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October 5, 2021
Wrong Side Again
The State of Florida Board of Medicine recently fined a physician $2,500 and issued a letter of concern after he performed surgery on the wrong testicle (Neal 2021). In addition, the physician must take some continuing medical education courses and give lecture at a medical facility on wrong-site surgeries.
The patient was scheduled for a varicocelectomy. Prior to the procedure, while in conversation with the patient, the physician marked the right testicle (the incorrect testicle) for the procedure. Following his erroneous mark, he did a varicocelectomy on the right testicle. But, during the procedure, he realized that the patient had consented to a left testicle varicocelectomy. He then performed a left testicle varicocelectomy.
Since the physician was the Board of Medicine’s purview, it is apparent why the focus was on the physician’s role. But what about the facility’s role? There should have been several opportunities to prevent this wrong-site mistake. We discuss those opportunities below.
Opportunities to prevent wrong-site surgery occur during:
Let’s start with the booking of the surgical case. In our October 30, 2012 Patient Safety Tip of the Week “Surgical Scheduling Errors” we highlighted a study by Wu et al. (Wu 2012), who did a qualitative and quantitative analysis of errors occurring during the surgical booking/scheduling process and identified not only patient safety issues but also analyzed the costs associated with the delays such errors end up causing. Looking at over 17,000 surgeries they found a booking error rate of 0.86%. Of the booking errors wrong side was listed on 36%. Another 25% were incomplete and may not have included the laterality. Wrong approach (eg. laparoscopic rather than open) accounted for 17% of the errors. Other booking errors included wrong patient information, wrong procedure, wrong site, and even wrong patient. Most of the errors were caught in the holding area or the OR but some were caught in the admission/registration area or assessment areas. The errors were discovered about equally between the first case of the day, the rest of the morning, and afternoon.
Your surgical booking process should require specific items be filled in and specific documents received before giving that case a final time slot. For example, you should require a copy of the informed consent and the history and physical before booking so that you can match the information on those against the scheduled procedure. Note that having a copy of the history and physical will also allow you to identify cases in which the H&P will “expire” before the 30-day Joint Commission requirement. You should also include pre-op orders where appropriate (eg. for prophylactic antibiotics).
Your booking form should also have an area any needed special equipment or implants can be recorded. We also recommend you have an area that indicates whether a surgical specimen (for pathology) is anticipated.
Abbreviations on booking logs and forms can be problematic and should not be used. Ophthalmologists like to use OD/OS for right eye and left eye in their notes. They should spell out right eye and left eye. We’ve seen cases where “OD” gets misinterpreted as “AD” and antibiotic drops get put in the right ear instead of the right eye. Similarly, some of us like to indicate right or left or bilateral by using circles around an “R”, “L”, or “B” respectively. That is particularly dangerous in scheduling since it is very easy to mistake these for the wrong side. Note that fax artifacts can further lead to misinterpretation of some abbreviations (see our June 19, 2012 Patient Safety Tip of the Week “More Problems with Faxed Orders” for a discussion on types of errors related to faxes and how to avoid them). So, you really shouldn’t use abbreviations at all on your booking forms. Similarly, you should not use acronyms on your scheduling forms since all parties may not understand those.
Surgical procedure codes may not match the description of the procedure being scheduled. For those who enter a procedure code on the scheduling form we always recommend a written description also be included so that staff can cross check to make sure what the intended procedure is and reconcile any discrepancies.
If more than one procedure is being scheduled on the patient, be sure that the consent form includes all the procedures (and that the other information for that subsequent procedure is also included if relevant).
Availability of imaging studies is another important facet to be considered during scheduling. Some hospitals or ASC’s (ambulatory surgery centers) include a checkbox on their booking form for the need for images to be present in the OR and clarify who is responsible for being sure those images are present. The same applies to copies of office notes. Having copies of office notes available may become critical when a discrepancy is noted when the patient is in the pre-op area or OR.
We also recommend that the surgical booking should include a question about whether a surgical specimen is likely to be taken. That can be of value in preparing staff to receive and correctly process any specimens and avoid lost or misplaced surgical specimens (note that this should also be an item on your Surgical Safety Checklist or equivalent).
Often it is a non-clinical person calling in the case from the physician’s office or clinic and just as often a non-clinical person is receiving the request at the facility and entering it into the schedule. That certainly can add vulnerabilities to scheduling. The Minnesota Alliance for Patient Safety, which has great resources on surgery scheduling and verification on its Safe Surgery website, has a scheduling form template. An important facet of that form is that there is a section that must be completed by the surgeon (or physician performing the procedure).
And there is one logical question that very few hospitals consider when scheduling cases: are there patients with similar names or similar sounding names scheduled on that same day? Our many columns on patient misidentification (see, for example, our March 26, 2019 Patient Safety Tip of the Week “Patient Misidentification”) discuss the frequency with which patients having similar sounding names are in the hospital at any one time. One statistic we like to point out is that, in one hospital district in Texas, 2488 patients were named Maria Garcia, and 231 of these (9.3%) also shared the same date of birth (Lippi 2017b)! Where possible, you should attempt to schedule cases with similar names on different days. If you can’t, you should attempt to somehow flag such cases with similar names on the paper or electronic schedule and on the surgical schedule white board.
The absence of primary source documents at any of these levels is a major factor contributing to wrong-site events. In some cases, the documents are available but staff do not take the time to review them. We suspect that may be more of a problem when doing what some would consider “minor” procedures.
Primary source documents include office notes or hospital admission notes, the booking document, the signed informed consent, and any relevant imaging studies. One critical issue we often see relates to the availability of the H&P at the time of surgery. Particularly since most patients having elective surgery are admitted on the day of surgery or are having same day surgery, the H&P must be available in advance. We’ve seen cases where the surgeon dictates the H&P on the day of admission and a readable copy may not be available for all the OR players to read. Therefore, it is imperative that your OR require the H&P from the surgeon’s office be available prior to the day of surgery (and remember it must be appropriately updated when it is done in advance). Having a “surgical home” is a good way to ensure this, whether the “surgical home” is staffed by surgeons, anesthesiologists, or preferably a multidisciplinary group. The other way, as described in our October 30, 2012 Patient Safety Tip of the Week “Surgical Scheduling Errors” is to cancel any elective cases for which a copy of both the informed consent and the H&P are not available at least a couple days in advance of the scheduled procedure.
But, speaking of primary source documents, what do you allow in the OR? We have seen cases where surgeons brought into the OR medical records or radiology images on multiple patients, not just the patient currently being operated on. That, of course, increases the risk that someone may inadvertently refer to the record of a different patient. We recommend you never allow records of more than one patient in the OR at a time. Find a place for the surgeon to temporarily store all those other records outside the OR.
A second opportunity to verify patient, site, laterality, and procedure is in the pre-surgical clinic or “surgical home”. Many of these are run by anesthesiologists, nurse practitioners, physician’s assistants, or surgeons themselves, though we prefer the truly multidisciplinary clinic. But we won’t go into detail about such pre-surgical venues since not all patients are seen in them.
A third important event in preventing wrong site surgery is the informed consent. We discussed this in detail in our September 10, 2013 Patient Safety Tip of the Week “Informed Consent and Wrong-Site Surgery”. In that column we note that the preoperative area is not the appropriate place for the informed consent process to take place. Proper informed consent requires the physician or practitioner provide the patient with details of the procedure, the potential benefits and potential harms, and the alternatives (including what might happen with the alternative of doing nothing). That discussion takes time and there must be adequate opportunity for the patient (and any surrogate) to ask questions. The pressures in the preoperative area cause considerable truncation of the informed consent process. Moreover, once a patient has committed to coming to the hospital or ASC for a procedure, they are very unlikely to say no. So, the more appropriate place for the informed consent to be performed is the physician’s office, clinic, or inpatient bedside if the patient is already admitted.
We strongly recommend that you not schedule surgery until you (the hospital or ASC) have in hand copies of the H&P, the booking form, the consent form, and imaging studies. While you might provide a tentative date and time for surgery you must have a “drop dead” date on which you will cancel that tentatively scheduled slot if you have not received these items. Things like the H&P may need updating to meet regulatory time frames, but you should have available at least the H&P from the office at the time the case was originally scheduled.
Having the consent form ahead of time will help in the preoperative verification process. It should prompt the surgeon to address the issues well before the day of the procedure and allow preoperative personnel to spot discrepancies long before the day of surgery so they can be resolved. We suggest all hospitals and ASC’s do spot audits to determine how frequently informed consents are being done on the day of the case rather than being done in advance.
The next opportunity to verify patient, site, laterality, and procedure is the pre-op “huddle”. Done correctly, the pre-op huddle includes the surgeon/operator, anesthesiologist, and circulating nurse plus the patient (before the patient has been administered any medications that might cloud his/her cognition). The pre-op huddle is a good time to ensure that all necessary equipment, supplies, implants, primary source documents, and images are ready to go and to discuss potential contingencies. That is also a good time to perform the surgical site marking so that multiple team members can verify the site marking.
Aside from the surgical “time out”, site marking has probably been one of the most important interventions aimed at reducing wrong-surgery events. Protocols do exist for site marking for most surgical specialties. But, in general, the site should be marked with indelible ink and the mark should be as close to the incision site as possible (keeping in mind how surgical draping might relate to that mark). See our May 14, 2019 Patient Safety Tip of the Week “Wrong-Site Surgery and Difficult-to-Mark Sites” for a discussion on marking those sites that are midline or otherwise difficult to mark. The site marking should be verified by the surgeon (or clinician responsible for the procedure) and the responsible nurse. Note that we also recommend including the anesthesiologist if the site marking is done as part of the pre-op “huddle”. And the patient must be included in verification of the site and the procedure to be performed. That means this must be done before the patient is administered any medications that might cloud his/her cognition. If the patient is incapable of participating in the site verification, a patient family member or other advocate should participate. And remember to have an interpreter for patients who don’t speak English or a signer for the hearing impaired patient present for the site marking. Note that the Minnesota Alliance for Patient Safety scheduling form template, mentioned above, includes an item regarding need for an interpreter.
The surgical time out and use of the Surgical Safety Checklist (or equivalent) are the last lines of defense for preventing wrong site surgery. See our many prior columns listed below for details on time outs and use of the checklists. But it is critical that you have full attention of all the surgical team members during the surgical time out and use of the checklist(s). Failure to speak up remains a problem in cases of wrong-site surgery. Unfortunately, the persistence of hierarchies in the OR remains problematic and all too often staff are afraid to speak up when they have questions. It is crucial that hospital clinical and administrative leadership support, not just with words but also with actions, a culture where all member of the team are encouraged to speak up.
We are often dismayed that hospitals or ambulatory surgery centers have no idea what their time out compliance rate is. A recent article in Outpatient Surgery (Bouchat-Friedman 2021) described how a hospital improved its time out compliance rate from 60% to 80-90%. But there is no reason you should not have rates of nearly 100%, especially for non-emergency procedures.
And we are not just talking about whether a surgical time out took place. We are talking about active participation by all OR staff during the time out. Our May 2020 What's New in the Patient Safety World column “Poor Timeout Compliance: Ring a Bell?” discussed how frequently one or more individuals are distracted during the time out.
How do you audit compliance with time outs? You can have an observer in the room to assess compliance. But the mere presence of an observer typically leads to the OR team complying with the time out in that session (the Hawthorne effect). Alternatively, as we have often recommended, you can use audio/video recording. A good system uses audio/video recording not only to audit time outs, but also to provide critiques to improve the time out process.
The Bouchat-Friedman article (Bouchat-Friedman 2021) focused on building a culture of safety. They found that, by giving each team member a specific role in the time out process, team members had less fear of speaking up if a potential problem is detected, and it also emphasizes the importance of the time out process.
They also note the importance of designating a specific team member to lead the time out. They recommend that individual should be someone who can refer to the consent form in the chart in order to ensure that what's noted on it matches the patient identifiers verbalized during the time out. We’ll add that they must also have access to all primary source documentation, including any relevant imaging studies and reports.
The Bouchat-Friedman article also emphasizes the importance of having support from the top of the organization, as we’ve emphasized above. They discuss an individual who still refused to take part in the process, so concerns were escalated up the chain of command and the hospital's leadership fully supported those efforts and made sure that individual was an active participant in the time out process moving forward.
The article goes on to discuss use of “awake time outs” where the patient can participate in the process. Our personal recommendation is that the items typically included in the surgical time out also be discussed in the pre-op “huddle”. Done correctly, the pre-op huddle includes the surgeon/operator, anesthesiologist, and circulating nurse plus the patient (before the patient has been administered any medications that might cloud his/her cognition).
Don’t forget that the time out should be repeated any time there is a change in the surgical team. For example, if a second surgeon enters the OR after the case has begun, a second time out should occur.
Patient positioning in the OR can also be a factor contributing to wrong-site events. If a patient’s position is changed during the procedure, there may be right-left confusion. Also, in our September 2021 What's New in the Patient Safety World column “Ambiguous Language in the OR” we noted it is a good idea to define a directional frame of reference at the start of a procedure, eg. left-right from the patient’s perspective or the surgeon’s prospective, use “toward the head” rather than “up/down”, etc. (Liu 2021). Change in position of the patient can also obscure the site marking. It’s a good practice to discuss right-left orientation with all staff any time you change a patient’s position.
The Pennsylvania Patient Safety Authority, which for many years has reported extensively on wrong-site surgery and wrong procedures, did its most recent extensive report last year (Yonash 2020). From the Pennsylvania Patient Safety Reporting System (PA-PSRS) database over a five-year period from 2015 to 2019, the authors found 368 instances of wrong-site surgery, 76% of which contributed to or resulted in temporary harm or permanent harm to the patient. That was an average of 1.42 wrong-site surgery events per year in Pennsylvania. Events occurred at both acute care hospitals (79%) and ambulatory surgical facilities (21%). There wasn’t much change in event frequency for this period compared to the previous two fiver-year periods (mean frequency 65.8, 51, and 58 during the five-year periods of 2005-2009, 2010-2014, and 2015- 2019, respectively).
The distribution by error type was: wrong side (52.7%), wrong site (31.5%), wrong procedure (12.5%), wrong patient (2.7%). Almost all body sites were affected, with spine procedures accounting for the largest portion (24%), followed by head/neck (17%), lower extremity (14%), and upper extremity (13%). Almost every specialty experienced wrong-site surgery events, though the type of event varied by specialty. For example, pain management was primarily associated with wrong side errors while interventional radiology had a relation with several types of error (wrong side, wrong site, and wrong procedure). And within specialties, certain procedures were more likely related to wrong-site surgical events. For example, in urology, procedures involving stents were over-represented.
The authors finish with a nice table containing 14 strategies to reduce the likelihood of wrong-site surgery, broken into the following 3 categories.
We’ve discussed most of those strategies above.
A recent Medscape article had some sobering statistics on wrong-site surgery (Page 2021). It noted studies which found that 25% of neurosurgeons had performed wrong-site surgeries and 25% of orthopedic surgeons reported performing at least one wrong-site surgery during their career. And it’s often more experienced surgeons who are involved in wrong-site surgery cases. Page notes that two thirds of the surgeons who perform wrong-site surgeries are in their 40s and 50s, compared with fewer than 25% younger than 40. Page also notes this “chilling statistic”: 12.4% of doctors who were involved in sentinel events in general had claims for more than one event.
Not all “wrong side” events are technically “surgeries”. For many years, the most frequent wrong site events in New York State were wrong side chest tube insertions. And wrong side thoracenteses can lead to pneumothoraxes (see our July 2014 What's New in the Patient Safety World column “Wrong-Sided Thoracenteses”). More recently, wrong side nerve blocks have topped the list in some states. Discussion of those is beyond the scope of today’s column but we refer you to good discussions of wrong side nerve blocks and strategies to prevent them (Vandebergh 2021, Balocco 2019). And, in our September 14, 2021 Patient Safety Tip of the Week “Wrong Eye Injections”, we discussed intraocular injections into the wrong eye. So, it is incumbent upon organizations to ensure that pre-procedure time outs and use of checklists are used for all procedures, whether in the OR or elsewhere. We often recommend policies and procedures that require a pre-procedure checklist be completed before the “procedure tray” is dispensed and opened. Some hospitals and ASC’s are using that concept for surgeries as well as procedures.
Some of our prior columns related to wrong-site surgery:
September 23, 2008 “Checklists and Wrong Site Surgery”
June 5, 2007 “Patient Safety in Ambulatory Surgery”
July 2007 “Pennsylvania PSA: Preventing Wrong-Site Surgery”
March 11, 2008 “Lessons from Ophthalmology”
July 1, 2008 “WHO’s New Surgical Safety Checklist”
January 20, 2009 “The WHO Surgical Safety Checklist Delivers the Outcomes”
September 14, 2010 “Wrong-Site Craniotomy: Lessons Learned”
November 25, 2008 “Wrong-Site Neurosurgery”
January 19, 2010 “Timeouts and Safe Surgery”
June 8, 2010 “Surgical Safety Checklist for Cataract Surgery”
December 6, 2010 “More Tips to Prevent Wrong-Site Surgery”
June 6, 2011 “Timeouts Outside the OR”
August 2011 “New Wrong-Site Surgery Resources”
December 2011 “Novel Technique to Prevent Wrong Level Spine Surgery”
October 30, 2012 “Surgical Scheduling Errors”
January 2013 “How Frequent are Surgical Never Events?”
January 1, 2013 “Don’t Throw Away Those View Boxes Yet”
August 27, 2013 “Lessons on Wrong-Site Surgery”
September 10, 2013 “Informed Consent and Wrong-Site Surgery”
July 2014 “Wrong-Sided Thoracenteses”
March 15, 2016 “Dental Patient Safety”
May 17, 2016 “Patient Safety Issues in Cataract Surgery”
July 19, 2016 “Infants and Wrong Site Surgery”
September 13, 2016 “Vanderbilt’s Electronic Procedural Timeout”
May 2017 “Another Success for the Safe Surgery Checklist”
May 2, 2017 “Anatomy of a Wrong Procedure”
June 2017 “Another Way to Verify Checklist Compliance”
March 26, 2019 “Patient Misidentification”
May 14, 2019 “Wrong-Site Surgery and Difficult-to-Mark Sites”
May 2020 “Poor Timeout Compliance: Ring a Bell?”
September 14, 2021 “Wrong Eye Injections”
See our prior columns on huddles, briefings, and debriefings:
References:
Neal DJ. A Tampa doctor did surgery on the wrong testicle, state board finds. Miami Herald 2021; June 2, 2021
Wu RL, Aufses AH. Characteristics and costs of surgical scheduling errors. Am J Surg 2012; 204(4): 468-473, October 2012
https://www.americanjournalofsurgery.com/article/S0002-9610%2812%2900191-2/fulltext
Minnesota Alliance for Patient Safety
https://mnpatientsafety.org/safe-surgery
Minnesota Alliance for Patient Safety scheduling form template
https://mnpatientsafety.org/sites/default/files/uploads/attachments/scheduling-form-template.doc
Lippi G, Chiozza L, Mattiuzzi C, Plebani M. Patient and Sample Identification. Out of the Maze? J Med Biochem 2017; 36(2): 107-112. Published online April 22, 2017
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5471642/
Bouchat-Friedman D. Run More Effective Time Outs. Standardized protocols, clear communication and engaged team members lead to safer patient care. Outpatient Surgery 2021; June 28, 2021
https://www.aorn.org/outpatient-surgery/articles/outpatient-surgery-magazine/2021/july/timeout
Liu C, McKenzie A, Sutkin G. Semantically Ambiguous Language in the Teaching Operating Room. Journal of Surgical Education 2021; Article in press 23 April 2021
https://www.sciencedirect.com/science/article/abs/pii/S1931720421000738?via%3Dihub
(Liu 2021)
Yonash R, Taylor M. Wrong-Site Surgery in Pennsylvania During 2015–2019: A Study of Variables Associated With 368 Events From 178 Facilities. Patient Safety 2020; 2(4), 24–39
https://patientsafetyj.com/index.php/patientsaf/article/view/wrong-site-surgery
Page L. MDs Doing Wrong-Site Surgery: Why Is It Still Happening? Medscape Medical News 2021; September 29, 2021
https://www.medscape.com/viewarticle/959938
Vandebergh V, Coll V, Keunen B. Prevention of Wrong-Side Nerve Blocks: Part 2. Anesthesiology News 2021; September 20, 2021
Balocco AL, Kransingh S, Lopez A, et al. Wrong-Side Nerve Blocks And the Use of Checklists. Part 1. Anesthesiology News 2019; October 19, 2019
Print “Wrong Side Again”
October 12, 2021
FDA Approval of Concussion Tool - Why Not a Fatigue Detection Tool?
The recent FDA clearance of a device that uses eye tracking to predict concussion (Brooks 2021) rekindled our curiosity about use of eye tracking as a patient safety tool. The EYE-SYNC technology includes neurocognitive batteries, symptom inventories, and standardized patient inventories to identify the type and severity of dysfunction after concussion. But the heart of the system is that it utilizes a series of 60-second eye tracking assessments under virtual reality. A clinical study showed that EYE-SYNC demonstrated sensitivity above 82% and specificity above 93%, for predicting concussion.
But our interest is in use of eye tracking methodologies to identify fatigue in healthcare workers. Our many columns listed below have highlighted the role fatigue in healthcare workers plays in medical errors and patient safety. We, ourselves, are not very good at recognizing when we are already in the early throes of fatigue. Hence, we need more objective methods of predicting and identifying fatigue. We’ve always suspected we will ultimately adopt technology as a means to identify fatigue earlier. In our July 29, 2014 Patient Safety Tip of the Week “The 12-Hour Nursing Shift: Debate Continues” we predicted that someday we will have the equivalent of the brief “sobriety” or “breathalyzer” test that can rapidly identify healthcare workers who are impaired by fatigue. We might envision that at regular intervals beyond 8 hours (maybe even sooner) or during periods of prolonged concentration the healthcare worker will get buzzed on his/her smartphone and have to complete some simple test of reaction times or attention span. If the worker scores outside the established threshold the hospital will need to have resources in place to take over duties of that worker (completely or at least temporarily until fatigue is alleviated by, for example, a nap).
Well, eye tracking has the capability to be that “breathalyzer” test equivalent and could potentially be performed in a nonobtrusive manner. There are a variety of ocular phenomena that can be used to detect early fatigue. In addition to eyelid drooping, alteration of saccadic eye movements, number of fixations, fixation durations, changes in the blink rate, and changes in pupillary responses may be early signs of fatigue.
Much of the work on the relationship between eye movements and fatigue has been done on people using computers. In healthcare, a logical specialty to analyze is the radiologist. Radiologists often spend long periods at computer screens reading various types of imaging. Our January 19, 2021 Patient Safety Tip of the Week “Technology to Identify Fatigue?” discussed many of those studies involving radiologists.
Of course, other occupations where fatigue is a significant factor leading to errors and accidents include airline pilot, bus driver, train engineer, etc. There is probably more research ongoing to come up with ways to identify fatigue in those occupations than in healthcare. Naeeri and colleagues (Naeeri 2021) recently performed a multimodal analysis of eye movements and fatigue in a simulated glass cockpit environment. The researchers first reviewed the literature on methods of assessing pilot fatigue, including psychometric testing, various physiologic testing, and eye tracking.
They noted that eye tracking can be done in a nonintrusive manner and can provide measures such as eye fixation position (or location), duration, pupil dilation, visual scanpath (i.e., the time order of the eye fixations that occurred on display), saccade, blink, and eyelid closure, in which eyelid closure slowed as fatigue increased and saccadic velocity decreased as fatigue increased after long simulated flights.
They correlated eye tracking with results of psychometric vigilance tests (PVT) and reaction times. The complicated regression models they used to assess the eye tracking results are beyond the scope of our column. You can see them in the Naeeri article itself, along with details of the psychomotor vigilance test used and the equipment used to do the eye tracking, plus the various tasks and procedures monitored in the pilots.
As in previous research, the increase in fatigue was verified through the PVT measures of reaction time, number of lapses, and number of false starts. The results allowed them to devise a unified PVT measure of combining three measures to quantify a fatigued state as a single point. As fatigue increased, eye fixation duration increased, visual entropies (i.e., transition and stationary) increased, eye fixation number decreased, and pupil size decreased. These phenomena enabled the researchers to discover viable fatigue prediction models based on expertise and using eye movement measures. Moreover, they found that there were differences between experienced and novice pilots. Unlike novices, the expert pilots had a greater number of eye fixations and shorter eye fixation duration. That suggests that more eye fixations might indicate more active information processing, whereas longer eye fixation might indicate the pilot needing more time to focus and process the information of interest. In addition, pupil size became progressively smaller for both expert and novices as fatigue increased but the experts’ pupil size remained relatively larger compared to the novice pilots as the task number increased. All this suggests that the experienced pilots were able to keep the arousal state better than the novices. It would certainly be of interest to see whether similar disparities exist in more experienced healthcare workers compared to more “novice” ones.
But only performing the test at a specified time (the “breathalyzer” model) would obviously miss many cases where a healthcare worker is already fatigued and at risk for committing errors. And it would require the healthcare worker take the time to administer the test, whether it is a psychomotor or physiologic test. Hence, the need for an unobtrusive tool. Sure, we could strap EEG electrodes to the heads of all healthcare workers and see the earliest signs of fatigue and lack of vigilance. But that obviously is impractical. We need an unobtrusive method similar to that used by Naeeri and colleagues in the simulated cockpit study.
Obviously, it would take considerable engineering expertise to develop similar eye tracking assessment methods in various healthcare settings, but these could theoretically be used to help identify fatigue and loss of vigilance in real time. We can envision implementation of such systems on almost any computer terminal that might be used by physicians, nurses, pharmacists, etc. It might even be applied to any situation in which sustained concentration for long periods is required (eg. during a surgical procedure), with strategically located cameras in the OR to do eye tracking in surgeons and other members of the surgical team.
The subsequent question is “what do you do with the results?” If a healthcare worker shows findings compatible with fatigue at the end of a first shift, you would preclude overtime (or at least consider a rest period prior to any overtime work). If a test performed, say 6 hours into a shift, shows findings compatible with fatigue, you might consider an intervention such as a quick nap (see our November 2012 What's New in the Patient Safety World column “The Mid-Day Nap” and our September 6, 2016 Patient Safety Tip of the Week “Napping Debate Rekindled”). For a radiologist, it might mean stepping away from the computer screen for a specified period of time. Or for a pharmacist preparing and dispensing medications, it might call for a brief rest break. But the dilemma becomes more complicated if you were to identify signs of fatigue in a surgeon in the midst of an operation.
We hope you’ll goo back to our January 19, 2021 Patient Safety Tip of the Week “Technology to Identify Fatigue?” for discussion of multiple studies using eye tracking technology in a variety of settings. This technology is a tool with great potential in healthcare and patient safety. It might provide an easy, inexpensive way to identify fatigue in healthcare workers. But the next question would be whether interventions based upon such detection can actually reduce errors in patient care. It’s about time these relatively simple techniques find their niche in healthcare.
Some of our other columns on the role of fatigue in Patient Safety:
November 9, 2010 “12-Hour Nursing Shifts and Patient Safety”
April 26, 2011 “Sleeping Air Traffic Controllers: What About Healthcare?”
February 2011 “Update on 12-hour Nursing Shifts”
September 2011 “Shiftwork and Patient Safety
November 2011 “Restricted Housestaff Work Hours and Patient Handoffs”
January 2012 “Joint Commission Sentinel Event Alert: Healthcare Worker Fatigue and Patient Safety
January 3, 2012 “Unintended Consequences of Restricted Housestaff Hours”
June 2012 “June 2012 Surgeon Fatigue”
November 2012 “The Mid-Day Nap”
November 13, 2012 “The 12-Hour Nursing Shift: More Downsides”
July 29, 2014 “The 12-Hour Nursing Shift: Debate Continues”
October 2014 “Another Rap on the 12-Hour Nursing Shift”
December 2, 2014 “ANA Position Statement on Nurse Fatigue”
August 2015 “Surgical Resident Duty Reform and Postoperative Outcomes”
September 2015 “Surgery Previous Night Does Not Impact Attending Surgeon Next Day”
September 29, 2015 “More on the 12-Hour Nursing Shift”
September 6, 2016 “Napping Debate Rekindled”
April 18, 2017 “Alarm Response and Nurse Shift Duration”
July 11, 2017 “The 12-Hour Shift Takes More Hits”
February 13, 2018 “Interruptions in the ED”
April 2018 “Radiologists Get Fatigued, Too”
August 2018 “Burnout and Medical Errors”
September 4, 2018 “The 12-Hour Nursing Shift: Another Nail in the Coffin”
August 2020 “New Twist on Resident Work Hours and Patient Safety”
August 25, 2020 “The Off-Hours Effect in Radiology”
September 2020 “Daylight Savings Time Impacts Patient Safety?”
January 19, 2021 “Technology to Identify Fatigue?”
References:
Brooks M. FDA Clears First Mobile Rapid Test for Concussion. Medscape Medical News 2021; October 05, 2021
https://www.medscape.com/viewarticle/960300
Naeeri S. Kang Z. Mandal S. Kim K. Multimodal Analysis of Eye Movements and Fatigue in a Simulated Glass Cockpit Environment. Aerospace 2021; 8: 283
https://www.mdpi.com/2226-4310/8/10/283
Print “FDA Approval of Concussion Tool – Why Not a Fatigue Detection Tool?”
October 19, 2021
COVID-19 Vaccine/
Flu Vaccine Mixups
On October 15, 2021 a headline read that 2 children in Indiana, aged 4- and 5-years old, were mistakenly administered the coronavirus vaccine rather than the intended flu vaccines (Genovese 2021). On the same day, ISMP (Institute for Safe Medication Practices) issued a NAN (National Alert Network) alert regarding mix-ups between the influenza (flu) vaccine and COVID-19 vaccines (ISMP 2021).
It was probably inevitable – COVID-19 vaccines get mistaken for influenza vaccines and vice versa. We’ve entered the time period where annual influenza vaccines are being administered at the same time we are seeing more patients receiving a COVID-19 vaccine or booster.
The ISMP NAN alert (ISMP 2021) notes that ISMP received reports of 16 cases of accidental influenza and coronavirus disease 2019 (COVID-19) vaccine mixups. All the events occurred in community/ambulatory care pharmacies. The alert goes on to describe multiple contributing factors:
Since both patients and clinicians have been told that it is safe to get both the COVID-19 and influenza vaccines at the same time, it is increasingly likely that materials for both vaccines will be present at the same time in offices, clinics, pharmacies, and other venues where vaccinations are being offered.
The problem is not unique to the COVID-19 vaccine. Our November 19, 2019 Patient Safety Tip of the Week “An Astonishing Gap in Medication Safety” was all about mistakes made in community vaccination programs. We gave examples of patients being administered insulin instead of flu vaccines and neuromuscular blocking agents (NMBA’s) instead of measles or hepatitis vaccines.
In hospitals and many clinic sites or physician offices we use a variety of tools to improve medication safety. These include barcoding, CPOE with clinical decision support, double checks, segregation of LASA (look-alike sound-alike) drugs in storage, ADC’s (automated dispensing cabinets) with alerts, “Do Not Disturb” vests to minimize distractions and interruptions during nurse medication rounds, smart pumps, and others. But those valuable tools are not used in many of the other healthcare venues where vaccines are administered, such as community pharmacies and “drive-thru” vaccination sites.
In community pharmacies, the pharmacist is often busy both preparing and dispensing medications as well as administering vaccinations. And today’s pharmacies are experiencing not only professional staff shortages, but many are also seeing shortages of non-professional staff. So, sometimes pharmacists are even performing tasks usually done by non-professional staff. Given how busy those pharmacies are, it is easy to see how distractions and interruptions might contribute to errors. The lack of a second clinician to perform an independent double check is also a problem in many community pharmacies.
The ISMP NANA alert goes on to describe measures to prevent such mixups from occurring:
In our November 19, 2019 Patient Safety Tip of the Week “An Astonishing Gap in Medication Safety” we noted there are guidelines for doing mass vaccination programs. The CDC has published “Guidelines for Large-Scale Influenza Vaccination Clinic Planning” (CDC 2015). The CDC guideline also has a link to a valuable skills checklist from Immunize.org for those administering the vaccines. CDC also has a “Vaccine Storage and Handling Toolkit” and Immunize.org also has a nice “Checklist for Safe Vaccine Storage and Handling”. Immunize.org has a wealth of valuable materials for those providing immunizations. One of their resources is a handout “Don’t Be Guilty of These Preventable Error s in Vaccine Administration!”, which describes common mistakes in vaccine administration.
And we offered the following questions you should be asking if your organization provides vaccinations:
There are obviously many other considerations in vaccine programs. We are only considering some of the safety issues associated with the processes of vaccine programs. We refer you to many other good resources involving all those other vaccination program issues, such as the CDC guidelines, Immunize.org resources, and ACIP (ACIP, Ezeanolue 2019) recommendations.
Fortunately, such mixups related to vaccination are relatively rare, but we can anticipate that they will increase during this period where a flurry of both coronavirus vaccinations and influenza vaccinations are being given. And, of course, there are numerous other vaccinations being given (shingles, hepatitis, HPV, etc.) that could also become part of similar vaccine mixups. Now is a good time for all organizations that provide vaccinations to review their practices. You could do a FMEA (Failure Mode and Effects Analysis) to identify potential vulnerabilities, but don’t wait to do your FMEA. Heed the recommendations in the ISMP NAN alert and those in our November 19, 2019 Patient Safety Tip of the Week “An Astonishing Gap in Medication Safety”.
References:
Genovese D. Walgreens says vaccine mix-ups are rare after Indiana family claims kids received COVID, not flu shots. Fox Business News 2021; October 15, 2021
https://www.foxbusiness.com/lifestyle/walgreens-vaccine-mixups-rare-covid-flu
ISMP (Institute for Safe Medication Practices). Mix-Ups Between the Influenza (Flu) Vaccine and COVID-19 Vaccines. ISMP NAN Alerts 2021; October 15, 2021
https://www.ismp.org/alerts/mix-ups-between-influenza-flu-vaccine-and-covid-19-vaccines
CDC. Guidelines for Large-Scale Influenza Vaccination Clinic Planning. CDC 2015; December 16, 2015
https://www.cdc.gov/flu/professionals/vaccination/vax_clinic.htm
Immunize.org
Immunize.org. Skills Checklist
https://www.immunize.org/catg.d/p7010.pdf
Immunize.org. Don’t Be Guilty of These Preventable Error s in Vaccine Administration!
https://www.immunize.org/catg.d/p3033.pdf
CDC. Vaccine Storage and Handling Toolkit. CDC
https://www.cdc.gov/vaccines/hcp/admin/storage/toolkit/storage-handling-toolkit.pdf
Immunize.org. Checklist for Safe Vaccine Storage and Handling.
https://www.immunize.org/catg.d/p3035.pdf
ACIP (Advisory Committee on Immunization Practices). ACIP Vaccine Recommendations and Guidelines.
https://www.cdc.gov/vaccines/hcp/acip-recs/index.html
Ezeanolue E, Harriman K, Hunter P, Kroger A, Pellegrini C. General Best Practice Guidelines for Immunization. Best Practices Guidance of the Advisory Committee on Immunization Practices (ACIP). Accessed on November 16, 2019.
https://www.cdc.gov/vaccines/hcp/acip-recs/general-recs/downloads/general-recs.pdf
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October 26, 2021
Opioid-Induced Respiratory Depression Costly in Fiscal as Well as Human Terms
We’ve done many columns on OIRD (opioid-induced respiratory depression), highlighting the human toll associated with this phenomenon. However, a recent study has also highlighted the fiscal toll associated with OIRD (Khanna 2021a).
We discussed the PRODIGY trial in our October 20, 2020 Patient Safety Tip of the Week “More on Post-operative Risks for Patients with OSA”. PRODIGY was a prospective, observational trial of blinded continuous capnography and oximetry conducted at 16 sites in the United States, Europe, and Asia aimed at prediction of opioid-induced respiratory depression on inpatient wards (Khanna 2020). Over 1300 patients on general care floors were receiving parenteral opioids (note: patients enrolled in the US were non-surgical patients and those enrolled elsewhere were postsurgical).
46% had one or more episodes of respiratory depression. Patients with ≥1 episode of respiratory depression were 2.5 times more likely to require some rescue intervention, including activation of a rapid response team. They also experienced 3 days longer mean hospital length of stay, which adds to costs.
A prediction model was developed using 5 independent variables: age ≥60 (in decades), sex, opioid naivety, sleep disorders, and chronic heart failure. The resultant PRODIGY score accurately predicted 74% of patients who would have episodes of respiratory depression and allowed separation of 3 groups (low-, medium-, and high-risk). Patients in the high-risk group by PRODIGY score were >6 times more likely to experience OIRD than the patients in the low-risk group.
The authors suggest that implementation of the PRODIGY score could determine the need for continuous monitoring and may be a first step to reduce the incidence and consequences of respiratory compromise in patients receiving opioids on the general care floor. This could certainly be welcome in those facilities that are resource-poor and cannot afford to do universal continuous monitoring with these modalities.
Patients in PRODIGY who had a respiratory depression (RD) episode often had multiple episodes. Khanna et al. did a secondary analysis of 250 patients from two of the PRODIGY participating centers to better understand these multiple episodes (Khanna 2021b), confirming that RD episodes were rarely isolated. One hundred and fifty-five patients had an RD episode, and of these 136 (88%) had multiple episodes. The number of RD episodes per patient increased with higher PRODIGY scores. The time from end of surgery to RD episode was also analyzed. The time to the first RD episode was 8.8 hours postoperatively with a peak occurrence of first RD episodes between 14:00–20:00 the day of surgery. Many subsequent episodes also occurred during this time, but there was a peak of RD occurrences the next morning from 02:00–06:00. The results suggested that the PRODIGY score not only calculates risk for a patient having an RD episode, but that these patients have more episodes. And the time distribution of RD episodes has important implications for postoperative continuous monitoring—specifically, such monitors should be applied upon dismissal from the recovery area.
A couple other interesting observations were seen in another post hoc analysis. Opioid use was significantly higher in the United States and Europe, compared to Asia. And there were differences by opioid type. 54% of patients who received only short-acting opioids (e.g., fentanyl) experienced ≥1 OIRD episode, whereas 45% who only received long-acting opioids experienced OIRD. Another interesting finding was that tramadol and epidural opioids were associated with a significant decrease in OIRD.
The most recent analysis of the PRODIGY data (Khanna 2021a) showed that respiratory depression on the general care floor is associated with a significantly longer length of stay and increased hospital costs. Patients with ≥1 respiratory depression episode had a longer length of stay compared to patients without respiratory depression. (mean LOS 6.4 days vs. 5.0 days, p = 0.009) and higher hospital cost ($21,892 vs. $18,206, p = 0.002). Propensity weighted analysis identified 17% higher costs for patients with ≥1 respiratory depression episode ($25,057 vs. $18,608, p = 0.007). Length of stay significantly increased total cost, with cost increasing exponentially for patients with ≥1 respiratory depression episode as length of stay increased.
Patient characteristics that significantly impacted length of stay and cost included use of multiple opioids; longer, high risk, or open surgery; respiratory depression; and medical conditions including chronic heart failure, hypertension, and sepsis.
The results of this analysis have potentially important implications. Many hospitals have been reluctant to implement universal continuous monitoring (with capnography and oximetry) in patients receiving opioids on general floors. Any savings from reduction of length of stay could potentially offset the costs of such monitoring. Khanna et al. suggest that future studies should explore whether early institution of these continuous monitoring measures, in combination with early proactive intervention, such as readjustment of analgesia, optimal fluid balance, aggressive incentive spirometry, and additional bronchodilation, mitigate the occurrence of respiratory depression and decrease hospital costs associated with such episodes.
Use of the PRODIGY score may help select patients who will benefit most from continuous monitoring, but it may well turn out that universal monitoring of patients receiving opioids may make sense from both a human and financial perspective.
As an aside, since we mentioned tramadol, there were 2 pertinent developments regarding tramadol recently. The FDA approved a combination pill, containing celecoxib and tramadol, for the treatment of adults with acute pain severe enough to require an opioid analgesic and for which alternative treatments fail to provide adequate pain relief (Brooks 2021). The same week, a study from Spain was published in JAMA showing that tramadol, compared with codeine, was significantly associated with a higher risk of subsequent all-cause mortality, cardiovascular events, and fractures (Xie 2021). An editorial accompanying that study (Kim 2021) cautions that the greatest risk of tramadol may involve the perception that tramadol is inherently safer than other opioids. We echo that point. Tramadol is an opioid and the potential effects of any opioid should be considered when prescribing it. You’ll recall our May 2017 What's New in the Patient Safety World column “FDA Finally Restricts Codeine in Kids; Tramadol, Too” added a contraindication to tramadol, stating that it should not be used to treat pain in children younger than 12 years and should not be used to treat pain in children younger than 18 years after a tonsillectomy and/or adenoidectomy.
Other Patient Safety Tips of the Week pertaining to opioid-induced respiratory depression and PCA safety:
References:
Khanna AK, Saager L, Bergese SD. et al. Opioid-induced respiratory depression increases hospital costs and length of stay in patients recovering on the general care floor. BMC Anesthesiol 2021; 21: 88
https://bmcanesthesiol.biomedcentral.com/articles/10.1186/s12871-021-01307-8#citeas
Khanna AK, Bergese SD, Jungquist CR, et al. Prediction of opioid-induced respiratory depression on inpatient wards using continuous capnography and oximetry: an international prospective, observational trial. Anesth Analg 2020; 131(4): 1012-1024
Khanna AK, Urman RD, Weingarten TN. One Year After PRODIGY—Do We Know More About Opioid-Induced Respiratory Depression? APSF Newsletter 2021; 36(2):
Xie J, Strauss VY, Martinez-Laguna D, et al. Association of Tramadol vs Codeine Prescription Dispensation With Mortality and Other Adverse Clinical Outcomes. JAMA 2021; 326(15): 1504-1515
https://jamanetwork.com/journals/jama/fullarticle/2785265
Kim HS, McCarthy DM, Lank PM. Tramadol, Codeine, and Risk of Adverse Outcomes. JAMA 2021; 326(15): 1483-1484
https://jamanetwork.com/journals/jama/fullarticle/2785282
Brooks M. FDA Approves Combo Pill for Severe, Acute Pain. Medscape Medical News 2021; October 19, 2021
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November 2, 2021
Adverse Drug Events After Hospitalization
Adverse drug events (ADE’s) are both a major cause for emergency department visits and hospitalizations but also a significant result of hospital discharge. 19-23% of patients discharged from hospitals experienced an adverse event, the majority being adverse drug events (Forster 2003, Forster 2004). Another study by Forster et al. (Forster 2005) found that, of adverse events occurring in patients discharged home from the general medical service, 27% were preventable and 33% were ameliorable.
So, it’s no surprise that a focus on preventing adverse drug events after hospital discharge is in order. Several recent studies have highlighted the magnitude and seriousness of adverse drug events occurring after hospital discharge.
In the recent PPSA (Pennsylvania Patient Safety Authority) analysis of medication reconciliation failures that led to serious events (Harper 2021) 16.1% (15 of 93) instances involved discharge. Events related to discharge often went unrecognized until the patient returned to the emergency room (ER) or was readmitted. Orders often contributed to the events. Dosage errors, omitted orders, and instructions that were unclear or that differed from the discharge medication list contributed to these types of events. The resulting medication error types were most often dose omission and wrong dose. The report also suggests that medication errors at discharge are also likely to be underreported and have the potential to be life-threatening.
Gurwitz et al. (Gurwitz 2021) conducted a randomized clinical trial to determine whether a multifaceted clinical pharmacist intervention improves medication safety for patients who are discharged from the hospital and prescribed medications within 1 or more of three high-priority, high-risk drug classes (anticoagulants, diabetes agents, and opioids). Interventions included an in-home assessment by a clinical pharmacist, evidence-based educational resources, communication with the primary care team, and telephone follow-up. Participants in the control group were provided educational materials via mail.
Disappointingly, there was no difference in the rate of adverse drug-related incidents or clinically important medication errors during the posthospitalization period between the intervention and control groups. 180 patients were randomized to the intervention group and 181 to the control group. 27.7% of all participants experienced 1 or more adverse drug-related incidents, and 18% experienced 1 or more clinically important medication errors. There were 81 adverse drug-related incidents identified in the intervention group and 72 in the control group. There were 44 clinically important medication errors in the intervention group and 45 in the control group. The intervention did not significantly alter the per-patient rate of adverse drug-related incidents or clinically important medication errors.
Those results somewhat mirror the results of the MARQUIS trial (Schnipper 2018). This trial studied the impact of a multifaceted medication reconciliation intervention at six US hospitals using the MARQUIS medication reconciliation implementation toolkit. The intervention included hiring or reallocating new staff to obtain medication histories, performing both admission and discharge medication reconciliation, improving access to preadmission medication sources, introducing policy, training staff on obtaining medication histories and patient counselling, implementing a gold standard medication reconciliation process including targeting of high-risk patients, improving healthcare information technology and utilizing social marketing and community engagement. The intervention was associated with a reduction in total, but not potentially harmful, medication discrepancies. Results also varied by site.
The accompanying editorial (Etchells 2018) suggested that, rather than the intervention being ineffective, it may simply have been difficult to implement. It noted that there were some encouraging signals. Of the four sites that implemented interventions, three did observe reductions in potentially harmful discrepancies.
A second study, MARQUIS2, was subsequently undertaken, utilizing a refined toolkit and larger number of North American hospitals (Schnipper 2021). Both the number of system-level interventions adopted per site and the proportion of patients receiving patient-level interventions increased over time. During the intervention, patients experienced a steady decline in their medication discrepancy rate from 2.85 discrepancies per patient to 0.98 discrepancies per patient. An interrupted time series analysis showed the intervention was associated with a 5% relative decrease in discrepancies per month over baseline temporal trends. MARQUIS2 included both system-level and patient-level interventions. The system-level interventions alone were not associated with decreased discrepancy rates. “In contrast, patient-level interventions, such as receipt of a BPMH or admission or discharge medication reconciliation performed by trained personnel, had a large effect” that grew over time. That suggested to the authors there might be a synergistic effect of patient-level and system-level interventions.
The patient-level interventions included:
The editorial accompanying the MARQUIS2 study (Grimes 2021) notes the importance of patient engagement and patient activation. Grimes notes that the MARQUIS2 results suggest either that patient-level interventions may be more important than system-level interventions, or that system-level interventions are necessary but not sufficient alone. Exploring ways to promote patient involvement and activation in their own care should be a focus of future research.
MARQUIS2 took place prior to the COVID-19 pandemic. One of the few positive aspects of that pandemic has been the flourishing of telemedicine. In our April 14, 2020 Patient Safety Tip of the Week “Patient Safety Tidbits for the COVID-19 Pandemic” we mentioned an interesting report from ISMP Canada (ISMP Canada 2020) about medication reconciliation and discharge communication using telemedicine. It described the process of medication reconciliation, including not only digital identification of medications but also visual identification (via video or sending photographs of the pills or containers via email). It went on to describe how the same systems can be used to educate patients at or just after hospital discharge (including ways to involve the patient’s PCP and community pharmacy).
Medication regimen reviews (MRR’s) have increasingly been performed using telemedicine. A study on pharmacist‐conducted retrospective medication regimen reviews (MRR’s) using telemedicine in nursing homes showed very encouraging results (Kane‐Gill 2021). Upon admission, pharmacists conducted medication reconciliation and prospective MRR for residents and also used telemedicine for communication with cognitively‐intact residents. Post‐admission, pharmacists received clinical decision support alerts to conduct targeted concurrent MRR’s and telemedicine. The intervention group had a 92% lower incidence of alert‐specific ADE’s than usual care.
A recent Canadian study (McGillion 2021) assessed virtual care post-discharge after surgery, using remote automated monitoring (RAM) to remotely obtain data on patients’ biophysical variables. Virtual care and RAM did not significantly increase days alive at home within 31 days of discharge from hospital after surgery, the primary outcome variable. Interestingly, however, more participants in the virtual care group than standard care group had a drug error detected (29.7% vs. 5.5%) and a drug error corrected (22.6% vs. 1.3%). Drug omission (patients not taking a drug they were supposed to take) was the most common drug error detected (18.2% vs. 3.5%). Many such omissions were patient-related (eg. intentional omission, forgetfulness, mistake, or financial barriers). But doctors and nurses were responsible in 18.5% of cases, such as failure to communicate clear instructions on what drugs should and should not be taken at home, failure to write a prescription for a new drug, and failure to provide an instruction to discontinue a drug. Pharmacists were associated with 3.6% of the drug errors, always related to a failure to provide the drug as prescribed. Virtual care with RAM also resulted in substantial absolute reductions in pain at seven, 15 and 30 days.
We think that greater use of telemedicine for medication reconciliation and medication regimen review offers great opportunity to reduce adverse drug events following hospital discharge.
A key question is how to fund the resources necessary to do this well. Hospitals are reluctant to spend money on interventions that might reduce their admissions (excepting those that lead to readmission penalties or those that are part of a global budget). Insurers responsible for all medical costs would benefit from such a good system, as would entities like Accountable Care Organizations (ACO’s). Alignment of incentives will ultimately be the key to successful implementation of interventions to reduce adverse medication events after hospital discharge.
Some of our previous columns on medication reconciliation:
October 23, 2007 “Medication Reconciliation Tools”
December 30, 2008 “Unintended Consequences: Is Medication Reconciliation Next?”
May 13, 2008 “Medication Reconciliation: Topical and Compounded Medications”
September 8, 2009 “Barriers to Medication Reconciliation”
August 2011 “The Amazon.com Approach to Medication Reconciliation”
January 2012 “AHRQ’s New Medication Reconciliation Tool Kit”
September 2012 “Good News on Medication Reconciliation”
October 1, 2019 “Electronic Medication Reconciliation: Glass Half Full or Half Empty?”
July 2020 “Not Following Medication Changes after Hospitalization?”
References:
Forster AJ, Murff HJ, Peterson JF, Gandhi TK, Bates DW. The incidence and severity of adverse events affecting patients after discharge from the hospital. Ann Intern Med 2003; 138(3): 161-167
https://www.acpjournals.org/doi/10.7326/0003-4819-138-3-200302040-00007
Forster AJ, Clark HD, Menard A, et al. Adverse events among medical patients after discharge from hospital. CMAJ 2004; 170(3): 345-349
https://www.cmaj.ca/content/170/3/345.long
Forster AJ, Murff HJ, Peterson JF, Gandhi TK, Bates DW. Adverse drug events occurring following hospital discharge. J Gen Intern Med 2005; 20(4): 317-323
https://link.springer.com/article/10.1111/j.1525-1497.2005.30390.x
Harper A, Kukielka E, Jones R. Medication Reconciliation Process Failures: A Study of Serious Events Reported by Pennsylvania Hospitals. Patient Safety Journal 2021; 3(1): 10-21
Gurwitz JH, Kapoor A, Garber L, et al. Effect of a Multifaceted Clinical Pharmacist Intervention on Medication Safety After Hospitalization in Persons Prescribed High-risk Medications: A Randomized Clinical Trial. JAMA Intern Med 2021; Published online March 01, 2021
https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2777050
Schnipper JL, Mixon A, Stein J, et al. Effects of a multifaceted medication reconciliation quality improvement intervention on patient safety: final results of the MARQUIS study
BMJ Quality & Safety 2018; 27: 954-964
https://qualitysafety.bmj.com/content/27/12/954
Etchells E, Fernandes O. Medication reconciliation: ineffective or hard to implement? BMJ Quality & Safety 2018; 27: 947-949
https://qualitysafety.bmj.com/content/27/12/947
Schnipper JL, Reyes Nieva H, Mallouk M, et al. Effects of a refined evidence-based toolkit and mentored implementation on medication reconciliation at 18 hospitals: results of the MARQUIS2 study. BMJ Qual Saf 2021; Epub ahead of print 29 April 2021
https://qualitysafety.bmj.com/content/early/2021/04/28/bmjqs-2020-012709
Grimes TC. Is it time for greater patient involvement to enhance transitional medication safety? BMJ Quality & Safety 2021; Published Online First: 20 August 2021
https://qualitysafety.bmj.com/content/early/2021/08/19/bmjqs-2021-014116.citation-tools
ISMP Canada. Virtual Medication History Interviews and Discharge Education. ISMP Canada Safety Bulletin 2020; 20(2): April 7, 2020
Kane‐Gill SL, Wong A, Culley CM, et al. Transforming the Medication Regimen Review Process Using Telemedicine to Prevent Adverse Events. J Am Geriatr Soc 2021; 69(2): 530-538 First Published 24 November 2020
https://agsjournals.onlinelibrary.wiley.com/doi/10.1111/jgs.16946
McGillion MH, Parlow J, Borges FK, et al. Post-discharge after surgery Virtual Care with Remote Automated Monitoring-1 (PVC-RAM-1) technology versus standard care: randomised controlled trial BMJ 2021; 374 :n2209
https://www.bmj.com/content/374/bmj.n2209
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November 9, 2021
Ensuring Safe Site Surgery
It seems we’ve been doing a lot of columns recently on wrong site surgery or procedures (see our Patient Safety Tips of the Week for September 14, 2021 “Wrong Eye Injections” and October 5, 2021 “Wrong Side Again”). Despite all our efforts to eliminate “wrong site surgery” (which includes both wrong procedures and surgery or procedures on the wrong site, side, or patient), such incidents have not disappeared.
The Pennsylvania Patient Safety Authority put forth “Draft Recommendations to Ensure Correct Surgical Procedures and Correct Nerve Blocks” (PPSA 2021) on October 23, 2021 to prevent wrong-site surgery. These recommendations were approved by the (Pennsylvania) Department of Health. Public comments will be accepted by Patient Safety Authority for 30 days from that date of publication. The recommendations are listed below:
Recommendations to ensure the correct surgical procedure is done on the correct site, side and patient:
Preoperative verification and reconciliation
Site Marking—Site marking recommendations apply to all procedures where there is more than one possible location for the procedure.
Time-Out and Intraoperative Verification
Accountability
Recommendations to ensure nerve blocks are performed at the correct site and correct patient:
Preoperative Verification and Reconciliation
Anesthesia Site Marking
Time-Out
Accountability
An article on wrong site surgery in ophthalmology last year (Parikh 2020) illustrates the importance of many of these recommendations. That study expands upon work previously done by John Simon that we’ve also discussed before (see our Patient Safety Tips of the Week for March 11, 2008 “Lessons from Ophthalmology” and May 17, 2016 “Patient Safety Issues in Cataract Surgery”). The new study reported on 143 cases of “confusion” in ophthalmic surgery cases in New York State between January 1, 2006, and December 31, 2017. Two-thirds (66.4%) involved cases of incorrect implants being used during cataract surgery (cataract extraction and intraocular lens implantation). Wrong eye blocks or anesthesia accounted for 14.0%, incorrect eye procedures accounted for 7.00%, incorrect refractive surgery measurements accounted for 4.20%, incorrect patient or procedure accounted for 3.50%, incorrect intraocular gas concentration accounted for 2.80%, and incorrect medication in surgery accounted for 2.10%.
Of all cases, 92 (64.3%) were deemed preventable by the Universal Protocol in its current format. The leading root cause of surgical confusions among all the cases was an inadequately performed time out, which accounted for nearly one third of all surgical confusions (32.2%).
However, one salient feature of their work was that 33 of the incorrect implant cases (34.7%) were not preventable by the Universal Protocol. Many were the result of “upstream” errors, originating in the clinic or office before surgery. Errors from incorrect orders or calculations before the day of surgery were the second most common cause, accounting for nearly one quarter of surgical confusions (21.7%). They also noted a contributing factor we have emphasized in the past – change in the OR schedule. Other contributing factors included multiple lenses present in the OR, staff accidentally obtaining the incorrect lens power from the storage room, poorly labeled lenses, human error leading to errors despite properly performed time outs, and incorrect decisions by surgeons regarding toxic medications.
Our original foray into wrong site surgery 25 years ago that led to development of a timeout process followed cases of wrong intraocular lens implantation that included several of those root causes (change in the surgical schedule, presence of multiple lenses in the OR, etc.). We discuss the issue of change in surgical schedule later. And we extend the issue of multiple lenses in the OR to the presence of multiple records in the OR. Any time you have charts or records or images of more than one patient in the OR, you are vulnerable to using records from the wrong patient. If a surgeon brings all his office notes for the day’s cases, make sure they are kept somewhere outside the OR and that only those records on the case at hand are allowed in the OR one at a time.
Parikh et al. note that the Universal Protocol and time outs typically are performed before the case begins and key aspects may be forgotten at the time of lens implantation, which occurs toward the end of the surgery. For the time out to be maximally effective, it must occur shortly before the intended action.
Problems with site markings also contributed to some cases. Seven cases involved ambiguous site markings, which were washed off during surgical preparations, were covered, or otherwise were not visible. Another was simply not marked, and 2 were marked incorrectly. Patients themselves sometimes contributed by mistakenly affirming that they were having a procedure on the incorrect eye.
The authors stressed that “upstream” errors, originating in the clinic or office before surgery, and ineffective communication during time outs suggest a need for modification of the Universal Protocol. We discussed many of those “upstream” issues in our October 5, 2021 Patient Safety Tip of the Week “Wrong Side Again”.
Wrong-site nerve blocks have actually become the most common type of wrong-site surgery, accounting for 25.7% of cases of wrong-site surgery reported to the Pennsylvania Patient Safety Reporting System (PA-PSRS) from July 2004 to September 2017 (Arnold 2018).
Balocco et al. (Balocco 2019) described risk factors for wrong-side nerve blocks. These included both physician-related factors, patient-related factors, and procedure-related factors.
Physician-related factors:
Patient-related factors:
Procedure-related factors:
Notice that changes in the OR schedule again showed up as a significant risk factor. We cannot overemphasize the need to communicate to all parties when such changes take place. In that case that got us started over 25 years ago on preventing wrong-site procedures, a patient had complained he had expected to be the first case of the day. Staff sought to accommodate him by inserting him earlier into the schedule and that was a primary factor in leading to 2 consecutive patients receiving wrong intraocular lens implants. We recommend that you somehow flag that changes have occurred on your OR white board or electronic surgical schedule and especially communicate to all when such changes occur after the day’s original schedule was published.
Balocco et al. went on to discuss the use of checklists to help avoid wrong-side nerve blocks.
Vandebergh et al. recently described strategies to prevent wrong-side nerve blocks (Vandebergh 2021). They discuss the roles of checklists, procedural markings, the “Time Out” or “Stop Before You Block”, influence of the environment and team, and use of simulated procedures. They also discuss how new technologies, such as a USB device that attaches to the ultrasound probe and senses when the patient’s skin is touched, triggering an audible alert (“Check the side of the block”) that can only be stopped by pressing a confirmation button on the device.
They also discuss another intervention that we’ve discussed in multiple columns. That is including on the procedure kit or tray a sticker that requires a checklist be completed before the contents of the kit/tray can be removed.
Wrong-site surgery and wrong-site procedures are sentinel events that should never occur. We have a whole variety of tools and procedures to prevent such occurrences, but you have to use them and do so religiously. Failure to comply with the time out process or have everyone fully participate remains a major factor in wrong-site surgeries. And such participation must be active. Staff cannot simply nod concurrence. They must be able to go to primary source documents and confirm that the patient, procedure, site and laterality are correct.
Some of our prior columns related to wrong-site surgery:
September 23, 2008 “Checklists and Wrong Site Surgery”
June 5, 2007 “Patient Safety in Ambulatory Surgery”
July 2007 “Pennsylvania PSA: Preventing Wrong-Site Surgery”
March 11, 2008 “Lessons from Ophthalmology”
July 1, 2008 “WHO’s New Surgical Safety Checklist”
January 20, 2009 “The WHO Surgical Safety Checklist Delivers the Outcomes”
September 14, 2010 “Wrong-Site Craniotomy: Lessons Learned”
November 25, 2008 “Wrong-Site Neurosurgery”
January 19, 2010 “Timeouts and Safe Surgery”
June 8, 2010 “Surgical Safety Checklist for Cataract Surgery”
December 6, 2010 “More Tips to Prevent Wrong-Site Surgery”
June 6, 2011 “Timeouts Outside the OR”
August 2011 “New Wrong-Site Surgery Resources”
December 2011 “Novel Technique to Prevent Wrong Level Spine Surgery”
October 30, 2012 “Surgical Scheduling Errors”
January 2013 “How Frequent are Surgical Never Events?”
January 1, 2013 “Don’t Throw Away Those View Boxes Yet”
August 27, 2013 “Lessons on Wrong-Site Surgery”
September 10, 2013 “Informed Consent and Wrong-Site Surgery”
July 2014 “Wrong-Sided Thoracenteses”
March 15, 2016 “Dental Patient Safety”
May 17, 2016 “Patient Safety Issues in Cataract Surgery”
July 19, 2016 “Infants and Wrong Site Surgery”
September 13, 2016 “Vanderbilt’s Electronic Procedural Timeout”
May 2017 “Another Success for the Safe Surgery Checklist”
May 2, 2017 “Anatomy of a Wrong Procedure”
June 2017 “Another Way to Verify Checklist Compliance”
March 26, 2019 “Patient Misidentification”
May 14, 2019 “Wrong-Site Surgery and Difficult-to-Mark Sites”
May 2020 “Poor Timeout Compliance: Ring a Bell?”
September 14, 2021 “Wrong Eye Injections”
October 5, 2021 “Wrong Side Again”
References:
PPSA (Pennsylvania Patient Safety Authority). Draft Recommendations to Ensure Correct Surgical Procedures and Correct Nerve Blocks. October 23, 2021
https://www.pacodeandbulletin.gov/Display/pabull?file=/secure/pabulletin/data/vol51/51-43/1784.html
Parikh R, Palmer V, Kumar A, Simon JW. Surgical Confusions in Ophthalmology: Description, Analysis, and Prevention of Errors from 2006 through 2017. Ophthalmology 2020; 127(3): 296-302
https://www.aaojournal.org/article/S0161-6420(19)30859-0/fulltext
Arnold TV. Update on Wrong-Site Surgery: More Data Provides More Insight. Pa Patient Saf Advis 2018; 15(1): 1-5
http://patientsafety.pa.gov/ADVISORIES/Pages/201803_WSSUpdate.aspx
Balocco AL, Kransingh S, Lopez A, et al. Wrong-Side Nerve Blocks And the Use of Checklists. Part 1. Anesthesiology News 2019; October 19, 2019
Vandebergh V, Coll V, Keunen B. Prevention of Wrong-Side Nerve Blocks: Part 2. Anesthesiology News 2021; September 20, 2021
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November 16, 2021
Cognitive Biases and Heuristics in the Delivery Room
Cognitive biases unfortunately often impact our diagnostic and therapeutic decisions in a negative manner. One such bias coloring our thinking is the “availability” bias (also known as the “recency” bias). This is where the most recent or most memorable cases from the past narrow our thinking about a current patient. We discussed this (and a variety of other biases) in our August 12, 2008 Patient Safety Tip of the Week “Jerome Groopman’s “How Doctors Think”. We all know how a previous bad experience with use of a medication may influence us not to use it again, even when we know the medical evidence tells us we should use it (one of the reasons so many patients with atrial fibrillation are never placed on coumadin). We often encountered this when trying to get surgeons to use DVT prophylaxis. Some would remember vividly one of their patients who had a hemorrhage when on DVT prophylaxis, so they would be reluctant to use DVT prophylaxis again.
Heuristics are simplified decision tools or shortcuts that are sometimes used in more complex decision-making scenarios. One researcher recently looked to see if decisions in the delivery room were influenced by such heuristics (Singh 2021). Singh explains that this behavior can be loosely predicted by a “win-stay/lose-shift” heuristic, according to which the decision-maker either switches strategies if the last outcome was a “loss” or continues with the same strategy if the last outcome was a “win.”
Singh examined records of over 86,000 deliveries from an urban and a suburban academic hospital over a 20-year period to see whether complications in the prior patient’s delivery mode (whether a cesarean or vaginal delivery) make the physician more likely to switch to the other delivery mode for their next patient, and the effect of this heuristic on the patient for whom it is used. The analysis suggested that, if the prior patient had complications in one delivery mode, the physician will be more likely to switch to the other—and likely inappropriate—delivery mode for the subsequent patient, regardless of patient indications. Moreover, there was evidence that this heuristic has small, suboptimal effects on patient health.
Singh was able to identify delivery mode and L&D (labor & delivery) complications using ICD (International Classification of Diseases) procedure and diagnosis codes in a large electronic database. The data showed that the probability of switching delivery modes increased as the number of complications in the prior delivery increases. When there are no prior complications, physicians are more likely to “stay” with the delivery mode they used for the prior patient. And, if the preceding delivery had complications, the odds of the physician switching to the other delivery mode increased.
Though it is difficult to assess from administrative data whether a delivery mode is appropriate or not, Singh does attempt to show that some of these delivery mode decisions were likely inappropriate for patients. According to Singh (Singh 2021b), complications during a vaginal delivery increased the likelihood of a subsequent C-section by up to 3.6%. That was about 23 potentially inappropriate C-sections per year per hospital studied. Complications during a cesarean increased the likelihood of a subsequent vaginal delivery by up to 3.4%. That’s about 50 potentially inappropriate vaginal deliveries per year per hospital studied.
In the editorial accompanying the Singh study, Li and Colby (Li 2021) emphasize that she found that “more experienced physicians use this decision rule more often, even though physicians who rely more on this rule have worse patient outcomes over time. The result demonstrates that the use of heuristics or simplified decision rules is a common human tendency even among smart, well-intentioned, highly trained doctors.”
Li and Colby also point out three well-established cognitive biases as potential causes of this maladaptive switching of delivery modes, whether individually or in concert: recency, affect heuristic, and confirmation bias. We’ve already noted the recency (or availability) bias above. That is where the most recent or most memorable cases from the past narrow our thinking about a current patient. The “affect heuristic” notes that people rely on their affective response to gauge how large a risk is and that a highly emotional response to a previous delivery complication would lead a physician to overestimate the risk in a subsequent delivery. Thirdly, our frequent nemesis – confirmation bias – may also come into play. They note that a physician may inadvertently seek and interpret evidence in a way that is consistent with his/her fears or concerns about a potential complication, which helps them feel comfortable that modality switching is appropriate for the current patient.
Singh gives another common example of this “win-stay/lose-shift” heuristic – a physician may be reluctant to prescribe a certain drug if a previous patient suffered an adverse event related to that drug (Singh 2021b). She notes that at least 2 interventions we use (clinical decision support algorithms and nudges) may help reduce use of this heuristic. The algorithms in clinical decision support systems suggest what might be best for a particular patient. The “nudge” example is placing a preferred drug at the top of a drop-down list and placing a drug that might best be avoided near the bottom of that drop-down list.
Our own experience would fit with that in Singh’s study. For years, hospitals have tracked VBAC (vaginal birth after cesarian) rates. The push was to get more VBAC’s done and reduce the C-section rates. We would see a cyclicality to VBAC rates. There would be a trend toward more VBAC’s. Then, after an obstetrician encountered a ruptured uterus in a patient with a planned VBAC (or even heard of such a case), the VBAC rates would plummet again.
The Singh study is one of few that have actually studied real-life use of heuristics in medical decision making by physicians. A systematic review on cognitive biases and heuristics in medical decision making (Blumenthal-Barby 2015) concluded that most of the studies on biases and heuristics in medical decision making are based on hypothetical vignettes, raising concerns about applicability of these findings to actual decision making. It also concluded that biases and heuristics have been underinvestigated in medical personnel compared with patients.
As physicians, we rarely are aware of cognitive biases underlying our medical decisions. And we also typically are not aware of when we are using a heuristic that may be inappropriate. And our patients are often subject to similar cognitive biases and inappropriate heuristics in their own medical thinking. One wonders if these phenomena have increased in the “age of disinformation”. We agree that having more real-life examples of maladaptive use of these would be helpful.
Some of our prior columns on diagnostic error and cognitive biases:
References:
Singh M. Heuristics in the delivery room. Science 2021; 374(6565): 324-329
https://www.science.org/doi/10.1126/science.abc9818
Singh M. People use mental shortcuts to make difficult decisions – even highly trained doctors delivering babies. The Conversation 2021; October 14, 2021
Li M, Colby H. Physicians’ flawed heuristics in the delivery room. Science 2021; 374(6565): 260-261
https://www.science.org/doi/10.1126/science.abl5647
Blumenthal-Barby JS, Krieger H. Cognitive Biases and Heuristics in Medical Decision Making: A Critical Review Using a Systematic Search Strategy. Medical Decision Making 2015; 35(4): 539-557
https://journals.sagepub.com/doi/10.1177/0272989X14547740
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November 23, 2021
The Perils of Hypertonic Sodium Chloride
When we hear about a patient safety incident involving a concentrated electrolyte solution, we immediately think about potassium chloride. But hypertonic sodium chloride is also a potentially dangerous solution.
We once described the unfortunate case of a 12-year-old juvenile diabetic who was inadvertently given 500 ml of hypertonic saline intravenously (Young 1979). He developed hypernatremia, hyperosmolality, metabolic acidosis, and hyperglycemia. Seizures and stupor ensued, followed by coma and death. Computerized cranial tomography revealed numerous small subcortical hemorrhages that were verified postmortem.
And we have a friend who developed osmotic demyelination syndrome (formerly known as central pontine myelinolysis) after overaggressive correction of hyponatremia using hypertonic saline. The need for rapid correction of hyponatremia (and the speed of such correction) needs to be balanced against the risk of overcorrection leading to the osmotic demyelination syndrome.
ISMP recently published an article on preventing errors during emergency use of hypertonic sodium chloride solutions (ISMP 2021). Though the major focus of the ISMP article was on very high concentrations of sodium chloride (eg. 23.4%) as used for emergency treatment of severe cerebral edema or other causes of increased intracranial pressure where herniation is imminent, their recommendations apply equally to use of any hypertonic sodium chloride solution.
ISMP found errors in multiple aspects of managing hypertonic sodium chloride solutions (storage, preparation, ordering, administration, monitoring). In the pharmacy there were numerous errors in which the wrong concentration of sodium chloride was used to manually compound a solution, often associated with look-alike labeling and packaging of the products. Sometimes, 500 ml. bags of 3% sodium chloride were stocked in various areas instead of 0.9% sodium chloride. Retrieval of the wrong concentration from ADC’s (automated dispensing cabinets) occasionally occurred. And intravenous administration errors also occurred (eg. infusing 3% sodium chloride solution longer than prescribed or administering the solution at 100 mL/hour instead of 25 mL/hour). There were also programming errors in smart pump infusions.
We refer you to the current ISMP article (ISMP 2021) itself for their full list of recommended risk-reduction strategies, but here are some of the highlights:
We are concerned about that last recommendation regarding monitoring. While that may be appropriate when using hypertonic sodium chloride to reduce intracranial pressure, monitoring at 6-hour intervals if you are using hypertonic sodium chloride to correct for severe symptomatic hyponatremia is inadequate. In such cases the rate of sodium correction in 24 hours with this regimen should not exceed 6 to 8 mEq/L in 24 hours or 12 to 14 mEq/L in 48 hours (based on case studies showing that there were no cases of central pontine myelinolysis if correction rates were less than 10 mEq/L over 24 hours). A 4- to 6-mmol/L increase in serum [Na+] is usually sufficient to reverse the most serious manifestations of acute hyponatremia (Verbalis 2013). So, in treating a patient with neurological symptoms (seizures, coma, etc.) from acute hyponatremia, a bolus of 3% sodium chloride is often used and the serum sodium should be checked in 20 minutes. It may be repeated if neurological symptoms have not improved, but the serum sodium must again be checked to ensure there is not overcorrection. A recent large series of treatment of symptomatic hyponatremia with hypertonic sodium chloride (Chifu 2021) noted that overcorrection was more likely when hypertonic sodium chloride was used and in severely symptomatic patients. Though there are no firm guidelines on the frequency at which serum sodium should be monitored, one recommendation is that the best way to avoid overly rapid correction is to check serum sodium every two hours and monitor urine output closely (Madeira 2014).
ISMP’s 2019 Guidelines for the Safe Use of Automated Dispensing Cabinets (ISMP 2019) recommended avoiding stocking vials/ampules of concentrated electrolytes, including sodium chloride in concentrations greater than 0.9%, in ADC’s. ISMP recommended that vials of 23.4% sodium chloride should not be stocked in ADCs, suggesting that the pharmacy should prepare, label with appropriate warnings, and hand-deliver any IV push doses of 23.4% sodium chloride used in critical care or emergency/urgent care units. But ISMP, in the current article (ISMP 2021), recognizes that the 23.4% sodium chloride may be needed so expediently that any delay waiting for the pharmacy to manually prepare a dose would be dangerous.
Bottom line: use of hypertonic sodium chloride can be a life-saving intervention in some circumstances. But you need to be very careful that errors with hypertonic sodium chloride do not cause patient harm. Take heed of ISMP’s recommendations for safe management of your hypertonic sodium chloride solutions.
References:
Young RSK, Truax BT. Hypernatremic Hemorrhagic Encephalopathy. Ann Neurol 1979; 5: 588-591
https://onlinelibrary.wiley.com/doi/abs/10.1002/ana.410050618?sid=nlm%3Apubmed
ISMP (Institute for Safe Medication Practices). Prevent Errors During Emergency Use of Hypertonic Sodium Chloride Solutions. ISMP Medication Safety Alert! Acute Care Edition 2021; 26(22): November 4, 2021
Verbalis JG, Goldsmith SR, Greenberg A, et al. Diagnosis, evaluation, and treatment of hyponatremia: expert panel recommendations. Am J Med 2013; 126(10 Suppl 1) :S1-42
https://www.amjmed.com/article/S0002-9343(13)00605-0/fulltext
Chifu I, Gerstl A, Lengenfelder B, et al. Treatment of symptomatic hyponatremia with hypertonic saline: a real-life observational study. Eur J Endocrinol 2021;1 84(5): 647-655
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8052513/
Madeira C, Chang D. How Should Hyponatremia Be Evaluated and Managed? The Hospitalist 2014; 2014(8)
ISMP (Institute for Safe Medication Practices). Guidelines for the Safe Use of Automated Dispensing Cabinets. ISMP 2019; February 7, 2019
https://www.ismp.org/resources/guidelines-safe-use-automated-dispensing-cabinets
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November 30, 2021
Fire in the OR
Our many columns on surgical fires have focused on fires on or around the patient, discussing both surgical fire prevention and immediate interventions to minimize patient harm.
But we haven’t discussed much about what happens in OR’s with more extensive fires or fires elsewhere in the hospital. A recent AORN article (Ervine 2021) notes that, all too often, routine fire drills in medical facilities “do not go beyond the red line of the OR”. Ervine goes on to describe how to involve OR staff in fire drills. She highlights the importance of involving all OR staff, including surgeons and anesthesiologists, in the planning process as well as the drills themselves and the post-drill evaluation.
The planning phase includes establishing a date and time for the drill and alerting the local fire department that this will be a drill. Ervine notes that planning and drills may uncover unexpected vulnerabilities, such as strobe lights that don’t work, audio alarms that cannot be heard, and fire doors that do not automatically close. Another important facet is to determine the evacuation route for your department. Do team members evacuate outside of the facility, or do they go to the next fire compartment? Does your department have more than one fire compartment?
Ervine suggests using multiple scenarios in your fire drills. For example, in one room the team could be in the middle of a procedure (complete with the radio playing at whatever the “normal” volume would be during a routine procedure). In another room the patient might just being transported to the room. And in another room, the team could be in the process of completing the procedure. Ervine also sometimes includes a scenario where there is a shortage of stretchers in the OR suite. She also includes a scenario where a staff member remains behind when the rest of the team evacuates (to test whether the other team members and the charge nurse make sure they can account for the entire team after they have evacuated to the designated space).
Planning also includes determining whether you have the appropriate fire extinguishers located throughout your department. (See our comments below on appropriate location and type of fire extinguishers in the OR.) Ervine also notes you should know where the fire pulls are located. Knowing the location of the closest fire pull is paramount in promptly alerting all staff quickly. And, as part of the planning, you should review your facility’s policy and procedure on who is responsible and allowed to shut off medical gases.
One facet we find deficient in drills of almost any kind in medical facilities is lack of appropriate monitoring on compliance with required steps and overall performance in the drills. Ervine notes that the “facilitator” of the fire drill needs to make sure the monitors of the drills have all the tools they need to evaluate the actions of staff during the drills. Those tools should include a checklist of items to record and some sort of scoring system. Monitors are present in each room and there should be an additional monitor in the hall near the entrance to your OR. The latter evaluates who is responding to the alarm, how promptly they arrived, and if they brought fire extinguishers with them.
Ervine assembles the perioperative team for a briefing just before starting the drill. The acronyms RACE (Rescue, Alarm, Confine, Extinguish/Evacuate) and PASS (Pull, Aim, Squeeze, Sweep) are reviewed. The different types and locations of fire extinguishers are discussed, as well as each team member’s assignment during the drill. Room and hallway monitors and charge nurse monitor review the evaluation forms with the facilitator.
Ervin holds a debriefing with the entire team at the end of the evacuation. Each team monitor reads the scenario from his or her room and reports how they were notified of the emergency; what decisions they made to care for the patient; if they could hear the alarm, see the flashing strobe lights, and hear any overhead paging that might have occurred during the drill.
Either the facilitator or the safety officer should provide feedback to the team of their observations during the fire drill and evacuation. During the debriefing, team members should also provide their feedback for the drill itself.
Note that Ervine recommends the debriefing take place at the end of the evacuation. We’d actually take it a step further and include as part of the drill restoration of the activities which had been ongoing in each OR prior to the fire alarm being pulled. For example, you might find that no one has turned medical gases back on, or that shortcuts were taken in re-establishing sterile procedure.
There is often confusion about fire extinguishers and the OR. Are they required in the OR? What type? A recent APSF “Rapid Response” (Williams 2021) clarifies these issues. It highlights discrepancies between recommendations of the National Fire Protection Association (NFPA) and those of ASA, APSF, and ECRI. NFPA and The Joint Commission require a fire extinguisher within 75 feet of every working location and that “clean agent-or water mist-type fire extinguishers shall be provided in operating rooms.” ASA, APSF, and ECRI do not believe the regulatory requirements are sufficient for protecting patients or staff in the event of a fire in the operating room. Specifically, the recommendation is that CO2 extinguishers be available. APSF also agrees with the specific ECRI recommendation that a 5 lb. CO2 extinguisher be mounted just inside the entrance of each operating room. (The APSF Rapid Response notes that a comment in the Annex (A.16.10.1.4) of the NFPA-99 document states that a CO2 extinguisher could be used in lieu of a clean agent extinguisher and that this comment can be cited if there is local resistance to supplying CO2 extinguishers in each operating room.)
The APSF “Rapid Response” makes a very important point about differences when the fire is on the patient vs. elsewhere in the OR. Specifically, it notes that in the event of a fire on the patient, a fire extinguisher is not the first method for extinguishing the fire. All surgical procedures that have a high risk of a fire (see our many columns on surgical fires listed below) must have a basin of water or saline readily available on the OR table. That would be the fastest method of dousing a fire on the patient. If the drapes are on fire, they should be pulled off the patient onto the floor and then a fire extinguisher could be used on the burning drapes. It would be an unusual occasion to require that a fire extinguisher be used on the patient. They also note that most OR drapes are impervious to water, which is why an extinguisher is needed if they are on fire. Just a reminder – materials that are said not to support combustion in room air, such as drapes and surgical gowns, may quickly ignite in oxygen-enriched environments (Culp 2013).
We like the way that Ervine has included multiple scenarios into the drills to account for circumstances that might complicate responses. You’ll recall we sometimes have added 2 drills together. For example, 2 incidents sometimes take advantage of fire alarms – behavioral health patients absconding or infants being abducted. We don’t think you need to add those to an OR fire drill (the perpetrators in these 2 scenarios would not likely pull a fire alarm in the OR). But the idea of adding complicating factors into your fire drills remains a good consideration.
The Ervine article is a good reminder that you need to prepare for potential fires in the OR. Of course, using drills to prepare for fires elsewhere in your healthcare facility is also important. Another recent AORN article has some good recommendations for those (Croke 2021). We also refer you back to our October 21, 2014 Patient Safety Tip of the Week “The Fire Department and Your Hospital” which had lots of information about hospital fires, including special considerations for fires in your MRI suites or behavior health units.
And, of course, don’t forget all our columns, listed below, on preventing and responding to surgical fires.
Our prior columns on surgical fires:
References:
Ervine HS. Conducting a Successful Fire Drill in the OR. AORN Journal 2021; 114(4): 287-289
https://aornjournal.onlinelibrary.wiley.com/doi/epdf/10.1002/aorn.13515
Williams J, Feldman JM, Ehrenwerth J. Fire Extinguisher in the Operating Room. APSF (Anesthesia Patient Safety Foundation) 2021; June 1, 2021
https://www.apsf.org/article/fire-extinguisher-in-the-operating-room/
Culp WC, Kimbrough BA, Luna S. Flammability of surgical drapes and materials in varying concentrations of oxygen. Anesthesiology 2013; 119(4): 770-776
Croke L. Preparing for fires in health care settings. AORN Journal 2021; 114(4): P7-P9
https://aornjournal.onlinelibrary.wiley.com/doi/10.1002/aorn.13524
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December 7, 2021
The Hidden Dialysis Catheter
One of the first patient safety incidents we investigated over thirty years ago was a case of massive blood loss in a patient undergoing dialysis (see our March 26, 2007 Patient Safety Tip of the Week “Alarms Should Point to the Problem”). An ESRD patient was having his regularly scheduled dialysis session. Since he would be in the dialysis center for several hours, he was in a comfortable lounge chair that tipped back. Also, since it was somewhat cool, he was offered a blanket to keep warm. Midway through the dialysis session, the low-pressure alarm rang. The nurse turned off the alarm and eyeballed the patient and saw no blood. Nothing further was done. Soon thereafter the low pressure alarm triggered again. This time it was recognized that the dialysis catheter had become dislodged and the patient had, in fact, had considerable blood loss. It had not been appreciated immediately because the blanket had been covering up the catheter site and the blood, rather than being visible on the floor, had been pooling in the webbing of the lounge chair.
The thrust of our March 26, 2007 Patient Safety Tip of the Week “Alarms Should Point to the Problem” was that alarm system setups should focus visual attention to that part of the system where the problem originates. Anyone who has ever spent time in an ICU or other high tech medical environment knows that the usual first response to an alarm is to turn the alarm off. Proper design of medical equipment therefore should force the responder to focus on the source of the problem. In the case at hand, the equipment and alarm were on the side of the patient opposite from the involved limb so that the visual attention of the responder was not directed immediately to the site the alarm was drawing attention to.
A second consideration was the complexity of the alarm screen. That complexity may lead to responders simply taking the easy way out and clearing the alarm, particularly if they anticipate the alarm will be re-triggered if something serious is really going on. The most reliable patient safety interventions are forcing functions. We’ve, therefore, suggested that these alarm systems program in a “hard” stop for this particular alarm that requires the responder to verify that he/she has inspected the access site. That verification should then become part of the medical record.
In our April 25, 2017 Patient Safety Tip of the Week “Dialysis and Alarm Fatigue” we discussed a case with striking similarities to that in our previous column (CDPH 2017). A patient admitted with an MI suffered deterioration of his chronic renal disease and was begun on continuous renal replacement therapy (CRRT) with a femoral catheter for dialysis access (technically, it was continuous veno-venous hemofiltration or CVVH). For comfort, the patient was covered with a blanket, which obscured the catheter access site. Unfortunately, at some point the return line became loose and disconnected from the femoral catheter which caused massive blood loss and cardiac arrest. He received CPR and blood transfusions and was resuscitated but died several days later. That case had a cascade of errors that all contributed to the fatal incident (see the prior column for details) but, once again, failure to heed the alarm was a major one.
In both the cases described in our prior columns, blankets had obscured the access sites. In yet another case of a dislodged dialysis needle (see our December 10, 2019 Patient Safety Tip of the Week “Dialysis Line Dislodgements”) a blanket also covered the access site (Fields 2010). So, that is a recurrent theme. Use of the blankets is a well-intentioned effort to keep the patients comfortable. But it obviously subverts the recommendation to maintain visualization of the access site at all times. We’ve previously recommended that, if a blanket is necessary, it should be one that has a substantial cut-out section that allows adequate visualization of the access site.
Recently, a report from the Veterans Health Administration (Walton 2021) identified 281 bleeding events, including 14 deaths, during hemodialysis treatments over an 18-year period. The onset of the bleeding was unwitnessed in 67% of the cases, leading to a delay in its discovery and intervention. Most deaths were associated with central venous catheter access. 33% of root cause analyses identified physical barriers to direct observation or an equipment issue as root causes.
Of the 14 bleeding events that resulted in death from catastrophic hemorrhage, 11 (79%) deaths were associated with hemodialysis through a central venous catheter and 3 (21%) deaths were reported in patients receiving hemodialysis through a vascular shunt or graft.
In every fatal event, bleeding was discovered only after irreversible hemorrhage had occurred. Mental status and the failure to maintain visibility of the access site were significant contributors to fatal events. In 57% of deaths, alteration of mental status or confusion contributed. Likewise, in 57% of deaths the access site was not visible to the staff because of physical environmental barriers blocking the view or the access site was covered and concealed from view. Both alteration of mental status and a dialysis site that was obscured from view were present in 36% of fatal cases.
An alteration to the patient’s mental or behavioral health status contributed to 19% of all bleeding events, whereas 31% were unintentionally disconnected by a patient with normal mental status. In 8, bleeding was the result of an intentional action by the patient such as disconnection of the dialysis machine from the shunt/graft in a moment of anger or frustration, and opening the hemodialysis ports or cutting through the central dialysis catheter in an attempted suicide.
In their review of root causes analyses (RCA’s) of these cases, Walton et al. highlighted four areas of attention and concern:
Many of these recommendations were discussed in our December 10, 2019 Patient Safety Tip of the Week “Dialysis Line Dislodgements”. In that column we noted a review (Saha 2017) that noted the following major factors leading to needle dislodgement:
They describe the role of the venous alarm monitor but note that multiple factors aside from venous pressure can affect the alarm. Plus, there are differences in venous pressure between grafts and fistulas. As a result of wide variation in venous pressures, staff often set the alarm thresholds at levels below that at which a dislodgement should have triggered an alarm. They then discuss various sensors that can detect blood leaks during venous needle dislodgement, noting the tradeoff between safety and cost.
In that column we also noted the work of the American Nephrology Nurses’ Association (ANNA) Venous Needle Dislodgement Special Project Workgroup (Axley 2012), which reviewed recommendations of care for venous needle dislodgement prevention and detection. They developed a set of easy-to-use tools outlining their recommendations. These focused especially on the procedures for taping and positioning of needles and lines. But they stressed that vascular access and needles should be visible at all times during hemodialysis. Checking the vascular access should be part of the monitoring routine. And, most importantly, “When the venous pressure alarm is activated, the vascular access, needle sites, and blood line positions should always be inspected prior to resetting the alarm and/or the alarm limits.” They also discussed the importance of patient and staff education about needle dislodgement, including caution that alarm systems are not infallible. They also included a risk assessment tool to help identify patients at high risk for venous needle displacement. When such high risk patients are identified, they suggest interventions such as stabilizing the access limb, using one-on-one monitoring, and consideration of a blood leak detection device.
Likewise, The Renal Association (The Renal Association 2018) recommends that connections and lines are kept in full view of dialysis staff during dialysis, secured with tape if necessary, and that any alarm should prompt visual inspection of these. It is customary in most units to place the dialysis machine on the same side as patient access, a practice we have recommended since our first column. They recommend local dialysis nursing supervision guidelines should be adhered to, though these vary from unit to unit. Some units have double-checking of line connections by 2 nurses included in their protocols for starting dialysis.
The excellent work of Walton et al. adds to a growing body of literature on these disastrous bleeding incidents during hemodialysis. Heeding the advice in their study and our prior columns hopefully can help prevent similar incidents in your facilities.
Some of our prior columns on dialysis, CKD, and ESRD:
March 26, 2007 “Alarms Should Point to the Problem”
February 2009 “Unintended Consequences of eGFR Reporting”
May 2009 “Erythropoiesis-Stimulating Agents and Mortality”
September 20, 2011 “When Practice Changes the Evidence: The CKD Story”
September 2013 “Is Nephrologist Caseload Related to Dialysis Mortality?”
September 2014 “New Tubing Connections”
June 23, 2015 “Again! Mistaking Antiseptic Solution for Radiographic Contrast”
November 1, 2016 “CMS Emergency Preparedness Rule”
April 25, 2017 “Dialysis and Alarm Fatigue”
July 16, 2019 “Avoiding PICC’s in CKD”
December 10, 2019 “Dialysis Line Dislodgements”
February 4, 2020 “Drugs and Chronic Kidney Disease”
October 2021 “Overdoing It on CKD?”
References:
CDPH (California Department of Public Health). Complaint Intake Number: CA00471877; posted 4/20/2017
http://www.cdph.ca.gov/certlic/facilities/Documents/2567_Kaiser220012544_IJAP_SanFrancisco.pdf
Fields R. When Needles Dislodge, Dialysis Can Turn Deadly ProPublica 2010; Nov. 10, 2010
https://www.propublica.org/article/when-needles-dislodge-dialysis-can-turn-deadly
Walton E, Charles M, Morrish W, Soncrant C, Mills P, Gunnar W. Hemodialysis Bleeding Events and Deaths: An 18-Year Retrospective Analysis of Patient Safety and Root Cause Analysis Reports in the Veterans Health Administration. J Patient Saf. 2021 September 24, 2021
Saha M, Allon M. Diagnosis, Treatment, and Prevention of Hemodialysis Emergencies. Clinical Journal of the American Society of Nephrology 2017; 12(2): 357-369
https://cjasn.asnjournals.org/content/12/2/357
Axley B, Speranza-Reid J, Williams H. Venous needle dislodgement inpatients on hemodialysis. Nephrology Nursing Journal 2012; 39(6): 435-445
https://www.annanurse.org/download/reference/journal/vndArticle.pdf
The Renal Association (UK). Severe blood loss in haemodialysis patients from dialysis line disconnection and femoral catheter removal. July 23, 2018
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December 14, 2021
Delayed Hemorrhage After Head Trauma in Anticoagulated Patients
Here’s a controversy that just won’t go away – what is the risk of missing an intracranial hemorrhage after a negative CT scan in patients with head trauma who are on anticoagulants or antithrombotics?
We’ve all seen isolated cases of such delayed hemorrhage. But large series have demonstrated the incidence of delayed hemorrhage to be quite low, suggesting that repeat imaging is not cost-effective and probably not indicated in most cases (see our September 21, 2021 Patient Safety Tip of the Week “Repeat CT in Anticoagulated Patients After Minor Head Trauma Not Cost-Effective”).
Researchers at Allegheny Health Network in Pennsylvania recently did a retrospective analysis of over 1,000 patients with head trauma over a three-year period (Chang 2021). Patients were included in the study if they were on antiplatelet and anticoagulant medications, including DOAC’s (direct anticoagulants), and suffered head trauma. The radiology reports for the initial examinations on these patients included a recommendation for repeat imaging to evaluate for delayed hemorrhage. Approximately 50% of patients in which repeat imaging was recommended received repeat imaging. Repeat examinations were typically performed within 24 hours (average follow-up time was 21 hours and 99% were within 3 days). There was a 1.8% incidence of delayed hemorrhage and 0.4% overall mortality. Patients on warfarin and clopidogrel had a higher rate of delayed hemorrhage (3.2%), compared to 0.9% in the DOAC group, and the difference was statistically significant (p<0.01). All deaths were in the clopidogrel/warfarin group. Patients on DOAC’s had a significantly lower risk of both delayed hemorrhage and mortality than those on warfarin/clopidogrel.
Moreover, taking any blood thinner concurrently with aspirin significantly increased the risk of delayed hemorrhage. In an interview with Medscape (Frellick 2021), Chang noted that about a third of the patients were taking aspirin in addition to anticoagulants and that, of the bleeds, nearly two thirds were in patients with concurrent aspirin therapy. Chang recommended repeat imaging should be obtained with every patient with anticoagulant or antiplatelet medicines who is also taking aspirin,
You’ll recall that, in our September 21, 2021 Patient Safety Tip of the Week “Repeat CT in Anticoagulated Patients After Minor Head Trauma Not Cost-Effective”, we highlighted a study by Borst et al. (Borst 2021) in patients on anticoagulants who had head trauma. The initial head computed tomography was negative in 82% of 1,377 patients. Of those with an initial negative head computed tomography, 12 patients (0.9%) developed an intracranial hemorrhage that was identified on the second head computed tomography (6 had intraventricular hemorrhage, 3 had subdural hematoma, 2 had subarachnoid hemorrhage, and 1 had an intraparenchymal hemorrhage). None of the patients with delayed intracranial hemorrhage developed a change in neurologic status, required an intracranial pressure monitor, or underwent neurosurgical intervention.
And see our July 8, 2014 Patient Safety Tip of the Week “Update: Minor Head Trauma in the Anticoagulated Patient” that highlighted several other studies on the issue. In that column we noted the paucity of data on patients taking DOAC’s, in whom the degree of anticoagulation is not easily measurable. So, the current Chang study is reassuring in that it seems to show less risk for delayed hemorrhage in patients taking DOAC’s.
Contrast the following two positions taken after the 2 most recent studies on this issue:
Overall, it seems the frequency of delayed intracranial hemorrhage in patients on anticoagulants is relatively low, and the frequency of such hemorrhage requiring intervention is even lower. We seem to be defining a population at greater risk of such delayed hemorrhage: older patients, those on older anticoagulants (particularly those with INR’s beyond the usual therapeutic range), and those on concomitant antiplatelet therapy.
One key parameter that is missing in virtually all the studies on this issue is timing of the initial CT scan in relation to the head trauma. Our own suspicion is that there is probably a “sweet spot” for timing of the initial CT scan in such patients. It might turn out that scans done at, for example, 8-12 hours following the head trauma might pick up all the hemorrhages. If that proves to be the case, then a single CT scan done at that time may be all that is necessary. So future research should attempt to answer that question. Alternatively, maybe the authors of previous studies can re-analyze their data and include this important parameter.
And, of course, it is important to remind all patients (and their families or caregivers) of symptoms to watch for (drowsiness, nausea/vomiting, or focal neurological symptoms) following head trauma regardless of whether they are on anticoagulants or not.
Also, keep in mind that the many clinical decision rules for imaging following mild head trauma (see list below) are not intended for patients who are on anticoagulants.
We are always trying to balance patient safety vs. the costs incurred by unnecessary testing or treatment. The Borst study (and several others in our prior columns) have estimated the costs incurred from overuse of CT scanning in this population, though we challenged the methodology used by Borst et al. in our September 21, 2021 Patient Safety Tip of the Week “Repeat CT in Anticoagulated Patients After Minor Head Trauma Not Cost-Effective” and suggest that cost is actually much less. Getting the answer to the question we posed above may help us appropriately balance safety and cost.
Some of our previous columns on head trauma in the anticoagulated patient:
April 16, 2007 “Falls With Injury”
July 17, 2007 “Falls in Patients on Coumadin or Heparin or Other Anticoagulants”
June 5, 2012 “Minor Head Trauma in the Anticoagulated Patient”.
July 8, 2014 “Update: Minor Head Trauma in the Anticoagulated Patient”
August 21, 2018 “Delayed CT Scan in the Anticoagulated Patient”
September 21, 2021 “Repeat CT in Anticoagulated Patients After Minor Head Trauma Not Cost-Effective”
Some of our previous columns on CT scans in minor head trauma:
April 16, 2007 “Falls With Injury”
July 17, 2007 “Falls in Patients on Coumadin or Heparin or Other Anticoagulants”
March 2010 “CATCH: New Clinical Decision Rule for CT in Pediatric Head Trauma”
November 23, 2010 “Focus on Cumulative Radiation Exposure”
June 5, 2012 “Minor Head Trauma in the Anticoagulated Patient”.
July 8, 2014 “Update: Minor Head Trauma in the Anticoagulated Patient”
January 2017 “Still Too Many CT Scans for Pediatric Appendicitis”
March 2017 “Update on CT Scanning after Minor Head Trauma”
September 2017 “Clinical Decision Rule Success”
August 21, 2018 “Delayed CT Scan in the Anticoagulated Patient”
September 21, 2021 “Repeat CT in Anticoagulated Patients After Minor Head Trauma Not Cost-Effective”
References:
Chang W, et al. Delayed Posttraumatic Intracranial Hemorrhage in Patients on Anticoagulant/antiplatelet Medications: Three Year Experience. 2021 Virtual Meeting of the Radiological Society of North America (RSNA); November 2021
Frellick M. Older Anticoagulants Increase Risk of Delayed Brain Hemorrhage After Trauma. Medscape Medical News 2021; December 02, 2021
https://www.medscape.com/viewarticle/964069
Borst J, Godat LN, Berndtson AE, et al. Repeat head computed tomography for anticoagulated patients with an initial negative scan is not cost-effective. Surgery 2021; 170(2): 623-627 Published online: March 26, 2021
https://www.surgjournal.com/article/S0039-6060(21)00117-3/fulltext
Susman E. Head Trauma Patients on Blood Thinners Need Surveillance
— Delayed intracranial bleeding observed in patients. MedPage Today 2021; December 1, 2021
https://www.medpagetoday.com/meetingcoverage/rsna/95962
Print “Delayed Hemorrhage After Head Trauma in Anticoagulated Patients”
December 21, 2021
Spinning Misinformation
Ah…spin! It’s not just for politicians and cable news. Unfortunately, it has also become a part of medical research and medical publications. In our February 16, 2010 Patient Safety Tip of the Week “Spin/Hype…Knowing It When You See It” we gave an example of a study that was “spun” in not just one, not just two, but three prestigious medical journals by several respected authors.
Randomized controlled trials (RCT’s) are the gold standard for determining whether a drug or procedure or other treatment is superior to placebo in a comparable population. But the literature is replete with examples where the primary outcome parameter of an RCT was not met, yet the published report on that RCT includes “spin” that suggests the study showed a positive result. And all too often, the busy clinician reads just the conclusion section of an abstract of a study published in a journal article and gets a positive impression that was not justified by the data in the study.
Khan et al. reported on the level and prevalence of spin in published cardiovascular randomized clinical trial reports with statistically nonsignificant primary outcomes (Khan 2019). They identified spin n 57% of abstracts and 67% of main texts of published articles. 11% had spin in the title, 38% had spin in the results section, and 54% had spin in the conclusions. Among the abstracts, spin was observed in 41% of results sections and 48% of conclusions sections. They conclude that, in reports of cardiovascular RCTs with statistically nonsignificant primary outcomes, investigators often manipulate the language of the report to detract from the neutral primary outcomes.
But sometimes it is not possible to perform an RCT with placebo or “standard care” as the comparator. For example, there may be a current treatment that is known to be successful. In such cases, a “noninferiority” trial is conducted, attempting to show that the new treatment is at least as good as the existing treatment.
A new study (Ito 2021) looked for the presence of “spin” in noninferiority oncology trials having results that were not statistically significant. Of 52 RCT’s published between 2010 and 2019, they identified spin in the abstract in 34 (65.4%) and spin in the main text in 38 (73.1%).
The researchers found that novel experimental treatments may be associated with a high spin prevalence. But, perhaps the most surprising finding of the Ito analysis was that trials with nonprofit funders only were more likely to have spin. We have always thought that spin is usually more common in studies that were funded by industry. But Ito et al. point out that it is publication bias rather than spin that is more common in industry-funded studies and that spin, per se, is actually more common in studies funded by non-profits.
In the accompanying editorial, Zhang and Guan (Zhang 2021) point out that spin was even more common in noninferiority trials analyzed by Ito et al. than in superiority oncology trials. They caution that “given the expanding influence of peer-reviewed publications on medical products’ regulatory approval, clinical use, and reimbursement, high levels of spin could mislead decision-makers under various situations and thus compromise patient health and health system efficiency. The findings of Ito et al. highlight that stakeholders should handle results for novel treatments that are not significant with caution.”
In our February 16, 2010 Patient Safety Tip of the Week “Spin/Hype…Knowing It When You See It” we noted an excellent review on the limitations of randomized controlled trials (Kaul and Diamond 2010). This paper is very good at helping you understand some complicated statistical issues but really emphasizes three points we have often made in the past:
Probably the most common form of “spin” is when the primary outcome is not met but a post-hoc analysis finds a subgroup of patients that had a positive outcome. Such post-hoc analyses are meant to be hypothesis-generating and should lead to performance of another RCT in a population represented by that particular subgroup. The results of that post-hoc analysis should never be adopted into practice without undergoing their own RCT. Another common form of spin is focusing on positive benefit in a secondary endpoint when the primary endpoint was not met. Ito et al. found that the most prevalent spin strategy in their analysis of noninferiority trials was focusing on the secondary endpoint or subgroup analysis.
Another form of spin is extrapolating data (particularly cost data) from other studies to show a cost benefit from a currently studied drug or procedure when the data from the current RCT failed to show a cost benefit (see our February 16, 2010 Patient Safety Tip of the Week “Spin/Hype…Knowing It When You See It” for an example).
Another big problem is when a treatment or procedure shows a positive result when studied in a very narrow population but the authors suggest that it is effective for a much broader population.
Particularly in oncology trials, use of surrogate markers can also lead to spin. An improvement in the surrogate marker may not translate to improvement in more clinically meaningful outcomes such as overall survival. But this is not limited to oncology trials. The recent controversial FDA approval of aducanumab for Alzheimer’s Disease was based upon improvement of a biomarker reflecting theoretical pathogenesis of the disorder but lacking evidence of clinical impact.
Ito et al. point out that, compared with superiority RCT’s, noninferiority RCT’s may have more factors that complicate interpretation, including noninferiority margin, assay sensitivity, and choice of analysis population.
Ito et al. also point out that safety is often a primary focus of noninferiority trials but that safety itself should not be the sole consideration. They caution that researchers should
consider the benefit of an experimental treatment based on the results of a confirmatory analysis of efficacy, not just on the safety of the treatment.
Boutron and Ravaud (Boutron 2018) did a literature review to determine the prevalence of some forms of “spin” in specific fields and the possible effects of some types of spin on readers’ interpretation and research dissemination. The article has a good discussion of the various types of spin. They also discuss why researchers would spin their reports and possible ways to avoid it. Among the reasons they posit is the pressure to publish, particularly in high-impact factor journals that favor publication of “positive” results.
We’ve always been suspicious of “noninferiority” trials. If a current treatment is effective, can you justify a new treatment that is quite likely to be marketed at a cost well above that of the existing treatment? Perhaps, the new treatment is “noninferior” to the existing treatment in terms of efficacy but has a more favorable side effect or safety profile. And, rarely, it may be looking to see if an existing low-cost drug might be “noninferior” to a current expensive treatment. But we always get our hackles up when we see “noninferiority” as an outcome.
“Spin” is everywhere these days. We can’t turn on the TV or radio without seeing it and it seems spin is the rule rather than the exception on many social media sites. Now we can’t even trust our medical journals to do a good job of rooting out spin. It’s important for our patients that we maintain a keen eye when interpreting results of any published studies.
References:
Khan MS, Lateef N, Siddiqi TJ, et al. Level and prevalence of spin in published cardiovascular randomized clinical trial reports with statistically nonsignificant primary outcomes: a systematic review. JAMA Netw Open 2019; 2(5): e192622
https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2732330
Ito C, Hashimoto A, Uemura K, Oba K. Misleading Reporting (Spin) in Noninferiority Randomized Clinical Trials in Oncology With Statistically Not Significant Results: A Systematic Review. JAMA Netw Open 2021; 4(12): e2135765
https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2786921
Zhang Y, Guan X. Misleading Reporting in Statistically Not Significant Oncology Trials—Joining Efforts Toward Unbiased Results Interpretation. JAMA Netw Open 2021; 4(12): e2138695
https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2786922
Kaul S, Diamond GA. Trial and Error: How to Avoid Commonly Encountered Limitations of Published Clinical Trials. J Am Coll Cardiol 2010 55: 415-427
http://content.onlinejacc.org/cgi/content/abstract/55/5/415
Boutron I, Ravaud P. Misrepresentation and distortion of research in biomedical literature. Proc Natl Acad Sci 2018; 115(11): 2613-2619
https://www.pnas.org/content/115/11/2613
Print “Spinning Misinformation”
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More Issues in Pediatric Safety
January 24, 2017
Dexmedetomidine to Prevent Postoperative Delirium
January 17, 2017
January 10, 2017
The 26-ml Applicator Strikes Again!
January 3, 2017
What’s Happening to “I’m Sorry”?
December 27, 2016
Tip of the Week on Vacation
December 20, 2016
End-of-Rotation Transitions and Mortality
December 13, 2016
More on Double-Booked Surgery
December 6, 2016
Postoperative Pulmonary Complications
November 29, 2016
Doubling Down on Double-Booked Surgery
November 22, 2016
Leapfrog, Picklists, and Healthcare IT Vulnerabilities
November 15, 2016
November 8, 2016
Managing Distractions and Interruptions
November 1, 2016
CMS Emergency Preparedness Rule
October 25, 2016
Desmopressin Back in the Spotlight
October 18, 2016
Yet More Questions on Contact Precautions
October 11, 2016
New Guideline on Preop Screening and Assessment for OSA
October 4, 2016
September 27, 2016
September 20, 2016
Downloadable ABCDEF Bundle Toolkits for Delirium
September 13, 2016
Vanderbilt’s Electronic Procedural Timeout
September 6, 2016
August 30, 2016
Can You Really Limit Interruptions?
August 23, 2016
ISMP Canada: Automation Bias and Automation Complacency
August 16, 2016
How Is Your Alarm Management Initiative Going?
August 9, 2016
August 2, 2016
Drugs in the Elderly: The Goldilocks Story
July 26, 2016
Confirmed: Keep Your OR Doors Closed
July 19, 2016
Infants and Wrong Site Surgery
July 12, 2016
Forget Brexit – Brits Bash the RCA!
July 5, 2016
Tip of the Week on Vacation
June 28, 2016
Culture of Safety and Catheter-Associated Infections
June 21, 2016
Methotrexate Errors in Australia
June 14, 2016
Nursing Monitoring of Patients on Opioids
June 7, 2016
CPAP for Hospitalized Patients at High Risk for OSA
May 31, 2016
More Frailty Measures That Predict Surgical Outcomes
May 24, 2016
Texting Orders – Is It Really Safe?
May 17, 2016
Patient Safety Issues in Cataract Surgery
May 10, 2016
Medical Problems in Behavioral Health
May 3, 2016
Clinical Decision Support Malfunction
April 26, 2016
Lots More on Preventing Readmissions But Where's the Beef?
April 19, 2016
Independent Double Checks and Oral Chemotherapy
April 12, 2016
April 5, 2016
Workarounds Overriding Safety
March 29, 2016
March 22, 2016
Radiology Communication Errors May Surprise You
March 15, 2016
March 8, 2016
Tip of the Week on Vacation
March 1, 2016
February 23, 2016
February 16, 2016
February 9, 2016
February 2, 2016
January 26, 2016
More on Frailty and Surgical Morbidity and Mortality
January 19, 2016
Patient Identification in the Spotlight
January 12, 2016
New Resources on Improving Safety of Healthcare IT
January 5, 2016
Lessons from AirAsia Flight QZ8501 Crash
December 29, 2015
More Medical Helicopter Hazards
December 22, 2015
The Alberta Abbreviation Safety Toolkit
December 15, 2015
Vital Sign Monitoring at Night
December 8, 2015
Danger of Inaccurate Weights in Stroke Care
December 1, 2015
TALLman Lettering: Does It Work?
November 24, 2015
Door Opening and Foot Traffic in the OR
November 17, 2015
Patient Perspectives on Communication of Test Results
November 10, 2015
Weighing in on Double-Booked Surgery
November 3, 2015
Medication Errors in the OR - Part 2
October 27, 2015
Sentinel Event Alert on Falls and View from Across the Pond
October 20, 2015
Updated Beers List
October 13, 2015
Dilaudid Dangers #3
October 6, 2015
Suicide and Other Violent Inpatient Deaths
September 29, 2015
More on the 12-Hour Nursing Shift
September 22, 2015
The Cost of Being Rude
September 15, 2015
Another Possible Good Use of a Checklist
September 8, 2015
TREWScore for Early Recognition of Sepsis
September 1, 2015
August 25, 2015
Checklist for Intrahospital Transport
August 18, 2015
Missing Obstructive Sleep Apnea
August 11, 2015
New Oxygen Guidelines: Thoracic Society of Australia and NZ
August 4, 2015
Tip of the Week on Vacation
July 28, 2015
July 21, 2015
Avoiding Distractions in the OR
July 14, 2015
July 7, 2015
June 30, 2015
What Are Appropriate Indications for Urinary Catheters?
June 23, 2015
Again! Mistaking Antiseptic Solution for Radiographic Contrast
June 16, 2015
June 9, 2015
Add This to Your Fall Risk Assessment
June 2, 2015
May 26, 2015
May 19, 2015
May 12, 2015
More on Delays for In-Hospital Stroke
May 5, 2015
Errors with Oral Oncology Drugs
April 28, 2015
April 21, 2015
April 14, 2015
Using Insulin Safely in the Hospital
April 7, 2015
March 31, 2015
Clinical Decision Support for Pneumonia
March 24, 2015
Specimen Issues in Prostate Cancer
March 17, 2015
March 10, 2015
FDA Warning Label on Insulin Pens: Is It Enough?
March 3, 2015
Factors Related to Postoperative Respiratory Depression
February 24, 2015
More Risks with Long-Acting Opioids
February 17, 2015
Functional Impairment and Hospital Readmission, Surgical Outcomes
February 10, 2015
The Anticholinergic Burden and Dementia
February 3, 2015
CMS Hopes to Reduce Antipsychotics in Dementia
January 27, 2015
The Golden Hour for Stroke Thrombolysis
January 20, 2015
He Didn’t Wash His Hands After What!
January 13, 2015
January 6, 2015
Yet Another Handoff: The Intraoperative Handoff
December 30, 2014
Data Accumulates on Impact of Long Surgical Duration
December 23, 2014
Iatrogenic Burns in the News Again
December 16, 2014
More on Each Element of the Surgical Fire Triad
December 9, 2014
December 2, 2014
ANA Position Statement on Nurse Fatigue
November 25, 2014
Misdiagnosis Due to Lab Error
November 18, 2014
Handwashing Fades at End of Shift, ?Smartwatch to the Rescue
November 11, 2014
Early Detection of Clinical Deterioration
November 4, 2014
Progress on Fall Prevention
October 28, 2014
RF Systems for Retained Surgical Items
October 21, 2014
The Fire Department and Your Hospital
October 14, 2014
October 7, 2014
Our Take on Patient Safety Walk Rounds
September 30, 2014
More on Deprescribing
September 23, 2014
Stroke Thrombolysis: Need to Focus on Imaging-to-Needle Time
September 16, 2014
Focus on Home Care
September 9, 2014
The Handback
September 2, 2014
Frailty and the Trauma Patient
August 26, 2014
Surgeons’ Perception of Intraoperative Time
August 19, 2014
Some More Lessons Learned on Retained Surgical Items
August 12, 2014
Surgical Fires Back in the News
August 5, 2014
Tip of the Week on Vacation
July 29, 2014
The 12-Hour Nursing Shift: Debate Continues
July 22, 2014
More on Operating Room Briefings and Debriefings
July 15, 2014
Barriers to Success of Early Warning Systems
July 8, 2014
Update: Minor Head Trauma in the Anticoagulated Patient
July 1, 2014
Interruptions and Radiologists
June 24, 2014
Lessons from the General Motors Recall Analysis
June 17, 2014
SO2S Confirms Routine Oxygen of No Benefit in Stroke
June 10, 2014
Another Clinical Decision Support Tool to Avoid Torsade de Pointes
June 3, 2014
More on the Risk of Sedative/Hypnotics
May 27, 2014
A Gap in ePrescribing: Stopping Medications
May 20, 2014
May 13, 2014
Perioperative Sleep Apnea: Human and Financial Impact
May 6, 2014
Monitoring for Opioid-induced Sedation and Respiratory Depression
April 29, 2014
More on the Unintended Consequences of Contact Isolation
April 22, 2014
Impact of Resident Workhour Restrictions
April 15, 2014
Specimen Identification Mixups
April 8, 2014
FMEA to Avoid Breastmilk Mixups
April 1, 2014
Expensive Aspects of Sepsis Protocol Debunked
March 25, 2014
March 18, 2014
Systems Approach Improving Stroke Care
March 11, 2014
We Miss the Graphic Flowchart!
March 4, 2014
Evidence-Based Prescribing and Deprescribing in the Elderly
February 25, 2014
Joint Commission Revised Diagnostic Imaging Requirements
February 18, 2014
February 11, 2014
Another Perioperative Handoff Tool: SWITCH
February 4, 2014
But What If the Battery Runs Low?
January 28, 2014
Is Polypharmacy Always Bad?
January 21, 2014
January 14, 2014
Diagnostic Error: Salient Distracting Features
January 7, 2014
Lessons From the Asiana Flight 214 Crash
December 24-31, 2013
Tip of the Week on Vacation
December 17, 2013
December 10, 2013
Better Handoffs, Better Results
December 3, 2013
Reducing Harm from Falls on Inpatient Psychiatry
November 26, 2013
Missed Care: New Opportunities?
November 19, 2013
Can We Improve Dilaudid/HYDROmorphone Safety?
November 12, 2013
More on Inappropriate Meds in the Elderly
November 5, 2013
Joint Commission Sentinel Event Alert: Unintended Retained Foreign Objects
October 29, 2013
PAD: The Pain, Agitation, and Delirium Care Bundle
October 22, 2013
How Safe Is Your Radiology Suite?
October 15, 2013
October 8, 2013
October 1, 2013
Fuels and Oxygen in OR Fires
September 24, 2013
Perioperative Use of CPAP in OSA
September 17, 2013
September 10, 2013
Informed Consent and Wrong-Site Surgery
September 3, 2013
Predicting Perioperative Complications: Slow and Simple
August 27 2013
Lessons on Wrong-Site Surgery
August 20 2013
Lessons from Canadian Analysis of Medical Air Transport Cases
August 13 2013
August 6, 2013
July 9-30, 2013
Tip of the Week on Vacation
July 2, 2013
June 25, 2013
June 18, 2013
DVT Prevention in Stoke – CLOTS 3
June 11, 2013
June 4, 2013
May 28, 2013
The Neglected Medications: IV Fluids
May 21, 2013
May 14, 2013
Acute Colonic Pseudo-Obstruction (Ogilvie’s Syndrome)
May 7, 2013
April 30, 2013
Photographic Identification to Prevent Errors
April 23, 2013
Plethora of Medication Safety Studies
April 16, 2013
April 9, 2013
Mayo Clinic System Alerts for QT Interval Prolongation
April 2, 2013
Absconding from Behavioral Health Services
March 26, 2013
Failure to Recognize Sleep Apnea Before Surgery
March 19, 2013
Dealing with the Violent Patient in the Emergency Department
March 12, 2013
More on Communicating Test Results
March 5, 2013
Underutilized Safety Tools: The Observational Audit
February 26, 2013
Insulin Pen Re-Use Incidents: How Do You Monitor Alerts?
February 19, 2013
Practical Postoperative Pain Management
February 12, 2013
CDPH: Lessons Learned from PCA Incident
February 5, 2013
Antidepressants and QT Interval Prolongation
January 29, 2013
A Flurry of Activity on Handoffs
January 22, 2013
You Don’t Know What You Don’t Know
January 15, 2013
January 8, 2013
More Lessons Learned on Retained Surgical Items
January 1, 2013
Don’t Throw Away Those View Boxes Yet
December 25, 2012
Tip of the Week on Vacation
December 18, 2012
Unintended Consequences of the CAUTI Measure?
December 11, 2012
December 4, 2012
Unintentional Perioperative Hypothermia: A New Twist
November 27, 2012
November 20, 2012
Update on Perioperative Management of Obstructive Sleep Apnea
November 13, 2012
The 12-Hour Nursing Shift: More Downsides
November 6, 2012
Using LEAN to Improve Stroke Care
October 30, 2012
October 23, 2012
Latent Factors Lurking in the OR
October 16, 2012
What is the Evidence on Double Checks?
October 9, 2012
Call for Focus on Diagnostic Errors
October 2, 2012
Test Results: Everyone’s Worst Nightmare
September 25, 2012
Preoperative Assessment for Geriatric Patients
September 18, 2012
September 11, 2012
In Search of the Ideal Early Warning Score
September 4, 2012
August 28, 2012
New Care Model Copes with Interruptions Better
August 21, 2012
More on Missed Followup of Tests in Hospital
August 14, 2012
August 7, 2012
Cognition, Post-Op Delirium, and Post-Op Outcomes
July 31, 2012
Surgical Case Duration and Miscommunications
July 24, 2012
FDA and Extended-Release/Long-Acting Opioids
July 17, 2012
July 10, 2012
Tip of the Week on Vacation
July 3, 2012
Recycling an Old Column: Dilaudid Dangers
June 26, 2012
Using Patient Photos to Reduce CPOE Errors
June 19, 2012
More Problems with Faxed Orders
June 12, 2012
Lessons Learned from the CDPH: Retained Foreign Bodies
June 5, 2012
Minor Head Trauma in the Anticoagulated Patient
May 29, 2012
Falls, Fractures, and Fatalities
May 22, 2012
Update on Preoperative Screening for Sleep Apnea
May 15, 2012
May 8, 2012
Importance of Nontechnical Skills in Healthcare
May 1, 2012
April 24, 2012
Fire Hazard of Skin Preps Oxygen
April 17, 2012
April 10, 2012
April 3, 2012
New Risk for Postoperative Delirium: Obstructive Sleep Apnea
March 27, 2012
March 20, 2012
Adverse Events Related to Psychotropic Medications
March 13, 2012
Medical Emergency Team Calls to Radiology
March 6, 2012
February 28, 2012
AACN Practice Alert on Delirium in Critical Care
February 21, 2012
Improving PCA Safety with Capnography
February 14, 2012
Handoffs More Than Battle of the Mnemonics
February 7, 2012
Another Neuromuscular Blocking Agent Incident
January 31, 2012
January 24, 2012
Patient Safety in Ambulatory Care
January 17, 2012
Delirium and Contact Isolation
January 10, 2012
January 3, 2012
Unintended Consequences of Restricted Housestaff Hours
December 20, 2011
December 13, 2011
December 6, 2011
Why You Need to Beware of Oxygen Therapy
November 29, 2011
November 22, 2011
Perioperative Management of Sleep Apnea Disappointing
November 15, 2011
November 8, 2011
WHOs Multi-professional Patient Safety Curriculum Guide
November 1, 2011
So Whats the Big Deal About Inserting an NG Tube?
October 25, 2011
October 18, 2011
October 11, 2011
October 4, 2011
Radiology Report Errors and Speech Recognition Software
September 27, 2011
The Canadian Suicide Risk Assessment Guide
September 20, 2011
When Practice Changes the Evidence: The CKD Story
September 13, 2011
Do You Use Fentanyl Transdermal Patches Safely?
September 6, 2011
August 30, 2011
Unintentional Discontinuation of Medications After Hospitalization
August 23, 2011
Catheter Misconnections Back in the News
August 16, 2011
August 9, 2011
Frailty and the Surgical Patient
August 2, 2011
July 26, 2011
July 19, 2011
Communication Across Professions
July 12, 2011
Psst! Pass it onHow a kids game can mold good handoffs
July 5, 2011
Sidney Dekker: Patient Safety. A Human Factors Approach
June 28, 2011
Long-Acting and Extended-Release Opioid Dangers
June 21, 2011
June 14, 2011
June 6, 2011
May 31, 2011
Book Review Human Factors and Team Psychology in a High Stakes Environment
May 24, 2011
May 17, 2011
Opioid-Induced Respiratory Depression Again!
May 10, 2011
Preventing Preventable Readmissions: Not As Easy As It Sounds
May 3, 2011
April 26, 2011
Sleeping Air Traffic Controllers: What About Healthcare?
April 19, 2011
DVT Prophylaxis in Acute Stroke: Controversy Reappears
April 12, 2011
Medication Issues in the Ambulatory Setting
April 5, 2011
March 29, 2011
The Silent Treatment:A Dose of Reality
March 22, 2011
An EMR Feature Detrimental to Teamwork and Patient Safety
March 15, 2011
March 8, 2011
Yes, Physicians Get Interrupted Too!
March 1, 2011
February 22, 2011
February 15, 2011
Controversies in VTE Prophylaxis
February 8, 2011
February 1, 2011
January 25, 2011
Procedural Sedation in Children
January 18, 2011
More on Medication Errors in Long-Term Care
January 11, 2011
NPSA (UK) How to Guide: Five Steps to Safer Surgery
January 4, 2011
December 28, 2010
HAIs: Looking In All The Wrong Places
December 21, 2010
More Bad News About Off-Hours Care
December 14, 2010
NPSA (UK): Preventing Fatalities from Medication Loading Doses
December 6, 2010
More Tips to Prevent Wrong-Site Surgery
November 30, 2010
SURPASS: The Mother of All Checklists
November 23, 2010
Focus on Cumulative Radiation Exposure
November 16, 2010
November 9, 2010
12-Hour Nursing Shifts and Patient Safety
November 2, 2010
Insulin: Truly a High-Risk Medication
October 26, 2010
Confirming Medications During Anesthesia
October 19, 2010
Optimizing Medications in the Elderly
October 12, 2010
October 5, 2010
September 28, 2010
September 21, 2010
September 14, 2010
Wrong-Site Craniotomy: Lessons Learned
September 7, 2010
Patient Safety in Ob/Gyn Settings
August 31, 2010
August 24, 2010
The BP Oil Spill Analogies in Healthcare
August 17, 2010
Preoperative Consultation Time to Change
August 10, 2010
Its Not Always About The Evidence
August 3, 2010
Tip of the Week on Vacation
July 27, 2010
EMRs Still Have A Long Way To Go
July 20, 2010
More on the Weekend Effect/After-Hours Effect
July 13, 2010
Postoperative Opioid-Induced Respiratory Depression
July 6, 2010
Book Reviews: Pronovost and Gawande
June 29, 2010
Torsade de Pointes: Are Your Patients At Risk?
June 22, 2010
Disclosure and Apology: How to Do It
June 15, 2010
Dysphagia in the Stroke Patient: the Scottish Guideline
June 8, 2010
Surgical Safety Checklist for Cataract Surgery
June 1, 2010
May 25, 2010
May 18, 2010
Real-Time Random Safety Audits
May 11, 2010
May 4, 2010
More on the Impact of Interruptions
April 27, 2010
April 20, 2010
HITs Limited Impact on Quality To Date
April 13, 2010
April 6, 2010
March 30, 2010
Publicly Released RCAs: Everyone Learns from Them
March 23, 2010
ISMPs Guidelines for Standard Order Sets
March 16, 2010
A Patient Safety Scavenger Hunt
March 9, 2010
Communication of Urgent or Unexpected Radiology Findings
March 2, 2010
Alarm Sensitivity: Early Detection vs. Alarm Fatigue
February 23, 2010
Alarm Issues in the News Again
February 16, 2010
Spin/HypeKnowing It When You See It
February 9, 2010
More on Preventing Inpatient Suicides
February 2, 2010
January 26, 2010
Preventing Postoperative Delirium
January 19, 2010
January 12, 2010
Patient Photos in Patient Safety
January 5, 2010
December 29, 2009
Recognizing Deteriorating Patients
December 22, 2009
December 15, 2009
December 8, 2009
December 1, 2009
Patient Safety Doesnt End at Discharge
November 24, 2009
Another Rough Month for Healthcare IT
November 17, 2009
November 10, 2009
Conserving ResourcesBut Maintaining Patient Safety
November 3, 2009
Medication Safety: Frontline to the Rescue Again!
October 27, 2009
Co-Managing Patients: The Good, The Bad, and The Ugly
October 20, 2009
Radiology AgainBut This Time Its Really Radiology!
October 13, 2009
October 6, 2009
Oxygen Safety: More Lessons from the UK
September 29, 2009
Perioperative Peripheral Nerve Injuries
September 22, 2009
Psychotropic Drugs and Falls in the SNF
September 15, 2009
ETTOs: Efficiency-Thoroughness Trade-Offs
September 8, 2009
Barriers to Medication Reconciliation
September 1, 2009
The Real Root Causes of Medical Helicopter Crashes
August 25, 2009
Interruptions, Distractions, InattentionOops!
August 18, 2009
Obstructive Sleep Apnea in the Perioperative Period
August 11, 2009
August 4, 2009
July 28, 2009
Wandering, Elopements, and Missing Patients
July 21, 2009
Medication Errors in Long Term-Care
July 14, 2009
Is Your Do Not Use Abbreviations List Adequate?
July 7, 2009
Nudge: Small Changes, Big Impacts
June 30, 2009
iSoBAR: Australian Clinical Handoffs/Handovers
June 23, 2009
June 16, 2009
Disclosing Errors That Affect Multiple Patients
June 9, 2009
CDC Update to the Guideline for Prevention of CAUTI
June 2, 2009
Why Hospitals Should FlyJohn Nance Nails It!
May 26, 2009
Learning from Tragedies. Part II
May 19, 2009
May 12, 2009
May 5, 2009
Adverse Drug Events in the ICU
April 28, 2009
Ticket Home and Other Tools to Facilitate Discharge
April 21, 2009
April 14, 2009
More on Rehospitalization After Discharge
April 7, 2009
March 31, 2009
Screening Patients for Risk of Delirium
March 24, 2009
March 17, 2009
March 10, 2009
Prolonged Surgical Duration and Time Awareness
March 3, 2009
Overriding AlertsLike Surfin the Web
February 24, 2009
Discharge Planning: Finally Something That Works!
February 17, 2009
Reducing Risk of Overdose with Midazolam Injection
February 10, 2009
Sedation in the ICU: The Dexmedetomidine Study
February 3, 2009
NTSB Medical Helicopter Crash Reports: Missing the Big Picture
January 27, 2009
Oxygen Therapy: Everything You Wanted to Know and More!
January 20, 2009
The WHO Surgical Safety Checklist Delivers the Outcomes
January 13, 2009
January 6, 2009
December 30, 2008
Unintended Consequences: Is Medication Reconciliation Next?
December 23, 2008
December 16, 2008
Joint Commission Sentinel Event Alert on Hazards of Healthcare IT
December 9, 2008
December 2, 2008
Playing without the ballthe art of communication in healthcare
November 25, 2008
November 18, 2008
Ticket to Ride: Checklist, Form, or Decision Scorecard?
November 11, 2008
November 4, 2008
October 28, 2008
More on Computerized Trigger Tools
October 21, 2008
October 14, 2008
October 7, 2008
Lessons from Falls....from Rehab Medicine
September 30, 2008
September 23, 2008
Checklists and Wrong Site Surgery
September 16, 2008
More on Radiology as a High Risk Area
September 9, 2008
Less is More.and Do You Really Need that Decimal?
September 2, 2008
August 26, 2008
August 19, 2008
August 12, 2008
Jerome Groopmans How Doctors Think
August 5, 2008
July 29, 2008
Heparin-Induced Thrombocytopenia
July 22, 2008
Lots New in the Anticoagulation Literature
July 15, 2008
July 8, 2008
July 1, 2008
WHOs New Surgical Safety Checklist
June 24, 2008
Urinary Catheter-Related UTIs: Bladder Bundles
June 17, 2008
Technology Workarounds Defeat Safety Intent
June 10, 2008
Monitoring the Postoperative COPD Patient
June 3, 2008
UK Advisory on Chest Tube Insertion
May27, 2008
If You Do RCAs or Design Healthcare ProcessesRead Gary Kleins Work
May20, 2008
CPOE Unintended Consequences Are Wrong Patient Errors More Common?
May13, 2008
Medication Reconciliation: Topical and Compounded Medications
May 6, 2008
Preoperative Screening for Obstructive Sleep Apnea
April 29, 2008
ASA Practice Advisory on Operating Room Fires
April 22, 2008
CMS Expanding List of No-Pay Hospital-Acquired Conditions
April 15, 2008
April 8, 2008
April 1, 2008
Pennsylvania PSAs FMEA on Telemetry Alarm Interventions
March 25, 2008
March 18, 2008
Is Desmopressin on Your List of Hi-Alert Medications?
March 11, 2008
March 4, 2008
Housestaff Awareness of Risks for Hazards of Hospitalization
February 26, 2008
Nightmares.The Hospital at Night
February 19, 2008
February 12, 2008
February 5, 2008
Reducing Errors in Obstetrical Care
January 29, 2008
Thoughts on the Recent Neonatal Nursery Fire
January 22, 2008
More on the Cost of Complications
January 15, 2008
Managing Dangerous Medications in the Elderly
January 8, 2008
Urinary Catheter-Associated Infections
January 1, 2008
December 25, 2007
December 18, 2007
December 11, 2007
CommunicationCommunicationCommunication
December 4, 2007
November 27,2007
November 20, 2007
New Evidence Questions Perioperative Beta Blocker Use
November 13, 2007
AHRQ's Free Patient Safety Tools DVD
November 6, 2007
October 30, 2007
Using IHIs Global Trigger Tool
October 23, 2007
Medication Reconciliation Tools
October 16, 2007
Radiology as a Site at High-Risk for Medication Errors
October 9, 2007
October 2, 2007
Taking Off From the Wrong Runway
September 25, 2007
Lessons from the National Football League
September 18, 2007
Wristbands: The Color-Coded Conundrum
September 11, 2007
Root Cause Analysis of Chemotherapy Overdose
September 4, 2007
August 28, 2007
Lessons Learned from Transportation Accidents
August 21, 2007
Costly Complications About To Become Costlier
August 14, 2007
More Medication-Related Issues in Ambulatory Surgery
August 7, 2007
Role of Maintenance in Incidents
July 31, 2007
Dangers of Neuromuscular Blocking Agents
July 24, 2007
Serious Incident Response Checklist
July 17, 2007
Falls in Patients on Coumadin or Other Anticoagulants
July 10, 2007
Catheter Connection Errors/Wrong Route Errors
July 3, 2007
June 26, 2007
Pneumonia in the Stroke Patient
June 19, 2007
Unintended Consequences of Technological Solutions
June 12, 2007
Medication-Related Issues in Ambulatory Surgery
June 5, 2007
Patient Safety in Ambulatory Surgery
May 29, 2007
Read Anything & Everything Written by Malcolm Gladwell!
May 22, 2007
May 15, 2007
Communication, Hearback and Other Lessons from Aviation
May 8, 2007
Doctor, when do I get this red rubber hose removed?
May 1, 2007
April 23, 2007
April 16, 2007
April 9, 2007
Make Your Surgical Timeouts More Useful
April 2, 2007
March 26, 2007
Alarms Should Point to the Problem
March 19, 2007
Put that machine back the way you found it!
March 12, 2007
March 5, 2007
February 26, 2007
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