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Ann Thorac Surg 2000;70:429-431
© 2000 The Society of Thoracic Surgeons


Original articles: general thoracic

Is general thoracic surgical practice evidence based?

James S. Lee, MDa, Dorothy M. Urschel, MS, John D. Urschel, MDa

a Department of Thoracic Surgical Oncology, Roswell Park Cancer Institute, Buffalo, New York, USA

Address requests for reprints and additional references to Dr John Urschel, Department of Surgery, St. Joseph’s Hospital, 50 Charlton Ave E, Hamilton, Ont L8N 4A6, Canada
e-mail: urschelj{at}fhs.mcmaster.ca


    Abstract
 Top
 Abstract
 Introduction
 Material and methods
 Results
 Comment
 References
 
Background. In evidence-based medicine clinical decisions are based on experimental evidence of treatment efficacy. There are no data on the extent to which general thoracic surgical practice is evidence based.

Methods. A list of 50 thoracic surgical treatments was derived from the operating room log of one surgeon practicing at both a tertiary care cancer center and an affiliated community general hospital. Minor diagnostic procedures and procedures performed as part of experimental protocols were excluded. For each treatment a Medline search was done to obtain the best published evidence supporting the treatment’s efficacy. The evidence was then placed in one of three categories developed by the Oxford Centre for Evidence-Based Medicine: (1) evidence from randomized controlled trials (RCTs); (2) convincing non-experimental evidence; and (3) interventions without substantial evidence.

Results. Category 1 evidence supported 7 of 50 thoracic surgical treatments. Category 2 evidence supported 32 treatments, and 11 treatments were without substantial supportive evidence.

Conclusions. The majority of commonly performed general thoracic surgical procedures are supported by nonexperimental evidence. Although there are many obstacles to the performance of surgical randomized controlled trials, the limitations of nonrandomized studies are such that continued emphasis on randomized controlled trials in general thoracic surgery is warranted. This study could serve as a baseline reference for future assessments of evidence-based medicine in general thoracic surgical practice.


    Introduction
 Top
 Abstract
 Introduction
 Material and methods
 Results
 Comment
 References
 
For many years the practice of medicine has been based on a combination of applied medical sciences, clinical experience, and intuitive clinical reasoning. Recently there has been a shift towards evidence-based medical practice. In this newer paradigm of medical practice, medical decision making is based on formal clinical experimental evidence, such as randomized clinical trials and metaanalyses of clinical trials. Although the principles of evidence-based medicine have had a significant impact on internal medicine practice, little information exists to assess their impact on general thoracic surgical practice.

We reviewed one surgeon’s practice to answer the question, "To what extent is current general thoracic surgical practice evidence based?"


    Material and methods
 Top
 Abstract
 Introduction
 Material and methods
 Results
 Comment
 References
 
An operating room log from one surgeon (JDU) practicing at a tertiary care cancer center and an affiliated community hospital was reviewed for major thoracic surgical treatments performed from 1997 to 1998. Minor diagnostic procedures, such as bronchoscopy, mediastinoscopy, and simple thoracoscopy for pleural biopsy, were excluded, as were operations performed as part of an institutional experimental protocol. A case list of 50 thoracic surgical treatment scenarios was derived from the log. Each item included in that list was then examined to determine whether or not the treatment in question was supported by evidence in the medical literature and to determine the quality of the evidence. A Medline search specifically seeking randomized controlled trials (RCTs) was done for each treatment in the case list. The search was restricted to English-language medical literature. Evidence available in published abstract form only (meeting presentations) was not used. Key references were selected for each treatment on the case list. Each treatment was assigned to one of the following three categories of evidence developed by the Oxford Centre for Evidence-Based Medicine [1]: category 1, evidence from randomized controlled trials; category 2, convincing nonexperimental evidence; or category 3, interventions without substantial evidence (Table 1). Category 1 evidence, presumed to be of highest quality, was based on randomized controlled trials (RCTs). Category 2 included nonrandomized prospective trials and large retrospective series. Category 3 included treatments supported by case reports or small (< 10 patients) clinical series. Treatments proved by RCTs to be inferior to alternative treatments were also designated as category 3.


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Table 1. Categories of Evidence Level in 50 Types of Thoracic Surgical Treatments

 

    Results
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 Abstract
 Introduction
 Material and methods
 Results
 Comment
 References
 
Category 1 (RCTs) evidence supported 7 of the 50 thoracic surgical treatments detailed in Table 2. Thirty-two treatments were supported by category 2 (convincing nonexperimental) evidence (Table 3) , and 11 treatments were considered to be without substantial supportive evidence, falling into category 3 (Table 4).


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Table 2. Category 1a Thoracic Surgical Treatments

 

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Table 3. Category 2a Thoracic Surgical Treatments

 

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Table 4. Category 3a Thoracic Surgical Treatments

 

    Comment
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 Abstract
 Introduction
 Material and methods
 Results
 Comment
 References
 
Medical practice has been criticized as not being based on solid evidence [2]. In evidence-based medicine this criticism is addressed; patient management decisions are based on experimental evidence whenever possible [3]. Traditional medical decision making, based on intuition, experience, and applied physiology, is discouraged. Surgeons have been sharply criticized for basing treatment choices on traditional surgical dogma and anecdotal personal experience rather than on randomized controlled trials [4]. Little published data describes the extent to which surgical practice is evidence based [5]. Moreover, no published studies examine the extent of evidence-based medicine in general thoracic surgical practice.

In this study the assignment of levels of evidence for each treatment scenario was troubling for the authors. Evidence-based medicine by its very nature puts great emphasis on randomized trials and devalues other types of evidence. The levels of evidence were assigned by taking the published references at face value. In other words, poor-quality randomized controlled trials were more influential than often-cited nonrandomized studies. Although this can be seen as a weakness in our methodology, it is also a general shortcoming of evidence-based medicine approaches to surgical interventions. The thoracic surgical community should prepare for evidence-based critiques of thoracic surgical practices by nonsurgeons.

This study used an Oxford Centre for Evidence-Based Medicine evidence classification scheme. Its simplicity makes it suitable for surgical applications [5]. Other classifications of evidence, such as the American College of Chest Physicians Antithrombotic Consensus Conference system [6], are more applicable to treatments that have been extensively studied in RCTs [7]. For example, the first two of five levels of evidence relate to confidence intervals of RCTs and metaanalyses of RCTs. At the present time, the general thoracic surgical literature does not have sufficient RCTs to make practical use of the American College of Chest Physicians antithrombotic classification. This study assessed specific surgical treatments rather than groups of patients receiving the treatments [5]. The numerator and denominator are not numbers of patients. Our approach runs the risk of overrepresenting uncommon treatments, which by definition are unlikely to be studied by RCTs [1]. The study results should therefore not be presented as a percentage of surgical patients treated with any given category of evidence-based treatments. Instead, the results are an estimate of the extent to which general thoracic surgical treatments are evidence based.

Our study showed that the majority of commonly performed general thoracic surgical procedures are supported by nonexperimental evidence. Only 7 of 50 treatments were supported by RCTs. Similar data have been reported for general surgical practice [5]. Many authors have discussed the difficulties encountered in carrying out surgical RCTs [8, 9]. The difficulties include variations in individual surgeons’ experience and preferences, patients’ preferences for a particular surgical treatment, and a lack of funding. In addition, surgical skill in a specific procedure profoundly influences the result of surgical RCTs [10]—a matter that is especially problematic in multiinstitutional studies [11]. Nevertheless, many RCTs have recently been carried out in general thoracic surgery, and there is increasing awareness of the limitations of nonrandomized data [11, 12]. The current study was done to answer the question, "To what extent is current general thoracic surgical practice evidence based?" For one surgeon’s practice the majority of treatments were based on nonexperimental evidence, with a minority of procedures based on RCTs or not substantiated by evidence at all. Although this study may not accurately reflect the practice of general thoracic surgery in North America, it represents a starting point for future assessments of evidence-based general thoracic surgery.


    References
 Top
 Abstract
 Introduction
 Material and methods
 Results
 Comment
 References
 

  1. Ellis J., Mulligan I., Rowe J., Sackett D.L. Inpatient general medicine is evidence based. Lancet 1995;346:407-410.[Medline]
  2. Smith R. Where is the wisdom...?. BMJ 1991;303:798-799.
  3. Sackett D.L., Rosenberg W.M., Gray J.A., Haynes R.B., Richardson W.S. Evidence based medicine. BMJ 1996;312:71-72.[Free Full Text]
  4. Horton R. Surgical research or comic opera. Lancet 1996;347:984-985.[Medline]
  5. Howes N., Chagla L., Thorpe M., McCulloch P. Surgical practice is evidence based. Br J Surg 1997;84:1220-1223.[Medline]
  6. Cook D.J., Guyatt G.H., Laupacis A., Sackett D.L., Goldberg R.J. Clinical recommendations using levels of evidence for antithrombotic agents. Chest 1995;108(Suppl 4):S227-S230.[Free Full Text]
  7. Cook D.J., Greengold N.L., Ellrodt A.G., Weingarten S.R. The relation between systematic reviews and practice guidelines. Ann Intern Med 1997;127:210-216.[Abstract/Free Full Text]
  8. Solomon M.J., McLeod R.S. Should we be performing more randomized controlled trials evaluating surgical operations?. Surgery 1995;118:459-467.[Medline]
  9. Maddern G.J. Surgery and evidence-based medicine. Med J Aust 1998;169:348-349.[Medline]
  10. van der Linden W. Pitfalls in randomized surgical trials. Surgery 1980;87:258-262.[Medline]
  11. Law S.Y., Wong J. Esophageal cancer surgery. Semin Surg Oncol 1997;13:281-287.[Medline]
  12. Law S., Wong J. Use of controlled randomized trials to evaluate new technologies and new operative procedures in surgery. J Gastrointest Surg 1998;2:494-495.[Medline]
  13. Fleming ID, Cooper JS, Henson DE, et al, eds. American Joint Committee on Cancer cancer staging handbook. 5th edition. Lippincott-Raven. Philadelphia, 1998:117–27.
  14. Masaoka A., Monden Y., Nakahara K., Tanioka T. Follow-up study of thymomas with special reference to their clinical stages. Cancer 1981;48:2485-2497.[Medline]
Accepted for publication February 11, 2000.




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