31 results on '"Puhan, Milo A."'
Search Results
2. Surgical Outcome Reporting. Moving From a Comic to a Tragic Opera?
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Abbassi, Fariba, Pfister, Matthias, Domenghino, Anja, Puhan, Milo A., and Clavien, Pierre-Alain
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Objectives: To assess the current quality of surgical outcome reporting in the medical literature and to provide recommendations for improvement. Background: In 1996, The Lancet labeled surgery as a "comic opera" mostly referring to the poor quality of outcome reporting in the literature impeding improvement in surgical quality and patient care. Methods: We screened 3 first-tier and 2 second-tier surgical journals, as well as 3 leading medical journals for original articles reporting on results of surgical procedures published over a recent 18-month period. The quality of outcome reporting was assessed using a prespecified 12-item checklist. Results: Six hundred twenty-seven articles reporting surgical outcomes were analyzed, including 125 randomized controlled trials. Only 1 (0.2%) article met all 12 criteria of the checklist, whereas 356 articles (57%) fulfilled less than half of the criteria. The poorest reporting was on cumulative morbidity burden, which was missing in 94% of articles (n= 591) as well as patient-reported outcomes missing in 83% of publications (n=518). Comparing journal groups for the individual criterion, we found moderate to very strong statistical evidence for better quality of reporting in high versus lower impact journals for 7 of 12 criteria and strong statistical evidence for better reporting of patientreported outcomes in medical versus surgical journals (P<0·001). Conclusions: The quality of outcomes reporting in the medical literature remains poor, lacking improvement over the past 20 years onmost key end points. The implementation of standardized outcome reporting is urgently needed to minimize biased interpretation of data thereby enabling improved patient care and the elaboration of meaningful guidelines. [ABSTRACT FROM AUTHOR]
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- 2024
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3. Causal Mediation Analysis with Multiple Time-varying Mediators.
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Tai, An-Shun, Lin, Sheng-Hsuan, Chu, Yu-Cheng, Yu, Tsung, Puhan, Milo A., and VanderWeele, Tyler
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In longitudinal studies with time-varying exposures and mediators, the mediational g-formula is an important method for the assessment of direct and indirect effects. However, current methodologies based on the mediational g-formula can deal with only one mediator. This limitation makes these methodologies inapplicable to many scenarios. Hence, we develop a novel methodology by extending the mediational g-formula to cover cases with multiple time-varying mediators. We formulate two variants of our approach that are each suited to a distinct set of assumptions and effect definitions and present nonparametric identification results of each variant. We further show how complex causal mechanisms (whose complexity derives from the presence of multiple time-varying mediators) can be untangled. We implemented a parametric method, along with a user-friendly algorithm, in R software. We illustrate our method by investigating the complex causal mechanism underlying the progression of chronic obstructive pulmonary disease. We found that the effects of lung function impairment mediated by dyspnea symptoms accounted for 14.6% of the total effect and that mediated by physical activity accounted for 11.9%. Our analyses thus illustrate the power of this approach, providing evidence for the mediating role of dyspnea and physical activity on the causal pathway from lung function impairment to health status. See video abstract at, http://links.lww.com/EDE/B988 . [ABSTRACT FROM AUTHOR]
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- 2023
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4. Is Statistical Significance Alone Obsolete? Let’s Turn to Meaningful Interpretation of Scientific and Real-world Evidence on Surgical Care.
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Puhan, Milo A. and Clavien, Pierre-Alain
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- 2024
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5. How to Establish Benchmarks for Surgical Outcomes?: A Checklist Based on an International Expert Delphi Consensus.
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Gero, Daniel, Muller, Xavier, Staiger, Roxane D., Gutschow, Christian A., Vonlanthen, René, Bueter, Marco, Clavien, Pierre-Alain, and Puhan, Milo A.
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Supplemental Digital Content is available in the text Objective: To define a standardized methodology for establishing benchmarks for relevant outcomes in surgery. Summary Background Data: Benchmarking is an established tool to improve quality in industry and economics, and is emerging in assessing outcome values in surgery. Despite a recent 10-step approach to identify such benchmark values, a standardized and more widely agreed-on approach is still lacking. Methods: A multinational web-based Delphi survey with a focus on methodological requirements for establishing benchmarks for surgical outcomes was performed. Participants were selected among internationally renowned specialists in abdominal, vascular, and thoracic surgery. Consensus was defined as ≥70% agreement and results were used to develop a checklist to establish benchmarks in surgery. Results: Forty-one surgical opinion leaders from 19 countries and 5 continents were involved. Experts' response rates were 98% and 80% in rounds 1 and 2, respectively. Upon completion of the final Delphi round, consensus was successfully achieved for 26 of 36 items covering the following areas: center eligibility, validation of databases, patient cohort selection, procedure selection, duration of follow-up, statistical analysis, and publication requirements regarding center-specific outcomes. Conclusions: This multinational Delphi survey represents the first expert-led process for developing a standardized approach for establishing benchmarks for relevant outcome measures in surgery. The provided consensual checklist customizes the methodology of outcome reporting in surgery and thus improves reproducibility and comparability of data and should ultimately serve to improve quality of care. [ABSTRACT FROM AUTHOR]
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- 2022
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6. Interleukin-6 Is an Early Plasma Marker of Severe Postoperative Complications in Thoracic Surgery: Exploratory Results From a Substudy of a Randomized Controlled Multicenter Trial.
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Neff, Thomas A., Braun, Julia, Rana, Dhanu, Puhan, Milo, Filipovic, Miodrag, Seeberger, Manfred, Stüber, Frank, Neff, Simona B., Beck-Schimmer, Beatrice, and Schläpfer, Martin
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- 2022
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7. Can Early Postoperative Complications Predict High Morbidity and Decrease Failure to Rescue Following Major Abdominal Surgery?
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Staiger, Roxane D., Gerns, Esther, Subirà, Mariona Castrejón, Domenghino, Anja, Puhan, Milo A., and Clavien, Pierre-Alain
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Objective: To assess whether specific patterns of early postoperative complications may predict overall severe morbidity after major surgery, warranting early escalation of care and prevention of failure to rescue. Summary of Background Data: It is unclear whether early postoperative complications predict a poor outcome. Detailed knowledge of the chronology and type of early complications after major surgery may alert clinicians when to expect higher risk for subsequent major negative events. Methods: All 90-day postoperative events following complex pancreas, liver, and rectal surgeries, and liver transplantation were analyzed over a 3-year period in a single tertiary center. Each complication was recorded regarding severity, type (cardiac, infectious, etc), etiology (surgical/medical), and timing of occurrence. The Comprehensive Complication Index (CCI
® ), covering the first 7 postoperative days, was calculated as a measure for early cumulative postoperative morbidity. The statistical analysis (descriptive, sequence pattern analyses, and logistic regression analyses) aimed to detect any combinations of events predicting poor outcome as defined by a cumulative CCI® ≥37.1 at 90-days. Results: The occurrence of ≥2 complications, irrespective of severity, type or etiology, was strongly associated with a severe postoperative course (P < 0.001). Even 2 mild complications (≤ grade II) greatly increased the chance for high morbidity compared to patients with 0 or 1 complication within the first postoperative week (odds ratio 10.2, 95% confidence interval 5.82–17.98). The CCI® at postoperative day 7 strongly predicted high 90-day morbidity (odds ratio 3.96 per 10 CCI® points, P < 0.001). Conclusion: Multiple complications of any cause or severity within the first postoperative days represents a “warning-signal” for overall high morbidity by 90 days, which should be used to trigger an escalation of care to prevent failure to rescue and eventually poor outcome. [ABSTRACT FROM AUTHOR]- Published
- 2020
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8. Anesthesia and Circulating Tumor Cells in Primary Breast Cancer Patients: A Randomized Controlled Trial.
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Hovaguimian, Frédérique, Braun, Julia, Z'graggen, Birgit Roth, Schläpfer, Martin, Dumrese, Claudia, Ewald, Christina, Dedes, Konstantin J., Fink, Daniel, Rölli, Urs, Seeberger, Manfred, Tausch, Christoph, Papassotiropoulos, Bärbel, Puhan, Milo A., and Beck-Schimmer, Beatrice
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- 2020
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9. Procedural Surgical RCTs in Daily Practice: Do Surgeons Adopt Or Is It Just a Waste of Time?
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Oberkofler, Christian E., Hamming, Jacob F., Staiger, Roxane D., Brosi, Philippe, Biondo, Sebastiano, Farges, Olivier, Legemate, Dink A., Morino, Mario, Pinna, Antonio D., Pinto-Marques, Hugo, Reynolds, John V., Robles Campos, Ricardo, Rogiers, Xavier, Soreide, Kjetil, Puhan, Milo A., Clavien, Pierre-Alain, and Rinkes, Inne Borel
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Objective: To assess the adoption of recommendation from randomized clinical trials (RCTs) and investigate factors favoring or preventing adoption. Background: RCT are considered to be the cornerstone of evidence-based medicine by representing the highest level of evidence. As such, we expect RCT's recommendations to be followed rigorously in daily surgical practice. Methods: We performed a structured search for RCTs published in the medical and surgical literature from 2009 to 2013, allowing a minimum of 5-year follow-up to convincingly test implementation. We focused on comparative technical or procedural RCTs trials addressing the domains of general, colorectal, hepatobiliary, upper gastrointestinal and vascular surgery. In a second step we composed a survey of 29 questions among ESA members as well as collaborators from their institutions to investigate the adoption of surgical RCTs recommendation. Results: The survey based on 36 RCTs (median 5-yr citation index 85 (24-474), from 21 different countries, published in 15 high-ranked journals with a median impact factor of 3.3 (1.23-7.9) at the time of publication. Overall, less than half of the respondents (47%) appeared to adhere to the recommendations of a specific RCT within their field of expertise, even when included in formal guidelines. Adoption of a new surgical practice was favored by watching videos (46%) as well as assisting live operations (18%), while skepticism regarding the methodology of a surgical RCT (40%) appears to be the major reason to resist adoption. Conclusion: In conclusion, surgical RCTs appear to have moderate impact on daily surgical practice. While RCTs are still accepted to provide the highest level of evidence, alternative methods of evaluating surgical innovations should also be explored. [ABSTRACT FROM AUTHOR]
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- 2019
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10. The Comprehensive Complication Index (CCI®) is a Novel Cost Assessment Tool for Surgical Procedures.
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Staiger, Roxane D., Cimino, Matteo, Javed, Ammar, Biondo, Sebastiano, Fondevila, Constantino, Périnel, Julie, Aragão, Ana Carolina, Torzilli, Guido, Wolfgang, Christopher, Adham, Mustapha, Pinto-Marques, Hugo, Dutkowski, Philipp, Puhan, Milo A., and Clavien, Pierre-Alain
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Supplemental Digital Content is available in the text 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 (R2 = 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). [ABSTRACT FROM AUTHOR]- Published
- 2018
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11. The Comprehensive Complication Index (CCI®).
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Clavien, Pierre-Alain, Vetter, Diana, Staiger, Roxane D., Slankamenac, Ksenija, Mehra, Tarun, Graf, Rolf, and Puhan, Milo Alan
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Objective: To explore the added value of the comprehensive complication index (CCI®) to standard assessment of postoperative morbidity, and to clarify potential controversies for its application. Background: The CCI® was introduced about 3 years ago as a novel metric of postoperative morbidity, integrating in a single formula all complications by severity, ranging from 0 (uneventful course) to 100 (death). It remains unclear, how often the CCI® adds to standard reporting of complications and how to apply it in complex postoperative courses. Methods: CCI® data were prospectively collected over a 1-year period at our institution. The proportion of patients with more than 1 complication and the severity of those complications were assessed to determine the additional value of the CCI® compared to the Clavien--Dindo classification. Complex and controversial cases were presented to 90 surgeons worldwide to achieve consensus in weighing each postoperative event. Descriptive statistics were used to evaluate agreement among surgeons and to suggest solutions for consistent use of the CCI®. Results: Complications were identified in 24% (290/1212) of the general surgical population. Of those, 44% (127/290) developed more than 1 complication by the time of discharge, and thereby CCI® added information to the standard grading system of complications. Information gained by the CCI® increased with the complexity of surgery and observation time. Conclusions: The CCI® adds information on postoperative morbidity in almost half of the patients developing complications, with particular value following extensive surgery and longer postoperative observation up to 3 months. Each single complication, independently of their inter-connection, should be included in the CCI® calculation to best mirror the patients' postoperative morbidity. [ABSTRACT FROM AUTHOR]
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- 2017
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12. Which Anesthesia Regimen Is Best to Reduce Morbidity and Mortality in Lung Surgery?: A Multicenter Randomized Controlled Trial.
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Beck-Schimmer, Beatrice, Bonvini, John M., Braun, Julia, Seeberger, Manfred, Neff, Thomas A., Risch, Tobias J., Stüber, Frank, Vogt, Andreas, Weder, Walter, Schneiter, Didier, Filipovic, Miodrag, and Puhan, Milo
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- 2016
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13. Conditioning With Sevoflurane in Liver Transplantation: Results of a Multicenter Randomized Controlled Trial.
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Beck-Schimmer, Beatrice, Bonvini, John M., Schadde, Erik, Dutkowski, Philipp, Oberkofler, Christian E., Lesurtel, Mickael, DeOliveira, Michelle L., Figueira, Estela R. R., Filho, Joel A. Rocha, Auler Jr, Jose Otavio Costa, D'Albuquerque, Luiz A. C., Reyntjens, Koen, Wouters, Patrick, Rogiers, Xavier, Debaerdemaeker, Luc, Ganter, Michael T., Weber, Achim, Puhan, Milo A., Clavien, Pierre-Alain, and Breitenstein, Stefan
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- 2015
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14. Setting Priorities for Comparative Effectiveness Research on Management of Primary Angle Closure: A Survey of Asia-Pacific Clinicians.
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Tsung Yu, Tianjing Li, Lee, Kinbo J., Friedman, David S., Dickersin, Kay, and Puhan, Milo A.
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- 2015
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15. Anesthesia and Circulating Tumor Cells: Reply.
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Hovaguimian, Fraderique, Braun, Julia, Schlapfer, Martin, Puhan, Milo A., Beck-Schimmer, Beatrice, Hovaguimian, Frédérique, and Schläpfer, Martin
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- 2021
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16. Development and Validation of a Prediction Score for Postoperative Acute Renal Failure Following Liver Resection.
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Slankamenac, Ksenija, Breitenstein, Stefan, Held, Ulrike, Beck-Schimmer, Beatrice, Puhan, Milo A., and Clavien, Pierre-Alain
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To develop and validate a score to predict postoperative acute renal failure (ARF) after liver resection.Postoperative ARF after major surgery is associated with morbidity and mortality. Early identification of patients at risk of ARF is important in order to provide protective kidney treatment.Postoperative ARF was prospectively assessed in consecutive patients undergoing liver resection. In randomly selected two-third of the total number of patients, multivariate logistic regression analysis was used to develop a new prediction score (including a full and a reduced model), based on the preoperative parameters of age, gender, preexisting chronic renal dysfunction, cardiovascular disease, diabetes, bilirubin, and alanine aminotransferase (ALT) levels. In the remaining last third of the patients, the new score was validated by calibrating the accuracy of the score (ClinicalTrials.gov NCT 00743132).Postoperative ARF occurred in 15.1% (86 of 569 consecutive patients) from 2002 to 2007 and was highly associated with mortality (22.5% vs. 0.8% without ARF, P < 0.001). In the 380 (two-third of the population) patients selected for the development of the prediction score, preoperatively elevated ALT, preexisting cardiovascular disease, chronic renal failure, and diabetes were the strongest predictors of ARF. Validating the full prediction model (0-22 points) to the remaining 189 patients (one-third of the population), the risk could be predicted accurately (mean predicted risk of 11.5% vs. an observed risk of 14.8%) without significant differences between predicted and observed risks across different risk categories (P = 0.98). Prediction with the reduced model including the 4 strongest predictors (0-7 points) was almost as accurate as with the full model (11.4% predicted vs. 14.8% observed) and also without significant differences across different risk categories (P = 0.75).The new prediction score (the full as well as the reduced model) accurately predicted postoperative ARF after liver resection. The use of these scores allows early identification of patients at high risk of ARF, and may support decision making for protective kidney interventions perioperatively. [ABSTRACT FROM AUTHOR]
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- 2009
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17. Assessment of Hepatic Steatosis by Expert Pathologists.
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El-Badry, Ashraf Mohammad, Breitenstein, Stefan, Jochum, Wolfram, Washington, Kay, Paradis, Valérie, Rubbia-Brandt, Laura, Puhan, Milo A., Slankamenac, Ksenija, Graf, Rolf, and Clavien, Pierre-Alain
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The presence of fat in the liver is considered a major risk for postoperative complication after liver surgery and transplantation. The current standard of quantification of hepatic steatosis is microscopic evaluation by pathologists, although consistency in such assessment remains unclear. Computerized image analysis is an alternative method for objective assessment of the degree of hepatic steatosis.High resolution images of hematoxylin and eosin stained liver sections from 46 consecutive patients, initially diagnosed with liver steatosis, were blindly assessed by 4 established expert pathologists from different institutions. Computerized analysis was carried out simultaneously on the same sections. Interobserver agreement and correlation between the pathologists’ and computerized assessment were evaluated using intraclass correlation coefficients (ICC), Spearman rank correlation coefficients, or descriptive statistics.Poor agreement among pathologists (ICC: 0.57) was found regarding the assessment of total steatosis, (ICC >0.7 indicates acceptable agreement). Pathologists’ estimation of micro- and macrosteatosis disclosed also poor correlation (ICC: 0.22, 0.55, respectively). Inconsistent assessment of histological features of steatohepatitis (lobular inflammation, portal inflammation, hepatocyte ballooning, and Mallory hyaline) was documented. Poor conformity was also shown between the computerized quantification and ratings of 3 pathologists (Spearman rank correlation coefficients: 0.22, 0.82, 0.28, and 0.38).Quantification of hepatic steatosis in histological sections is strongly observer-dependent, not reproducible, and does not correlate with the computerized estimation. Current standards of assessment, previously published data and the clinical relevance of hepatic steatosis for liver surgery and transplantation must be challenged. [ABSTRACT FROM AUTHOR]
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- 2009
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18. In Reply.
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Beck-Schimmer, Beatrice and Puhan, Milo
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- 2017
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19. Lung-protective Role of Halogenated Anesthetics.
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Beck-Schimmer, Beatrice and Puhan, Milo
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- 2017
20. Added salt and cancer mortality: confounding by smoking.
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Faeh, David, Rohrmann, Sabine, Puhan, Milo, and Braun, Julia
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- 2014
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21. Reply to: the "Reply to Slankamenac et al's Comprehensive Complication Index Validation Study (November 2014)".
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Slankamenac, Ksenija, Puhan, Milo A., and Clavien, Pierre-Alain
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- 2016
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22. Surgeon-Scientists Going Extinct - Last Call for Action or Too Late?
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Pfister M, Li Z, Huwyler F, Tibbitt MW, Puhan MA, and Clavien PA
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Objective: To define the concept of surgeon-scientists and identify the root causes of their decline in number and impact. The secondary aim was to provide actionable remedies., Background: Surgeons who conduct research in addition to patient care are referred to as «surgeon-scientists». While their value to society remains undisputed, their numbers and associated impact have been plunging. While reasons have been well identified along with proposals for countermeasures, their application have largely failed., Methods: We conducted a systematic review covering all aspects of surgeon-scientists together with a global online survey among 141 young academic surgeons. Using gap analysis, we determined implementation gaps for proposed measures. Then, we developed a comprehensive rescue package., Results: A surgeon-scientist must actively and continuously engage in both patient care and research. Competence in either field must be established through protected training and criteria of excellence, particularly reflecting contribution to innovation. The decline of surgeon-scientists has reached unprecedented magnitude. Leadership turning hospitals into «profit-factories» is one reason, a flawed selection process not exclusively based on excellence another. Most importantly, the appreciation for the academic mission has vanished. Along with fundamentally addressing these root causes, surgeon-scientists' path to excellence must be streamlined, and their continuous devotion for innovation cherished., Conclusion: The journey of the surgeon-scientist is at crossroads. As society, we either adapt and shift our priorities again towards innovation or capitulate to the greed for profit, permanently losing these invaluable professionals. Successful rescue packages must not only involve hospitals and universities but also the political sphere., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)
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- 2024
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23. Milestones in Surgical Complication Reporting. Clavien-Dindo Classification 20 Years & Comprehensive Complication Index (CCI®) 10 Years.
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Abbassi F, Pfister M, Lucas KL, Domenghino A, Puhan MA, and Clavien PA
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Objective: To provide improved guidance for the consistent application of the Clavien-Dindo classification (CDC) and Comprehensive Complication Index (CCI®) in challenging clinical scenarios., Background: Standardized outcome reporting is key for proper assessment of surgical procedures. A recent consensus conference recommended the CDC and the CCI® for assessing postoperative morbidity. Several challenging scenarios for grading complications still require evidence-based guidance, and the use of the two metrics in RCTs remains unexplored., Methods: We assessed the use of the CDC and CCI® as an outcome measure in a systematic literature search. Additionally, we asked 163 international surgeons to critically evaluate and independently grade complications in 20 complex clinical scenarios. Finally, a core group of five experts used this information to develop consistent recommendations., Results: Until July 2023, 1327 RCTs selected the CDC and/or CCI® to assess morbidity. Annual use was steadily increasing with now over 200 new RCTs per year. However, only a third (n=335) of published RCTs provided the complete range of CDC grades, including all subgrades. Eighty-nine out of 163 surgeons (response rate 55%) completed the questionnaire that served as basis for the recommendations: Repetitive interventions that are required to treat one complication, complications followed by further complications, complications occurring prior to referral, and expected and unrelated complications to the original procedure should all be counted separately and included in the CCI®. Invasive blank diagnostic interventions should not be considered a complication., Conclusion: The increasing use of the CDC and CCI® in RCTs highlights the importance of their standardized application. The current consensus on various difficult scenarios may offer novel guidance for the consistent use of the CDC and CCI®, aiming to improve complication reporting, and better-quality control, ultimately benefiting all healthcare stakeholders, and first and foremost, all patients., (Copyright © 2024 Wolters Kluwer Health, Inc. All rights reserved.)
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- 2024
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24. Defining Global Benchmarks in Bariatric Surgery: A Retrospective Multicenter Analysis of Minimally Invasive Roux-en-Y Gastric Bypass and Sleeve Gastrectomy.
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Gero D, Raptis DA, Vleeschouwers W, van Veldhuisen SL, Martin AS, Xiao Y, Galvao M, Giorgi M, Benois M, Espinoza F, Hollyman M, Lloyd A, Hosa H, Schmidt H, Garcia-Galocha JL, van de Vrande S, Chiappetta S, Menzo EL, Aboud CM, Lüthy SG, Orchard P, Rothe S, Prager G, Pournaras DJ, Cohen R, Rosenthal R, Weiner R, Himpens J, Torres A, Higa K, Welbourn R, Berry M, Boza C, Iannelli A, Vithiananthan S, Ramos A, Olbers T, Sepúlveda M, Hazebroek EJ, Dillemans B, Staiger RD, Puhan MA, Peterli R, and Bueter M
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- Academic Medical Centers, Adult, Age Factors, Benchmarking, Cohort Studies, Female, Gastrectomy adverse effects, Gastric Bypass adverse effects, Global Health, Hospitals, High-Volume, Humans, Internationality, Laparoscopy adverse effects, Length of Stay, Male, Middle Aged, Minimally Invasive Surgical Procedures adverse effects, Minimally Invasive Surgical Procedures methods, Obesity, Morbid diagnosis, Obesity, Morbid epidemiology, Postoperative Complications epidemiology, Postoperative Complications physiopathology, Registries, Retrospective Studies, Risk Assessment, Sex Factors, Weight Loss, Body Mass Index, Gastrectomy methods, Gastric Bypass methods, Laparoscopy methods, Obesity, Morbid surgery, Quality of Life
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Objective: To define "best possible" outcomes for bariatric surgery (BS)(Roux-en-Y gastric bypass [RYGB] and sleeve gastrectomy [SG])., Background: Reference values for optimal surgical outcomes in well-defined low-risk bariatric patients have not been established so far. Consequently, outcome comparison across centers and over time is impeded by heterogeneity in case-mix., Methods: Out of 39,424 elective BS performed in 19 high-volume academic centers from 3 continents between June 2012 and May 2017, we identified 4120 RYGB and 1457 SG low-risk cases defined by absence of previous abdominal surgery, concomitant procedures, diabetes mellitus, sleep apnea, cardiopathy, renal insufficiency, inflammatory bowel disease, immunosuppression, anticoagulation, BMI>50 kg/m and age>65 years. We chose clinically relevant endpoints covering the intra- and postoperative course. Complications were graded by severity using the comprehensive complication index. Benchmark values were defined as the 75th percentile of the participating centers' median values for respective quality indicators., Results: Patients were mainly females (78%), aged 38±11 years, with a baseline BMI 40.8 ± 5.8 kg/m. Over 90 days, 7.2% of RYGB and 6.2% of SG patients presented at least 1 complication and no patients died (mortality in nonbenchmark cases: 0.06%). The most frequent reasons for readmission after 90-days following both procedures were symptomatic cholelithiasis and abdominal pain of unknown origin. Benchmark values for both RYGB and SG at 90-days postoperatively were 5.5% Clavien-Dindo grade ≥IIIa complication rate, 5.5% readmission rate, and comprehensive complication index ≤33.73 in the subgroup of patients presenting at least 1 grade ≥II complication., Conclusion: Benchmark cutoffs targeting perioperative outcomes in BS offer a new tool in surgical quality-metrics and may be implemented in quality-improvement cycle.ClinicalTrials.gov Identifier NCT03440138.
- Published
- 2019
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25. Benchmarks in Pancreatic Surgery: A Novel Tool for Unbiased Outcome Comparisons.
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Sánchez-Velázquez P, Muller X, Malleo G, Park JS, Hwang HK, Napoli N, Javed AA, Inoue Y, Beghdadi N, Kalisvaart M, Vigia E, Walsh CD, Lovasik B, Busquets J, Scandavini C, Robin F, Yoshitomi H, Mackay TM, Busch OR, Hartog H, Heinrich S, Gleisner A, Perinel J, Passeri M, Lluis N, Raptis DA, Tschuor C, Oberkofler CE, DeOliveira ML, Petrowsky H, Martinie J, Asbun H, Adham M, Schulick R, Lang H, Koerkamp BG, Besselink MG, Han HS, Miyazaki M, Ferrone CR, Fernández-Del Castillo C, Lillemoe KD, Sulpice L, Boudjema K, Del Chiaro M, Fabregat J, Kooby DA, Allen P, Lavu H, Yeo CJ, Barroso E, Roberts K, Muiesan P, Sauvanet A, Saiura A, Wolfgang CL, Cameron JL, Boggi U, Yoon DS, Bassi C, Puhan MA, and Clavien PA
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- Asia epidemiology, Europe epidemiology, Follow-Up Studies, Hospital Mortality trends, Humans, Incidence, Retrospective Studies, Survival Rate trends, United States epidemiology, Benchmarking, Pancreatic Diseases surgery, Pancreaticoduodenectomy methods, Postoperative Complications epidemiology
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Objective: To use the concept of benchmarking to establish robust and standardized outcome references after pancreatico-duodenectomy (PD)., Background: Best achievable results after PD are unknown. Consequently, outcome comparisons among different cohorts, centers or with novel surgical techniques remain speculative., Methods: This multicenter study analyzes consecutive patients (2012-2015) undergoing PD in 23 international expert centers in pancreas surgery. Outcomes in patients without significant comorbidities and major vascular resection (benchmark cases) were analyzed to establish 20 outcome benchmarks for PD. These benchmarks were tested in a cohort with a poorer preoperative physical status (ASA class ≥3) and a cohort treated by minimally invasive approaches., Results: Two thousand three hundred seventy-five (38%) low-risk cases out of a total of 6186 PDs were analyzed, disclosing low in-hospital mortality (≤1.6%) but high morbidity, with a 73% benchmark morbidity rate cumulated within 6 months following surgery. Benchmark cutoffs for pancreatic fistulas (B-C), severe complications (≥ grade 3), and failure-to-rescue rate were 19%, 30%, and 9%, respectively. The ASA ≥3 cohort showed comparable morbidity but a higher in hospital-mortality (3% vs 1.6%) and failure-to-rescue rate (16% vs 9%) than the benchmarks. The proportion of benchmark cases performed varied greatly across centers and continents for both open (9%-93%) and minimally invasive (11%-62%) PD. Centers operating mostly on complex PD cases disclosed better results than those with a majority of low-risk cases., Conclusion: The proposed outcome benchmarks for PD, established in a large-scale international patient cohort and tested in 2 different cohorts, may allow for meaningful comparisons between different patient cohorts, centers, countries, and surgical techniques.
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- 2019
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26. Defining Benchmarks for Major Liver Surgery: A multicenter Analysis of 5202 Living Liver Donors.
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Rössler F, Sapisochin G, Song G, Lin YH, Simpson MA, Hasegawa K, Laurenzi A, Sánchez Cabús S, Nunez MI, Gatti A, Beltrame MC, Slankamenac K, Greig PD, Lee SG, Chen CL, Grant DR, Pomfret EA, Kokudo N, Cherqui D, Olthoff KM, Shaked A, García-Valdecasas JC, Lerut J, Troisi RI, De Santibanes M, Petrowsky H, Puhan MA, and Clavien PA
- Subjects
- Adult, Benchmarking, Blood Transfusion, Female, Humans, Length of Stay, Liver Failure etiology, Male, Patient Readmission statistics & numerical data, Postoperative Complications, Hepatectomy methods, Living Donors
- Abstract
Objective: To measure and define the best achievable outcome after major hepatectomy., Background: No reference values are available on outcomes after major hepatectomies. Analysis in living liver donors, with safety as the highest priority, offers the opportunity to define outcome benchmarks as the best possible results., Methods: Outcome analyses of 5202 hemi-hepatectomies from living donors (LDs) from 12 high-volume centers worldwide were performed for a 10-year period. Endpoints, calculated at discharge, 3 and 6 months postoperatively, included postoperative morbidity measured by the Clavien-Dindo classification, the Comprehensive Complication Index (CCI), and liver failure according to different definitions. Benchmark values were defined as the 75th percentile of median morbidity values to represent the best achievable results at 3 month postoperatively., Results: Patients were young (34 ± [9] years), predominantly male (65%) and healthy. Surgery lasted 7 ± [2] hours; 2% needed blood transfusions. Mean hospital stay was 11.7± [5] days. 12% of patients developed at least 1 complication, of which 3.8% were major events (≥grade III, including 1 death), mostly related to biliary/bleeding events, and were twice higher after right hepatectomy. The incidence of postoperative liver failure was low. Within 3-month follow-up, benchmark values for overall complication were ≤31 %, for minor/major complications ≤23% and ≤9%, respectively, and a CCI ≤33 in LDs with complications. Centers having performed ≥100 hepatectomies had significantly lower rates for overall (10.2% vs 35.9%, P < 0.001) and major (3% vs 12.1%, P < 0.001) complications and overall CCI (2.1 vs 8.5, P < 0.001)., Conclusions: The thorough outcome analysis of healthy LDs may serve as a reference for evaluating surgical performance in patients undergoing major liver resection across centers and different patient populations. Further benchmark studies are needed to develop risk-adjusted comparisons of surgical outcomes.
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- 2016
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27. The comprehensive complication index: a novel and more sensitive endpoint for assessing outcome and reducing sample size in randomized controlled trials.
- Author
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Slankamenac K, Nederlof N, Pessaux P, de Jonge J, Wijnhoven BP, Breitenstein S, Oberkofler CE, Graf R, Puhan MA, and Clavien PA
- Subjects
- Diverticulitis, Colonic surgery, Esophageal Neoplasms surgery, Europe, Humans, Pancreatic Diseases surgery, Sample Size, Sensitivity and Specificity, Endpoint Determination methods, Postoperative Complications classification, Randomized Controlled Trials as Topic, Research Design
- Abstract
Objective: To test whether the newly developed comprehensive complication index (CCI) is more sensitive than traditional endpoints for detecting between-group differences in randomized controlled trials (RCTs)., Background: A major challenge in RCTs is the choice of optimal endpoints to detect treatment effects. Mortality is no longer a sufficient marker in studies, and morbidity is often poorly defined. The CCI, integrating all complications including their severity in a linear scale ranging from 0 (no complication) to 100 (death), is a new tool, which may be more sensitive than other traditional endpoints to detect treatment effects on postoperative morbidity., Methods: The CCI was tested in 3 published RCTs from European centers evaluating pancreas, esophageal and colon resections. To compare the sensitivity of the CCI with traditional morbidity endpoints, for example, presence of any (yes/no) or only the most severe complications, all postoperative events were assessed, and the CCI calculated. Treatment effects and sample size calculations were compared using the CCI and traditional endpoints., Results: Although RCTs failed to show between-group differences using any or most severe complications, the CCI revealed significant differences between treatment groups in 2 RCTs-after pancreas (P=0.009) and esophageal surgery (P=0.014). The CCI in the RCT on colon resections confirmed the absence of between-group differences (P=0.39). The required sample sizes in trials are up to 9 times lower for the CCI than for traditional morbidity endpoints., Conclusions: This study demonstrates superiority of the CCI to traditional endpoints. The CCI may serve as an appealing endpoint for future RCTs and may reduce the sample size.
- Published
- 2014
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28. The comprehensive complication index: a novel continuous scale to measure surgical morbidity.
- Author
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Slankamenac K, Graf R, Barkun J, Puhan MA, and Clavien PA
- Subjects
- Adult, Female, Health Status Indicators, Humans, Male, Randomized Controlled Trials as Topic, Risk Assessment, Sensitivity and Specificity, Severity of Illness Index, Surveys and Questionnaires, Postoperative Complications classification
- Abstract
Objective: To develop and validate a comprehensive complication index (CCI) that integrates all events with their respective severity., Background: Reporting of surgical complications is inconsistent and often incomplete. Most studies fail to provide information about the severity of complications, or inform only on the most severe event, ignoring events of lesser severity., Methods: We used an established classification of complications, adopting methods from operation risk index analysis in marketing research to develop a formula that considers all complications that may occur in a patient. The weights of each grade of complication, defined as median reference values, were obtained from 472 participants, who rated 30 different complications. Validation to assess sensitivity to treatment effects and validity of the CCI was performed by 4 different approaches, based on 1299 patients., Results: The CCI is calculated as the sum of all complications that are weighted for their severity (multiplication of the median reference values from patients and physicians). The final formula yields a continuous scale to rank the severity of any combination of complications from 0 to 100 in a single patient. The CCI was highly sensitive in detecting treatment effect differences in the context of a randomized trial (effect size detected by CCI vs conventional standardized morbidity outcomes). It also showed a negative correlation with postoperative health status (r = -0.24, P = 0.002), and high correlation with the results of patient-rated single and multiple complications on conjoint analysis (r = 0.94, P < 0.001)., Conclusions: The CCI summarizes all postoperative complications and is more sensitive than existing morbidity endpoints. It may serve as a standardized and widely applicable primary endpoint in surgical trials and other interventional fields of medicine. The CCI can be readily computed on the basis of tabulated complications according to the Clavien-Dindo classification (available at www.assessurgery.com).
- Published
- 2013
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29. Protection of pharmacological postconditioning in liver surgery: results of a prospective randomized controlled trial.
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Beck-Schimmer B, Breitenstein S, Bonvini JM, Lesurtel M, Ganter M, Weber A, Puhan MA, and Clavien PA
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- Aged, Aspartate Aminotransferases blood, Female, Humans, Length of Stay statistics & numerical data, Male, Middle Aged, Postoperative Complications, Prospective Studies, Sevoflurane, Treatment Outcome, Anesthetics, Inhalation administration & dosage, Hepatectomy methods, Ischemic Postconditioning methods, Methyl Ethers administration & dosage, Reperfusion Injury prevention & control
- Abstract
Objectives: : To elucidate the possible organ-protective effect of pharmacological postconditioning in patients undergoing liver resection with inflow occlusion., Background: : Inflow occlusion reduces blood loss during liver transection in selected patients but is potentially harmful due to ischemia-reperfusion injury. Preventive strategies include the use of repetitive short periods of ischemia interrupted by a reperfusion phase (intermittent clamping), application of a short period of ischemia before transection (ischemic preconditioning), or pharmacological preconditioning before transection. Whether intervention after resection (postconditioning) may confer protection is unknown., Methods: : A 3 arm, prospective, randomized trial was designed for patients undergoing liver resection with inflow occlusion to compare the effects of pharmacological postconditioning with the volatile anesthetic agent sevoflurane (n = 48), intermittent clamping (n = 50), or no protective intervention (continuous inflow occlusion, n = 17). Endpoints included peak serum aspartate transaminase level, postoperative complications, and hospital stay. All patients were intravenously anesthetized with propofol. In patients with postconditioning, propofol infusion was stopped upon reperfusion and replaced with sevoflurane for 10 minutes., Results: : Compared with the control group, both postconditioning (P = 0.044) and intermittent clamping (P = 0.015) significantly reduced aspartate transaminase levels. The risk of complications was significantly decreased by postconditioning, odds ratio, 0.08 [95% confidence interval (CI), 0.02-0.36; P = 0.001]) and intermittent clamping, odds ratio, 0.50 [95% CI, 0.26-0.96; P = 0.038], compared with controls. Both interventions reduced length of hospital stay, postconditioning -4 days [95% CI, -6 to -1; P = 0.009], and intermittent clamping -2 days, [95% CI, -4 to 0; P = 0.019]., Conclusions: : Pharmacological postconditioning reduces organ injury and postoperative complications. This easily applicable strategy should be used in patients with prolonged continuous inflow occlusion.
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- 2012
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30. The impact of complications on costs of major surgical procedures: a cost analysis of 1200 patients.
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Vonlanthen R, Slankamenac K, Breitenstein S, Puhan MA, Muller MK, Hahnloser D, Hauri D, Graf R, and Clavien PA
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- Adult, Aged, Aged, 80 and over, Anastomosis, Roux-en-Y economics, Bile Duct Diseases economics, Bile Duct Diseases surgery, Cohort Studies, Colectomy economics, Colonic Diseases economics, Colonic Diseases surgery, Costs and Cost Analysis, Female, Gastric Bypass economics, Humans, Liver Diseases economics, Liver Diseases surgery, Male, Middle Aged, Pancreatic Diseases economics, Pancreatic Diseases surgery, Postoperative Complications mortality, Postoperative Complications prevention & control, Prospective Studies, Quality of Health Care economics, Surgical Procedures, Operative mortality, Survival Rate, Young Adult, Hospital Costs statistics & numerical data, Postoperative Complications economics, Surgical Procedures, Operative economics
- Abstract
Objective: To assess the impact of postoperative complications on full in-hospital costs per case., Background: Rising expenses for complex medical procedures combined with constrained resources represent a major challenge. The severity of postoperative complications reflects surgical outcomes. The magnitude of the cost created by negative outcomes is unclear., Patients and Methods: Morbidity of 1200 consecutive patients undergoing major surgery from 2005 to 2008 in a tertiary, high-volume center was assessed by a validated, complication score system. Full in-hospital costs were collected for each patient. Statistical analysis was performed using a multivariate linear regression model adjusted for potential confounders., Results: This study population included 393 complex liver/bile duct surgeries, 110 major pancreas operations, 389 colon resections, and 308 Roux-en-Y gastric bypasses. The overall 30-day mortality rate was 1.8%, whereas morbidity was 53.8%. Patients with an uneventful course had mean costs per case of US$ 27,946 (SD US$ 15,106). Costs increased dramatically with the severity of postoperative complications and reached the mean costs of US$ 159,345 (SD US$ 151,191) for grade IV complications. This increase in costs, up to 5 times the cost of a similar operation without complications, was observed for all types of investigated procedures, although the magnitude of the increase varied, with the highest costs in patients undergoing pancreas surgery., Conclusion: This study demonstrates the dramatic impact of postoperative complications on full in-hospital costs per case and that complications are the strongest indicator of costs. Furthermore, the study highlights a relevant savings capacity for major surgical procedures, and supports all efforts to lower negative events in the postoperative course.
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- 2011
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31. Are there better guidelines for allocation in liver transplantation? A novel score targeting justice and utility in the model for end-stage liver disease era.
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Dutkowski P, Oberkofler CE, Slankamenac K, Puhan MA, Schadde E, Müllhaupt B, Geier A, and Clavien PA
- Subjects
- Adult, Cold Ischemia, Female, Guidelines as Topic, Humans, Logistic Models, Male, Middle Aged, Risk Assessment, United States, Waiting Lists, End Stage Liver Disease surgery, Health Care Rationing standards, Liver Transplantation mortality, Resource Allocation standards, Severity of Illness Index, Tissue and Organ Procurement standards
- Abstract
Objectives: To design a new score on risk assessment for orthotopic liver transplantation (OLT) based on both donor and recipient parameters., Background: The balance of waiting list mortality and posttransplant outcome remains a difficult task in the era of the model for end-stage liver disease (MELD)., Methods: Using the United Network for Organ Sharing database, a risk analysis was performed in adult recipients of OLT in the United States of America between 2002 and 2010 (n = 37,255). Living donor-, partial-, or combined-, and donation after cardiac death liver transplants were excluded. Next, a risk score was calculated (balance of risk score, BAR score) on the basis of logistic regression factors, and validated using our own OLT database (n = 233). Finally, the new score was compared with other prediction systems including donor risk index, survival outcome following liver transplantation, donor-age combined with MELD, and MELD score alone., Results: Six strongest predictors of posttransplant survival were identified: recipient MELD score, cold ischemia time, recipient age, donor age, previous OLT, and life support dependence prior to transplant. The new balance of risk score stratified recipients best in terms of patient survival in the United Network for Organ Sharing data, as in our European population., Conclusions: The BAR system provides a new, simple and reliable tool to detect unfavorable combinations of donor and recipient factors, and is readily available before decision making of accepting or not an organ for a specific recipient. This score may offer great potential for better justice and utility, as it revealed to be superior to recent developed other prediction scores.
- Published
- 2011
- Full Text
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