How to develop a Research Protocol ?

1. How to develop a Research Protocol ? Dr.Shaik Shaffi Ahamed Ph.D., Assistant Professor Department of Family & Community Medicine College of Medicine King Saud University

2. This session --------- By the end of this session, you will be able to: Understand what is Research ? Identify the components of a research protocol Explain the role of each part within the overall process of protocol development Understand the importance of research protocol Able to write a research protocol

3. What is Research? A systematic investigation, involving thecollection of information (data), to solve aproblem or contribute to knowledge about a theory or practice.Research is critical in medicine because itleads to new discoveries and can changepeoples’ lives by improving health and well being. Research helps to provide scientificunderstanding and solves practical problems.

4. Research (cont.) Relies on methods and principles that willproduce credible and verifiable results. All research starts with an idea or questionbased on personal experiences.

5. Scientific Approach The most sophisticated method of acquiringknowledge is by scientific approach.Combines important features of inductionand deduction together with other methodsto create a system of acquiring knowledge.Generally more reliable than other methods.Approach used most often to performmedical research.

6. Scientific research is an integrated approach of deduction and induction Deduction Hypothesis generation known truths In sample population Universe Testing the hypothesis Induction (Inference on hypothesis) generalization of the results

7. MODEL OF THE RELATIONSHIP BETWEEN DIFFERENT TYPES OF RESEARCH Epidemiological Biomedical Policy making, planning, Management evaluation Health systems research Statistical Behavioral Social & economic

8. Causal model of risk factors for CVD Morbidity and Mortality (Stroke, MI) Biological Risk Factors (Hypertension, Blood Lipids, Homocysteine) Genetic Risk Factors (Family History) Behavioral Risk Factors (Cigarette, Diet, Exercise) Environmental Factors (Socioeconomic Status, Work Environment)

9. Preventable Causes of Disease BEINGS Biological factors and Behavioral Factors Environmental factors Immunologic factors Nutritional factors Genetic factors Services, Social factors, and Spiritual factors [JF Jekel, Epidemiology, Biostatistics, and Preventive Medicine, 1996]

10. Clinical issues and questions in the practice of medicine IssueQuestion Normality/abnormality Is a person sick or well? What abnormalities are associated with having a disease ? Diagnosis How accurate are diagnostic tests or strategies used to find a disease ? FrequencyHow often does a disease occur ? Risk What factors are associated with an increased likelihood of disease ? PrognosisWhat are the consequences of having a disease ?

11. Treatment How does treatment change the future course of a disease ? PreventionDoes intervention on people without disease keep disease from arising? Does early detection and treatment improve the course of disease ? Cause What conditions result in disease ? What are the pathogen tic mechanisms of disease ?

12. Protocol writing

13. Key Points of Your Proposal Whatis your question ? Why is your study important ? How are you going to do it ?

14. Choosing a topic Should beinteresting– to investigator, funding agency, journal editors, consumers (colleagues, public, medical community), etc. Relevance- add new information to the scientific world Simple and manageable in scope (feasibility in terms of money, time, manpower) Expected results likely to alter clinical or health policy decisions in future

15. The GOOD IDEA must be • Feasible • Do-able by you • Do-able at your institution, hospital & community • Acceptable to your institution • In conformity with human welfare policies • Conceptually significant

16. Steps in conduct of research planning and execution The first and foremost is formulating a research question, the most challenging part

17. Identify the Question Sources for identifying the question or problem: Personal experiences Literature review Theories Ideas from others

18. Identify the Question Criteria for evaluating the question: Significance Practicality Feasibility Interest to researcher

19. RESEARCH QUESTION IT SHOULD BE A SINGLE SENTENCE IN THE FORM OF A QUESTION. IT SHOULD BE CLEAR UNAMBIGUOUS AND SPECIFIC

20. RESEARCH QUESTION IS DRUG “A” BETTER THAN DRUG “B” IN THE MANAGEMENT OF HEPATIC FAILURE IN PATIENTS WITH CIRROSIS? IS ALCOHOLISM RELATED TO THE DEVELOPMENT OF CIRROSIS LIVER?

21. What to have in a complete study protocol ? • Title • Summary • Background (Literature Review), Preliminary Studies, and Justification/Rationale • Study Objectives and/or Questions • Testable Hypotheses • Study Design • Study Population and Methods of Recruitment • Variables List and Sample Size

22. • Methods of Data Collection • Data Collection Tools • Plan of Analysis • Timeline • Issues for Ethical Review & Approvals • Operational Planning and Budgeting • Plan of Dissemination/Results Reporting • References

23. Title Title must reflect the central theme:selling point Attractive and easy to understand Concise and Informative: avoid non-informative words like “ A study of---”

24. Background Briefly sketch the background of the proposal. Critically evaluate the existing knowledge – What is the general situation and how is the problem developing? – Will it grow rapidly if unchecked? – What has been done so far to address the problem and with what effect? Specifically identify the gaps the proposed research is intended to fill. – What do you propose to do? – Explain why it is a good idea ? State concisely the importance of your research

25. Significance State concisely and clearly the importance of your study. Emphasize on any novelty or innovation Convey the significance of your research to 1) scientific contribution 2) improving in public health 3) change in health policies 4) change in patient care etc.,

26. Study Objectives State the objectives of the proposal: Describe concisely and realistically what the specific research is intended to accomplish Avoid grandiose designs- Over-ambitious proposals that aim to do everything – burdens, determinants, prevention and control of…. Specify clear objectives

27. Objective -examples • To study whether SNP markers are associated with obesity and hypertension phenotypes. To assess the general population knowledge & attitude towards Organ donation To identify the risk factors for Type-II diabetes Hypotheses Any hypotheses to be tested. • Have clear hypotheses • State hypotheses in form of short bulleted list • Avoid narrative paragraphs

28. Hypothesis and Specific Aims List the specific aims one by one concisely Not too many aims; 2-4 best Be specific, no general and ambiguous statements Be realistic, no unachievable aims Aims should be logically linked and arranged accordingly; testing your hypothesis

29. When you divide a section into subsections, all the pieces should be of the same pie

30. Hypothesis-example • We hypothesize that standard care plus new intervention (additional drug) will be superior to standard care alone in reducing CVD mortality among patients with preexisting heart disease. • We hypothesize that prophylaxis with inhaled drug A will be superior to oral preparation of drug B in preventing acute exacerbation of reactive airway disease. • We hypothesize that low birth weight is an independent risk factor for type II diabetes.

31. Key Points of Your Proposal Whatis your question Hypothesis Why is your study important  Significance How are you going to do it  Research design

32. Develop the Study Design • A study design is the researcher’s overall planto obtain the answer (s) to the question beingasked and the hypothesis being tested • It spells out strategies to develop informationthat is accurate, objective and meaningful • It explains methods that will be used to collectand analyze data

33. Study Design • Describe the overall design of the study, example: • This is a randomized, double blind placebo controlled trail. • This is a cross sectional survey

34. Research Designs

35. Feasibility- Study subjects What is the estimated sample size? Who is the study subject (case definition)? Selection criteria (inclusion & exclusion) How they are sampled ? (sampling) Time span for meeting the sample size

36. Can we meet the sample size? Estimated sample size (based on the research hypothesis, outcome variable) Estimated subjects likely to be available for recruitment Estimated subjects likely to refuse Estimated subjects likely to be lost to follow up

37. Study Population and Method ofRecruitment -- Describe clearly what type of subjects will be studied -- How will they be identified -- Inclusion and Exclusion criteria -- Describe each step involved in recruitment of study subjects -- Describe the role of research personnel in this process -- Mention “informed consent”

38. Variables List • State all the information that is to be collected (demographic data, clinical and lab data) in detail.

39. Method of data collection Explain precisely when and how the data will be collected, and measured (units). Explain method of ensuring quality control

40. Data Collection Tools • Explain why a particular tool is being used to collect the data. For instance, if a survey questionnaire is being used explain reliability and validity of the instrument. • Pretest

41. Analyzing the Data Upon completion of the study, data should be analyzedList out the appropriate statistical tests based on the type of data

42. Plan of analysis List the names of variables that will be used in the analyses. State the name of statistical analysis that will be performed to assess the outcome.

43. References • The list of references should be at the end of the proposal. List names of all authors, the title of the publication, the name of journal, year, volume, page numbers.

44. Benefits of Writing Proposal Allow you to review and critically evaluate the published literature of your interested topic. Develop novel ideas during writing proposal. Convince yourself and others that your research is worth doing. Keep you focused on your research work.

47. Writing Stages 2. Writing the First Draft 1. Getting in the Mood 4. Finishing 3. Revising, Revising, Revising Save multiple copies of your draft

48. Conclusions • Developing, and communicating a research protocol is a sophisticated and time-consuming process.It is important to understand the steps indeveloping a research protocol in order toperform an appropriate study and obtainreliable results.

49. Thank You