UNC ECHO, HBCU Health Promotion Alliance, NC A&T School of Agriculture Workshop on Grantwriting for Health Dispariti

1. UNC ECHO, HBCU Health Promotion Alliance, NC A&T 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/How%20to%20write%20successful%20proposals.ppt “Writing a grant proposal”, by Malcolm Gordon, Ph.D., National Institute of Mental Health, 1999 www.charityadvantage.com/iaswr/images/grantproposals.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 PHS 398 Instructions

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.” PHS 398 Instructions

6. Don’t believe everything “The PHS estimates that it will take approximately 40 hours to complete this application for a regular research project grant.” PHS 398 Instructions

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 PHS 398 Instructions

8. a. Specific Aims (outline labeling is inconsistent) The framework for the entire proposal, including the research plan. PHS 398 Instructions

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 Hinda Zlotnik, Ph.D.

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. Hinda Zlotnik, Ph.D.

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. From Hinda Zlotnik, Ph.D.

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 PHS 398 Instructions

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. Adapted from the PHS 398 Instructions

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. V. Schoenbach

16. The Review Process - 2 Purchasing metaphor • Want to buy, have money to spend • Want to be an informed consumer • Don’t want to be duped • Want value for money V. Schoenbach

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

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 Malcolm Gordon, Ph.D.

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 PHS 398 Instructions

21. c. Preliminary Studies/Progress Report “Preliminary Studies. For new applications, use this section to provide an account of the principal investigator/program director’s 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] PHS 398 Instructions

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.” Malcolm Gordon, Ph.D.

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 2003;95(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. . . .” From Paul Godley, M.D., Ph.D.

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. Hinda Zlotnik, Ph.D.

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. Hinda Zlotnik, Ph.D.

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. Hinda Zlotnik, Ph.D.

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. Hinda Zlotnik, Ph.D.

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 PHS 398 Instructions

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 from PHS 398 instructions

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 from PHS 398 instructions

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 Hinda Zlotnik, Ph.D.

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 Hinda Zlotnik, Ph.D.

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. Hinda Zlotnik, Ph.D.

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 Hinda Zlotnik, Ph.D.

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. Hinda Zlotnik, Ph.D.

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. Hinda Zlotnik, Ph.D.

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.” From Paul Godley, M.D., Ph.D.

38. Research Design – Example (cont’d) “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.” From Paul Godley, M.D., Ph.D.

39. Research Design – Example (cont’d) “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.” From Paul Godley, M.D., Ph.D.

40. Research Design – Example (cont’d) “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).” From Paul Godley, M.D., Ph.D.

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 Malcolm Gordon, Ph.D.

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. Malcolm Gordon, Ph.D.

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. Hinda Zlotnik, Ph.D.

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. Hinda Zlotnik, Ph.D.

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, … V. Schoenbach

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 V. Schoenbach

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. • Don’t ramble--give sufficient background to make the significance of the proposed research very clear. • Frame questions in terms of testable hypotheses. Hinda Zlotnik, Ph.D.

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. • Don’t overinterpret or misinterpret data. Hinda Zlotnik, Ph.D.

50. The Research Plan: Summary of General Considerations - 3 • Don’t 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 don’t, and how this will affect the outcome. Hinda Zlotnik, Ph.D.