Protocol writing. What is your research question ? Why is your study important ? How are you going...
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Transcript of Protocol writing. What is your research question ? Why is your study important ? How are you going...
![Page 1: Protocol writing. What is your research question ? Why is your study important ? How are you going to do it ? Key Points of Your Proposal.](https://reader031.fdocuments.us/reader031/viewer/2022020320/56649f275503460f94c3e781/html5/thumbnails/1.jpg)
Protocol writing
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What is your research question ?
Why is your study important ?
How are you going to do it ?
Key Points of Your Proposal
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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
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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
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Steps in conduct of research
planning and execution
The first and foremost is
formulating a research question,
the most challenging part
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Identify the Research Question
Sources for identifying the research question or problem:
Personal experiences Literature review Theories Ideas from others
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Identify the Research Question
Criteria for evaluating the research question:
Significance Practicality Feasibility Interest to researcher
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RESEARCH QUESTION
IT SHOULD BE A SINGLE SENTENCE IN THE FORM OF A QUESTION.
IT SHOULD BE CLEAR , UNAMBIGUOUS AND SPECIFIC
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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?
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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
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• 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
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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---”
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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
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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.,
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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
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• Objective -examples 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
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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
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When you divide a section into subsections, all the pieces should be of the same pie
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• 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.
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What is your question
Hypothesis
Why is your study important
Significance
How are you going to do it
Research design
Key Points of Your Proposal
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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
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• 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
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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
*Community intervention
To evaluate community programs * Evaluation
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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
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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
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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”
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Variables List
• State all the information that is to be collected
(demographic data, clinical and lab data) in detail.
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Method of data collection
• Explain precisely when and how the data will be collected, and measured (units).
• Explain method of ensuring quality control
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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
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Analyzing the Data
Upon completion of the study, data should be analyzed
List out the appropriate statistical tests based on the type of data
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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.
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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.
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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.
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Writing Stages
2. Writing the First Draft2. Writing the First Draft
4. Finishing4. Finishing3. Revising, Revising, Revising3. Revising, Revising, Revising
1. Getting in the Mood1. Getting in the Mood
Save multiple copies of your draft
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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.
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Thank You