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Research Design and Methods

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Research Design and Methods Betsy Myers Hospital for Special Surgery Research Plan Portray What you intend to do Specific Aims Why it is important Background and ... – PowerPoint PPT presentation

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Title: Research Design and Methods


1
Research Design and Methods
  • Betsy Myers
  • Hospital for Special Surgery

2
Research Plan
  • Portray
  • What you intend to do
  • Specific Aims
  • Why it is important
  • Background and Significance

3
Research Plan
  • What has been done so far
  • Preliminary Studies
  • How you are going to do it
  • Research Design and Methods

4
Getting Started
  • Read instructions on how to prepare Research
    Design and Methods section

5
Instructions
  • Describe the research design conceptual or
    clinical framework, procedures, and analyses to
    be used to accomplish the specific aims of the
    project.

Instructions for PHS 398 Rev. 09/2004
http//grants1.nih.gov/grants/funding/phs398/phs39
8.doc
6
Instructions
  • include how the data will be collected,
    analyzed, and interpreted as well as the
    data-sharing plan as appropriate.

Instructions for PHS 398 Rev. 09/2004
http//grants1.nih.gov/grants/funding/phs398/phs39
8.doc
7
Instructions
  • Describe any new methodology and its advantage
    over existing methodologies. Describe any novel
    concepts, approaches, tools, or technologies for
    the proposed studies.

Instructions for PHS 398 Rev. 09/2004
http//grants1.nih.gov/grants/funding/phs398/phs39
8.doc
8
Instructions
  • Discuss the potential difficulties and
    limitations of the proposed procedures and
    alternative approaches to achieve the aims.
  • provide a tentative sequence or timetable for
    the project.

Instructions for PHS 398 Rev. 09/2004
http//grants1.nih.gov/grants/funding/phs398/phs39
8.doc
9
Main Points That You Must Get Across
  • Research design, if carried out successfully,
    will accomplish Specific Aims
  • Methods are feasible and well developed
  • Approach is original

10
Main Points That You Must Get Across
  • Data will be analyzed correctly
  • Enough subjects/specimens will be tested to lead
    to conclusive results
  • Limitations are of minor concern only
  • Study can be accomplished in requested time

11
Organization
  • No one organization fits all proposals
  • Try to organize in logical sequence of Specific
    Aims and corresponding experiments

12
Outline
  • Start with an outline

D. RESEARCH DESIGN AND METHODS D1.
Overview Flowchart Brief description D2. Aim
1 Rationale Design
13
Audience
  • Write for reviewers and funding agency staff

14
Audience
  • Reviewers are informed readers but not
    necessarily experts in your specific area
  • Funding agency (NIH) personnel want to know
    health impact
  • Keep in mind that you need to be very clear and
    you need to emphasize health significance
    throughout

15
Organization
  • Consider giving overview at start of entire
    section
  • Describe overall approach that will be used to
    achieve aims
  • Consider using flowchart or table

16
Example of Chart
Aim 2
Aim 1
Col2.3?tk/
Ex-vivo analysis QCT, HMM, QAR, IHC
X
Experimental Col2.3?tk/ EGR-1-/-
Control Col2.3?tk/ EGR-1/
EGR-1-/-
Part 2
Part 1
Aim 3
microPET/CT
Mayer-Kuckuk
17
For Each Specific Aim
  • Reiteration of Research Question
  • Rationale
  • Design, Approach
  • Methods
  • Anticipated Results, Interpretation
  • Difficulties, Limitations, Alternative approaches

Or could include section on Detailed
Methods common to more than one Specific
Aim after description of Aims
18
Rationale
  • Directly and succinctly reiterate why you are
    doing this Specific Aim

19
Design/Approach
  • Briefly describe
  • Design of study
  • Choice of specimens
  • Choice of interventions/independent factors and
    outcome assessments

20
Measurements
  • Describe techniques and equipment for measuring
    all variables
  • Use illustrations
  • Demonstrate that measurements will be accurate,
    precise, sensitive, specific

21
Novel Methods
  • Emphasize what is new about your methods
  • Point out advantages to using your proposed
    techniques over other approaches

22
Data Analysis
  • Describe approach for data analysis in detail

Conclusions Interpretation
Raw Data
Analysis should not be Black Box
23
Data Analysis
  • If using analytic statistics, specify
  • Statistical parameters and tests
  • Assumptions of tests
  • Alpha level
  • Alpha probability of falsely rejecting null
    hypothesis
  • Reference if statistical approach is not well
    known

24
Power Analysis
  • Remember that you need to determine
  • How many specimens are needed to have a certain
    probability of detecting an effect?

25
Keep in Mind...
  • Goal is to demonstrate that enough data will be
    collected to support analysis
  • Straightforward procedure
  • But is ballpark approach

26
Number of Specimens in Research Plan
  • State assumptions and methods used for power
    analysis
  • Specify primary outcome variable
  • Specify factor(s) or independent variable(s) of
    interest

27
Number of Specimens in Research Plan
  • State proposed statistical test or interval
    estimation
  • Examples
  • Analysis of variance
  • Linear regression
  • Note that each test has specific formula for
    power/number of specimens

28
Number of Specimens in Research Plan
  • Give alpha level
  • Alpha probability of falsely rejecting null
    hypothesis
  • Give beta level or power
  • Beta probability of falsely accepting null
    hypothesis
  • Describe effect size

29
Effect Size
  • to answer the question What are my chances of
    finding it?, the researcher needs to have some
    idea of how big it is
  • J Cohen
  • Statistical Power Analysis for the Behavioral
    Sciences

30
Effect Size
  • Ratio of expected difference to measure of
    variability
  • Based on
  • Published work
  • Preliminary studies
  • Educated guess
  • Use an effect size of scientific or clinical
    importance

31
Number of Specimens
  • Calculate number
  • Hand calculation
  • Computer programs, e.g., nQuery, PASS
  • If using educated guess for effect size,
    determine number for several effect sizes
  • Adjust for loss of laboratory animals if
    applicable

32
Expected Results and Interpretation
  • Remember to discuss expected results and
    interpretation of analysis

Research question
Close the loop
Interpretation of results to answer...
Study design
Collection of information
Analysis of findings
33
Limitations
  • Include segment on potential difficulties
    limitations at one of following locations
  • Under each Specific Aim
  • End of entire Research Design and Methods section
  • As they occur in methods
  • Use limitations to point to future studies

34
Timetable
  • Include timeline or timetable at end of Research
    Design and Methods
  • Give enough detail for evaluation
  • Make certain it is reasonable

35
Ending
  • Close Research Design and Methods with overall
    statement about significance of studies
  • Be enthusiastic

36
Tips on Clarity and Style
  • Make appearance conducive to easy reading on
    paper and on screen
  • Neat
  • White space
  • 11-12 point font

37
Tips on Clarity and Style
  • Proofread
  • Make figures, tables, and legends legible

38
Length
  • Stick to page length recommendations
  • RO1
  • Research Plan must be lt25 pages
  • Specific Aims 1
  • Background 3
  • Preliminary Studies 6-8
  • gt Research Design/Methods 13-15

39
Informative Writing
  • Target readers understanding
  • Inform the reader
  • Explain what is difficult to understand
  • Say only what needs to be said

40
Avoid
  • Overly ambitious research plans
  • Contingent Specific Aims
  • Complex, emerging techniques without establishing
    familiarity or including expert
  • Too little detail on data analysis
  • Under-powered studies

41
Summary Successful Research Design and Methods
  • Bright idea
  • Well developed and clearly described methods
  • Appropriate data analysis
  • Large enough sample size
  • Plenty of time to do the work
  • Only minor limitations
  • Clear pathway to strong conclusions
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