Arvid Steinar Haugen | Department of Anaesthesia and Intensive Care, Haukeland University Hospital, Bergen, Norway
Research group on Quality, Safety and Outcome after Surgery and Critical Illness, Department of Clinical Medicine, University of Bergen, Bergen, Norway
Studies on effectiveness of quality tools (i.e., checklists) must include assessment of actual use state Alex Haynes, William Berry, and Atul Gawande in an Editorial accompanying our study: “Effect of the World Health Organization Checklist on Patient Outcomes – A Stepped Wedge Cluster Randomized Controlled Trial” [1&2]. They highlight that we reported a positive ‘dose effect’ by assessing the actual use of the checklist. Haynes and colleagues also underline the importance of using a cluster randomized controlled methodology and a carefully structured implementation program.
In 2009, Haynes and colleagues found the WHO SSC to mitigate morbidity by 36.4% (11%–7%) and mortality by 46.7% (1.5%–0.8%) in a global population. In support of these findings, two systematic literature reviews with meta-analysis summarize that SSCs reduce both morbidity and mortality4&5. However, a large pre/post-designed study from Canada showed no improvement in morbidity or mortality, and subsequently raised discussions about the effectiveness of SSC implementation in high income countries[6&7]. Hence, randomized studies have been warranted. Our study was encouraged by the results from the above referred Haynes study, and the urge to conduct randomized controlled trials. A short overview of the article awarded the ESA Prize and supported by an unrestricted Research Grant from Baxter in 2015 is provided below.
We carried out a stepped wedge cluster randomized controlled trial in two Norwegian hospitals in 2009–2010; a tertiary teaching hospital and a central community hospital with 1100 and 300 beds, respectively. The checklist intervention was sequentially implemented in steps over up to 4 weeks until all 5 clusters – cardiothoracic, neurosurgery, orthopaedic, general, and urologic surgery – had implemented the intervention. The implementation consisted of lectures, using videos of how to do the checklist, available information material, and piloting the implementation, with evaluations and feedback on compliance. Primary outcome of the study was in-hospital complications registered by International Classification of Diseases, Tenth Revision codes and in-hospital mortality up to 30 days. Complications were associated with respiratory or cardiac system, infections, wound rupture, nervous system, bleeding, embolism, mechanical/technical, anaesthesia-related, or unplanned return to the operating theatre. Secondary outcome was length of in-hospital stay.
In our study a total of 2212 control procedures were compared with 3083 procedures in the intervention group. The complication rates decreased from 19.9% to 12.4% (P<0.001) for all procedures from control to intervention. We also compared the control procedures with 2263 procedures of actual checklist treatment (using all three parts of the SSC). Hence, complications were reduced from 19.9% to 11.5% (P<0.001). Other explanatory or possible confounding factors such as age, gender, comorbidity, type of surgery/anaesthesia, emergency, and study time points were adjusted for, though the SSC effect remained. Odds ratio was 1.95 (95% CI 1.59–2.40) when not using the SSC. Length of in-hospital stay was reduced by 0.8 days when utilizing the SSC (95% CI 0.11–1.43). Overall in-hospital mortality up to 30 days after surgery showed a non-significant decrease from 1.6% to 1.0% for both hospitals; in a sub-analysis a significant reduction was observed with a decrease from 1.9% to 0.2% in one of the hospitals.
Our findings are supported in a recent published study of WHO SSC compliance impact on risk-adjusted clinical outcomes, including the Sign-in, Time-out, and Sign-out complications, which decreased from 16.9% to 11.2%, with an odds ratio 0.57 (95% CI, 0.37–0.87) when all three parts had been utilized.
In summary, actual use of the WHO SSC was associated with reductions in morbidity, mortality, and length of in-hospital stay.
1. Haugen AS, Søfteland E, Almeland SK et al. Ann Surg 2015;261(5):821-828.
2. Haynes AB, Berry WR, Gawande AA. Ann Surg 2015;261(5):829-830.
3. Haynes AB, Weiser TG, Berry WR et al. N Engl J Med 2009;360(5):491-499.
4. Borchard A, Schwappach DLB et al. Ann Surg 2012;256(6):925-933.
5. Bergs J, Hellings J, Cleemput et al. Br J Surg 2014;101(3):150-8.
6. Urbach DR, Govindarajan A, Saskin R, et al. N Engl J Med 2014;370(11):1029-1038.
7. Leape LL. N Engl J Med 2014;370(11):1063-1064.
8. WHO. [International Classification of Diseases (ICD) web site]. Available at: http://www.who.int/classifications/icd/en/. Accessed 11.18, 2015.
9. Mayer E, Sevdalis N, Rout S. et al. Ann Surg 2016;263(1):58-63.