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The Surgical Safety Check List – May #urojc

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Ever since the World Health Organisation launched the Safe Surgery Saves Lives campaign in 2007, surgical safety has been drawn to the forefront of the daily surgical routine. The introduction of the 19-point Surgical Safety Checklist, aimed at reducing preventable complications, has become key, with shouts of ‘time-out’ or ‘checklist’ becoming the norm at the start of each case. Equally whether known as the ‘huddle’ or ‘team brief’, the meeting of all team members at the beginning of the list not only helps plan for any changes from the normal routine, but gives a good chance to get to know any new members of staff and helps to promote the team-based atmosphere that encompasses a productive operating list. In the 2009 study evaluating the benefits of the Surgical Safety Checklist, a reduction in both the mortality rate and rate of inpatient complications were found to be significantly reduced1. Implementation of these safety protocols however requires effort and engagement from all members of the theatre team.

In the May, the International Urology Journal Club (@iurojc) #urojc debated a study by Haynes et al in which the reduction of 30-day mortality following the implementation of a voluntary, checklist-based surgical quality improvement program2. The study identified that hospitals completing the program had a significantly lower rate of 30-day mortality following inpatient surgery.

One of the first topics brought up in the debate is the variability in the implementation of safety checklists.

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@StorkBrian raised the possibility that due to the addition of more items at the surgical time out, effectiveness decreases. Whether there is a lack of ability to concentrate on too much paper work was discussed

Conflicting evidence regarding the effect surgical checklists have on mortality was identified, with @WallisCJD bringing up the paper by Urbach et al as an example3.

The different outcomes from the two studies may however be attributed to the difference in follow up period and study design.

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Another aspect of study design discussed was the inclusion criteria – which excluded day case procedures. Whether the outcome in 30-day mortality would be different if these are included, as they are more likely to be lower-risk surgery, is unclear.

Equally whether 30-day mortality is the most appropriate endpoint for the study was questioned – although clearly very important, it would be interesting to know if other factors, such as significant morbidity, altered following the quality improvement program.

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Although the surgical checklist has become part of our daily life, the question as to why they are important was raised by @CanesDavid, with a variety of responses.

For many, it seemed that alongside the safety promotion, it helps to promote cohesive teamwork and communication, which may give all team members the confidence to voice any concerns.

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Giving all team members the ability to speak up with confidence if they identify any concerns will only benefit patients and staff.

Equally, the culture of safety promoted in teams who engage with the surgical checklist process may not be limited to the checklist itself, but to the surgical environment in general

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One clear concern some have with the mandating of the surgical checklist is ensuring it does not just become a ‘tick-box’ exercise

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Regardless of whether you find the checklist another form to fill, or a key part of your operating list, the goal of the process is clear: to protect our patients from preventable mistakes.

This study, confirming the original findings from the 2009 study that surgical safety checklists improve operative mortality, adds to the argument that this must become an inherent part of our practice. Key in this study however was the entire program promoting engagement in the concept of surgical safety, and supporting the team as a unit in this. The debate around this paper has highlighted that although the process of completing the mandatory checklists is important, perhaps the more important aspect is creating a culture of safety, openness and honest communication in which all team members can work together to promote safe surgery.

 

Sophia Cashman is a urology trainee working in the East of England region, UK. Her main areas of interest are female and functional urology. @soph_cash

 

References

1. Haynes AB, Weiser TG, Berry WR, et al. A Surgical Safety Checklist to Reduce Morbidity and Mortality in a Global Population. New England Journal of Medicine 2009;360(5):491-9
2. Haynes AB, Edmondson LBA, Lipsitz SR, et al. Mortality Trends After a Voluntary Checklist-based Surgical Safety Collaborative. Annals of Surgery 2017. Published Ahead-of-Print
3. Urbach DR, Govindarajan A, Saskin R, et al. Introduction of Surgical Safety Checklists in Ontario, Canada. New England Journal of Medicine 2014;370(11):1029-1038

 

Is maintenance BCG an unnecessary evil? Summary of the April 2015 #urojc

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Sophia CashmanThe current BCG shortage, and the effect this is having on our bladder cancer patients, is an issue that continues to weigh heavily on many urologists. With no immediate solution in sight, and limited availability, a variety of tactics are being advocated to optimally use the current supply.

The April 2015 International Urology Journal Club #urojc debate focused on the timely paper by Martínez-Piñeiro et al1. This paper reported the results of a randomised trial evaluating the outcomes of BCG induction followed by a modified three year maintenance regimen versus standard BCG induction alone in patients with high-risk non-muscle-invasive bladder cancer. The investigators concluded there was no observed decrease in recurrence and progression rates in those receiving just induction compared to induction and maintenance regimen.

This very topical debate kicked off on Sunday 12th April.

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Coinciding with the USANZ Annual Scientific Meeting, this month’s debate gave both those who were live tweeting at the conference, and those learning about the benefits of social media as a new concept, the opportunity to see the #urojc debate in action.

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One of the first points of discussion raised was the difference between the maintenance protocol used in the study, consisting of one BCG installation every three months for three years, and the standard SWOG schedule.

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The lack of difference in outcome between the two groups raised the question as to whether this indicated that their modified maintenance protocol is less effective that the current strategies.

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The theme of alternative maintenance schedules continued, with some variation in practice noted.

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Some of the variability in maintenance may be due to the tolerability and side effects experienced.

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Although there may be a degree of acceptance amongst patients if there is thought to be a chance of improvement in risks of disease recurrence or progression.

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The reason for the variability of response to BCG therapy between patients remains unclear.

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For the patient, the lack of understanding of why this is the case may be a cause of distress, especially when faced with adverse effects and toxicity.

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Inevitably it was not long until the key on-going issue of the lack of available BCG was raised.

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This issue continues to cause a lot of angst for both patients and their treating urologists, with no immediate solution evident. There may however be light at the end of a somewhat long tunnel with the restarting of production by Sanofi.

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In the mean time, the downstream effects of the production delay continues to compromise the treatment options for bladder cancer patients.

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As the availability remains largely outside of clinicians’ hands, perhaps our focus at present needs to be on other factors we can control in order to improve the outcomes for our bladder cancer patients.

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This debate surrounding this paper has raised a number of key points that, in the face of the BCG shortage, are worth considering. Until the supply is re-established, the BCG we have needs to be optimally used – however perhaps the most effective maintenance schedule needs further investigation. Or perhaps, due to the variation in tolerability and effectiveness between individuals, maintenance therapy needs to remain a more fluid concept.

As always, the #urojc debate involved healthy international discussions. This gives the unique ability to understand the global viewpoints on the study findings, and the current BCG crisis. Analytics of the debate using the #urojc hash tag from the website www.symplur.com again demonstrated the excellent involvement from participants, with over 180,000 unique impressions.

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Thanks to all of those who participated this month. We look forward to the #urojc May debate – I am sure it will be as lively as ever.

1. Martínez-Piñeiro L, Portillo JA, Fernández JM, et al. Maintenance Therapy with 3-monthly Bacillus Calmette-Guérin for 3 Years is Not Superior to Standard Induction Therapy in High-risk Non-muscle-invasive Urothelial Bladder Carcinoma: Final Results of Randomised CUETO Study 98013. European Urology March 2015 (Article In Press)

 

A new take on GPS navigation? Summary of the June #urojc twitter debate.

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The diagnosis and management of prostate cancer continues to rapidly evolve, with heavy debates at each stage of the evolution process. The key trade off between avoiding the over diagnosis and overtreatment of low risk indolent tumours, versus failing to diagnose and act on what may progress to aggressive disease, is an on going theme in the debate.

Research into various diagnostic tools to help both the patient and clinician stratify individual risk is on going, however the heavy consequence of undertreating perhaps leads more into active treatment than clinically necessary.

The June #urojc twitter debate focused on the new and hugely important paper by Klein E et al, to which we were given open access to courtesy of European Urology.  The authors of this US study focus on the potential underuse of Active Surveillance (AS), and propose a Genomic Prostate Score in order to help risk stratify patients considering both surveillance and active therapy. Based on three studies, a prostatectomy study, a biopsy study, and a validation study, a 17-gene assay was created which was shown to predict both high stage and high grade disease at diagnosis.

The debate kicked off with the suggestions from the hosts that at genomics may make their way into AS protocols

 

Which was rapidly agreed

However inevitably the issue of cost was raised

Parth Modi praised the study design and results, however raised a valid question

And the further issue of logistics of samples provided for genomic testing was debated

With the possibility of low disease volume in samples contributing

Which launched a debate as to whether for those with low volume disease, the discussion of opting for genomics was a discussion too far

Alternatives to genomics in predicting progressive disease were discussed. However again the cost of these tests were debated – although generally thought to be less expensive than genomic testing.

 

Followed by perhaps an early contender for best tweet…

 

The host again posed an on point question

With responses suggesting there remains room for further work until genomics plays a role in day-to-day treatment plans

David Canes helped to put the debate into real terms by using an example case for discussion, which raised the point of interpretation of results being dependent on likely treatment decision, not necessarily treatment decision based fully on results

Which raised some slightly more pragmatic suggestions

GPS results however are not necessarily clear-cut. Like all prognostic indicators, they can be interpreted in variable ways. Is there a possibility that they could add to the quagmire in the decision making process for patients?

Ultimately the theme of the debate was summed up excellently by Matt Cooperberg. GPS is not offering a definitive strategy to decide who will and will not progress, or who should decide on active treatment. It does however mark a movement into individualised care, which may well be the future for prostate cancer treatment

Congratulations to David Canes for winning the Best Tweet prize which is a complimentary manuscript to Research Reports in Urology published by @DovePress.

Many thanks to all of those who participated in the debate. We look forward to next month’s #urojc discussion!

Sophia Cashman is a first year urology trainee working in the East of England region, UK. Her main areas of interest are female and functional urology. @soph_cash

 

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