EDITORIAL URRENT C OPINION
Improving perioperative outcomes and the giants of evidence-based medicine Natalie F. Holt a,b
INTRODUCTION Advances in technology are making it possible to perform complex operations on high-risk patients who, in previous decades, would not have been surgical candidates. Yet, on a frailer patient population, the ability to withstand perioperative complications is decreased. In fact, it has been shown that the occurrence of a 30-day complication is a greater risk factor than preoperative patient illness in determining survival after major surgery [1]. The articles in this section on anesthesia and medical disease focus on topics related to the prevention of perioperative complications through improved preoperative preparation and perioperative patient management. The review by Hall et al. (pp. 349–355) on the perioperative management of aspirin illustrates how a once widely held belief (e.g., the bleeding risk associated with aspirin use required its discontinuation 1 week prior to surgery) may be called into question by a reanalysis of evidence [2]. The management of antiplatelet agents is one of several topics discussed in the American Heart Association/American College of Cardiology’s new ‘Guideline on Perioperative Cardiovascular Evaluation and Management of Patients Undergoing Noncardiac Surgery’, reviewed by Thompson et al. (pp. 342–348). The other reviews in this section (Nygren et al. (pp. 364–369) on perioperative oral carbohydrates, Shander et al. (pp. 356–363) on blood conservation strategies, and Ertmer et al. (pp. 370–377) on the role of starches in intraoperative fluid therapy) deal with topics related to Enhanced Recovery After Surgery (ERAS) guidelines. In 2010, the ERAS Society was founded in Sweden out of a surgical research group interested in establishing best practices and standardization of care for the purpose of improving patient outcomes. That group in turn was extending on the work of Dr Henrik Kehlet [3], who, in the 1990s, put forth the idea using multimodal surgical and anesthetic techniques to reduce the surgical stress response, improve pain control and patient morbidity, and reduce patient length of stays. The American Society for Enhanced Recovery, pioneered
at the Duke University Medical Center, and officially established in 2014, follows goals in parallel with the ERAS Society. The ERAS concept relies heavily on the use of evidence-based protocols. Evidence-based medicine (EBM) was a term popularized in the 1990s [4,5]; however, the roots of EBM go back to the late 1960s when a few clinicians began to question the scientific evidence behind the medical dogmas and sought to use epidemiological principles to test their validity. What follows is a brief account of some of the leaders of EBM, whose achievements laid the foundation for the work of ERAS.
ARCHIE COCHRANE AND THE COCHRANE COLLABORATION Archie Cochrane (1909–1988) was a Scottish clinician and epidemiologist at the Welsh National School of Medicine. He famously advocated the value of randomized controlled trials (RCTs) for medical decision-making, stating ‘You should randomize till it hurts’ [6]. He codified his beliefs in the book Effectiveness and Efficiency: Random Reflections on Health Services, which was published in 1972 and received widespread acclaim [6,7]. In response to a need for maintaining a repository of systematic reviews of RCTs in all fields of medicine, Cochrane, along with Iain Chalmers, established the Cochrane Center in the UK in 1992, which ultimately transformed into the Cochrane Collaboration [8]. The Cochrane Anesthesia Review Group was founded in 2000 and focuses on interventions
a
Department of Anesthesiology, Yale University School of Medicine, New Haven and bAmbulatory Procedures Unit, Veterans Affairs Connecticut Healthcare System, West Haven, Connecticut, USA Correspondence to Assistant Professor, Natalie F. Holt, Department of Anesthesiology, Yale University School of Medicine, 333 Cedar Street, TMP 3, P.O. Box 208051, New Haven, CT 06520-8051, USA. Tel: +1 203 654 1677; fax: +1 203 865 2586; e-mail: [email protected] Curr Opin Anesthesiol 2015, 28:339–341 DOI:10.1097/ACO.0000000000000188
0952-7907 Copyright ß 2015 Wolters Kluwer Health, Inc. All rights reserved.
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Copyright © 2015 Wolters Kluwer Health, Inc. All rights reserved.
Anesthesia and medical disease
related to anesthesia, intensive care, prehospital medicine, and emergency medicine [9]. Interestingly, Cochrane was also a coauthor on the first RCT on the use of aspirin in the secondary prevention of mortality from myocardial infarction in patients with vascular disease [10].
THOMAS CHALMERS AND THE METAANALYSIS Thomas Chalmers (1917–1995) was a pioneer in advocacy of randomized trials and the use of the meta-analysis. He believed that nonrandomized trials were associated with a high false-positive rate [11]. In 1977, he famously submitted a pooled analysis of randomized trials on the use of anticoagulants in patients after myocardial infarction to the New England Journal of Medicine, which represented the first use of the technique of metaanalysis [12]. From 1973 to 1983, he was Dean of the Mount Sinai School of Medicine, where he developed the Department of Biostatistics and the first Department of Geriatrics.
ALVAN FEINSTEIN AND CLINICAL EPIDEMIOLOGY Alvan Feinstein (1925–2001) is widely credited as the father of clinical epidemiology. He earned degrees in mathematics and medicine, and then spent most of his career at the Yale School of Medicine, where he founded and directed the Robert Wood Johnson Clinical Scholars Program from 1974 to 1996. Feinstein held many strong and sometimes controversial ideas about research methods [13]. His main tenet, however, was to apply highquality data to answer a well framed research hypothesis, while avoiding detection bias [14]. He coined the term ‘clinimetrics’, a technique in which ‘raw data is collected into groups [and the] grouped data are summarized and compared’ [14,15]. Feinstein wrote six major books on clinical epidemiology and was the coeditor of the Journal of Clinical Epidemiology from 1982 until his sudden death in 2001 [16]. During a 2-year visiting professorship at McMaster University, Feinstein was responsible for mentoring several young physicians, one of whom was David Sackett [17].
DAVID SACKETT AND CRITICAL APPRAISAL David Sackett (1934–) is a Canadian physician who founded the first Department of Clinical Epidemiology and Biostatistics at McMaster University in Canada in 1967 and is considered by many to be the 340
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father of EBM [8]. At that time, McMaster University was a novel medical school being designed on the principle that physicians would be taught the clinical disciplines alongside epidemiological principles. Sackett wrote a series of articles and taught a course at McMaster based on the principle of ‘critical appraisal’. The idea was to teach medicine in small groups using a problem-based learning method. The critical appraisal method appeared as a series of articles in the Canadian Medical Association Journal in 1981 [18]. In addition, Sackett codified his work in a book entitled Clinical Epidemiology: a Basic Science for Clinical Medicine [19]. In the 1990s, Sackett went on to create the Oxford Centre for Evidence-Based Medicine at Oxford University. Sackett inspired the careers of many leaders of EBM, including Brian Haynes and Gordon Guyatt.
GORDON GUYATT AND THE RATIONAL CLINICAL EXAMINATION Gordon Guyatt (1953–) is a Canadian internist who led the medical residency program at McMaster University and is distinguished for popularizing the term EBM, based largely on the work of David Sackett [4,5]. He explained EBM as a paradigm shift in medical practice, ‘requiring new skills of the physician, including efficient literature searching and the application of formal rules of evidence evaluating the clinical literature’. Guyatt taught the skills of EBM at McMaster University through a series of published Readers’ Guides. These formed the basis for the popular Users’ Guides to the Medical Literature series that began publication in Journal of the American Medical Association in 1993 under the direction of Guyatt and Sackett and at the encouragement of JAMA deputy editor Drummond Rennie [20]. Initially planned to comprise 10 articles over 3 years, the Users’ Guides ultimately continued for 8 years and included 32 articles [18]. In 1979, Guyatt founded the Medical Reform Group, a Canadian organization that supports the concept of universal healthcare. He remains a spokesperson for this organization.
CONCLUSION As one author has noted, the ‘irony of the rapid expansion in the volume of information generated by EBM is the growing difficulty of applying what has been learnt’ [21]. The next step in the EBM movement is the translation of knowledge into practice if not policy. Widespread geographic variations in health services utilization [22] and overuse and misuse of untested treatments [23] have been Volume 28 Number 3 June 2015
Copyright © 2015 Wolters Kluwer Health, Inc. All rights reserved.
Giants of evidence-based medicine Holt
recognized for years; however, the application of evidence-based solutions to these problems has been more difficult than anticipated [24,25]. In the face of mounting healthcare budgets, the need for programs such as ERAS that are designed to maximize resource utilization while enhancing patient outcomes is all the more relevant. Acknowledgements None. Financial support and sponsorship None. Conflicts of interest There are no conflicts of interest.
REFERENCES 1. Henderson WG, DePalma RG, Mosca C, et al., Participants in the VA National Surgical Quality Improvement Program. Determinants of long-term survival after major surgery and the adverse effect of postoperative complications. Ann Surg 2005; 242:326–341. 2. Schulman PM, Gerstein WH, Petersen TR, Tawil I. Should more patients continue aspirin therapy perioperatively?: clinical impact of aspirin withdrawal syndrome. Ann Surg 2012; 255:811–819. 3. Kehlet H. Multimodal approach to control postoperative pathophysiology and rehabilitation. Br J Anaesth 1997; 78:606–617. 4. Guyatt G. Evidence-based medicine. ACP J Club 1991; 1991 (Suppl 2): A16. 5. Evidence-Based Medicine Working Group. Evidence-based medicine. A new approach to teaching the practice of medicine. JAMA 1992; 268:2420– 2425. 6. Cochrane A. Effectiveness and efficiency: random reflections on health services. London, UK: Nuffield Provincial Hospital Trust; 1972.
7. Challoumas D, Dimitrakakis G. Archibald Cochrane (1909–1988): the father of evidence-based medicine. Interact Cardiovasc Thorac Surg 2014; 18:121– 124. 8. Smith R, Rennie D. Evidence-based medicine: an oral history. JAMA 2014; 311:365–367. 9. Cracknell J, Moller AM, Pace NL. The Cochrane Collaboration and its worldwide contributions to anaesthesia research and care. Br J Anaesth 2013; 111:523–525. 10. Elwood PC, Cochrane AL, Burr ML, et al. A randomized controlled trial of acetyl salicylic acid in the secondary prevention of mortality from myocardial infarction. Br Med J 1974; 436–440. 11. Sacks H, Chalmers TC, Smith H Jr. Randomized versus historical controls for clinical trials. Am J Med 1982; 72:233–240. 12. Chalmers TC, Matta RJ, Smith H Jr, Kunzler AM. Evidence favoring the use of anticoagulants in the hospital phase of acute myocardial infarction. N Engl J Med 1977; 297:1091–1096. 13. Fletcher RH. Alvan Feinstein, the father of clinical epidemiology, 1925–2001. J Clin Epidemiol 2001; 54:1188–1190. 14. Miettinen OS. Feinstein and study design. J Clin Epidemiol 2002; 55:1167– 1172. 15. Feinstein AR. Clinical epidemiology: the architecture of clinical research. WB Saunders; 1985. 16. Kessler DA, Horowitz RI. In memoriam, Alvan R. Feinstein, MD. Am J Med 2002; 112:501. 17. Sackett DL. Clinical epidemiology. What, who, and whither. J Clin Epidemiol 2002; 55:1161–1166. 18. Evidence-based medicine: a short history of a modern medical movement. Virtual Mentor 2013; 15:71–76. 19. Sackett DL, Haynes RB, Guyatt GH, Tugwell P. Clinical epidemiology: a basic science for clinical medicine. 2nd ed. Boston, BA: Little Brown; 1991; pp. 441. 20. Guyatt GH, Rennie D. Users’ guides to the medical literature. JAMA 1993; 270:2096–2097. 21. Woolf S. Evidence-based medicine: a historical and international overview. Proc R Coll Physicians Edinb 2001; 31 (Suppl 9):39–41. 22. Kosecoff J, Park RE, Winslow CM, et al. Does inappropriate use explain geographic variations in the use of healthcare services? A study of three procedures. JAMA 1987; 258:2533–2537. 23. Eddy DM. Clinical policies and the quality of clinical practice. N Engl J Med 1982; 307:343–347. 24. Horowitz C, Silver A, Fein A, et al. Limited impact of a multicenter intervention to improve the quality and efficiency of pneumonia care. Chest 2004; 126:100–107. 25. Chassin MR. Improving the quality of healthcare: what’s taking so long? Health Aff (Millwood) 2013; 32:1761–1765.
0952-7907 Copyright ß 2015 Wolters Kluwer Health, Inc. All rights reserved.
www.co-anesthesiology.com
Copyright © 2015 Wolters Kluwer Health, Inc. All rights reserved.
341
Improving perioperative outcomes and the giants of evidence-based medicine Natalie F. Holt a,b
INTRODUCTION Advances in technology are making it possible to perform complex operations on high-risk patients who, in previous decades, would not have been surgical candidates. Yet, on a frailer patient population, the ability to withstand perioperative complications is decreased. In fact, it has been shown that the occurrence of a 30-day complication is a greater risk factor than preoperative patient illness in determining survival after major surgery [1]. The articles in this section on anesthesia and medical disease focus on topics related to the prevention of perioperative complications through improved preoperative preparation and perioperative patient management. The review by Hall et al. (pp. 349–355) on the perioperative management of aspirin illustrates how a once widely held belief (e.g., the bleeding risk associated with aspirin use required its discontinuation 1 week prior to surgery) may be called into question by a reanalysis of evidence [2]. The management of antiplatelet agents is one of several topics discussed in the American Heart Association/American College of Cardiology’s new ‘Guideline on Perioperative Cardiovascular Evaluation and Management of Patients Undergoing Noncardiac Surgery’, reviewed by Thompson et al. (pp. 342–348). The other reviews in this section (Nygren et al. (pp. 364–369) on perioperative oral carbohydrates, Shander et al. (pp. 356–363) on blood conservation strategies, and Ertmer et al. (pp. 370–377) on the role of starches in intraoperative fluid therapy) deal with topics related to Enhanced Recovery After Surgery (ERAS) guidelines. In 2010, the ERAS Society was founded in Sweden out of a surgical research group interested in establishing best practices and standardization of care for the purpose of improving patient outcomes. That group in turn was extending on the work of Dr Henrik Kehlet [3], who, in the 1990s, put forth the idea using multimodal surgical and anesthetic techniques to reduce the surgical stress response, improve pain control and patient morbidity, and reduce patient length of stays. The American Society for Enhanced Recovery, pioneered
at the Duke University Medical Center, and officially established in 2014, follows goals in parallel with the ERAS Society. The ERAS concept relies heavily on the use of evidence-based protocols. Evidence-based medicine (EBM) was a term popularized in the 1990s [4,5]; however, the roots of EBM go back to the late 1960s when a few clinicians began to question the scientific evidence behind the medical dogmas and sought to use epidemiological principles to test their validity. What follows is a brief account of some of the leaders of EBM, whose achievements laid the foundation for the work of ERAS.
ARCHIE COCHRANE AND THE COCHRANE COLLABORATION Archie Cochrane (1909–1988) was a Scottish clinician and epidemiologist at the Welsh National School of Medicine. He famously advocated the value of randomized controlled trials (RCTs) for medical decision-making, stating ‘You should randomize till it hurts’ [6]. He codified his beliefs in the book Effectiveness and Efficiency: Random Reflections on Health Services, which was published in 1972 and received widespread acclaim [6,7]. In response to a need for maintaining a repository of systematic reviews of RCTs in all fields of medicine, Cochrane, along with Iain Chalmers, established the Cochrane Center in the UK in 1992, which ultimately transformed into the Cochrane Collaboration [8]. The Cochrane Anesthesia Review Group was founded in 2000 and focuses on interventions
a
Department of Anesthesiology, Yale University School of Medicine, New Haven and bAmbulatory Procedures Unit, Veterans Affairs Connecticut Healthcare System, West Haven, Connecticut, USA Correspondence to Assistant Professor, Natalie F. Holt, Department of Anesthesiology, Yale University School of Medicine, 333 Cedar Street, TMP 3, P.O. Box 208051, New Haven, CT 06520-8051, USA. Tel: +1 203 654 1677; fax: +1 203 865 2586; e-mail: [email protected] Curr Opin Anesthesiol 2015, 28:339–341 DOI:10.1097/ACO.0000000000000188
0952-7907 Copyright ß 2015 Wolters Kluwer Health, Inc. All rights reserved.
www.co-anesthesiology.com
Copyright © 2015 Wolters Kluwer Health, Inc. All rights reserved.
Anesthesia and medical disease
related to anesthesia, intensive care, prehospital medicine, and emergency medicine [9]. Interestingly, Cochrane was also a coauthor on the first RCT on the use of aspirin in the secondary prevention of mortality from myocardial infarction in patients with vascular disease [10].
THOMAS CHALMERS AND THE METAANALYSIS Thomas Chalmers (1917–1995) was a pioneer in advocacy of randomized trials and the use of the meta-analysis. He believed that nonrandomized trials were associated with a high false-positive rate [11]. In 1977, he famously submitted a pooled analysis of randomized trials on the use of anticoagulants in patients after myocardial infarction to the New England Journal of Medicine, which represented the first use of the technique of metaanalysis [12]. From 1973 to 1983, he was Dean of the Mount Sinai School of Medicine, where he developed the Department of Biostatistics and the first Department of Geriatrics.
ALVAN FEINSTEIN AND CLINICAL EPIDEMIOLOGY Alvan Feinstein (1925–2001) is widely credited as the father of clinical epidemiology. He earned degrees in mathematics and medicine, and then spent most of his career at the Yale School of Medicine, where he founded and directed the Robert Wood Johnson Clinical Scholars Program from 1974 to 1996. Feinstein held many strong and sometimes controversial ideas about research methods [13]. His main tenet, however, was to apply highquality data to answer a well framed research hypothesis, while avoiding detection bias [14]. He coined the term ‘clinimetrics’, a technique in which ‘raw data is collected into groups [and the] grouped data are summarized and compared’ [14,15]. Feinstein wrote six major books on clinical epidemiology and was the coeditor of the Journal of Clinical Epidemiology from 1982 until his sudden death in 2001 [16]. During a 2-year visiting professorship at McMaster University, Feinstein was responsible for mentoring several young physicians, one of whom was David Sackett [17].
DAVID SACKETT AND CRITICAL APPRAISAL David Sackett (1934–) is a Canadian physician who founded the first Department of Clinical Epidemiology and Biostatistics at McMaster University in Canada in 1967 and is considered by many to be the 340
www.co-anesthesiology.com
father of EBM [8]. At that time, McMaster University was a novel medical school being designed on the principle that physicians would be taught the clinical disciplines alongside epidemiological principles. Sackett wrote a series of articles and taught a course at McMaster based on the principle of ‘critical appraisal’. The idea was to teach medicine in small groups using a problem-based learning method. The critical appraisal method appeared as a series of articles in the Canadian Medical Association Journal in 1981 [18]. In addition, Sackett codified his work in a book entitled Clinical Epidemiology: a Basic Science for Clinical Medicine [19]. In the 1990s, Sackett went on to create the Oxford Centre for Evidence-Based Medicine at Oxford University. Sackett inspired the careers of many leaders of EBM, including Brian Haynes and Gordon Guyatt.
GORDON GUYATT AND THE RATIONAL CLINICAL EXAMINATION Gordon Guyatt (1953–) is a Canadian internist who led the medical residency program at McMaster University and is distinguished for popularizing the term EBM, based largely on the work of David Sackett [4,5]. He explained EBM as a paradigm shift in medical practice, ‘requiring new skills of the physician, including efficient literature searching and the application of formal rules of evidence evaluating the clinical literature’. Guyatt taught the skills of EBM at McMaster University through a series of published Readers’ Guides. These formed the basis for the popular Users’ Guides to the Medical Literature series that began publication in Journal of the American Medical Association in 1993 under the direction of Guyatt and Sackett and at the encouragement of JAMA deputy editor Drummond Rennie [20]. Initially planned to comprise 10 articles over 3 years, the Users’ Guides ultimately continued for 8 years and included 32 articles [18]. In 1979, Guyatt founded the Medical Reform Group, a Canadian organization that supports the concept of universal healthcare. He remains a spokesperson for this organization.
CONCLUSION As one author has noted, the ‘irony of the rapid expansion in the volume of information generated by EBM is the growing difficulty of applying what has been learnt’ [21]. The next step in the EBM movement is the translation of knowledge into practice if not policy. Widespread geographic variations in health services utilization [22] and overuse and misuse of untested treatments [23] have been Volume 28 Number 3 June 2015
Copyright © 2015 Wolters Kluwer Health, Inc. All rights reserved.
Giants of evidence-based medicine Holt
recognized for years; however, the application of evidence-based solutions to these problems has been more difficult than anticipated [24,25]. In the face of mounting healthcare budgets, the need for programs such as ERAS that are designed to maximize resource utilization while enhancing patient outcomes is all the more relevant. Acknowledgements None. Financial support and sponsorship None. Conflicts of interest There are no conflicts of interest.
REFERENCES 1. Henderson WG, DePalma RG, Mosca C, et al., Participants in the VA National Surgical Quality Improvement Program. Determinants of long-term survival after major surgery and the adverse effect of postoperative complications. Ann Surg 2005; 242:326–341. 2. Schulman PM, Gerstein WH, Petersen TR, Tawil I. Should more patients continue aspirin therapy perioperatively?: clinical impact of aspirin withdrawal syndrome. Ann Surg 2012; 255:811–819. 3. Kehlet H. Multimodal approach to control postoperative pathophysiology and rehabilitation. Br J Anaesth 1997; 78:606–617. 4. Guyatt G. Evidence-based medicine. ACP J Club 1991; 1991 (Suppl 2): A16. 5. Evidence-Based Medicine Working Group. Evidence-based medicine. A new approach to teaching the practice of medicine. JAMA 1992; 268:2420– 2425. 6. Cochrane A. Effectiveness and efficiency: random reflections on health services. London, UK: Nuffield Provincial Hospital Trust; 1972.
7. Challoumas D, Dimitrakakis G. Archibald Cochrane (1909–1988): the father of evidence-based medicine. Interact Cardiovasc Thorac Surg 2014; 18:121– 124. 8. Smith R, Rennie D. Evidence-based medicine: an oral history. JAMA 2014; 311:365–367. 9. Cracknell J, Moller AM, Pace NL. The Cochrane Collaboration and its worldwide contributions to anaesthesia research and care. Br J Anaesth 2013; 111:523–525. 10. Elwood PC, Cochrane AL, Burr ML, et al. A randomized controlled trial of acetyl salicylic acid in the secondary prevention of mortality from myocardial infarction. Br Med J 1974; 436–440. 11. Sacks H, Chalmers TC, Smith H Jr. Randomized versus historical controls for clinical trials. Am J Med 1982; 72:233–240. 12. Chalmers TC, Matta RJ, Smith H Jr, Kunzler AM. Evidence favoring the use of anticoagulants in the hospital phase of acute myocardial infarction. N Engl J Med 1977; 297:1091–1096. 13. Fletcher RH. Alvan Feinstein, the father of clinical epidemiology, 1925–2001. J Clin Epidemiol 2001; 54:1188–1190. 14. Miettinen OS. Feinstein and study design. J Clin Epidemiol 2002; 55:1167– 1172. 15. Feinstein AR. Clinical epidemiology: the architecture of clinical research. WB Saunders; 1985. 16. Kessler DA, Horowitz RI. In memoriam, Alvan R. Feinstein, MD. Am J Med 2002; 112:501. 17. Sackett DL. Clinical epidemiology. What, who, and whither. J Clin Epidemiol 2002; 55:1161–1166. 18. Evidence-based medicine: a short history of a modern medical movement. Virtual Mentor 2013; 15:71–76. 19. Sackett DL, Haynes RB, Guyatt GH, Tugwell P. Clinical epidemiology: a basic science for clinical medicine. 2nd ed. Boston, BA: Little Brown; 1991; pp. 441. 20. Guyatt GH, Rennie D. Users’ guides to the medical literature. JAMA 1993; 270:2096–2097. 21. Woolf S. Evidence-based medicine: a historical and international overview. Proc R Coll Physicians Edinb 2001; 31 (Suppl 9):39–41. 22. Kosecoff J, Park RE, Winslow CM, et al. Does inappropriate use explain geographic variations in the use of healthcare services? A study of three procedures. JAMA 1987; 258:2533–2537. 23. Eddy DM. Clinical policies and the quality of clinical practice. N Engl J Med 1982; 307:343–347. 24. Horowitz C, Silver A, Fein A, et al. Limited impact of a multicenter intervention to improve the quality and efficiency of pneumonia care. Chest 2004; 126:100–107. 25. Chassin MR. Improving the quality of healthcare: what’s taking so long? Health Aff (Millwood) 2013; 32:1761–1765.
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341
