Study Results
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Basic Information
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COMPLETED
70639 participants
OBSERVATIONAL
2012-07-31
2014-04-30
Brief Summary
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Detailed Description
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After Institutional Review Board (IRB) approval (Facultad de Medicina, Pontificia Universidad Católica de Chile, Santiago, Chile), a retrospective analysis of all surgical encounters on patients age 15 and above from January 2005 to December 2012 at our center will be reviewed.
Encounter data will include up to 14 diagnostic and procedure International Classification of Diseases, 9th Revision, Clinical Modification (ICD-9-CM) codes, demographic data, date of admission and discharge, emergency status, healthcare system used and in-hospital death. A 5-level "high risk" variable was created in order to account for surgical complexity and associated in-hospital mortality (level 1, surgeries with \<1% in-hospital mortality; level 2, 1% to \<5%; level 3, 5% to \<10%; level 4, 10% to \<15%; level 5, \> or = 15%)6.
Surgical heterogeneity will be calculated by the Internal Herfindahl Index, which represents the diversity or comprehensiveness of the types of procedures performed at a facility.
Statistics:
Propensity score (PS) analysis will be used to control for differences in baseline characteristics. The PS is the conditional probability of receiving an exposure (e.g. checklist) given a set of measured covariates. To estimate the PS, a logistic regression model will be used in which "treatment" status (checklist performed vs. not performed) will be regressed on the baseline (pre-treatment) characteristics.
PS analysis will be implemented in two ways to control for confounding:
1. PS matching: matching will be performed using a one-to-one nearest neighbor caliper matching without replacement with a caliper size of 0.2 standard deviations. Balances in the distribution of baseline covariates will be assessed by estimating absolute standardized differences of the covariates between the two groups before and after matching. Any imbalanced covariates (standardized difference \>10%) after matching will be adjusted for in the final analysis. As the PS matched sample does not consist of independent observations, we will use a marginal regression model with robust standard errors.
2. PS weighting: the entire sample will be weighted by the inverse probability of the treatment weights derived from the PS. If a subject has a higher probability of being in a group, it will be considered over-represented and therefore will be assigned a lower weight. Conversely, if the subject has a smaller probability, it will be considered as under-represented and will be assigned a higher weight. We then will fit a weighted linear regression model using an indicator variable representing checklist intervention status as the sole predictor, and mortality as our outcome variable.
Data will be expressed as mean (SD; standard deviation) or median (IQR, interquartile range) unless otherwise stated. A two-sided p value less than 0.05 will be considered significant. The analyses will be performed using STATA v.12.0 (StataCorp, College Station, TX).
Conditions
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Study Design
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CASE_CONTROL
RETROSPECTIVE
Study Groups
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Pre Checklist
All surgical encounters before surgical checklist implementation
No interventions assigned to this group
Post Checklist
All surgical encounters after surgical checklist implementation
Surgical checklist
Use of the World Health Organization Surgical checklist
Interventions
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Surgical checklist
Use of the World Health Organization Surgical checklist
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patients less than 15 years old
15 Years
ALL
No
Sponsors
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Pontificia Universidad Catolica de Chile
OTHER
Responsible Party
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Principal Investigators
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Hector J Lacassie, MD
Role: PRINCIPAL_INVESTIGATOR
Pontificia Universidad Catolica de Chile
References
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Haynes AB, Weiser TG, Berry WR, Lipsitz SR, Breizat AH, Dellinger EP, Herbosa T, Joseph S, Kibatala PL, Lapitan MC, Merry AF, Moorthy K, Reznick RK, Taylor B, Gawande AA; Safe Surgery Saves Lives Study Group. A surgical safety checklist to reduce morbidity and mortality in a global population. N Engl J Med. 2009 Jan 29;360(5):491-9. doi: 10.1056/NEJMsa0810119. Epub 2009 Jan 14.
de Vries EN, Ramrattan MA, Smorenburg SM, Gouma DJ, Boermeester MA. The incidence and nature of in-hospital adverse events: a systematic review. Qual Saf Health Care. 2008 Jun;17(3):216-23. doi: 10.1136/qshc.2007.023622.
Tscholl DW, Weiss M, Kolbe M, Staender S, Seifert B, Landert D, Grande B, Spahn DR, Noethiger CB. An Anesthesia Preinduction Checklist to Improve Information Exchange, Knowledge of Critical Information, Perception of Safety, and Possibly Perception of Teamwork in Anesthesia Teams. Anesth Analg. 2015 Oct;121(4):948-956. doi: 10.1213/ANE.0000000000000671.
Schwarze ML, Barnato AE, Rathouz PJ, Zhao Q, Neuman HB, Winslow ER, Kennedy GD, Hu YY, Dodgion CM, Kwok AC, Greenberg CC. Development of a list of high-risk operations for patients 65 years and older. JAMA Surg. 2015 Apr;150(4):325-31. doi: 10.1001/jamasurg.2014.1819.
Wachtel RE, Dexter F. Differentiating among hospitals performing physiologically complex operative procedures in the elderly. Anesthesiology. 2004 Jun;100(6):1552-61. doi: 10.1097/00000542-200406000-00031.
Urbach DR, Govindarajan A, Saskin R, Wilton AS, Baxter NN. Introduction of surgical safety checklists in Ontario, Canada. N Engl J Med. 2014 Mar 13;370(11):1029-38. doi: 10.1056/NEJMsa1308261.
de Vries EN, Prins HA, Crolla RM, den Outer AJ, van Andel G, van Helden SH, Schlack WS, van Putten MA, Gouma DJ, Dijkgraaf MG, Smorenburg SM, Boermeester MA; SURPASS Collaborative Group. Effect of a comprehensive surgical safety system on patient outcomes. N Engl J Med. 2010 Nov 11;363(20):1928-37. doi: 10.1056/NEJMsa0911535.
Calland JF, Turrentine FE, Guerlain S, Bovbjerg V, Poole GR, Lebeau K, Peugh J, Adams RB. The surgical safety checklist: lessons learned during implementation. Am Surg. 2011 Sep;77(9):1131-7.
Leape LL. The checklist conundrum. N Engl J Med. 2014 Mar 13;370(11):1063-4. doi: 10.1056/NEJMe1315851. No abstract available.
Conley DM, Singer SJ, Edmondson L, Berry WR, Gawande AA. Effective surgical safety checklist implementation. J Am Coll Surg. 2011 May;212(5):873-9. doi: 10.1016/j.jamcollsurg.2011.01.052. Epub 2011 Mar 12.
Other Identifiers
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12-218
Identifier Type: -
Identifier Source: org_study_id
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