Jeffrey Parks MD FACS
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30 Day Mortality a Bad Indicator of Quality?

3/3/2015

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Today in the NY Times there is an article questioning the utility of the 30 day mortality as a valid quality metric in cardiac surgery.  In some states, hospitals are required by law to publicly report 30 day mortality rates after cardiac procedures like valve replacement and coronary bypass grafting.  The article presents a case study wherein a 94 year old patient underwent aortic valve replacement and, unsurprisingly, suffers multiple post operative setbacks and complications.  Ultimately, discussions of palliative care and withdrawal of aggressive support were delayed until she reached the magical 30 day milestone.  On day 31, she was made DNR and expired shortly thereafter.  

The article makes valid critical points about the arbitrary nature of "30 day mortality rates".  Specifically, that surgeons may be reluctant to pursue aggressive care in certain patients for fear of hurting their "stats".  In addition, there is a real concern that palliative/hospice care may be delayed even when it becomes obvious that the situation is futile, thereby subjecting the patient to weeks of unnecessary suffering hooked up to ventilators in an ICU.  

These are good points.  But the lede has been buried.

The real question ought to be:  "Why the hell would you perform aortic valve replacement on a 94 year old patient?"   Simply choose to not put such a patient on the operating table and you don't have to worry about keeping her alive for 30 days.  And if surgeons feel increasingly dissuaded from performing high risk surgery on poor surgical candidates, then so be it.  Maybe that wouldn't be such a bad thing.  I like the idea of total transparency in surgery.  I like published mortality rates.  I like the idea of comparing hospitals using hard cold data.  And I think Americans ought to have a right to  access information that may impact decision making in terms of where an operation is performed.  This ought not to be all that controversial....
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Diverting a Pelvic Anastomosis: Should it be routine?

2/10/2015

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JACS this month has a solid study from Japan on the use of diverting stomas in the setting of rectal cancer.  This was a prospective, multicenter cohort study of 936 patients who underwent low anterior resection (LAR) for rectal tumors within 10 cm of the anal verge.  The results were as follows:

...overall rate of symptomatic AL was 13.2% (52 of 394) in patients with DS vs 12.7% (69 of 542) in cases without DS (p = 0.84). Symptomatic AL requiring re-laparotomy occurred in 4.7% (44 of 936) of all patients, occurring in 1.0% (4 of 394) of patients with DS vs 7.4% (40 of 542) of patients without DS (p < 0.001). After PSM, the 2 groups were nearly balanced, and the incidence rates of symptomatic AL in patients with and without DS were 10.9% and 15.8% (p = 0.26). The incidences of AL requiring re-laparotomy in patients with and without DS were 0.6% and 9.1% (p < 0.001)
This suggests that diverting ostomy (either a loop ileostomy or transverse colostomy) constructed during a LAR for lower rectal tumors can attenuate the deleterious effects of anastomotic leaks.  Which makes complete sense.  Leaks happen in gastrointestinal surgery.  This is a vexing, unspoken problem for surgeons who perform a lot of bowel surgery.  Did you know that, depending on the literature cited, leaks can complicate anywhere from 3%-28% of anastomoses?  That's a lot of leaks!  And the consequences of a leak, especially pelvic colorectal connections, can be devastating.  The idea behind a diverting stoma is to protect an immature, potentially compromised anastomosis.  Patients with rectal cancer are often treated with neoadjuvant chemo-radiation (not specified in the paper above) and that distal rectal stump used in the anastomosis is not always the best hunk of flesh to work with.   Small leaks, which, unprotected, can lead to rapid pelvic sepsis and eventual complete anastomotic dehiscence, can be mitigated by proximal diversion.  Instead of stool pumping out through a micro-perforation, a small leak can, with time and re-direction of fecal flow, be allowed to scar down and heal spontaneously.

I don't do a lot of low rectal cancer resections but I find the diverting ileostomy to be an extremely useful tool in my armamentarium in the setting of severe perforated diverticulitis.  A lot of these patients need urgent or semi-urgent operative intervention after failure of conservative management.   A bowel prep is usually contra-indicated.  The pelvis is contaminated.  The surrounding tissues are often edematous and friable.  In the old days, everyone got a Hartmann's procedure (end colostomy and Hartmann's rectal pouch left in the pelvis.  But we found over the years that reversing a Hartmann's colostomy was frought with morbidity.  Leaks could occur.  Surrounding structures could be injured.  And sometimes the post peritonitis scarring resulted in a frozen, socked in pelvis with marginally identifiable anatomy.  As a matter of fact, for a variety of reasons, only about 70-75% of Hartmann's colostomies ever get reversed.

My practice is to make liberal use of the loop ileostomy if I have any concern about my pelvic colorectal anastomosis.  This allows the new conduit to heal without the stress of fecal matter flowing through it.  A barium enema is ordered after 6 weeks or so to confirm healing and the patient is brought back to the OR  for a pretty straight forward, far less stress-inducing loop ileostomy reversal.  
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No More Toradol?

2/3/2015

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There is an interesting paper from JAMA Surgery this month (on-line version only as of yet) that studies the use of NSAID's  (non steroidal anti-inflammatory drugs) in the post operative period and their impact on anastomotic leak rates.  NSAID's are medicines like Alleve and Motrin.  As a surgeon, I prescribe Motrin to most of my post op hernia and laparoscopy patients for non-narcotic pain control.  I am also a big fan of the intravenously administered NSAID, Toradol.  Toradol is an extremely useful adjunct in the management of post operative pain in the inpatient setting.  I order it often.  (Also, NFL football players seem to like it, not always to their benefit.)

The risk with Toradol and other NSAID's in the post op period was usually related to kidney injury and potential bleeding complications.  But NSAID's work by attenuating the body's natural inflammatory response to stress.  And sometimes that inflammatory response is beneficial.  As a surgeon I need that inflammatory response to occur, especially if I am sewing one end of bowel to another.  Those inflammatory mediators bring the kinds of cells and proteins necessary for a strong anastomosis.  

The JAMA paper is a large retrospective cohort study over over 13,000 patients who had undergone colorectal or bariatric surgery at over 40 hospitals in Washington state.  The question the investigators asked was: how was the leak rate affected when NSAID's were started within 24 hours of surgery?  The findings:
The overall 90-day rate of anastomotic leaks was 4.3% for all patients (151 patients [4.8%] in the NSAID group and 417 patients [4.2%] in the non-NSAID group; P = .16). After risk adjustment, NSAIDs were associated with a 24% increased risk for anastomotic leak (odds ratio, 1.24 [95% CI, 1.01-1.56]; P = .04). This association was isolated to nonelective colorectal surgery, for which the leak rate was 12.3% in the NSAID group and 8.3% in the non-NSAID group 
That's a significant finding!  The good news is that the statistical differences were only seen in patients undergoing non-elective colon surgery.  These are typically semi-urgent cases in a patient population already compromised by factors of infection or malignancy.  NSAID's, given their mechanism of action, could very well function as a tipping point that compromises anastomotic healing in such cases.  Further study is certainly warranted, but I'm inclined to change my practice.  The next perforated diverticulitis case I get that can be treated with a single stage sigmoid colectomy will probably just get a PCA post op.  
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Dense Breasts and the Law

1/22/2015

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This past December, Ohio became the 20th state to pass a law mandating that hospitals and clinics performing mammography screening to notify a patient in writing if results suggest something known as  "dense breast tissue".   Standard mammography creates a 2-D image of breast tissue.  In general, this is sufficient for screening purposes.  However, especially in younger patients, the presence of dense breast parenchyma can lead to higher false negative readings and more indeterminate results that may lead to higher rates of invasive biopsies.  

A newer imaging technology, called digital tomosynthesis, creates highly focused 3-D images of breast tissue.  Initial research seems to suggest that this can improve both early detection rates of smaller cancers and eliminate the need for unnecessary biopsy procedures on clinically insignificant findings.  The law passed in December is supposed to prompt patients to ask their respective health care providers about the need for follow up digital tomosynthesis.

Several questions are begging to be asked:

1) Why don't we just screen everyone with 3D digital mammography?  Well, it's an issue of cost, of course.  For most women, standard 2D mammography is sufficient.  The 3-D machines cost twice as much and some insurance companies will give patients a hard time about coverage.  Most tertiary care centers and dedicated breast cancer facilities have the technology but universal availability is a problem.  Rural and critical access hospitals simply cannot afford to invest in an expensive new technology that may only be intermittently indicated.  In the long haul, as costs inevitable plateau and decrease, it is certain that 3-D digital mammography represents the future.  But for now, we run the risk of creating tiered levels of care, depending on where one lives.

2) Why is this being handled by the state legislative bodies?  Wouldn't it make more sense for medical decision making protocols to come from , like, oh, I don't know, trained healthcare professionals rather than laymen elected officials in Columbus?  Wouldn't a consensus statement from, say, the American Society of Breast Surgeons or a similar entity, make more sense?  Do we not have enough laws on the books?  What would be the consequences of violations of such a law?   Criminal prosecution, in addition to any tort liability?  Doctors and hospital administrators cuffed and read their Miranda rights in the physician lounge?  Will this set the precedent for future legislation guiding physician/patient communication paradigms?  When I take out a patient's colon cancer, the expected standard of care surveillance recommendation would be for that patient to get another colonoscopy one year after surgery.  What if I don't document that recommendation exactly as per state guidelines?  What if the patient is either non compliant or never received the written notification because of a change in address?   Am I criminally liable?  It all just strikes me as unnecessary and absurd.  It ought to be enough to expect doctors and healthcare providers to be professionally responsible and to fulfill basic standard of care requirements.  Deviations from these standards put one at risk of malpractice litigation.  There's enough negative reinforcement in that threat alone.....








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Surgery and Patient Satisfaction

1/18/2015

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The concept of "patient satisfaction" has assumed a prominent perch in American healthcare delivery.  Somehow, this vague, nebulous metric has been indiscriminately tied into the way we reimburse hospitals and physicians.  In fact, patient satisfaction can represent up to 30 % of a hospital's score in the federal value-based purchasing system, which can greatly affect Medicare payments (by as much as 1%).  

Controversy has arisen, however, regarding the validity of "patient satisfaction" as a useful yardstick.  Two articles from the literature illustrating this recently caught my eye.  

JAMA Surgery in April 2013 published a much cited article that evaluated the relationship between patient satisfaction scores and hospital compliance with Surgical Care Improvement Project (SCIP) metrics.  Interestingly, in a study of 31 hospitals, patient satisfaction was found to be independent of the extent to which hospitals followed standard guidelines to help reduce post operative infectious complications.  

A couple of months ago, Annals of Surgery studied 171 hospitals over 11 years, looking for a correlation between patient satisfaction and surgical outcomes.  The findings of the study certainly raised some eyebrows.  The only surgical outcome indicator associated with high patient satisfaction scores was a low mortality rate.  (Let us hope that no one is surprised by this particularity.)  More confounding was that complications and higher readmission rates after surgery had no statistical effect on a patient's reported satisfaction experience.  The only variables associated with high satisfaction scores, other than low mortality, were larger hospitals (in square footage, I guess) and hospitals with a high surgical volume.  

These papers highlight the concern many of us in the trenches have with using subjective, highly capricious metrics like HCAHPS (Hospital Consumer Assessment of Healthcare Providers and Systems) scores as a reliable measure of quality.  You end up in an upside down world where patients with horrible surgical complications effusively praise their doctors and nurses for being so "compassionate and caring during a difficult time" and, on the other hand, where patients who sail through difficult major colon resections give a hospital a bad score because their TV only had three working channels and the newspaper delivery volunteer was rude every morning.  

Quality is a metric that cannot be measured via proxies.  We need to start being more honest about it.  Using HCAHPS and patient satisfaction scores is just a fancy way of equivocating on transparency.  We have a perfectly fine, already available method of measuring quality: simply open up the drapes and let some light into the world of surgical outcomes.  If you want to let the public know how well a hospital or surgeon is performing, don't think you are providing a valid answer by instead publishing bullshit like "patient satisfaction is very high!".  Publish the actual outcomes.  If a hospital performs 1,000 hernia repairs every year, then maybe the public has a right to know recurrence rates, infectious complications, mortality rates, etc.  Same thing with abdominal procedures and orthopedic interventions.  We have been doing the exact same thing in the realm of cardiothoracic surgery for years.  Open up the books.  May the best man win.  




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    Jeffrey C. Parks MD, FACS

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