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UNC ECHO, HBCU Health Promotion Alliance, NC A

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12/4/2004. 1. UNC ECHO, HBCU Health Promotion Alliance, NC A&T School of ... deserves to be kicked to death by a jackass, and I'm just the one to do it' ... – PowerPoint PPT presentation

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Title: UNC ECHO, HBCU Health Promotion Alliance, NC A


1
UNC ECHO, HBCU Health Promotion Alliance, NC AT
School of Agriculture Workshop on Grantwriting
for Health Disparities Research
  • Victor J. Schoenbach, Ph.D.
  • Director, Minority Health Project
  • Department of Epidemiology
  • UNC-Chapel Hill School of Public Health
  • www.unc.edu/vschoenb/
  • This presentation can be downloaded
    from www.minority.unc.edu/present/2004/

2
An honest politician
  • That lowdown scoundrel deserves to be kicked to
    death by a jackass, and I'm just the one to do
    it Congressional candidate in Texas.

3
Portions drawn from
  • A Grant Writing Primer by Hinda Zlotnik, Ph.D.
  • MARC/MBRS Program, NIGMS
  • brin.hpcf.upr.edu/symposium/How20to20write20suc
    cessful20proposals.ppt
  • Writing a grant proposal, by Malcolm Gordon,
    Ph.D., National Institute of Mental Health, 1999
  • www.charityadvantage.com/iaswr/images/grantproposa
    ls.pdf
  • Both downloaded 11/26/2004

4
Proposal components
  • Abstract
  • Budget, Biographical Sketches, Resources
  • Research Plan
  • A. Specific Aims (and hypotheses)
  • B. Background and Significance
  • C. Preliminary Studies / Progress Report (and
    background of investigators)
  • D. Research Design and Methods
  • E. Human Subjects Research
  • G. Literature cited

5
Follow instructions
  • Read and follow the instructions carefully to
    avoid delays, misunderstandings and possible
    return of the application. Adherence to font and
    margin requirements is necessary for several
    reasons.…
  • Use English and avoid jargon.

6
Dont believe everything
  • The PHS estimates that it will take
    approximately 40 hours to complete this
    application for a regular research project
    grant.

7
Proposal components
  • Abstract
  • Budget, Biographical Sketches, Resources
  • Research Plan
  • A. Specific Aims (and hypotheses) 1 page
  • B. Background and Significance
  • C. Preliminary Studies / Progress Report (and
    background of investigators)
  • D. Research Design and Methods
  • E. Human Subjects Research
  • G. Literature cited

8
a. Specific Aims
  • (outline labeling is inconsistent)
  • The framework for the entire proposal, including
    the research plan.

9
Requirements for a Good Specific Aims Section
  • Brief introduction including the long range goal
    of the project
  • The goals of this particular application
  • The central hypothesis to be examined
  • Rationale for the project
  • Specific aims
  • Anticipated results

10
Rationale
  • This is the underlying reason for the studies you
    propose.
  • The rationale must be relevant to the problem
    that has been presented in the introduction.

11
A dubious rationale
  • It isn't pollution that's harming the
    environment. It's the impurities in our air and
    water that are doing it. Al Gore, Vice
    President

12
Specific Aims
  • Statements of (measurable) end results, not means
    to an end.
  • Brief, focused, and limited in scope.
  • Each aim flows logically into the next aim.
  • Each should be briefly expanded upon.
  • Be realistic do not overestimate your
    capabilities for completing the work in the time
    requested.

13
Proposal components
  • Abstract
  • Budget, Biographical Sketches, Resources
  • Research Plan
  • A. Specific Aims (and hypotheses)
  • B. Background and Significance 2-3 pages
  • C. Preliminary Studies / Progress Report (and
    background of investigators)
  • D. Research Design and Methods
  • E. Human Subjects Research
  • G. Literature cited

14
b. Background and Significance
  • Sketch the background, critically evaluate
    existing knowledge, and specifically identify
    gaps.
  • State concisely the importance and health
    relevance by relating the specific aims to broad,
    long-term objectives.
  • State how scientific knowledge or clinical
    practice will be advanced. Describe the effect on
    the concepts, methods, technologies, treatments,
    services or preventative interventions that drive
    this field.

15
The Review Process
  • Lynchpin of the NIH review process is the initial
    review group (IRG).
  • Helpful to know the psychology and sociology of
    review committees many agendas.
  • Helpful to know who is on the review committee,
    what is their expertise, what they have published.

16
The Review Process - 2
  • Purchasing metaphor
  • Want to buy, have money to spend
  • Want to be an informed consumer
  • Dont want to be duped
  • Want value for money

17
The Review Process - 2
  • Marketing metaphor
  • Stimulate interest, be in fashion
  • Convey information
  • Build positive regard
  • Avoid unrealistic expectations
  • Package attractively

18
Proposals not scored or downgraded
  • Fatally flawed methodology or infeasible
  • Incomplete missing key detail
  • Serious human subjects concern
  • Likely not to provide any new or important
    substantive knowledge

19
Would you fund this advance?
  • If somebody has a bad heart, they can plug this
    jack in at night as they go to bed and it will
    monitor their heart throughout the night. And
    the next morning, when they wake up dead,
    there'll be a record. Mark S. Fowler, FCC
    Chairman

20
Proposal components
  • Abstract
  • Budget, Biographical Sketches, Resources
  • Research Plan
  • A. Specific Aims (and hypotheses)
  • B. Background and Significance
  • C. Preliminary Studies / Progress Report (and
    background of investigators) 8-10 pgs
  • D. Research Design and Methods
  • E. Human Subjects Research
  • G. Literature cited

21
c. Preliminary Studies/Progress Report
  • Preliminary Studies. For new applications, use
    this section to provide an account of the
    principal investigator/program directors
    preliminary studies pertinent to this
    application, including his/her preliminary
    experience with and outreach to the proposed
    racial/ethnic group members. This information
    will also help to establish the experience and
    competence of the investigator to pursue the
    proposed project. pilot studies

22
Preliminary Studies
  • … results obtained from prior research that are
    relevant to the proposed research, including
    results that bear on the feasibility of the
    proposed research, on the adequacy of sample
    sizes you will have access to, and on the
    likelihood that the major hypotheses of the study
    will be supported.

23
Preliminary Studies Example
  • A recently published examination of racial
    differences in prostate cancer treatment outcomes
    sets the stage for successful completion of the
    proposed project. The study was conducted by the
    investigators, who have extensive experience in
    population based case-control studies of cancer
    etiology and in case-control studies of cancer
    screening.
  • Godley PA, Schenck AP, Amamoo MA, Schoenbach VJ,
    Peacock S, Manning M, et al. Racial differences
    in mortality among Medicare recipients after
    treatment for localized prostate cancer. J Natl
    Cancer Inst 200395(22)1702-10.
  • We investigated whether racial disparities in
    outcomes of clinically localized prostate cancer
    vary by treatment. Merged SEER and Medicare files
    provided data (age, race, stage, grade, census
    tract socioeconomic status, and date of death) on
    5,747 black and 38,242 white patients with
    clinically localized prostate cancer, aged 65 to
    84, first diagnosed between 1986 and 1996 in five
    SEER sites. . . .

24
Preliminary Studies
  • Describe published studies in limited detail and
    include the most important figures and/or tables.
  • Describe unpublished studies in more complete
    detail, including newer data.
  • Do not duplicate the preliminary studies with the
    proposed studies.

25
Preliminary Studies
  • Include the results of your recent work that have
    direct relevance to the studies proposed in your
    grant application.
  • Exclude any studies in which the relationship to
    your proposed study is not relevant.

26
Editorial Considerations for Preliminary Studies
  • Supporting data should be placed as close as
    possible to where it is referenced in the text of
    the application.
  • All figures/graphs and tables should be clear and
    legible.
  • Methodology should be placed in the figure/table
    legends, not in the text.

27
Technical Considerations for Preliminary Studies
  • Graphs should be uncomplicated ... the simpler,
    the better.
  • Each table or figure should be designed to convey
    a single point or idea.
  • Extraneous or irrelevant data should be avoided.

28
Proposal components
  • Abstract
  • Budget, Biographical Sketches, Resources
  • Research Plan
  • A. Specific Aims (and hypotheses)
  • B. Background and Significance
  • C. Preliminary Studies / Progress Report (and
    background of investigators)
  • D. Research Design and Methods 8-14 pgs
  • E. Human Subjects Research
  • G. Literature cited

29
d. Research Design and Methods
  • As described in the PHS 398 instructions
  • Conceptual or clinical framework, procedures, and
    analyses to accomplish the specific aims
  • How data will be collected, analyzed,
    interpreted, and shared
  • Novel concepts, approaches, methodologies, tools,
    or technologies

30
d. Research Design and Methods (more from the PHS
398 instructions)
  • Discuss potential difficulties and limitations
    and alternative approaches
  • Tentative sequence or timetable
  • Hazards to personnel and precautions to be
    exercised

31
THE RESEARCH DESIGN
  • The heart and soul of the application.
  • Should state precisely
  • What you propose to do
  • How you plan to do it
  • What the result will mean in terms of the overall
    project
  • What pitfalls you might encounter
  • Alternative approaches to cope with anticipated
    problems

32
Research Design Organizational Structure
  • Restate each specific aim and for
  • each, provide
  • 1. Introduction
  • 2. Methods of approach
  • 3. Anticipated findings or results
  • 4. Potential pitfalls/alternative approaches

33
Research Design (continued-1)
  • 1. INTRODUCTION
  • Each section of the research design should
    restate the hypothesis to be tested, the
    rationale for the study, overall approaches to be
    taken, and the anticipated results.

34
Research Design (continued-2)
  • 2. METHODS OF APPROACH
  • Separate sections based on the specific aims
    should be used to develop each of the planned set
    of studies.
  • Avoid emphasis on routine methods
  • Use detailed methods only for unfamiliar
    technology

35
Research Design (continued-3)
  • 3. ANTICIPATED RESULTS
  • Summarize your results.
  • Emphasize only the most important results.
  • Do not overinflate or overinterpret the results.
  • If limitations exist, they should not be ignored,
    but should be discussed in a positive manner.

36
Research Design (continued-4)
  • 4. POTENTIAL PROBLEMS
  • Anticipate potential problems, and discuss them
    but do not overemphasize them.
  • Offer alternative strategies.
  • Reconcile the results of differing approaches.

37
Research Design Example
  • The cases for the proposed study will be males
    with a diagnosis of prostate cancer who have died
    in the years 1997 to 2000. A merged SEER/Medicare
    dataset, Patient Entitlement and Diagnosis
    Summary File (PEDSF) for years 1997 to 2000, will
    be used to identify the cases. The PSA screening
    exposure will be documented for each case from
    1988, when PSA screening became widely available,
    to the date of diagnosis of the case. Since
    prostate cancer can be a relatively slow growing
    cancer, by limiting the study to most recent
    cases available in the SEER/Medicare dataset we
    are allowing as much as 12 years for patients who
    were not screened or patients who were
    unsuccessfully screened to become fatal cases.
    Ideally, cases in a case-control study of
    screening efficacy should be those who have
    suffered an adverse outcome of the condition that
    screening is intended to identify or prevent
    (41). Five SEER regions (Atlanta, Connecticut,
    Detroit, San Francisco and Seattle) were selected
    because they provided a substantial number of
    African American cases for analyses and included
    data collected since 1986.

38
Research Design Example (contd)
  • The following potential cases will be excluded
    from the dataset
  • Subjects with a diagnosis of a non-prostate
    cancer before or after the prostate cancer
    diagnosis
  • Subjects with prostatic intraepithelial
    neoplasia as the only prostate cancer diagnosis
  • Subjects with a missing month of diagnosis
  • Subject who were diagnosed with prostate cancer
    at death
  • Subjects without Medicare coverage during the
    study period
  • No age restrictions will be used.
  • An analysis of the 1996 PEDSF file reveals that
    924 deaths among prostate cancer cases meet these
    criteria. Approximately 4,000 cases can be
    expected over the proposed 4-year study period.
    Of the 924 deaths among prostate cancer patients,
    739 were Caucasian and 185 were African American.

39
Research Design Example (contd)
  • Exposure Assessment
  • The proposed study will compare the screening
    exposure of deceased cases to the screening
    exposure of living controls. This approach has
    been used previously in case-control studies of
    cancer screening, and the use of deceased cases
    not be a source of addition bias (55, 56).
  • Screening PSA determinations were not reimbursed
    by Medicare until 2000 (57). However, PSA tests
    were frequently charged to Medicare prior to 2000
    and appear in Medicare administrative data files.
    Diagnostic PSA testing was covered by Medicare so
    some of the PSA tests appearing in Medicare files
    may be from screening and not diagnostic patient
    encounters. The high prevalence of PSA testing
    supports the probability that PSA tests were
    predominantly screening and not diagnostic in
    intent. Freeman et al. (57) found that 37 of men
    in 1998 SEER/Medicare files had a PSA test. Among
    1996 controls matched to the 924 cases described
    above, 65 of men had PSA tests billed to
    Medicare between 1988 and 1996. It is unlikely
    that the majority of men ages 65 years and over
    had PSA testing solely for diagnostic purposes.

40
Research Design Example (contd)
  • DATA ANALYSIS
  • The analysis of the primary specific aim will
    examine exposure to PSA testing only, since PSA
    screening has been widely used since 1988, is the
    most sensitive screening test for prostate
    cancer, and has been documented in Medicare
    claims files since 1996. Our analysis will use
    conditional logistic regression, with
    case-control status as the dependent variable and
    PSA testing as the independent variables. We will
    assess the impact of the following potential
    confounding variables race, age, SEER site,
    income and education (57). In this context a
    confounding variable is a determinant (or
    surrogate for a determinant) of prostate cancer
    death and is also associated with the probability
    of undergoing prostate cancer screening.
  • Since the analysis will evaluate fatal prostate
    cancer as the endpoint, comparison of screening
    between cases and controls is only appropriate
    for the period prior to the diagnosis of prostate
    cancer. Therefore, using an approach similar to
    that of Friedman (19), we will estimate odds
    ratios for screened with PSA since 1988. Since
    this approach is only appropriate for cases
    diagnosed after 1988, any case diagnosed prior to
    that time will be excluded. We will also examine
    shorter intervals that may correspond to
    estimates of the detectable preclinical phase, as
    described by Weiss et al. (58).

41
Research Design (continued-5)
  • In general a review committee will be concerned
    with four aspects of the proposal
  • its importance
  • its feasibility
  • the technical merits of the methodology
  • its innovativeness

42
Research Design (continued-6)
  • Regarding technical merit, the review committee
    considers
  • conceptual framework guiding the research
  • measurement of key variables
  • sampling plan of the research
  • procedures for data collection
  • data analysis plan for the research.

43
Most Common Reasons for Failure
  • Lack of a good original idea.
  • Unimportant or unresponsive problem.
  • Unacceptable rationale.
  • Lack of expertise, experience, or resources.
  • Superficial or unfocused research design.

44
Why you want to write with precision
  • "Your food stamps will be stopped effective March
    1992 because we received notice that you passed
    away. May God bless you. You may reapply if there
    is a change in your circumstances." Department
    of Social Services, Greenville, South Carolina

45
Most Common Reasons for Failure (more)
  • Unrealistic amount of work proposed.
  • Uncertain outcomes and/or lack of future
    directions.
  • Disorganized/poorly written application.
  • Lack of progress.

46
Practical suggestions for how to proceed
  • Serve as a reviewer.
  • Form a team, identify a leader, set a schedule
  • Find out who will be reviewing the proposal and
    with what criteria
  • Find a model proposal to emulate
  • Make an outline of the proposal in a word
    processing document, add notes, write text
  • Review and revise, review and revise, …

47
Practical suggestions - 2
  • Outline of Research Design and Methods section
  • Overview
  • Design
  • Subjects (eligibility, recruitment, consent)
  • Data collection (measures, procedures, lab
    analyses)
  • Pretesting, piloting
  • Data analysis (variables, approach), sample size
  • Quality control and data management
  • Timetable and project management

48
The Research Plan Summary of General
Considerations - 1
  • Read and follow instructions carefully.
  • Specific aims are statements of end results.
    They are measurable statements, not means to an
    end.
  • Make the logic very clear and write a focused
    research plan.
  • Dont ramble--give sufficient background to make
    the significance of the proposed research very
    clear.
  • Frame questions in terms of testable hypotheses.

49
The Research Plan Summary of General
Considerations - 2
  • Clearly delineate the problem and the purpose of
    the research.
  • Emphasize the specific advantages of doing the
    research as you propose.
  • Consider alternative strategies there is
    concern when only a single approach is given or a
    single uncertain result serves as the basis for
    the project.
  • Include preliminary data if possible.
  • Dont overinterpret or misinterpret data.

50
The Research Plan Summary of General
Considerations - 3
  • Dont detail routine methods, but include
    comments that can convey your expertise to the
    reader.
  • List relevant intellectual and physical resources
    available to you.
  • Consider and discuss all variables that will
    impact the outcome. That is, which ones need to
    be controlled, which ones dont, and how this
    will affect the outcome.

51
The Research Plan Summary of General
Considerations - 4
  • Discuss the limitations of your conclusions, if
    any.
  • Prioritize the tasks proposed and provide time
    estimates.
  • Use shorter words rather than longer ones unless
    they are technical.
  • Use short sentences and avoid jargon.
  • Make sure the proposal flows logically from
    section to section, i.e. methods proposed
    logical extension of the specific aims.

52
Resources
  • Succinct overview Proposal Writing The
    Business of Science, by Wendy Sanders. The
    Whitaker Foundation, 2004, www.whitaker.org/sander
    s.html
  • Quick Guide for Grant Applications
    (deainfo.nci.nih.gov/extra/extdocs/gntapp.htm)
  • Guide Writing a grant proposal, Malcolm
    Gordon, Ph.D., National Institute of Mental
    Health, July 1999 www.charityadvantage.com/iaswr/i
    mages/grantproposals.pdf

53
Resources
  • www.training.nih.gov/careers/careercenter/grants.h
    tml
  • Getting started useful links
    (grants.nih.gov/grants/useful_links.htm)
  • Current NIH application forms (grants.nih.gov/gran
    ts/forms.htm)
  • fdncenter.org/learn/faqs/html/proposal_writing.htm
    l
  • Proposal writing short course
    (www.fdncenter.org/learn/shortcourse/prop1.html)
    available in Spanish and French

54
Resources
  • Books
  • Designing clinical research an epidemiologic
    perspective, Stephen B. Hulley and Steven R.
    Cummings and others. Baltimore, Williams and
    Wilkins, 1988
  • How to Write a Successful Research Grant
    Application A Guide for Social and Behavioral
    Scientists, by Willo Pequegnat, Ellen Stover.
    Plenum Publishing Corporation (September 1, 1995,
    Paperback 252 pages, ISBN 030644965X)

55
Resources
  • AAPMR-RPC Residents Research Packet American
    Academy of Physical Medicine and Rehabilitation.
    Finding a Mentor, Funding, Searching the
    Literature, Research Design, Research Proposals,
    The IRB, Statistics, Presenting Your Work
  • www.aapmr.org/resident/resrchpac/respacka.htm
  • Sigma Xi Grant Writing Course Series, 5-day
    intensive course presented by the Grantsmanship
    Center, Inc. (TGCI) for Sigma Xi tuition
    1,000
  • www.sigmaxi.org/meetings/grant/index.shtml
    earlycareer_at_sigmaxi.org

56
Resources
  • My home page www.unc.edu/vschoenb/ has these
    links
  • epid160.epidemiology.us Introduction to
    epidemiology (includes on-line recorded lectures)
  • www.epidemiolog.net Epidemiology learning
    resources and The Evolving Text (el Texto en
    Desarrollo)
  • www.minority.unc.edu Minority Health Project,
    includes slide presentations, webcasts, readings

57
  • If we don't succeed, we run the risk of
    failure. Bill Clinton
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