Quality of MBSAQIP data: bad luck, or lack of QA plan?

BACKGROUND: National clinical registries are commonly used in clinical research, quality improvement, and health policy. However, little is known about methodological challenges associated with these registry analyses that could limit their impact and compromise patient safety. This study examined the quality of Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MSBASQIP) data to assess its usability potential and improve data collection methodologies. METHODS: We developed a single flat file (n = 168,093) using five subsets (Main, BMI, Readmission, Reoperation, and Intervention) of the 2015 MBSAQIP Participant User Data File (PUF). Logic and validity tests included (1) individual profiles of patient's body mass index (BMI) changes over time, (2) individual patient care pathways, and (3) correlation analysis between variable pairs associated with the same clinical encounters. RESULTS: 8888 (5.3%) patients did not have postoperative weight/BMI data; 20% of patients had different units for preoperative and postoperative weights. Postoperative weight measurements ranged between - 71 and 132% of preoperative weight. There were 325 (3.7%) hospital readmissions reported on the day of or day after MBS. The self-reporting of "emergency" vs. "planned" interventions did not correlate with the type of procedure and its indication. Up to 20% of data could potentially be unused for analysis due to data quality issues. CONCLUSIONS: Our analysis revealed various data quality issues in the 2015 MBSAQIP PUF related to completeness, accuracy, and consistency. Since information on where the surgery was performed is lacking, it is not possible to conclude whether these issues represent data errors, patient outliers, or inappropriate care. Including automated data checks and biomedical informatics oversight, standardized coding for complications, additional de-identified facility and provider information, and training/mentorship opportunities in data informatics for all researchers who get access to the data have been shown to be effective in improving data quality and minimizing patient safety concerns.

Disparity in access to bariatric surgery among African-American men.

BACKGROUND: Despite improvements in safety and effectiveness in surgical management of extreme obesity, men and racial minorities are less likely to receive metabolic and bariatric surgery (MBS) compared to other patient groups. This study examines the racial and gender disparities in access to MBS to understand the mechanism that drives these problems and to propose strategies for closing the disparity gap. METHODS: Using 2013-2014 National Health and Nutrition Examination Survey data, we estimated the proportion of individuals, by race and gender, who were eligible for MBS based on Body Mass Index (BMI) and comorbidity profile. We analyzed the 2015 MBS Accreditation and Quality Improvement Program Participant Use Data File to examine differences in patient characteristics, comorbidities, and postsurgical outcomes among African-American (AA) and White men. Predictors of poor outcomes were identified using unconditional logistic regression models. RESULTS: AA men represented 11% of eligible patients but only 2.4% of actual MBS patients. Compared to White men, AA men were younger, had higher BMI, were more likely to have a history of hypertension, renal insufficiency, required dialysis, and had American Society of Anesthesiologists class 4 or 5 (all P values < 0.01). After surgery, AA men were more likely to suffer from postoperative complications (adjusted odds ratio (aOR) 1.25, 95% confidence interval (CI) 1.02-1.52) and stayed in the hospital for more than 4 days (aOR 1.51, 95% CI 1.26-1.82) compared to White men. CONCLUSIONS: Despite being eligible for MBS based on both BMI and obesity-related comorbidities, AA men are significantly less likely to undergo MBS. Those AA men who receive surgery are significantly younger than White men but also experience greater comorbidities compared to White men and all women. Further longitudinal studies into patient-, system-, and provider-level barriers are necessary to understand and address these disparities.

Financial modeling of current surgical robotic system in outpatient laparoscopic cholecystectomy: how should we think about the expense?

INTRODUCTION: More than 500,000 robotically assisted procedures were performed worldwide in 2013. Despite broad adoption, there remains a lack of clarity concerning the added cost of the robotic system to the procedure especially in light of an increasing number of ambulatory procedures which are now marketed by hospitals, surgeons and the manufacturer. These procedures are associated with much less reimbursement than inpatient procedures. It is unclear whether these added expenses can be absorbed in these scenarios. Reports vary in opinion concerning the added net costs during robotically assisted laparoscopic hernia or cholecystectomy. METHODS: The worldwide revenues, procedures, and the installed base of robotic system data were reviewed and reanalyzed from the 2013 Intuitive Surgical Investors report. This provided an opportunity to look cost per case projections from the vantage point of actual revenue. RESULTS: This analysis was based on revenue of 2.27 billion US dollars in the three categories of capital acquisition, instrumentation and accessories, and service revenue. These revenues were then spread across 523,000 cases with varying assumptions. Without regard to expense offsets, the additional cost ranges from $2908 to $8675 depending on what system was purchased and the ability to distribute costs against case volume. Estimates of commercial and government revenue were then compared against these expenses. CONCLUSION: The use of the extraordinary technology in the face of low-morbidity low-cost established minimally invasive procedures needs to withstand scrutiny of outcome assessment, revenue and expense considerations and appropriateness review in order to create financially viable approaches to high-volume minimally invasive procedures. Revenue estimates associated with outpatient reimbursement make it difficult to support these expenses, recognizing inpatient procedures represent a different net financial picture.

Preliminary evaluation of the pattern cutting and the ligating loop virtual laparoscopic trainers.

INTRODUCTION: The Fundamentals of Laparoscopic Surgery (FLS) trainer is currently the standard for training and evaluating basic laparoscopic skills. However, its manual scoring system is time-consuming and subjective. The Virtual Basic Laparoscopic Skill Trainer (VBLaST©) is the virtual version of the FLS trainer which allows automatic and real time assessment of skill performance, as well as force feedback. In this study, the VBLaST© pattern cutting (VBLaST-PC©) and ligating loop (VBLaST-LL©) tasks were evaluated as part of a validation study. We hypothesized that performance would be similar on the FLS and VBLaST© trainers, and that subjects with more experience would perform better than those with less experience on both trainers. METHODS: Fifty-five subjects with varying surgical experience were recruited at the Learning Center during the 2013 SAGES annual meeting and were divided into two groups: experts (PGY 5, surgical fellows and surgical attendings) and novices (PGY 1-4). They were asked to perform the PC or the ligating loop task on the FLS and the VBLaST© trainers. Their performance scores for each trainer were calculated and compared. RESULTS: There were no significant differences between the FLS and VBLaST© scores for either the PC or the ligating loop task. Experts' scores were significantly higher than the scores for novices on both trainers. CONCLUSION: This study showed that the subjects' performance on the VBLaST© trainer was similar to the FLS performance for both tasks. Both the VBLaST-PC© and the VBLaST-LL© tasks permitted discrimination between the novice and expert groups. Although concurrent and discriminant validity has been established, further studies to establish convergent and predictive validity are needed. Once validated as a training system for laparoscopic skills, the system is expected to overcome the current limitations of the FLS trainer.

Validation of the VBLaST peg transfer task: a first step toward an alternate training standard.

BACKGROUND: The FLS trainer lacks objective and automated assessments of laparoscopic performance and requires a large supply of relatively expensive consumables. Virtual reality simulation has a great potential as a training and assessment tool of laparoscopic skills and can overcome some limitations of the FLS trainer. This study was carried out to assess the value of our Virtual Basic Laparoscopic Surgical Trainer (VBLaST(©)) in the peg transfer task compared to the FLS trainer and its ability to differentiate performance between novice, intermediate, and expert groups. METHODS: Thirty subjects were divided into three groups: novices (PGY1-2, n = 10), intermediates (PGY3-4, n = 10), and experts (PGY5, surgical fellows and attendings, n = 10). All subjects performed ten trials of the peg transfer task on each simulator. Assessment of laparoscopic performance was based on FLS scoring while a questionnaire was used for subjective evaluation. RESULTS: The performance scores in the two simulators were correlated, though subjects performed significantly better in the FLS trainer. Experts performed better than novices only on the FLS trainer while no significant differences were observed between the other groups. Moreover, a significant learning effect was found on both trainers, with a greater improvement of performance on the VBLaST(©). Finally, 82.6% of the subjects preferred the FLS over the VBLaST(©) for surgical training which could be attributed to the novelty of the VR technology and existing deficiencies of the user interface for the VBLaST(©). CONCLUSION: This study demonstrated that the VBLaST(©) reproduced faithfully some aspects of the FLS peg transfer task (such as color, size, and shape of the peg board, etc.) while other aspects require additional development. Future improvement of the user interface and haptic feedback will enhance the value of the system as an alternative to the FLS as the standard training tool for laparoscopic surgery skills.

Effect of haptic feedback in laparoscopic surgery skill acquisition.

BACKGROUND: The benefits of haptic feedback in laparoscopic surgery training simulators is a topic of debate in the literature. It is hypothesized that novice surgeons may not benefit from the haptic information, especially during the initial phase of learning a new task. Therefore, provision of haptic feedback to novice trainees in the early stage of training may be distracting and detrimental to learning. A controlled experiment was conducted to examine the effect of haptic feedback on the learning curve of a complex laparoscopic suturing and knot-tying task. METHODS: The ProMIS and the MIST-VR surgical simulators were used to represent conditions with and without haptic feedback, respectively. A total of 20 novice subjects (10 per simulator) were trained to perform suturing and knot-tying and practiced the tasks in 18 sessions of 1 h each. RESULTS: At the end of the 3-week training period, the subjects performed equally fast but more consistently with haptics (ProMIS) than without haptics (MIST-VR). The subjects showed a slightly higher learning rate and reached the first plateau of the learning curve earlier with haptic feedback. CONCLUSION: In general, learning with haptic feedback was significantly better than learning without it for a laparoscopic suturing and knot-tying task, but only during the first 5 h of training. Haptic feedback may not be warranted in laparoscopic surgical trainers. The benefits of a shorter time to the first performance plateau and more consistent initial performance should be balanced with the cost of implementing haptic feedback in surgical simulators.

Minimally invasive surgery and cancer: controversies part 1.

Perhaps there is no more important issue in the care of surgical patients than the appropriate use of minimally invasive surgery (MIS) for patients with cancer. Important advances in surgical technique have an impact on early perioperative morbidity, length of hospital stay, pain management, and quality of life issues, as clearly proved with MIS. However, for oncology patients, historically, the most important clinical questions have been answered in the context of prospective randomized trials. Important considerations for MIS and cancer have been addressed, such as what are the important immunologic consequences of MIS versus open surgery and what is the role of laparoscopy in the staging of gastrointestinal cancers? This review article discusses many of the key controversies in the minimally invasive treatment of cancer using the pro-con debate format.

Using a dynamic training environment to acquire laparoscopic surgery skill.

BACKGROUND: Current physical laparoscopic surgical simulators provide training only for static tasks, which do not develop the more advanced hand-eye coordination skills needed to navigate the dynamic surgical environment. A novel dynamic minimally invasive training environment (DynaMITE) was developed to address this need. This study aimed to evaluate further the utility of the system as a training and skill assessment tool. Two studies were performed with a second-generation design. The authors hypothesized that the dynamic task environment would be challenging to novices and would differentiate experienced surgeons from the inexperienced by emphasising the dynamic skills gained through surgical experience. METHODS: The participants in the first study were 42 novice and experienced surgeons attending the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) 2007 Learning Center, whereas the second controlled laboratory study had 16 participants (5 novices and 11 experienced surgeons). The participants performed two tasks: an aiming task and an object manipulation task. Both tasks were positioned on a dynamic platform that moved in five different trajectories. RESULTS: The subjective feedback from the surgeons at the SAGES Learning Center was positive. The results from the controlled study showed significant performance deterioration in the fast diagonal task compared with the task of aiming and manipulating in the static environment for both experience groups but no performance differences between the groups. CONCLUSIONS: Dynamic tasks are challenging, and surgeons need to be trained specifically for these tasks. The DynaMITE system can provide training benefits for dynamic skill development, even for expert surgeons who may have had no opportunity to gain these skills through their surgical practice.

Effects of experience on force perception threshold in minimally invasive surgery.

BACKGROUND: Distorted haptic feedback by the surgical instrumentation is a major problem in minimally invasive surgery (MIS). Friction force generated by the rubber seal in the trocars masks the haptic information needed to perceive the properties and structure of the target tissue, resulting in an increased haptic perception threshold in naïve subjects. This can lead to over application of forces in surgery. OBJECTIVE: This paper examines the effect of surgical experience on the psychophysics of force perception and force application efficiency in MIS. METHOD: A controlled experiment was conducted using a mixed design, with friction and vision as independent within-subjects factors, experience as a between-subjects factor, and applied force and detection time as dependent measures. Fourteen subjects (eight novices and six experienced surgeons) performed a simulated tissue probing task. Performance data were recorded by a custom-built force-sensing system. RESULTS: When friction was present, higher thresholds and longer detection times were observed for both experienced and inexperienced subjects. In all cases, experienced surgeons applied a greater force than novices, but were quicker to detect contact with tissue, resulting in higher force application efficiency. CONCLUSION: Surgeons seem to have adapted to the higher threshold in haptic perception by reacting faster, even while applying more force to the tissue, keeping within the limits of safety.

How much feedback is necessary for learning to suture?

BACKGROUND: Many laparoscopic simulation training systems exist and have been shown to transfer learning of surgical skills to the operating room. The manner in which the training is structured to maximize learning has not been examined. There are many aspects to the acquisition of laparoscopic skills during training, one of which is the availability of knowledge of results (KR). Knowledge of results is information about the outcome of motor skill execution, usually provided to individuals at the end of the execution. The timing and nature of KR can affect how well people learn new motor skills. In addition, detailed instruction during learning can also affect skill acquisition. We studied the effects of KR and instruction on the learning curve of a suturing and knot-tying task. We hypothesized that KR was necessary for skill acquisition, and that detailed instruction would help trainees to learn to perform the task more correctly and reach a performance plateau earlier. In addition, the overall workload of a trainee during training would decrease as skills improved, especially when KR and coaching were provided. METHODS: Nine medical students with no previous laparoscopic surgical experience were randomly and evenly divided into three groups with different KR conditions: (1) no KR, (2) KR, (3) KR + instruction. Each subject attended a training session for 1 h each day, 6 days a week for 4 consecutive weeks. Performance measures such as task time, smoothness of instrument, and path length were recorded for each trial. Workload was assessed using the NASA-TLX questionnaire. RESULTS: While KR was necessary for learning to suture, continual instruction had limited additional benefits. However, KR + instruction did reduce subjects' perceived overall workload. CONCLUSIONS: Surgical training could be carried out effectively with only knowledge of results. These results have implications for the staffing of surgical skills laboratories.

The emergence of radiofrequency identification tags: applications in surgery.

Radiofrequency identification (RFID) is a wireless method of automatic identification. Currently, RFID tags are emerging into our environment in many aspects of our lives. Applications are being developed in a variety of fields, including health care. Aspects of surgical care will lend themselves to this approach. This technology could provide large amounts of data that not only carry the promise of improving health care, but also may have an impact on personal aspects of our daily lives. Each of us must become familiar with the risks and benefits of RFID use.

Comparison of the sensitivity of physical and virtual laparoscopic surgical training simulators to the user's level of experience.

BACKGROUND: The recent focus on quality of care and patient safety has been accompanied by increased interest in standardizing the training for laparoscopic surgeons. Studies have shown that laparoscopic simulators can be used to train surgical skills. Therefore, we designed an experiment to compare the effectiveness of two popular training systems. One system was based on a physical model, whereas the other used a virtual reality model. METHODS: A total of 32 medical students and residents were tested on both simulators. Time required for task completion and number of errors committed were recorded and compared. RESULTS: The physical training system differentiated among experience levels on three of the five tasks when time was used as a measure and four of five tasks when score was used, whereas the virtual reality system yielded statistically significant results in eight of 13 tasks for time and in five of 13 tasks for score. CONCLUSION: The physical model is more sensitive than the virtual reality one in detecting differences in levels of laparoscopic surgical experience.

Multimedia presentations in the age of the Health Insurance and Accountability Act.

The privacy rule of the Health Insurance Portability and Accountability Act (HIPAA) has made all physicians think more about their patients' privacy. In addition to safeguarding health information in routine office practice, doctors now are starting to consider the effects of the regulations on other professional activities including professional clinical multimedia presentations. This article explains specifically where and how multimedia (e.g., images, video) patient information may be used and shared. Although HIPAA itself is a lengthy and detailed document, a few simple rules can be extracted, which when followed, ensure that neither presentations nor patient privacy need to be sacrificed.

Laparoscopic esophagogastric devascularization in bleeding varices.

BACKGROUND: Bleeding from esophageal varices is the major cause of death in patients with portal hypertension. The ideal surgical procedure should effectively control bleeding and maintain liver function with low rates of encephalopathy. Based on this objective, laparoscopic devascularization of the lower esophagus and upper stomach was studied. METHODS: Eighteen patients were studied prospectively who underwent a laparoscopic esophagogastric devascularization procedure for variceal hemorrhage. The diaphragmatic hiatus and esophagus are dissected. The lower 7 or 8 cm of esophagus is devascularized. Devascularization of the gastric fundus is then accomplished by meticulous dissection and ligation of the short gastric vessels. The hepatogastric ligament is opened, permitting identification and isolation/ligation of the left gastric vessels. The dissection and ligation of the vessels at lesser curvature proceeded up to the diaphragmatic hiatus with devascularization of the external varices from the retroperitoneum or mediastinum at the esophagogastric junction. RESULTS: Mean operating room time was 111 min (range, 80-140 min) (6 emergent/12 elective). Mean blood loss 388 ml (range, 150-650 ml). Intensive care unit stay averaged 48 h, with a mean hospitalization of 11 days. Liver function and coagulation parameters remained stable postoperatively. Duplex sonography on the portal and splenic veins revealed patency in all patients. The flow velocity in the portal vein decreased from 15.5 +/- 4.1 to 13.4 +/- 3.5 cm/s postoperatively ( p = 0.021). Splenic vein velocity was unchanged. Bleeding recurred in 6 patients, and grade 1 encephalopathy developed in 1 patient. Follow-up endoscopy (8-24 months) demonstrated substantial reduction in variceal grade. CONCLUSION: Laparoscopic devascularization of the lower esophagus and the upper stomach is technically feasible and promising. Rapid recovery and control of variceal hemorrhage are accomplished in most patients without exposing them to the risk of open surgery.

A comparison of holding strength of various surgical clips.

Due to advances in clip design, new types of surgical ligation clips are available that may reduce clip failure and improve function, especially for 5-mm clip appliers. We tested a preformed spring clip based on a 5-mm applier against other commonly used clips from 5- and 10-mm multiloading clip appliers. Five different clips were compared using a digital force gauge to test perpendicular pulloff force after application to tubing of varying thickness and compliance. The average pull-off force for commonly used 5-mm and 10-mm clip appliers was 0.29 +/- 0.06 and 0.35 +/- 0.05 kg, respectively. Average pull-off force for the new preformed spring clip was 0.53 +/- 0.07 kg (p <0.0001). The new clip technology has significantly higher pull-off force than other currently used clips. This may be particularly beneficial in procedures requiring 5-mm clip appliers, which are known to place clips with lower holding force.

Transballoon trocar insertion during preperitoneal hernia repair.

Trocar insertion during laparoscopic preperitoneal hernia repair (TEP) can be troublesome because the space into which the trocars are inserted is smaller than that available for transabdominal approaches. Insertion of the trocars directly into the balloon used to dissect the preperitoneal space can facilitate this process. The insertion of a 5-mm trocar into the balloon does not usually result in balloon deflation, and a second trocar can be placed into the balloon as well. Removing the balloon, despite the trocars inside it, is straightforward, allowing the placement of a cannula at the balloon insertion site and initiation of the hernia repair.

Imaging systems in minimally invasive surgery.

The imaging system is the eye of the laparoscopic surgeon. The success or failure of a minimally invasive procedure depends on the quality and working order of the imaging system used. The components that work together to produce an image on the monitor is called the imaging chain. The image displayed will be good as the chain's weakest component. Understanding how the pieces of this process work together will allow the surgeon to troubleshoot basic system problems, leading to improved image displays and safer operating environments. Continuous refinement of laparoscopes, lighting systems, cameras, monitors, and displays lead to an ever-improving operating environment.