People take corticosteroids (“steroids”) either because they do not produce enough due to problems with their adrenal/ pituitary glands OR as treatment for inflammatory conditions e.g. asthma, arthritis. This research only concerns those who are taking steroids as treatment for inflammatory conditions. It is not known whether these people need extra steroids if they require surgery. Too little steroid at the time of an operation is associated with low blood pressure and dehydration. Too much is associated with poor wound healing and increased infections. We have been asked by the Medical Royal Colleges to do some research to find out whether extra steroids around the time of surgery is needed or not. Before we design a study to answer this question, we need some preliminary information. We need to establish how many people who have operations are taking steroids and whether people taking steroids are similar and have similar post-operative outcomes to those who do not. We will link information about people in hospital who have had major operations to GP records to see who was taking steroids and who was not. We can then use both hospital and GP records after the operations to give us information about their recovery. This will allow us to describe the number of people taking steroids who have operations, and compare them with other people having the same operation. We will use statistical methods to account for known differences (e.g. age and smoking) that might influence these clinical outcomes.
Around 1% of the UK population take oral corticosteroids. It is unknown whether patients taking therapeutic corticosteroids need peri-operative supplementation. National guidelines suggest supplementation, but state that there is little evidence on which this is based. The central purpose of this study is to provide data that will be used to inform a future RCT study design that would aim to establish the effectiveness and cost-effectiveness of this intervention. This application focuses on establishing the size of the problem to the NHS and providing information regarding the population and outcomes by asking the following questions:
1. What proportion of people who present for major surgery are taking oral corticosteroids in England, and how does this proportion vary across different surgical procedures?
2. What are the clinical outcomes after surgery for people who present for major surgery and are taking oral corticosteroids in England?
3. Are the clinical outcomes after surgery for people who present for major surgery and are taking oral corticosteroids in England different to the clinical outcomes for a similar group of patients who are not taking corticosteroids?
This retrospective cohort study will use HES- and ONS-linked CPRD data to determine the answers. Adult patients undergoing major surgery between 2010-2020 will be selected within HES using pre-defined procedure codes Prescribing data from the CPRD dataset will establish therapeutic corticosteroid use of ≥7.5mg prednisolone (equivalent) / day for ≥1month in the 3-months prior to the surgical event. The numbers and proportions of people who present for major surgery and are taking oral corticosteroids, will be reported overall and by major procedure, using standard descriptive statistics/tabulations. Similarly, clinical outcomes for these people will be described overall and by major procedure. Propensity-adjusted analyses will characterise differing clinical outcomes after surgery between those taking therapeutic corticosteroids and those who do not.
Surgical complications presenting to primary or secondary care (e.g. wound infection); Inpatient length of stay; Number of primary and secondary care contacts after discharge from hospital following the index surgical procedure, taking into account the number in the preceding 12 months; Frequency of GP consultations; Admission to hospital; Number of surgical procedures and diagnostic tests; Prescriptions issued in primary care; All-cause mortality.
Ben Gibbison - Chief Investigator - University of Bristol
Ben Gibbison - Corresponding Applicant - University of Bristol
Barnaby Reeves - Collaborator - University of Bristol
Georgina Russell - Collaborator - University of Bristol
Jessica Harris - Collaborator - University of Bristol
HES Admitted Patient Care;ONS Death Registration Data;Patient Level Index of Multiple Deprivation