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Table 4
Medicare facility payments at hospitals participating in Keystone Surgery, and in the entire cohort, after Keystone Surgery implementation compared to before (CI: confidence interval).

Table 5 demonstrates the adverse outcomes as well as change in payment for each operation individually, to further clarify whether specific procedures types were impacted differently by the Keystone program. The findings were similar for each procedure, with no evidence of improved outcomes or reduced payments following Keystone implementation. The relative risk for mortality (RR 1.31, 95% CI 1.09-1.53), and the overall length of stay (.46 day increase, 95% CI .05-.87) increased slightly for appendectomy, and the length of stay for carotid endarterectomy increased by .17 days (95% CI .04-.31).

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Relative risks of adverse outcomes and change in total payment by procedure type, at hospitals participating in Keystone Surgery, vs non-participating controls (CI: confidence interval)
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In this study, we found that implementation of a checklist-based intervention across Michigan was not associated with improved surgical outcomes (mortality, complications, or serious complications) in Medicare patients. When stratifying by type of procedure, including a spectrum of low- and high-risk operations, there was still no evidence of improvement in outcomes. In addition, we found no evidence that the program decreased resource utilization (reoperations or readmissions) or costs (Medicare payments). When compared to a national cohort of similar hospitals not participating in the program, these findings persisted.

Studies evaluating the effectiveness of surgical checklists are mixed. While numerous studies have reported significant improvements in surgical outcomes and safety culture following surgical checklist implementation,( 1 , MADEMOISELLE R Glitter Heel Sandals quality from china cheap DVnKs2
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) the majority of these studies have occurred in small populations or single institutions with controlled environments, and did not include a control group. On the other hand, multiple recent population-based studies of real world checklist implementation in surgical patients have failed to report significant associations with improved outcomes,( PUMA Fierce Rope Sizes 5510 sale cheap online cheap sale hot sale NBJnD
, 42 ) but have been criticized due to methodological concerns. The evaluation of mandatory checklist adoption in Ontario, Canada by Urbach and colleagues,( 9 ) for example, only evaluated outcomes 3 months following checklist implementation and included a substantial proportion of low-risk outpatient procedures. Moreover, though checklist-adoption was mandatory, the implementation strategies used to support adoption were variable.( 10 , 11 )

The methods used in this study overcome many of the limitations of prior work. First, rather than include low-risk and outpatient procedures only, we evaluated a cohort comprised of both low- and high-risk patients. Second, we incorporated a much longer follow-up period, as we assessed outcomes up to 3 years following implementation. Third, we evaluated a program that was supported by a standardized and comprehensive implementation strategy, unlike the variable implementation support seen in Ontario. And finally, to limit confounding, we included a cohort of similar, non-participating hospitals as a control group. Given these additional strengths, we believe the findings of this study demonstrate strong evidence that surgical checklist implementation in the real world, even when supported by a robust and comprehensive implementation strategy, may have a limited impact on surgical outcomes.

The lack of an association between Keystone Surgery implementation and reduced costs is a new and interesting finding. To our knowledge, no studies have directly evaluated the impact of surgical checklists on hospitals costs or Medicare payments. A previous economic evaluation of the Keystone ICU project reported that $3,375 was saved with each medical infection averted, and estimated that more than $50,000 in additional health care costs could ultimately be saved by the program.( 43 ) Studies estimating potential savings following use of surgical checklists, such as those by Semel and colleagues,( Red Valentino studded strap boots buy cheap footlocker cheap sale looking for manchester great sale online UMOfJc
) assume program effectiveness will be similar to the results reported in the Safe Surgery Saves Lives Study,( 1 ) which has not been consistently replicated across all studies of surgical checklist implementation. Although estimated cost savings in their analysis were robust to variations in the cost of implementation, the authors did not consider the scenario presented here: a comprehensive implementation strategy was used to broadly implement a checklist that did not improve outcomes. In other words, substantial resources (financial and otherwise) were used to implement the program, but the intervention did not appear to generate cost savings.

This study has several limitations. First, given this study only includes Medicare patients, it may not generalizable to patients younger than 65 years old. Second, the use of administrative data may limit robust risk-adjustment, due to miscoding and imprecision, and the lack of granular clinical detail.( classic brand new unisex sale online Shein Moment Black PU limited edition cheap online 2B94J
, 46 ) Despite these limitations, Medicare data was purposely chosen for this study for multiple reasons. First, Medicare patients comprise a substantial number of all patients undergoing the operations in question, and represent a cohort with increased risks of morbidity and mortality for whom these results may be most applicable. Second, the use of Medicare data allows for a novel evaluation of healthcare costs associated with surgical checklist implementation through an analysis of Medicare payments, which has not been done previously. And most importantly, the use of Medicare data allows for evaluation of both participating and non-participating hospitals, which limits concern for confounding from competing quality improvement programs or organizations. A third limitation of our study is a lack of detail regarding implementation and program compliance at participating hospitals. Multiple prior studies have reported associations between these details and checklist effectiveness.( 47 , 48 ) Though compliance data would help explain why Keystone Surgery program implementation was not effective, the purpose of the present study was to evaluate the impact of the program on clinical outcomes, rather than assess why it did or did not work. A detailed assessment of program implementation, including a qualitative assessment of the barriers to implementation, is beyond the scope of the present study.