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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 Significance. Research Plan. What has been done so far Preliminary Studies How you are going to do it

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research design and methods

Research Design and Methods

Betsy Myers

Hospital for Special Surgery

research plan
Research Plan

Portray

  • What you intend to do
    • Specific Aims
  • Why it is important
    • Background and Significance
research plan3
Research Plan
  • What has been done so far
    • Preliminary Studies
  • How you are going to do it
    • Research Design and Methods
getting started
Getting Started

Read instructions on how to prepare Research Design and Methods section

instructions
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/phs398.doc

instructions6
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/phs398.doc

instructions7
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/phs398.doc

instructions8
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/phs398.doc

main points that you must get across
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
main points that you must get across10
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
organization
Organization
  • No one organization fits all proposals
  • Try to organize in logical sequence of Specific Aims and corresponding experiments
outline
Outline

Start with an outline

  • D. RESEARCH DESIGN AND METHODS
  • D1. Overview
    • Flowchart
    • Brief description
  • D2. Aim 1
    • Rationale
    • Design
audience
Audience
  • Write for reviewers and funding agency staff
audience14
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
organization15
Organization

Consider giving overview at start of entire section

  • Describe overall approach that will be used to achieve aims
  • Consider using flowchart or table
example of chart

Load

Load

Example of Chart

Aim 2

Aim 1

Col2.3tk+/+

Ex-vivo analysis

QCT, HMM, QAR, IHC

X

Control

Col2.3tk+/+

EGR-1+/+

Experimental

Col2.3tk+/+

EGR-1-/-

EGR-1-/-

Part 2

Part 1

Aim 3

microPET/CT

Mayer-Kuckuk

for each specific aim
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

rationale
Rationale
  • Directly and succinctly reiterate why you are doing this Specific Aim
design approach
Design/Approach

Briefly describe

  • Design of study
  • Choice of specimens
  • Choice of interventions/independent factors and outcome assessments
m easurements
Measurements

Describe techniques and equipment for measuring all variables

  • Use illustrations
  • Demonstrate that measurements will be accurate, precise, sensitive, specific
novel methods
Novel Methods
  • Emphasize what is new about your methods
  • Point out advantages to using your proposed techniques over other approaches
data analysis
Data Analysis

Describe approach for data analysis in detail

Conclusions &

Interpretation

Raw Data

Analysis should not

be Black Box

data analysis23
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
power analysis
Power Analysis
  • Remember that you need to determine
    • How many specimens are needed to have a certain probability of detecting an effect?
keep in mind
Keep in Mind...
  • Goal is to demonstrate that enough data will be collected to support analysis
  • Straightforward procedure
  • But is “ballpark” approach
number of specimens in research plan
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
number of specimens in research plan27
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
number of specimens in research plan28
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
effect size
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

effect size30
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

number of specimens
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
expected results and interpretation
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

Analysis of

findings

Collection of

information

limitations
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
timetable
Timetable

Include timeline or timetable at end of Research Design and Methods

  • Give enough detail for evaluation
  • Make certain it is reasonable
ending
Ending
  • Close Research Design and Methods with overall statement about significance of studies
  • Be enthusiastic
tips on clarity and style
Tips on Clarity and Style

Make appearance conducive to easy reading on paper and on screen

  • Neat
  • White space
  • 11-12 point font
tips on clarity and style37
Tips on Clarity and Style
  • Proofread
  • Make figures, tables, and legends legible
length
Length

Stick to page length recommendations

  • RO1:

Research Plan must be <=25 pages

    • Specific Aims: 1
    • Background: 3
    • Preliminary Studies: 6-8
    • => Research Design/Methods: 13-15
informative writing
Informative Writing

Target readers’ understanding

  • Inform the reader
  • Explain what is difficult to understand
  • Say only what needs to be said
avoid
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
summary successful research design and methods
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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