Writing Research Hypothesis and Aims Handout -...
Transcript of Writing Research Hypothesis and Aims Handout -...
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Residency Research Program 2011 - 2012
Writing Research Hypotheses and Specific Aims
Cynthia Carnes, PharmD, PhD Professor and Associate Dean
July 19, 2011
Residency Research Program 2011 - 2012
Outline
• Define the research question
• From a question to a hypothesis
• Developing specific aims to test a hypothesis
Residency Research Program 2011 - 2012
Define the research question
Spend enough time to develop a good question • READ, READ, READ • A thorough literature review will help identify a high quality question • Look for knowledge gaps or areas of controversy. • Are you interested/excited/convinced about your idea?
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Study hypothesis vs. Study Purpose
Every study has a purpose, not every study has a hypothesis
Every study does not require a
hypothesis
Residency Research Program 2011 - 2012
Studies with a purpose
• May be observational, exploratory or descriptive
• Allow for a “first look”
• May be hypothesis generating
Residency Research Program 2011 - 2012
How does the question lead to a hypothesis?
• This is where you begin to really narrow your question.
• A solid hypothesis: – Makes predictions about relationships between
variables (cause and effect) – Should address at least a part of the research
question – Is well-grounded in existing literature and
knowledge
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Residency Research Program 2011 - 2012
Writing your Hypothesis
• A hypothesis is a tentative statement that proposes a possible explanation to some phenomenon or event.
• A good hypothesis will: – Have a strong rationale and address all or a
portion of your research question – Have a measurable, reproducible outcome
measure or measures
Residency Research Program 2011 - 2012
What makes a good quality hypothesis? • It makes a prediction (you don’t have to agree with
the prediction).
• It describes the relationship between an independent (controlled) variable and a dependent (measured outcome) variable.
• It is feasible for the scope of your project.
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How do you get from a hypothesis to specific aims?
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Hypothesis to Specific Aims
Once you have a good hypothesis, it should lead directly to your aims.
Brainstorm ways to test your hypothesis. Most hypotheses can be addressed in different ways,
so don’t limit your thinking too quickly (avoid love at first sight).
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Hypothesis testing: Considerations for constructing aims
• Know your assumptions
• Know the limitations of your measurements
• CONTROLS, CONTROLS, CONTROLS • Confounding variables can lead you astray
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Specific Aims
Specific Aims are the roadmap for the project. If you are going to measure it, it should be addressed in
the aims. If you measure it, have a plan to use it. If you have an interesting idea that is not directly testing
your hypothesis…save it for later.
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How do you develop specific aims?
• Begin with the end in mind
• The specific aim or aims should be directly linked to the hypothesis.
• Each aim should be highly focused
• FEASIBILITY (time, resources, statistical power)
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What should be measured? • Optimal (True) endpoints
– Longevity – Prevention of events (reduced morbidity) – Improvement in quality of life – Cost savings
References: 1. DeMets DL and Califf RM. Lessons learned from recent cardiovascular trials.
Part I. Circulation 2002; 106: 746-751. 2. Hilsenbeck SG, Clark GM. Surrogate endpoints in chemoprevention of breast
cancer: guidelines for evaluations of new biomarkers. J Cell Biochem Supple 1993; 17G: 205-11.
3. Fleming TR. Surrogate markers in AIDS and cancer trials. Stat Med 1994; 13: 1423-35
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What if you don’t have the time or resources to get to a true endpoint?
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Surrogate Endpoints
• Validation of surrogate endpoints – Changes in the surrogate must predict a relevant
clinical outcome AND – Capture the effect of the intervention on the clinical
outcome
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Surrogate Endpoints • Benefits
– Shorter latency – Reduced size/cost/duration of trials – Avoidance of unethical practices – May be more feasible
• Limitations – Misclassification – Assumes causality or close linkage to disease
process – May not be a complete picture (multi-factorial)
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Putting it all together
Research question
Purpose or Hypothesis
Specific Aims What is measured? How is it measured? What are the controls? How will you interpret your data?
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Harinstein, et al. Use of an Abnormal Laboratory Value-Drug Combination Alert to Detect Drug-Induced Thrombocytopenia in Critically Ill Patients
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Questions for Group Discussion
• What is the research question?
• What is the hypothesis?
• How could the hypothesis be tested?
• Are the objectives (aims) appropriate in scope?
Residency Research Program 2011 - 2012
Steinhardt, et al. National Survey: Pharmacist Career Ladders
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Residency Research Program 2011 - 2012
Questions for Group Discussion
• What is the research question?
• What is the hypothesis?
• How could the hypothesis be tested?
• Are the objectives (aims) appropriate in scope?
Residency Research Program 2011 - 2012
Kozminski, et al. Pharmacist Integration into the Medical Home: A Qualitative Analysis
Residency Research Program 2011 - 2012
Questions for Group Discussion
• What is the research question?
• What is the hypothesis?
• How could the hypothesis be tested?
• Are the objectives (aims) appropriate in scope?
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Residency Research Program 2011 - 2012
Hedrick, et al. Risk of Hypoglycemia in Hospitalized Patients Prescribed a Sulfonylurea
Residency Research Program 2011 - 2012
Questions for Group Discussion
• What is the research question?
• What is the hypothesis?
• How could the hypothesis be tested?
• Are the objectives (aims) appropriate in scope?
Residency Research Program 2011 - 2012
Johnson, et al. The Impact of Tacrolimus Monotherapy on the Development of Hyperlipidemia after Liver Transplantation
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Residency Research Program 2011 - 2012
Questions for Group Discussion
• What is the research question?
• What is the hypothesis?
• How could the hypothesis be tested?
• Are the objectives (aims) appropriate in scope?
Residency Research Program 2011 - 2012
Bhavsar, et al. Impact of a Lidoderm® Patch Prior Authorization on Utilization and Cost
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Questions for Group Discussion
• What is the research question?
• What is the hypothesis?
• How could the hypothesis be tested?
• Are the objectives (aims) appropriate in scope?
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Residency Research Program 2011 - 2012
Summary • Start with a good question that you are interested in pursuing. • Develop a testable hypothesis. • Develop feasible, focused aims to test the hypothesis.
“Being busy does not always mean real work. The object of all work is production or accomplishment and to either of these ends there must be forethought, system, planning, intelligence, and honest purpose, as well as perspiration. Seeming to do is not doing.” Thomas Edison
Residency Research Program 2011 - 2012
Questions and/or Comments?