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Antibiotic prophylaxis for severe acute pancreatitis
556
The American Journal of Surgery, Vol 203, No 4, April 2012
Assumed as standard of care, the mesh placement distorted the fundamental principles of surgery, and shifted inguinal hernia from a disease itself to a risk factor. Surgery of inguinal hernia is in fact becoming surgery of prevention of complications from mesh placement, forgetting that the mesh itself is the main complication of the hernia surgery. Surgery remains an art technically based on 4 principles: what is united is separated (dieresis); what is separated is united (synthesis); what is exceeding is removed (exeresis); and what is missed is added (prosthesis). The use of prosthetic materials has thus its main indication in case of lack of tissue to prevent recurrence. Bassini, following these basic principles, showed that in most patients this lack of tissue is only apparent, and that surgery of hernia is a surgery of synthesis and not of prosthesis. He showed that the mobilization and the use of the musculoaponeurotic triple layer for the repair is sufficient and effective.3,4 His astonishing results (2% of recurrences) 100 years ago show the way of the future and offer a valid alternative to the use of mesh. With this indiscriminate use of prosthetic materials arises also an important bioethical problem. The goal of medicine is beneficence. The first step to reach this goal is “primum non nocere” (nonmaleficence).5 It is also well known that there are several situations in medicine where decisions cannot be made without the risk of inflicting some burden to patients. This does not seem to be the case with inguinal hernioplasty. In fact, most of the procedures can be performed with cooptation of viable tissue (synthesis) without the insertion of a foreign body (prosthesis). Unfortunately, it seems that many surgeons have forgotten the surgical principles of Parè, thus failing to reach the real goal at stake: the good of the patient.
M. Tuveri, M.D. Department of General Surgery S. Elena Clinic Quartu S. Elena, Italy R. Demontis, M.D. Department of Legal Medicine University of Cagliari Cagliari, Italy E. Nicolò, M.D., F.A.C.S. Department of General Surgery Jefferson Regional Medical Center, Pittsburgh, PA, USA S. Pisu, M.D., Ph.D. Department of Legal Medicine University of Cagliari, Cagliari, Italy doi:10.1016/j.amjsurg.2009.10.031
References 1. Danto LA. Inguinodynia and ilioinguinal neurectomy. Am J Surg 2008 [Epub ahead of print]. 2. Klinge U, Krones CJ. Can we sure that the meshes do improve the recurrence rate? Hernia 2005;9:1–2. 3. Bassini E. New operative method for the cure of inguinal hernia. Woodbury: Cyné-Med, Inc; 2008. 4. Nicolò E, Bassini E. Procedure for the Radical Cure of Inguinal Hernia. Woodbury: Cyné-Med, Inc; 2008. 5. Pellegrino E, Thomasma DC. For the patient’s good. New York: Oxford University Press; 1988.
Antibiotic prophylaxis for severe acute pancreatitis To the Editor: 1
Jafri et al, in a recent meta-analysis of antibiotic prophylaxis for severe acute pancreatitis, concluded that, “The present meta-analysis presents conclusive evidence that antibiotic prophylaxis for SAP is not beneficial in protecting against infected necrosis, surgical intervention, or reducing mortality” (p. 812). This conclusion rests on a basic error in statistical reasoning, with potential consequences that could seriously disadvantage patients. This is despite the evident care with which the authors have executed their literature search and analysis. The authors base their claim on summary risk ratio estimates of .79 (95% confidence interval [CI], .56 –1.11) for infected necrosis, .88 (95% CI, .65–1.20) for surgical intervention, and .76 (95% CI, .49 –1.16) for mortality. Thus, the estimated effect of antibiotic prophylaxis based on the aggregated data is a 24% mortality reduction. Moreover, under the usual interpretation of a confidence interval, these aggregated data are reasonably compatible with any effect
between a 51% mortality reduction and a 16% mortality increase. Data that show a 24% mortality reduction and are compatible with a mortality reduction up to 51% can hardly be said to exclude benefit. Jafri et al1 cited small sample sizes and wide confidence intervals of the individual studies as limitations of the trials they aggregated and of their meta-analytic sensitivity analyses. The identical caveat applies to the summary results for each of these end points. That the component studies are individually too small to reach a conclusion does not imply that their aggregation is sufficiently large. As an example, the estimated 24% mortality reduction reflects 16% mortality among 249 controls and 12% mortality among 253 patients receiving prophylactic antibiotic, equivalent to an N-to-treat of 26 patients per life saved if the estimated effect is real. The power of a 2-arm randomized trial of this size to detect such a reduction would be 23.6% for a 2-sided test based on the Pearson chi-squared statistic, and 34.2% for a 1-sided test. To achieve 80% power for a 2-sided test in these circumstances
Letters to the Editor would require 2,574 patients (SAS version 9.2 PROC POWER, SAS Institute, Inc, Cary, NC). Unless component studies were prospectively designed for this purpose, which did not occur here, the power of a meta-analysis should not substantially exceed the power of a single study of the same number of patients. The corresponding sample size for a 50% reduction is 516, about the number present in the meta-analysis, for which a 50% reduction is just inside the corresponding reported confidence interval. Thus, at most, the data provide justification for a claim that accumulated data are not consistent with a mortality reduction beyond 50%. More evidence is needed for a stronger conclusion. Physicians inclined to provide empiric antibiotic coverage of patients with severe acute pancreatitis should not refrain from doing so based on this meta-analysis. Far from being dispositive against antibiotic prophylaxis, the reported data show nonsignificant trends toward benefits for overall mortality, infected necrosis, and surgical intervention. The fundamental nature of the statistical error represented by the published conclusion, and the poten-
557 tial implications of this error for clinicians and their patients if antibiotic coverage is indeed protective, exemplify the need for improved statistical training of medical researchers and vigilance as to statistical matters by influential medical journals. Peter B. Imrey, Ph.D. Department of Quantitative Health Sciences Cleveland Clinic Foundation Cleveland, OH Ryan Law, D.O. Department of Internal Medicine Cleveland Clinic Foundation Cleveland, OH doi:10.1016/j.amjsurg.2009.12.007
Reference 1. Jafri NS, Subal SM, Idstein MR, et al. Am J Surg 2009;197:806 –13.
Is it time for the American College of Surgeons to air its “dirty laundry”? To the Editor: I read with interest the editorial opinion of Drs Butler, Longaker, and Britt regarding the paucity of underrepresented minorities (URMs) in academic surgery and their proposal to incorporate the so-called “Rooney Rule” (the mandate by the National Football League [NFL] to interview at least 1 URM for any opening for head coach) to increase the numbers of URM in academic surgical faculty positions.1 When the Rooney Rule was adopted by the NFL in 2002, I believed that it would only lead to token interviews for URMs (often the same few candidates) and have little effect on hiring practices; however, it has been an unqualified success as documented by the authors (increase in African-American NFL head coaches from 6% in 2002 to 22% in 2006). The “Augusta Rule” coined by the authors is an excellent idea and should certainly be part of ongoing efforts to increase the numbers of URMs in academic surgical faculty positions. Increasing the numbers of URMs in medical schools and surgical residencies is also critical as are attempts to increase graduation rates in secondary education and college enrollment/graduation of URMs (the so-called pipeline effect). All of these efforts are necessary to overcome longstanding discriminatory practices recently outlined by a panel of experts convened and supported by the American Medical Association (AMA) in 2008.2 The resulting publication detailed racist policies going back to the inception of the AMA and that existed throughout organized medicine for over a century. These policies effectively excluded URMs from these societies, which spawned alternative organizations for URMs such as the Na-
tional Medical Association. Ronald M. Davis, immediate pastpresident of the AMA (in 2008) acknowledged the “stain left by a legacy of discrimination” and offered a public apology from the AMA to demonstrate the “current moral orientation of the organization” and to set a path to correct the inequities that have resulted from these discriminatory policies.3 The AMA should be commended for publicly airing its “dirty laundry” and finally taking responsibility for aiding, abetting and instigating discrimination within the medical profession and US society. Dr Britt, as incoming president of the American College of Surgeons (ACS), is it time for similar scrutiny of ACS membership policies of the past with publication and public apology for any discriminatory practices/policies that are revealed? William C. Cirocco, M.D., F.A.C.S. Shawnee Mission, KS doi:10.1016/j.amjsurg.2010.03.005
References 1. Butler PD, Longaker MT, Britt LD. Editorial opinion: addressing the paucity of underrepresented minorities in academic surgery: can the “Rooney Rule” be applied to academic surgery?. Am J Surg 2010;199: 255– 62. 2. Baker RB, Washington HA, Olakanmi O, et al. African American physicians and organized medicine, 1846 –1968: origins of a racial divide. JAMA 2008;300:306 –14. 3. Davis RM. Achieving racial harmony for the benefit of patients and communities: contrition, reconciliation, and collaboration. JAMA 2008;300:323–25.
The American Journal of Surgery, Vol 203, No 4, April 2012
Assumed as standard of care, the mesh placement distorted the fundamental principles of surgery, and shifted inguinal hernia from a disease itself to a risk factor. Surgery of inguinal hernia is in fact becoming surgery of prevention of complications from mesh placement, forgetting that the mesh itself is the main complication of the hernia surgery. Surgery remains an art technically based on 4 principles: what is united is separated (dieresis); what is separated is united (synthesis); what is exceeding is removed (exeresis); and what is missed is added (prosthesis). The use of prosthetic materials has thus its main indication in case of lack of tissue to prevent recurrence. Bassini, following these basic principles, showed that in most patients this lack of tissue is only apparent, and that surgery of hernia is a surgery of synthesis and not of prosthesis. He showed that the mobilization and the use of the musculoaponeurotic triple layer for the repair is sufficient and effective.3,4 His astonishing results (2% of recurrences) 100 years ago show the way of the future and offer a valid alternative to the use of mesh. With this indiscriminate use of prosthetic materials arises also an important bioethical problem. The goal of medicine is beneficence. The first step to reach this goal is “primum non nocere” (nonmaleficence).5 It is also well known that there are several situations in medicine where decisions cannot be made without the risk of inflicting some burden to patients. This does not seem to be the case with inguinal hernioplasty. In fact, most of the procedures can be performed with cooptation of viable tissue (synthesis) without the insertion of a foreign body (prosthesis). Unfortunately, it seems that many surgeons have forgotten the surgical principles of Parè, thus failing to reach the real goal at stake: the good of the patient.
M. Tuveri, M.D. Department of General Surgery S. Elena Clinic Quartu S. Elena, Italy R. Demontis, M.D. Department of Legal Medicine University of Cagliari Cagliari, Italy E. Nicolò, M.D., F.A.C.S. Department of General Surgery Jefferson Regional Medical Center, Pittsburgh, PA, USA S. Pisu, M.D., Ph.D. Department of Legal Medicine University of Cagliari, Cagliari, Italy doi:10.1016/j.amjsurg.2009.10.031
References 1. Danto LA. Inguinodynia and ilioinguinal neurectomy. Am J Surg 2008 [Epub ahead of print]. 2. Klinge U, Krones CJ. Can we sure that the meshes do improve the recurrence rate? Hernia 2005;9:1–2. 3. Bassini E. New operative method for the cure of inguinal hernia. Woodbury: Cyné-Med, Inc; 2008. 4. Nicolò E, Bassini E. Procedure for the Radical Cure of Inguinal Hernia. Woodbury: Cyné-Med, Inc; 2008. 5. Pellegrino E, Thomasma DC. For the patient’s good. New York: Oxford University Press; 1988.
Antibiotic prophylaxis for severe acute pancreatitis To the Editor: 1
Jafri et al, in a recent meta-analysis of antibiotic prophylaxis for severe acute pancreatitis, concluded that, “The present meta-analysis presents conclusive evidence that antibiotic prophylaxis for SAP is not beneficial in protecting against infected necrosis, surgical intervention, or reducing mortality” (p. 812). This conclusion rests on a basic error in statistical reasoning, with potential consequences that could seriously disadvantage patients. This is despite the evident care with which the authors have executed their literature search and analysis. The authors base their claim on summary risk ratio estimates of .79 (95% confidence interval [CI], .56 –1.11) for infected necrosis, .88 (95% CI, .65–1.20) for surgical intervention, and .76 (95% CI, .49 –1.16) for mortality. Thus, the estimated effect of antibiotic prophylaxis based on the aggregated data is a 24% mortality reduction. Moreover, under the usual interpretation of a confidence interval, these aggregated data are reasonably compatible with any effect
between a 51% mortality reduction and a 16% mortality increase. Data that show a 24% mortality reduction and are compatible with a mortality reduction up to 51% can hardly be said to exclude benefit. Jafri et al1 cited small sample sizes and wide confidence intervals of the individual studies as limitations of the trials they aggregated and of their meta-analytic sensitivity analyses. The identical caveat applies to the summary results for each of these end points. That the component studies are individually too small to reach a conclusion does not imply that their aggregation is sufficiently large. As an example, the estimated 24% mortality reduction reflects 16% mortality among 249 controls and 12% mortality among 253 patients receiving prophylactic antibiotic, equivalent to an N-to-treat of 26 patients per life saved if the estimated effect is real. The power of a 2-arm randomized trial of this size to detect such a reduction would be 23.6% for a 2-sided test based on the Pearson chi-squared statistic, and 34.2% for a 1-sided test. To achieve 80% power for a 2-sided test in these circumstances
Letters to the Editor would require 2,574 patients (SAS version 9.2 PROC POWER, SAS Institute, Inc, Cary, NC). Unless component studies were prospectively designed for this purpose, which did not occur here, the power of a meta-analysis should not substantially exceed the power of a single study of the same number of patients. The corresponding sample size for a 50% reduction is 516, about the number present in the meta-analysis, for which a 50% reduction is just inside the corresponding reported confidence interval. Thus, at most, the data provide justification for a claim that accumulated data are not consistent with a mortality reduction beyond 50%. More evidence is needed for a stronger conclusion. Physicians inclined to provide empiric antibiotic coverage of patients with severe acute pancreatitis should not refrain from doing so based on this meta-analysis. Far from being dispositive against antibiotic prophylaxis, the reported data show nonsignificant trends toward benefits for overall mortality, infected necrosis, and surgical intervention. The fundamental nature of the statistical error represented by the published conclusion, and the poten-
557 tial implications of this error for clinicians and their patients if antibiotic coverage is indeed protective, exemplify the need for improved statistical training of medical researchers and vigilance as to statistical matters by influential medical journals. Peter B. Imrey, Ph.D. Department of Quantitative Health Sciences Cleveland Clinic Foundation Cleveland, OH Ryan Law, D.O. Department of Internal Medicine Cleveland Clinic Foundation Cleveland, OH doi:10.1016/j.amjsurg.2009.12.007
Reference 1. Jafri NS, Subal SM, Idstein MR, et al. Am J Surg 2009;197:806 –13.
Is it time for the American College of Surgeons to air its “dirty laundry”? To the Editor: I read with interest the editorial opinion of Drs Butler, Longaker, and Britt regarding the paucity of underrepresented minorities (URMs) in academic surgery and their proposal to incorporate the so-called “Rooney Rule” (the mandate by the National Football League [NFL] to interview at least 1 URM for any opening for head coach) to increase the numbers of URM in academic surgical faculty positions.1 When the Rooney Rule was adopted by the NFL in 2002, I believed that it would only lead to token interviews for URMs (often the same few candidates) and have little effect on hiring practices; however, it has been an unqualified success as documented by the authors (increase in African-American NFL head coaches from 6% in 2002 to 22% in 2006). The “Augusta Rule” coined by the authors is an excellent idea and should certainly be part of ongoing efforts to increase the numbers of URMs in academic surgical faculty positions. Increasing the numbers of URMs in medical schools and surgical residencies is also critical as are attempts to increase graduation rates in secondary education and college enrollment/graduation of URMs (the so-called pipeline effect). All of these efforts are necessary to overcome longstanding discriminatory practices recently outlined by a panel of experts convened and supported by the American Medical Association (AMA) in 2008.2 The resulting publication detailed racist policies going back to the inception of the AMA and that existed throughout organized medicine for over a century. These policies effectively excluded URMs from these societies, which spawned alternative organizations for URMs such as the Na-
tional Medical Association. Ronald M. Davis, immediate pastpresident of the AMA (in 2008) acknowledged the “stain left by a legacy of discrimination” and offered a public apology from the AMA to demonstrate the “current moral orientation of the organization” and to set a path to correct the inequities that have resulted from these discriminatory policies.3 The AMA should be commended for publicly airing its “dirty laundry” and finally taking responsibility for aiding, abetting and instigating discrimination within the medical profession and US society. Dr Britt, as incoming president of the American College of Surgeons (ACS), is it time for similar scrutiny of ACS membership policies of the past with publication and public apology for any discriminatory practices/policies that are revealed? William C. Cirocco, M.D., F.A.C.S. Shawnee Mission, KS doi:10.1016/j.amjsurg.2010.03.005
References 1. Butler PD, Longaker MT, Britt LD. Editorial opinion: addressing the paucity of underrepresented minorities in academic surgery: can the “Rooney Rule” be applied to academic surgery?. Am J Surg 2010;199: 255– 62. 2. Baker RB, Washington HA, Olakanmi O, et al. African American physicians and organized medicine, 1846 –1968: origins of a racial divide. JAMA 2008;300:306 –14. 3. Davis RM. Achieving racial harmony for the benefit of patients and communities: contrition, reconciliation, and collaboration. JAMA 2008;300:323–25.