The Anatomy of a Protocol

Jul 31, 2014

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The Anatomy of a Protocol. Background Research Question (hypotheses) Design Study Population Measurement Predictors (intervention) Outcomes Confounders (Randomization integrity) <Procedure> Analysis Relevance/Contribution. Research Protocol Page Allocation.

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The Anatomy of a Protocol

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The Anatomy of a Protocol • Background • Research Question (hypotheses) • Design • Study Population • Measurement • Predictors (intervention) • Outcomes • Confounders (Randomization integrity) • <Procedure> • Analysis • Relevance/Contribution
Research ProtocolPage Allocation
Your argument needs to leave the reader with the following impression: This is an important question to answer (it may also be interesting?) We need to know the answer to this question because……. it will have an impact on ____________ it will change _____________________ We do not know the answer to this question. The question can be answered by this study.
THE ARGUMENT PARADIGM • The Big Picture • how big is the problem? • burden of morbidity/mortality • impact on quality of life? • productivity? • cost of problem • __________________________________________________ • Where does your question fit in? • Is it a logical next step? • burden of illness • determinants • interventions • cost ____________________________________ What will your question answer that isn’t known already? Better mousetrap (no study to date has adequately answered the question, the right answer could change how we do things, this study can/will solve this problem) Fill a hole (no one knows and we need to know because it could make a difference) Your question!
The Research Cycle Burden of disease Causation Determinants Implementation Measurement Efficacy Efficiency Effectiveness After P Tugwell, 1985
PAGE ALLOCATION • The Big Picture • How big is the problem? • Burden of morbidity? • Impact on quality of life? • Productivity? • Cost of problem? __________________________________________________________ • Where does your question fit in? • Is it a logical next step? • Burden of illness • Determinants • Interventions • Cost _________________________________________________________________ What will your question answer that isn’t known already? Better mousetrap (no study to date has adequately answered the question, the right answer could change how we do things, this study can/ will solve this problem) Fill a hole (no one knows and we need to know because it could make a difference)
GETTING STARTED • Decide what you want to know from reviewing the literature • sketch out the logic of your argument and find the related lit OR • read some review articles to get a handle on the area, the assumptions, the unknowns • Summarize as you go – the key elements? • Having problems? Figure out why? • question is not well defined? • you have too many questions? • your question is at the wrong part of the research cycle?
Appendix 1: A Summary of Studies Which Have Examined the Relationship between Benzodiazepines,Psychotropics and Injury in the Elderly

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