1. Planning and Organising a Research Study
Anna Miller, MBChB, MPH
Senior Technical Advisor
EGPAF Global Technical Policy Unit
Operations Research Training
Kampala, Uganda
5 November 2009

2. Learning Objectives
Gain a comprehensive understanding of how to plan and organise a study from the literature review stage until utilisation of findings

3. Session overview Group activity and feedback / discussion
Slide presentation
Country experience-sharing and Question & Answer

4. Group Exercise!
Each group receives a set of cards with all key elements of planning and implementing a research study on them. They must organise them according to how they think they are put together over time. Cards will be stuck onto flip-chart paper. Each group will then present their picture to the others and talk about why things have been arranged in this way.

5. Life! Experience! Problems!
Question
Literature review
Identify
research
team
Situational
Analysis
Design Study (incl exit strategy)
Write protocol and budget
Sourcing of potential donors
Planning
phase
IRB submission
Submission for funding
Establish research team
Decide on authorship
Define roles & responsibilities
TIME
Design tools, train team
Links to stakeholders
Implement-
ation phase
Implement intervention
Data collection
Data quality
systems
Conduct evaluation
Data analysis
Follow
Through
phase
Close out study
Write Up Findings
Disseminate Findings

6. Communication Ethical Considerations
Life! Experience! Problems!
Ethical
Considerations
Situational
Analysis
Literature review
Identify
research
team
Question
Design Study
Write protocol and budget
Sourcing of potential donors
Planning
phase
IRB submission
Submission for funding
Establish research team
Decide on authorship
Define roles & responsibilities
Links to stakeholders
Implement-
ation phase
Implement intervention
Data collection
Data quality
systems
Conduct evaluation
Data analysis
Close out study
Follow
Through
phase
Write Up Findings
Disseminate Findings

7. Timeframe
Timeframe from question to dissemination of results varies according to size of study
10-12 years for a big new study
Much shorter with selected Operations Research (already have much experience and data to draw from)
2 months pilot
2 year writing papers / proposals
6 months from funding to field (recruitment of community interviewers etc)
Another 3 months to start of data collection
Shapes of timeframe – see paper and make slides

8. The Seven “P”s Prior Planning and Preparation Prevents a Pretty Poor
Performance

9. Question & Study Design
Need to have a good question with the correct methods to answer that question
Wrong question + wrong methods = can’t answer question = unethical and waste of resources
Involve statistician early and make sure study will sufficiently powered to attribute any changes to the intervention that was implemented
Identify your research team early - experts who know about the specific methods and/or issue being investigated

10. Literature Review What is a literature review?
Why (and when) are they necessary?
How do I conduct a literature review?

11. What is a literature review?
A systematic critical review and appraisal of what has been published on a topic by researchers and other experts
Not simply a descriptive account of what has been published
Usually part of a larger piece of work, such as a research paper
Can also be done on its own (e.g. annotated bibliography)

12. Qualities of a good literature review
Organized around and directly related to the research question that you are addressing
Synthesizes results into a summary of what is and what is not known
Provides the reader with information on the existing knowledge about a topic, and the strengths and weaknesses of that knowledge
Identifies questions for future research

13. When should I do one? When writing proposals
When writing research articles
Can you think of any other times when a literature review could be helpful?

14. Why should I do one?
To identify gaps in current knowledge/practice that merit further investigation (to justify your research)
To demonstrate that your research will fill a gap and contribute to the field
To provide a theoretical/methodological basis for your research
To provide context for your research
To show your audience that you’ve “done your homework”
Ask participants: “Why should you do a lit review?”
(Then click to display answers)

15. How to: Conducting literature reviews
What to include
Peer-reviewed publications
Grey literature
Where to search
PubMed (and other databases, e.g. PsycInfo)
Google Scholar
Organization / gov’t websites, etc.
EGPAF journal access through GW Library
Remember to look in the EGPAF Publication Database (on the intranet) before you request an article… it might already be there!

16. PubMed Managed by the U.S. National Institutes of Health (NIH)
PubMed is an online database of freely accessible biomedical journal citations and abstracts
Managed by the U.S. National Institutes of Health (NIH)
Includes MEDLINE
PubMed “Quick Start” help guide:
PubMed tutorials:
PubMed search:

17. To do a basic PubMed search by subject:
1. Identify the key concepts for your search.
For example, if your main question is “What is the risk of HIV transmission through breastfeeding?” you could enter the terms HIV and breastfeeding in the search box.
2. Enter the terms in the search box. You do not need to use words like “and” or “the.”
3. Click Search.

18. You can limit your search in a few ways…
Let’s say you only want articles about HIV and breastfeeding where Cathy Wilfert is one of the authors.
You would enter HIV and breastfeeding in the search box, and enter Wilfert C in the author field.
Then click Search.
You can also also limit by journal, publication date, etc.

19. More on search limits…
PubMed contains free citations and abstracts, but some articles are also “open access.” This means you can access the full text of the article for free.
To search only for articles with free full text, enter your search terms, then select the “Links to free full text” box.
Then click Search.

20. Click here
When we search for HIV and breastfeeding articles where Cathy Wilfert is one of the authors, these are the results.
Let’s say we want article 2. Click on the title of the article.

21. Link to free full text This article has a link to free full text.
For articles that do not have free full text available, you can request the article through our partnership with GW’s med school library.
Instructions for requesting articles through GW library are in your workshop materials.

22. Google Scholar
Google Scholar allows you to easily search for citations, abstracts, and articles across many disciplines at once
Searches documents from peer-reviewed publications, academic publishers, professional societies, books, etc.
Articles are ranked by weighing the full text of the article, the author, the publication where the article appears, and how often the article is cited in other literature
Google Scholar help:
Google Scholar search:
If you have internet access, try doing a search!

23. 1 4 2 3 You can see the most recent
papers by clicking on “Recent articles” 1 4 2 3
Title of the article: This links to the abstract, or full text if available for free.
Cited by: Tells you who has cited this paper.
Related articles: Searches for similar articles.
Web search: Searches the web (via Google) for mentions of this article.
As with PubMed results, if free full text is not available online, you can request it through our GW library partnership.

24. Writing a Lit Review: Sections of a literature review
Introduction
Broad overview of your topic
Brief explanation of how you organized the literature review (see next slide)
Body
Discussion and critical evaluation of the literature
Conclusion and recommendations
What has the literature taught us?
What are the major gaps and why are they important?
This section then leads into your research…

25. Ways to organize your review
“Pro & con”: works that support your position and those that do not
May also consider including works that present an entirely different position
By methodology: Randomized controlled trials, observational studies, etc.
Others: chronological, thematic, trends…
These are just 2 examples of how to organize a lit review. Participants may have other suggestions.

26. Things to consider when reviewing articles
What is the author’s main argument? Is it clearly defined?
Has the author evaluated the literature on the topic?
Quality and appropriateness of the study design
How was the data collected and analyzed?
Were the study components appropriate for the problem?
What are the strengths and limitations of the study?
Are the author’s conclusions valid?
How do the findings contribute to the field?
How does the article and its findings relate to your work specifically?
You may not need to address all of these questions, it will depend on your topic and what type of article/document you are reviewing.

27. Exit Strategy For Study
Prepare exit strategy at the beginning
This is especially important with communities receiving interventions
They need to know from the start what they can expect, for how long, and what will happen afterwards.
This exit strategy should be integrated into consent, community communications, IEC materials etc
It should also include plans for dissemination of results to participating communities

28. Establish research team
Establishing team and setting up systems for management of team (may be combined functions in one or two people depending on size and budget for study. But same principles apply and systems / responsibilities needed for all of these):
Finance
Administration including procurement
Logistics
Implementation of intervention
Evaluation (should be different from those doing implementation as hard to be objective about the work you’ve done)

29. Protocol And Budget Need to be written together (as for programming)
Protocol requires lead person be identified to do the writing
Need to identify funder and use their guidance / formats for protocol and budget
Follow submission guidelines for funding and submit by due date!
Submit to Institutional Review Board around same time – does not have to be funded before beginning IRB processes (right?!)
Factor in sufficient time for regulatory processes – always take longer than you think

30. Issues For Budget…
Produce a time-bound chart of all activities by monthly or quarterly basis. Cost each activity
Often divided into in and out of country costs (international collaborations)
Budget lines may include:
Supplies and equipment
Office
Research (intervention, data management and analysis)
Administration
Salaries
Consultants
Communication with community advisory boards
Regulatory fees
Participant reimbursement as per national standards (e.g. 150R per visit in SA; 3-5USd per visit in Zim)

31. Establish Research Team
Identify person in charge!
Document specific roles and responsibilities of individuals and institutions involved
Agree any ongoing involvement if current employment arrangements change
Involve statistician / data analyst at design stage; don’t wait until the end
Outline your data analysis plan at the time of funding and certainly before data collection starts

32. Authorship Definition of an Author
Substantial contributions to conception and design, acquisition of data, or analysis and interpretation of data;
drafting the article or revising it critically for important intellectual content; and
final approval of the version to be published.
Authors should meet conditions 1, 2, and 3.
Adapted from: International Committee of Medical Journal Editors

33. Contributorship Examples of Contributors
Person who provided purely technical help and/or writing assistance
Department chair or supervisor who provided only general support
All contributors who do not meet the criteria for authorship should be listed in an acknowledgments section
If such assistance was available, the authors should disclose the identity of the individuals who provided assistance with study design, data collection, data analysis, or manuscript preparation and the entity that supported it in the published article. Financial and material support should also be acknowledged.
Adapted from: International Committee of Medical Journal Editors

34. Design Tools & Train Team
Develop appropriate research tools to fit the methods and answer the question
Develop written protocols for all aspects of research, data collection and quality assurance of data
Involve statistician at design stage of tools
Develop locally appropriate IEC materials and informed consent forms
Train everyone involved in research team in specific protocols and tools

35. Linkages to others including policy makers and communities
Programmes made stronger by evidence and research made stronger by understanding programme needs and realities
Stakeholders can also give valuable input to improve the research approach
Make early linkages with policy makers and key stakeholders who will take the findings of the study forwards into action
They will be more likely to do this if they are aware and invested from the beginning
Community advisory boards

36. Implement intervention and conduct evaluation as per protocol …

37. Data Collection & Quality
Serious offence to fabricate data
Get people invested in good data quality from the outset
Early involvement of statistician and data analysis plan
Written protocol for data collection, quality assurance and analysis
Collect data meticulously
Make sure:
Good quality questions
Interviewers appropriately trained
Right conditions for delivery of questions (e.g. being overheard asking confidential questions)
Additional quality control including blind retesting of samples

38. Data Analysis
Have written data analysis plan matching variables with questions being asked
Develop this with statistician right at the beginning
Refine it as needed during implementation and data collection phase
Data analysis is an iterative process between all investigators (including statistician) – not a “one stop shop”
See example data analysis plan

39. Writing Up Findings
Prioritise writing up informally to share with community participants and local stakeholders as early as possible
Often forgotten
Can offer helpful interpretations and discussion
Plan all publications, their authors and timeframe for completion, submission
Generally use IMRAD Format – see writing workshop and other resources
Follow guidelines for authorship
Select target journal and use their guidelines for submission

40. Overlapping Publications
Duplicate submission: most journals do not accept manuscripts being considered simultaneously by other journals
Redundant publication: publication of a paper that overlaps substantially with one already published in print or electronic media
Duplicate Submission
Among the principal considerations that have led to this policy are: 1) the potential for disagreement when two (or more) journals claim the right to publish a manuscript that has been submitted simultaneously to more than one; and 2) the possibility that two or more journals will unknowingly and unnecessarily undertake the work of peer review, edit the same manuscript, and publish the same article.
Redundant Publication
Readers of primary source periodicals, whether print or electronic, deserve to be able to trust that what they are reading is original unless there is a clear statement that the author and editor are intentionally republishing an article.
This policy does not preclude the journal considering a paper that has been rejected by another journal, or a complete report that follows publication of a preliminary report, such as an abstract or poster displayed at a professional meeting.
It also does not prevent journals from considering a paper that has been presented at a scientific meeting but was not published in full or that is being considered for publication in a proceedings or similar format.
See ICMJE guidelines for acceptable forms of overlapping publications
Adapted from: International Committee of Medical Journal Editors

41. Potential Conflicts of Interest: Project Support
The conditions of project funding have the potential to bias and otherwise discredit the research.
Authors should describe the role of the study sponsor, if any, in:
study design;
collection, analysis, and interpretation of data;
writing the report; and
the decision to submit the report for publication.
If the supporting source had no such involvement, the authors should so state.
Adapted from: International Committee of Medical Journal Editors

42. Privacy and Confidentiality: Patients and Study Participants
Identifying information should not be published unless it is essential for scientific purposes
In these cases, the patient (or parent/guardian) must give written informed consent for publication
Informed consent should be obtained if there is any doubt that anonymity can be maintained.
For example, masking the eye region in photographs of patients is inadequate protection of anonymity.
Informed consent for this purpose requires that an identifiable patient be shown the manuscript to be published.
Authors should disclose to these patients whether any potential identifiable material might be available via the Internet as well as in print after publication.
Patient consent should be written and archived either with the journal, the authors, or both, as dictated by local regulations or laws.
Adapted from: International Committee of Medical Journal Editors

43. Think You’re Finished? Think Again!
Most documents will have to go through some or all of the following processes before they are ready to be distributed to the public:
Author and co-author approval
Partner/donor approval
Permissions for data use and/or borrowed material
Copyediting and Proofreading
Design and Typesetting
Printing
Dissemination
For peer-reviewed articles, publisher will handle these steps

44. Share country experiences Q&A

45. Questions For Discussion (if needed)
What are your own experiences in beginning a piece of research and taking it to its conclusion?
How did the sequence of events unfold and what did you learn from this?
If you were starting to answer a new operations research question yourself tomorrow, what would you differently?
Have you experienced any challenges regarding authorship or conflict of interest? If so, how were these resolved?
Adapted from: International Committee of Medical Journal Editors

46. Acknowledgments
Frances Cowan
Jo Keatinge
Cori Mazzeo
Sara Teitelman