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Commentary and Perspective   |    
A Wake-up Call on the Hazards of Regulatory Mandates in Orthopaedic SurgeryCommentary on an article by Zhong Wang, PhD, MPH, et al.: “Compliance with Surgical Care Improvement Project Measures and Hospital-Associated Infections Following Hip Arthroplasty”
B. Sonny Bal, MD, JD, MBA
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This article was chosen to appear electronically on June 27, 2012, before publication of the final, definitive version.



Disclosure: The author did not receive payments or services, either directly or indirectly (i.e., via his institution), from a third party in support of any aspect of this work. He, or his institution, has had a financial relationship, in the thirty-six months prior to submission of this work, with an entity in the biomedical arena that could be perceived to influence or have the potential to influence what is written in this work. The author has not had any other relationships, or engaged in any other activities, that could be perceived to influence or have the potential to influence what is written in this work. The complete Disclosures of Potential Conflicts of Interest submitted by authors are always provided with the online version of the article.

Copyright © 2012 by The Journal of Bone and Joint Surgery, Inc.
J Bone Joint Surg Am, 2012 Aug 01;94(15):e116 1-2. doi: 10.2106/JBJS.L.00638
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Dr. Wang and colleagues have addressed a timely topic that is of interest to orthopaedic surgeons, i.e., the impact of compliance with SCIP (Surgical Care Improvement Project) performance guidelines relating to infection prevention and venous thromboembolism (VTE) prophylaxis after arthroplasty. The authors examined data on 17,714 total hip arthroplasties at 128 New York state hospitals performed during the year 2008, and during the time when hospitals were at risk of losing payments for what the Centers for Medicare and Medicaid Services determined to be certain reasonably preventable events (such as VTE and surgical site infection) after arthroplasty. The authors found that, in response to the threat of payment cuts, hospital compliance with SCIP guidelines increased from levels of just over 90% to nearly 100%.
Increased compliance with SCIP infection prevention guidelines did not lead to reductions in infection outcomes following hip replacement. Of concern, however, was the finding that increased compliance with VTE prophylaxis was associated with a higher risk of surgical site infections. In other words, mandating a complete compliance with SCIP VTE prevention measures resulted in unintended consequences related to increased infections following hip replacement. To put it bluntly, increased compliance with SCIP VTE-2 measures that require timely application of chemoprophylactic agents, such as warfarin, low-molecular-weight heparin, or factor Xa inhibitor, ended up hurting patients, with no demonstrable benefit.
The reasoning behind this unintended cross-measure effect will be familiar to arthroplasty surgeons. The etiological relationship between aggressive administration of low-molecular-weight heparin and the ensuing risk of surgical site infection is well known1. Low-molecular-weight heparin addresses the risk of nonfatal VTE, albeit at the risk of hematoma formation2. Finally, as arthroplasty surgeons will recognize, postoperative hematoma formation, wound drainage, and a mean international normalized ratio of >1.5 are important risk factors for periprosthetic infection3. In response to external pressures to change professional behaviors, surgeons most likely switched from warfarin to low-molecular-weight heparin and/or changed the timing of VTE prophylaxis to ensure compliance with SCIP VTE-2 measures. These changes have been shown to lead to an increased risk of bleeding episodes that, not surprisingly, might end up with more infections.
The findings of this paper are both interesting and disturbing. At the least, these data should be disseminated widely among surgeons, hospitalists, compliance staff, and most importantly, the public whose health is at issue. Apparently, strict compliance with the SCIP VTE and infection guidelines led to patient injury, with no evidence of benefit in terms of reduced infection or blood clot risk after hip replacement. With the increased focus on data collection in our health-care system, facilitated in part by the electronic medical record systems, more such investigations will hopefully be forthcoming. The authors acknowledged some key limitations of their work, e.g., that their study was based on examining a large body of administrative data limited to one geographic area. Nonetheless, the striking finding is consistent with what common sense and reasonable logic from orthopaedic clinicians would have predicted—namely, that aggressive and early anticoagulation leads to bleeding and infections after major joint replacement surgery.
Phrased differently, this study shows that compliance with the SCIP VTE-2 measures is harmful to patients, and that in order to reduce the risk of infection after total hip surgery, it might pay to be less compliant with SCIP guidelines than to be overly compliant. While administrative data may or may not accurately capture the nuances of clinical practice, this study is a wake-up call as an example of what can happen when centralized bureaucratic intermeddling with the practice of medicine results in strict mandates and strictures that alter the behavior of trained and experienced clinicians.
The limitations of this analysis are properly acknowledged by the authors, and I commend this study for shedding some light on the misguided orgy of regulatory mandates that are washing down on orthopaedic surgeons. This is an interesting paper that will be read by JBJS readers, but in truth, it should be required reading for those who devised the SCIP guidelines. Most importantly, this paper should be released to the public who can judge the relative value of centralized mandates that purportedly increase public safety.
Burnett  RS;  Clohisy  JC;  Wright  RW;  McDonald  DJ;  Shively  RA;  Givens  SA;  Barrack  RL. Failure of the American College of Chest Physicians-1A protocol for Lovenox in clinical outcomes for thromboembolic prophylaxis. J Arthroplasty.  2007  Apr;22(  3):317-24.[PubMed][CrossRef]
 
Tasker  A;  Harbord  R;  Bannister  GC. Meta-analysis of low molecular weight heparin versus placebo in patients undergoing total hip replacement and post-operative morbidity and mortality since their introduction. Hip Int.  2010  Jan-Mar;20(  1):64-74.[PubMed]
 
Parvizi  J;  Ghanem  E;  Joshi  A;  Sharkey  PF;  Hozack  WJ;  Rothman  RH. Does “excessive” anticoagulation predispose to periprosthetic infection?J Arthroplasty.  2007  Sep;22(  6 Suppl 2):24-8.  Epub 2007 Jul 26.[PubMed][CrossRef]
 

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References

Burnett  RS;  Clohisy  JC;  Wright  RW;  McDonald  DJ;  Shively  RA;  Givens  SA;  Barrack  RL. Failure of the American College of Chest Physicians-1A protocol for Lovenox in clinical outcomes for thromboembolic prophylaxis. J Arthroplasty.  2007  Apr;22(  3):317-24.[PubMed][CrossRef]
 
Tasker  A;  Harbord  R;  Bannister  GC. Meta-analysis of low molecular weight heparin versus placebo in patients undergoing total hip replacement and post-operative morbidity and mortality since their introduction. Hip Int.  2010  Jan-Mar;20(  1):64-74.[PubMed]
 
Parvizi  J;  Ghanem  E;  Joshi  A;  Sharkey  PF;  Hozack  WJ;  Rothman  RH. Does “excessive” anticoagulation predispose to periprosthetic infection?J Arthroplasty.  2007  Sep;22(  6 Suppl 2):24-8.  Epub 2007 Jul 26.[PubMed][CrossRef]
 
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Philip R Hardy MD
Posted on August 07, 2012
Misdirected mandates - an innocent error or something more sinister
Jacksonville Orthopaedic Institute

The fact that aggressive anticoagulation leads to increased bleeding events and subsequent increased incidence of infections is no surprise to those of us that actually take care of patients. The fact that the incidence of fatal pulmonary embolism has thus far never been decreased by any form of intervention remains unchanged. Since aggressive anticoagulation clearly increases the cost of care without proven benefit, one must wonder what was the motivation to pass such a mandate in the first place. Maybe I'm just a skeptic, but the money flows from the pharmaceutical companies to the people in Washington, and since they both stand to profit from such legislation, I believe that's the purpose. I would be interested to see if someone can prove me wrong.

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