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What’s New in the Patient Safety World

December 2022

 

 

·       Scary Stat on Surgery in the Elderly

·       Unintended Consequences of a QTc Formula?

·       Game Changer to Prevent SSI’s in Abdominal Surgery?

·       Rapid Response Team Activations and Medication-Related Events

 

 

 

Scary Stat on Surgery in the Elderly

 

 

A pretty scary statistic emerged from a one-year follow-up on community-living patients, aged 65 years or older, who underwent major surgery. Gill and colleagues (Gill 2022) analyzed data on 5590 Medicare beneficiaries from the National Health and Aging Trends Study (NHATS).

 

The overall one-year mortality rate was 13.4%. That means that nearly 1 of every 7 community-living older US adults died in the year after major surgery. Mortality rates were 7.4% for elective surgeries and 22.3% for nonelective surgeries.

 

As you’d expect, mortality rates were greater as age increased. Mortality was highest for persons aged 90 years or older, intermediate for those aged 80 to 84 and 85 to 89 years, and lowest for those in the youngest 3 age groups. Unadjusted hazard ratios were 2.44 for those aged 80 to 84 years, 2.89 for those aged 85 to 89 years, and 6.06 for those aged 90 years or older.

 

Frailty and dementia played a major roles in the mortality risk. 1-year mortality was 6.0% for persons who were nonfrail, but 27.8% for those who were frail. Similarly, 1-year mortality was 11.6% for persons without dementia, but 32.7% for those with probable dementia.

 

And, of course, as pointed out in the editorial accompanying the Gill study (Perone 2022), the cumulative mortality over the course of the year suggests that death is not associated with surgery alone but also with chronic conditions (and changes derived from surgery) and the overall life expectancy of the population.

 

It is not clear what the 1-year mortality rate for a comparable population who did not have surgery would have been. But Gill et al. do state that the expected 1-year mortality

rate for their analytic sample, based on actuarial life tables was only 4.9%, considerably lower than the 13.4% overall mortality rate reported in their study.

 

Gill and colleagues and the editorialists both point to programs such as the American

College of Surgeons Geriatric Surgery Verification Program for recommendations

to improve outcomes after geriatric surgery (see our September 17, 2019 Patient Safety Tip of the Week “ACS Geriatric Surgery Verification Program”).

 

 

Some of our columns on preparation of patients prior to surgery:

 

 

 

Some of our prior columns on preoperative assessment and frailty:

 

 

References:

 

 

Gill TM, Vander Wyk B, Leo-Summers L, Murphy TE, Becher RD. Population-Based Estimates of 1-Year Mortality After Major Surgery Among Community-Living Older US Adults. JAMA Surg 2022; Published online October 19, 2022

https://jamanetwork.com/journals/jamasurgery/article-abstract/2797666

 

 

Perone JA, Anaya DA. Patient Experience Following Surgery in the Geriatric Population—Increased Relevance and Importance of Longer-Term Surgical Outcomes. JAMA Surg 2022; Published online October 19, 2022

https://jamanetwork.com/journals/jamasurgery/article-abstract/2797673

 

 

 

 

 

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Unintended Consequences of a QTc Formula?

 

 

We’ve done many columns on the importance of drugs and other conditions that prolong the QT interval, predisposing to the potentially lethal arrhythmia Torsade de Pointes. But might there be unintended consequences? A recent study in the oncology literature (Richardson 2022) suggests that use of certain formulas for calculating the QTc interval may erroneously preclude some patients from receiving the most appropriate chemotherapy.

 

The 3 most commonly used formulas for determining the adjusted QTc by oncologists are the Bazett, Fridericia, and Framingham formulas. Because some chemotherapy agents may prolong the QTc, Richardson and colleagues looked at how inappropriate modifications to chemotherapy might occur with each of those 3 formulas.

 

The percentage of ECG’s with grade 3 QTc prolongation differed by formula: Framingham 1.8%, Fridericia 2.8%, and Bazett 9.0% for all patients. For those patients receiving QT-prolonging chemotherapy the percentage of ECG’s with grade 3 QTc prolongation were: Framingham 2.7%, Fridericia 4.5%, and Bazett 12.5%. The Bazett formula resulted in a median QTc value 26.4 milliseconds higher than Fridericia and 27.8 milliseconds higher than Framingham.

 

Of the ECG’s classified as grade 3 by Bazett, 81.0% were grade 2 or less by either Fridericia or Framingham. 17.9% of evaluated clinical changes associated with prolonged QTc were deemed inappropriate when using either Fridericia or Framingham formula.

 

The authors conclude that use of the Bazett formula likely was associated with inappropriate changes in clinical management. These data support the use of a standard QTc formula (such as Fridericia or Framingham) for QTc correction in oncology. They argue for standardization of QTc monitoring practices across oncology.

 

The Richardson study did not report on patient outcomes or unwanted arrhythmias, so it is not known whether preferential use of the Fridericia or Framingham formulas allows more patients to receive certain chemotherapy agents safely. But it does raise the possibility that many patients are being denied the most appropriate management simply because of the formula chosen.

 

 

Some of our prior columns on QT interval prolongation and Torsade de Pointes:

 

  June 29, 2010 “Torsade de Pointes: Are Your Patients At Risk?”

  February 5, 2013 “Antidepressants and QT Interval Prolongation”

  April 9, 2013 “Mayo Clinic System Alerts for QT Interval Prolongation”

  June 10, 2014 “Another Clinical Decision Support Tool to Avoid Torsade de Pointes”

  April 2015 “Anesthesia and QTc Prolongation”

  October 10, 2017 “More on Torsade de Pointes”

  June 25, 2019 “Found Dead in a Bed – Part 2”

  April 7, 2020 “Patient Safety Tidbits for the COVID-19 Pandemic”

  February 16, 2021 “New Methods for QTc Monitoring”

  November 22, 2022 “The Apple Watch and Patient Safety”

 

 

References:

 

 

Richardson DR, Parish PC, Tan X, et al. Association of QTc Formula With the Clinical Management of Patients With Cancer. JAMA Oncol 2022; 8(11): 1616-1623 Published online September 22, 2022

https://jamanetwork.com/journals/jamaoncology/article-abstract/2796766

 

 

 

 

 

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Game Changer to Prevent SSI’s in Abdominal Surgery?

 

 

Surgical site infections (SSI’s) remain a significant problem, particularly in abdominal surgeries. What if we had a simple, inexpensive intervention that could reduce SSI’s? Investigators recently completed a study that suggests we have one!

 

ChEETAh was a multicenter, cluster randomized trial in seven low-income and middle-income countries (Benin, Ghana, India, Mexico, Nigeria, Rwanda, South Africa), across a wide range of operation types, hospital types, and countries. Investigators randomly assigned 81 surgery locations to either the current practice group (n = 42) or the intervention group (n = 39). The intervention was a change of sterile gloves and change to sterile instruments before closure of the surgical incision in a variety of abdominal surgical procedures.

 

Data was obtained on over 13,000 patients. Glove and instrument change took place in 58 (0.8%) of 7157 patients in the current practice group and 6044 (98.3%) of 6144 patients in the intervention group. The SSI rate was 18.9% in the current practice group versus 16.0% in the intervention group (adjusted risk ratio: 0.87, p=0·0032).

 

The authors conclude that ChEETah robustly shows that routine change of gloves and instruments before wound closure reduced surgical site infections in clean–contaminated, contaminated, and dirty surgery, which was consistent across several sensitivity analyses. Lack of heterogeneity of effect across any of the prespecified subgroups suggests that the effect is consistent across a wide range of patients.

 

The accompanying editorial (Abiad 2022) notes some limitations of the study (cluster design, intention-to-treat analysis, lack of blinding, and failure to differentiate double-gloving from single-gloving). But it concludes that, despite these limitations, the results of the trial are plausible, meaningful, and impactful. Change of gloves and instruments before skin closure in clean–contaminated and contaminated–dirty abdominal procedures prevents one of every eight SSI’s, and the results are possibly if not probably generalizable globally and to non-abdominal surgery.

 

Although the study had a pragmatic design and was done solely in low-income and middle-income countries and the SSI rates were quite high in both the usual care group and intervention group, we agree the results may well be generalizable. We’d like to see this study replicated in the US and other high-income countries, and perhaps in surgeries in addition to abdominal surgery. But this could well be a game changer!

 

 

References:

 

 

NIHR Global Research Health Unit on Global Surgery. Routine sterile glove and instrument change at the time of abdominal wound closure to prevent surgical site infection (ChEETAh): a pragmatic, cluster-randomised trial in seven low-income and middle-income countries. Lancet 2022; 400(10365): 1767-1776 November 19, 2022

https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(22)01884-0/fulltext?dgcid=raven_jbs_etoc_feature_lancet

 

 

Abiad MF, Kaafarani HMA. Changing gloves and switching instruments to decrease surgical site infection in abdominal surgery. Lancet 2022; 400(10365): 1742-1743 November 19, 2022

https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(22)01998-5/fulltext?dgcid=raven_jbs_etoc_email

 

 

 

 

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Rapid Response Team Activations and Medication-Related Events

 

 

Despite a considerable literature on rapid response teams, we’ve yet to see a comprehensive analysis of the underlying reasons for such activations. Of course, a variety of physiological parameters are what lead to such activations, but we are talking about the underlying causes of those physiological phenomena.

 

A new study from Australia (Levkovich 2022) found that medication-related events led to a substantial proportion of Medical Emergency Team (MET) activations. The study was conducted at two academic teaching hospitals in Melbourne, Australia that had mature Rapid Response Systems. Over a 3-week study period, they found 628 MET activations. Of these, 23.2% were medication related: an incidence of 15.5 medication-related MET activation per 1000 admissions. Medication-related MET activations occurred a median of 46.6 hours earlier in an admission than non-medication-related activations, and this group also had more repeat MET activations during their admission.

 

Most importantly, 63% of medication-related MET activations were felt to be potentially preventable. Some specific examples were:

·       tachycardia due to omission of beta-blocking agents (10.9%)

·       hypotension due to cumulative toxicity (9.8%) or inappropriate use (10.9%) of antihypertensives.

 

Over half (55.5%) of the medication-related MET activations were related to medication errors and cardiovascular medications were most often involved. Omissions of cardiovascular medications were the most common error. But inappropriate use of cardiovascular medications was also common. Such adverse drug reactions were often dose-related (18.5%) or time-related (17.8%). Beta blockers and antihypertensives were the medications most often implicated.

 

The accompanying editorial (Hδrkδnen 2022) expressed surprise that more typical high-alert medications, such as anticoagulants and opioids were not commonly involved in MET activations in this study. The authors suggest might be because those serious ADE’s

are managed differently (eg. with antidotes) before there is a need for a MET. Another potential reason is that cardiovascular medications can cause rapid hemodynamic changes resulting in a MET/RRT activation, whereas anticoagulant and opiate errors typically do not. A third reason might be that cardiac arrest cases were excluded from the sample.

 

The editorialists suggest that the high number of events related to omission of cardiovascular medications might be related to either ineffective medication reconciliation on admission or to long waits in the emergency department or boarding of patients admitted to the emergency department.

 

The Levkovich study is an important contribution to our understanding of unexpected clinical deterioration of patients in the hospital. Hospitals could probably benefit from common cause analysis (see our October 2020 What's New in the Patient Safety World column “Common Cause Analysis”) of their RCA’s (root cause analyses) on rapid response team activations.

 

 

Our other columns on rapid response teams:

 

 

 

References:

 

 

Levkovich BJ, Orosz J, Bingham G, et al. Medication-related Medical Emergency Team activations: a case review study of frequency and preventability. BMJ Quality & Safety 2022; Published Online First: 05 July 2022

https://qualitysafety.bmj.com/content/early/2022/07/05/bmjqs-2021-014185

 

 

Hδrkδnen M, Syyrilδ T, Schepel L. Adverse drug events leading to medical emergency team activation in hospitals: what can we learn? BMJ Quality & Safety 2022; Published Online First: 21 November 2022

https://qualitysafety.bmj.com/content/early/2022/11/20/bmjqs-2022-015275?rss=1

 

 

 

 

 

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