DOI: 10.26190/mddw-by48
title: Evidence-based Processes and Outcomes of Care (EPOC): Improving services and outcomes for joint replacement patients

description: Dataset includes REDCap database and extract of this including compliance data generated using R code. Variables include 1681 variables for the broader study including details re site, surgeon, patient demographic and co-morbid health information, dates of surgery and follow up, surgical care data, antibiotic and VTE chemical and mechanical prophylaxis data, patient reported measures, details re surgical complications up to one year post surgery and health services utilisation data.
description: Data were collected prospectively from patients and sites at key points prior to and following surgery. Data collected at sites were sent to the primary researchers via email, post or transported by the primary investigators (for some local sites). Paper data was stored in locked cabinets at the sites and offices of the investigators which are in a secure research facility. Electronic data received via email were stored in password protected data systems on secure health systems. Data were initially entered password-protected Microsoft Excel spread sheets; however, the size and complexity of the data was too great for Excel so a project specific secure REDCap (Vanderbilt University, 2017) online database was established that was managed through University of New South Wales (UNSW). Data sent by sites were reviewed for completeness as they were received and site coordinators contacted if any data was missing. An audit by researchers of 100% of the medical records of participating patients was undertaken prior to analyses to ensure missing data were minimised and to verify accuracy and completeness of data. The audit focused ensuring data regarding prophylaxis, history of co-morbid conditions and other relevant factors relevant to VTE and infection including previous VTE or resistant infections, allergy to drugs and cardiac conditions. We also verified the accuracy of complications included in the composite outcome during audits or by contacting surgeons, GP and other health providers. Data were entered into REDCap project specific database supported by UNSW. R language for statistical analysis and reporting was used to automatically generate compliance data. Compliance data were calculated from care data reported at baseline, acute and follow-up. Compliance was rated against the following guidelines: i. Therapeutic Guidelines: Antibiotics (2010) for the prevention of infection ii. National Health and Medical Research Council (NHMRC) Clinical Practice Guideline for the prevention of venous thromboembolism (VTE) for patients admitted to Australian hospitals (2009) Algorithms were developed to make decisions regarding whether the prophylaxis (care data) was compliant or consistent with the definitions and were able to take patient indications and contraindications for prophylaxis into account. An extract from the REDCap database was run through the R programme to determine compliance data. From this an excel spreadsheet was created. There are two spreadsheets used for analyses: The first includes the extract from R with all cases entered. The second extract only includes those patients with any followup data for whom compliance was calculated. The first extract is used to describe the larger sample, the second addresses the primary research questions. Data were analysed using SAS and SPSS. See also http://www.clinicaltrials.gov/. The Clinical trials registration number is ClinicalTrials.gov Identifier: NCT01899443.