What’s New in the Patient Safety World

October 2017



·         End of the Oxygen in MI and Stroke Debate?

·         Updated Guidelines for VAP and HAP

·         More Support for Disclosure and Apology

·         Joint Commission Sentinel Event Alert on Handoffs




End of the Oxygen in MI and Stroke Debate?



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






Hofmann R, James SK, Jernberg T, et al. Oxygen Therapy in Suspected Acute Myocardial Infarction. NEJM 2017; published online first August 28, 2017




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)







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Updated Guidelines for VAP and HAP



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.







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







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More Support for Disclosure and Apology



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:








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




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




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






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Joint Commission Sentinel Event Alert on Handoffs



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







TJC (The Joint Commission). Inadequate hand-off communication. Sentinel Event Alert 2017; 58: 1-6 September 12, 2017






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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




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