Submit 3

Project proposal Proforma

Please delete the examples given below after completing the form

1. Title
e.g. Multicentre observational cohort study of NSAIDs as risk factor for postoperative adverse events in gastrointestinal surgery 

2. Introduction (include why is this topic important, what has been done in this area before and what this research study will add)
e.g.  Thousands of GI resections are performed every year. Small single centre case series have questioned the safety of NSAID use after GI surgery. This study will provide stronger evidence on the safety of NSAID use after GI surgery.

3. Research Question (in the form of a question)
e.g. What is the safety profile of post-operative NSAID use after gastrointestinal resection?

4. Hypothesis 
e.g. The 30-day adverse event rate will be greater in patients not taking NSAIDs compared to patients who are taking NSAIDs

5. Study design (include a flow diagram) 
e.g. Prospective Cohort study

6. Patient population (inclusion / exclusion criteria)

7. Interventions (if any)

8. Comparator (if any)

8. Primary outcome (ideally just 1 outcome; include time at which it will be assessed) e.g. 30 day adverse event rate following GI surgery

9. Secondary outcomes (include time at which it will be assessed)

10. Variables that data will be collected for (give variable and how it will be measured) 
e.g. Age (years), ASA (I, II, III, IV, V), date of operation (DD/MM/YYYY), NSAIDs used post-operatively (yes/no), adverse event within 30-days (yes/no)

11. Proposed analysis plan 
e.g. Differences in adverse event rates between the NSAID and non-NSAID group will be tested with the Chi-squared test. Multivariable binary logistic regression will be used to test the influence of clinically plausible variables on the outcome measures. 

12. Project Consultant advisor and email address