Evidence into practice: protocol for a new mixed-methods approach to explore the relationship between trials evidence and clinical practice through systematic identification and analysis of articles citing randomised controlled trials.

INTRODUCTION: Randomised controlled trials (RCTs) provide high-quality evidence to inform practice. However, much routine care is not based on available RCT evidence. Understanding this disconnect may improve trial design, reporting and implementation. Published literature commenting on RCTs may yield relevant insights. This protocol presents a new approach examining how researchers understand, contextualise and use evidence from RCTs, through analysis of letters, editorials and discussion pieces citing individual RCTs. Surgical case studies will illustrate its ability to identify wide-ranging factors influencing application of trials evidence. METHODS AND ANALYSIS: In-depth study of published literature will explore written responses to RCTs. After purposefully selecting individual RCTs, we will systematically identify all citing articles covered in Web of Science and Scopus. Editorials, discussions and letters will be included. These are considered most likely to provide critiques and opinions about index RCTs. Original articles and reviews will be excluded. Clinical specialty, RCT design, outcomes and bibliographical data will be collected for RCTs and citing articles. Citing articles will be thematically analysed using the constant comparison technique to explore author understanding, contextualisation and relationship to clinical practice for the index trial. Coding will include generic issues relevant to all RCTs, such as sample size or blinding, and features specific to surgery, such as learning curve. Index trial quality will be examined using validated tools. Results will be combined to create a broad overview of the understanding and use of RCT evidence. ETHICS AND DISSEMINATION: This study involves secondary use of existing articles and does not require ethical approval. Pilot work will establish its feasibility and inform progression to larger scale utilisation across a broad range of RCTs. Findings will be published in a peer-reviewed journal and presented at surgical and methodological conferences. Results will guide future work on trial design to optimise implementation of results.

Short-term outcomes after emergency surgery for complicated peptic ulcer disease from the UK National Emergency Laparotomy Audit: a cohort study.

OBJECTIVES: This study used national audit data to describe current management and outcomes of patients undergoing surgery for complications of peptic ulcer disease (PUD), including perforation and bleeding. It was also planned to explore factors associated with fatal outcome after surgery for perforated ulcers. These analyses were designed to provide a thorough understanding of current practice and identify potentially modifiable factors associated with outcome as targets for future quality improvement. DESIGN: National cohort study using National Emergency Laparotomy Audit (NELA) data. SETTING: English and Welsh hospitals within the National Health Service. PARTICIPANTS: Adult patients admitted as an emergency with perforated or bleeding PUD between December 2013 and November 2015. INTERVENTIONS: Laparotomy for bleeding or perforated peptic ulcer. PRIMARY AND SECONDARY OUTCOME MEASURES: The primary outcome was 60-day in-hospital mortality. Secondary outcomes included length of postoperative stay, readmission and reoperation rate. RESULTS: 2444 and 382 procedures were performed for perforated and bleeding ulcers, respectively. In-hospital 60-day mortality rates were 287/2444 (11.7%, 95% CI 10.5% to 13.1%) for perforations, and 68/382 (17.8%, 95% CI 14.1% to 22.0%) for bleeding. Median (IQR) 2-year institutional volume was 12 (7-17) and 2 (1-3) for perforation and bleeding, respectively. In the exploratory analysis, age, American Society of Anesthesiology score and preoperative systolic blood pressure were associated with mortality, with no association with time from admission to operation, surgeon grade or operative approach. CONCLUSIONS: Patients undergoing surgery for complicated PUD face a high 60-day mortality risk. Exploratory analyses suggested fatal outcome was primarily associated with patient rather than provider care factors. Therefore, it may be challenging to reduce mortality rates further. NELA data provide important benchmarking for patient consent and has highlighted low institutional volume and high mortality rates after surgery for bleeding peptic ulcers as a target for future research and improvement.