How to Develop a Research Protocol ? By Dr.Shaik Shaffi Ahamed Asst. Professor Dept. of Family

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How to Develop a ResearchProtocol?ByDr.Shaik
Shaffi AhamedAsst. ProfessorDept. of Family
Community Medicine
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What is Research?A systematic investigation,
involving thecollection 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
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MODEL OF THE RELATIONSHIP BETWEEN DIFFERENT TYPES
OF RESEARCH
Epidemiological
Biomedical
Policy making, planning, Management
evaluation
Health systems research
Statistical
Behavioural
Social economic
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• 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

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• (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

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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 ?

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• 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 pathogenetic mechanisms of
  disease ?

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

• is an integrated approach of deduction and
  induction

Deduction Hypothesis generation
known truths
In sample population
Universe
Testing the hypothesis
Induction (Inference on hypothesis) generalization
of the results
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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.

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• 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

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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
• New interventions chosen for trial should have
  some supportive evidence to its superiority over
  the conventional treatment in one way or other

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Steps in conduct of research

• designing, planning and execution
• The first and foremost is
• formulating a research question,
• the most challenging part

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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
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Identify the QuestionSources for identifying
the question orproblem Personal experiences
Literature review Theories Ideas from others
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Identify the QuestionCriteria for evaluating
the 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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Why Research question?

• Scientific community
• Health professionals
• Funding agency
• Journal editors
• Administrators, health policy makers
• Lay public
• Ethical committee

• to communicate convince
• the need and nature of the study
• in a simple but single sentence

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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.

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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?

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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
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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.

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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.

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Literature ReviewDetermine what published
datasuggests about the question
orproblemClarify the value of the
questionClarify what is already knownProvide
sources for reference
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Literature Review Primary SourcesJournal
articles, books, abstractsWritten by the
person(s) who conductedthe researchSecondary
SourcesReview articles that summarize
researchWritten by someone other than
primaryinvestigator
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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.

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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
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Frame a HypothesisThe nature of the hypothesis
willdetermine Sample group for study
Measuring instruments Study design
Procedures Statistical techniques
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1. What is the Conceptual hypothesis (CH)
Refining Research Question

• 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?
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2. Pick up an operational hypothesis CH
usually contains many theoretical principles
Refining Research Question

• Do beta-carotenoids protect against human
  cancer?

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3. Identify the study variables
Refining Research Question
Do beta-carotenoids protect against human
cancer?

• 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

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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
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5. What is the Study design?
Refining Research Question
Do beta-carotenoids protect against human
cancer?
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Develop the Study DesignA study design is the
researchers 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
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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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• 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., )

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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

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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

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

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Analyzing the DataUpon completion of the
study, data shouldbe analyzedList out the
appropriate statistical tests based on the type
of data
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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
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• Thank You