ProtocolwritingUG(1431). - King Saud University Medical Student

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Transcript ProtocolwritingUG(1431). - King Saud University Medical Student

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
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
What is Research?
A systematic investigation, involving the
collection of information (data), to solve a
problem or contribute to knowledge about a theory or
practice.
Research is critical in medicine because it
leads to new discoveries and can change
peoples’ lives by improving health and well being.
Research helps to provide scientific
understanding and solves practical problems.
Research (cont.)
Relies on methods and principles that will
produce credible and verifiable results.
All research starts with an idea or question
based on personal experiences.
Scientific Approach
The most sophisticated method of acquiring
knowledge is by scientific approach.
Combines important features of induction
and deduction together with other methods
to create a system of acquiring knowledge.
Generally more reliable than other methods.
Approach used most often to perform
medical research.
Scientific research
is an integrated approach of deduction and induction
Deduction
Hypothesis generation
Testing the hypothesis
Induction
(Inference on hypothesis)
generalization of the results
known truths
In sample
population
Universe
MODEL OF THE RELATIONSHIP BETWEEN DIFFERENT TYPES OF RESEARCH
Epidemiological
Biomedical
Statistical
Behavioral
Social &
economic
Health
systems
research
Policy making,
planning,
Management
evaluation
Causal model of risk factors for CVD
Morbidity and Mortality
(Stroke, MI)
Biological Risk Factors
(Hypertension, Blood Lipids, Homocysteine)
Genetic Risk Factors
Behavioral Risk Factors
(Family History)
(Cigarette, Diet, Exercise)
Environmental Factors
(Socioeconomic Status, Work Environment)
Preventable Causes of Disease
BEINGS
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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]
Clinical issues and questions in
the practice of medicine
Issue
Question
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 ?
Frequency How 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 ?
Treatment How does treatment change the future
course of a disease ?
Prevention Does 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 ?
Protocol writing
Key Points of Your Proposal
What is your question ?
Why is your study important ?
How are you going to do it ?
Choosing a topic
•
•
•
•
Should be interesting – 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
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
Steps in conduct of research
planning and execution
The first and foremost is
formulating a research question,
the most challenging part
Identify the Question
Sources for identifying the
question or problem:
Personal experiences
Literature review
Theories
Ideas from others
Identify the Question
Criteria for evaluating the question:
Significance
Practicality
Feasibility
Interest to researcher
RESEARCH QUESTION
IT SHOULD BE A SINGLE SENTENCE IN THE FORM
OF A QUESTION.
IT SHOULD BE CLEAR UNAMBIGUOUS AND
SPECIFIC
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?
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
•
• 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
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---”
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
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.,
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
• 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
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
When you divide a section into subsections,
all the pieces should be of the same pie
• 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.
Key Points of Your Proposal
What is your question
Hypothesis
Why is your study important
 Significance
How are you going to do it
 Research design
Develop the Study Design
• A study design is the researcher’s overall plan
to obtain the answer (s) to the question being
asked and the hypothesis being tested
• It spells out strategies to develop information
that is accurate, objective and meaningful
• It explains methods that will be used to collect
and analyze data
• 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
Research Designs
Purpose
Study Design
To determine frequency & burden
of a disease
* Cross sectional survey (Prevalence)
* Cohort study (Incidence)
To identify the risk factors
* Cohort study
* Case-Control study
To determine prognosis of a
disease
* Cohort study
To determine efficacy/
effectiveness of new treatment
* Clinical trials
To evaluate community programs
* Evaluation
*Community intervention
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
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
Study Population and Method of
Recruitment
-- 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”
Variables List
• State all the information that is to be collected
(demographic data, clinical and lab data) in detail.
Method of data collection
• Explain precisely when and how the
data will be collected, and measured
(units).
• Explain method of ensuring quality
control
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
Analyzing the Data
Upon completion of the study, data
should be analyzed
List out the appropriate statistical tests
based on the type of data
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.
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.
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.
Writing Stages
2. Writing the First Draft
1. Getting in the Mood
Save multiple copies
of your draft
3. Revising, Revising, Revising
4. Finishing
Conclusions
• Developing, and communicating a
research protocol is a sophisticated and
time-consuming process.
It is important to understand the steps in
developing a research protocol in order to
perform an appropriate study and obtain
reliable results.
Thank You