Flying under the
radar in the last few decades have been an epidemic of emergency department
visits and hospitalization related to insulin-related hypoglycemia. But
recently researchers (Geller
2014), using 2 large national data sources, found that there were an
estimated 97,648 ED visits annually related to insulin-related hypoglycemia.
Moreover, almost one-third (29.3%) resulted in hospitalization and severe
neurological sequelae were estimated to occur in 60%.
Insulin-treated patients 80 years or older were more than twice as likely to
visit the ED and nearly 5 times as likely to be subsequently hospitalized.
Geller et al. note
that the number of patients in the US taking insulin has increased 50% over the
last decade. When they looked at reasons for the hypoglycemia, the most
commonly identified precipitants were reduced food intake and administration of
the wrong insulin product. While almost half of the cases noted a meal-related
misadventure, 22% involved the patient taking a wrong insulin product and 12% a
wrong dose. One of the biggest problems was the patient taking a rapid-acting
insulin rather than the intended long-acting one.
They recommend focusing efforts on education of patients on
several aspects of insulin use, including having patients demonstrate to
providers their understanding and simulation. They also call for continued
efforts to better differentiate the various insulin products. They also note a
trend in recent diabetes treatment guidelines to relax targets in patients with
advanced age, short life expectancies, and high risk of hypoglycemia.
In an accompanying
commentary Sei J. Lee (Lee 2014)
puts this trend in perspective, noting that the 100,000 ED visits annually for
hypoglycemia have gotten far less attention than the 715,000 annual MI’s
despite the fact that most hypoglycemia is caused by the health care system.
Lee also points a finger at the pharmaceutical industry for its role in driving
guidelines to aim for tighter glucose control and lower HbA1c levels. Lee notes
that the ACCORD
trial in type II diabetics showed increased mortality when patients are
treated to an overly aggressive HbA1c target (mean HbA1c 6.4%). Lee recommends
that rather than prescribing a target for HbA1c, specifying a range might be
more likely to remind us not to overtreat. Also we
need to be very careful that widely-used quality metrics do not inadvertently
drive overtreatment. Lastly, Lee raises the question of avoiding insulin all
together in patients age 80 years and older.
References:
Geller AI, Shehab N, Lovegrove MC, et al. National
Estimates of Insulin-Related Hypoglycemia and Errors Leading to Emergency
Department Visits and Hospitalizations. JAMA
Intern Med 2014; Published online March 10, 2014
http://archinte.jamanetwork.com/article.aspx?articleid=1835360
Lee SJ. So Much
Insulin, So Much Hypoglycemia. JAMA
Intern Med 2014; Published online March 10, 2014
http://archinte.jamanetwork.com/article.aspx?articleid=1835356
The Action to
Control Cardiovascular Risk in Diabetes Study Group. Effects of Intensive Glucose
Lowering in Type 2 Diabetes. N Engl J Med 2008; 358: 2545-2559
http://www.nejm.org/doi/full/10.1056/NEJMoa0802743
Print “April
2014 Insulin-Induced Hypoglycemia Rising”
Among our numerous columns dealing with use of checklists in
healthcare and other industries the WHO Surgical Safety Checklist has probably
attracted the most attention. Our July 1, 2008 Patient Safety Tip of the Week “WHO’s
New Surgical Safety Checklist” described the tool and provided the link to download the
checklist tool and instructions how to use it. We also discussed checklist design and use in
our September 23, 2008 Patient Safety Tip of the Week “Checklists
and Wrong Site Surgery”.
In our January 20,
2009 Patient Safety Tip of the Week “The
WHO Surgical Safety Checklist Delivers the Outcomes” we discussed the
striking improvements in patient outcomes following implementation of the WHO
Surgical Safety Checklist at hospitals in eight different countries. Haynes and
colleagues (Haynes 2009) demonstrated that mortality at 30-days
post-op decreased from 1.5% before introduction of the checklist to 0.8% after.
Rate of any complication decreased from 11% to 7%. Both these outcomes were
highly statistically significant. That’s a relative risk reduction of
approximately 36% for mortality and major morbidity!
That striking improvement in outcomes occurred even without
complete adherence to all items on the checklist. We discussed the debate as to
whether the striking improvement was attributable to use of the checklist per
se or to the change in “culture” that accompanied use of the checklist.
But recent widespread adoption of a surgical checklist in
over 100 hospitals in Ontario, Canada failed to demonstrate significant
reductions in adjusted rates for mortality or complications (Urbach
2014). The rate of any complication decreased from 3.86% to 3.82%
and mortality at 30-days post-op decreased from 0.71% to 0.65% in Canadian
study, neither being statistically significant. There was also no significant
changes in rates of hospital
readmission and emergency department visits within 30 days after discharge. This
result was surprising, especially since self-reported compliance with the
checklist was over 90% at almost all participating hospitals.
In an accompanying
editorial Lucian Leape discusses potential reasons
for lack of evidence of improvement in Ontario hospitals after implementation
of the checklist (Leape 2014). He suspects the most likely reason was that
the checklist was not accurately used, despite the reported 98% compliance in
the study. He also notes that since the checklist was adopted unmodified in 90%
of hospitals the local buy-in and team building that are needed for true
adoption were likely lacking. He also feels that the 3-month period was
probably far too short for significant improvement to have occurred.
We have several of
our own thoughts on why the Ontario study failed to show improvement after
implementation of the checklist and, thus, differed from the prior studies. One
is that the results of the original study (Haynes 2009) were almost too good to be true. The
school of thought popularized by John Ioannidis says that “if it sounds too
good to be true, it probably is not true” (Ioannidis
2005, Pereira
2012) and might apply here. That school concludes that most large treatment
effects emerge from small studies, and when additional trials are performed,
the effect sizes become typically much smaller. That is a distinct possibility here,
given that the Ontario study was so much bigger than any of the other studies.
But the Haynes study was not the only one to demonstrate
striking improvement in outcomes after implementation of a surgical checklist.
Improvements of a similar magnitude were seen after implementation of the
SURPASS checklist (de
Vries 2010). That checklist is a very
comprehensive checklist that deals with the entire surgical pathway, including
pre- and post-operative care as well as events within the OR (see our November
30, 2010 Patient Safety Tip of the Week “SURPASS:
The Mother of All Checklists”). After implementation of SURPASS the number
of complications per 100 patients dropped from 27.3 to 16.7 and in-hospital
mortality dropped from 1.5% to 0.8%. Note that outcomes at several comparable
hospitals considered “control” hospitals did not change. And no other
significant programs were introduced at the time, further suggesting that the
improvements were due to implementation of the checklist. Moreover,
complication rates were significantly lower in those patients for whom 80% or
more of the checklist items were completed. But the authors are quick to note
that the benefits of the checklist implementation are not just due to the
checklist but also due to the development of a “culture of safety” that results
from such implementation. Also of note was that these improvements occurred at
hospitals which already had relatively high levels of quality of care.
Another study (van
Klei 2012) demonstrated a 15% reduction in
adjusted mortality rates after implementation of WHO’s
Surgical Safety Checklist and showed outcomes were better in those with full
checklist completion compared to those with partial completion or noncompliance.
Another group
implemented both team training and a comprehensive surgical checklist and
demonstrated significant reduction of 30-day morbidity (Bliss
2012). Overall adverse event rates decreased from 23.60% for historical
control cases and 15.90% in cases with only team training, to 8.20% in cases
with checklist use.
A recent systematic review of the impact of surgical
checklists (Treadwell
2014) noted that 10 of 21 studies on implementation of surgical checklists
included data on outcomes. Outcomes from those reporting were generally
favorable, showing decreases in both inhospital
mortality and complication rates.
So did all these prior studies overestimate the impact of
checklist implementation on patient outcomes? Only time will tell.
Another possible reason for the difference between the
Ontario study and the other studies has to do with difference in the baseline
(historical) levels of mortality and complications. While it’s not clear that
exactly the same things were being measured across studies, the rate of any
complication decreased from 11% to 7% in Haynes study compared to 3.86% to
3.82% in Ontario study. Mortality at 30-days post-op decreased from 1.5% before
introduction of the checklist to 0.8% after in Haynes study compared to 0.71%
to 0.65% in Ontario study. So was it that the Ontario hospitals were already
performing at a relatively high level and had less room to improve? The study
on the SURPASS checklist outcomes (de Vries
2010) showed improvements comparable to those in the Haynes study and was
done at hospitals said to be already performing at high levels (note, however,
that the mortality rates in the Ontario study were lower than that in the
SURPASS study even after the latter showed improvement).
Another consideration is whether the 3-month measurement
timeframe (both before and after implementation) in the Ontario study was
simply too short to demonstrate improved outcomes. Well, that was the same
timeframe used in the SURPASS study and they demonstrated striking improvement.
Our last consideration has to do with Lucian Leape’s comments about the fact that the checklist was
seldom modified at the local level in the Ontario hospitals. That suggests that
the “culture” aspect of using checklists never developed. In fact, the Ontario
hospitals were basically mandated to use a checklist. We all know that our
medical staffs don’t like to have anything “foisted upon them” from the
outside. So there may well have been a difference compared to the hospitals
that voluntarily (and usually enthusiastically) adopted the checklists in some
of the other studies.
The systematic review by Treadwell et al. (Treadwell
2014) cautions that the association between checklists and improved outcomes
does not necessarily imply causation. First, they note that checklists are
often implemented as part of a multifaceted strategy to improve care. They also
note there may be reporting bias (i.e. perhaps only those with positive
outcomes reported outcome data). And, third, it’s possible that not all
surgical checklists are beneficial.
It’s important to keep in mind that none of these studies
was a randomized controlled trial (RCT) and there are several practical
barriers to doing such an RCT. They all have before/after observational designs
and it is conceivable that factors other than just the checklist are important.
Indeed, we strongly suspect that the change in culture is probably more
important that the checklist per se. Developing
checklists is not enough. You need to involve your staff in development of
those checklists and educate all staff in their importance and implementation.
You need to audit the use of and adherence to the checklists you develop. The
audit should be done for anything you develop a checklist for, not just a safe
surgery checklist.
Don’t let the Ontario study dissuade you on the importance
of checklists. Checklists are some of the most valuable tools we have available
in quality improvement and patient safety. They are simple and save time in the
long run. Most take only minutes to complete. They are also the least expensive
of all tools. All the items in the WHO Surgical Safety Checklist have
negligible financial costs. None of the favorable studies above published the
likely financial savings resulting from the improvements but they would
obviously be substantial. The ROI on checklists is incredibly high, both in
human terms and financial terms.
Some of our prior columns on checklists:
References:
Haynes AB, Weiser TG, Berry WR, et al. for the Safe Surgery
Saves Lives Study Group. A Surgical Safety Checklist to Reduce Morbidity and
Mortality in a Global Population. N Engl J Med.
Online First January 14, 2009 (DOI: 10.1056/NEJMsa0810119), in Print January
29, 2009
http://content.nejm.org/cgi/content/full/NEJMsa0810119
WHO Surgical Safety Checklist
http://www.who.int/entity/patientsafety/safesurgery/tools_resources/SSSL_Checklist_finalJun08.pdf
Urbach DR, Govindarajan
A, Saskin R, et al. Introduction of Surgical Safety
Checklists in Ontario, Canada. N Engl J Med 2014;
370: 1029-1038
http://www.nejm.org/doi/full/10.1056/NEJMsa1308261
Leape LL. The Checklist Conundrum
(editorial). N Engl J Med 2014; 370:1063-1064
http://www.nejm.org/doi/full/10.1056/NEJMe1315851
Ioannidis JP. Why most published research findings
are false. PLoS Med 2005; 2(8): e124
http://www.plosmedicine.org/article/info:doi/10.1371/journal.pmed.0020124
Pereira TV, Horwitz RI, Ioannidis
JPA. Empirical Evaluation of Very Large Treatment Effects of Medical
Interventions. JAMA 2012;
308(16): 1676-1684
http://jama.jamanetwork.com/article.aspx?articleid=1386610
de Vries
EN, Prins HA, Crolla RMPH, et al. for the SURPASS Collaborative Group. Effect
of a Comprehensive Surgical Safety System on Patient Outcomes. N Engl J Med 2010; 363: 1928-1937
http://www.nejm.org/doi/pdf/10.1056/NEJMsa0911535
van Klei
WA, Hoff RG van Aarnhem EEH et al. Effects of the
Introduction of the WHO “Surgical Safety Checklist” on In-Hospital Mortality: A
Cohort Study. Ann Surg 2012; 255: 44-49
Bliss LA, Ross-Richardson CB, Sanzar
LJ, et al. Thirty-Day Outcomes Support Implementation of a Surgical Safety
Checklist. J Am Coll Surg
2012; 215: 766-776
http://www.journalacs.org/article/S1072-7515%2812%2900965-9/abstract
Urbach DR, Govindarajan
A, Saskin R, et al. Introduction of Surgical Safety
Checklists in Ontario, Canada. N Engl J Med 2014;
370: 1029-1038
http://www.nejm.org/doi/full/10.1056/NEJMsa1308261
Leape LL. The Checklist Conundrum
(editorial). N Engl J Med 2014; 370:1063-1064
http://www.nejm.org/doi/full/10.1056/NEJMe1315851
Treadwell JR, Lucas S, Tsou ay. Surgical checklists: a systematic
review of impacts and implementation. BMJ
Qual Saf 2014; 23: 299-31
http://qualitysafety.bmj.com/content/23/4/299.full.pdf+html
Print “April
2014 Checklists Don’t Always Lead to Improvement”
Cases with surgical complications cost more. Duh. Sounds
like an oxymoron. Of course they cost more. But who is really paying attention?
An analysis of patients undergoing elective colorectal
surgery showed 35% of patients developed at least one complication (Zoucas 2014).
Complications increased hospital costs at least 2-fold, primarily due to
increased length of stay and ICU costs. Largest costs were related to wound
dehiscence and suture line failure requiring reoperation. In addition, if a
patient required readmission because of a complication, costs were further
substantially increased. Factors that increased complication rates were
obesity, complexity of surgery, and factors related to the surgeon.
A study of surgical complications in cancer patients demonstrated
a significant financial cost attributable to surgical complications (Short 2014).
The researchers looked at the AHRQ PSI’s (patient safety indicators) in
patients having 6 cancer surgeries: colectomy, rectal resection, esophagectomy, pancreatic resection, pneumonectomy,
and pulmonary lobectomy. They found that the occurrence of one PSI increased
the hospital cost by 20% for most types of surgery but for respiratory failure
the costs increased 53-77%.
The authors note that, whether justified or not, there seems
to be a higher tolerance for complications in patients with cancer undergoing
surgery compared to patients with benign conditions. However, many
complications in cancer patients may in fact be preventable or avoidable.
Post-op DVT or pulmonary embolism increased costs 28-37%.
Certainly cancer is a significant risk factor for DVT/PE but that makes it even
more imperative that appropriate prophylaxis be used in such patients. A
decubitus increased costs 28-60%. Malnutrition or other factors related to
cancer might make render such patients at greater risk for decubiti. But that
just increases the need for appropriate surveillance and preventive measures.
Of course, in the current reimbursement system hospitals
have little financial incentive to avoid surgical complications. Yes, such
cases cost hospitals more but they also bill more in most cases. Researchers
have demonstrated that for patients with Medicare and private insurance,
hospitals actually reap higher contribution margins for cases with surgical
complications (Eappen 2013).
However, as we move to different reimbursement models (eg.
accountable care organizations, bundled payments, global budgets, capitation
and others) any savings from avoiding surgical complications should begin to
accrue to someone other than the payors. So the
financial incentive will be added to the moral imperative to improve care and
avoid complications.
References:
Zoucas E, Marie-Louise Lydrup M-L. Hospital costs associated with surgical
morbidity after elective colorectal procedures: a retrospective observational
cohort study in 530 patients. Patient
Safety in Surgery 2014; 8:
2 (3 January 2014)
http://www.pssjournal.com/content/8/1/2
Short MN, Aloia TA, Ho V. The
influence of complications on the costs of complex cancer surgery. Cancer 2014;
120(7): 1035–1041
http://onlinelibrary.wiley.com/doi/10.1002/cncr.28527/full
Eappen S, Lane BH, Rosenberg B, et
al. Relationship Between Occurrence of Surgical
Complications and Hospital Finances. JAMA 2013; 309(15): 1599-1606
http://jama.jamanetwork.com/article.aspx?articleid=1679400
Print “April
2014 Surgical Complications and Cost”
Just a little over a
year ago (see our February 26, 2013 Patient Safety Tip of the Week “Insulin
Pen Re-Use Incidents: How Do You Monitor Alerts?”) we highlighted reports
of the occurrence in Western New York of insulin pens being used on multiple
patients, potentially causing cross-contamination of patients with blood-borne
pathogens. The focus of our column was as much on how organizations are made
aware of unsafe practices discovered elsewhere as it was on the insulin pens
themselves. The above episodes occurred despite several warnings from ISMP, the
FDA, and CDC as referenced in our column. We provided recommendations and
referred readers to several articles by ISMP. Both ISMP and the VA Health
System have discouraged use of insulin pens (or multi-dose pen injectors for
other drugs) in hospitals.
Last month another
hospital alerted more than 4,200 patients who may have received insulin from an
insulin pen reservoir of possible exposure to hepatitis viruses and human
immunodeficiency virus (HIV) due to possible blood contamination (Reuters
2014).
Shortly after the
Western New York insulin pen incidents were reported ISMP issued a call
for removal of insulin pens from use in inpatient settings (ISMP
2013). They cited similar incidents occurring at multiple hospitals since
2009. Many of those instances have occurred despite warnings from ISMP, the
FDA, and CDC. And they cited evidence that blood and other materials have been
found in such pens after use. They note that such pens were originally
introduced for use in ambulatory care. They note that placing a label on the
pen for a single patient has its difficulties and that other problems are seen,
such as using the pens as multi-dose vials, risk of needlesticks,
etc. They note that the VA National Center for Patient Safety has now
prohibited use of multi-dose pen devices on patient care units in VA facilities
with certain exceptions (VA 2013).
ISMP went on to note
the ease with which such errors are likely to occur when providers not fully
familiar with the safety issues around such pens are now confronted with such
pens. They note that we cannot reasonably expect education and inservicing to reach all necessary parties and that
punishment of those who never learned the correct use of such devices is not
appropriate. Hence, they suggest the best solution is removal of such devices
from the inpatient setting (with the exception of those circumstances
identified by the VA NCPS and outlined in the ISMP article).
Please refer to our
February 26, 2013 Patient Safety Tip of the Week “Insulin
Pen Re-Use Incidents: How Do You Monitor Alerts?” and our April 2013 What’s
New in the Patient Safety World column “More
Tips on Insulin Pen Safety” for our recommendations for hospitals and for
links to the important ISMP, VA, FDA and CDC communications on insulin pen
safety.
If testing is done on the 4000+ patients in the current
episode we can pretty much guarantee that several will test positive for some
of the pathogens even if none were actually contaminated at that hospital
through use of the insulin pens on multiple patients. Testing on about 500 of
the 716 patients who could have been exposed to hepatitis or HIV because of the
misuse of insulin pens on diabetic patients in the Western New York episode
showed that at least fourteen tested positive for hepatitis B and at least six
others tested positive for hepatitis C (Zremski
2013). And if the human toll and quality and patient safety issues
are not enough to get you to ensure such episodes don’t occur at your facility,
your CFO might let you know that the cost of one full course of hepatitis C
with the newer drugs just on the market is about $84,000 (Pollack
2014).
Don’t you think you better act now?
References:
Reuters staff. New York hospital warns patients of possible
HIV, hepatitis exposure. Reuters March 13, 2014
http://www.reuters.com/article/2014/03/13/us-usa-newyork-hospital-idUSBREA2C0B320140313
ISMP (Institute for Safe Medication Practices). Ongoing
concern about insulin pen reuse shows hospitals need to consider transitioning
away from them. ISMP Medication Safety Alert. Acute Care Edition. February 7,
2013
http://www.ismp.org/Newsletters/acutecare/showarticle.asp?id=41
VA Patient Safety Alert. Multi-dose pen injectors. January
17, 2013
http://www.patientsafety.gov/alerts/AL13-04MultiDosePens.pdf
Zremski J. 20 Buffalo VA patients
test positive for hepatitis. The Buffalo News. May 9, 2013
http://www.buffalonews.com/20130509/20_buffalo_va_patients_test_positive_for_hepatitis.html
Pollack A. Lawmakers Attack Cost of New Hepatitis Drug. New
York Times. March 21, 2014
Print “April
2014 Insulin Pens - Again”
No one questions the
importance of prophylaxis against deep venous thrombosis and pulmonary embolism
(collectively known as venous thrombembolsim or VTE)
in patients at high risk for such occurrences. But we’ve done several columns
that have called into question the use of the VTE prophylaxis measure as a
measure of quality because of biases and other flaws.
In our November 2013
What’s New in the Patient Safety World column “Are
VTE Measures Flawed as Quality Measures?” we highlighted a study (Bilimoria
2013) that looked at
almost a million surgical patients in almost 3000 hospitals for VTE prophylaxis
rates, VTE event rates, and use of imaging in VTE screening. They found that greater
hospital VTE prophylaxis adherence rates were weakly associated with worse
risk-adjusted VTE event rates. When they looked at hospitals with higher
“structural” quality scores (based on 8 factors commonly thought to be
associated with higher commitment to quality) they found higher VTE prophylaxis adherence rates but worse risk-adjusted VTE
rates. Risk-adjusted VTE rates increased significantly with VTE imaging use
rates in a stepwise fashion, leading to their conclusion that surveillance bias limits the usefulness
of the VTE quality measure for hospitals.
In our February 15,
2011 Patient Safety Tip of the Week “Controversies
in VTE Prophylaxis” we highlighted a study by some very respected
investigators in the surgical quality improvement field (Qadan
2011) that questioned the current recommendations on venous thrombembolism (VTE) prophylaxis in elective major
surgery. The authors collected data on DVT and PE in patients electively
undergoing 4 major surgical procedures (colorectal resection, total knee
replacement, total hip replacement, and hysterectomy) from a large database
from a consortium of academic medical centers for two periods of time
(2003-2004 vs. 2007-2008). The study demonstrated a substantial increase in the
use of pharmacologic DVT prophylaxis between the two time periods. Yet the
rates of DVT and PE were not significantly impacted by this increased use of
such prophylaxis. Moreover, the overall rates of DVT and PE were actually
quite low and the rates in patients who did not receive pharmacoprophylaxis
actually decreased between the two time periods. The authors concluded that
this may show that clinical judgment of physicians in choosing which patients
need pharmacoprophylaxis is remarkable.
Now another study has questioned the utility of the VTE
prophylaxis measure (JohnBull
2014). The authors used publicly reported data from CMS to see if
there was a correlation between VTE prophylaxis rates and outcome rates and
found no correlation. They found that VTE rates at hospitals reporting 100%
compliance with VTE prophylaxis were no different than those at hospitals in
the bottom quintile of prophylaxis rates. Though the authors note that meeting
the minimal standards to comply with the SCIP VTE measure may play a role, they
concur with the previous authors also that surveillance bias may be a
contributing factor.
Has the time finally come to move on from the VTE
prophylaxis process measures to other measures that are less subject to biases
and are better matched with actual patient outcomes?
References:
Bilimoria KY, Chung J, Ju
MH, et al. Evaluation of Surveillance Bias and the Validity of the Venous
Thromboembolism Quality Measure. JAMA 2013; 310(14): 1482-1489
http://jama.jamanetwork.com/article.aspx?articleid=1748150&resultClick=1
Qadan M, Polk HC, Hohmann
SF, Fry DE. A reassessment of needs and practice patterns in pharmacologic
prophylaxis of venous thromboembolism following elective major surgery. Ann Surg 2011; 253(2): 215-220
JohnBull EA, Lau BD, Schneider EB,
et al. No Association Between Hospital-Reported
Perioperative Venous Thromboembolism Prophylaxis and Outcome Rates in Publicly
Reported Data (Research Letter). JAMA Surgery 2014; online first February 5,
2014
http://archsurg.jamanetwork.com/article.aspx?articleid=1818821
Print “April
2014 Another Rap on the VTE Prophylaxis Measure”
Print “April
2014 What's New in the Patient Safety World (full
column)”
Print “April
2014 Insulin-Induced Hypoglycemia Rising”
Print “April
2014 Checklists Don’t Always Lead to Improvement”
Print “April
2014 Surgical Complications and Cost”
Print “April
2014 Insulin Pens - Again”
Print “April
2014 Another Rap on the VTE Prophylaxis Measure”
Print “April
2014 What's New in the Patient Safety World (full
column in PDF version)”
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