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Surgical safety checklists in developing countries
REVIEW International Journal of Surgery 12 (2014) 2e6
Contents lists available at ScienceDirect
International Journal of Surgery journal homepage: www.journal-surgery.net
Review
Surgical safety checklists in developing countries Sayinthen Vivekanantham a, *, Rahul Prashanth Ravindran a, Kumaran Shanmugarajah b, Mahiben Maruthappu b, Joseph Shalhoub a a b
Imperial College School of Medicine, Imperial College London, London SW7 2AZ, UK Harvard University, Cambridge, MA 01451, USA
a r t i c l e i n f o
a b s t r a c t
Article history: Received 29 September 2013 Accepted 24 October 2013 Available online 13 November 2013
The World Health Organization Surgical Safety Checklist (WHO SSC) has demonstrated efficacy in developed and developing countries alike. Recent increases in awareness of surgical morbidity in developing countries has placed greater emphasis on strategies to improve surgical safety in resourcelimited settings. The implementation of surgical safety checklists in low-income countries has specific barriers related to resources and culture. Adapting and amending existing surgical safety checklists, as well as considering factors unique to developing countries, may allow the potential of this simple intervention to be fully harnessed in a wider setting. This review will address the benefits and challenges of implementation of surgical safety checklists in developing countries. Moreover, inspiration for the original checklist is revisited to identify areas that will be of particular benefit in a resource-poor setting. Potential future strategies to encourage the implementation of checklists in these countries are also discussed. Ó 2013 Surgical Associates Ltd. Published by Elsevier Ltd. All rights reserved.
Keywords: Surgery Safety Checklists Developing countries World Health Organization
1. Introduction The surgical mortality in developing countries is 10 times higher than developed nations1 and deaths attributed to anesthesia are 1000-fold higher,2,3 clearly demonstrating the need to improve safety in this setting. By simply implementing checklists and protocols from developed countries to developing countries we may not be harnessing their complete benefits. This review will consider the role of surgery in addressing the overall burden of disease in the developing world and discuss the impact of the World Health Organization Surgical Safety Checklist (WHO SSC) in this setting. Suggestions for appropriately adapting and expanding the WHO SSC for developing countries to improve the safety of surgery globally are also discussed.4
2. Importance of surgery in developing countries The recent WHO report ‘Safe Surgery Saves Lives’ has helped prioritize surgical care throughout the world.5 Surgery has previously been perceived to be a cost-ineffective intervention relative
to GDP in low-income countries.6 However, Gosselin et al. have measured the cost per Disability-Adjusted-Life-Year (DALY) in Sierra Leone, which highlighted that the price per DALY averted was $32.78 through surgery, which compares favorably with nonsurgical interventions.7 Another study in Cambodia evaluated the cost of trauma surgery and this was also deemed to be costeffective relative to other medical interventions.8 Aside from cost being a barrier to the expansion of surgery in developing countries, it was also thought that surgery only benefited a small percentage of the population. This implied that resources would be more effectively utilized on alternative management strategies. Jamison et al. have countered this position; they have estimated that 11% of the global burden of disease can be treated by surgery, particularly by operating on those suffering trauma or cancer.9 These findings underpin the acknowledgment of the increased benefit surgery can provide in developing countries. It is vital that as increased surgical interventions are employed in these settings, safety standards are initiated and improved in parallel.
3. Importance of the WHO SSC in the developing world * Corresponding author. Tel.: þ44 (0) 798101 5718. E-mail addresses: [email protected] (S. Vivekanantham), [email protected] (R.P. Ravindran), kumaran.shanmugarajah@ tbrc.mgh.harvard.edu (K. Shanmugarajah), [email protected] (M. Maruthappu), [email protected] (J. Shalhoub).
Vast differences between developed and developing countries, for example in healthcare budgets, reflect differences in measures needed to ensure surgical safety.9 In light of this, we believe the WHO SSC is even more critical in developing countries compared to
1743-9191/$ e see front matter Ó 2013 Surgical Associates Ltd. Published by Elsevier Ltd. All rights reserved. http://dx.doi.org/10.1016/j.ijsu.2013.10.016
REVIEW S. Vivekanantham et al. / International Journal of Surgery 12 (2014) 2e6
developed countries. For example, surgeons in rural areas may have to perform a higher number of operations and operate in situations where they may not be specialists.10 This may lead to simple checks being omitted because of the pressure of the workload, as well as unfamiliarity with the procedure performed. Checklists would be particularly useful in such settings. The WHO SSC was developed with the aim of routinely checking information at three critical stages of surgery (Fig. 1). Use of this initiative has been associated with reduced operative error and improved outcomes.4 In particular patient mortality fell from 1.5% to 0.8% following the implementation of this checklist. Importantly, this data was acquired from four high-income and four low-income or middle-income countries, as classified by the World Bank,11 thereby demonstrating its applicability throughout the world.4 Numerous other studies have looked into the implementation of the WHO SSC globally.12e14 In 2012, Borchard et al. performed a systematic review of the effectiveness of safety checklists in surgery and encouragingly found that the relative risk of mortality fell to 0.57 (95% CI: 0.42e0.76) when checklists were used.14 Furthermore,
3
the relative risk of complications also fell after the implementation of the checklists (0.63 [95% CI: 0.58e0.67]).14 Whilst the WHO SSC was trialed worldwide, evidence suggests it is particularly effective in a resource-poor setting. Following the implementation of the WHO SSC, the largest decrease in complications (74.3%) was in low-income or middle-income countries.4 Furthermore, in the same study, two of the four hospital sites in the low-income and middle-income countries group had a decrease in surgical site infections and total complication rates, compared to only one of the four hospital sites in high-income countries.4 These findings highlight that the WHO SSC has the potential for significant impact specifically in the context of developing countries. A possible explanation for these observations could be that a number of safety measures outlined in the WHO SSC were already used in developed countries prior to the formal introduction of the checklist. For example, observations from high-income countries from the initial WHO SSC study showed pulse oximetry was used for intra-operative monitoring in 99.0% of cases before the checklist
Fig. 1. Elements of the World Health Organization Surgical Safety Checklist. Reproduced with permission.4
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was introduced, compared to 86.0% in sites of low-income or middle-income countries.4 In addition, prior to the implementation of the WHO SSC, intra-operative observers noted 63.9% of cases in sites of high-income countries performed an oral confirmation of the patient’s identity and surgical site prior to operation. However, this was only observed in 34.3% of cases in developing countries.4 These studies have identified areas in which the WHO SSC may have a particular impact in developing countries. While studies on the WHO SSC have demonstrated encouraging outcomes, its usage remains poor, with checklist compliance having been reported as low as 12%.14,15 Cultural differences may play a role in the reduced uptake of surgical safety checklists in developing countries. In Thai culture, for example, it is against societal norm to make marks on other people16 so this may prevent them marking the operative site. Moreover, people in Thailand only introduce themselves when meeting initially, and are typically shy about expressing their position thereafter. This may explain why team members were more reluctant to introduce themselves by name and role during the ‘time-out’ period.17 Furthermore, economic limitations may limit the full implementation of the checklist because of the requirement of certain equipment which may not be affordable in the developing world.18 In Thailand, surgical site marking and hair removal were typically not completed prior to checklist implementation.17 A contributing factor could be shortage of materials; however, these items were then acquired following the implementation of a checklist, which perhaps served to highlight their absence. We have established that whilst the WHO SSC has some efficacy in the developing world, there still remains scope to improve its benefits there. We now shift focus to concentrate on ways that this could potentially be done.
4. Developing checklists in resource-limited settings using past inspiration
Fig. 2. The different stages of the Formula 1 pit stop, where numbers denote the order of the different actions. Reproduced with permission.20
Checklists from other industries contributed towards the development of the WHO SSC.19 In order to adapt the WHO SSC to further benefit surgical safety in developing countries, it may be useful to revisit the founding principles that initially inspired the creation of the checklist, and see if further lessons may be gleaned. The high-pressure environment of surgery is found only in a handful of other careers. Notably, Formula 1 (F1) racing and aviation both require high levels of teamwork, focus and performance, similar to that seen in an operating theater. This especially holds true in resource-limited theaters, often with a higher caseload. In F1, the pit stop requires the coordinated efforts of many team members to perform the necessary steps as efficiently as possible (Fig. 2). In many ways this parallels the post-operative handover process in surgery. In developing countries there is less staff to look after patients and therefore correct and complete information transfer is critical. Considering this, variations or further criteria could be introduced to the WHO SSC in developing countries to maximize its benefit at the post-operative handover stage. Catchpole et al. consulted the Ferrari F1 race director to identify similarities between surgical handover and racing safety.20 This included, for example, the necessity of having a designated leader (in F1 this is the ‘lollipop’ man and it was decided the anesthetist should assume this role).20 In developing countries, the role of the anesthetist is often assumed by nursing teams. This unclear definition as to who is responsible for completing the checklist may contribute to lower usage in developing countries, due to confusion as to who should be responsible for delivering the checklist in resource-limited settings. Compliance could be improved through creating tailored regional definitions as to the specific person who
is responsible for conducting the WHO SSC within the operating theaters in developing counties. Meticulous training and practice is required for the ideal F1 pit stop; however, there is no structured training for the post-operative handover, especially in developing countries. Catchpole et al. accounts for this, in part, by highlighting the low staff turnover in F1 compared to constantly rotating doctors and nurses in the healthcare world. Ensuring that staff work in the same roles as far as possible, with minimal rotation between different positions, might help further reduce complication rates in resource-limited settings. Karl mentions several other factors that vary between surgery and the aviation industry, beyond the use of checklists.21 For example, in surgery there is an emphasis on documenting what is done rather than actually focusing on doing it safely. Also in surgery, people are expected to know how to deal with emergencies by memory, whilst in aviation there is a quick reference handbook for all major emergencies that can be accessed for assistance. Utilizing a similar resource in developing countries to cover a range of emergency procedures might be a separate initiative that can improve surgical safety globally. Finally, and importantly, below 10,000 feet all airlines have ‘sterile cockpit rules’ where there can be no discussion apart from that which is relevant to the safety of the flight.21 This is in contrast to surgery where there often is irrelevant discussion that is not policed, even during critical parts of a procedure. Incorporating ‘sterile operating rules’ at key aspects of surgical procedures might help improve surgical safety in developing and developed countries alike. Although it is helpful to draw comparisons from other industries, ultimately surgical practice is unique. Therefore, whilst
REVIEW S. Vivekanantham et al. / International Journal of Surgery 12 (2014) 2e6
other industries’ standards of practice can be examined, we appreciate that not all lessons can be directly translated into surgery. We anticipate that these lessons will form the foundation upon which improvements to surgical practice can made, taking into account the complexity and uniqueness of surgical patients. Surgical safety checklists have been shown to reduce errors; however, they have not completely eliminated them. This highlights the ongoing importance of good clinical judgment and the appreciation of significant inter-patient variation by gaining experience as a surgeon. 5. New directions for using checklists in resource-limited settings While some studies have demonstrated a positive benefit of the WHO SSC there are ways in which checklists could be further developed. Specific checklists have been created to suit different surgical specialties, for example neurosurgery22 and ophthalmology.23 At this time, it is unclear whether changes to content, structure, delivery and specialty-specificity of checklists could lead to further benefits to patient safety and quality of treatment, with more research in this area sure to provide the answer. With caseload variations between developed and developing countries in terms of volume and types of procedures, use of checklists across different specialties created in developed countries might need to be further modified to ensure maximal benefit for use in resourcelimited settings. Although surgical research has been quick to embrace the potential of checklists, the adoption of checklists beyond the operating room has been limited.24 Checklists have been harnessed recently in cardiac catheterization25 and crisis situations.26 With further clinical situations trialing checklists in the developed world, it will become more readily apparent where benefit may be derived through their implementation and give direction for further uses of checklists in developing settings. In order to improve compliance in developing countries it may be useful to adjust the WHO SSC, taking cultural variations into account. Surgical practitioners of various ethnicities in different countries could be consulted to identify any specific areas of the checklist that might present a barrier to its uptake in regions with different social norms. Amendments could then be made to accommodate cultural variations. The efficacy of the WHO SSC has inspired the formation of various sister organizations that promote the use of medical checklists worldwide. Project Check is an umbrella organization that aims to act as a central source for all clinical checklists. The organization aims to make clinical checklists suitable for many different situations globally, enhancing safety around the world.15 Furthermore, the charity Lifebox was created to subsidize the cost of purchasing pulse oximeters by hospitals in developing countries as this may be a barrier to full implementation of the checklist in these settings.27 More recently, a study has demonstrated that successful implementation of the WHO SSC with provision of pulse oximeters in a resource-limited setting in Moldova resulted in a reduction in overall post-operative complications from 21.5% to 8.8%.28 Further initiatives to support the global implementation of checklists will help reduce surgical complications in developing settings. ‘Checklist fatigue’ is when the overuse of checklists results in reduced overall compliance. The WHO SSC is designed to minimize this by only including checks for common and preventable sources of error.19 With the occurrence of ‘checklist fatigue’ recognized in the developed world,29,30 measures to prevent this should be enforced in resource-limited settings. We believe this limitation is less likely to occur if the previously outlined benefits of using
5
checklists are stressed to those responsible for checklist compliance in developing countries. We also propose that following a reassessment of the components of the checklist, the checklist should be tailored specifically to various developing world settings, taking into account cultural differences and local practices; only one checklist should be implemented within a country or region. 6. Conclusions It is estimated that at least half a million deaths per year would be prevented worldwide if the WHO SSC was correctly implemented.31 Any human system is prone to error; however, checklists are proving to be an effective mechanism through which this can be reduced within surgery and beyond. We believe the benefits from these measures will be of particular value in developing countries, where resources and surgical practice lag behind that of developed countries. Inspiration for developing safety checklists originated from examining protocols from other industries, where maintaining safety is considered as important as achieving an outcome. These industries provide ideas for further development of surgical safety checklists, and there is an impetus to implement more ideas from these other fields to improve the efficacy of checklists in developing countries. Whilst we acknowledge that checklists cannot replace good clinical acumen, we feel that there is still scope for improving safety by increasing and adapting the usage of this tool in the developing world. Interventions to improve surgical safety through checklists e whether pre-operatively, during surgery, post-operatively, or in a crisis setting e may also act as inspiration for other areas of medicine. The direction and future application of these initiatives holds many possibilities and remains an exciting opportunity to further drive down adverse outcomes within surgery, particularly in developing settings. Conflicts of interest Sayinthen Vivekanantham is founding Director of Global Medical Education Trust (GMET), a recently established charity that aims to improve the quality of medical education and learning within healthcare in developing countries. Mahiben Maruthappu & Joseph Shalhoub are co-founding Directors and Kumaran Shanmugarajah is the Secretary of the World Surgical Association (WSA), a recently established non-profit improving surgical care delivery in resource-limited settings. They have no other conflicts of interest to declare. Funding None. Ethical approval None. Author contribution Sayinthen Vivekanantham e Extrapolation of initial concept, drafting of the article, ideas for initiatives. Rahul Prashanth Ravindran e Drafting of the article, ideas for initiatives. Kumaran Shanmugarajah e Review and editing of the article. Mahiben Maruthappu e Review and editing of the article. Joseph Shalhoub e Conception of idea, review and editing of the article. Acknowledgments None.
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References 1. Weiser TG, Regenbogen SE, Thompson KD, et al. An estimation of the global volume of surgery: a modelling strategy based on available data. Lancet 2008;372(9633):139e44. 2. Ouro-Bang’na Maman AF, Tomta K, Ahouangbévi S, Chobli M. Deaths associated with anaesthesia in Togo, West Africa. Trop Doct 2005;35(4):220e2. 3. Li G, Warner M, Lang BH, Huang L, Sun LS. Epidemiology of anesthesiarelated mortality in the United States, 1999e2005. Anesthesiology 2009;110(4):759e65. 4. Haynes AB, Weiser TG, Berry WR, et al. A surgical safety checklist to reduce morbidity and mortality in a global population. N Engl J Med 2009;360(5): 491e9. 5. World Health Organisation. Safe surgery saves lives [cited 2013 12/04/13]. Available from: http://who.int/patientsafety/safesurgery/en/index.html; 2013. 6. Bickler SW, Spiegel D. Improving surgical care in low- and middle-income countries: a pivotal role for the World Health Organization. World J Surg 2010;34(3):386e90. 7. Gosselin RA, Thind A, Bellardinelli A. Cost/DALY averted in a small hospital in Sierra Leone: what is the relative contribution of different services? World J Surg 2006;30(4):505e11. 8. Gosselin RA, Heitto M. Cost-effectiveness of a district trauma hospital in Battambang, Cambodia. World J Surg 2008;32(11):2450e3. 9. Dean T, Jamison JGB, Measham Anthony R, et al. Disease control priorities in developing countries. 2nd ed.; 2006. p. 1e1448. 10. Venkatesh R. Outcomes of high volume cataract surgeries in a developing country. Br J Ophthalmol 2005;89(9):1079e83. 11. Bank W. Data & statistics: country classification. Available from: http://data. worldbank.org/about/country-classifications; 2006. 12. Bliss LA, Ross-Richardson CB, Sanzari LJ, et al. Thirty-day outcomes support implementation of a surgical safety checklist. ACS 2012;215(6):766e76. 13. Fudickar A, Hörle K, Wiltfang J, Bein B. The effect of the WHO surgical safety checklist on complication rate and communication. Dtsch Ärztebl Int 2012;109(42):695e701. 14. Borchard A, Schwappach DLB, Barbir A, Bezzola P. A systematic review of the effectiveness, compliance, and critical factors for implementation of safety checklists in surgery. Ann Surg 2012;256(6):925e33. 15. Spence J, Goodwin B, Enns C, Dean H. Student-observed surgical safety practices across an urban regional health authority. BMJ Qual Saf 2011;20(7): 580e6.
16. Kachru Y, Smith LE. Cultures, contexts, and world englishes, Routledge, 2008. 17. Kasatpibal N, Senaratana W, Chitreecheur J, Chotirosniramit N, Pakvipas P, Junthasopeepun P. Implementation of the world health organization surgical safety checklist at a university hospital in Thailand. Surg Infect 2012;13(1): 50e6. 18. Funk LM, Weiser TG, Berry WR, et al. Global operating theatre distribution and pulse oximetry supply: an estimation from reported data. Lancet 2010;376(9746):1055e61. 19. Weiser TG, Haynes AB, Lashoher A, et al. Perspectives in quality: designing the WHO surgical safety checklist. Int J Qual Health Care 2010;22(5):365e70. 20. Catchpole KR, De Leval MR, McEwan A, et al. Patient handover from surgery to intensive care: using Formula 1 pit-stop and aviation models to improve safety and quality. Pediatr Anesth 2007;17(5):470e8. 21. Karl RC. Aviation. J Gastrointest Surg Off J Soc Surg Aliment Tract 2009;13(1):6e8. 22. Zuckerman SL, Green CS, Carr KR, Dewan MC, Morone PJ, Mocco J. Neurosurgical checklists: a review. Neurosurg Focus 2012;33(5):E2. 23. Cavallini GM, Campi L, Maria M, Forlini M. Clinical risk management in eye outpatient surgery: a new surgical safety checklist for cataract surgery and intravitreal anti-VEGF injection. Graefes Arch Clin Exp Ophthalmol 2012;251(3): 889e94. 24. Marjot T, Maruthappu M, Shalhoub J. Checklists for invasive procedures. N Engl J Med 2013;368(3):293e4. 25. Regueiro A, Price S, Haxby EJ. Minimizing risk in the cardiac catheterization laboratory. Rev Esp Cardiol (Engl Ed) 2013:1e4. 26. Arriaga AF, Bader AM, Wong JM, et al. Simulation-based trial of surgical-crisis checklists. N Engl J Med 2013;368(3):246e53. 27. Merry A, Eichhorn J, Wilson I. Extending the WHO ‘safe surgery saves lives’ project through global oximetry. Anaesthesia 2009:1045e50. 28. Kwok AC, Funk LM, Baltaga R, et al. Implementation of the world health organization surgical safety checklist, including introduction of pulse oximetry, in a resource-limited setting. Ann Surg 2013;257(4):633e9. 29. Hales B, Terblanche M, Fowler R, Sibbald W. Development of medical checklists for improved quality of patient care. Int J Qual Health Care 2007;20(1):22e 30. 30. Hales BM, Pronovost PJ. The checklistda tool for error management and performance improvement. J Crit Care 2006;21(3):231e5. 31. World Health Organisation. New scientific evidence supports WHO findings: a surgical safety checklist could save hundreds of thousands of lives [cited 2013 12/ 04/13]. Available from: http://who.int/patientsafety/safesurgery/checklist_ saves_lives/en/index.html; 2013.
Contents lists available at ScienceDirect
International Journal of Surgery journal homepage: www.journal-surgery.net
Review
Surgical safety checklists in developing countries Sayinthen Vivekanantham a, *, Rahul Prashanth Ravindran a, Kumaran Shanmugarajah b, Mahiben Maruthappu b, Joseph Shalhoub a a b
Imperial College School of Medicine, Imperial College London, London SW7 2AZ, UK Harvard University, Cambridge, MA 01451, USA
a r t i c l e i n f o
a b s t r a c t
Article history: Received 29 September 2013 Accepted 24 October 2013 Available online 13 November 2013
The World Health Organization Surgical Safety Checklist (WHO SSC) has demonstrated efficacy in developed and developing countries alike. Recent increases in awareness of surgical morbidity in developing countries has placed greater emphasis on strategies to improve surgical safety in resourcelimited settings. The implementation of surgical safety checklists in low-income countries has specific barriers related to resources and culture. Adapting and amending existing surgical safety checklists, as well as considering factors unique to developing countries, may allow the potential of this simple intervention to be fully harnessed in a wider setting. This review will address the benefits and challenges of implementation of surgical safety checklists in developing countries. Moreover, inspiration for the original checklist is revisited to identify areas that will be of particular benefit in a resource-poor setting. Potential future strategies to encourage the implementation of checklists in these countries are also discussed. Ó 2013 Surgical Associates Ltd. Published by Elsevier Ltd. All rights reserved.
Keywords: Surgery Safety Checklists Developing countries World Health Organization
1. Introduction The surgical mortality in developing countries is 10 times higher than developed nations1 and deaths attributed to anesthesia are 1000-fold higher,2,3 clearly demonstrating the need to improve safety in this setting. By simply implementing checklists and protocols from developed countries to developing countries we may not be harnessing their complete benefits. This review will consider the role of surgery in addressing the overall burden of disease in the developing world and discuss the impact of the World Health Organization Surgical Safety Checklist (WHO SSC) in this setting. Suggestions for appropriately adapting and expanding the WHO SSC for developing countries to improve the safety of surgery globally are also discussed.4
2. Importance of surgery in developing countries The recent WHO report ‘Safe Surgery Saves Lives’ has helped prioritize surgical care throughout the world.5 Surgery has previously been perceived to be a cost-ineffective intervention relative
to GDP in low-income countries.6 However, Gosselin et al. have measured the cost per Disability-Adjusted-Life-Year (DALY) in Sierra Leone, which highlighted that the price per DALY averted was $32.78 through surgery, which compares favorably with nonsurgical interventions.7 Another study in Cambodia evaluated the cost of trauma surgery and this was also deemed to be costeffective relative to other medical interventions.8 Aside from cost being a barrier to the expansion of surgery in developing countries, it was also thought that surgery only benefited a small percentage of the population. This implied that resources would be more effectively utilized on alternative management strategies. Jamison et al. have countered this position; they have estimated that 11% of the global burden of disease can be treated by surgery, particularly by operating on those suffering trauma or cancer.9 These findings underpin the acknowledgment of the increased benefit surgery can provide in developing countries. It is vital that as increased surgical interventions are employed in these settings, safety standards are initiated and improved in parallel.
3. Importance of the WHO SSC in the developing world * Corresponding author. Tel.: þ44 (0) 798101 5718. E-mail addresses: [email protected] (S. Vivekanantham), [email protected] (R.P. Ravindran), kumaran.shanmugarajah@ tbrc.mgh.harvard.edu (K. Shanmugarajah), [email protected] (M. Maruthappu), [email protected] (J. Shalhoub).
Vast differences between developed and developing countries, for example in healthcare budgets, reflect differences in measures needed to ensure surgical safety.9 In light of this, we believe the WHO SSC is even more critical in developing countries compared to
1743-9191/$ e see front matter Ó 2013 Surgical Associates Ltd. Published by Elsevier Ltd. All rights reserved. http://dx.doi.org/10.1016/j.ijsu.2013.10.016
REVIEW S. Vivekanantham et al. / International Journal of Surgery 12 (2014) 2e6
developed countries. For example, surgeons in rural areas may have to perform a higher number of operations and operate in situations where they may not be specialists.10 This may lead to simple checks being omitted because of the pressure of the workload, as well as unfamiliarity with the procedure performed. Checklists would be particularly useful in such settings. The WHO SSC was developed with the aim of routinely checking information at three critical stages of surgery (Fig. 1). Use of this initiative has been associated with reduced operative error and improved outcomes.4 In particular patient mortality fell from 1.5% to 0.8% following the implementation of this checklist. Importantly, this data was acquired from four high-income and four low-income or middle-income countries, as classified by the World Bank,11 thereby demonstrating its applicability throughout the world.4 Numerous other studies have looked into the implementation of the WHO SSC globally.12e14 In 2012, Borchard et al. performed a systematic review of the effectiveness of safety checklists in surgery and encouragingly found that the relative risk of mortality fell to 0.57 (95% CI: 0.42e0.76) when checklists were used.14 Furthermore,
3
the relative risk of complications also fell after the implementation of the checklists (0.63 [95% CI: 0.58e0.67]).14 Whilst the WHO SSC was trialed worldwide, evidence suggests it is particularly effective in a resource-poor setting. Following the implementation of the WHO SSC, the largest decrease in complications (74.3%) was in low-income or middle-income countries.4 Furthermore, in the same study, two of the four hospital sites in the low-income and middle-income countries group had a decrease in surgical site infections and total complication rates, compared to only one of the four hospital sites in high-income countries.4 These findings highlight that the WHO SSC has the potential for significant impact specifically in the context of developing countries. A possible explanation for these observations could be that a number of safety measures outlined in the WHO SSC were already used in developed countries prior to the formal introduction of the checklist. For example, observations from high-income countries from the initial WHO SSC study showed pulse oximetry was used for intra-operative monitoring in 99.0% of cases before the checklist
Fig. 1. Elements of the World Health Organization Surgical Safety Checklist. Reproduced with permission.4
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S. Vivekanantham et al. / International Journal of Surgery 12 (2014) 2e6
was introduced, compared to 86.0% in sites of low-income or middle-income countries.4 In addition, prior to the implementation of the WHO SSC, intra-operative observers noted 63.9% of cases in sites of high-income countries performed an oral confirmation of the patient’s identity and surgical site prior to operation. However, this was only observed in 34.3% of cases in developing countries.4 These studies have identified areas in which the WHO SSC may have a particular impact in developing countries. While studies on the WHO SSC have demonstrated encouraging outcomes, its usage remains poor, with checklist compliance having been reported as low as 12%.14,15 Cultural differences may play a role in the reduced uptake of surgical safety checklists in developing countries. In Thai culture, for example, it is against societal norm to make marks on other people16 so this may prevent them marking the operative site. Moreover, people in Thailand only introduce themselves when meeting initially, and are typically shy about expressing their position thereafter. This may explain why team members were more reluctant to introduce themselves by name and role during the ‘time-out’ period.17 Furthermore, economic limitations may limit the full implementation of the checklist because of the requirement of certain equipment which may not be affordable in the developing world.18 In Thailand, surgical site marking and hair removal were typically not completed prior to checklist implementation.17 A contributing factor could be shortage of materials; however, these items were then acquired following the implementation of a checklist, which perhaps served to highlight their absence. We have established that whilst the WHO SSC has some efficacy in the developing world, there still remains scope to improve its benefits there. We now shift focus to concentrate on ways that this could potentially be done.
4. Developing checklists in resource-limited settings using past inspiration
Fig. 2. The different stages of the Formula 1 pit stop, where numbers denote the order of the different actions. Reproduced with permission.20
Checklists from other industries contributed towards the development of the WHO SSC.19 In order to adapt the WHO SSC to further benefit surgical safety in developing countries, it may be useful to revisit the founding principles that initially inspired the creation of the checklist, and see if further lessons may be gleaned. The high-pressure environment of surgery is found only in a handful of other careers. Notably, Formula 1 (F1) racing and aviation both require high levels of teamwork, focus and performance, similar to that seen in an operating theater. This especially holds true in resource-limited theaters, often with a higher caseload. In F1, the pit stop requires the coordinated efforts of many team members to perform the necessary steps as efficiently as possible (Fig. 2). In many ways this parallels the post-operative handover process in surgery. In developing countries there is less staff to look after patients and therefore correct and complete information transfer is critical. Considering this, variations or further criteria could be introduced to the WHO SSC in developing countries to maximize its benefit at the post-operative handover stage. Catchpole et al. consulted the Ferrari F1 race director to identify similarities between surgical handover and racing safety.20 This included, for example, the necessity of having a designated leader (in F1 this is the ‘lollipop’ man and it was decided the anesthetist should assume this role).20 In developing countries, the role of the anesthetist is often assumed by nursing teams. This unclear definition as to who is responsible for completing the checklist may contribute to lower usage in developing countries, due to confusion as to who should be responsible for delivering the checklist in resource-limited settings. Compliance could be improved through creating tailored regional definitions as to the specific person who
is responsible for conducting the WHO SSC within the operating theaters in developing counties. Meticulous training and practice is required for the ideal F1 pit stop; however, there is no structured training for the post-operative handover, especially in developing countries. Catchpole et al. accounts for this, in part, by highlighting the low staff turnover in F1 compared to constantly rotating doctors and nurses in the healthcare world. Ensuring that staff work in the same roles as far as possible, with minimal rotation between different positions, might help further reduce complication rates in resource-limited settings. Karl mentions several other factors that vary between surgery and the aviation industry, beyond the use of checklists.21 For example, in surgery there is an emphasis on documenting what is done rather than actually focusing on doing it safely. Also in surgery, people are expected to know how to deal with emergencies by memory, whilst in aviation there is a quick reference handbook for all major emergencies that can be accessed for assistance. Utilizing a similar resource in developing countries to cover a range of emergency procedures might be a separate initiative that can improve surgical safety globally. Finally, and importantly, below 10,000 feet all airlines have ‘sterile cockpit rules’ where there can be no discussion apart from that which is relevant to the safety of the flight.21 This is in contrast to surgery where there often is irrelevant discussion that is not policed, even during critical parts of a procedure. Incorporating ‘sterile operating rules’ at key aspects of surgical procedures might help improve surgical safety in developing and developed countries alike. Although it is helpful to draw comparisons from other industries, ultimately surgical practice is unique. Therefore, whilst
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other industries’ standards of practice can be examined, we appreciate that not all lessons can be directly translated into surgery. We anticipate that these lessons will form the foundation upon which improvements to surgical practice can made, taking into account the complexity and uniqueness of surgical patients. Surgical safety checklists have been shown to reduce errors; however, they have not completely eliminated them. This highlights the ongoing importance of good clinical judgment and the appreciation of significant inter-patient variation by gaining experience as a surgeon. 5. New directions for using checklists in resource-limited settings While some studies have demonstrated a positive benefit of the WHO SSC there are ways in which checklists could be further developed. Specific checklists have been created to suit different surgical specialties, for example neurosurgery22 and ophthalmology.23 At this time, it is unclear whether changes to content, structure, delivery and specialty-specificity of checklists could lead to further benefits to patient safety and quality of treatment, with more research in this area sure to provide the answer. With caseload variations between developed and developing countries in terms of volume and types of procedures, use of checklists across different specialties created in developed countries might need to be further modified to ensure maximal benefit for use in resourcelimited settings. Although surgical research has been quick to embrace the potential of checklists, the adoption of checklists beyond the operating room has been limited.24 Checklists have been harnessed recently in cardiac catheterization25 and crisis situations.26 With further clinical situations trialing checklists in the developed world, it will become more readily apparent where benefit may be derived through their implementation and give direction for further uses of checklists in developing settings. In order to improve compliance in developing countries it may be useful to adjust the WHO SSC, taking cultural variations into account. Surgical practitioners of various ethnicities in different countries could be consulted to identify any specific areas of the checklist that might present a barrier to its uptake in regions with different social norms. Amendments could then be made to accommodate cultural variations. The efficacy of the WHO SSC has inspired the formation of various sister organizations that promote the use of medical checklists worldwide. Project Check is an umbrella organization that aims to act as a central source for all clinical checklists. The organization aims to make clinical checklists suitable for many different situations globally, enhancing safety around the world.15 Furthermore, the charity Lifebox was created to subsidize the cost of purchasing pulse oximeters by hospitals in developing countries as this may be a barrier to full implementation of the checklist in these settings.27 More recently, a study has demonstrated that successful implementation of the WHO SSC with provision of pulse oximeters in a resource-limited setting in Moldova resulted in a reduction in overall post-operative complications from 21.5% to 8.8%.28 Further initiatives to support the global implementation of checklists will help reduce surgical complications in developing settings. ‘Checklist fatigue’ is when the overuse of checklists results in reduced overall compliance. The WHO SSC is designed to minimize this by only including checks for common and preventable sources of error.19 With the occurrence of ‘checklist fatigue’ recognized in the developed world,29,30 measures to prevent this should be enforced in resource-limited settings. We believe this limitation is less likely to occur if the previously outlined benefits of using
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checklists are stressed to those responsible for checklist compliance in developing countries. We also propose that following a reassessment of the components of the checklist, the checklist should be tailored specifically to various developing world settings, taking into account cultural differences and local practices; only one checklist should be implemented within a country or region. 6. Conclusions It is estimated that at least half a million deaths per year would be prevented worldwide if the WHO SSC was correctly implemented.31 Any human system is prone to error; however, checklists are proving to be an effective mechanism through which this can be reduced within surgery and beyond. We believe the benefits from these measures will be of particular value in developing countries, where resources and surgical practice lag behind that of developed countries. Inspiration for developing safety checklists originated from examining protocols from other industries, where maintaining safety is considered as important as achieving an outcome. These industries provide ideas for further development of surgical safety checklists, and there is an impetus to implement more ideas from these other fields to improve the efficacy of checklists in developing countries. Whilst we acknowledge that checklists cannot replace good clinical acumen, we feel that there is still scope for improving safety by increasing and adapting the usage of this tool in the developing world. Interventions to improve surgical safety through checklists e whether pre-operatively, during surgery, post-operatively, or in a crisis setting e may also act as inspiration for other areas of medicine. The direction and future application of these initiatives holds many possibilities and remains an exciting opportunity to further drive down adverse outcomes within surgery, particularly in developing settings. Conflicts of interest Sayinthen Vivekanantham is founding Director of Global Medical Education Trust (GMET), a recently established charity that aims to improve the quality of medical education and learning within healthcare in developing countries. Mahiben Maruthappu & Joseph Shalhoub are co-founding Directors and Kumaran Shanmugarajah is the Secretary of the World Surgical Association (WSA), a recently established non-profit improving surgical care delivery in resource-limited settings. They have no other conflicts of interest to declare. Funding None. Ethical approval None. Author contribution Sayinthen Vivekanantham e Extrapolation of initial concept, drafting of the article, ideas for initiatives. Rahul Prashanth Ravindran e Drafting of the article, ideas for initiatives. Kumaran Shanmugarajah e Review and editing of the article. Mahiben Maruthappu e Review and editing of the article. Joseph Shalhoub e Conception of idea, review and editing of the article. Acknowledgments None.
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