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Journal ArticleDOI

Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey.

01 Aug 2004-Annals of Surgery (Ann Surg)-Vol. 240, Iss: 2, pp 205-213
TL;DR: The new complication classification appears reliable and may represent a compelling tool for quality assessment in surgery in all parts of the world.
Abstract: Growing demand for health care, rising costs, constrained resources, and evidence of variations in clinical practice have triggered interest in measuring and improving the quality of health care delivery. For a valuable quality assessment, relevant data on outcome must be obtained in a standardized and reproducible manner to allow comparison among different centers, between different therapies and within a center over time.1–3 Objective and reliable outcome data are increasingly requested by patients and payers (government or private insurance) to assess quality and costs of health care. Moreover, health policy makers point out that the availability of comparative data on individual hospital's and physician's performance represents a powerful market force, which may contribute to limit the costs of health care while improving quality.4 Conclusive assessments of surgical procedures remain limited by the lack of consensus on how to define complications and to stratify them by severity.1,5–8 In 1992, we proposed general principles to classify complications of surgery based on a therapy-oriented, 4-level severity grading.1 Subsequently, the severity grading was refined and applied to compare the results of laparoscopic versus open cholecystectomy9 and liver transplantation.10 This classification has also been used by others11–13 and was recently suggested to serve as the basis to assess the outcome of living related liver transplantation in the United States (J. Trotter, personal communication). However, the classification system has not yet been widely used in the surgical literature. The strength of the previous classification relied on the principle of grading complications based on the therapy used to treat the complication. This approach allows identification of most complications and prevents down-rating of major negative outcomes. This is particularly important in retrospective analyses. However, we felt that modifications were necessary, particularly in grading life-threatening complications and long-term disability due to a complication. We also felt that the duration of the hospital stay can no longer be used as a criterion to grade complications. Although definitions of negative outcomes rely to a large extend on subjective “value” appraisals, the grading system must be tested in a large cohort of patients. Finally, a classification is useful only if widely accepted and applied throughout different countries and surgical cultures. Such a validation was not done with the previous classification. Therefore, the aim of the current study was 3-fold: first, to propose an improved classification of surgical complications based on our experience gained with the previous classification1; second, to test this classification in a large cohort of patients who underwent general surgery; and third, to assess the reproducibility and acceptability of the classification through an international survey.

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Citations
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Journal ArticleDOI
TL;DR: This 5-year evaluation provides strong evidence that the classification of complications is valid and applicable worldwide in many fields of surgery, and subjective, inaccurate, or confusing terms such as “minor or major” should be removed from the surgical literature.
Abstract: Background and Aims:The lack of consensus on how to define and grade adverse postoperative events has greatly hampered the evaluation of surgical procedures. A new classification of complications, initiated in 1992, was updated 5 years ago. It is based on the type of therapy needed to correct the co

7,537 citations


Cites background or methods or result from "Classification of surgical complica..."

  • ...These criteria constituted the framework of the revised classification system.(7) Before this publication, the grading system was evaluated by 150 surgeons from 10 centers around the world, indicating that the new proposal was indeed understandable, simple, and reproducible....

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  • ...Most of the original reports (n 112, 63%) did not use terms such as “minor or major complications” in any parts of the article, which is consistent with the recommendations made in the original report.(7) Of the remaining studies (n 45, 37%) the term minor was mostly used to refer to grades I and II complications, whereas major related to grades III to V complications....

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  • ...For example, living donor liver(86) and kidney(122) transplantation studies applied the “so-called” Clavien classification, but they based the system mostly on the initial classification,(2,136) arguing that it was appropriate for their purpose, and that the prospective database was initiated before the introduction of the new system.(7) This has resulted in a letter to the editor suggesting to respect the new system to prevent confusion and allow meaningful comparison between the data in Japan and United States....

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  • ...With the participation of 10 centers around the world, we presented revisions in the grading system, proposing more objective criteria and some flexibility by allowing a contraction of grades to adjust to the patient population studied.(7) In contrast to the initial classification,(2) this revised system(7) rapidly gained acceptance by a number of investigators, and became increasingly used in large scale trials....

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  • ...Another source of confusion in the literature was the terminology given to the classification system, and how it was referred to, probably because no special denomination was provided in our original publication.(7) Authors would like to refer to a name to prevent confusion with other systems....

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Journal ArticleDOI
TL;DR: Implementation of the checklist was associated with concomitant reductions in the rates of death and complications among patients at least 16 years of age who were undergoing noncardiac surgery in a diverse group of hospitals.
Abstract: The rate of death was 1.5% before the checklist was introduced and declined to 0.8% afterward (P = 0.003). Inpatient complications occurred in 11.0% of patients at baseline and in 7.0% after introduction of the checklist (P<0.001). Conclusions Implementation of the checklist was associated with concomitant reductions in the rates of death and complications among patients at least 16 years of age who were undergoing noncardiac surgery in a diverse group of hospitals.

4,764 citations

Journal ArticleDOI
TL;DR: Recommendations for the assessment of surgery based on a five-stage description of the surgical development process are proposed and the widespread use of prospective databases and registries are encouraged.

1,456 citations

Journal ArticleDOI
TL;DR: The use of a lung-protective ventilation strategy in intermediate-risk and high-risk patients undergoing major abdominal surgery was associated with improved clinical outcomes and reduced health care utilization.
Abstract: The two intervention groups had similar characteristics at baseline. In the intention-to-treat analysis, the primary outcome occurred in 21 of 200 patients (10.5%) assigned to lung-protective ventilation, as compared with 55 of 200 (27.5%) assigned to nonprotective ventilation (relative risk, 0.40; 95% confidence interval [CI], 0.24 to 0.68; P = 0.001). Over the 7-day postoperative period, 10 patients (5.0%) assigned to lung-protective ventilation required noninvasive ventilation or intubation for acute respiratory failure, as compared with 34 (17.0%) assigned to nonprotective ventilation (relative risk, 0.29; 95% CI, 0.14 to 0.61; P = 0.001). The length of the hospital stay was shorter among patients receiving lung-protective ventilation than among those receiving nonprotective ventilation (mean difference, −2.45 days; 95% CI, −4.17 to −0.72; P = 0.006). CONCLUSIONS As compared with a practice of nonprotective mechanical ventilation, the use of a lung-protective ventilation strategy in intermediate-risk and high-risk patients undergoing major abdominal surgery was associated with improved clinical out comes and reduced health care utilization. (IMPROVE ClinicalTrials.gov number, NCT01282996.)

1,086 citations

References
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Journal ArticleDOI
TL;DR: A 36-item short-form survey designed for use in clinical practice and research, health policy evaluations, and general population surveys to survey health status in the Medical Outcomes Study is constructed.
Abstract: A 36-item short-form (SF-36) was constructed to survey health status in the Medical Outcomes Study. The SF-36 was designed for use in clinical practice and research, health policy evaluations, and general population surveys. The SF-36 includes one multi-item scale that assesses eight health concepts: 1) limitations in physical activities because of health problems; 2) limitations in social activities because of physical or emotional problems; 3) limitations in usual role activities because of physical health problems; 4) bodily pain; 5) general mental health (psychological distress and well-being); 6) limitations in usual role activities because of emotional problems; 7) vitality (energy and fatigue); and 8) general health perceptions. The survey was constructed for self-administration by persons 14 years of age and older, and for administration by a trained interviewer in person or by telephone. The history of the development of the SF-36, the origin of specific items, and the logic underlying their selection are summarized. The content and features of the SF-36 are compared with the 20-item Medical Outcomes Study short-form.

33,857 citations

Journal ArticleDOI
TL;DR: EuroSCORE is a simple, objective and up-to-date system for assessing heart surgery, soundly based on one of the largest, most complete and accurate databases in European cardiac surgical history and is recommend its widespread use.
Abstract: Objective: To construct a scoring system for the prediction of early mortality in cardiac surgical patients in Europe on the basis of objective risk factors. Methods: The EuroSCORE database was divided into developmental and validation subsets. In the former, risk factors deemed to be objective, credible, obtainable and difficult to falsify were weighted on the basis of regression analysis. An additive score of predicted mortality was constructed. Its calibration and discrimination characteristics were assessed in the validation dataset. Thresholds were defined to distinguish low, moderate and high risk groups. Results: The developmental dataset had 13 302 patients, calibration by Hosmer Lemeshow Chi square was (8) = 8.26 (P 200 μmol/l (2), active endocarditis (3) and critical preoperative state (3). Cardiac factors were unstable angina on intravenous nitrates (2), reduced left ventricular ejection fraction (30-50%: 1, 60 mmHg (2). Operation-related factors were emergency (2), other than isolated coronary surgery (2), thoracic aorta surgery (3) and surgery for postinfarct septal rupture (4). The scoring system was then applied to three risk groups. The low risk group (EuroSCORE 1-2) had 4529 patients with 36 deaths (0.8%), 95% confidence limits for observed mortality (0.56-1.10) and for expected mortality (1.27-1.29). The medium risk group (EuroSCORE 3-5) had 5977 patients with 182 deaths (3%), observed mortality (2.62-3.51), predicted (2.90-2.94). The high risk group (EuroSCORE 6 plus) had 4293 patients with 480 deaths (11.2%) observed mortality (10.25-12.16), predicted (10.93-11.54). Overall, there were 698 deaths in 14 799 patients (4.7%), observed mortality (4.37-5.06), predicted (4.72-4.95). Conclusion: EuroSCORE is a simple, objective and up-to-date system for assessing heart surgery, soundly based on one of the largest, most complete and accurate databases in European cardiac surgical history. We recommend its widespread use.

3,288 citations

Journal ArticleDOI
TL;DR: In this article, the authors provide reliable risk-adjusted morbidity and mortality rates after major surgery to the 123 Veterans Affairs Medical Centers (VAMCs) performing major surgery, and use risk adjusted outcomes in the monitoring and improvement of the quality of surgical care to all veterans.
Abstract: ObjectiveTo provide reliable risk-adjusted morbidity and mortality rates after major surgery to the 123 Veterans Affairs Medical Centers (VAMCs) performing major surgery, and to use risk-adjusted outcomes in the monitoring and improvement of the quality of surgical care to all veterans.Summary Backg

1,435 citations

Journal Article
01 May 1992-Surgery
TL;DR: Risk factors for development of complications were determined, and the classification was also used to analyze the value of a modified APACHE II as a preoperative prognostic score, which supported the relevance of the proposed classification.

1,413 citations


"Classification of surgical complica..." refers background or methods in this paper

  • ...This perspective tends to minimize subjective interpretation and any tendency to downrate complications because it is based on hard facts.(1) This approach is particularly important in retrospective studies where postoperative problems are often poorly reported, whereas the therapy to treat a complication is well documented in both physician and nursing reports....

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  • ...Classification of Surgical Complications The previous classification consisted of 4 severity grades.(1,9,10) Grade 1 included minor risk events not requiring therapy (with exceptions of analgesic, antipyretic, antiemetic, and antidiarrheal drugs or drugs required for lower urinary tract infection)....

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  • ...In 1992, we proposed general principles to classify complications of surgery based on a therapy-oriented, 4-level severity grading.(1) Subsequently, the severity grading was refined and applied to compare the results of laparoscopic versus open cholecystectomy(9) and liver transplantation....

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  • ...Definition of Negative Outcome As in the previous publication of 1992, we kept the 3 definitions of negative outcomes by differentiating complications, failure to cure, and sequelae.(1) Complications were defined as any deviation from the normal postoperative course....

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