MHE3 Research Methods Unit

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MHE3Research Methods Unit

• Lecture 1
• Introduction to Research and Ethics
• Affette McCaw-Binns

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MHE3 Understanding Research

• Biostatistics
• Dr. Marvin Reid TMRI
• Dr. Ian Hambleton
• Dr. Novi Younger
• Epidemiology
• Prof. Rainford Wilks - ERU
• Dr. Marshall Tulloch Reid - ERU
• Dr. Namvar Zohoori - ERU
• Research Methods and Course Coordinator
• Dr. Affette McCaw-Binns Comm H

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Format

• Lectures
• Seminar/Laboratory
• Integrate skills from the three disciplines
• Class divided into two groups
• Three labs per group
• Group work
• Develop research proposal
• Use same groups as for other subjects (?)

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Goal

• Develop capacity to
• Read
• Analyse
• Interpret
• Critique medical literature
• Develop an interest in research

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Course material

• Web site being established to post
• Course outline
• Lecture notes
• Other information as develops
• When this is established, will let you know
• Until then
• Class rep will be given a hard copy of my lecture
  notes
• Will provide it electronically if Im given a
  clean diskette

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Why research skills?

• The best care for patients in the 21st century
  requires an ability to use the medical literature
  to solve clinical problems
• Health professionals should be able to address
  clinical dilemmas through
• Careful definition of the problem
• Efficient review of the literature
• Brief and efficient screening of articles to find
  the most relevant and valid information

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Undergraduate research skills - I

• Develop an understanding of research
• Its uses
• Its similarities and differences from
• biomedical research
• basic research in other disciplines
• Use research as an approach to problem solving by
  applying a scientific and logical approach to
• Problem solving
• Decision making during health practice

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Undergraduate research skills - II

• Develop the skill to identify useful research
  questions focused on priority problems
• Understand the research process
• Sampling
• Threats to validity and reliability
• Other basic research issues

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Undergraduate research skills - III

• Familiarity with
• Data collections techniques
• Study types
• Importance of community based, action oriented
  approaches and multidisciplinary research
• Understand how to
• Be a good research consumer
• Assess research results
• Use them to improve health care

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Types of ResearchPatho-physiological research

• Study of the physiological and pathological
  causes of disease at the cellular/molecular level
• Basis for development of clinical medicine and
  therapeutics

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Types of Research Epidemiological approach

• Study of the development, frequency, distribution
  and consequences of disease and other health
  related states in human populations
• Principles
• Disease does not develop at random
• Not all persons are equally likely to develop a
  particular disease
• By identifying risk factors for disease
  development, one is able to develop ways to
  control or prevent its occurrence

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Types of Research Health systems research

• Examines health intervention outcomes from
  social, psychological, physical and economic
  perspectives
• Improve the health of a community by enhancing
  the efficiency and effectiveness of the health
  system
• Supports health system development
• People and actions whose purpose is to improve
  health

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Four main elements of health

• Human biology includes
• genetic inheritance
• process of ageing
• robustness of our body systems
• Environment
• factors external to the person
• individual have little or no control, e.g.
• water supply
• adequacy of sanitation
• Lifestyle
• aggregation of decisions by individuals that
  affect their health
• individuals have some control, e.g.
• smoking, diet
• Health care
• includes quantity, quality and access to health
  care

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Example, AIDS

• Basic or laboratory scientist
• Microbiologist
• HIV infectious agent
• Immunologist
• describe role of CD4 and T-lymphocyte in
  monitoring disease status

• Epidemiologist
• Biology
• contaminated blood/body fluids vector
• Sociology
• circumstances which contribute to HIV
  transmission among humans
• drug use
• promiscuity

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Types of Studies I

• Descriptive
• Tells us what is happening in regard to a
  phenomenon being studied
• Does not explain why things happen
• Only describes what is occurring
• Types
• Case reports/series
• Cross sectional studies

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Types of Studies II

• Explanatory
• Attempts to explain a phenomenon by specifying
  how or why it has happened
• Requires more attention to study design, data
  collection methods
• Hypothesis formulation is critical
• Types
• Cross-sectional
• Cohort
• Case-control
• Experimental studies

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Types of Studies III

• Evaluative
• Studies that appraise the value of health care
• Reviews
• Are programmes achieving their stated objectives?
• Trials
• Is this the most effective method of care?
• Types
• Programme trials
• Clinical trials
• Audits

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Types of data

• Primary
• Data collected principally for use by the
  investigator
• Secondary
• Data collected for other purposes and used by
  other investigators (e.g. Census)

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Sources of secondary data

• General data
• Census, population estimates (STATIN)
• Vital statistics (RGD)
• Health services data
• Hospital statistics (HMSR)
• Community returns (MCSR)
• Notification of disease (Surveillance unit)
• General practice returns
• Individual records
• Hospital referrals

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Summary I

• Several methods for acquiring, stating and
  establishing knowledge
• The scientific method applies a set of rules to
  produce scientifically valid knowledge
• Inherent to scientific approach is scepticism
  regarding content of knowledge and underlying
  methodology

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Summary II Epidemiological research

• Focus consequences of disease / health related
  states in human populations
• Aims to clarify the contribution of
• Biology
• Environment
• Lifestyle
• Health care
• to human health and health outcomes

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Summary III Health systems research

• Application of research to structure, process and
  outcome of health related interventions in
  populations or clinical settings
• Focus to improve the quality, appropriateness,
  effectiveness, including cost-effectiveness of
  health service delivery

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ETHICS The rules of the game Selecting the
Research Problem

• VALUE OF THE PROJECT
• Is the study worthwhile?
• What will it accomplish?
• Will it be used by policy makers or significantly
  contribute to the process of theory building?
• Whom will it serve?

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Participation

• Participation should be voluntary
• People should not feel coerced
• Are there implicit sanctions?
• Are there hidden expectations?
• Issue generalizability
• Are volunteers different from those who refuse?

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Safety Do no harm

• Physical
• Interventions/Experiments
• Monitoring outcomes/side effects
• Stopping rules
• Psychological
• Participants are sometimes asked to face aspects
  of themselves they do not normally consider, e.g.
  deviant behaviour
• Probing sensitive issues may injure self-esteem

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Informed Consent I

• Participants should
• Base their voluntary participation on a full
  understanding of the possible risks involved
• Have the purposes of the study explained to them
• Be given a description of how the study will
  affect them, including risks associated with the
  research

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Informed Consent II

• Participants should
• Be told that involvement is entirely voluntary
  and that they can leave the study at any time
• Be given a written information leaflet which
  contains
• The above information which they can take away
• Identifies the principal investigator/institution
• Sign a statement indicating they are aware of the
  risks but choose to participate anyway

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Special Groups

• Mentally incapacitated
• Agencies or carers should be involved to provide
  advice regarding appropriate participation
• Consent needs to be obtained from the legal
  guardian

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Special Groups Children

• Informed consent from parents/guardians and the
  child if s/he is sufficiently intelligent/ mature
  to make this practical
• ?ageable to read and understand
• Risks considered in terms of
• therapeutic (potentially benefit to the child)
• non-therapeutic research (no direct benefit to
  the child)

• Potential risks
• Physical disturbance
• Discomfort
• Anxiety
• Pain
• Psychological disturbance to the child or the
  parents
• Serious harm

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Why paediatric research?

• Disease processes differ between adults and
  children some diseases have no close analogies
  in the adult
• Pharmokinetics of many drugs vary with age and
  their beneficial or adverse effects are different
  in adults and children
• Because the antecedents of many adult diseases
  have their origins in early life, studies in the
  very young may identify strategies for preventing
  diseases, eg HTN

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Anonymity and confidentiality

• Anonymity
• Cannot identify a response with a respondent
• No identifying details on questionnaire
• Difficulty keeping track of who has or hasnt
  responded or cleaning data if there are errors
• Confidentiality
• Researcher can identify a given persons
  responses but promises not to do so publicly
• Interviewers/data analysts trained in ethical
  responsibility
• Names replaced with identification numbers which
  are kept under secure storage

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Analysis and Reporting

• Technical limitations and failures
• Researchers have an obligation to make any
  shortcomings known to their readers
• Report negative findings
• Feedback
• Organised method to share findings (individual or
  group) with participants or other professionals
  interested in the findings
• Immediate feedback to subject (Case
  report/referral)
• Seminars
• Publications

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Ethical Review Boards

• Panel which reviews all research proposals
  involving human subjects as a guarantee that
  subjects rights and interests will be protected
• Faculty of Medical Sciences
• Ministry of Health
• ERB may
• Require revision of the study design
• Refuse to approve a study

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FEASIBILITY

• Do we have the
• time
• financial resources to accomplish the stated
  goal?
• Are subjects available?
• Will subjects cooperate?
• Are facilities/equipment/skills available?

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Summary ETHICAL ISSUES

• What are the risks, the benefits?
• Are subjects aware of the potential risks and
  benefits? The consequences?
• Have participants consented freely?
• Is the study well designed and planned?
• Do we have personal biases?