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Minimally invasive operative techniques: Is less always more?
ARTICLE IN PRESS
Minimally invasive operative techniques: Is less always more? Kyle H. Sheetz, MD, MS,a,b and Justin B. Dimick, MD, MPH,a,b Ann Arbor, MI
From the Center for Healthcare Outcomes and Policy,a Ann Arbor, MI; and Department of Surgery,b University of Michigan Medical School, Ann Arbor, MI
MINIMALLY INVASIVE OPERATIONS have transformed operative practice. The trend for surgeons to adopt these techniques is driven by many factors, such as improvements in patient safety compared with open operation. Whether laparoscopic procedures are always the safer option is a matter of debate. Although proficiency is not guaranteed, modern postgraduate surgical education, including subspecialty fellowships, is designed to produce surgeons well trained in laparoscopy. Many practicing surgeons completed residency long before these techniques were introduced. For those surgeons, opportunities to retrain are limited. Taking time out of a busy practice to “retool” is simply not a financial reality for many. Furthermore, postresident training is not standardized and consists of Continued Medical Education courses (eg, weekend seminars or courses at conferences) or proctoring by another surgeon. The implications of this ad hoc “on-the-job” learning are unclear. Hospital credentialing and surgeon privileging are safeguards against undertrained surgeons implementing complex minimally invasive approaches into practice. Training aside, it is important to recognize that financial pressures are placed on surgeons to adopt these techniques. Unfortunately, there is very little research to inform decisions about whether individual surgeons should be credentialed. Most existing literature asks a different question: Which approach, on average, is safer for patients included in the study? Studies fall short in understanding
There are no funding sources directly related to the content of this article. Accepted for publication October 25, 2016. Reprint requests: Kyle H. Sheetz, MD, MS, Center for Healthcare Outcomes and Policy, 2800 Plymouth Rd, Bldg 16, Flr. 1, Ann Arbor, MI 48109. E-mail: [email protected]. Surgery 2016;j:j-j. 0039-6060/$ - see front matter Ó 2016 Elsevier Inc. All rights reserved. http://dx.doi.org/10.1016/j.surg.2016.10.037
variation in safety across different providers. Unlike pharmacologic treatments where interventions are standardized across physicians, the effectiveness of an operation is never independent of the individual performing it. Consider the following examples intended to show how comparative effectiveness research in surgery is unique. Primary care doctors treat hypertension. They prescribe an evidence-based antihypertensive medication as initial therapy. The potential for this decision to lower blood pressure is based on several factors including dosage, patient biology, and medication compliance. After the decision about which intervention to prescribe, the physician cannot easily modify the clinical outcome. In contrast, consider surgeons treating resectable early stage colon cancer. Like primary care doctors, surgeons must choose what they think is the best intervention. Unlike the primary care doctors, the outcome from the operation a surgeon chooses to perform is influenced by many factors including their specific expertise performing that procedure. Most trials of laparoscopy do not address provider heterogeneity and can be potentially misleading in 2 specific ways. These trials may overlook the risks of the learning curve by including only expert surgeons. Several prominent studies examining laparoscopic operations for colon and rectal cancer found similar rates of cancer recurrence and long-term survival.1,2 These studies also observed lower rates of complications and perioperative mortality with laparoscopy. Surgeons included in these trials were selected for their experience in performing colorectal resections laparoscopically. It is understandable how these favorable data would motivate surgeons to adopt the seemingly safer laparoscopic approach. Trials also can be misleading when they include surgeons without significant expertise. The Veterans Administration inguinal hernia trial found recurrence rates to be greater in patients treated with minimally invasive repairs.3 However, a post hoc analysis stratified surgeons by overall SURGERY 1
ARTICLE IN PRESS 2 Sheetz and Dimick
Surgery j 2016 Odds Ratio (95% CI)
Complications
Lower risk with laparoscopic colectomy
Higher risk with laparoscopic colectomy
Top 25%
Surgeon Volume
Middle 50% Bottom 25%
Mortality
0.5
0.7
0.9
1.1
1.3
0.5
0.7
0.9
1.1
1.3
Top 25%
Surgeon Volume
Middle 50% Bottom 25%
Fig. Odds ratios for complications and mortality stratified by surgeon’s annual experience with laparoscopic colectomy. Adapted from Sheetz et al.4
experience with laparoscopic inguinal hernia repair. There were several important findings. Recurrence rates after laparoscopic repairs for the high-volume surgeons were significantly lower than those for the low-volume surgeons. The recurrence rates for high-volume surgeons were similar whether they performed the repair open or laparoscopically. Finally, they found no significant difference in recurrence rates after open repairs between the low- and high-volume laparoscopic surgeons. A recent study by our group in Health Services Research explicitly examined the relationship between comparative safety and provider experience after laparoscopic and open colectomy.4 The study uses national Medicare data, capturing a heterogeneous group of surgeons varying in their experience with laparoscopy. To reduce selection bias from patient factors, the analysis used instrumental variable methods. There are 2 important findings. First, consistent with the randomized trials, laparoscopic colectomy was on average safer than open operation. Second, the magnitude of this benefit is correlated with provider experience. In fact, patients going to low-volume laparoscopic surgeons actually had greater mortality and complication (Fig). This study suggests that we cannot assume laparoscopic operation is always the safest option. This editorial has implications for the design of clinical trials in operation. Investigators should
consider the experience required to achieve proficiency for all operations included in a clinical trial. The IDEAL (Idea, Development, Exploration, Assessment, Long-term) study recommendations published in Lancet in 2009 highlight several issues in assessing the effectiveness of new operative techniques.5 They advocate evaluating learning curves in the pretrial period in order to avoid misinterpretation of data related to differences in surgeon proficiency. They also endorse the use of observational data and advanced statistical techniques in cases where trials are not feasible. Although trials remain the gold standard for comparative effectiveness research, observational data may offer certain advantages in assessing post-trial effectiveness after a new technology has disseminated in to practice. This editorial also has implications for hospital credentialing committees. In many cases, credentialing is the final barrier for surgeons looking to incorporate new operations in to their practice. Because these decisions impact patient safety, the credentialing process should be more data driven. One option is to establish minimal volume criteria for specific operations. Last year, 3 academic medical centers announced the “Take the Volume Pledge.”6 This effort restricts certain procedures to hospitals and surgeons who perform more than a minimum number. The volume thresholds vary by procedure. However, as demonstrated by
ARTICLE IN PRESS Sheetz and Dimick 3
Surgery Volume j, Number j
the significant pushback against this pledge, there are substantial barriers to this practice. In its defense, volume data are widely available for most common operations, either through administrative databases or through professional societies (eg, the Society of Thoracic Surgeons) who already collect this information to increase transparency about outcomes for specific surgeons or hospitals. There are opportunities to be more precise. As an alternative, proficiency-based credentialing may be more precise. Evaluating operative videos to assess surgeon skill is one option.7 Although more labor intensive, this provides a direct measure of competency rather than relying on proxy measures such as procedural volume. This editorial highlights a novel observation about the relative safety of laparoscopic and open operation. For some surgeons, an open operation is actually safer, and this is fine. As a field, we should accept that volume standards alone are inadequate. Proficiency is the true target for evidence-based credentialing. The next step is to
understand how each new technology helps individual surgeons provide safe and effective care. REFERENCES 1. Bonjer HJ, Deijen CL, Abis GA, Cuesta MA, van der Pas MH, de Lange-de Klerk ES, et al. A randomized trial of laparoscopic versus open surgery for rectal cancer. New England J Med 2015;372:1324-32. 2. Clinical Outcomes of Surgical Therapy Study Group. A comparison of laparoscopically assisted and open colectomy for colon cancer. New England J Med 2004;350:2050-9. 3. Neumayer L, Giobbie-Hurder A, Jonasson O, Fitzgibbons R Jr, Dunlop D, Gibbs J, et al. Open mesh versus laparoscopic mesh repair of inguinal hernia. New England J Med 2004; 350:1819-27. 4. Sheetz KH, Norton EC, Birkmeyer JD, Dimick JB. Provider experience and the comparative safety of laparoscopic and open colectomy. Health Services Res 2016. 5. McCulloch P, Altman DG, Campbell WB, Flum DR, Glasziou P, Marshall JC, et al. No surgical innovation without evaluation: the IDEAL recommendations. Lancet 2009;374:1105-12. 6. Urbach DR. Pledging to eliminate low-volume surgery. New England J Med 2015;373:1388-90. 7. Birkmeyer JD, Finks JF, O’Reilly A, Oerline M, Carlin AM, Nunn AR, et al. Surgical skill and complication rates after bariatric surgery. New England J Med 2013;369:1434-42.
Minimally invasive operative techniques: Is less always more? Kyle H. Sheetz, MD, MS,a,b and Justin B. Dimick, MD, MPH,a,b Ann Arbor, MI
From the Center for Healthcare Outcomes and Policy,a Ann Arbor, MI; and Department of Surgery,b University of Michigan Medical School, Ann Arbor, MI
MINIMALLY INVASIVE OPERATIONS have transformed operative practice. The trend for surgeons to adopt these techniques is driven by many factors, such as improvements in patient safety compared with open operation. Whether laparoscopic procedures are always the safer option is a matter of debate. Although proficiency is not guaranteed, modern postgraduate surgical education, including subspecialty fellowships, is designed to produce surgeons well trained in laparoscopy. Many practicing surgeons completed residency long before these techniques were introduced. For those surgeons, opportunities to retrain are limited. Taking time out of a busy practice to “retool” is simply not a financial reality for many. Furthermore, postresident training is not standardized and consists of Continued Medical Education courses (eg, weekend seminars or courses at conferences) or proctoring by another surgeon. The implications of this ad hoc “on-the-job” learning are unclear. Hospital credentialing and surgeon privileging are safeguards against undertrained surgeons implementing complex minimally invasive approaches into practice. Training aside, it is important to recognize that financial pressures are placed on surgeons to adopt these techniques. Unfortunately, there is very little research to inform decisions about whether individual surgeons should be credentialed. Most existing literature asks a different question: Which approach, on average, is safer for patients included in the study? Studies fall short in understanding
There are no funding sources directly related to the content of this article. Accepted for publication October 25, 2016. Reprint requests: Kyle H. Sheetz, MD, MS, Center for Healthcare Outcomes and Policy, 2800 Plymouth Rd, Bldg 16, Flr. 1, Ann Arbor, MI 48109. E-mail: [email protected]. Surgery 2016;j:j-j. 0039-6060/$ - see front matter Ó 2016 Elsevier Inc. All rights reserved. http://dx.doi.org/10.1016/j.surg.2016.10.037
variation in safety across different providers. Unlike pharmacologic treatments where interventions are standardized across physicians, the effectiveness of an operation is never independent of the individual performing it. Consider the following examples intended to show how comparative effectiveness research in surgery is unique. Primary care doctors treat hypertension. They prescribe an evidence-based antihypertensive medication as initial therapy. The potential for this decision to lower blood pressure is based on several factors including dosage, patient biology, and medication compliance. After the decision about which intervention to prescribe, the physician cannot easily modify the clinical outcome. In contrast, consider surgeons treating resectable early stage colon cancer. Like primary care doctors, surgeons must choose what they think is the best intervention. Unlike the primary care doctors, the outcome from the operation a surgeon chooses to perform is influenced by many factors including their specific expertise performing that procedure. Most trials of laparoscopy do not address provider heterogeneity and can be potentially misleading in 2 specific ways. These trials may overlook the risks of the learning curve by including only expert surgeons. Several prominent studies examining laparoscopic operations for colon and rectal cancer found similar rates of cancer recurrence and long-term survival.1,2 These studies also observed lower rates of complications and perioperative mortality with laparoscopy. Surgeons included in these trials were selected for their experience in performing colorectal resections laparoscopically. It is understandable how these favorable data would motivate surgeons to adopt the seemingly safer laparoscopic approach. Trials also can be misleading when they include surgeons without significant expertise. The Veterans Administration inguinal hernia trial found recurrence rates to be greater in patients treated with minimally invasive repairs.3 However, a post hoc analysis stratified surgeons by overall SURGERY 1
ARTICLE IN PRESS 2 Sheetz and Dimick
Surgery j 2016 Odds Ratio (95% CI)
Complications
Lower risk with laparoscopic colectomy
Higher risk with laparoscopic colectomy
Top 25%
Surgeon Volume
Middle 50% Bottom 25%
Mortality
0.5
0.7
0.9
1.1
1.3
0.5
0.7
0.9
1.1
1.3
Top 25%
Surgeon Volume
Middle 50% Bottom 25%
Fig. Odds ratios for complications and mortality stratified by surgeon’s annual experience with laparoscopic colectomy. Adapted from Sheetz et al.4
experience with laparoscopic inguinal hernia repair. There were several important findings. Recurrence rates after laparoscopic repairs for the high-volume surgeons were significantly lower than those for the low-volume surgeons. The recurrence rates for high-volume surgeons were similar whether they performed the repair open or laparoscopically. Finally, they found no significant difference in recurrence rates after open repairs between the low- and high-volume laparoscopic surgeons. A recent study by our group in Health Services Research explicitly examined the relationship between comparative safety and provider experience after laparoscopic and open colectomy.4 The study uses national Medicare data, capturing a heterogeneous group of surgeons varying in their experience with laparoscopy. To reduce selection bias from patient factors, the analysis used instrumental variable methods. There are 2 important findings. First, consistent with the randomized trials, laparoscopic colectomy was on average safer than open operation. Second, the magnitude of this benefit is correlated with provider experience. In fact, patients going to low-volume laparoscopic surgeons actually had greater mortality and complication (Fig). This study suggests that we cannot assume laparoscopic operation is always the safest option. This editorial has implications for the design of clinical trials in operation. Investigators should
consider the experience required to achieve proficiency for all operations included in a clinical trial. The IDEAL (Idea, Development, Exploration, Assessment, Long-term) study recommendations published in Lancet in 2009 highlight several issues in assessing the effectiveness of new operative techniques.5 They advocate evaluating learning curves in the pretrial period in order to avoid misinterpretation of data related to differences in surgeon proficiency. They also endorse the use of observational data and advanced statistical techniques in cases where trials are not feasible. Although trials remain the gold standard for comparative effectiveness research, observational data may offer certain advantages in assessing post-trial effectiveness after a new technology has disseminated in to practice. This editorial also has implications for hospital credentialing committees. In many cases, credentialing is the final barrier for surgeons looking to incorporate new operations in to their practice. Because these decisions impact patient safety, the credentialing process should be more data driven. One option is to establish minimal volume criteria for specific operations. Last year, 3 academic medical centers announced the “Take the Volume Pledge.”6 This effort restricts certain procedures to hospitals and surgeons who perform more than a minimum number. The volume thresholds vary by procedure. However, as demonstrated by
ARTICLE IN PRESS Sheetz and Dimick 3
Surgery Volume j, Number j
the significant pushback against this pledge, there are substantial barriers to this practice. In its defense, volume data are widely available for most common operations, either through administrative databases or through professional societies (eg, the Society of Thoracic Surgeons) who already collect this information to increase transparency about outcomes for specific surgeons or hospitals. There are opportunities to be more precise. As an alternative, proficiency-based credentialing may be more precise. Evaluating operative videos to assess surgeon skill is one option.7 Although more labor intensive, this provides a direct measure of competency rather than relying on proxy measures such as procedural volume. This editorial highlights a novel observation about the relative safety of laparoscopic and open operation. For some surgeons, an open operation is actually safer, and this is fine. As a field, we should accept that volume standards alone are inadequate. Proficiency is the true target for evidence-based credentialing. The next step is to
understand how each new technology helps individual surgeons provide safe and effective care. REFERENCES 1. Bonjer HJ, Deijen CL, Abis GA, Cuesta MA, van der Pas MH, de Lange-de Klerk ES, et al. A randomized trial of laparoscopic versus open surgery for rectal cancer. New England J Med 2015;372:1324-32. 2. Clinical Outcomes of Surgical Therapy Study Group. A comparison of laparoscopically assisted and open colectomy for colon cancer. New England J Med 2004;350:2050-9. 3. Neumayer L, Giobbie-Hurder A, Jonasson O, Fitzgibbons R Jr, Dunlop D, Gibbs J, et al. Open mesh versus laparoscopic mesh repair of inguinal hernia. New England J Med 2004; 350:1819-27. 4. Sheetz KH, Norton EC, Birkmeyer JD, Dimick JB. Provider experience and the comparative safety of laparoscopic and open colectomy. Health Services Res 2016. 5. McCulloch P, Altman DG, Campbell WB, Flum DR, Glasziou P, Marshall JC, et al. No surgical innovation without evaluation: the IDEAL recommendations. Lancet 2009;374:1105-12. 6. Urbach DR. Pledging to eliminate low-volume surgery. New England J Med 2015;373:1388-90. 7. Birkmeyer JD, Finks JF, O’Reilly A, Oerline M, Carlin AM, Nunn AR, et al. Surgical skill and complication rates after bariatric surgery. New England J Med 2013;369:1434-42.