1. Proposal Writing Muhammad Tahir Public Health Epidemiologist Acknowledgements: Dr. Naveed Zafar Janjua

2. Course overview During the course duration students will practice writing a grant proposal on the research question of their interest Students will submit sections of their proposal at each deadline which will be reviewed and graded At the end of course students will submit a 15 page proposal

3. Course objectives To learn skills in organizing and writing a research proposal To learn elements and requirement of grant proposal submitted to PMRC or any other funding agency for grant Understand the principles of power analysis and sample size calculations for research studies Understand the principles that guide the protection of human subjects and ethical issues in research as documented in research proposal Prepare a grant proposal ready for submission to an funding agency

4. Purpose of the course This course is designed to help students develop the critical thinking and writing skills relevant to the preparation of a grant application The class will be interactive and students will learn by practicing writing of each element of the proposal and come prepare in class to discuss in front of whole class. The faculty and peer will give feedback for improvement It is mandatory for each student to submit section of their proposal at each deadline. At the end of this course, each student will submit a final proposal including all sections.

5. Course pre-requisite This course is not intended to teach methods though there will be some discussion to refresh concepts and issues. Therefore, students are expected to have taken and passed the fundamentals of biostatistics and basic epidemiology courses.

6. Course enrollment requirements Selection of supervisor Identification of an idea/topic leading to research question Preparation of one page about planned research, bring with you on first day of class

7. Class attendance/Evaluation As per institute and University policy

8. Milestones/Deadlines Specific aims/objectives…….. Literature search/Critique….. Intro/Background……………. Methods……………………… Questionnaire & tools………. Human subject consideration…. Operational plan……………….. Draft submission…………………

9. Plagiarism The plagiarism is defined as the misappropriation of the work of others as one’s own, whether found in print or electronic media. Any paper submitted by a student for formal assessment during the course, must be written by the student in his/her own words, except for quotations from published and published sources, which shall be clearly indicated and acknowledged. The plagiarism may be in the following forms: The verabatim copying of another person’s work without acknowledgement Paraphrasing of another person’s work by simply changing a few words or altering the order of presentation, without acknowledgement Quotation of phrases from another person’s work without due acknowledgent

10. Research & Elements of proposal

11. Research A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge (DHHS US) A structured activity which is intended to provide new knowledge which is generalizable (i.e. of value to others in a similar situation) and intended for wider dissemination (UK Department of heatlh, 2002)

12. What is a proposal/Protocol It is the formal design or plan of an experiment or research activity A document detailing research plan The protocol includes a description of the research design or methodology to be employed, the eligibility requirements for prospective subjects and controls, the treatment regimens, and the proposed methods of analysis that will be performed on collected data. It is the plan submitted to the grant agency for research support

13. Why a proposal needed The proposal act as a manual for members of the research team to ensure they adhere to the methods outlined As your research ideas develop into a workable study a written protocol will help to formalize your ideas and gain feedback from others through peer review A well written protocol is also necessary for your application of: Funding agencies Ethics commitees Research governance commitees As your study gets underway, the proposal can then be used to monitor the study’s progress and evaluate its outcomes The protocol encourages the reader to think about the study rigorously and provides communication between all of the people involved

14. Elements of proposal Summary Background & significance Aims and objectvies Research methods Setting Study design Study population Sampling and recruitment Exposure assessment Outcome assessment

15. Elements of proposal cont.. Intervention Randomization Data collection Quality assurance and quality control Sample size and power Data management Plan of analysis Expected benefits/expected impact Human subjects consideration Time line Budget Plan of dissemination Operation planning/manual of operations etc

16. Abstract/Summary Summarize the aims or objectives of the study and give a brief outline of the design and methods Last thing to write before proposal submission

17. Background/Introduction The introduction should outline the background to the research, including a critical review of the current knowledge or literature, including published and unpublished work in the area Any gaps in the evidence should be identified as should the potential value of furthering knowledge in this field, such as theoretical or clinical applications of the study outcomes. If applicable, the research hypothesis should also be included in this section, with an explanation of the reasons for undertaking the work.

18. Aims and objectives Outline concise and precise objectives that should follow on from the hypothesis

19. Methods Study design: what study design is most appropriate to answer your particular research question Setting: where will the research take place? Your study may take place in a number of different sites, or you may be visiting patients in their homes Subjects/Patients: Define who will be study population. What is rationale and why they were chosen Inclusion and exclusion criteria In long term studies and trials more details criteria of completed enrollment etc

20. Methods cont.. Randomization methods: some research stratified, randomized control studies, require a random allocation of patients to the different experimental groups or interventions. You will need to explain the randomization methods you will use. Methods of assessment or measurement: what data will be collected and why. What instruments will you use and are they the most appropriate? If you are using any equipment, it should be clearly described. Outcome measures/Objectives: the measurement outcomes used to support or reject the hypothesis can be stated and separated into primary and secondary outcomes. E.g. primary outcomes or endpoints are most important to your hypothesis, there may be only 1 or 2. secondary outcomes may provide support to the hypothesis, but without primary outcomes they could not confirm the hypothesis.

21. Intervention (if applicable): not all studies will involve any intervention, but where ever it is applicable, its description should be given. If you are giving a treatment or investigation, the dose, timing, method of administration, should be detailed. All necessary safeguards and potential risks should be made clear, including the methods by which intervention will be monitored. Methods cont..

22. Data collection, management & analysis: Explain how the data will be collected and managed. Who will have access to it. The methods of the data analysis should be specified and may include following points: Method of data entry Plan of analysis, including assumptions of analysis Data analysis package Presentation of demographic and outcome data summaries Planned presentation of the data i.e. graphs, tables, and figures Methods cont..

23. Do a literature search Make a clinical obseration ProblemImplement new ideas Refine the observation into research qestion Built a research team Meet with area specialists Apply for grant funding Satisfy requirements Move your protocol into action Collect data Analyze data Communicate results

24. Research Question Identification of problem or question to solve Start general to narrow down Why a good research question? Drives researcher by providing focus Guide towards design What is the good research question?

25. FINER-O Feasible Interesting Novel Ethical Relevant Operationalized (Hyully & Cummings, 1988) Research Question

26. Feasible: Adequate number of subjects Adequate technical expertise Affordable time and money Manageable in scope Interesting: To the investigators, peers, funding agency and journals Research Question

27. Novel: New information, confirms or refutes previous findings Application of findings in one population to others Improved measurement techniques for exposure disease relationships Ethical: Study should not be pose unacceptable physical risks or invasion of privacy Research Question

28. Relevant: To scientific knowledge To clinial and health policy To future research directions Research Question

29. Reaching at a research question Observation and clinical experience: Irritation about a particular thing in your practice Interest into problem Do literature search What has already been investigated Identify data gaps

30. Research question Locate relevant literature Access your local library MESH terms Search databases and search widely Utilize web based resources Other sources of information: Confrence proceedings Colleagues Product information

31. Review literature: Global review for a broad understanding of the area Defined review for depth of understanding Critically review the literature Access both qualitative and quantitative studies Identify what is known about your question Now, identify the gaps which then leads you to refining your research question Research question

32. Examples What is a relationship between health and perinatal outcomes? Is it appropriate?? Critique??

33. Problems in above question? Vague Broad Not operationalized population

34. Does women aged 20-45 living in karachi who have Hb <11g/dl more likely to give birth to low birth weight (<2500g) babies? Is it appropriate?? Critique??

35. Questions vs objectives Statement of question vs. statement of action Objective stem from question Start with “to” To estimate proportion of health care workers who received sharp injureis during past 6 months at general practitioners clinics in Swabi, NWFP

36. Objectives Always backed up by the specific explicit hypothesis Should include Exposure Outcome Confounder if any specific Population Time bound