Towards a Standardization of Learning Curve Assessment in Minimally Invasive Liver Surgery.

OBJECTIVE: The aim was to analyze the learning curves of minimal invasive liver surgery(MILS) and propose a standardized reporting. SUMMARY BACKGROUND DATA: MILS offers benefits compared to open resections. For a safe introduction along the learning curve, formal training is recommended. However, definitions of learning curves and methods to assess it lack standardization. METHODS: A systematic review of PubMed, Web of Science, and CENTRAL databases identified studies on learning curves in MILS. The primary outcome was the number needed to overcome the learning curve. Secondary outcomes included endpoints defining learning curves, and characterization of different learning phases(competency, proficiency and mastery). RESULTS: 60 articles with 12'241 patients and 102 learning curve analyses were included. The laparoscopic and robotic approach was evaluated in 71 and 18 analyses and both approaches combined in 13 analyses. Sixty-one analyses (60%) based the learning curve on statistical calculations. The most often used parameters to define learning curves were operative time (n=64), blood loss (n=54), conversion (n=42) and postoperative complications (n=38). Overall competency, proficiency and mastery were reached after 34 (IQR 19-56), 50 (IQR 24-74), 58 (IQR 24-100) procedures respectively. Intraoperative parameters improved earlier (operative time: competency to proficiency to mastery: -13%, 2%; blood loss: competency to proficiency to mastery: -33%, 0%; conversion rate (competency to proficiency to mastery; -21%, -29%), whereas postoperative complications improved later (competency to proficiency to mastery: -25%, -41%). CONCLUSIONS: This review summarizes the highest evidence on learning curves in MILS taking into account different definitions and confounding factors. A standardized three-phase reporting of learning phases (competency, proficiency, mastery) is proposed and should be followed.

Perioperative outcome assessment from the perspectives of different stakeholders: need for reconsideration?

Standardised and universal perioperative endpoint reporting are the cornerstone for outcomes assessment, reliable clinical trials, and health services research. The Outcome4medicine initiative recently reported consensus recommendations on how to assess the quality of surgical interventions, proposing a framework for surgical outcome assessment and quality improvement after medical interventions. In the same field, the Standardised Endpoints in Perioperative Medicine - Core Outcome Measures for Perioperative and Anaesthetic Care (StEP-COMPAC) group recently proposed standardised and valid measures of mortality and morbidity, derived from a three-stage Delphi process. Here a core group of the Outcome4medicine conference discusses how these two initiatives are aligned and emphasises the importance of standardised outcome assessment by integrating the perspectives of different stakeholders.

Quality and Outcome Assessment for Surgery.

ABSTRACT: This forum summarizes the proceedings of the joint European Surgical Association (ESA)/American Surgical Association (ASA) symposium on Quality and Outcome Assessment for Surgery that took place in Bordeaux, France, as part of the celebrations of the 30th anniversary of the ESA. Three presentations focused on a) the main messages from the Outcome4Medicine Consensus Conference, which took place in Zurich, Switzerland, in June 2022, b) the patient perspective, and c) benchmarking were hold by ESA members and discussed by ASA members in a symposium attended by members of both associations.

A Spectrofluorometric Method for Real-Time Graft Assessment and Patient Monitoring.

Biomarkers are powerful clinical diagnostics and predictors of patient outcome. However, robust measurements often require time and expensive laboratory equipment, which is insufficient to track rapid changes and limits direct use in the operating room. Here, this study presents a portable spectrophotometric device for continuous real-time measurements of fluorescent and non-fluorescent biomarkers at the point of care. This study measures the mitochondrial damage biomarker flavin mononucleotide (FMN) in 26 extended criteria human liver grafts undergoing hypothermic oxygenated perfusion to guide clinical graft assessment. Real-time data identified seven organs unsuitable for transplant that are discarded. The remaining grafts are transplanted and FMN values correlated with post-transplant indicators of liver function and patient recovery. Further, this study shows how this device can be used to monitor dialysis patients by measuring creatinine in real-time. Our approach provides a simple method to monitor biomarkers directly within biological fluids to improve organ assessment, patient care, and biomarker discovery.

Delivering Safe Surgical Care While Simultaneously Caring for Patients With COVID-19; Assessment of Patient Selection, Volume and Outcomes in a Tertiary Care Hospital.

Objectives: Compare patient selection and postoperative outcomes after surgical treatment for gastrointestinal disorders before and during the SARS-CoV-2 pandemic. Methods: We assessed gastrointestinal surgeries conducted at a tertiary center from 2017-2021 for differences in patient populations and procedures before (up to February 2020) and during the pandemic (March 2020 to December 2021). We analyzed mortality, Intensive Care Unit (ICU) length of stay, admission to ICU and postoperative complications for complex procedures using descriptive statistics and regression models. Results: 7309 procedures were analyzed, showing a caseload reduction in March and October 2020, but no statistical evidence for fewer overall procedures overall. Population characteristics differed with lower Body Mass Indices in 2020 and 2021, more patients smoking and with diabetes treated in 2020. There was no increased mortality, ICU length of stay and in 1,144 complex procedures assessed low overall morbidity at 90 days postoperative. Conclusion: Delivering surgical care while treating patients for COVID-19 in the same hospital was safe. Healthcare officials should consider continuing surgical care during future health crises as consequences of limiting surgical treatment for gastrointestinal disorders may be fatal for patients.

FDG-PET/CT: novel method for viability assessment of livers perfused ex vivo.

PURPOSE: Ex vivo liver machine perfusion is a promising option to rescue marginal liver grafts mitigating the donated organ shortage. Recently, a novel liver perfusion machine that can keep injured liver grafts alive for 1 week ex vivo was developed and reported in Nature Biotechnology. However, liver viability assessment ex vivo is an unsolved issue and the value of 18F-fluorodeoxyglucose (FDG)-PET/CT for such purpose was explored. MATERIALS AND METHODS: Discarded two human and six porcine liver grafts underwent FDG-PET/CT for viability assessment after 1 week of ex vivo perfusion. PET parameters [standardized uptake value (SUV)max, SUVmean, SUVpeak and total lesion glycolysis] were compared between hepatic lobes and between porcine and human livers. The prevalence of FDG-negative organ parts was recorded. The estimated effective radiation dose for PET/CT was calculated. RESULTS: All organs were viable with essentially homogeneous FDG uptake. Of note, viability was preserved in contact areas disclosing the absence of pressure necrosis. Four porcine and two human organs had small superficial FDG-negative areas confirmed as biopsy sites. Total lesion glycolysis was significantly higher in the right hepatic lobe (P = 0.012), while there was no significant difference of SUVmax, SUVmean and SUVpeak between hepatic lobes. There was no significant difference in FDG uptake parameters between porcine and human organs. The estimated effective radiation dose was 1.99 ± 1.67 mSv per organ. CONCLUSION: This study demonstrates the feasibility of FDG-PET/CT for viability assessment of ex vivo perfused liver grafts after 1 week.

Allocation of liver grafts worldwide - Is there a best system?

BACKGROUND & AIMS: An optimal allocation system for scarce resources should simultaneously ensure maximal utility, but also equity. The most frequent principles for allocation policies in liver transplantation are therefore criteria that rely on pre-transplant survival (sickest first policy), post-transplant survival (utility), or on their combination (benefit). However, large differences exist between centers and countries for ethical and legislative reasons. The aim of this study was to report the current worldwide practice of liver graft allocation and discuss respective advantages and disadvantages. METHODS: Countries around the world that perform 95 or more deceased donor liver transplantations per year were analyzed for donation and allocation policies, as well as recipient characteristics. RESULTS: Most countries use the model for end-stage liver disease (MELD) score, or variations of it, for organ allocation, while some countries opt for center-based allocation systems based on their specific requirements, and some countries combine both a MELD and center-based approach. Both the MELD and center-specific allocation systems have inherent limitations. For example, most countries or allocation systems address the limitations of the MELD system by adding extra points to recipient's laboratory scores based on clinical information. It is also clear from this study that cancer, as an indication for liver transplantation, requires special attention. CONCLUSION: The sickest first policy is the most reasonable basis for the allocation of liver grafts. While MELD is currently the standard for this model, many adjustments were implemented in most countries. A future globally applicable strategy should combine donor and recipient factors, predicting probability of death on the waiting list, post-transplant survival and morbidity, and perhaps costs. LAY SUMMARY: An optimal allocation system for scarce resources should simultaneously ensure maximal utility, but also equity. While the model for end-stage liver disease is currently the standard for this model, many adjustments were implemented in most countries. A future globally applicable strategy should combine donor and recipient factors predicting probability of death on the waiting list, post-transplant survival and morbidity, and perhaps costs.

The Comprehensive Complication Index (CCI®) is a Novel Cost Assessment Tool for Surgical Procedures.

OBJECTIVE: The aim of this study was to identify a readily available, reproducible, and internationally applicable cost assessment tool for surgical procedures. SUMMARY OF BACKGROUND DATA: Strong economic pressure exists worldwide to slow down the rising of health care costs. Postoperative morbidity significantly impacts on cost in surgical patients. The comprehensive complication index (CCI), reflecting overall postoperative morbidity, may therefore serve as a new marker for cost. METHODS: Postoperative complications and total costs from a single tertiary center were prospectively collected (2014 to 2016) up to 3 months after surgery for a variety of abdominal procedures (n = 1388). CCI was used to quantify overall postoperative morbidity. Pearson correlation coefficient (rpears) was calculated for cost and CCI. For cost prediction, a linear regression model based on CCI, age, and type of surgery was developed and validated in an international cohort of patients. RESULTS: We found a high correlation between CCI and overall cost (rpears = 0.75) with the strongest correlation for more complex procedures. The prediction model performed very well (R = 0.82); each 10-point increase in CCI corresponded to a 14% increase to the baseline cost. Additional 12% of baseline cost must be added for patients older than 50 years, or 24% for those over 70 years. The validation cohorts showed a good match of predicted and observed cost. CONCLUSION: Overall postoperative morbidity correlates highly with cost. The CCI together with the type of surgery and patient age is a novel and reliable predictor of expenses in surgical patients. This finding may enable objective cost comparisons among centers, procedures, or over time obviating the need to look at complex country-specific cost calculations (www.assessurgery.com).

Insurance status does not affect short-term outcomes after oncological colorectal surgery in Europe, but influences the use of minimally invasive techniques: a propensity score-matched analysis.

BACKGROUND AND PURPOSE: Controversy exists whether surgical treatment is influenced by insurance status. American studies suggest higher morbidity and decreased survival in uninsured patients with colorectal cancer (CRC). It remains elusive, however, whether these findings apply to European countries with mandatory, government-driven insurance systems. We aimed to analyze whether operative techniques, quality of surgery, and complication rates differ among patients covered by statutory (SI) versus private (PI) healthcare insurance. METHODS: Based on a prospective national surgical quality database, patients undergoing elective resection for CRC during 2007-2015 were identified. A propensity score match of eligible patients with SI and PI yielded 765 patients per group. RESULTS: Hierarchical status of the operating surgeon differed substantially (p = 0.001): junior surgeons operated on > 50% of patients with SI, whereas over 80% of patients with PI were operated by senior surgeons. Minimally invasive techniques were used more frequently in patients with PI (p = 0.001) and patients with SI undergoing colonic resection showed an increased conversion rate (OR 2.44). Median duration of surgery (p = 0.001) and blood loss (p = 0.002) were higher in patients with SI; however, length of hospital stay was equal. Neither the rate of positive resection margins nor the number of resected lymph nodes differed among groups. Complications and mortality occurred with similar frequencies for patients undergoing colon (p = 0.140) and rectal (p = 0.335) resection. CONCLUSION: The use of minimally invasive techniques was favored in patients with PI; however, the quality of oncological resection was not affected by insurance status and only minor differences in perioperative complications observed.

Toward a Consensus on Centralization in Surgery.

OBJECTIVES: To critically assess centralization policies for highly specialized surgeries in Europe and North America and propose recommendations. BACKGROUND/METHODS: Most countries are increasingly forced to maintain quality medicine at a reasonable cost. An all-inclusive perspective, including health care providers, payers, society as a whole and patients, has ubiquitously failed, arguably for different reasons in environments. This special article follows 3 aims: first, analyze health care policies for centralization in different countries, second, analyze how centralization strategies affect patient outcome and other aspects such as medical education and cost, and third, propose recommendations for centralization, which could apply across continents. RESULTS: Conflicting interests have led many countries to compromise for a health care system based on factors beyond best patient-oriented care. Centralization has been a common strategy, but modalities vary greatly among countries with no consensus on the minimal requirement for the number of procedures per center or per surgeon. Most national policies are either partially or not implemented. Data overwhelmingly indicate that concentration of complex care or procedures in specialized centers have positive impacts on quality of care and cost. Countries requiring lower threshold numbers for centralization, however, may cause inappropriate expansion of indications, as hospitals struggle to fulfill the criteria. Centralization requires adjustments in training and credentialing of general and specialized surgeons, and patient education. CONCLUSION/RECOMMENDATIONS: There is an obvious need in most areas for effective centralization. Unrestrained, purely "market driven" approaches are deleterious to patients and society. Centralization should not be based solely on minimal number of procedures, but rather on the multidisciplinary treatment of complex diseases including well-trained specialists available around the clock. Audited prospective database with monitoring of quality of care and cost are mandatory.

Managing multicentre clinical trials with open source.

BACKGROUND: Multicentre clinical trials are challenged by high administrative burden, data management pitfalls and costs. This leads to a reduced enthusiasm and commitment of the physicians involved and thus to a reluctance in conducting multicentre clinical trials. OBJECTIVE: The purpose of this study was to develop a web-based open source platform to support a multi-centre clinical trial. METHODS: We developed on Drupal, an open source software distributed under the terms of the General Public License, a web-based, multi-centre clinical trial management system with the design science research approach. RESULTS: This system was evaluated by user-testing and well supported several completed and on-going clinical trials and is available for free download. CONCLUSION: Open source clinical trial management systems are capable in supporting multi-centre clinical trials by enhancing efficiency, quality of data management and collaboration.

An independent jury-based consensus conference model for the development of recommendations in medico-surgical practice.

BACKGROUND: There is an increasing demand for standardization in the choice of treatments for specific conditions, so-called personalized medicine. The task is far from trivial, because the perspectives from many stakeholders must be respected, including patients and health care providers, as well as payers or governments to better control costs while optimizing quality of care. One approach to provide widely accepted therapies is the consensus conference. METHODS: We describe a novel methodology to achieve consensus in controversial areas with the main goal to minimize biases. RESULTS: The principle of this approach relies on a clear distinction between those who provide the evidence (experts) and those who draw the final recommendations (the jury). The jury consists of individuals with sufficient background knowledge to cover the perspectives of all stakeholders' without being involved directly in the topic under evaluation. The organizing committee, the experts, and the jury interact within 3 phases: Preparation, the actual consensus conference, and deliberations. Each question is addressed by a panel of experts, leading to the proposition of recommendations at the conference meeting, which are challenged by the jury and the audience. Based on all available information, the jury finalizes the consensus recommendations, which are eventually published and made available to all. CONCLUSION: This novel model of consensus conference allows the construction of consensual, evidence-based, explicit recommendations for therapies in a process that may also identify issues for further research, eventually fostering progress in the field.

The wealth of nations and the dissemination of cardiovascular research.

BACKGROUND: This study aimed at understanding whether investigators from less wealthy countries were at a disadvantage in disseminating their research, after accounting for potential differences in research quality and infrastructure. METHODS AND RESULTS: In this bibliometric analysis a representative random selection of 10% (n=1002 studies) of all abstracts submitted to the European Society of Cardiology (ESC) congress 2006 was followed for publication and citation from September 2006 to December 2011. The main variable of interest was the per-capita gross domestic product (GDP) of the country of the principal investigator. Using multivariable models that adjusted for socioeconomic indicators and previously identified markers of research quality, we examined the relationship between per-capita GDP and three study endpoints: Acceptance at the ESC congress, full-text publication, and number of two-year citations. Among 1002 abstracts from 63 countries, per-capita GDP was positively correlated with all three study endpoints. After adjusting for markers of research quality and infrastructure, per-capita GDP remained a strong predictor for acceptance at the ESC congress (adjusted OR for every 10,000 USD increase in per-capita GDP, 1.44; 95% CI, 1.15 to 1.80), full-text publication within 5years (adjusted OR, 1.49; 95% CI, 1.17 to 1.90), and high citation frequency (adjusted OR, 2.30; 95% CI, 1.31 to 4.04). These findings were largely consistent in a subgroup of abstracts of high-quality, prospective clinical trials. CONCLUSION: Investigators in less wealthy countries face challenges to disseminate their research, even after accounting for potential differences in the quality of their work and research infrastructure.

The use of fatty liver grafts in modern allocation systems: risk assessment by the balance of risk (BAR) score.

OBJECTIVE: To integrate the amount of hepatic steatosis in modern liver allocation models. BACKGROUND: The aim of this study was to combine the 2 largest liver transplant databases (United States and Europe) in 1 comprehensive model to predict outcome after liver transplantation, with a novel focus on the impact of the presence of steatosis in the graft. METHODS: We adjusted the balance of risk (BAR) score for its application to the European Liver Transplant Registry (ELTR) database containing 11,942 patients. All liver transplants from ELTR and United Network for Organ Sharing with recorded liver biopsies were then combined in one survival analysis in relation to the presence of graft micro- (n = 9,677) and macrosteatosis (n = 11,516). RESULTS: Microsteatosis, regardless of the amount, was associated with a similar relationship between mortality and BAR score as nonsteatotic livers. Low-grade macrosteatotic liver grafts (≤30% macrosteatosis) resulted in 5-year graft-survival rates of 60% or more up to BAR 18, comparable to nonsteatotic grafts. However, use of moderate or severely steatotic liver grafts (>30% macrosteatosis) resulted in acceptable outcome only if the cumulative risk at transplant was low, that is, BAR score of 9 or less. CONCLUSIONS: Microsteatotic or 30% or less macrosteatotic liver grafts can be used safely up to BAR score of 18 or less, but liver grafts with more than 30% macrosteatotis should be used with risk adjustment, that is, up to BAR score of 9 or less.

Trainee satisfaction in surgery residency programs: modern management tools ensure trainee motivation and success.

OBJECTIVE: To assess trainee satisfaction in their surgery residency with a validated instrument and identify the contributing factors. BACKGROUND: Currently, surgery is deemed unattractive by medical students and ignored by many candidates planning to enter an academic career. New insights on the rational for such lack of interest are needed. Job satisfaction is a central concept in organizational and behavioral research that is well understood by large companies such as Google, IBM, and Toyota. Similar assessment can likewise be used to improve trainee satisfaction in surgery residency. METHODS: A survey among 2039 surgery residents was conducted in three European countries analyzing satisfaction at work using the Global Job Satisfaction Instrument (validated in Emergency Room physicians). Crucial factors covering different aspects of surgery residency where identified using the GJS instrument combined with multiple logistic regression analysis. RESULTS: With an overall response rate of 23%, we identified trainee dissatisfaction in one third of residents. Factors affecting satisfaction related almost exclusively to training issues, such as assignment of surgery procedures according to skills (OR 4.2), training courses (OR 2.7), availability of a structured training curriculum (OR 2.4), bedside teaching, and availability of morbidity-mortality conferences (OR 2.3). A good working climate among residents (OR 3.7) and the option for part time work (OR 2.1) were also significant factors for trainee satisfaction. Increased working hours had a modest (OR 0.98)-though cumulative- negative effect. The sex of the trainee was not related to trainee satisfaction. CONCLUSION: Validated measurement of job satisfaction as used in the industry appears to be an efficient tool to assess trainee satisfaction in surgery residency and thereby identify the key contributing factors. Improvement of conceptual training structures and working conditions might facilitate recruitment, decrease drop-out, and attract motivated candidates with possibly better quality of care.

The model for end-stage liver disease allocation system for liver transplantation saves lives, but increases morbidity and cost: a prospective outcome analysis.

We analyzed the first 100 patients who underwent liver transplantation by Model for End-Stage Liver Disease (MELD) allocation, and compared the outcome of patients on the waiting list and after orthotopic liver transplantation with the last 100 patients who underwent transplantation prior to the introduction of the MELD system in July 2007. MELD allocation resulted in decreased waiting list mortality (386 versus 242 deaths per 1000 patient-years, P < 0.0001) and the transplantation of sicker recipients (uncorrected median MELD score 13.5 versus 20, P = 0.003). Recipient posttransplant morbidity was significantly higher, mainly caused by increased percentage of renal failure requiring renal replacement therapy (13 versus 46%, P < 0.0001). However, kidney function recovered in most cases within 6 months after OLT. Hospital mortality remained similar in both groups (6% versus 9%). Patient 1-year survival was 91% versus 83% (pre-MELD versus MELD era, P = 0.2154), graft 1-year survival was 88% versus 78% (P = 0.1013), respectively. Costs accumulated were significantly higher after introduction of the MELD policy (US $81,967 versus US $127,453, a 55% increase, P = 0.02) with a strong correlation with the individual MELD score (P < 0.0001). The MELD system addresses the goal of fairness well. However, the postoperative course appears more difficult in the MELD era with increased financial burden, but reasonable patient and graft survival. This is the inevitable price to balance justice and utility in liver graft allocation.