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Surgery_Schwartz_13921 | Surgery_Schwartz | resection. Br J Surg. 2016;103:962-970. 180. Lim P, Morris OJ, Nolan G, et al. Sham feeding with chewing gum after elective colorectal resectional surgery: a random-ized clinical trial. Ann Surg. 2013;257:1016-1024. 181. Delaney CP, Wolff BG, Viscusi ER, et al. Alvimopan, for post-operative ileus following bowel resection: a pooled analysis of phase III studies. 2007; Ann Surg 245:355-363. 182. Adam MA, Lee LM, Kim J, et al. Alvimopan provides addi-tional improvement in outcomes and cost savings in enhanced recovery colorectal surgery. Ann Surg. 2016;264:141-146. 183. Barletta JF, Asgeirsson T, El-Badawi KI, et al. Introduction of alvimopan into an enhanced recovery protocol for colectomy Brunicardi_Ch50_p2113-p2136.indd 213201/03/19 9:39 AM 2133OPTIMIZING PERIOPERATIVE CARE: ENHANCED RECOVERY AND CHINESE MEDICINECHAPTER 50offers benefit in open but not laparoscopic colectomy. J Lapa-roendosc Adv Surg Tech A. 2011;21:887-891. 184. Keller DS, Flores-Gonzalez JR, Ibarra S, et al. Is | Surgery_Schwartz. resection. Br J Surg. 2016;103:962-970. 180. Lim P, Morris OJ, Nolan G, et al. Sham feeding with chewing gum after elective colorectal resectional surgery: a random-ized clinical trial. Ann Surg. 2013;257:1016-1024. 181. Delaney CP, Wolff BG, Viscusi ER, et al. Alvimopan, for post-operative ileus following bowel resection: a pooled analysis of phase III studies. 2007; Ann Surg 245:355-363. 182. Adam MA, Lee LM, Kim J, et al. Alvimopan provides addi-tional improvement in outcomes and cost savings in enhanced recovery colorectal surgery. Ann Surg. 2016;264:141-146. 183. Barletta JF, Asgeirsson T, El-Badawi KI, et al. Introduction of alvimopan into an enhanced recovery protocol for colectomy Brunicardi_Ch50_p2113-p2136.indd 213201/03/19 9:39 AM 2133OPTIMIZING PERIOPERATIVE CARE: ENHANCED RECOVERY AND CHINESE MEDICINECHAPTER 50offers benefit in open but not laparoscopic colectomy. J Lapa-roendosc Adv Surg Tech A. 2011;21:887-891. 184. Keller DS, Flores-Gonzalez JR, Ibarra S, et al. Is |
Surgery_Schwartz_13922 | Surgery_Schwartz | RECOVERY AND CHINESE MEDICINECHAPTER 50offers benefit in open but not laparoscopic colectomy. J Lapa-roendosc Adv Surg Tech A. 2011;21:887-891. 184. Keller DS, Flores-Gonzalez JR, Ibarra S, et al. Is there value in alvimopan in minimally invasive colorectal surgery? Am J Surg. 2016;212:851-856. 185. Hirsch CH, Sommers L, Olsen A, et al. The natural history of functional morbidity in hospitalized older patients. J Am Geriatr Soc. 1990;38:1296-1303. 186. Gillis C, Li C, Lee L, et al. Prehabilitation versus rehabilita-tion: a randomized control trial in patients undergoing colorec-tal resection for cancer. Anesthesiology. 2014;121:937-947. 187. Nygren J, Soop M, Thorell A, et al. An enhanced-recovery protocol improves outcome after colorectal resection already during the first year: a single-center experience in 168 con-secutive patients. Dis Colon Rectum. 2009;52:978-985. 188. Teeuwen PH, Bleichrodt RP, Strik C, et al. Enhanced recovery after surgery (ERAS) versus conventional | Surgery_Schwartz. RECOVERY AND CHINESE MEDICINECHAPTER 50offers benefit in open but not laparoscopic colectomy. J Lapa-roendosc Adv Surg Tech A. 2011;21:887-891. 184. Keller DS, Flores-Gonzalez JR, Ibarra S, et al. Is there value in alvimopan in minimally invasive colorectal surgery? Am J Surg. 2016;212:851-856. 185. Hirsch CH, Sommers L, Olsen A, et al. The natural history of functional morbidity in hospitalized older patients. J Am Geriatr Soc. 1990;38:1296-1303. 186. Gillis C, Li C, Lee L, et al. Prehabilitation versus rehabilita-tion: a randomized control trial in patients undergoing colorec-tal resection for cancer. Anesthesiology. 2014;121:937-947. 187. Nygren J, Soop M, Thorell A, et al. An enhanced-recovery protocol improves outcome after colorectal resection already during the first year: a single-center experience in 168 con-secutive patients. Dis Colon Rectum. 2009;52:978-985. 188. Teeuwen PH, Bleichrodt RP, Strik C, et al. Enhanced recovery after surgery (ERAS) versus conventional |
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Surgery_Schwartz_13937 | Surgery_Schwartz | a systematic review and evidence-based guidelines. Ann Surg. 2014;259:413-431. 245. Markar SR, Karthikesalingam A, Low DE. Enhanced recovery pathways lead to an improvement in postoperative outcomes following esophagectomy: systematic review and pooled anal-ysis. Dis Esophagus. 2015;28:468-475. 246. Barreca M, Renzi C, Tankel J, et al. Is there a role for enhanced recovery after laparoscopic bariatric surgery? Preliminary results from a specialist obesity treatment center. Surg Obes Relat Dis. 2016;12:119-126. 247. Hahl T, Peromaa-Haavisto P, Tarkiainen P, et al. Outcome of laparoscopic gastric bypass (LRYGB) with a program for enhanced recovery after surgery (ERAS). Obes Surg. 2016;26:505-511. 248. Lemanu DP, Singh PP, Berridge K, et al. Randomized clinical trial of enhanced recovery versus standard care after laparo-scopic sleeve gastrectomy. Br J Surg. 2013;100:482-489. 249. Rickey J, Gersin K, Yang W, et al. Early discharge in the bar-iatric population does not increase | Surgery_Schwartz. a systematic review and evidence-based guidelines. Ann Surg. 2014;259:413-431. 245. Markar SR, Karthikesalingam A, Low DE. Enhanced recovery pathways lead to an improvement in postoperative outcomes following esophagectomy: systematic review and pooled anal-ysis. Dis Esophagus. 2015;28:468-475. 246. Barreca M, Renzi C, Tankel J, et al. Is there a role for enhanced recovery after laparoscopic bariatric surgery? Preliminary results from a specialist obesity treatment center. Surg Obes Relat Dis. 2016;12:119-126. 247. Hahl T, Peromaa-Haavisto P, Tarkiainen P, et al. Outcome of laparoscopic gastric bypass (LRYGB) with a program for enhanced recovery after surgery (ERAS). Obes Surg. 2016;26:505-511. 248. Lemanu DP, Singh PP, Berridge K, et al. Randomized clinical trial of enhanced recovery versus standard care after laparo-scopic sleeve gastrectomy. Br J Surg. 2013;100:482-489. 249. Rickey J, Gersin K, Yang W, et al. Early discharge in the bar-iatric population does not increase |
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Surgery_Schwartz_13950 | Surgery_Schwartz | of Houpupaiqi Heji on the gastrintestinal function of patients after gastric cancer surgery. Mod Oncol. 2015;23:1268-1270. 299. Zhang X, Yuan H, Qin W. Study on early enteral nutrition combined with acupuncture to promote the recovery of gastro-intestinal function in patients after surgery. Chinese Journal of Surgery of Integrated Traditional and Western Medicine. 2016;22:542-545. 300. Jian W, Heng L, Hui QQ. Effect of Da-Cheng-Qi-Tang on gastrointestinal motility in patients undergoing laparotomy. Hepatogastroenterology. 2011;58:1887-1892. 301. You S, Wu X, Liu M. Effects of dachengqi decoction on gut hormones and intestinal movement after cholecystectomy. Zhongguo Zhong Xi Yi Jie He Za Zhi. 1994;14:522-524. 302. Yang Y, Zuo HQ, Li Z, et al. Comparison of efficacy of simo decoction and acupuncture or chewing gum alone on postop-erative ileus in colorectal cancer resection: a randomized trial. Sci Rep. 2017;7:37826. 303. Chen Z, Cao L, Wen Z, et al. Study of Evodia hot compress plus | Surgery_Schwartz. of Houpupaiqi Heji on the gastrintestinal function of patients after gastric cancer surgery. Mod Oncol. 2015;23:1268-1270. 299. Zhang X, Yuan H, Qin W. Study on early enteral nutrition combined with acupuncture to promote the recovery of gastro-intestinal function in patients after surgery. Chinese Journal of Surgery of Integrated Traditional and Western Medicine. 2016;22:542-545. 300. Jian W, Heng L, Hui QQ. Effect of Da-Cheng-Qi-Tang on gastrointestinal motility in patients undergoing laparotomy. Hepatogastroenterology. 2011;58:1887-1892. 301. You S, Wu X, Liu M. Effects of dachengqi decoction on gut hormones and intestinal movement after cholecystectomy. Zhongguo Zhong Xi Yi Jie He Za Zhi. 1994;14:522-524. 302. Yang Y, Zuo HQ, Li Z, et al. Comparison of efficacy of simo decoction and acupuncture or chewing gum alone on postop-erative ileus in colorectal cancer resection: a randomized trial. Sci Rep. 2017;7:37826. 303. Chen Z, Cao L, Wen Z, et al. Study of Evodia hot compress plus |
Surgery_Schwartz_13951 | Surgery_Schwartz | acupuncture or chewing gum alone on postop-erative ileus in colorectal cancer resection: a randomized trial. Sci Rep. 2017;7:37826. 303. Chen Z, Cao L, Wen Z, et al. Study of Evodia hot compress plus electro-acupuncture in patients who have undergone abdominal surgery. Int J Clin Exp Med. 2015;8:16167-16174. 304. Wu X. Practice of Abdominal Surgery. 3rd ed. Tianjin Science and Technology Press; 2004. 305. Cui Z, Kong D. 74 cases of biiliary liver abscess treated with integrated traditional and western medicine. Chinese Journal of Surgery of Integrated Traditional and Western Medicine. 2014;20:167-169. 306. Sun S, Xu W. Effects of TPN and immune regulator radix astragali on postoperative patients of obstructive jaundice. J Parenter Enteral Nutr. 2002;9:151-157. 307. Ma X, Yang W, Zhang X. The study of effect of shiquan dabu decoction in surgeical nutrition therapy. Beijing Journal of Traditional Chinese Medicine. 1991;4:31-32. 308. Dong Y, Cui Z. Acupuncture research on adhesive | Surgery_Schwartz. acupuncture or chewing gum alone on postop-erative ileus in colorectal cancer resection: a randomized trial. Sci Rep. 2017;7:37826. 303. Chen Z, Cao L, Wen Z, et al. Study of Evodia hot compress plus electro-acupuncture in patients who have undergone abdominal surgery. Int J Clin Exp Med. 2015;8:16167-16174. 304. Wu X. Practice of Abdominal Surgery. 3rd ed. Tianjin Science and Technology Press; 2004. 305. Cui Z, Kong D. 74 cases of biiliary liver abscess treated with integrated traditional and western medicine. Chinese Journal of Surgery of Integrated Traditional and Western Medicine. 2014;20:167-169. 306. Sun S, Xu W. Effects of TPN and immune regulator radix astragali on postoperative patients of obstructive jaundice. J Parenter Enteral Nutr. 2002;9:151-157. 307. Ma X, Yang W, Zhang X. The study of effect of shiquan dabu decoction in surgeical nutrition therapy. Beijing Journal of Traditional Chinese Medicine. 1991;4:31-32. 308. Dong Y, Cui Z. Acupuncture research on adhesive |
Surgery_Schwartz_13952 | Surgery_Schwartz | X. The study of effect of shiquan dabu decoction in surgeical nutrition therapy. Beijing Journal of Traditional Chinese Medicine. 1991;4:31-32. 308. Dong Y, Cui Z. Acupuncture research on adhesive intestinal obstruction. Clin J Chinese Med. 2001;3:86-88. 309. Li G, Ma J, Shang H, et al. Application of Dechengqi decoc-tion in abdominal surgery. World Chinese Journal of Diges-tion. 2008;16:1672-1676. 310. Li H, Hong Y, Huang M. Clinical effect observation of Chinese herbal enema, external application and acupuncture in adhe-sive ileus. Journal of Guangzhou University of Traditional Chinese Medicine. 2007;24:282-285.Brunicardi_Ch50_p2113-p2136.indd 213601/03/19 9:39 AM | Surgery_Schwartz. X. The study of effect of shiquan dabu decoction in surgeical nutrition therapy. Beijing Journal of Traditional Chinese Medicine. 1991;4:31-32. 308. Dong Y, Cui Z. Acupuncture research on adhesive intestinal obstruction. Clin J Chinese Med. 2001;3:86-88. 309. Li G, Ma J, Shang H, et al. Application of Dechengqi decoc-tion in abdominal surgery. World Chinese Journal of Diges-tion. 2008;16:1672-1676. 310. Li H, Hong Y, Huang M. Clinical effect observation of Chinese herbal enema, external application and acupuncture in adhe-sive ileus. Journal of Guangzhou University of Traditional Chinese Medicine. 2007;24:282-285.Brunicardi_Ch50_p2113-p2136.indd 213601/03/19 9:39 AM |
Surgery_Schwartz_13953 | Surgery_Schwartz | Understanding, Evaluating, and Using Evidence for Surgical PracticeAndrew J. Benjamin, Andrew B. Schneider, Jeffrey B. Matthews, and Gary An 51chapterINTRODUCTIONThe singular importance of this chapter rests on the following chain of reasoning:1. The state of surgical science and knowledge is constantly changing.2. The education of a surgeon is a continuous process.3. Surgeons need to know how to evaluate new surgical knowl-edge to maintain their education in order to best serve their patients.4. This chapter provides guidance as to how surgeons might navigate, interpret and apply this new knowledge.Notably, this reasoning also applies to the process of acquisition of new knowledge itself, which explains why this inaugural chapter on evidence-based medicine is occurring in the 11th edition of this book. Recognizing the impermanence and fluidity of knowledge is a critical insight for the responsible surgeon, but so too is realizing that “good practice” cannot occur without reference | Surgery_Schwartz. Understanding, Evaluating, and Using Evidence for Surgical PracticeAndrew J. Benjamin, Andrew B. Schneider, Jeffrey B. Matthews, and Gary An 51chapterINTRODUCTIONThe singular importance of this chapter rests on the following chain of reasoning:1. The state of surgical science and knowledge is constantly changing.2. The education of a surgeon is a continuous process.3. Surgeons need to know how to evaluate new surgical knowl-edge to maintain their education in order to best serve their patients.4. This chapter provides guidance as to how surgeons might navigate, interpret and apply this new knowledge.Notably, this reasoning also applies to the process of acquisition of new knowledge itself, which explains why this inaugural chapter on evidence-based medicine is occurring in the 11th edition of this book. Recognizing the impermanence and fluidity of knowledge is a critical insight for the responsible surgeon, but so too is realizing that “good practice” cannot occur without reference |
Surgery_Schwartz_13954 | Surgery_Schwartz | of this book. Recognizing the impermanence and fluidity of knowledge is a critical insight for the responsible surgeon, but so too is realizing that “good practice” cannot occur without reference points as to what should be done given the current imperfect state of knowledge. These dual recognitions inform the organization of this chapter, which introduces and describes the currently accepted approach to evidence-based medicine, and then follows by noting a series of current issues that anticipate the likelihood that what is meant by “evidence-based medicine” will evolve over the coming years. Also note that this chapter is not intended to be a primer on statistics and clinical trial design; there are entire textbooks devoted to those subjects. Rather, this chapter will focus on how those tools are aggregated and presented in order to inform a surgeon how to keep abreast with current developments in practice.WHAT IS EVIDENCE-BASED MEDICINE?For centuries, the practice of medicine was | Surgery_Schwartz. of this book. Recognizing the impermanence and fluidity of knowledge is a critical insight for the responsible surgeon, but so too is realizing that “good practice” cannot occur without reference points as to what should be done given the current imperfect state of knowledge. These dual recognitions inform the organization of this chapter, which introduces and describes the currently accepted approach to evidence-based medicine, and then follows by noting a series of current issues that anticipate the likelihood that what is meant by “evidence-based medicine” will evolve over the coming years. Also note that this chapter is not intended to be a primer on statistics and clinical trial design; there are entire textbooks devoted to those subjects. Rather, this chapter will focus on how those tools are aggregated and presented in order to inform a surgeon how to keep abreast with current developments in practice.WHAT IS EVIDENCE-BASED MEDICINE?For centuries, the practice of medicine was |
Surgery_Schwartz_13955 | Surgery_Schwartz | tools are aggregated and presented in order to inform a surgeon how to keep abreast with current developments in practice.WHAT IS EVIDENCE-BASED MEDICINE?For centuries, the practice of medicine was guided primarily by anecdotal experience, often based on rationales that did not arise from a rigorous scientific process and sustained by the fundamental barriers associated with being able to learn from one’s experience (e.g., cognitive bias). For example, treatments such as bloodletting and purging were based on ostensible prin-ciples of bodily humors originating from the Ancient Greeks, and persisted well into the 18th century despite repeated disas-trous outcomes. To a great degree, the goal of the Scientific Method, through its emphasis on skepticism and falsifiability, is predicated upon overriding observational/experiential bias by the application of rigorous methodology statistical analysis. The dangers of bias were recognized at the dawn of the Scien-tific Era, and continue to | Surgery_Schwartz. tools are aggregated and presented in order to inform a surgeon how to keep abreast with current developments in practice.WHAT IS EVIDENCE-BASED MEDICINE?For centuries, the practice of medicine was guided primarily by anecdotal experience, often based on rationales that did not arise from a rigorous scientific process and sustained by the fundamental barriers associated with being able to learn from one’s experience (e.g., cognitive bias). For example, treatments such as bloodletting and purging were based on ostensible prin-ciples of bodily humors originating from the Ancient Greeks, and persisted well into the 18th century despite repeated disas-trous outcomes. To a great degree, the goal of the Scientific Method, through its emphasis on skepticism and falsifiability, is predicated upon overriding observational/experiential bias by the application of rigorous methodology statistical analysis. The dangers of bias were recognized at the dawn of the Scien-tific Era, and continue to |
Surgery_Schwartz_13956 | Surgery_Schwartz | overriding observational/experiential bias by the application of rigorous methodology statistical analysis. The dangers of bias were recognized at the dawn of the Scien-tific Era, and continue to manifest today (Box: The History and Sources of Bias in Biomedical Literature).Introduction2137What is Evidence-Based Medicine?2137Searching for Information: Patient/Population, Intervention, Comparison, and Outcome / 2139Types of Studies / 2139Hierarchies of Evidence / 2140Tools to Evaluate a Body of Evidence / 2140Synthesis of Evidence—Clinical Guidelines / 2142The Challenges of Applying EBM to Surgery2144Analysis of a Surgical Randomized Control Trial / 2144Internal Validity / 2144External Validity / 2146Additional Challenges to Conducting a Surgical RCT / 2146Use and Misuse of Statistical Significance2147Type I and Type II Errors / 2147P Values / 2147Alternative to P Values / 2148How do the Tools of EBM Perform?2148External Consistency / 2148Internal Consistency / 2148System | Surgery_Schwartz. overriding observational/experiential bias by the application of rigorous methodology statistical analysis. The dangers of bias were recognized at the dawn of the Scien-tific Era, and continue to manifest today (Box: The History and Sources of Bias in Biomedical Literature).Introduction2137What is Evidence-Based Medicine?2137Searching for Information: Patient/Population, Intervention, Comparison, and Outcome / 2139Types of Studies / 2139Hierarchies of Evidence / 2140Tools to Evaluate a Body of Evidence / 2140Synthesis of Evidence—Clinical Guidelines / 2142The Challenges of Applying EBM to Surgery2144Analysis of a Surgical Randomized Control Trial / 2144Internal Validity / 2144External Validity / 2146Additional Challenges to Conducting a Surgical RCT / 2146Use and Misuse of Statistical Significance2147Type I and Type II Errors / 2147P Values / 2147Alternative to P Values / 2148How do the Tools of EBM Perform?2148External Consistency / 2148Internal Consistency / 2148System |
Surgery_Schwartz_13957 | Surgery_Schwartz | Significance2147Type I and Type II Errors / 2147P Values / 2147Alternative to P Values / 2148How do the Tools of EBM Perform?2148External Consistency / 2148Internal Consistency / 2148System Issues / 2148Validity / 2149Implications of EBM / 2149The Alternatives to EBM2149What can Researchers do to Improve the Validity of Research Findings?2149The History and Sources of Bias in Biomedical LiteratureIn Sir Francis Bacon’s initial description of the scientific method in his Novum Organum1 he notes what he terms the “idols of the mind,” in essence recognizing and classifying the sources of cognitive bias that limit the reliability of sub-jective observation and interpretation. These “idols” are:• Idols of the tribe (Idola tribus): A humans’ tendency to per-ceive more order and regularity in systems than truly exists, and arises from their preconceived ideas about things• Idols of the cave (Idola specus): Arising from an individ-ual’s personal limitations in reasoning due to particular | Surgery_Schwartz. Significance2147Type I and Type II Errors / 2147P Values / 2147Alternative to P Values / 2148How do the Tools of EBM Perform?2148External Consistency / 2148Internal Consistency / 2148System Issues / 2148Validity / 2149Implications of EBM / 2149The Alternatives to EBM2149What can Researchers do to Improve the Validity of Research Findings?2149The History and Sources of Bias in Biomedical LiteratureIn Sir Francis Bacon’s initial description of the scientific method in his Novum Organum1 he notes what he terms the “idols of the mind,” in essence recognizing and classifying the sources of cognitive bias that limit the reliability of sub-jective observation and interpretation. These “idols” are:• Idols of the tribe (Idola tribus): A humans’ tendency to per-ceive more order and regularity in systems than truly exists, and arises from their preconceived ideas about things• Idols of the cave (Idola specus): Arising from an individ-ual’s personal limitations in reasoning due to particular |
Surgery_Schwartz_13958 | Surgery_Schwartz | systems than truly exists, and arises from their preconceived ideas about things• Idols of the cave (Idola specus): Arising from an individ-ual’s personal limitations in reasoning due to particular personalities, subjective likes and dislikesBrunicardi_Ch51_p2137-p2152.indd 213728/02/19 4:19 PM 2138• Idols of the marketplace (Idola fori): Arising from the con-fusion in the use of language and taking some words in sci-ence to have a different meaning than their common usage• Idols of the theatre (Idola theatri): Arising from the following of academic dogma and not asking questions about the worldThese descriptions still resonate today, illustrating just how long the dangers of cognitive bias have been recognized, and just how embedded those tendencies may be. For instance, the following are sources of bias in biomedical literature:• Publication bias: publishers incentivized to accept posi-tive results• Prevailing field bias: supporting entrenched opinions• Citation bias: tendency | Surgery_Schwartz. systems than truly exists, and arises from their preconceived ideas about things• Idols of the cave (Idola specus): Arising from an individ-ual’s personal limitations in reasoning due to particular personalities, subjective likes and dislikesBrunicardi_Ch51_p2137-p2152.indd 213728/02/19 4:19 PM 2138• Idols of the marketplace (Idola fori): Arising from the con-fusion in the use of language and taking some words in sci-ence to have a different meaning than their common usage• Idols of the theatre (Idola theatri): Arising from the following of academic dogma and not asking questions about the worldThese descriptions still resonate today, illustrating just how long the dangers of cognitive bias have been recognized, and just how embedded those tendencies may be. For instance, the following are sources of bias in biomedical literature:• Publication bias: publishers incentivized to accept posi-tive results• Prevailing field bias: supporting entrenched opinions• Citation bias: tendency |
Surgery_Schwartz_13959 | Surgery_Schwartz | are sources of bias in biomedical literature:• Publication bias: publishers incentivized to accept posi-tive results• Prevailing field bias: supporting entrenched opinions• Citation bias: tendency to cite positive studies• Time-lag bias: delay the reporting of negative results• Reporting bias: emphasizing positive over negative resultsKey Points1 Cognitive bias is inescapable, and limits the ability of both individual practitioners and the surgical field in general, to advance and improve in a scientific fashion. Evidence Based Medicine is an attempt to codify the process of interpret-ing experience, assessing the literature and translating it into practice.2 Dealing with and interpreting the vast amount of surgical literature available on the Internet can be daunting, and this task can be aided by the application of identified formats for executing online search. The PICO (Patient/Population, Intervention, Comparison and Outcome) format is a com-monly used method for codifying online | Surgery_Schwartz. are sources of bias in biomedical literature:• Publication bias: publishers incentivized to accept posi-tive results• Prevailing field bias: supporting entrenched opinions• Citation bias: tendency to cite positive studies• Time-lag bias: delay the reporting of negative results• Reporting bias: emphasizing positive over negative resultsKey Points1 Cognitive bias is inescapable, and limits the ability of both individual practitioners and the surgical field in general, to advance and improve in a scientific fashion. Evidence Based Medicine is an attempt to codify the process of interpret-ing experience, assessing the literature and translating it into practice.2 Dealing with and interpreting the vast amount of surgical literature available on the Internet can be daunting, and this task can be aided by the application of identified formats for executing online search. The PICO (Patient/Population, Intervention, Comparison and Outcome) format is a com-monly used method for codifying online |
Surgery_Schwartz_13960 | Surgery_Schwartz | aided by the application of identified formats for executing online search. The PICO (Patient/Population, Intervention, Comparison and Outcome) format is a com-monly used method for codifying online search.3 Not all literature or evidence is created equal. There exist various approaches, such as the Oxford Center for Evidence Based Medicine (CEBM) Levels of Evidence or the GRADE (Grading and Recommendations, Assessment, Development and Evaluation) system, that have been developed to provide guidance in assessing and reifying scientific literature.4 The conversion of evidence into clinical practice often mani-fests in the creation of clinical guidelines. As with all things related to evidence based medicine, not all guidelines are created equal, and therefore there are certain characteristics that can be used to evaluate the quality of a particular clini-cal guideline.5 There are specific challenges in the application of evidence based medicine to surgery, not least of which is the | Surgery_Schwartz. aided by the application of identified formats for executing online search. The PICO (Patient/Population, Intervention, Comparison and Outcome) format is a com-monly used method for codifying online search.3 Not all literature or evidence is created equal. There exist various approaches, such as the Oxford Center for Evidence Based Medicine (CEBM) Levels of Evidence or the GRADE (Grading and Recommendations, Assessment, Development and Evaluation) system, that have been developed to provide guidance in assessing and reifying scientific literature.4 The conversion of evidence into clinical practice often mani-fests in the creation of clinical guidelines. As with all things related to evidence based medicine, not all guidelines are created equal, and therefore there are certain characteristics that can be used to evaluate the quality of a particular clini-cal guideline.5 There are specific challenges in the application of evidence based medicine to surgery, not least of which is the |
Surgery_Schwartz_13961 | Surgery_Schwartz | that can be used to evaluate the quality of a particular clini-cal guideline.5 There are specific challenges in the application of evidence based medicine to surgery, not least of which is the difficulty in performing a truly randomized clinical trial. The CONSORT (Consolidated Standard of Reporting Clinical Trials) guidelines were developed to serve as minimal rec-ommendations for reporting randomized clinical trials.6 The well-known saying “There are lies, damn lies and then statistics” points to the recognition that statistical tools can be prone to misuse, and emphasizes the need to understand the appropriate application, limits of and interpretation of reported statistics.7 Evidence based medicine has not thus far been held to its own standards of evidence. Recognizing that available “evidence” is a constantly shifting landscape should warn one against the dangers of epistemic certainty, and further emphasizes the fact that surgical education is an ongoing and perpetual | Surgery_Schwartz. that can be used to evaluate the quality of a particular clini-cal guideline.5 There are specific challenges in the application of evidence based medicine to surgery, not least of which is the difficulty in performing a truly randomized clinical trial. The CONSORT (Consolidated Standard of Reporting Clinical Trials) guidelines were developed to serve as minimal rec-ommendations for reporting randomized clinical trials.6 The well-known saying “There are lies, damn lies and then statistics” points to the recognition that statistical tools can be prone to misuse, and emphasizes the need to understand the appropriate application, limits of and interpretation of reported statistics.7 Evidence based medicine has not thus far been held to its own standards of evidence. Recognizing that available “evidence” is a constantly shifting landscape should warn one against the dangers of epistemic certainty, and further emphasizes the fact that surgical education is an ongoing and perpetual |
Surgery_Schwartz_13962 | Surgery_Schwartz | available “evidence” is a constantly shifting landscape should warn one against the dangers of epistemic certainty, and further emphasizes the fact that surgical education is an ongoing and perpetual process.In the medical field, the transition from accumulated anec-dote to true statistical analysis can be seen in the emergence of clinical epidemiology as a field in 1938, which began to shift the focus from descriptions of individual patients to trends affect-ing entire populations. This shift, however, was accompanied by new challenges, as different means of turning anecdotal experience into statistics (e.g., case series, observational stud-ies, retrospective studies, prospective studies) meant that now practitioners needed to be able to compare these “scientific” presentations against each other in order to best establish their practices. The processes and methods of aggregating, compar-ing, and translating these different types of data from the medi-cal literature into clinical | Surgery_Schwartz. available “evidence” is a constantly shifting landscape should warn one against the dangers of epistemic certainty, and further emphasizes the fact that surgical education is an ongoing and perpetual process.In the medical field, the transition from accumulated anec-dote to true statistical analysis can be seen in the emergence of clinical epidemiology as a field in 1938, which began to shift the focus from descriptions of individual patients to trends affect-ing entire populations. This shift, however, was accompanied by new challenges, as different means of turning anecdotal experience into statistics (e.g., case series, observational stud-ies, retrospective studies, prospective studies) meant that now practitioners needed to be able to compare these “scientific” presentations against each other in order to best establish their practices. The processes and methods of aggregating, compar-ing, and translating these different types of data from the medi-cal literature into clinical |
Surgery_Schwartz_13963 | Surgery_Schwartz | each other in order to best establish their practices. The processes and methods of aggregating, compar-ing, and translating these different types of data from the medi-cal literature into clinical practice were explicitly established in the latter part of the 20th century, particularly arising from efforts at McMaster University, which eventually led to a fun-damental framework for literature-informed medical decision-making known as evidence-based medicine (EBM).EBM is defined as the “conscientious, explicit and judi-cious use of current best evidence in making decisions about treating individual patients.”2,3 This term was coined by Gordon Guyatt in 1991, focusing on assessing the credibility of the medical literature, understanding the presented results, and applying the information to individual practice. EBM is defined by three epistemological principles4:• Principle 1: Not all evidence is created equal, and the practice of medicine should be based on the best available | Surgery_Schwartz. each other in order to best establish their practices. The processes and methods of aggregating, compar-ing, and translating these different types of data from the medi-cal literature into clinical practice were explicitly established in the latter part of the 20th century, particularly arising from efforts at McMaster University, which eventually led to a fun-damental framework for literature-informed medical decision-making known as evidence-based medicine (EBM).EBM is defined as the “conscientious, explicit and judi-cious use of current best evidence in making decisions about treating individual patients.”2,3 This term was coined by Gordon Guyatt in 1991, focusing on assessing the credibility of the medical literature, understanding the presented results, and applying the information to individual practice. EBM is defined by three epistemological principles4:• Principle 1: Not all evidence is created equal, and the practice of medicine should be based on the best available |
Surgery_Schwartz_13964 | Surgery_Schwartz | to individual practice. EBM is defined by three epistemological principles4:• Principle 1: Not all evidence is created equal, and the practice of medicine should be based on the best available evidence• Principle 2: The pursuit of truth is best accomplished by evaluation of the totality of the evidence, and not selecting evidence that favors a particular claim• Principle 3: Clinical decision-making requires consideration of patients’ values and preferenceThe adoption of EBM in the discipline of surgery has lagged compared to nonsurgical specialties. To a great extent, this is due to the challenges of achieving the highest level of evidence noted in principle 1: definitive conclusions from a randomized controlled trial (RCT). A literature analysis of MEDLINE from 1966 to 2000 demonstrated that only 15.1% of the 134,689 RCTs evaluated a surgical topic.5 In the early days of EBM during the 1990s, surgical RCTs accounted for only 7% of published articles in surgical journals; most of the | Surgery_Schwartz. to individual practice. EBM is defined by three epistemological principles4:• Principle 1: Not all evidence is created equal, and the practice of medicine should be based on the best available evidence• Principle 2: The pursuit of truth is best accomplished by evaluation of the totality of the evidence, and not selecting evidence that favors a particular claim• Principle 3: Clinical decision-making requires consideration of patients’ values and preferenceThe adoption of EBM in the discipline of surgery has lagged compared to nonsurgical specialties. To a great extent, this is due to the challenges of achieving the highest level of evidence noted in principle 1: definitive conclusions from a randomized controlled trial (RCT). A literature analysis of MEDLINE from 1966 to 2000 demonstrated that only 15.1% of the 134,689 RCTs evaluated a surgical topic.5 In the early days of EBM during the 1990s, surgical RCTs accounted for only 7% of published articles in surgical journals; most of the |
Surgery_Schwartz_13965 | Surgery_Schwartz | that only 15.1% of the 134,689 RCTs evaluated a surgical topic.5 In the early days of EBM during the 1990s, surgical RCTs accounted for only 7% of published articles in surgical journals; most of the articles were retrospective studies and case series,6 which are essentially aggregated anecdotes. Over the next decade, the rela-tive frequency of RCTs in surgery further decreased, account-ing for 3.4% of all publications in 2003.5 As a result, most of the available evidence to guide surgical practice today remains based on retrospective reviews, nonrandomized trials, and expert opinion. The barriers to performing prospective RCTs in surgery remain substantial: standardization of clinical pre-sentation and, of course, accounting for variations in operative technique and the ability to blind studies to reduce experimental bias. The relative paucity in RCTs in surgery make it even more 1Brunicardi_Ch51_p2137-p2152.indd 213828/02/19 4:19 PM 2139UNDERSTANDING, EVALUATING, AND USING | Surgery_Schwartz. that only 15.1% of the 134,689 RCTs evaluated a surgical topic.5 In the early days of EBM during the 1990s, surgical RCTs accounted for only 7% of published articles in surgical journals; most of the articles were retrospective studies and case series,6 which are essentially aggregated anecdotes. Over the next decade, the rela-tive frequency of RCTs in surgery further decreased, account-ing for 3.4% of all publications in 2003.5 As a result, most of the available evidence to guide surgical practice today remains based on retrospective reviews, nonrandomized trials, and expert opinion. The barriers to performing prospective RCTs in surgery remain substantial: standardization of clinical pre-sentation and, of course, accounting for variations in operative technique and the ability to blind studies to reduce experimental bias. The relative paucity in RCTs in surgery make it even more 1Brunicardi_Ch51_p2137-p2152.indd 213828/02/19 4:19 PM 2139UNDERSTANDING, EVALUATING, AND USING |
Surgery_Schwartz_13966 | Surgery_Schwartz | studies to reduce experimental bias. The relative paucity in RCTs in surgery make it even more 1Brunicardi_Ch51_p2137-p2152.indd 213828/02/19 4:19 PM 2139UNDERSTANDING, EVALUATING, AND USING EVIDENCE FOR SURGICAL PRACTICECHAPTER 51important that surgeons understand the best-practice methods to critically appraise available evidence, while recognizing the limitations and potential pitfalls of those methods, in order to optimize their practice and decision-making regarding patient care when high quality evidence may not be available. Herein we present the steps of such a workflow, starting with an initial search for information, identification of the classes of informa-tion that such a search can return, and then guidelines by which that information is evaluated, compared, and aggregated.Searching for Information: Patient/Population, Intervention, Comparison, and OutcomeTechnology has substantively changed how information can be sought and retrieved. Online search engines such as | Surgery_Schwartz. studies to reduce experimental bias. The relative paucity in RCTs in surgery make it even more 1Brunicardi_Ch51_p2137-p2152.indd 213828/02/19 4:19 PM 2139UNDERSTANDING, EVALUATING, AND USING EVIDENCE FOR SURGICAL PRACTICECHAPTER 51important that surgeons understand the best-practice methods to critically appraise available evidence, while recognizing the limitations and potential pitfalls of those methods, in order to optimize their practice and decision-making regarding patient care when high quality evidence may not be available. Herein we present the steps of such a workflow, starting with an initial search for information, identification of the classes of informa-tion that such a search can return, and then guidelines by which that information is evaluated, compared, and aggregated.Searching for Information: Patient/Population, Intervention, Comparison, and OutcomeTechnology has substantively changed how information can be sought and retrieved. Online search engines such as |
Surgery_Schwartz_13967 | Surgery_Schwartz | for Information: Patient/Population, Intervention, Comparison, and OutcomeTechnology has substantively changed how information can be sought and retrieved. Online search engines such as MEDLINE via PubMed, which contains over 26 million citations, have dramatically enhanced the ability to access bio-medical literature.7 However, there is a very real potential for such access to become overwhelming. Effective and efficient use of search engines can be enhanced by framing the clinical question in a format designed to improve the relevancy of search results. PICO is one such format, where the acronym stands for Patient/Population, Intervention, Comparison, and Outcome.8• Patient or population is the specific group of individuals for which the questions is being asked.• Intervention is the treatment or technique of interest for the defined patient or population. Intervention might be a proce-dure, such as “laparoscopic appendectomy” or be defined as an exposure of interest, such as | Surgery_Schwartz. for Information: Patient/Population, Intervention, Comparison, and OutcomeTechnology has substantively changed how information can be sought and retrieved. Online search engines such as MEDLINE via PubMed, which contains over 26 million citations, have dramatically enhanced the ability to access bio-medical literature.7 However, there is a very real potential for such access to become overwhelming. Effective and efficient use of search engines can be enhanced by framing the clinical question in a format designed to improve the relevancy of search results. PICO is one such format, where the acronym stands for Patient/Population, Intervention, Comparison, and Outcome.8• Patient or population is the specific group of individuals for which the questions is being asked.• Intervention is the treatment or technique of interest for the defined patient or population. Intervention might be a proce-dure, such as “laparoscopic appendectomy” or be defined as an exposure of interest, such as |
Surgery_Schwartz_13968 | Surgery_Schwartz | the treatment or technique of interest for the defined patient or population. Intervention might be a proce-dure, such as “laparoscopic appendectomy” or be defined as an exposure of interest, such as “smoking.”• Comparison is the alternative treatment or technique to which you are comparing the intervention. Terms might include, for example, “open appendectomy” or “observation.”• Outcome of interest is the final step of the PICO format. Examples include “mortality,” “operative time,” and “wound infection.”As with all online search strategies, there is a trade-off between the specificity of the search and the breadth of the returned items. When using PICO to inform clinical decision-making, it is generally advantageous to be as precise and specific as possible when initiating a search: this increases the likelihood the search will return information most germane to the particular clinical scenario. This is accomplished by the use of “AND” in the framing of the search to encompass the | Surgery_Schwartz. the treatment or technique of interest for the defined patient or population. Intervention might be a proce-dure, such as “laparoscopic appendectomy” or be defined as an exposure of interest, such as “smoking.”• Comparison is the alternative treatment or technique to which you are comparing the intervention. Terms might include, for example, “open appendectomy” or “observation.”• Outcome of interest is the final step of the PICO format. Examples include “mortality,” “operative time,” and “wound infection.”As with all online search strategies, there is a trade-off between the specificity of the search and the breadth of the returned items. When using PICO to inform clinical decision-making, it is generally advantageous to be as precise and specific as possible when initiating a search: this increases the likelihood the search will return information most germane to the particular clinical scenario. This is accomplished by the use of “AND” in the framing of the search to encompass the |
Surgery_Schwartz_13969 | Surgery_Schwartz | increases the likelihood the search will return information most germane to the particular clinical scenario. This is accomplished by the use of “AND” in the framing of the search to encompass the set of questions of interest. For example, one could construct a query consisting of a particular procedure, with a particular method, with a particular outcome metric, such as “(distal pancreatectomy) AND splenectomy AND (splenic preservation) AND morbidity” to frame a PICO question.Types of StudiesPrinciple 1 of EBM states that not all evidence is created equal; therefore, evaluating the evidentiary quality of the results of an online search requires classifying the returned search items by type of study. As noted earlier, acknowledging that the “gold standard” level of evidence, RCTs, are rare in the surgical literature, the application of EBM to surgery requires increased familiarity with the types of alternative studies available, with their relative strengths and weaknesses. These | Surgery_Schwartz. increases the likelihood the search will return information most germane to the particular clinical scenario. This is accomplished by the use of “AND” in the framing of the search to encompass the set of questions of interest. For example, one could construct a query consisting of a particular procedure, with a particular method, with a particular outcome metric, such as “(distal pancreatectomy) AND splenectomy AND (splenic preservation) AND morbidity” to frame a PICO question.Types of StudiesPrinciple 1 of EBM states that not all evidence is created equal; therefore, evaluating the evidentiary quality of the results of an online search requires classifying the returned search items by type of study. As noted earlier, acknowledging that the “gold standard” level of evidence, RCTs, are rare in the surgical literature, the application of EBM to surgery requires increased familiarity with the types of alternative studies available, with their relative strengths and weaknesses. These |
Surgery_Schwartz_13970 | Surgery_Schwartz | rare in the surgical literature, the application of EBM to surgery requires increased familiarity with the types of alternative studies available, with their relative strengths and weaknesses. These types are listed below:• Meta-analysis: A meta-analysis is a technique to combine similarly published data in order to increase the overall 2statistical power compared to each study individually. The amount of interstudy heterogeneity (methods, study popula-tion, endpoints, etc.) should be limited to allow for the gen-eration of informative conclusions. The pooling of similar studies enables researchers to generate a new statistical con-clusion based on a substantially larger sample size. These approaches, though useful, have their limitations: the inclu-sion of inappropriate studies and the mislabeling of a meta-analysis leading to inaccurate conclusions. Attention should be directed toward this type of evidence when clinical guide-lines do not exist.• Systematic Review: Like | Surgery_Schwartz. rare in the surgical literature, the application of EBM to surgery requires increased familiarity with the types of alternative studies available, with their relative strengths and weaknesses. These types are listed below:• Meta-analysis: A meta-analysis is a technique to combine similarly published data in order to increase the overall 2statistical power compared to each study individually. The amount of interstudy heterogeneity (methods, study popula-tion, endpoints, etc.) should be limited to allow for the gen-eration of informative conclusions. The pooling of similar studies enables researchers to generate a new statistical con-clusion based on a substantially larger sample size. These approaches, though useful, have their limitations: the inclu-sion of inappropriate studies and the mislabeling of a meta-analysis leading to inaccurate conclusions. Attention should be directed toward this type of evidence when clinical guide-lines do not exist.• Systematic Review: Like |
Surgery_Schwartz_13971 | Surgery_Schwartz | and the mislabeling of a meta-analysis leading to inaccurate conclusions. Attention should be directed toward this type of evidence when clinical guide-lines do not exist.• Systematic Review: Like meta-analyses, systematic reviews use standardized methods to search for and appraise studies in order to attempt to reduce bias. However, systematic reviews do not utilize quantitative methods to summarize the results. For this reason, systematic reviews are often not considered to provide the same strength of evidence as a meta-analysis.• Cross-Sectional Studies: In a cross-sectional study, expo-sures and outcomes are measured at a single point in time. The prevalence of the outcome is then compared in patients who did and did not have the exposure. Multiple exposures and outcomes can be measured at the same time, which is an advantage; however, there are important limitations. One significant limitation is that a temporal relationship cannot be determined between exposure and outcome | Surgery_Schwartz. and the mislabeling of a meta-analysis leading to inaccurate conclusions. Attention should be directed toward this type of evidence when clinical guide-lines do not exist.• Systematic Review: Like meta-analyses, systematic reviews use standardized methods to search for and appraise studies in order to attempt to reduce bias. However, systematic reviews do not utilize quantitative methods to summarize the results. For this reason, systematic reviews are often not considered to provide the same strength of evidence as a meta-analysis.• Cross-Sectional Studies: In a cross-sectional study, expo-sures and outcomes are measured at a single point in time. The prevalence of the outcome is then compared in patients who did and did not have the exposure. Multiple exposures and outcomes can be measured at the same time, which is an advantage; however, there are important limitations. One significant limitation is that a temporal relationship cannot be determined between exposure and outcome |
Surgery_Schwartz_13972 | Surgery_Schwartz | at the same time, which is an advantage; however, there are important limitations. One significant limitation is that a temporal relationship cannot be determined between exposure and outcome because they are measured simultaneously. These studies will often form the foundation for more definitive studies.• Case Control Study: In a case-control study, cohorts are determined by the presence or absence of a particular out-come of interest. This is in contrast to a cross-sectional study where samples are determined by the presence or absence of an exposure. Once the samples have been identi-fied based upon outcome, then possible prior exposures are identified, and the odds of those exposures are compared between cohorts.• Case Series: A Case Series involves a report of a small group of patients that share specified clinical features; this gener-ally does not include description of a control group. Case series are prevalent in the field of surgery, and some of the most famous eponymous | Surgery_Schwartz. at the same time, which is an advantage; however, there are important limitations. One significant limitation is that a temporal relationship cannot be determined between exposure and outcome because they are measured simultaneously. These studies will often form the foundation for more definitive studies.• Case Control Study: In a case-control study, cohorts are determined by the presence or absence of a particular out-come of interest. This is in contrast to a cross-sectional study where samples are determined by the presence or absence of an exposure. Once the samples have been identi-fied based upon outcome, then possible prior exposures are identified, and the odds of those exposures are compared between cohorts.• Case Series: A Case Series involves a report of a small group of patients that share specified clinical features; this gener-ally does not include description of a control group. Case series are prevalent in the field of surgery, and some of the most famous eponymous |
Surgery_Schwartz_13973 | Surgery_Schwartz | that share specified clinical features; this gener-ally does not include description of a control group. Case series are prevalent in the field of surgery, and some of the most famous eponymous procedures originated from case series, including the Whipple procedure9 and Nissen fundo-plication.10 This type of study provides weak evidence due to issues with patient selection, biases, and confounding factors. However, the findings from a case series can be used to gen-erate hypotheses for a randomized control trial.• Expert Opinion: Expert opinions represent the lowest level of evidence and is representative of a clinician’s individual experience and anecdotes. Prior to evidence-based medicine, expert opinion was the primary means of teaching medicine and shaping the field. However, the opinions of clinicians can vary substantially leading to a wide range of potential unproven treatments for a medical issue. Thus, expert opinion should only be solicited in the complete absence of | Surgery_Schwartz. that share specified clinical features; this gener-ally does not include description of a control group. Case series are prevalent in the field of surgery, and some of the most famous eponymous procedures originated from case series, including the Whipple procedure9 and Nissen fundo-plication.10 This type of study provides weak evidence due to issues with patient selection, biases, and confounding factors. However, the findings from a case series can be used to gen-erate hypotheses for a randomized control trial.• Expert Opinion: Expert opinions represent the lowest level of evidence and is representative of a clinician’s individual experience and anecdotes. Prior to evidence-based medicine, expert opinion was the primary means of teaching medicine and shaping the field. However, the opinions of clinicians can vary substantially leading to a wide range of potential unproven treatments for a medical issue. Thus, expert opinion should only be solicited in the complete absence of |
Surgery_Schwartz_13974 | Surgery_Schwartz | opinions of clinicians can vary substantially leading to a wide range of potential unproven treatments for a medical issue. Thus, expert opinion should only be solicited in the complete absence of evidence in the literature.It should also be noted that irrespective of the type of study or recommendation, there are additional factors that can contribute to bias in publication. To a great degree these are extrapolations of the sources of individual cognitive bias, but writ large across an entire community (see Box: The History and Sources of Bias in Biomedical Literature).Brunicardi_Ch51_p2137-p2152.indd 213928/02/19 4:19 PM 2140SPECIFIC CONSIDERATIONSPART IIHierarchies of EvidenceThe original architects of EBM codified the notion that certain types of evidence are superior to others based on charac-teristics of study design, depicting this concept as a “pyra-mid,” with expert opinion comprising the base of the pyramid and randomized controlled trials at the peak (Fig. 51-1). | Surgery_Schwartz. opinions of clinicians can vary substantially leading to a wide range of potential unproven treatments for a medical issue. Thus, expert opinion should only be solicited in the complete absence of evidence in the literature.It should also be noted that irrespective of the type of study or recommendation, there are additional factors that can contribute to bias in publication. To a great degree these are extrapolations of the sources of individual cognitive bias, but writ large across an entire community (see Box: The History and Sources of Bias in Biomedical Literature).Brunicardi_Ch51_p2137-p2152.indd 213928/02/19 4:19 PM 2140SPECIFIC CONSIDERATIONSPART IIHierarchies of EvidenceThe original architects of EBM codified the notion that certain types of evidence are superior to others based on charac-teristics of study design, depicting this concept as a “pyra-mid,” with expert opinion comprising the base of the pyramid and randomized controlled trials at the peak (Fig. 51-1). |
Surgery_Schwartz_13975 | Surgery_Schwartz | based on charac-teristics of study design, depicting this concept as a “pyra-mid,” with expert opinion comprising the base of the pyramid and randomized controlled trials at the peak (Fig. 51-1). Although conceptually appealing, this initial attempt to “rank” the evidence was relatively simplistic and rested on unproven assumptions that RCT were inherently superior to observational studies. While RCTs theoretically provide higher quality evi-dence compared to observational studies, RCTs can also have significant limitations and biases (see later section, “The Chal-lenges of Applying EBM to Surgery”). Furthermore, translating the results from well-crafted RCTs can be challenging, where the specific restrictive criteria for executing a high-quality RCT can inherently limit its applicability to clinical scenarios not specifically noted or tested in the RCT. Therefore, one could find oneself in the situation of trying to compare an RCT on a related but clearly distinct use case with a | Surgery_Schwartz. based on charac-teristics of study design, depicting this concept as a “pyra-mid,” with expert opinion comprising the base of the pyramid and randomized controlled trials at the peak (Fig. 51-1). Although conceptually appealing, this initial attempt to “rank” the evidence was relatively simplistic and rested on unproven assumptions that RCT were inherently superior to observational studies. While RCTs theoretically provide higher quality evi-dence compared to observational studies, RCTs can also have significant limitations and biases (see later section, “The Chal-lenges of Applying EBM to Surgery”). Furthermore, translating the results from well-crafted RCTs can be challenging, where the specific restrictive criteria for executing a high-quality RCT can inherently limit its applicability to clinical scenarios not specifically noted or tested in the RCT. Therefore, one could find oneself in the situation of trying to compare an RCT on a related but clearly distinct use case with a |
Surgery_Schwartz_13976 | Surgery_Schwartz | to clinical scenarios not specifically noted or tested in the RCT. Therefore, one could find oneself in the situation of trying to compare an RCT on a related but clearly distinct use case with a well performed obser-vational study that more closely approximated the clinical sce-nario in question. This led to the subsequent development of more refined frameworks to assess the quality of evidence in order to try and address these issues, although there is currently no consensus on a single framework. The current situation is that while many newer systems have devised ways in which studies can move up and down the pyramid, for well-designed studies, the pyramid largely remains intact.The initial hierarchies of evidence were limited because they entangled the method of evidence collection with underly-ing study design. They failed to recognize principle 2 of EBM: “the pursuit of truth is best accomplished by evaluation of the totality of evidence” and the principle that “health claims be | Surgery_Schwartz. to clinical scenarios not specifically noted or tested in the RCT. Therefore, one could find oneself in the situation of trying to compare an RCT on a related but clearly distinct use case with a well performed obser-vational study that more closely approximated the clinical sce-nario in question. This led to the subsequent development of more refined frameworks to assess the quality of evidence in order to try and address these issues, although there is currently no consensus on a single framework. The current situation is that while many newer systems have devised ways in which studies can move up and down the pyramid, for well-designed studies, the pyramid largely remains intact.The initial hierarchies of evidence were limited because they entangled the method of evidence collection with underly-ing study design. They failed to recognize principle 2 of EBM: “the pursuit of truth is best accomplished by evaluation of the totality of evidence” and the principle that “health claims be |
Surgery_Schwartz_13977 | Surgery_Schwartz | underly-ing study design. They failed to recognize principle 2 of EBM: “the pursuit of truth is best accomplished by evaluation of the totality of evidence” and the principle that “health claims be based upon systematic reviews which summarize the best avail-able evidence.”4 The earliest hierarchies positioned systematic reviews at the top of the pyramid followed by RCTs; how-ever, this classification failed to acknowledge that systematic reviews can summarize any type of evidence. Cohort studies, case-control studies, and even case reports can be the subject of systematic review. The importance of systematic review in EBM cannot be understated: systematic reviews are the most 3cited type of study, and these studies are essential for the devel-opment of clinical guidelines and influencing the direction of future studies.2,11 When applied in a timely manner, systematic reviews have resulted in major practice changes, for example, encouraging early postoperative enteral feeding compared | Surgery_Schwartz. underly-ing study design. They failed to recognize principle 2 of EBM: “the pursuit of truth is best accomplished by evaluation of the totality of evidence” and the principle that “health claims be based upon systematic reviews which summarize the best avail-able evidence.”4 The earliest hierarchies positioned systematic reviews at the top of the pyramid followed by RCTs; how-ever, this classification failed to acknowledge that systematic reviews can summarize any type of evidence. Cohort studies, case-control studies, and even case reports can be the subject of systematic review. The importance of systematic review in EBM cannot be understated: systematic reviews are the most 3cited type of study, and these studies are essential for the devel-opment of clinical guidelines and influencing the direction of future studies.2,11 When applied in a timely manner, systematic reviews have resulted in major practice changes, for example, encouraging early postoperative enteral feeding compared |
Surgery_Schwartz_13978 | Surgery_Schwartz | the direction of future studies.2,11 When applied in a timely manner, systematic reviews have resulted in major practice changes, for example, encouraging early postoperative enteral feeding compared to parenteral nutrition to prevent sepsis.12Tools to Evaluate a Body of EvidenceBy 2002, over 100 unique evidence rating systems existed,2 and the differences among them may be nontrivial. Depending upon the specific criteria used, the “strength” of evidence might dif-fer widely from system to system. For example, the American Association of Orthopedic Surgeons (AAOS) published guide-lines in 2009 for prevention of venous thromboembolism (VTE) in patients undergoing hip or knee surgery that conflicted with the widely used American College of Chest Physician (ACCP) guidelines, despite having access to the same data. While the ACCP considered VTE prophylaxis to be a grade 1 recommen-dation with level A evidence, the AAOS recommendation var-ied based upon risk of pulmonary embolism and | Surgery_Schwartz. the direction of future studies.2,11 When applied in a timely manner, systematic reviews have resulted in major practice changes, for example, encouraging early postoperative enteral feeding compared to parenteral nutrition to prevent sepsis.12Tools to Evaluate a Body of EvidenceBy 2002, over 100 unique evidence rating systems existed,2 and the differences among them may be nontrivial. Depending upon the specific criteria used, the “strength” of evidence might dif-fer widely from system to system. For example, the American Association of Orthopedic Surgeons (AAOS) published guide-lines in 2009 for prevention of venous thromboembolism (VTE) in patients undergoing hip or knee surgery that conflicted with the widely used American College of Chest Physician (ACCP) guidelines, despite having access to the same data. While the ACCP considered VTE prophylaxis to be a grade 1 recommen-dation with level A evidence, the AAOS recommendation var-ied based upon risk of pulmonary embolism and |
Surgery_Schwartz_13979 | Surgery_Schwartz | access to the same data. While the ACCP considered VTE prophylaxis to be a grade 1 recommen-dation with level A evidence, the AAOS recommendation var-ied based upon risk of pulmonary embolism and bleeding, with no recommendation being greater than B and all recommenda-tions being based upon level III evidence.13 In the following section we present a few of the most widely accepted tools for assessing the quality of evidence.CEBM Levels of Evidence. One of the most widely adopted systems for grading evidence is the Oxford Center for Evi-dence Based Medicine (CEBM) Levels of Evidence. The origi-nal CEBM system was released in 2000 and was subsequently updated in 2011. Earlier systems of evidence ranking were criti-cized because they categorically placed randomized trials above observational studies, although observational studies and even anecdotes can occasionally give the “best” evidence in certain clinical situations. CEBM was therefore developed to not only improve the ranking of | Surgery_Schwartz. access to the same data. While the ACCP considered VTE prophylaxis to be a grade 1 recommen-dation with level A evidence, the AAOS recommendation var-ied based upon risk of pulmonary embolism and bleeding, with no recommendation being greater than B and all recommenda-tions being based upon level III evidence.13 In the following section we present a few of the most widely accepted tools for assessing the quality of evidence.CEBM Levels of Evidence. One of the most widely adopted systems for grading evidence is the Oxford Center for Evi-dence Based Medicine (CEBM) Levels of Evidence. The origi-nal CEBM system was released in 2000 and was subsequently updated in 2011. Earlier systems of evidence ranking were criti-cized because they categorically placed randomized trials above observational studies, although observational studies and even anecdotes can occasionally give the “best” evidence in certain clinical situations. CEBM was therefore developed to not only improve the ranking of |
Surgery_Schwartz_13980 | Surgery_Schwartz | studies, although observational studies and even anecdotes can occasionally give the “best” evidence in certain clinical situations. CEBM was therefore developed to not only improve the ranking of evidence but also to aid clinicians in quickly searching for the best evidence available for a given clinical question (Table 51-1). It is designed as both a tool for traditional critical appraisal as well as a pragmatic system that clinicians can use to answer clinical questions in real time. It can be used as a heuristic that clinicians and patients can utilize to answer clinical questions quickly and without resorting to preap-praised sources.14 The CEBM Levels of Evidence system begins with choosing a clinical question from the first column of the table provided by the creators (see Table 51-1) (for example, “How common is the problem?”, “Does this intervention help?”, or “Is this test worthwhile?”). Therefore, each row of the CEBM Levels of Evidence represents a series of steps one | Surgery_Schwartz. studies, although observational studies and even anecdotes can occasionally give the “best” evidence in certain clinical situations. CEBM was therefore developed to not only improve the ranking of evidence but also to aid clinicians in quickly searching for the best evidence available for a given clinical question (Table 51-1). It is designed as both a tool for traditional critical appraisal as well as a pragmatic system that clinicians can use to answer clinical questions in real time. It can be used as a heuristic that clinicians and patients can utilize to answer clinical questions quickly and without resorting to preap-praised sources.14 The CEBM Levels of Evidence system begins with choosing a clinical question from the first column of the table provided by the creators (see Table 51-1) (for example, “How common is the problem?”, “Does this intervention help?”, or “Is this test worthwhile?”). Therefore, each row of the CEBM Levels of Evidence represents a series of steps one |
Surgery_Schwartz_13981 | Surgery_Schwartz | 51-1) (for example, “How common is the problem?”, “Does this intervention help?”, or “Is this test worthwhile?”). Therefore, each row of the CEBM Levels of Evidence represents a series of steps one should fol-low to find the best evidence for the question chosen. Strong evidence is likely to be found in columns to the left of the table, while weak evidence will be found in columns to the right. After completing a clinical query using the table, a final “level” of evidence is assigned on a scale from 1 to 5 based upon the types of studies found to answer the initial question (1 = highest rated evidence; 5 = lowest rated evidence). However, the levels are not intended to provide one with a definitive judgment regarding the quality of evidence. There may be cases where “lower level” evi-dence—for example, an observational study with a large treat-ment effect—provides stronger evidence than a “higher level” study, such as a systematic review with an inconclusive result.CEBM should be | Surgery_Schwartz. 51-1) (for example, “How common is the problem?”, “Does this intervention help?”, or “Is this test worthwhile?”). Therefore, each row of the CEBM Levels of Evidence represents a series of steps one should fol-low to find the best evidence for the question chosen. Strong evidence is likely to be found in columns to the left of the table, while weak evidence will be found in columns to the right. After completing a clinical query using the table, a final “level” of evidence is assigned on a scale from 1 to 5 based upon the types of studies found to answer the initial question (1 = highest rated evidence; 5 = lowest rated evidence). However, the levels are not intended to provide one with a definitive judgment regarding the quality of evidence. There may be cases where “lower level” evi-dence—for example, an observational study with a large treat-ment effect—provides stronger evidence than a “higher level” study, such as a systematic review with an inconclusive result.CEBM should be |
Surgery_Schwartz_13982 | Surgery_Schwartz | example, an observational study with a large treat-ment effect—provides stronger evidence than a “higher level” study, such as a systematic review with an inconclusive result.CEBM should be thought of as a hierarchy of the likely best evidence. An advantage of CEBM is that it allows the potential of resorting to individual studies for the best evidence, while other systems generally assume that there is a systematic RCTCohort studyCase control studyCase seriesCase reportsAnimal researchIn-vitro researchExpert experience/opinionFigure 51-1. Evidence-based hierarchy.Brunicardi_Ch51_p2137-p2152.indd 214028/02/19 4:19 PM 2141UNDERSTANDING, EVALUATING, AND USING EVIDENCE FOR SURGICAL PRACTICECHAPTER 51Table 51-1Oxford center for evidence-based medicine 2011 levels of evidenceQUESTIONSTEP 1 (LEVEL 1*)STEP 2 (LEVEL 2*)STEP 3 (LEVEL 3*)STEP 4 (LEVEL 4*)STEP 5 (LEVEL 5)How common is the problem?Local and current random sample surveys (or censuses)Systematic review of surveys that allow | Surgery_Schwartz. example, an observational study with a large treat-ment effect—provides stronger evidence than a “higher level” study, such as a systematic review with an inconclusive result.CEBM should be thought of as a hierarchy of the likely best evidence. An advantage of CEBM is that it allows the potential of resorting to individual studies for the best evidence, while other systems generally assume that there is a systematic RCTCohort studyCase control studyCase seriesCase reportsAnimal researchIn-vitro researchExpert experience/opinionFigure 51-1. Evidence-based hierarchy.Brunicardi_Ch51_p2137-p2152.indd 214028/02/19 4:19 PM 2141UNDERSTANDING, EVALUATING, AND USING EVIDENCE FOR SURGICAL PRACTICECHAPTER 51Table 51-1Oxford center for evidence-based medicine 2011 levels of evidenceQUESTIONSTEP 1 (LEVEL 1*)STEP 2 (LEVEL 2*)STEP 3 (LEVEL 3*)STEP 4 (LEVEL 4*)STEP 5 (LEVEL 5)How common is the problem?Local and current random sample surveys (or censuses)Systematic review of surveys that allow |
Surgery_Schwartz_13983 | Surgery_Schwartz | 1 (LEVEL 1*)STEP 2 (LEVEL 2*)STEP 3 (LEVEL 3*)STEP 4 (LEVEL 4*)STEP 5 (LEVEL 5)How common is the problem?Local and current random sample surveys (or censuses)Systematic review of surveys that allow matching to local circumstances**Local non-random sample**Case-series**n/aIs this diagnostic or monitoring test accurate? (Diagnosis)Systematic review of cross-sectional studies with consistently applied reference standard and blindingIndividual cross-sectional studies with consistently applied reference standard and blindingNon-consecutive studies, or studies without consistently applied reference standards**Case-control studies, or “poor or non-independent reference standard**Mechanism-based reasoningWhat will happen if we do not add a therapy? (Prognosis)Systematic review of inception cohort studiesInception cohort studiesCohort study or control arm of randomized trial*Case-series or case-control studies, or poor quality prognostic cohort study**n/aDoes this intervention help? (Treatment | Surgery_Schwartz. 1 (LEVEL 1*)STEP 2 (LEVEL 2*)STEP 3 (LEVEL 3*)STEP 4 (LEVEL 4*)STEP 5 (LEVEL 5)How common is the problem?Local and current random sample surveys (or censuses)Systematic review of surveys that allow matching to local circumstances**Local non-random sample**Case-series**n/aIs this diagnostic or monitoring test accurate? (Diagnosis)Systematic review of cross-sectional studies with consistently applied reference standard and blindingIndividual cross-sectional studies with consistently applied reference standard and blindingNon-consecutive studies, or studies without consistently applied reference standards**Case-control studies, or “poor or non-independent reference standard**Mechanism-based reasoningWhat will happen if we do not add a therapy? (Prognosis)Systematic review of inception cohort studiesInception cohort studiesCohort study or control arm of randomized trial*Case-series or case-control studies, or poor quality prognostic cohort study**n/aDoes this intervention help? (Treatment |
Surgery_Schwartz_13984 | Surgery_Schwartz | studiesInception cohort studiesCohort study or control arm of randomized trial*Case-series or case-control studies, or poor quality prognostic cohort study**n/aDoes this intervention help? (Treatment Benefits)Systematic review of randomized trials or n-of-1 trialsRandomized trial or observational study with dramatic effectNon-randomized controlled cohort/follow-up study**Case-series, case-control studies, or historically controlled studies**Mechanism-based reasoningWhat are the COMMON harms? (Treatment Harms)Systematic review of randomized trials, systematic review of nested case-control studies n-of-1 trial with the patient you are raising the question about, or observational study with dramatic effectIndividual randomized trial or (exceptionally) observational study with dramatic effectNon-randomized controlled cohort/follow-up study (post-marketing surveillance) provided there are sufficient numbers to rule out a common harm. (For long-term harms the duration of follow-up must be | Surgery_Schwartz. studiesInception cohort studiesCohort study or control arm of randomized trial*Case-series or case-control studies, or poor quality prognostic cohort study**n/aDoes this intervention help? (Treatment Benefits)Systematic review of randomized trials or n-of-1 trialsRandomized trial or observational study with dramatic effectNon-randomized controlled cohort/follow-up study**Case-series, case-control studies, or historically controlled studies**Mechanism-based reasoningWhat are the COMMON harms? (Treatment Harms)Systematic review of randomized trials, systematic review of nested case-control studies n-of-1 trial with the patient you are raising the question about, or observational study with dramatic effectIndividual randomized trial or (exceptionally) observational study with dramatic effectNon-randomized controlled cohort/follow-up study (post-marketing surveillance) provided there are sufficient numbers to rule out a common harm. (For long-term harms the duration of follow-up must be |
Surgery_Schwartz_13985 | Surgery_Schwartz | controlled cohort/follow-up study (post-marketing surveillance) provided there are sufficient numbers to rule out a common harm. (For long-term harms the duration of follow-up must be sufficient.)**Case-series, case-control, or historically controlled studies**Mechanism-based reasoningWhat are the RARE harms? (Treatment Harms)Systematic review of randomized trials or n-of-1 trialRandomized trial or (exceptionally) observational study with dramatic effect Is this (early detection) test worthwhile? (Screening)Systematic review of randomized trialsRandomized trialNon-randomized controlled cohort/follow-up study**Case-series, case-control, or historically controlled studies**Mechanism-based reasoning*Level may be graded down on the basis of study quality, Imprecision, Indirectness (study PICO does not match questions PICO), because of inconsistency between studies, or because the absolute effect size is very small; Level may be graded up if there is a large or very large effect | Surgery_Schwartz. controlled cohort/follow-up study (post-marketing surveillance) provided there are sufficient numbers to rule out a common harm. (For long-term harms the duration of follow-up must be sufficient.)**Case-series, case-control, or historically controlled studies**Mechanism-based reasoningWhat are the RARE harms? (Treatment Harms)Systematic review of randomized trials or n-of-1 trialRandomized trial or (exceptionally) observational study with dramatic effect Is this (early detection) test worthwhile? (Screening)Systematic review of randomized trialsRandomized trialNon-randomized controlled cohort/follow-up study**Case-series, case-control, or historically controlled studies**Mechanism-based reasoning*Level may be graded down on the basis of study quality, Imprecision, Indirectness (study PICO does not match questions PICO), because of inconsistency between studies, or because the absolute effect size is very small; Level may be graded up if there is a large or very large effect |
Surgery_Schwartz_13986 | Surgery_Schwartz | PICO does not match questions PICO), because of inconsistency between studies, or because the absolute effect size is very small; Level may be graded up if there is a large or very large effect size.**As always, a systematic review is generally better than an individual study.How to cite the Levels of Evidence TableOCEBM Levels of Evidence Working Group*. “The Oxford 2011 Levels of Evidence”.Oxford Centre for Evidence-Based Medicine. http://www.cebm.net/index.aspx?o=5653*OCEBM Table of Evidence Working Group = Jeremy Howick, Iain Chalmers (James Lind Library), Paul Glasziou, Trish Greenhaigh, Carl Heneghan, Alessandro Liberati, Ivan Moschetti, Bob Phillips, Hazel Thornton, Olive Goddard, and Mary HodgkinsanBrunicardi_Ch51_p2137-p2152.indd 214128/02/19 4:19 PM 2142SPECIFIC CONSIDERATIONSPART IIDefinitions of GRADE Evidence QualityHigh quality – Further research is very unlikely to change confidence in the estimate of effect.Moderate quality – Further research is likely to have an | Surgery_Schwartz. PICO does not match questions PICO), because of inconsistency between studies, or because the absolute effect size is very small; Level may be graded up if there is a large or very large effect size.**As always, a systematic review is generally better than an individual study.How to cite the Levels of Evidence TableOCEBM Levels of Evidence Working Group*. “The Oxford 2011 Levels of Evidence”.Oxford Centre for Evidence-Based Medicine. http://www.cebm.net/index.aspx?o=5653*OCEBM Table of Evidence Working Group = Jeremy Howick, Iain Chalmers (James Lind Library), Paul Glasziou, Trish Greenhaigh, Carl Heneghan, Alessandro Liberati, Ivan Moschetti, Bob Phillips, Hazel Thornton, Olive Goddard, and Mary HodgkinsanBrunicardi_Ch51_p2137-p2152.indd 214128/02/19 4:19 PM 2142SPECIFIC CONSIDERATIONSPART IIDefinitions of GRADE Evidence QualityHigh quality – Further research is very unlikely to change confidence in the estimate of effect.Moderate quality – Further research is likely to have an |
Surgery_Schwartz_13987 | Surgery_Schwartz | of GRADE Evidence QualityHigh quality – Further research is very unlikely to change confidence in the estimate of effect.Moderate quality – Further research is likely to have an important impact confidence in the estimate of effect and may change the estimate.Low quality – Further research is very likely to have an important impact on confidence in the estimate of effect and is likely to change the estimate.Very low quality – Any estimate of effect is very uncertain.review available. Additionally, other systems are built around considering the strength of evidence for therapeutic effects and harms, while CEBM allows appraisal of evidence for prevalence of disease, accuracy of diagnostic tests, prognosis, therapeutic effects, rare harms, common harms, and usefulness of screening.Grading and Recommendations, Assessment, Development, and Evaluation. Alternatively, the Grading and Recommendations, Assessment, Development and Evaluation (GRADE) system classifies the quality of evidence | Surgery_Schwartz. of GRADE Evidence QualityHigh quality – Further research is very unlikely to change confidence in the estimate of effect.Moderate quality – Further research is likely to have an important impact confidence in the estimate of effect and may change the estimate.Low quality – Further research is very likely to have an important impact on confidence in the estimate of effect and is likely to change the estimate.Very low quality – Any estimate of effect is very uncertain.review available. Additionally, other systems are built around considering the strength of evidence for therapeutic effects and harms, while CEBM allows appraisal of evidence for prevalence of disease, accuracy of diagnostic tests, prognosis, therapeutic effects, rare harms, common harms, and usefulness of screening.Grading and Recommendations, Assessment, Development, and Evaluation. Alternatively, the Grading and Recommendations, Assessment, Development and Evaluation (GRADE) system classifies the quality of evidence |
Surgery_Schwartz_13988 | Surgery_Schwartz | and Recommendations, Assessment, Development, and Evaluation. Alternatively, the Grading and Recommendations, Assessment, Development and Evaluation (GRADE) system classifies the quality of evidence into one of four levels: high, moderate, low, and very low15 (Box: Definitions of GRADE Evidence Quality). Evidence quality in the GRADE system is not assigned solely on study design. For example, a randomized controlled trial begins at “high quality,” but may be demoted due to one or more of the following: study limitations, inconsistent results, indirectness of evidence, imprecision, or reporting bias. Alternatively, observational studies (cohort or case-control studies) start as “low quality” but may be upgraded if there is a large magnitude of the treatment effect, evidence of a dose-response relationship, or if all plausible biases would decrease the magnitude of a treatment effect. Thus, the GRADE system of evaluating the quality of evidence provides more granularity than the | Surgery_Schwartz. and Recommendations, Assessment, Development, and Evaluation. Alternatively, the Grading and Recommendations, Assessment, Development and Evaluation (GRADE) system classifies the quality of evidence into one of four levels: high, moderate, low, and very low15 (Box: Definitions of GRADE Evidence Quality). Evidence quality in the GRADE system is not assigned solely on study design. For example, a randomized controlled trial begins at “high quality,” but may be demoted due to one or more of the following: study limitations, inconsistent results, indirectness of evidence, imprecision, or reporting bias. Alternatively, observational studies (cohort or case-control studies) start as “low quality” but may be upgraded if there is a large magnitude of the treatment effect, evidence of a dose-response relationship, or if all plausible biases would decrease the magnitude of a treatment effect. Thus, the GRADE system of evaluating the quality of evidence provides more granularity than the |
Surgery_Schwartz_13989 | Surgery_Schwartz | relationship, or if all plausible biases would decrease the magnitude of a treatment effect. Thus, the GRADE system of evaluating the quality of evidence provides more granularity than the traditional hierarchy system, which assigns quality based upon study design alone. Although the GRADE system has significant advantages, it is more complex and has a steeper learning curve than traditional systems. Finally, GRADE is intended for appraising a body of evidence, such as in a systematic review.In addition to providing a transparent approach to grading evidence quality, the GRADE system outlines an approach to the development and assignment of strength to clinical recommendations. GRADE’s sophisticated hierarchy of evidence allows the system to protect against both superficial assessment and unwarranted confidence in all classes of study design. Since its development, the increasing use of GRADE has resulted in higher quality and rigor of systematic reviews due to standards outlined by | Surgery_Schwartz. relationship, or if all plausible biases would decrease the magnitude of a treatment effect. Thus, the GRADE system of evaluating the quality of evidence provides more granularity than the traditional hierarchy system, which assigns quality based upon study design alone. Although the GRADE system has significant advantages, it is more complex and has a steeper learning curve than traditional systems. Finally, GRADE is intended for appraising a body of evidence, such as in a systematic review.In addition to providing a transparent approach to grading evidence quality, the GRADE system outlines an approach to the development and assignment of strength to clinical recommendations. GRADE’s sophisticated hierarchy of evidence allows the system to protect against both superficial assessment and unwarranted confidence in all classes of study design. Since its development, the increasing use of GRADE has resulted in higher quality and rigor of systematic reviews due to standards outlined by |
Surgery_Schwartz_13990 | Surgery_Schwartz | unwarranted confidence in all classes of study design. Since its development, the increasing use of GRADE has resulted in higher quality and rigor of systematic reviews due to standards outlined by the system.15 In creating a recommendation regarding a body of evidence, GRADE allows experts to account for limitations in bodies of evidence comprising of RCTs, while also allowing for the rating of observational studies as high quality in cases where RCTs are not feasible (i.e., an RCT cannot ethically be performed). GRADE therefore potentially allows for observational studies to provide definitive evidence of causal association (e.g., alcohol causing cirrhosis or asbestos causing mesothelioma) where RCTs may not be ethical or necessary.One of the major advantages of GRADE is that it specifi-cally addresses the process of moving from evidence to recom-mendations. The process begins with the creation of a summary of findings table. A summary of findings table consists of a presentation | Surgery_Schwartz. unwarranted confidence in all classes of study design. Since its development, the increasing use of GRADE has resulted in higher quality and rigor of systematic reviews due to standards outlined by the system.15 In creating a recommendation regarding a body of evidence, GRADE allows experts to account for limitations in bodies of evidence comprising of RCTs, while also allowing for the rating of observational studies as high quality in cases where RCTs are not feasible (i.e., an RCT cannot ethically be performed). GRADE therefore potentially allows for observational studies to provide definitive evidence of causal association (e.g., alcohol causing cirrhosis or asbestos causing mesothelioma) where RCTs may not be ethical or necessary.One of the major advantages of GRADE is that it specifi-cally addresses the process of moving from evidence to recom-mendations. The process begins with the creation of a summary of findings table. A summary of findings table consists of a presentation |
Surgery_Schwartz_13991 | Surgery_Schwartz | addresses the process of moving from evidence to recom-mendations. The process begins with the creation of a summary of findings table. A summary of findings table consists of a presentation not only of evidence quality but also estimates of the relative and absolute effects of patient-centered outcomes (Fig. 51-2). The summary of findings format was created to min-imize framing effects, where different raters may come to varied conclusions based upon identical information due to the infor-mation having a contrasting presentation in terms of gain versus loss.16 GRADE and similar EBM systems specifically takes into consideration judgement of risk versus benefit, resource use, feasibility, and equity to attempt to make decision-making as consistent as possible across a range of reviewers.2 Despite all of the aforementioned considerations when constructing a guide-line, it is important to realize that patient values or preferences may immediately invalidate any recommendation. Evidence | Surgery_Schwartz. addresses the process of moving from evidence to recom-mendations. The process begins with the creation of a summary of findings table. A summary of findings table consists of a presentation not only of evidence quality but also estimates of the relative and absolute effects of patient-centered outcomes (Fig. 51-2). The summary of findings format was created to min-imize framing effects, where different raters may come to varied conclusions based upon identical information due to the infor-mation having a contrasting presentation in terms of gain versus loss.16 GRADE and similar EBM systems specifically takes into consideration judgement of risk versus benefit, resource use, feasibility, and equity to attempt to make decision-making as consistent as possible across a range of reviewers.2 Despite all of the aforementioned considerations when constructing a guide-line, it is important to realize that patient values or preferences may immediately invalidate any recommendation. Evidence |
Surgery_Schwartz_13992 | Surgery_Schwartz | Despite all of the aforementioned considerations when constructing a guide-line, it is important to realize that patient values or preferences may immediately invalidate any recommendation. Evidence is often constructed based upon measurement of outcomes such as morbidity, mortality, or survival; however, patients may be more concerned with quality of life or avoiding invasive inter-ventions. GRADE attempts to acknowledges this intrinsic vari-ability within its system of grading.In terms of the overall strength of a recommendation that GRADE can assign, two grades are possible: “strong” and “weak.” A strong recommendation is one where positive effects of an intervention clearly outweigh the negative effects or vice versa. A weak recommendation is one where the asso-ciation is less clear, either because of low quality evidence or because the evidence clearly suggests that the positive and negative effects are similar. However, quality of evidence is not the only factor that affects the | Surgery_Schwartz. Despite all of the aforementioned considerations when constructing a guide-line, it is important to realize that patient values or preferences may immediately invalidate any recommendation. Evidence is often constructed based upon measurement of outcomes such as morbidity, mortality, or survival; however, patients may be more concerned with quality of life or avoiding invasive inter-ventions. GRADE attempts to acknowledges this intrinsic vari-ability within its system of grading.In terms of the overall strength of a recommendation that GRADE can assign, two grades are possible: “strong” and “weak.” A strong recommendation is one where positive effects of an intervention clearly outweigh the negative effects or vice versa. A weak recommendation is one where the asso-ciation is less clear, either because of low quality evidence or because the evidence clearly suggests that the positive and negative effects are similar. However, quality of evidence is not the only factor that affects the |
Surgery_Schwartz_13993 | Surgery_Schwartz | because of low quality evidence or because the evidence clearly suggests that the positive and negative effects are similar. However, quality of evidence is not the only factor that affects the strength of a recommenda-tion (Table 51-2). Factors such as uncertainty of patient values or whether an intervention is an appropriate use of resources can play a role in the strength of a recommendation as well. Therefore, it is important to note that a “strong” or “weak” rec-ommendation may be given regardless of the classification of the evidence. For example, there is a strong recommendation that patients with Zollinger-Ellison syndrome be treated with PPI. This recommendation is made despite weak evidence to support this practice because the potential benefits far out-weigh the potential risks.17Although the systems for grading evidence are well devel-oped, it is important to remember that the studies used for evi-dence are judged based on their internal validity, or the extent to which a | Surgery_Schwartz. because of low quality evidence or because the evidence clearly suggests that the positive and negative effects are similar. However, quality of evidence is not the only factor that affects the strength of a recommenda-tion (Table 51-2). Factors such as uncertainty of patient values or whether an intervention is an appropriate use of resources can play a role in the strength of a recommendation as well. Therefore, it is important to note that a “strong” or “weak” rec-ommendation may be given regardless of the classification of the evidence. For example, there is a strong recommendation that patients with Zollinger-Ellison syndrome be treated with PPI. This recommendation is made despite weak evidence to support this practice because the potential benefits far out-weigh the potential risks.17Although the systems for grading evidence are well devel-oped, it is important to remember that the studies used for evi-dence are judged based on their internal validity, or the extent to which a |
Surgery_Schwartz_13994 | Surgery_Schwartz | the systems for grading evidence are well devel-oped, it is important to remember that the studies used for evi-dence are judged based on their internal validity, or the extent to which a causal conclusion is warranted based upon applica-tion of the results to the study population. This means that care must be exercised when applying a recommendation to a given patient, as the external validity of a recommendation, or gener-alizability of a causal conclusion to populations outside of the scope of the original studies, may not be appropriate. Therefore, all evidence must be applied within the context of the patient in front of you.Synthesis of Evidence—Clinical GuidelinesThe Institute of Medicine defines a clinical guideline as “state-ments that include recommendations, intended to optimize patient care, that are informed by a systematic review of evidence and an assessment of the benefits and harms of alterna-tive care options.”18 Clinical guidelines may reflect previous published | Surgery_Schwartz. the systems for grading evidence are well devel-oped, it is important to remember that the studies used for evi-dence are judged based on their internal validity, or the extent to which a causal conclusion is warranted based upon applica-tion of the results to the study population. This means that care must be exercised when applying a recommendation to a given patient, as the external validity of a recommendation, or gener-alizability of a causal conclusion to populations outside of the scope of the original studies, may not be appropriate. Therefore, all evidence must be applied within the context of the patient in front of you.Synthesis of Evidence—Clinical GuidelinesThe Institute of Medicine defines a clinical guideline as “state-ments that include recommendations, intended to optimize patient care, that are informed by a systematic review of evidence and an assessment of the benefits and harms of alterna-tive care options.”18 Clinical guidelines may reflect previous published |
Surgery_Schwartz_13995 | Surgery_Schwartz | patient care, that are informed by a systematic review of evidence and an assessment of the benefits and harms of alterna-tive care options.”18 Clinical guidelines may reflect previous published studies of varying design and quality, as well as expert opinion, and often represent the highest level of applied clinical evidence. Numerous guidelines have been published; however, like individual studies, even guidelines can vary in quality. The highest quality and most clinically useful guide-lines tend to have the following qualities:4Brunicardi_Ch51_p2137-p2152.indd 214228/02/19 4:19 PM 2143UNDERSTANDING, EVALUATING, AND USING EVIDENCE FOR SURGICAL PRACTICECHAPTER 51Summary of findings:Compression stockings compared with no compression stockings for people taking long flightsPatients or population: Anyone taking a long flight (lasting more than 6 hours)Settings: International air travelIntervention: Compression stockings1Comparison: Without stockingsOutcomesIllustrative comparative | Surgery_Schwartz. patient care, that are informed by a systematic review of evidence and an assessment of the benefits and harms of alterna-tive care options.”18 Clinical guidelines may reflect previous published studies of varying design and quality, as well as expert opinion, and often represent the highest level of applied clinical evidence. Numerous guidelines have been published; however, like individual studies, even guidelines can vary in quality. The highest quality and most clinically useful guide-lines tend to have the following qualities:4Brunicardi_Ch51_p2137-p2152.indd 214228/02/19 4:19 PM 2143UNDERSTANDING, EVALUATING, AND USING EVIDENCE FOR SURGICAL PRACTICECHAPTER 51Summary of findings:Compression stockings compared with no compression stockings for people taking long flightsPatients or population: Anyone taking a long flight (lasting more than 6 hours)Settings: International air travelIntervention: Compression stockings1Comparison: Without stockingsOutcomesIllustrative comparative |
Surgery_Schwartz_13996 | Surgery_Schwartz | population: Anyone taking a long flight (lasting more than 6 hours)Settings: International air travelIntervention: Compression stockings1Comparison: Without stockingsOutcomesIllustrative comparative risks* (95% CI)Relativeeffect(95% CI)Number ofparticipants(studies)Qualityof theevidence(GRADE)Comments Assumed riskCorresponding riskWithout stockingsWith stockingsSymptomaticdeep vein thrombosis (DVT)See comment See comment Not estimable2821(9 studies)See comment0 participants developed symptomatic DVT in these studies.Symptom-lessdeep vein thrombosis Low risk population2RR 0.10(0.04 to 0.26) 2637(9 studies) ++++High10 per 10001 per 1000 (0 to 3)High risk population230 per 10003 per 1000(1 to 8)Superficial vein thrombosis13 per 10006 per 1000(2 to 15)RR 0.45(0.18 to 1.13)1804(8 studies)+++OModerate3 OedemaPost-flight values measured on a scale from 0, no oedema, to 10, maximum oedema.The mean oedema score ranged across control groups from6 to 9.The mean oedema score in the | Surgery_Schwartz. population: Anyone taking a long flight (lasting more than 6 hours)Settings: International air travelIntervention: Compression stockings1Comparison: Without stockingsOutcomesIllustrative comparative risks* (95% CI)Relativeeffect(95% CI)Number ofparticipants(studies)Qualityof theevidence(GRADE)Comments Assumed riskCorresponding riskWithout stockingsWith stockingsSymptomaticdeep vein thrombosis (DVT)See comment See comment Not estimable2821(9 studies)See comment0 participants developed symptomatic DVT in these studies.Symptom-lessdeep vein thrombosis Low risk population2RR 0.10(0.04 to 0.26) 2637(9 studies) ++++High10 per 10001 per 1000 (0 to 3)High risk population230 per 10003 per 1000(1 to 8)Superficial vein thrombosis13 per 10006 per 1000(2 to 15)RR 0.45(0.18 to 1.13)1804(8 studies)+++OModerate3 OedemaPost-flight values measured on a scale from 0, no oedema, to 10, maximum oedema.The mean oedema score ranged across control groups from6 to 9.The mean oedema score in the |
Surgery_Schwartz_13997 | Surgery_Schwartz | studies)+++OModerate3 OedemaPost-flight values measured on a scale from 0, no oedema, to 10, maximum oedema.The mean oedema score ranged across control groups from6 to 9.The mean oedema score in the intervention groups was on average4.7 lower(95% CI –4.9 to –4.5). 1246(6 studies)++OOLow4 Pulmonary embolusSee commentSee commentNot estimable2821(9 studies)See comment0 participants developed pulmonary embolus in these studies.5DeathSee commentSee commentNot estimable2821(9 studies)See comment0 participants died in these studies.Adverse effectsSee commentSee commentNot estimable1182(4 studies)See commentThe tolerability of the stockings was described as very good with no complaints of side effects in 4 studies.6*The basis for the assumed risk is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the intervention group and the relative effect of the intervention (and its 95% CI).CI: Confidence interval; RR: Risk ratio GRADE: | Surgery_Schwartz. studies)+++OModerate3 OedemaPost-flight values measured on a scale from 0, no oedema, to 10, maximum oedema.The mean oedema score ranged across control groups from6 to 9.The mean oedema score in the intervention groups was on average4.7 lower(95% CI –4.9 to –4.5). 1246(6 studies)++OOLow4 Pulmonary embolusSee commentSee commentNot estimable2821(9 studies)See comment0 participants developed pulmonary embolus in these studies.5DeathSee commentSee commentNot estimable2821(9 studies)See comment0 participants died in these studies.Adverse effectsSee commentSee commentNot estimable1182(4 studies)See commentThe tolerability of the stockings was described as very good with no complaints of side effects in 4 studies.6*The basis for the assumed risk is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the intervention group and the relative effect of the intervention (and its 95% CI).CI: Confidence interval; RR: Risk ratio GRADE: |
Surgery_Schwartz_13998 | Surgery_Schwartz | (and its 95% confidence interval) is based on the assumed risk in the intervention group and the relative effect of the intervention (and its 95% CI).CI: Confidence interval; RR: Risk ratio GRADE: GRADE Working Group grades of evidence (see explanations)11 All the stockings in the 9 trials included in this review were below-knee compression stockings. In four trials the compression strength was 20–30 mmHg at the ankle. It was 10–20 mmHg in the other four trials. Stockings come in different sizes. If a stocking is too tight around the knee it can prevent essential venous return causing the blood to pool around the knee. Compression stockings should be fitted properly. A stocking that is too tight could cut into the skin on a long flight and potentially cause ulceration and increased risk of DVT. Some stockings can be slightly thicker than normal leg covering and can be potentially restrictive with tight foot wear. It is a good idea to wear stockings around the house prior to travel to | Surgery_Schwartz. (and its 95% confidence interval) is based on the assumed risk in the intervention group and the relative effect of the intervention (and its 95% CI).CI: Confidence interval; RR: Risk ratio GRADE: GRADE Working Group grades of evidence (see explanations)11 All the stockings in the 9 trials included in this review were below-knee compression stockings. In four trials the compression strength was 20–30 mmHg at the ankle. It was 10–20 mmHg in the other four trials. Stockings come in different sizes. If a stocking is too tight around the knee it can prevent essential venous return causing the blood to pool around the knee. Compression stockings should be fitted properly. A stocking that is too tight could cut into the skin on a long flight and potentially cause ulceration and increased risk of DVT. Some stockings can be slightly thicker than normal leg covering and can be potentially restrictive with tight foot wear. It is a good idea to wear stockings around the house prior to travel to |
Surgery_Schwartz_13999 | Surgery_Schwartz | DVT. Some stockings can be slightly thicker than normal leg covering and can be potentially restrictive with tight foot wear. It is a good idea to wear stockings around the house prior to travel to ensure a good, comfortable fitting. Stockings were put on 2 to 3 hours before the flight in most of the trials. The availability and cost of stockings can vary.2Two trials recruited high risk participants defined as those with previous episodes of DVT, coagulation disorders, severe obesity, limited mobility due to bone or joint problems, neoplastic disease within the previous two years, large varicose veins or, in one of the studies, participants taller than 190 cm and heavier than 90 kg. The incidence for 7 trials that excluded high risk participants was 1.45% and the incidence for the 2 trials that recruited high-risk participants (with at least one risk factor) was 2.43%. We have rounded these off to 10 and 30 per 1000 respectively.3The confidence interval crosses no difference and does | Surgery_Schwartz. DVT. Some stockings can be slightly thicker than normal leg covering and can be potentially restrictive with tight foot wear. It is a good idea to wear stockings around the house prior to travel to ensure a good, comfortable fitting. Stockings were put on 2 to 3 hours before the flight in most of the trials. The availability and cost of stockings can vary.2Two trials recruited high risk participants defined as those with previous episodes of DVT, coagulation disorders, severe obesity, limited mobility due to bone or joint problems, neoplastic disease within the previous two years, large varicose veins or, in one of the studies, participants taller than 190 cm and heavier than 90 kg. The incidence for 7 trials that excluded high risk participants was 1.45% and the incidence for the 2 trials that recruited high-risk participants (with at least one risk factor) was 2.43%. We have rounded these off to 10 and 30 per 1000 respectively.3The confidence interval crosses no difference and does |
Surgery_Schwartz_14000 | Surgery_Schwartz | that recruited high-risk participants (with at least one risk factor) was 2.43%. We have rounded these off to 10 and 30 per 1000 respectively.3The confidence interval crosses no difference and does not rule out a small increase.4The measurement of oedema was not validated or blinded to the intervention. All of these studies were conducted by the same investigators.5If there are very few or no events and the number of participants is large, judgement about the quality of evidence (particularly judgements about precision) may be based on the absolute effect. Here the quality rating may be considered “high” if the outcome was appropriately assessed and the event, in fact, did not occur in 2821 studied participants.6None of the other trials reported adverse effects, apart from 4 cases of superficial vein thrombosis in varicose veins in the knee region that were compressed by the upper edge of the stocking in one trial.Figure 51-2. Example of a “summary of findings” | Surgery_Schwartz. that recruited high-risk participants (with at least one risk factor) was 2.43%. We have rounded these off to 10 and 30 per 1000 respectively.3The confidence interval crosses no difference and does not rule out a small increase.4The measurement of oedema was not validated or blinded to the intervention. All of these studies were conducted by the same investigators.5If there are very few or no events and the number of participants is large, judgement about the quality of evidence (particularly judgements about precision) may be based on the absolute effect. Here the quality rating may be considered “high” if the outcome was appropriately assessed and the event, in fact, did not occur in 2821 studied participants.6None of the other trials reported adverse effects, apart from 4 cases of superficial vein thrombosis in varicose veins in the knee region that were compressed by the upper edge of the stocking in one trial.Figure 51-2. Example of a “summary of findings” |
Surgery_Schwartz_14001 | Surgery_Schwartz | from 4 cases of superficial vein thrombosis in varicose veins in the knee region that were compressed by the upper edge of the stocking in one trial.Figure 51-2. Example of a “summary of findings” table.Brunicardi_Ch51_p2137-p2152.indd 214328/02/19 4:19 PM 2144SPECIFIC CONSIDERATIONSPART IITable 51-2Factors that affect the strength of a recommendationFACTOREXAMPLES OF STRONG RECOMMENDATIONSEXAMPLES OF WEAK RECOMMENDATIONSQuality of evidenceMany high quality randomized trials have shown the benefit of inhaled steroids in asthmaOnly case series have examined the utility of pleurodesis in pneumothoraxUncertainty about the balance between desirable and undesirable effectsAspirin in myocardial infarction reduces mortality with minimal toxicity, inconvenience, and costWarfarin in low risk patients with atrial fibrillation results in small stroke reduction but increased bleeding risk and substantial inconvenienceUncertainty or variability in values and preferencesYoung patients with | Surgery_Schwartz. from 4 cases of superficial vein thrombosis in varicose veins in the knee region that were compressed by the upper edge of the stocking in one trial.Figure 51-2. Example of a “summary of findings” table.Brunicardi_Ch51_p2137-p2152.indd 214328/02/19 4:19 PM 2144SPECIFIC CONSIDERATIONSPART IITable 51-2Factors that affect the strength of a recommendationFACTOREXAMPLES OF STRONG RECOMMENDATIONSEXAMPLES OF WEAK RECOMMENDATIONSQuality of evidenceMany high quality randomized trials have shown the benefit of inhaled steroids in asthmaOnly case series have examined the utility of pleurodesis in pneumothoraxUncertainty about the balance between desirable and undesirable effectsAspirin in myocardial infarction reduces mortality with minimal toxicity, inconvenience, and costWarfarin in low risk patients with atrial fibrillation results in small stroke reduction but increased bleeding risk and substantial inconvenienceUncertainty or variability in values and preferencesYoung patients with |
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