The Anatomy of Research

1. The Anatomy of Research Presented by: Shahrzad Bazargan-Hejazi, PhD September 2013

2. Objectives: • Outline tangible element of a research question • Identify decisions to be made for selection of research design • Describe the purpose of literature review • Identify decisions to be made in choosing the study subjects • Identify decisions to be made in choosing study variables

3. The Research Process The steps of any population health research project are:

4. Identifying a study topic is often the most challenging part of a research project.Each of the possible study topics has its own set of virtues and shortcomings. What Is Research made of Study Question! ?

5. Brainstorming • Review of previous scholarly work • Meeting experts • Attending conferences • Participating in meetings • Building relationship with an expert/mentor

6. Brainstorming Questions

7. Key Words: Example Initial brainstorming about aging Osteoporosis Falls Bedsores Physical therapy Calcium Rehabilitation Prevention Home safety Bone density

8. Topic Mapping Begin by creating a long list of possible study topics: Jot down areas of personal interest Ask friends / colleagues for ideas Skim abstracts, journals, and books for inspiration What topics emerge as a repeating theme? What might be enjoyable to explore?

9. MeSH (Medical Subject Headings)

10. Exposure, Disease, Population Most topics in population health research can be expressed in terms of: [exposure] and [disease/outcome] in [population]

11. Examples of Types of Exposures

12. Examples of Types of Diseases

13. Examples of Types of Populations

14. “EDP” Study Questions Are exercise habits [exposure] related to the risk of bone fractures [disease] in adults with diabetes [population]? Is reproductive history [exposure] related to the risk of stroke [disease] among women living in rural Ontario [population]? Is household wealth [exposure] related to the risk of hospitalization for asthma [disease] in Australian children younger than 5 years old [population]?

15. FINER Criteria for a Research Question • F = Feasible • Adequate # of subjects, • Adequate technical expertise, • Affordable in time, money, • Manageable in scope. • It helps to know your limits early on to avoid wasting time and effort over something that is not going to work.

16. FINER Criteria for a Research Question (cont.) • I = Interesting • Answering the question is interesting, not because, you have to do it. • Confirm the interest of the question with your mentor before investing energy and time in development of research protocol

17. FINER Criteria for a Research Question (cont.) • N = Novel • It contributes to new information by: • confirming or refuting previous findings, • extends previous findings, • provides new findings • you should be able to answer the “so what” question

18. FINER Criteria for a Research Question (cont.) • E = Ethical • A good research question should be ethical • It should not posses unacceptable physical risk to the subjects or invasion of their privacy • If so you need to find some other ways to answer your research question

19. FINER Criteria for a Research Question (cont.) • R = Relevant Is the outcome of the study: • relevant to scientific knowledge, • clinical management, • health policy, and/or • guides future research direction

20. Problems & Solutions The RQ is not FINER 1. Not feasible (too broad) • Not enough subject available • Method beyond your skills • Too expensive 2. Not interesting, novel, or relevant • Consult with your mentor • Modify RQ

21. Problems & Solutions 3. • Uncertain ethical suitability • Consult with IRB • Modify RP 4. The study plan is vague • Write the outline of the RP as soon as you can

22. Exercise • What is the relationship between depression and health? • Write in a single sentence a predictor, outcome, and population. • Discuss whether it meets the FINER criteria • Rewrite the sentence in a form that overcomes any problems in meeting criteria.

23. Points to Consider • Is the question important and relevant? • Can the question be answered the way it is written? • To answer the question what needs to be defined? • Is the answer to the question population sensitive?

24. Possible Answer • Among college freshmen, does depression assessed by the CES-D predict health status measured by the Rand General Health Questionnaire four years later?

25. Study Goals & Specific Objectives The literature review and consideration of a study approach should lead to the selection of one very specific study topic that can be stated in terms of a single overarching study goal or study question. A study goal often includes the specific exposure, disease, and population that will be the focus of the study

26. Examples of Study Goals

27. Study Goals & Specific Objectives After finalizing the overarching study goal, the researcher should identify three or more specific objectives (also called specific aims or specific hypotheses) that stem from the main study goal. Each of these specific objectives should take the form of a measurable question or a “to” statement. Each should represent a logical step toward answering the main study question.

28. Example Study goal: “to assess the impact of lead poisoning on school performance in kindergarten students in southeast Michigan.” Specific objective #1: To measure the prevalence of high blood lead levels in a random sample of kindergarten students in southeast Michigan.

29. Example Study goal: “to assess the impact of lead poisoning on school performance in kindergarten students in southeast Michigan.” Specific objective #2: To determine whether children in that sample with high blood lead levels have lower scores on academic tests than children with lower blood lead levels.

30. Example Study goal: “to assess the impact of lead poisoning on school performance in kindergarten students in southeast Michigan.” Specific objective #3: To estimate the total impact of high blood lead levels on kindergarten performance in southeast Michigan by applying the rates in the sample population to the total population of the region.

31. Example Study goal: “to assess the impact of lead poisoning on school performance in kindergarten students in southeast Michigan.” Note that all three of these specific objectives relate to the overall study goal and provide a clear pathway for achieving the main goal.

32. ICMJE ICMJE = International Committee of Medical Journal Editors Most journals in the population health sciences require manuscripts to conform to ICMJE’s Uniform Requirements for Manuscripts Submitted to Biomedical Journals

33. ICMJE Authorship Criteria Each coauthor must have met all three of the following conditions: • Substantial contributions to conception and design and/or acquisition of data and/or analysis and interpretation of data • Drafting the article and/or revising it critically for important intellectual content • Final approval of the version to be published

34. ICMJE Authorship Criteria • “Acquisition of funding, collection of data, or general supervision of the research group alone does not constitute authorship.”

35. Authorship Example #1 • A person who conducts interviews for the project but does not contribute further would not be eligible for authorship. • An interviewer who also writes a paragraph for the discussion section would meet authorship criteria.

36. Authorship Example #2 • A hospital laboratory technician who analyzes blood samples of patients included in a clinical study but makes no further contributions would not be eligible for authorship. • A lab tech who analyzes the samples and writes part of the methods section describing laboratory techniques would be a coauthor.

37. Authorship Example #3 • A data entry assistant who makes no additional contributions to the project would not be considered an author. • A data manager who runs statistical tests and creates a table for the manuscript would meet authorship criteria.

38. Authorship Example #4 • A technical editor who cleans up the grammar and spelling in a manuscript does not earn authorship. • An editor who raises important questions about the interpretation of the results and the meaning of the work may be eligible for authorship.

39. Authorship Criteria • “All persons designated as authors should qualify for authorship, and all those who qualify should be listed.” • No gift authorships • No ghost authorships

40. Authorship Order A typical justification for authorship order: • The first author is the person who was the most involved in writing the manuscript. • The remaining authors are listed in order of contribution, defined in terms of time dedicated to the project as well as intellectual contribution. • List authors with equal contributions in alphabetical order • The senior (supervising) author is listed last, unless s/he prefers to be listed in order of contribution.

41. Decisions about Authorship • Publications are an important metric of success in the sciences and academia, and authorship is often the only reward for the time put into a project. As a result, authorship decisions can be very stressful. • It is helpful to decide before a contributor does any work on the project whether that person will be a coauthor and what role s/he will play. • At the end of the project, there should be no surprises about who is being included or excluded as an author.

42. Decisions about Authorship • If someone making a minor contribution will not be a coauthor, make sure that s/he is not asked to write any part of the paper or to provide critical feedback. • If someone will be a coauthor, make sure that s/he has the opportunity to make an important intellectual contribution to the writing of the paper. • Any disputes over authorship criteria or the order of authors are usually best referred to the senior author on the paper.