Developing a Research Project

David Narita, MD AHC, April 7th, 2011

Steps in starting clinical research Form your question Do research about your question (get all the information) Ask for advice/input Refine your question (hypothesis, aims, ideas how to conduct, results you want to see) Check excitement levels Choose a study A clinical hypothesis Is a clearly worded statement Is based on available evidence Is based on clear rationale - it can be explained by theory and/or from previous experiences Is a statement that can be accepted/ rejected/ modified/ revised on the basis of new evidence from further information gathering, assessment or evaluation of therapy How to form a clear hypothesis A provider in a hospital notices that children with kidney failure tend to have more cardiac arrhythmias. She asks the question, Why do children in kidney failure have more cardiac arrhythmias? Then she proposes a general hypothesis: Kidney failure affects the amount of cardiac arrhythmias in children. This is a good general hypothesis but it doesnt give us direction in how to design our research. We need to give more direction: Cardiac arrhythmias are increased in kidney failure Now there is some direction, but it is still not testable. Her research leads her to believe that potassium levels are involved high potassium levels can cause cardiac arrhythmias. The final step is to write the hypothesis in a way that it can be tested. Increased cardiac arrhythmias in children with kidney failure are due to high potassium levels. This is a testable hypothesis she has given us something we can measure (potassium levels) and has eliminated other variables such as the presence of acidosis . Now she can see if there is a correlation between potassium levels and cardiac arrhythmias. Aims Why are you doing the study? What do you hope to gain through the study? Investigate the relationship of serum potassium levels and cardiac arrhythmias in kidney failure. Present this relationship in a way can help us predict and prevent unnecessary cardiac deaths. Ideas of How to Conduct the Study (starting to think about methods) How might I carry this study out? What do I need to take into account? Errors/confounders? Ethics? Cost/feasibility? Choose all children under the age of 12 with kidney failure (Creatinine > x mol/L) Monitor patients for cardiac arrhythmias continuously during their hospitalization Measure serum potassium levels daily and immediately when the patient is having an arrhythmia Collect as many cases as possible in one year Results I want to see (starting to think about results) Potassium level (mEq/L) <r1 no arrhythmias r1-r2 not life-threatening arrhythmias >r2 life-threatening arrhythmias