Developing a Research Protocol: Model & Methods for Effective Results

1. How to Develop a ResearchProtocol?ByDr.Shaik Shaffi AhamedAsst. ProfessorDept. of Family & Community Medicine

2. What is Research?A systematic investigation, involvingthecollection of information (data), to solve aproblem or contribute to knowledge about a theory or practiceRelies on methods and principles that willproduce credible and verifiable resultsResearch helps provide scientificunderstanding and solves practical problems

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

4. BCG vaccination is not effective. Why ? • BCG vaccination coverage is good but not effective • Immuno-microbiological factors Poor nutrition (low protein intake) Poor immune reaction (race-specific) Tubercle bacillus strains Atypical mycobacterial infection ---- BIOMEDICAL PROBLEMS • Technical factors Quality of BCG vaccine ---- BIOMEDICAL PROBLEMS (iii) Operational factors Storage and transport of vaccine Handling of vaccine after reconstitution Technique of vaccination Logistic support (supply of vaccine, vaccinating equipment) ----- HEALTH SYSTEMS RESEARCH

5. (b) BCG vaccination coverage is poor (i) Operational factors Coverage and efficiency of local health services ---- HEALTH SYSTEMS RESEARCH (ii) Human factors Indifference of population toward immunization Fear of reaction and low level of confidence in BCG Decline in concern about tuberculosis ----- BEHAVIOURAL PROBLEMS

6. 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 ? Prognosis What are the consequences of having a disease ?

7. 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 pathogenetic mechanisms of disease ?

8. IntroductionResearch is critical in medicine because itleads to new discoveries and can changepeoples’ lives by improving health and well beingAll research starts with an idea or questionbased on personal experiencesResearch shapes the world we live in bycontinually questioning and testing humanknowledge and understanding

9. IntroductionThere are many ways in which humans acquire knowledge and gather informationin order to solve problemsMany questions are answered andproblems solved based on inheritedcustoms, traditions and experiencesMore complex questions may beanswered through a process of logicalreasoning

10. What is Reasoning?Inductive - the process ofdeveloping generalization fromspecific observationsDeductive - the process ofdeveloping specific predictionsfrom general principles

11. Scientific ApproachThe most sophisticated method of acquiringknowledge that has been developedCombines important features of inductionand deduction together with other methodsto create a system of acquiring knowledgeGenerally more reliable than other methodsApproach used most often to performmedical research

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

13. OBJECTIVE OF MEDICAL RESEARCH • Increase understanding of casual association , both etiologic agents and risk factors to disease. • To improve methods of diagnosis • To optimize therapy and management of the sick.

14. Execution of Research: Conceptualizing the problem: Need Background & Ratinale Formulating the Objectives Generating hypotheses Testing hypotheses Designing the Approach Research design Methods and Materials Target population Study population Methods of collection Analysis and Interpretation of results

15. 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 manageablein scope (feasibility in terms of money, time, manpower) • Expected results likely toalter clinical or health policy decisions in future • New interventions chosen for trial should have somesupportiveevidence to its superiorityover the conventional treatment in one way or other

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

17. Identify the QuestionGood or poor research is defined by thequestion being askedThe question should be well understood, andthe problem well definedSelecting a question should not be rushedIf the question is hurried, proceeding in anorderly fashion may be difficult and mayproduce unreliable results

18. Identify the QuestionSources for identifying the question orproblem:Personal experiences Literature review Theories Ideas from others

19. Identify the QuestionCriteria for evaluating the question:Significance Practicality Feasibility Interest to researcher

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

21. 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?

22. to communicate & convince the need and nature of the study in a simple but single sentence Scientific community Health professionals Funding agency Journal editors Administrators, health policy makers Lay public Ethical committee Why Research question?

23. Fully refined RQ • The fully refined research question should indicate the objective of the study, • specify the major outcome and predictive variables • the setting and the intended study subjects. • The implied biological rationale and study design should be explicit in the research question.

24. Refining Research Question Fully refined Research Question “Do beta-carotenoids protect against human cancer?” Is the risk of developing lung cancer low among cohorts with high beta-carotenoid dietary intake, compared to cohorts with low beta-carotenoid dietary intake among male smokers residing in Riyadh?

25. Refining Research Question Fully refined Research Question “Do beta-carotenoids protect against human cancer?” Is the risk of developing lung cancer low among cohorts with high beta-carotenoid dietary intake, compared to cohorts with low beta-carotenoid dietary intake among male smokers residing in Riyadh? Cohort Study

26. Refining Research Question Fully refined Research Questions • Is there an association between serum retinoic acid level and development of lung cancer among male smokers residing in Riyadh? - A case-control study • Does administration of beta-carotenoid (specify dose, route and duration) reduce the risk of developing lung cancer among male smokers residing in Riyadh? – A randomized placebo controlled trial.

27. REVIEW OF LITERATURE • SHOULD GO BACK ATLEAST FIVE YEARS • SHOULD BE STRUCTURED BY CONTENT OR GEOGRAPHIC REGION • SHOULD BE A CIRITICAL REVIEW THAT ASSESSES THE STRENGTHS AND WEAKNESS OF THE DESIGN USED IN THE STUDIES REVIEWED.

28. Literature ReviewDetermine what published datasuggests about the question orproblemClarify the value of the questionClarify what is already knownProvide sources for reference

29. Literature ReviewPrimary Sources:Journal articles, books, abstractsWritten by the person(s) who conductedthe researchSecondary Sources:Review articles that summarize researchWritten by someone other than primaryinvestigator

30. OBJECTIVE • SHOULD BE GENERAL AND SPECIFIC • gen: prevalence of hiv • specific: prevalence of hiv in unmarried adults • SHOULD CONTAIN WHAT YOU EXPECT TO DO • SHOULD BE ONLY ONE PRIMARY SPECIFIC OBJECTIVE. • IF YOU HAVE SECONDARY OBJECTIVE - IT WILL BE DIFFICULT TO DESIGN A STUDY TO ANSWER MORE THAN ONE OBJECTIVES AT ONCE.

31. Frame a HypothesisThe hypothesis is a statement that describes the results the researcher expectsIt examines relationships or differencesThe null hypothesis is a statement thatexpects no relationships or differences toexistA study should be designed to test thehypothesis or null hypothesis

32. Frame a HypothesisThe nature of the hypothesis willdetermine:Sample group for study Measuring instruments Study design Procedures Statistical techniques

33. Refining Research Question 1. What is the Conceptual hypothesis (CH) After deciding on the topic - gather knowledge from all possible sources - arrive at a meaningful conceptual hypothesis CH: “Beta-carotenoids have protective role against development of human cancer” Can you think of a Research Question (RQ) ? RQ:“Do beta-carotenoids protect against human cancer?”

34. 2. Pick up an operational hypothesisCH usually contains many theoretical principles OH1: Dietary deficiency of beta-carotenoid is associated with increased risk of lung cancer. OH2: Exposure to or treatment with beta-carotenoid can decrease the risk of lung cancer OH3: Low levels of serum retinoic acid are associated with increased risk of lung cancer. Refining Research Question “Do beta-carotenoids protect against human cancer?”

35. Exposure variables Diet habits (beta-carotenoids) Serum retinoic acid level Receptors of retinoic acid Markers of retinoic acid Outcome variables All cancers (cancer registry) Organ Specific cancers e.g. lung cancer Cell atypia e.g. sputum cytology 3. Identify the study variables Refining Research Question “Do beta-carotenoids protect against human cancer?”

36. 4. Specify the nature of comparisons Refining Research Question “Do beta-carotenoids protect against human cancer?” E.g. Strength of Association Comparison of risk between 2 groups Case-control study: Cohort study, RCT: Odds ratio Relative risk

37. 5. What is the Study design? OH1: Dietary deficiency of beta-carotenoid is associated with increased risk of lung cancer. Cohort or Case-control or RCT OH2: Exposure to or treatment with beta-carotenoid can decrease the risk of lung cancer Cohort or RCT OH3: Low levels of serum retinoic acid are associated with increased risk of lung cancer. Cohort orCase-control Refining Research Question “Do beta-carotenoids protect against human cancer?”

38. Develop the Study DesignA study design is the researcher’s overall planto obtain the answer(s) to the question beingasked and the hypothesis being testedIt spells out strategies to develop informationthat is accurate, objective and meaningfulIt explains methods that will be used to collectand analyze dataIt includes time frame to conduct study

39. Research Designs

40. Methodology --Study subjects --Selection of study subjects --Sampling method --Criteria for inclusion/exclusion --Sample size --Study & Outcome variables --Measurement of study & outcome variables (data form, Questionnaire) --Place of study (Community, OP, IP, Case records, College., )

41. Feasibility • Availability of resources (funding) • Infrastructure • Technical expertise(subject expert, methodological expert & statistical expert) • No extra stress to the patients or existing system (in terms of money, manpower or other resources) • No Ethical violation

42. 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

43. 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 • Extend of the problem in target population • Knowledge of biological behavior of disease & study subjects • Pilot study required ?

44. Analyzing the DataUpon completion of the study, data shouldbe analyzedList out the appropriate statistical tests based on the type of data

45. ConclusionsDeveloping, conducting andcommunicating a research protocol is asophisticated and time-consuming processIt is important to understand the steps indeveloping a research protocol in order toperform an appropriate study and obtainreliable results

46. Thank You