Writing Research Proposals

1. Writing Research Proposals Margarita Alegria, Professor Harvard Medical School, Cambridge Health Alliance Academy Health June 4, 2007

2. I. Overviews of research branches and support mechanism II. Formulations of research problem A. Good idea of research priorities of funding institute 1. Concepts paper, pre-proposal B. Get acquainted with literature review C. Contact with researchers in the area III. Thinking about theory/concept: development of a theoretical/conceptual framework and rationale for research proposal IV. Selecting critical issues A. Narrowing the topic B. Selecting the target population C. Aims and preliminary studies

3. Databases with NIH Information • CRISP (Computer retrieval of information on Scientific Projects) • Contains information on research projects and programs funded by DHHS including NIH, CDC, FDC, HRSA and AHRQ • Useful for identifying the appropriate institute to fund a grant, the best study section to review it, and the most appropriate funding mechanism. • NIH Guide for Grants and Contracts • contains weekly announcements detailing extramural funding programs and policies of the NIH and other public service entities.

4. According to studies, as many as 80% of all applications are misdirected or inappropriate. Become familiar with a source before applying. If a phone number or email address is provided, call and discuss whether your work matches their interests. The Foundation Center is a major publisher of non-federal funding opportunities and has current and historical information on every foundation in the U.S. Do Some Homework

5. Review Criteria • Scientific significance of idea • Originality/Innovation • Rigor of design and methodology • Data analysis strategy • Human subjects • Research environment • Investigative team • Budget

6. Review Criteria and rating of unsolicited research grant and other publications • Significance • Does this study address an important problem? • How will scientific knowledge be advanced and what effect will the study have on the concepts or methods that drive this field? More and more seen in applied terms • Approach: • Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to project aims? • Does the applicant acknowledge potential problem areas and consider alternative tactics? • Innovation: • Is the project original, employing novel concepts, approaches or methods? • Does the project challenge existing paradigms or develop new methodologies or technologies?

7. Developing the Research Question • Statement of the problem • What do you want to do? • What questions are you asking in the research? • What are your goals? • State your objectives clearly. Be specific and concrete (use measurable concepts). • State your objectives in declarative form. • List your objectives in order of priority or as building blocks and follow this order throughout proposal (i.e., use parallel structure).

8. Example of Specific Aims of R01 The central aims of NLAAS are: 1. To estimate the lifetime and 12-month prevalence of psychiatric disorders and the rates of mental health services use for Latino and Asian American populations, adjusting for age and gender effects using nationwide representative samples of Latinos and Asian Americans. • To estimate the relation of social position, environmental context, and psychosocial factors with the prevalence of psychiatric disorders and utilization rates of mental health services in nationwide representative samples of Latinos and Asian Americans.

9. Example of the Research Problem Project Objectives: We will compare the cost, sustainability and effectiveness of 3 innovative strategies to improve the treatment of depression in primary care. The three strategies are: 1) financial incentives for providers; 2) a program designed to help patients communicate more effectively with their physicians regarding their depression; 3) the use of volunteer aides who act as peer support counselors and advocates with the care team .

10. Significance of Research Problem • Why are your questions and answers important? • Theoretical significance: contribution to basic knowledge • Methodological significance: new methods will be developed or old methods adapted • Applied significance: solution of a specific real-world problem • Social significance: benefits to society at large

11. Example of Significance of Research Problem Considerable evidence exists in the clinical research literature supporting the view that Attention-Deficit /Hyperactivity Disorder (ADHD) is a disabling disorder that affects individuals across the lifespan (Barkley, 2003). However, it is not clear whether the correlates, comorbidity, and impairment of the disorder in probability treatment referral samples are similar to those identified in probability community samples. These variables have not been systematically compared in the two populations using the same methods. This comparison is important since findings from convenience or probability treatment samples can be consonant with clinician’s experience but biased and unrepresentative of the general population with the disorder. This discrepancy was coined by Cohen and Cohen (1984) as “the clinician’s illusion” i.e., the attribution of the characteristics of patients with a disorder identified through clinical experience (one could also add, through non probabilistic treatment samples) to the entire population with the disorder.

12. Review of Relevant Literature • How have these questions been answered before? [Have the questions been asked? Have related questions been asked (e.g., with different populations)? What answers have been obtained? • What are the limitations of past research? • How will you build on past strengths while overcoming limitations? Why is your research worthwhile and necessary?

13. Your review of previous research should be critical and evaluative synthesizing rather than comprehensive. Show that you know the past research so well that you can summarize its major themes, findings, strengths, and weaknesses. • Maintain parallel structure in this section. Discuss the literature relevant to your first aim/question (and hypothesis) first, then discuss the literature for your second aim/question, and so on.

14. Hypothesis • What answers are you proposing for the research question? • A hypothesis describes a relationship between two or more variables. • In your hypotheses, the variables must be identifiable conceptually and capable of empirical observation. • Similarly, the relationship among the variables (and changes in those relationships) must be identifiable conceptually and operationalizable. • Your hypotheses must be testable.

15. Order your hypotheses to correspond to your already-stated research questions. • Develop alternative hypotheses whenever possible. In predicting a particular relationship between variables (or explanation for a particular variable), consider alternative explanations and test for them in your research. Anticipate alternative explanations for your expected results and devise additional tests to falsify those competing hypotheses.

16. Conceptual Framework

17. Overall, low socioeconomic status, comorbid psychiatric conditions, and lack of family and social supports are consistent markers of non-compliance with treatment, and relapse following treatment completion (Daley & Marlatt 1992). For women in particular, symptoms of depression are believed to play an important role in persistence of substance abuse (Galaif, Nyamathi, & Stein, 1999; Wang, Collins, DiClemente, Wingood, & Kohler, 1997; Zuckerman, Amaro, Bauchner, & Cabral, 1989). Relationships with drug using partners are strongly associated with relapse of drug use (Tuten & Jones 2003) and post-treatment drug use continuation (Amaro & Hardy-Fanta 1995; Grella, Scott, Foss, Joshi, & Hser, 2003). Moreover, childhood experience of sexual abuse is a significant predictor of drug use disorder, as well as a risk factor for unsuccessful treatment and eventual relapse (Snow & Anderson 2000). Hypotheses of Remission From Drug Dependence Symptoms and Drug Use Cessation

18. Study Design • Are the design and measurement strategies the best ones for testing the hypotheses in terms of sensitivity to processes under study, experimental control, and statistical power? Are independent and depend variables and covariates clearly specified? • Has any preliminary (pilot) work been carried out to help document feasibility of recruitment and methods, and the validity of the measures? • Is sample adequately described? Is sample representative of population or subpopulations of interest? Has subject attrition been considered? Are criteria for inclusion/exclusion clear and complete?

19. Are the manipulations of independent variables potent enough to result in changes in outcome (dependent) variables? 5. If some of measures are based on self-report, are there other measures that would help to establish their external validity? 6. Have all possible confounds been considered, such that the results will test the effects of the manipulation or process of interest? 7. Is the study replicable in terms of sampling strategies and measurement methods? 8. Are results likely to be generalizable, and what conclusions will be drawn?

20. 9. Have the investigators considered limitations and potential problems, and do they indicate how they will deal with these problems? Have sources of bias been considered (testers blind to group placement, recall response bias)? If testing is repeated, are measures susceptible to practice effects or reactivity? 10. Does the proposal reflect a process of “thinking through” the issues under investigation from the available research literature to the testable hypotheses, operational measurement, expected results, and interpretation of alternative findings?

21. Study Design of Inner City Latina Drug Use Study (ICLDUS) Three-wave longitudinal research project to study drug use patterns and correlates among low-income inner city Latina women, ages 18 to 35. Women were interviewed at baseline (Wave I) and at two follow-ups (Wave II and III) with an average of fourteen months between data collection periods. Two groups of women were studied: a sample of 275 crack/cocaine or heroin drug-using women and a sample of 443 community women living in the same neighborhoods, extended metro San Juan area. Two groups of women were recruited for the study: cocaine/crack and injecting drug users from drug copping areas (e.g., crack houses or shooting galleries where drugs are sold), and non-drug users who lived within a one-mile radius of the copping areas.

22. Study Design-Continuation • ICLDUS survey instrument was administered in 1996-1997 to a sample of 718 women, for a response rate of 81.4%. The first follow up was conducted with a total of 696 women between July 1998 and June of 1999. A total of 681 women were re-interviewed for the second follow up during July of 1999 through November of 2000. • Respondents who remained in the study for the three waves as compared to those who dropped out from Wave I to Wave II (n=54) or from Wave II to Wave III (n=29) were more likely to be from the copping sample, older (30-38 years of age), returned migrants to the island, self-reported drug users, HIV positive, and women practicing sex work.

23. Outcome Measures Last year arrest -established by asking respondent if they had been arrested (yes=1) within last 12 months. Practicing sex workby query asking if respondent had engage in any sexual practices in last 12 months in exchange for money, drugs or other personal favors; (1) if yes, 0 if otherwise. An item asked if they had committed any suicide attempt in the last year, which was coded 1 for those who said yes, 0 if otherwise. Intimate partner violence- recount of times, during the last 12 months, their partner/spouse responded to domestic conflict through inflicting physical of psychological harm using the Conflict Tactic Scale (Straus 1990a; Straus 1990b). Deathwas assessed by reports of death of the respondent and later confirmed with death certificate or by testimony of family and friends.

24. Study Design of System Cost Effectiveness and Managed Care The objective of study is to evaluate the cost effectiveness of managed care as compared to public health system care on the treatment of depression. Tracking depression Tx allows us to assess system effects in the distribution of resources to untreated, ineffectively treated and effectively treated cases proportional to costs. Is managed care able to provide more effective depression Tx for the same costs as the public health system?

25. Definition of Appropriate Treatment • No Treatment: • Persons who did not receive any formal mental health • treatment (no visits w/in a 12 month period to mental • or general health provider to discuss mh problem). • Not Effective Treatment: • Persons who received minimal counseling (less than 4 • visits) or those without antidepressant medication, or • those that report no visits but do report receiving • antidepressants under no medical supervision. • • Effective Treatment: • Persons who received effective counseling (4+) with • no effective medication or received minimal or • effective counseling (1-3 visits) and antidepressants.

26. V. Ten (10) hints A. Read instructions B. Follow page limitations – make use of appendices C. Use as an example another successful proposal in the area of interest D. Develop a team – if you do not have experts, get consultants E. Don’t assume reviewers will know – be very specific (if no pilot data, you are in trouble) F. Clear concise writing style a. Keep together related ideas b. Shorten long sentences c. Eliminate redundant ideas G. Allow time for thorough editing – send your proposal to experts (try to get critical input upfront rather than back end)-Do not submit a proposal for consultation

27. H. Include potential pitfalls and limitations I. Contact member of program review for advice J. The situation for new applicants is difficult, but not impossible VI. Fatal mistakes in grant writing A. Let’s get a grant to pay for treatment or services B. Signing up for the wrong race (do what you do best) C. Trust me - I’m an expert (skipping the details or concrete information) D. Ignoring the pink sheet E. I’m going to develop …. F. Excuses – explaining why the study can’t be done the right way G. Not re-submitting H. Being out of sync w the field-only found through networking (eg. one more study in depression in primary care)