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Introduction: Therapeutic clinical trials frequently lack diverse representation, hindering generalizability and exacerbating preexisting disparities in clinical outcomes. This study explored associations between breast cancer patient demographics, clinical trial eligibility, and enrollment in a National Cancer Institute (NCI)-designated cancer center., Patients and Methods: This prospective cohort study included patients with breast cancer screened for therapeutic clinical trials from July 2020 to January 2024. Eligibility was determined by the provider and study coordinator. Patient characteristics were abstracted from the electronic medical record. Rurality and neighborhood disadvantage were mapped by address using rural-urban commuting area codes and area deprivation index (ADI), respectively. Likelihood of eligibility and enrollment by race, rurality, and neighborhood disadvantage were evaluated using risk ratios (RR) and 95% confidence intervals (CIs) from modified Poisson regression models., Results: Of 343 patients screened for therapeutic trials, the mean age was 56 years (SD 13), 33% were Black/other race, 22% lived in highly disadvantaged areas, and 16% in rural areas. Most patients were screened for one trial (87%). Overall, 54% of patients were eligible for trials, and of those, 58% enrolled. Similar likelihoods of eligibility and enrollment were seen by race and rurality. Though not significant, patients living in highly disadvantaged areas trended toward higher likelihood of enrollment (RR 1.24, 95% CI 0.99-1.55)., Conclusions: Over half of trial-eligible patients, even across race, rurality, or neighborhood disadvantage, enrolled, surpassing the national average. In contrast to national trends, there was higher enrollment among patients of higher ADI., Competing Interests: Disclosures: Erica Stringer-Reasor Consultation: Lilly, Merck, AstraZeneca, Novartis, Grants: V foundation, Susan G. Komen Jahan Nusrat Advisory board: AstraZeneca Gabrielle B. Rocque Research: Pfizer, Genentech, Daiichi Sankyo Consulting: Armada, Gilead, Pfizer ., (© 2024. The Author(s).)

Background: People experiencing financial burden are underrepresented in clinical trials., Objective: Describe the prevalence of cost-related considerations influential to trial participation and their associations with person-level characteristics., Design: This cross-sectional study used and assessed how three cost-related considerations would influence the decision to participate in a hypothetical clinical trial., Participants: A total of 3682 US adult respondents to the Health Information National Trends Survey MAIN MEASURES: Survey-weighted multivariable logistic regression estimated associations between respondent characteristics and odds of reporting cost-related considerations as very influential to participation., Key Results: Among 3682 respondents, median age was 48 (IQR 33-61). Most were non-Hispanic White (60%), living comfortably or getting by on their income (74%), with ≥ 1 medical condition (61%). Over half (55%) of respondents reported at least one cost-related consideration as very influential to trial participation, including if usual care was not covered by insurance (reported by 42%), payment for participation (24%), or support for participation (24%). Respondents who were younger (18-34 vs. ≥ 75, adjusted odds ratio [aOR] 4.3, 95% CI 2.3-8.1), more educated (high school vs.

An ideal model for decision making in cancer is shared decision-making (SDM). Primary facilitators in this model are information-seeking about treatment options and patient-physician trust. Previous studies have investigated the role of each of these parameters individually. However, little is known about their convergent role in treatment decision-making. Therefore, we explored perspectives of metastatic breast cancer (MBC) patients and healthcare professionals about the influence of health information-seeking and physician trust in the SDM process. Qualitative interviews with 20 MBC patients and 6 community oncologists, as well as 3 separate focus groups involving lay navigators, nurses, and academic oncologists, were conducted, recorded, and transcribed. Qualitative data analysis employed a content analysis approach, which included a constant comparative method to generate themes from the transcribed textual data. Five emergent themes were identified (1) physicians considered themselves as the patients' primary source of treatment information; (2) patients trusted their physician's treatment recommendations; (3) patients varied in their approach to seeking further health information regarding the discussed treatment options (e.g., internet websites, family and friends, support groups); (4) other healthcare professionals were cognizant of their fundamental role in facilitating further information-seeking; and (5) patient and physician discordant perspectives on shared decision making were present. Patient procurement of treatment information and the capacity to use it effectively in conjunction with patient trust in physicians play an important role in the shared decision-making process.

Despite the recognized advantage of surgical meshes in abdominal hernia repair, reports of long term complications after implantation are increasing. 25 chronic hernia rats underwent incisional repair (n = 5/mesh group) with compressed poly(tetra-fluoro-ethylene) (cPTFE), expanded poly(tetra-fluoro-ethylene) (ePTFE), polypropylene (PP), poly(ethylene-terephtalate) + collagen (PET + C), and porcine intestinal submucosa (SIS). At 30 days, the extent and strength of intra-abdominal adhesions was evaluated, along with tissue-mesh integration, material shrinkage, and inflammatory response. The extent and tenacity of adhesions were reduced in PET + C and SIS, while tissue contraction was largely reduced in the presence of cPTFE. The tissue integration was not affected by composition or material construction. The host tissue response was elevated and arrested in a chronic imflammatory phase in the presence of PET + C and SIS, and resolved in the case of cPTFE. The different composition and material construction did not affect significantly the overall performance of the evaluated surgical meshes, apart from PP.

Background: Salvaging infected prosthetic material after ventral hernia repair is rarely successful. Most cases require mesh excision and complex abdominal wall reconstruction, with variable success rates. We report two cases of mesh salvage with a novel use of percutaneous drainage and antibiotic irrigation., Cases: Two patients developed infected seromas after laparoscopic ventral hernia repair. One patient with a remote history of methicillin-resistant Staphylococcus aureus (MRSA) mesh infection underwent laparoscopic ventral hernia repair with a 20 x 23-cm piece of Parietex composite mesh. Two weeks post-operatively, he developed fevers and MRSA was aspirated from the seroma. Another patient had a 32 x 33-cm piece of ePTFE placed for repair. He subsequently developed a massive seroma requiring repeated aspirations. Four months following the repair, he developed an infected seroma with Klebsiella pneumonia. Each patient underwent percutaneous drainage of their abscesses with a six-French-pigtail catheter under ultrasound guidance. After 2 weeks of parenteral antibiotics and clinical resolution, the patients were placed on 4 weeks of gentamicin irrigations (80 mg in 30 cc solution) via the drain three times per day. Once therapy was completed, the drains were removed. The first patient also remains on daily oral doxycycline for suppression for his MRSA. Both patients have remained free of clinical signs of infection at 12 and 16 months, respectively, following the completion of therapy., Conclusion: Percutaneous drainage followed by antibiotic irrigation is a potential alternative to prosthetic removal when treating infected mesh in carefully selected patients.

Background: The NDO Plicator is a device developed for endoscopic treatment of gastroesophageal reflux disease (GERD) by approximation of tissues together with a double-pledgeted U-stitch. It was theorized that this device may facilitate transgastric natural orifice translumenal endoscopic surgery (NOTES) because closure of the transgastric defect remains a key component for advancement of this new technology., Methods: A standardized 12-mm gastrotomy was created endoscopically in four pigs using a combination of needle-knife cautery and balloon dilation. As the endoscope was removed, a Savary soft-tipped wire was introduced into the stomach, and the NDO Plicator was subsequently advanced over the wire. Each defect was identified, and the device was positioned. If necessary, the Plicator's tissue grasper was used to hold the superior aspect of the gastrotomy and bring the opposed borders of the defect within the jaws of the device. The device was fired three times, leaving three pledgeted suture bundles to close the gastric defect. After closure, each animal was explored, and the integrity of the closure was assessed. The animals underwent in vivo contrast fluoroscopy and ex vivo burst pressure testing studies for assessment of leakage at the closure site., Results: The first animal was used to test feasibility, refine techniques, and develop a standard procedure. All of the next three animals studied showed complete sealing of the gastrotomy site without evidence of contrast extravasation on multiplanar fluoroscopic imaging. Each stomach was excised, submerged in water, and subjected to a pressurized air leak test. No leaks were noted until pressures exceeded 55 mmHg., Conclusion: This study supports the use of the NDO Plicator for closure of standardized gastric defects in a porcine model. In addition to closing NOTES gastrotomies, the NDO Plicator may be a particularly useful tool for obtaining complete closure of gastric perforations and anastomotic leaks, and for performing stomal reduction after gastric bypass procedures. The mechanical properties of a closure are not the only factor determining whether a leak will develop. Tissue opposition, ischemia, and tension are important factors that are not easily or reliably measured. The physiologic relevance of gastric bursting pressure is not known. Therefore, corollary animal studies with longer-term evaluation are necessary before research proceeds to clinical trials.

Abstract It has been suggested that induction of the heat shock response in the mammalian embryo during the critical period of organogenesis can result in anatomical malformation. We measured serum heat shock protein 70 (Hsp70), anti-Hsp70, and anti-Hsp60 in samples taken from expectant mothers at 16 weeks gestation. Samples from women whose babies were born with a birth defect (n = 30) were compared with controls who gave birth to healthy babies (n = 46). Anti-Hsp70 levels were significantly elevated in patients who later gave birth to babies with cleft lip or palate or neurological abnormalities (n = 10): 260 (223-406) microg/mL compared to 150 (88-207) microg/mL in controls (P < 0.001). No significant differences were found in serum Hsp70 and anti-Hsp60 levels between cases and controls. This finding of increased maternal anti-Hsp70 in patients who later gave birth to babies with these abnormalities suggests a previous stressful event may have contributed to the pathogenesis. Further work is required to determine whether Hsp70 has a direct or indirect role in this pathogenesis or whether anti-Hsp70 is simply a marker of a prior increase in Hsp70 due to a physiological stress that itself resulted in the damage. This work is consistent with previous studies showing a buffering role for Hsps in evolution.

Type 2 diabetes patients are subject to oxidative stress as a result of hyperglycemia. The aim of this study was to determine whether administration of the antioxidant folic acid, previously shown to reduce homocysteine levels, would reduce circulating levels of Hsp70 while improving the condition of type 2 diabetes patients with microalbuminuria. Plasma homocysteine fell from pretreatment values of 12.9 to 10.3 microM (P < 0.0001). The urine albumin-creatinine ratio fell from 12.4 to 10.4 mg/mM (P = 0.38). Pretreatment Hsp70 levels were higher in patients not taking insulin (5.32 ng/mL) compared with those on insulin (2.44 ng/mL) (P = 0.012). Folic acid supplementation resulted in a significant fall in Hsp70 (5.32 to 2.05 ng/mL) (P = 0.004). There was no change in Hsp70 in those receiving insulin. Folic acid supplementation in non-insulin-treated type 2 diabetes patients, therefore, resulted in a fall in Hsp70, reflecting an improvement in oxidative stress. The data shows that improvement in homocysteine status can lead to a reduction in Hsp70, indicating the possibility of its use as a marker for severity of disease.

Two cases of congenital cytomegalovirus infection associated with autism are reported. The viral hypothesis of autism is discussed along with a brief review of the literature. Suggestions are made for future research.