In the past we often
routinely provided supplemental oxygen to patients who had suffered stroke or
MI. But evidence began to appear that using oxygen in patients lacking evidence
of hypoxemia might be of no benefit. Indeed, some evidence that hyperoxia might even be harmful began to appear (see our
numerous columns on the potential dangers of oxygen listed at the end of
today’s column). The debate about use of oxygen in stroke and MI continued in
the absence of randomized controlled trials.
Now, hopefully, the
debate should end with the recent publication of results of randomized trials
of oxygen in these two conditions.
First, the DETO2X-AMI trial was a registry-based randomized
clinical trial using nationwide Swedish registries for patient enrollment and
data collection (Hoffmann
2017). Patients with suspected myocardial infarction and an oxygen
saturation of 90% or higher were randomly assigned to receive either
supplemental oxygen (6 liters per minute for 6 to 12 hours, delivered through
an open face mask) or ambient air. The study was open-label (that is, it was
not double-blinded). Though hypoxemia developed more frequently in the ambient
air group than the oxygen group (7.7% vs. 1.9%) there was no difference in the
primary outcome of death from any cause within 1 year (5.0% and 5.1% in the
oxygen and ambient air groups, respectively). Though more patients in the
oxygen group were rehospitalized with MI within one
year, this difference did not reach statistical significance. Results were
consistent across all predefined subgroups. The authors conclude that routine
use of supplemental oxygen in patients with suspected myocardial infarction who
did not have hypoxemia was not found to reduce 1-year all-cause mortality.
Regarding stroke,
the Stroke Oxygen Study (Roffe
2017) was a single-blind randomized clinical trial in the United
Kingdom. Patients were enrolled within 24 hours of hospital admission if they
had no clear indications for or contraindications to oxygen treatment. Participants
were randomized 1:1:1 to continuous oxygen for 72 hours, nocturnal oxygen
(21:00 to 07:00 hours) for 3 nights, or control (oxygen only if clinically
indicated). Oxygen was given via nasal tubes at 3 L/min if baseline oxygen
saturation was 93% or less and at 2 L/min if oxygen saturation was greater than
93%. The primary outcome was reported using the modified Rankin Scale score assessed
at 90 days by postal questionnaire. The unadjusted odds ratio for a better
outcome was 0.97 for oxygen vs control, and the odds ratio was 1.03 for
continuous vs nocturnal oxygen (neither statistically significant). No subgroup
could be identified that benefited from oxygen. The authors concluded that among
nonhypoxic patients with acute stroke, the
prophylactic use of low-dose oxygen supplementation did not reduce death or
disability at 3 months. These findings do not support low-dose oxygen in this
setting.
So we now have evidence from randomized trials that fail to
show any benefit from routine use of oxygen in patients with MI or stroke who
are not hypoxemic. Hopefully, the debate is now over.
Also timely is the
recent publication of the updated British Thoracic Society Guideline for
Oxygen Use in Adults in Healthcare and Emergency Settings (O'Driscoll 2017).
We discussed the BTS guideline in our January 27, 2009 Patient Safety Tip of
the Week “Oxygen
Therapy: Everything You Wanted to Know and More!”.
Many of the recommendations in the 2008 BTS guideline are unchanged but the
scope of the guideline has been expanded to cover several new categories. The guideline continues to make the
distinction in target oxygen saturation goals for most (94–98%) and those at
risk for hypercapnic respiratory failure (88–92%).
Some of our prior
columns on potential harmful effects of oxygen:
April 8, 2008 “Oxygen
as a Medication”
January 27, 2009 “Oxygen
Therapy: Everything You Wanted to Know and More!”
April 2009 “Nursing
Companion to the BTS Oxygen Therapy Guidelines”
October 6, 2009 “Oxygen
Safety: More Lessons from the UK”
July 2010 “Cochrane
Review: Oxygen in MI”
December 6, 2011 “Why
You Need to Beware of Oxygen Therapy”
February 2012 “More
Evidence of Harm from Oxygen”
March 2014 “Another
Strike Against Hyperoxia”
June 17, 2014 “SO2S
Confirms Routine O2 of No Benefit in Stroke”
December 2014 “Oxygen
Should Be AVOIDed”
August 11, 2015 “New
Oxygen Guidelines: Thoracic Society of Australia and NZ”
November 2016 “Oxygen
Tank Monitoring”
November 2016 “More
on Safer Use of Oxygen”
References:
Hofmann R, James SK, Jernberg T,
et al. Oxygen Therapy in Suspected Acute Myocardial Infarction. NEJM 2017;
published online first August 28, 2017
http://www.nejm.org/doi/full/10.1056/NEJMoa1706222?query=featured_home
Roffe C, Nevatte
T, Sim J, et al for the Stroke Oxygen Study Investigators and the Stroke Oxygen
Study Collaborative Group. Effect of Routine Low-Dose Oxygen Supplementation on
Death and Disability in Adults With Acute Stroke. The
Stroke Oxygen Study Randomized Clinical Trial. JAMA 2017; 318(12): 1125-1135, September 26,
2017
O'Driscoll BR, Howard LS, Earis J,
Mak V. British Thoracic Society Guideline for Oxygen
Use in Adults in Healthcare and Emergency Settings. BMJ Open Respir Res 2017; 4(1)
http://bmjopenrespres.bmj.com/content/4/1/e000170
Print “October
2017 End of the Oxygen in MI and Stroke Debate?”
Updated guidelines for the management of hospital-acquired
pneumonia (HAP) and ventilator-associated pneumonia (VAP) were recently
published in the European Respiratory Journal (Torres 2017).
These were developed by a task force of
several European medical societies, though the task force also included several
experts from the US. The report does acknowledge differences between the
US and European approaches in several areas.
The numerous recommendations are beyond the scope of this
column but the guideline addresses some of the following issues:
For each of the questions/topics addressed, the guideline
summarizes the evidence base and strength of the recommendations and includes
comments about the utilization of resources necessary.
This is yet another valuable resource in your quest to avoid
hospital-acquired infections.
References:
Torres A, Niederman MS, Chastre J, et al. International ERS/ESICM/ESCMID/ALAT
guidelines for the management of hospital-acquired pneumonia and
ventilator-associated pneumonia: guidelines for the management of
hospital-acquired pneumonia (HAP)/ventilator-associated pneumonia (VAP) of the
European Respiratory Society (ERS), European Society of Intensive Care Medicine
(ESICM), European Society of Clinical Microbiology and Infectious Diseases
(ESCMID) and Asociación Latinoamericana
del Tórax (ALAT). European Respiratory Journal 2017
50: 1700582
http://erj.ersjournals.com/content/50/3/1700582.long
Print “October
2017 Updated Guidelines for VAP and HAP”
We have been
advocates of disclosure and apology after serious adverse events for over two
decades. Not only is such transparency ethically the right thing to do but
evidence has been accumulating that such disclosure, along with sincere
apology, does not lead to higher liability costs. In fact, “communication-and-resolution
programs” may even save money. Such programs communicate with patients when
adverse events occur, investigate and explain what happened and, where
appropriate, apologize and proactively offer compensation.
In our January 3,
2017 Patient Safety Tip of the Week “What’s
Happening to “I’m Sorry”?”
we discussed several communication-and-resolution programs, including
the successes of some but also the barriers encountered in implementing others.
A new publication in Health Affairs describes the process
and outcomes from communication-and-resolution programs program used by two
academic medical centers and two of their community hospitals in Massachusetts (Mello 2017).
91% of the program events did not meet compensation eligibility criteria, and
those events that did were not costly to resolve (the median payment was
$75,000). Only 5 percent of events led to malpractice claims or lawsuits.
Overall, clinicians were supportive of the program but desired better
communication about it from staff members. 39.6% of clinicians said they were
not familiar or not very familiar with the CARe
program but, of those who were familiar, 89.8% gave it a moderately-to-strongly
positive rating.
In our January 3,
2017 Patient Safety Tip of the Week “What’s
Happening to “I’m Sorry”?” we discussed a couple other studies by
Mello and colleagues. Results from a demonstration project in New York
City were less impressive (Mello 2016a). The
communication-and-resolution program implemented in surgical departments of 5
NYC acute care hospitals was quite successful in handling events not caused by
substandard care, but less consistent in offering compensation in cases
involving substandard care. But one striking finding in that study was that
clinician awareness of the communication-and-resolution program was quite low
and many felt the program did not likely help avoid a lawsuit. The authors felt
that, in those cases where there were violations of standard of care, there was
difficulty adhering to the principle that compensation should be proactively
offered.
The current study by Mello et al. on the Massachusetts
experience emphasizes the importance of adherence to the program and commitment
to offer compensation proactively. The Massachusetts hospitals were able to
adhere to their CRP commitments more consistently than hospitals in the earlier
demonstration project in New York. In the New York hospitals resistance by
insurers and physicians were noted as factors preventing them from making offers.
The other prior paper by Mello and colleagues was a study of
a communication-and-resolution program (CRP) involving six hospitals and
clinics and a liability insurer in Washington State (Mello 2016b). It found
that sites experienced small victories in resolving particular cases and
streamlining some working relationships, but they were unable to successfully
implement a collaborative CRP. Barriers included the insurer's distance from
the point of care, passive rather than active support from top leaders,
coordinating across departments and organizations, workload, nonparticipation
by some physicians, and overcoming distrust.
The Massachusetts experience is reassuring and hopefully
will go a long way to assuage some of the negative attitudes discussed in our January 3, 2017 Patient Safety Tip of
the Week “What’s
Happening to “I’m Sorry”?”. We strongly
support these programs as “the right thing to do”.
Some of our prior
columns on Disclosure & Apology:
July 24, 2007 “Serious
Incident Response Checklist”
June 16, 2009 “Disclosing Errors That Affect Multiple
Patients”
June 22, 2010 “Disclosure
and Apology: How to Do It”
September 2010 “Followup
to Our Disclosure and Apology Tip of the Week”
November 2010 “IHI:
Respectful Management of Serious Clinical Adverse Events”
April 2012 “Error
Disclosure by Surgeons”
June 2012 “Oregon
Adverse Event Disclosure Guide”
December 17, 2013 “The
Second Victim”
July 14, 2015 “NPSF’s
RCA2 Guidelines”
June 2016 “Disclosure
and Apology: The CANDOR Toolkit”
August 9, 2016 “More
on the Second Victim”
January 3, 2017 “What’s
Happening to “I’m Sorry”?”
Other very valuable
resources on disclosure and apology:
References:
Mello MM, Kachalia A, Roche S, et
al. Outcomes In Two Massachusetts Hospital Systems
Give Reason For Optimism About Communication-And-Resolution Programs. Health Affairs 2017; 36: 1795-1803
http://content.healthaffairs.org/content/36/10/1795.abstract
Mello MM, Armstrong SJ, Greenberg Y, McCotter
PI, Gallagher TH. Challenges of Implementing a Communication-and-Resolution
Program Where Multiple Organizations Must Cooperate. Health Services Research
2016; 51(Suppl S3): 2550-2568 December 2016
https://www.ncbi.nlm.nih.gov/pubmed/27807858
Mello MM, Greenberg Y, Senecal SK,
Cohn JS. Case Outcomes in a Communication-and-Resolution Program in New York
Hospitals. Health Services Research 2016; 51(Suppl S3):
2583-2599 December 2016
https://www.ncbi.nlm.nih.gov/pubmed/27781266
Print “October
2017 More Support for Disclosure and Apology”
One of our most frequent topics has been handoffs in
healthcare or other industries (see the full list of prior columns at the end
of today’s column). Communication breakdowns are involved in over 75% of
serious patient adverse events and transitions of care are particularly
vulnerable to such communication breakdowns. Hence, optimal performance of
handoffs is of utmost importance in preventing errors at such transitions.
The Joint Commission recently published a Sentinel Even
Alert on faulty handoffs (TJC
2017). Much of the content was based upon The Joint Commission Center for Transforming
Healthcare’s Hand-off Communications Project. That project involved 10
hospitals that used the Robust Process Improvement® (RPI®) and its Targeted Solutions
Tool® (TST®) for Hand-off Communications to identity the root causes of and
solutions to the problem of inadequate hand-offs. The Sentinel Event Alert
illustrates how one hospital reduced its ineffective hand-offs by almost 60
percent while reducing the number of adverse events related to hand-off
communication, using the TST® tool. It also discusses the I-PASS program, which
we’ve written about extensively.
The Sentinel Even Alert emphasizes the need for leadership
to prioritize a systemic approach to handoffs and provide appropriate resources
for such. It recommends that content of handoffs be standardized and
standardized tools (forms, templates, checklists, protocols, mnemonics, etc.) should
be used. It notes that mnemonics (like I-PASS) may be helpful in guiding
handoffs but the training and culture are critical to effective handoffs. Content
should be in both verbal and written form and handoffs preferably should be
face-to-face, with ample time and opportunities to ask questions. Locations for
conducting handoffs should be free from interruptions, and include multidisciplinary
team members and the patient and family, as appropriate. It lists various items
and parameters that should be part of handoffs. While it stresses the
face-to-face communication, it does recognize that the electronic medical
record and other technologies may be used to enhance the handoff process.
Importance should be placed on training in conducting
handoffs, using tools like real-time observation and performance feedback, role-playing
and simulation, use of champions and coaches, and independent learning.
It also stresses that you need to have some way of measuring
and monitoring the success of handoffs and the impact on adverse events.
The Sentinel Event Alert is well referenced and has good
recommendations. While it emphasizes standardizing content and tools, we don’t
think they are suggesting that the same content and tools be used for all
handoffs across the organization. In our many columns listed below we have
emphasized that the content and format of handoffs may differ based upon the
type of transition of care occurring.
Read about many other
handoff issues (in both healthcare and other industries) in some of our
previous columns:
May 15, 2007 “Communication,
Hearback and Other Lessons from Aviation”
May 22, 2007 “More
on TeamSTEPPS™”
August 28, 2007 “Lessons
Learned from Transportation Accidents”
December 11,
2007 “Communication…Communication…Communication”
February 26, 2008
“Nightmares….The
Hospital at Night”
September 30, 2008 “Hot
Topic: Handoffs”
November 18, 2008 “Ticket
to Ride: Checklist, Form, or Decision Scorecard?”
December 2008 “Another
Good Paper on Handoffs”.
June 30, 2009 “iSoBAR:
Australian Clinical Handoffs/Handovers”
April 25, 2009
“Interruptions,
Distractions, Inattention…Oops!”
April 13, 2010 “Update
on Handoffs”
July 12, 2011 “Psst!
Pass it on…How a kid’s game can mold good handoffs”
July 19, 2011
“Communication
Across Professions”
November 2011 “Restricted
Housestaff Work Hours and Patient Handoffs”
December 2011 “AORN
Perioperative Handoff Toolkit”
February 14, 2012
“Handoffs
– More Than Battle of the Mnemonics”
March 2012 “More
on Perioperative Handoffs”
June 2012 “I-PASS
Results and Resources Now Available”
August 2012 “New
Joint Commission Tools for Improving Handoffs”
August 2012 “Review
of Postoperative Handoffs”
January 29, 2013 “A
Flurry of Activity on Handoffs”
December 10, 2013 “Better
Handoffs, Better Results”
February 11, 2014 “Another
Perioperative Handoff Tool: SWITCH”
March 2014 “The
“Reverse” Perioperative Handoff: ICU to OR”
September 9, 2014 “The
Handback”
December 2014 “I-PASS
Passes the Test”
January 6, 2015 “Yet
Another Handoff: The Intraoperative Handoff”
March 2017 “Adding
Structure to Multidisciplinary Rounds”
August 22, 2017 “OR
to ICU Handoff Success”
References:
TJC (The Joint Commission). Inadequate hand-off
communication. Sentinel Event Alert 2017; 58: 1-6 September 12, 2017
https://www.jointcommission.org/assets/1/18/SEA_58_Hand_off_Comms_9_6_17_FINAL_(1).pdf
Print “October
2017 Joint Commission Sentinel Event Alert on Handoffs”
Print “October
2017 What's New in the Patient Safety World (full
column)”
Print “October
2017 End of the Oxygen in MI and Stroke Debate?”
Print “October
2017 Updated Guidelines for VAP and HAP”
Print “October
2017 More Support for Disclosure and Apology”
Print “October
2017 Joint Commission Sentinel Event Alert on Handoffs”
Print “PDF
version”
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