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48 result(s) for "Malthaner, Richard A."
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Development of force-based metrics for skills assessment in minimally invasive surgery
Background The loss of haptic information that results from the reduced-access conditions present in minimally invasive surgery (MIS) may compromise the safety of the procedures. This limitation must be overcome through training. However, current methods for determining the skill level of trainees do not measure critical elements of skill attainment. This study aimed to evaluate the usefulness of force information for the assessment of skill during MIS. Methods To achieve the study goal, experiments were performed using a set of sensorized instruments capable of measuring instrument position and tissue interaction forces. Several force-based metrics were developed as well as metrics that combine force and position information. Results The results show that experience level has a strong correlation with the new force-based metrics presented in this article. In particular, the integral and the derivative of the forces or the metrics that combine force and position provide the strongest correlations. Conclusions This study showed that force-based metrics are better indications of performance than metrics based on task completion time or position information alone. The proposed metrics can be automatically computed, are completely objective, and measure important aspects of performance.
Circulating tumor cells detected in follow-up predict survival outcomes in tri-modality management of advanced non-metastatic esophageal cancer: a secondary analysis of the QUINTETT randomized trial
Background Our aim was to establish if presence of circulating tumor cells (CTCs) predicted worse outcome in patients with non-metastatic esophageal cancer undergoing tri-modality therapy. Methods We prospectively collected CTC data from patients with operable non-metastatic esophageal cancer from April 2009 to November 2016 enrolled in our QUINTETT esophageal cancer randomized trial (NCT00907543). Patients were randomized to receive either neoadjuvant cisplatin and 5-fluorouracil (5-FU) plus radiotherapy followed by surgical resection (Neoadjuvant) or adjuvant cisplatin, 5-FU, and epirubicin chemotherapy with concurrent extended volume radiotherapy following surgical resection (Adjuvant). CTCs were identified with the CellSearch® system before the initiation of any treatment (surgery or chemoradiotherapy) as well as at 6-, 12-, and 24-months post-treatment. The threshold for CTC positivity was one and the findings were correlated with patient prognosis. Results CTC data were available for 74 of 96 patients and identified in 27 patients (36.5%) at a median follow-up of 13.1months (interquartile range:6.8-24.1 months). Detection of CTCs at any follow-up visit was significantly predictive of worse disease-free survival (DFS;hazard ratio [HR]: 2.44; 95% confidence interval [CI]: 1.41-4.24; p =0.002), regional control (HR: 6.18; 95% CI: 1.18-32.35; p =0.031), distant control (HR: 2.93; 95% CI: 1.52-5.65; p =0.001) and overall survival (OS;HR: 2.02; 95% CI: 1.16-3.51; p =0.013). After adjusting for receiving neoadjuvant vs. adjuvant chemoradiotherapy, the presence of CTCs at any follow-up visit remained significantly predictive of worse OS ([HR]:2.02;95% [Cl]:1.16-3.51; p =0.013) and DFS (HR: 2.49;95% Cl: 1.43-4.33; p =0.001). Similarly, any observed increase in CTCs was significantly predictive of worse OS (HR: 3.14; 95% CI: 1.56-6.34; p =0.001) and DFS (HR: 3.34; 95% CI: 1.67-6.69; p <0.001). Conclusion The presence of CTCs in patients during follow-up after tri-modality therapy was associated with significantly poorer DFS and OS regardless of timing of chemoradiotherapy.
The quality of life in neoadjuvant versus adjuvant therapy of esophageal cancer treatment trial (QUINTETT): Randomized parallel clinical superiority trial
Background We compared the health‐related quality of life (HRQOL) in patients undergoing trimodality therapy for resectable stage I‐III esophageal cancer. Methods A total of 96 patients were randomized to standard neoadjuvant cisplatin and 5‐fluorouracil chemotherapy plus radiotherapy (neoadjuvant) followed by surgical resection or adjuvant cisplatin, 5‐fluorouracil, and epirubicin chemotherapy with concurrent extended volume radiotherapy (adjuvant) following surgical resection. Results There was no significant difference in the functional assessment of cancer therapy‐esophageal (FACT‐E) total scores between arms at 1 year (p = 0.759) with 36% versus 41% (neoadjuvant vs. adjuvant), respectively, showing an increase of ≥15 points compared to pre‐treatment (p = 0.638). The HRQOL was significantly inferior at 2 months in the neoadjuvant arm for FACT‐E, European Organization for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ‐OG25), and EuroQol 5‐D‐3 L in the dysphagia, reflux, pain, taste, and coughing domains (p < 0.05). Half of patients were able to complete the prescribed neoadjuvant arm chemotherapy without modification compared to only 14% in the adjuvant arm (p < 0.001). Chemotherapy related adverse events of grade ≥2 occurred significantly more frequently in the neoadjuvant arm (100% vs. 69%, p < 0.001). Surgery related adverse events of grade ≥2 were similar in both arms (72% vs. 86%, p = 0.107). There were no 30‐day mortalities and 2% vs. 10% 90‐day mortalities (p = 0.204). There were no significant differences in either overall survival (OS) (5‐year: 35% vs. 32%, p = 0.409) or disease‐free survival (DFS) (5‐year: 31% vs. 30%, p = 0.710). Conclusion Trimodality therapy is challenging for patients with resectable esophageal cancer regardless of whether it is given before or after surgery. Newer and less toxic protocols are needed. This randomized trial assessed the health related quality of life in esophageal cancer patients undergoing neoadjuvant versus adjuvant trimodality therapy. Every patient experienced at least one adverse event. The quality of life was worse for patients undergoing neoadjuvant compared to adjuvant chemoradiation with no significant difference in either overall survival or disease‐free survival. More effective therapy is needed.
Assessing clinician performance using a multi-modality clinical decision-support system for lung cancer prognostication
Surgery is the primary treatment for early-stage lung cancer. Adjuvant therapy is offered to patients who are at a high risk of recurrence, however, determining the patients that would benefit from additional therapy is often difficult. In this study, we aimed to develop a clinical decision support system (CDSS) for post-surgery lung cancer prognostication integrating a multi-modality deep learning model (DLM). Pre-operative medical images and clinical, surgical, and pathological information were fed into an externally validated DLM. A CDSS was then developed to display the patient information and DLM results for potential clinical use. Four oncologists evaluated each patient's recurrence probability, their confidence level, and their post-surgery recommendations both with and without the DLM information. The CDSS DLM information demonstrated the potential to improve user prediction performance and confidence. This exploratory study is the first to integrate a multi-modality DLM for prognostication with a CDSS, as well as the first study of clinician attitudes towards CDSSs for lung cancer.
High-concentration oxygen and surgical site infections in abdominal surgery: a meta-analysis
Background There has been recent interest in using high-concentration oxygen to prevent surgical site infections (SSIs). Previous meta-analyses in this area have produced conflicting results. With the publication of 2 new randomized controlled trials (RCTs) that were not included in previous meta-analyses, an updated review is warranted. Our objective was to perform a meta-analysis on RCTs comparing high- and low-concentration oxygen in adults undergoing open abdominal surgery. Methods We completed independent literature reviews using electronic databases, bibliographies and other sources of grey literature to identify relevant studies. We assessed the overall quality of evidence using grade guidelines. Statistical analysis was performed on pooled data from included studies. A priori subgroup analyses were planned to explain statistical and clinical heterogeneity. Results Overall, 6 studies involving a total of 2585 patients met the inclusion criteria. There was no evidence of a reduction in SSIs with high-concentration oxygen (risk ratio 0.77, 95% confidence interval 0.50–1.19, p = 0.24). We observed substantial heterogeneity among studies. Conclusion There is moderate evidence that high-concentration oxygen does not reduce SSIs in adults undergoing open abdominal surgery.
Identifying Primary Spontaneous Pneumothorax from Administrative Databases: A Validation Study
Introduction. Primary spontaneous pneumothorax (PSP) is a disorder commonly encountered in healthy young individuals. There is no differentiation between PSP and secondary pneumothorax (SP) in the current version of the International Classification of Diseases (ICD-10). This complicates the conduct of epidemiological studies on the subject. Objective. To validate the accuracy of an algorithm that identifies cases of PSP from administrative databases. Methods. The charts of 150 patients who consulted the emergency room (ER) with a recorded main diagnosis of pneumothorax were reviewed to define the type of pneumothorax that occurred. The corresponding hospital administrative data collected during previous hospitalizations and ER visits were processed through the proposed algorithm. The results were compared over two different age groups. Results. There were 144 cases of pneumothorax correctly coded (96%). The results obtained from the PSP algorithm demonstrated a significantly higher sensitivity (97% versus 81%, p = 0.038 ) and positive predictive value (87% versus 46%, p < 0.001 ) in patients under 40 years of age than in older patients. Conclusions. The proposed algorithm is adequate to identify cases of PSP from administrative databases in the age group classically associated with the disease. This makes possible its utilization in large population-based studies.
The cost of laparoscopic myotomy versus pneumatic dilatation for esophageal achalasia
The two main treatment options for esophageal achalasia are laparoscopic distal esophageal myotomy (LM) and pneumatic dilatation (PD). Our objective was to compare the costs of these management strategies. We constructed a decision analytic model consisting of two treatment strategies for patients diagnosed with achalasia. Probabilities of events were systematically derived from a literature review, supplemented by expert opinion when necessary. Costs were estimated from the perspective of a third-party payer and society, including both direct and indirect costs. Future costs were discounted at a rate of 5.5% over a time horizon of 5 and 10 years. Uncertainty in the probability estimates was incorporated using probabilistic sensitivity analyses. We tested uncertainty in the model by modifying key assumptions and repeating the analysis. From the societal perspective, the expected cost per patient was $10,789 (LM) compared with $5,315 (PD) five years following diagnosis, and $11,804 (LM) compared with $7,717 (PD) after 10 years. The 95% confidence interval of the incremental cost per patient treated with LM was ($5,280, $5,668) after five years, and ($3,863, $4,311) after 10 years. The incremental cost of LM was similar from the third-party payer perspective and in the secondary model analyzed. Initial LM is a more costly management strategy under all clinically plausible scenarios tested in this model. Further research is needed to determine patients' preferences for the two treatment modalities, and society's willingness to bear the incremental cost of LM for those who choose it.
Adjuvant concurrent chemoradiation using intensity-modulated radiotherapy and simultaneous integrated boost for resected high-risk adenocarcinoma of the distal esophagus and gastro-esophageal junction
Purpose Multimodality therapy leads to improved outcomes for adenocarcinoma of the distal esophagus and gastroesophageal junction (GEJ) over surgery alone. At our institution, adjuvant chemoradiation (chemoRT) using IMRT and SIB is standard of care for resected high-risk disease. In this study, we review our experience with a recent cohort of patients treated in this manner. Methods and materials We identified 18 patients with resected T3 and/or N1 adenocarcinoma of the distal esophagus and GEJ who received adjuvant chemoRT. A large elective volume (PTV1) and a smaller high-risk volume (PTV2) were irradiated simultaneously using IMRT and an SIB technique. All patients received concurrent chemotherapy. Relevant clinical outcomes are reported. Results The median dose to 95% of PTV1 was 3747cGy and to 95% of PTV2 was 4876cGy. All RT was given in a median of 28 daily fractions. Four patients did not complete chemotherapy. At a median follow up of 952 days from the start of RT, 7 of 18 patients were dead; of these, 3 had developed local recurrence only; 3 had developed both local and distant recurrence; 1 died of a late toxicity, without recurrence. OS was 88% at 1year, 76% at 2 years and 58% at 3 years. Freedom from local recurrence was 88% at 1 year, 82% at 2 years and 82% at 3 years. Freedom from distant recurrence was 72% at 1 year, 67% at 2 years and 56% at 3 years. Toxicity was acceptable. Conclusions Adjuvant concurrent chemoRT with IMRT and SIB is feasible for resected high-risk adenocarcinoma of the distal esophagus and GEJ. Our results describe how modern treatment techniques can be employed as part of a treatment paradigm that is neither commonly used nor commonly described in the literature.
Hemolysis with rapid transfusion systems in the trauma setting
Rapid infusion system allows rapid infusion of resuscitation fluids at body temperature in trauma patients. Packed red blood cells are subjected to high external pneumatic pressure (up to 300 mm Hg) and rapid infusion rates through a 170-microm filter. This study was conducted to outline hemolysis that may occur in the setting of massive transfusion (> 10 units). Measurements of various parameters were made before and after infusion of 17 units of outdated (38-82 d) packed red blood cells through a Level 1 Rapid Infuser, including lactate dehydrogenase (LDH), potassium, plasma hemoglobin, hematocrit and total hemoglobin. Hemolysis, expressed as a percentage, was calculated from these parameters. Hemolysis observed in this experiment ranged from near 0 to 0.05%. All the units had plasma potassium concentrations of 15 mmol/L or more. Transfusion of 17 units with the Level 1 Rapid Infuser did not cause a clinically significant amount of hemolysis.