Clinical Efficacy of Combined Surgical Patient Safety System and the World Health Organization’s Checklists in Surgery

This nonrandomized clinical trial investigates the association of combining the preoperative and postoperative Surgical Patient Safety System with the World Health Organization surgical safety checklist in perioperative care with morbidity, mortality, and length of hospital stay among patients in 3 surgical departments.


Patient safety checklists have been introduced and recommended as a standard of 23
surgical care (Birkmeyer, 2010;de Vries et al., 2011). Studies based on data from 24 electronic patient administrative systems show that checklist use may reduce 25 mortality and morbidity in surgery (de Vries et al., 2010;van Klei et al., 2012;Haynes 26 et al., 2009). Safe Surgery checklists have been recommended by the World Health 27 Organization (WHO) since 2008 as a strategy to avoid adverse events (AE) during 28 surgery. More than 6000 hospitals have implemented Safe Surgery checklists in their 29 operating theatres (OTs) (http://www.who.int/patientsafety/safesurgery/en/), including 30 Haukeland University Hospital (HUH). 31 This multicentre research project will also introduce a system of patient safety 32 checklists at each point of care during the surgical patients' stay, not only in the 33 operating theatres (OTs). The system combines new checklists on patient care (parts 34 of SURPASS) with the already established Safe Surgery checklist (WHO) in the OTs.

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At the same time securing reliability, validity and quality of the patient, morbidity and 36 mortality data will be an essential part of the study. 37 Today the discharging physician reviews the medical journal and makes a medical 38 summary including coding diseases and complications relevant for the current 39 admission. International Classification of Diseases (ICD-10) codes are used to set 40 diagnoses for clinical, epidemiological and quality purposes 41 (http://www.who.int/classifications/icd/ICD10Volume2_en_2010.pdf). The ICD-10 42 codes are also used for registrations on national mortality and morbidity in the 43 Norwegian National Patient Register (NPR). Questions have been raised as to the 44 accuracy and quality of the data in such registers in Norway, e.g. in patients with 45 sepsis (Flaatten, 2004), and intensive care patients (Aardal et al., 2005). In a Danish 46 study on relations between ICD-10 coding in the National Registry of Patients and the 47 hospitals' discharge summary and medical records, a high reliability between ICD-10 48 scores and co-morbidity was found (Thygesen et al., 2011). To our knowledge similar 49 studies have not been done in Norway. As a crucial part of this investigation we 50 concurrently will evaluate the reliability and validity of our patient administrative data 51 by comparing the post discharge ICD-10 codes to actual data available directly from 52 medical journal systems as documented by health care personnel in the journal texts. 53

Objective 54
The main objectives of this study are to: 55  Perform a systematic review of published studies on effects of safety checklists in 56 medicine. 57  Explore effects on morbidity and mortality after implementing a system of patient 58 safety checklists at each point of care during the surgical patients' stay (elements of 59 SURPASS and the WHO Safe Surgery list combined), in a cohort of surgical patients 60 in different surgical departments in one hospital, with patients from departments not 61 having the system introduced serving as controls from three hospitals. 62  Investigate the validity of the post discharge ICD-10 codes for complications 63 compared to actual information found in medical journal systems texts.

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Discrepancies between patient information on complications registered as 65 ICD-10 codes and information on complications documented in the actual 66 electronic patient journal 67 Registration of ICD-10 codes on complications and complications documented 68 in the actual electronic patient journal will be registered separately and then 69 compared as to discrepancies between these. This is done to evaluate and 70 validate complication data (ICD-10 codes) used for primary outcome 71 measures. 72 This project aims to produce a systematic review on present knowledge on effects of 73 using safety checklists in medicine. Implementation of a checklist system throughout 74 surgical care may reduce patient morbidity and mortality. The reliability of patient 75 data is crucial to make firm conclusions as to such effects. This project aims to 76 investigate if such morbidity and mortality effects are obtainable in two Norwegian 77 hospitals while at the same time making a crucial evaluation of the patient data used 78 in this study itself. 79 We hypothesise 80 1. An updated systematic review of the research literature provide evidence that 81 safety checklists use does enhance safety and reduces patient mortality and 82 morbidity 83 2. Implementation of the patient safety checklist system will reduce patient 84 mortality and morbidity in the checklist cohort, and subsequent effects on 85 length of stay 86 3. The sensitivity and specificity of ICD-10 coding vs. medical journal information 87 is poor, with study results to be adjusted accordingly. has reduced patient mortality and morbidity. In addition, safety checklist use 105 has been associated with better human performance, improved compliance 106 with evidence-based practices, promoted consistency of care, and reduction of 107 technical omissions. None of the included studies reported that safety 108 checklists have negative effects on patient safety issues. 109 2. Implement the new patient safety checklist system and measure effects on 110 morbidity, mortality and length of hospital stay. 111 A prospective stepped wedge trial design (Brown & Lilford, 2006;Brown et al., 112 2008) will be used when implementing the validated patient safety checklist 113 system in the Neurosurgical Department, the Orthopaedic Clinic and the 114 Department of Gynaecology and Obstetrics at HUH. Patients from 115 departments not using the patient safety checklist system serve as controls, 116 this includes the Head and Neck Clinic (HUH), the Thoracic Surgery Section of 117 the Heart Department (HUH) and two hospitals outside our own municipality 118 (Health Trust Førde, and Health Trust Fonna -Haugesund Hospital). Primary 119 end-points to be measured prospectively include length of hospital stay and 120 morbidity and mortality utilizing the ICD-10 codes for complications collected 121 electronically from the hospital patient administrative systems. 122

Validation of morbidity and mortality data. 123
Today ICD-10 codes are produced by discharging physicians to summarize 124 diagnoses at discharge and any complications having occurred during patient 125 stay. In order to validate HUH's and Health Trust Førde's ICD-10 coding on 126 patient morbidity and mortality we will randomize inclusion for quality check 127 comparing the ICD-10 codes used at discharge to all actual information on 128 morbidity and mortality as documented in the electronic patient journal (EPJ) -129 DIPS. This validation should include approximately 700 patients, all having 130 undergone major surgery. Such a comparison is essential to gain knowledge 131 on the quality of generated ICD-10 data and thus important to the quality of 132 results in this study. 133

Intervention study sample 134
Three surgical units at HUH (Department of Neurosurgery, Orthopaedic Clinic, and 135 Department of Gynaecology and Obstetrics) will have the checklist system 136 implemented. Approximately 3700 patients will be included before and 3700 patients 137 after checklist implementation. The Control Group includes 7400 patients. 138

Data collection 139
For the study on mortality and morbidity we will extract ICD-10 codes used at 140 discharge from the hospitals NPR file, as all Norwegian hospitals report their ICD-10 141 codes and procedure codes to NPR. In addition to registering all ICD-10 codes on 142 each patient, we will collect demographic data (age, gender, height and weight), 143 American Society of Anaesthesiologists Physical Health Classification (ASA), dates 144 of admission and discharge, and all surgical procedures and major treatments. Data 145 will be processed through Webport using a system previously developed locally for 146 the WHO Surgical Safety Checklist project. 147 The primary end points, morbidity and mortality, are registered during hospitalization 148 and postoperatively up to 30 days. Morbidity will be registered as major complications 149 according pneumonia, re-intubation, ventilator use longer than 24 hours, cardiac arrest, 153 myocardial infarction, sepsis, shock, coma longer than 24 hours, prosthetic/graft 154 failure, and bleeding. Additional complications to these, as reported by de Vries 155 (2010) will be included in order to make comparisons possible. 156 The study investigating reliability and validity of the ICD-10 codes will be done in 157 detail: A prospective random selection of 700 patients, 200 patients from Health Trust 158 Førde and 500 patients from the HUH, all having undergone major surgery. Present 159 knowledge should suggest one or several major complications caused by procedures 160 or iatrogenic causes in at least 17 % the surgical patients (de Vries, 2010). Then an 161 inclusion of 700 patients is needed in order to find such complications in 119 cases.

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We will identify all post discharge ICD-10 codes for each patient. These codes will be 163 thoroughly reviewed for accuracy and completeness by comparing to the actual 164 information as documented by physicians and nurses in the EPJs throughout the 165 total hospital stay. Primary outcome is here to investigate that registered ICD-10 166 codes have adequate sensitivity and specificity compared to the information in the 167 patients' medical journal. 168

Statistics 169
Descriptive and inferential statistical methods will be used to analyse data.

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Confidence intervals (95% CI) for sensitivity and specificity will be calculated using 171 the normal approximation for the standard error of proportions.