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Health Research Methodology

         lecture notes


       By: Tilahun Nigatu

         January 2007
                              1
Contents

1. Introduction to Health research
2. Identifying and prioritizing topics for research
3. Analysis and statement of the problem
4. Literature review
5. Formulation of research objectives
6. Methodology
7. Designing a research instrument
8. Referencing styles
9. Preparation of research protocol
10. Application of statistical packages


                                                      2
1. Introduction to Health Research

Key questions:

What is a question?
What is a problem?
What is a research?
Why a research is conducted?
Who should be involved in research?


                                           3
Basic questions in health system

•What are health needs of people?
•What is the coverage of health interventions?
•How can we use resources cost-effectively?
•How can we control environmental factors?
Without research answering these questions is
 unthinkable



                                                 4
Health problems


• Health problems
• Health service problems
• Other Health-related problems

A Health research is needed to solve these
 problems

                                             5
Health systems research

             A systematic
collection, analysis and interpretation
   of health and health related data
     to answer a certain question
         or to solve a problem




                                          6
Characteristics of research

Demands clear statement of the problem
Requires clear objectives & methods
Builds on existing data
Involves systematic process
Have clear vision of outcome




                                         7
Purposes of health research

• Basic research:
   to generate new knowledge and technology
• Applied research:
  to facilitate prioritizing, designing and evaluation
  of interventions
Science progresses by falsification rather than
  verification


                                                         8
Quantitative Vs Qualitative

Quantitative research:
Tries to quantify things in terms of numbers
Has explanatory purpose

Qualitative research:
Tries to describe things in terms of contexts
Has exploratory purpose

                                                9
Who should be involved in health
                research?
Everyone concerned with the problem under study
  should get involved
      Policy makers
      Managers
      Health care providers
      Community

But level of participation and type of role depends
  on level, complexity, and focus of the study
                                                      10
Guidelines for successful research
1.    Focus on priority problems
2.    Action-oriented
3.    Multi-disciplinary
4.    Participatory
5.    Timely
6.    Cost-effective
7.    Simple, short-term designs
8.    Clear results
9.    Honest limitations
10.   Expressed implications and recommendations
                                                   11
It is a must

It is a must for any research to be:

•   Purposeful
•   Targeted
•   Credible
•   Timely

                                       12
Basic study steps

State the problem (what are the questions?)
Devise a plan of action(what will I do?)
Implement the plan (how I do it?)
Analyze data (what happened?)
Interpret data (what does this mean?)
Re-examination (is my logic correct? What next?)



                                                   13
2. Identifying and prioritizing
      topics for research




                              14
Identification of a topic


A health information is required for:

   –   Description of health situation
   –   Evaluation of health problems
   –   Definition of problem situations




                                          15
When does a problem situations requires
                  research?


•     When is a perceived discrepancy between
      reality and expectation
•     When reasons for the discrepancy are unclear
•     When there is more than one possible answer to
      a question or more than one solution to a
      problem


                                                   16
How do you think about a research topic?


•    From personal experiences/observations
•    By discussion with community/health workers
•    By contacting researchers/experts on the topic
•    By reading journals/articles’ recommendations
•    From formal advertisement by organizations




                                                      17
Prioritization of a research topic

Criteria
2. Relevance
3. Avoidance of duplication
4. Urgency (timeliness)
5. Political acceptability
6. Feasibility of study
7. Application of results
8. Ethical acceptability
                                           18
Features of a good topic

• Interesting and able to catch eyes of a
  reader
• Short and precise (specific)
• Related to the general objective of the study




                                              19
3. Analysis and statement of the
            problem




                               20
1. Analyzing the problem


Why we need to analyze a problem?

• To pool knowledge
• To clarify the problem and related factors
• To determine focus and scope of the research



                                                 21
Steps in analyzing a problem

1. Clarify the view points of participants
2. Specify and describe the core problem
    (nature, distribution, size, intensity)
3. Analyze the problem
   – Write the core problem
   – Think of all possible contributing factors
   – Identify further contributing factors
   – Categorize factors
   – Construct conceptual framework
                                                  22
2. Deciding focus and scope of research

Points to consider in deciding include:
• Usefulness of information to be collected
• Feasibility of analysis data to be collected
• Duplication of findings with previous studies




                                                  23
3. Formulating statement of the problem

Statement of the problem is the first major section in
  a research proposal

Why is it important to state and define the problem
  well? Because,
• It is a foundation for a research
• It facilitates search of information
• It justifies why the research should be conducted
                                                    24
Contents of statement of the problem
• A concise description of nature of the problem: what is it,
  its magnitude, distribution,severity & consequences

• Systematic elucidation of why the proposed research
  should be undertaken
   – Brief description of any attempts to solve the problem
     in the past-success,failure & challenges
   – Provide a convincing argument that available
     knowledge is insufficient to solve the problem under
     study

• Brief description of the significance of the proposed study:
  how results will be useful
                                                                25
4. Literature review




                       26
What is a literature review?

A systematic analysis and interpretation of available
  information about a topic of study

It is an excellent opportunity to develop professional
   confidence in the field of study




                                                     27
Why do we review literature?
                 (reasons)

•   To know more about a problem
•   To avoid duplication of information
•   To learn the gaps in the arena of study
•   To learn various methods that others used
•   To forecast challenges that might be faced in the
    conduct of study



                                                    28
What do we review?
                (Sources)


• Library (published information)
• Electronic search engines (internet)
• Gray literature (Unpublished ones)




                                         29
How do we write a review of literature?

Three steps in writing review of literature
• Consider your analysis of the problem
• Organize notes based on factors
• Decide the order (you have three options)
   – From broader to specific
   – From global to local
   – From past to present


                                              30
Bias in literature review
This is distortion of available information to reflect
  unreal situation

Common types of bias in literature
• Playing down controversies & differences
• Restricting to supporting references
• Drawing far-fetched conclusions from small studies
• Using rhetoric rather than reasoning

                                                         31
Important tips on literature review


•   Search widely
•   Evaluate relevance of an information to your study
•   Include information directly relevant to your study
•   Mention sources for all bold statements
•   Write a coherent discussion in your own words



                                                      32
In general

Literature review should be
     • Adequate
     • Relevant and
     • Critical


It must answer the questions:
     • How much is known about a topic?
     • What is not known about the topic?
     • What should be done on what is lacking?
                                                 33
5. Formulation of research
        objectives




                             34
Types of objectives

1. Estimation objectives
  – Estimates magnitude of an event
2. Association objectives
  – Analyses factors associated with an event
3. Evaluation objectives
  – Evaluates associations


                                                35
Categories of objectives
• General objective:
   – Summarizes what is to be achieved by the study
   – Should be clearly related to the statement of the
     problem


• Specific objectives
   –   Logically connected parts of the general objective
   –   Focus the study on the essentials
   –   Direct the design of investigation
   –   Orient collection, analysis & interpretation of data

                                                              36
Why should research objectives be
               developed?
It is because research objectives:

       Focus the study
       Avoids unnecessary information
       Facilitates organizing of the study




                                             37
How should we state objectives?

We do have three possible ways:

        As positive statements
        As research questions
        As a hypothesis

A hypothesis is a prediction of relationships between
  one or more factors and the problem under study
  that can be tested
                                                    38
Criteria for setting research objectives
Research objectives should be
• Focused, each covering a single point
• Ordered in a logical sequence
• Realistic and feasible to answer
• Operational using action-verbs
• Measurable in terms of outcomes at the end




                                               39
Action-verbs Vs non-action verbs
Action-verbs
    To determine   To compare      To verify
    To calculate   To describe     To asses
    To explore     To test         To establish
    To identify
Non-action verbs
   To appreciate   To understand   To show
   To share        To believe      to study

                                                  40
In short

Objectives must be SMART
       Specific
       Measurable
       Achievable
       Realistic
       Time-bound

                           41
6. Methodology




                 42
Basic questions
•   What is the choice of the study design?
•   What should be the study population?
•   How many study subjects are needed?
•   How should study subjects be selected?
•   How data collection tools be developed?
•   How should data be collected?
•   How the collected data is going to be managed?
•   How data quality will get assured?

                                                     43
Study designs

Four major study designs
• Cross-sectional
• Case-control
• Cohort
• Experimental

Selection of the study design depends on the
  objective of a study
                                               44
Populations
• Target population: the population to whom the
  results would be applied
• Source population: the population from whom
  study subjects would be obtained
• Sampling frame: the list of potential from which
  the sample is drawn
• Sample: Subjects who are selected
• Study subjects: the actual participants of the study


                                                     45
Sample size determinants
• The study design & sampling method
• P=the level of the magnitude
• d=the magnitude the change you want to be able
  to detect reliably (margin of error)
• à=how sure you want to be that a change of the
  magnitude would have occurred by chance (level
  of significance)
• 1-ß=how sure you want to be that you will observe
  a change of magnitude if it did in fact occur
  (power)
• Response rate, loss to follow up
                                                 46
Sample size

•   For estimating single mean
•   For estimating single proportion
•   For estimating difference between two means
•   For estimating difference between two proportions
•   Finite population correction




                                                   47
Sampling techniques
1. Probability sampling
     •   Simple random
     •   Stratified random
     •   Systematic random
     •   Cluster sampling
     •   Multistage sampling
2. Non-probability sampling
     •   Purposive/Judgmental/
     •   Convenience/Reliance/
     •   Consecutive
     •   Snow ball

                                 48
Study variables
A variable is a characteristic of a person, object or
    phenomenon that can take on different values expressed
    in numbers or categories.
Types of variables
3. Dependent/outcome/response variable
   –    Used to measure the problem under study
2. Independent/exposure/predictor variable
   –   Used to measure determinants of a problem
3. Confounding variable
   –   A variable associated with both the exposure and outcome


                                                                  49
Types of data
1. Primary data: data that one has collected oneself
     • Better understood by the researcher
     • Usually contains few variables

2. Secondary data: data that has already been
   collected by somebody else
     • Not well understood by the researcher
     • Very large number of variables


                                                   50
Data collection


Two broad categories of data collection
2. Quantitative data collection
3. Qualitative data collection




                                          51
Quantitative data collection
Techniques

•   Interview administered questionnaire
•   Self-administered questionnaire
•   Direct measurement
•   Review of record



                                           52
Qualitative data collection
Techniques

•   Key informant interview
•   In-depth interview
•   Focus group discussions
•   Observations (direct, participant)



                                         53

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Health research methods

  • 1. Health Research Methodology lecture notes By: Tilahun Nigatu January 2007 1
  • 2. Contents 1. Introduction to Health research 2. Identifying and prioritizing topics for research 3. Analysis and statement of the problem 4. Literature review 5. Formulation of research objectives 6. Methodology 7. Designing a research instrument 8. Referencing styles 9. Preparation of research protocol 10. Application of statistical packages 2
  • 3. 1. Introduction to Health Research Key questions: What is a question? What is a problem? What is a research? Why a research is conducted? Who should be involved in research? 3
  • 4. Basic questions in health system •What are health needs of people? •What is the coverage of health interventions? •How can we use resources cost-effectively? •How can we control environmental factors? Without research answering these questions is unthinkable 4
  • 5. Health problems • Health problems • Health service problems • Other Health-related problems A Health research is needed to solve these problems 5
  • 6. Health systems research A systematic collection, analysis and interpretation of health and health related data to answer a certain question or to solve a problem 6
  • 7. Characteristics of research Demands clear statement of the problem Requires clear objectives & methods Builds on existing data Involves systematic process Have clear vision of outcome 7
  • 8. Purposes of health research • Basic research: to generate new knowledge and technology • Applied research: to facilitate prioritizing, designing and evaluation of interventions Science progresses by falsification rather than verification 8
  • 9. Quantitative Vs Qualitative Quantitative research: Tries to quantify things in terms of numbers Has explanatory purpose Qualitative research: Tries to describe things in terms of contexts Has exploratory purpose 9
  • 10. Who should be involved in health research? Everyone concerned with the problem under study should get involved Policy makers Managers Health care providers Community But level of participation and type of role depends on level, complexity, and focus of the study 10
  • 11. Guidelines for successful research 1. Focus on priority problems 2. Action-oriented 3. Multi-disciplinary 4. Participatory 5. Timely 6. Cost-effective 7. Simple, short-term designs 8. Clear results 9. Honest limitations 10. Expressed implications and recommendations 11
  • 12. It is a must It is a must for any research to be: • Purposeful • Targeted • Credible • Timely 12
  • 13. Basic study steps State the problem (what are the questions?) Devise a plan of action(what will I do?) Implement the plan (how I do it?) Analyze data (what happened?) Interpret data (what does this mean?) Re-examination (is my logic correct? What next?) 13
  • 14. 2. Identifying and prioritizing topics for research 14
  • 15. Identification of a topic A health information is required for: – Description of health situation – Evaluation of health problems – Definition of problem situations 15
  • 16. When does a problem situations requires research? • When is a perceived discrepancy between reality and expectation • When reasons for the discrepancy are unclear • When there is more than one possible answer to a question or more than one solution to a problem 16
  • 17. How do you think about a research topic? • From personal experiences/observations • By discussion with community/health workers • By contacting researchers/experts on the topic • By reading journals/articles’ recommendations • From formal advertisement by organizations 17
  • 18. Prioritization of a research topic Criteria 2. Relevance 3. Avoidance of duplication 4. Urgency (timeliness) 5. Political acceptability 6. Feasibility of study 7. Application of results 8. Ethical acceptability 18
  • 19. Features of a good topic • Interesting and able to catch eyes of a reader • Short and precise (specific) • Related to the general objective of the study 19
  • 20. 3. Analysis and statement of the problem 20
  • 21. 1. Analyzing the problem Why we need to analyze a problem? • To pool knowledge • To clarify the problem and related factors • To determine focus and scope of the research 21
  • 22. Steps in analyzing a problem 1. Clarify the view points of participants 2. Specify and describe the core problem (nature, distribution, size, intensity) 3. Analyze the problem – Write the core problem – Think of all possible contributing factors – Identify further contributing factors – Categorize factors – Construct conceptual framework 22
  • 23. 2. Deciding focus and scope of research Points to consider in deciding include: • Usefulness of information to be collected • Feasibility of analysis data to be collected • Duplication of findings with previous studies 23
  • 24. 3. Formulating statement of the problem Statement of the problem is the first major section in a research proposal Why is it important to state and define the problem well? Because, • It is a foundation for a research • It facilitates search of information • It justifies why the research should be conducted 24
  • 25. Contents of statement of the problem • A concise description of nature of the problem: what is it, its magnitude, distribution,severity & consequences • Systematic elucidation of why the proposed research should be undertaken – Brief description of any attempts to solve the problem in the past-success,failure & challenges – Provide a convincing argument that available knowledge is insufficient to solve the problem under study • Brief description of the significance of the proposed study: how results will be useful 25
  • 27. What is a literature review? A systematic analysis and interpretation of available information about a topic of study It is an excellent opportunity to develop professional confidence in the field of study 27
  • 28. Why do we review literature? (reasons) • To know more about a problem • To avoid duplication of information • To learn the gaps in the arena of study • To learn various methods that others used • To forecast challenges that might be faced in the conduct of study 28
  • 29. What do we review? (Sources) • Library (published information) • Electronic search engines (internet) • Gray literature (Unpublished ones) 29
  • 30. How do we write a review of literature? Three steps in writing review of literature • Consider your analysis of the problem • Organize notes based on factors • Decide the order (you have three options) – From broader to specific – From global to local – From past to present 30
  • 31. Bias in literature review This is distortion of available information to reflect unreal situation Common types of bias in literature • Playing down controversies & differences • Restricting to supporting references • Drawing far-fetched conclusions from small studies • Using rhetoric rather than reasoning 31
  • 32. Important tips on literature review • Search widely • Evaluate relevance of an information to your study • Include information directly relevant to your study • Mention sources for all bold statements • Write a coherent discussion in your own words 32
  • 33. In general Literature review should be • Adequate • Relevant and • Critical It must answer the questions: • How much is known about a topic? • What is not known about the topic? • What should be done on what is lacking? 33
  • 34. 5. Formulation of research objectives 34
  • 35. Types of objectives 1. Estimation objectives – Estimates magnitude of an event 2. Association objectives – Analyses factors associated with an event 3. Evaluation objectives – Evaluates associations 35
  • 36. Categories of objectives • General objective: – Summarizes what is to be achieved by the study – Should be clearly related to the statement of the problem • Specific objectives – Logically connected parts of the general objective – Focus the study on the essentials – Direct the design of investigation – Orient collection, analysis & interpretation of data 36
  • 37. Why should research objectives be developed? It is because research objectives: Focus the study Avoids unnecessary information Facilitates organizing of the study 37
  • 38. How should we state objectives? We do have three possible ways: As positive statements As research questions As a hypothesis A hypothesis is a prediction of relationships between one or more factors and the problem under study that can be tested 38
  • 39. Criteria for setting research objectives Research objectives should be • Focused, each covering a single point • Ordered in a logical sequence • Realistic and feasible to answer • Operational using action-verbs • Measurable in terms of outcomes at the end 39
  • 40. Action-verbs Vs non-action verbs Action-verbs To determine To compare To verify To calculate To describe To asses To explore To test To establish To identify Non-action verbs To appreciate To understand To show To share To believe to study 40
  • 41. In short Objectives must be SMART Specific Measurable Achievable Realistic Time-bound 41
  • 43. Basic questions • What is the choice of the study design? • What should be the study population? • How many study subjects are needed? • How should study subjects be selected? • How data collection tools be developed? • How should data be collected? • How the collected data is going to be managed? • How data quality will get assured? 43
  • 44. Study designs Four major study designs • Cross-sectional • Case-control • Cohort • Experimental Selection of the study design depends on the objective of a study 44
  • 45. Populations • Target population: the population to whom the results would be applied • Source population: the population from whom study subjects would be obtained • Sampling frame: the list of potential from which the sample is drawn • Sample: Subjects who are selected • Study subjects: the actual participants of the study 45
  • 46. Sample size determinants • The study design & sampling method • P=the level of the magnitude • d=the magnitude the change you want to be able to detect reliably (margin of error) • à=how sure you want to be that a change of the magnitude would have occurred by chance (level of significance) • 1-ß=how sure you want to be that you will observe a change of magnitude if it did in fact occur (power) • Response rate, loss to follow up 46
  • 47. Sample size • For estimating single mean • For estimating single proportion • For estimating difference between two means • For estimating difference between two proportions • Finite population correction 47
  • 48. Sampling techniques 1. Probability sampling • Simple random • Stratified random • Systematic random • Cluster sampling • Multistage sampling 2. Non-probability sampling • Purposive/Judgmental/ • Convenience/Reliance/ • Consecutive • Snow ball 48
  • 49. Study variables A variable is a characteristic of a person, object or phenomenon that can take on different values expressed in numbers or categories. Types of variables 3. Dependent/outcome/response variable – Used to measure the problem under study 2. Independent/exposure/predictor variable – Used to measure determinants of a problem 3. Confounding variable – A variable associated with both the exposure and outcome 49
  • 50. Types of data 1. Primary data: data that one has collected oneself • Better understood by the researcher • Usually contains few variables 2. Secondary data: data that has already been collected by somebody else • Not well understood by the researcher • Very large number of variables 50
  • 51. Data collection Two broad categories of data collection 2. Quantitative data collection 3. Qualitative data collection 51
  • 52. Quantitative data collection Techniques • Interview administered questionnaire • Self-administered questionnaire • Direct measurement • Review of record 52
  • 53. Qualitative data collection Techniques • Key informant interview • In-depth interview • Focus group discussions • Observations (direct, participant) 53