Effects of Checklists in Surgical Care - a Study on Morbidity, Mortality and Data Quality

1.0 Background Surgical procedures are high risk events and patients may suffer complications or die post operatively. A report from an on-going patient safety campaign "In Safe Hands" lead by the Norwegian Knowledge Centre for the Health Services reveals that approximately 16 % of all Norwegian hospital admissions in 2010 involved an adverse event (AE) (Deilkås, 2011). A review study on AEs in 2008 included a wide range of in-hospital patients from Australia, Canada, New Zealand, the United Kingdom, and the United States of America (US) (de Vries et al., 2008). 9 % of the patients experienced an AE, with 7. 4 % of these ending fatally. The majority of the AEs occurred during surgical treatment or was related to drug administration. The authors claimed that almost half of these could have been prevented if checklists covering the entire surgical pathway had been used (de Vries et al., 2008). Implementation of such a system, called the Surgical Patient Safety System (SURPASS) did in fact result in a reduction of in-hospital morbidity (from 27.3% to 16.7%) and mortality (from 1.5 % to 0.8 %) (de Vries, 2010).

Patient safety checklists have been introduced and recommended as a standard of surgical care (Birkmeyer, 2010; de Vries et al., 2011). Studies based on data from electronic patient administrative systems show that checklist use may reduce mortality and morbidity in surgery (de Vries et al., 2010; van Klei et al., 2012; Haynes et al., 2009). Safe Surgery checklists have been recommended by the World Health Organization (WHO) since 2008 as a strategy to avoid adverse events (AE) during surgery. More than 6000 hospitals have implemented Safe Surgery checklists in their operating theatres (OTs) (http://www.who.int/patientsafety/safesurgery/en/), including Haukeland University Hospital (HUH).

This multicentre research project will also introduce a system of patient safety checklists at each point of care during the surgical patients' stay, not only in the operating theatres (OTs). The system combines new checklists on patient care (parts of SURPASS) with the already established Safe Surgery checklist (WHO) in the OTs. At the same time securing reliability, validity and quality of the patient, morbidity and mortality data will be an essential part of the study.

Today the discharging physician reviews the medical journal and makes a medical summary including coding diseases and complications relevant for the current admission. International Classification of Diseases (ICD-10) codes are used to set diagnoses for clinical, epidemiological and quality purposes (http://www.who.int/classifications/icd/ICD10Volume2_en_2010.pdf). The ICD-10 codes are also used for registrations on national mortality and morbidity in the Norwegian National Patient Register (NPR). Questions have been raised as to the accuracy and quality of the data in such registers in Norway, e.g. in patients with sepsis (Flaatten, 2004), and intensive care patients (Aardal et al., 2005). In a Danish study on relations between ICD-10 coding in the National Registry of Patients and the hospitals' discharge summary and medical records, a high reliability between ICD-10 scores and co-morbidity was found (Thygesen et al., 2011). To our knowledge similar studies have not been done in Norway. As a crucial part of this investigation we concurrently will evaluate the reliability and validity of our patient administrative data by comparing the post discharge ICD-10 codes to actual data available directly from medical journal systems as documented by health care personnel in the journal texts.

2.0 Objective