014), but not a larger PI (P = .11). Of the 16 comorbidities assessed, VCSA and LV were associated with more than BMI and SFCSA. However, each measure could be associated with different comorbidities. A higher BMI was associated with increased insulin use (P = .034), hypertension (P = .007), and history of obstructive sleep apnea (P = .015), none of which were associated with PI. BMI and PI were the only measures associated with a history of deep vein thrombosis/pulmonary embolism (both P < .01). Only SFCSA was found to be associated with gastroesophageal reflux disease (P = .029). VCSA (P = .038) and LV (P = .001) were associated with nonalcoholic fatty liver disease. CONCLUSION: No measure could account for all obesity-related comorbidities, implying the need for targeted measurements. However, PI was the least effective measure.

Publication Bias in Upper Gastrointestinal Oncology Clinical Trials.

PURPOSE: Evidence-based medicine requires evaluation of the medical literature to guide clinical reasoning and treatment recommendations. The presence of publication bias towards exclusion of non-statistically significant clinical trials may be leading to an incomplete evaluation of the literature and cause potentially incomplete guidance for patients. We aimed to compare publication rates and impact of publications of positive and negative outcome clinical trials. METHODS: We queried the US National Library of Medicine Clinical Trials database identifying clinical trials with reported results on the topics of pancreatic, liver, and gastric cancer. A "positive" trial was defined as having a statistically significant difference between the treatment arms, while a "negative" did not. Data collected included termination cause, intervention, funding type, publication rates, and journal characteristics. RESULTS: In total, 535 clinical trials were examined, across all pathologies clinical trials with significant findings for the primary outcome were published at a higher rate (99%) compared to those with non-significant findings (77%) (p < 0.01). Significantly, more studies with significant findings reached at least 80% of their estimated enrollment goal versus non-significant studies, 72% and 53% respectively (p < 0.01). Three of four metrics for impact of publication showed no difference between significant and non-significant studies once they reached publication. CONCLUSION: These findings suggest that clinical trials of three of the most common upper gastrointestinal malignancies have a publication bias towards studies with significant primary outcome findings. This study has implications to the way evidence-based medicine is practiced as the medical literature appears to be failing to capture important data for consideration of clinical decision making.