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Formulating a ResearchQuestion / Hypothesis

Dilip R KarnadMD, FACP, FRCP

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Getting the idea

Developing the research hypothesis

Defining the objective of the research

Framing a tentative research question

Appropriate study design

Framing the final research question

Doing Research the first steps towards the Nobel Prize

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Single incident RepeatedobservationUnusual

UnexpectedParadoxical

Chance? Pattern

Why did it happen? Is it really exceptional?

Case Report Hypothesis

Getting the research idea - Curiosity

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Interesting Observation

Pattern

Tentative hypothesis

Hypothesis

Experiment

Observation

Confirmation

Process of Research

Problem

Convert to research studyGetting the idea

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Identify What is the problem?

Prioritize Why is this important?

Rationale Can the problem be solved?

Importance What are the benefits to society?

Is the idea worth pursuing?

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Lets plan a research study

Hypothesis:Computer games make children smarter

Important? Can be solved? Benefits to society?

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Is an answer already available?

Literature search

Is the question fully answered?

Have previous attempts failed? Why?

If answered, is this being used in clinicalpractice? Why not?

Limitations of previous studies

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Converting Hypothesis into Research study

Hypothesis: Computer games make children smarter

Start with a broad, general question / hypothesis

Narrow down or focus on a specific problem

Design a study to address specific hypothesis

Computer games What type? Which one? How muchtime?

Children Age? Gender? Class in school? Language

Smarter IQ? Maths? Interview? Problem-solving?

General knowledge? Marks in exam?

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Structured, holistic approach for researchplanning - SHARP

1 Set up a causal model2 Establish a fact-hypothesis matrix3 Develop a variable indicator measurement

matrix4 Select the study design5 Define sampling method, sample size

6 Define statistical methods7 Consider ethical issues8 Set up operational plan

Charlton KE et al. S A J Clin Nutr 2000;13:1

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Hypothesis Fact (published literature)

Playing with other children betteradjusted in society

Play helps in cognitive, social andemotional development

Negative emotions channelized inharmless activities Play allows expression of negativeemotions - hate, gaining control of situation, conflicts

Games - More cerebral stimuli -Imagination

Computer games vast range of images, sounds, animation,information

Recreation Break from routine studiesGames help in Concentration -Important for preparing for boardexaminations

Computer games teach children tosit in one place, prolongedconcentration

Therefore computer games improve

students scholastic performance?? ? ? ?

Research question

Fact hypothesis matrixHypothesis: Computer games make children smarter

Computer games may improve scholastic performance

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Characteristics of a good hypothesis

Must be based on facts (publishedstudies)

Should not have already been proven. Should be convincing

Often fills gaps in current knowledge

Usually explains more than one

situation

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Should we have several alternativeexplanations for all possible resultseven before we start the study?

Are there any other possibilities that

explain the problem?

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Hypothesis generationAlternative hypothesis

Our conclusion:Cause effect relationship Coffee drinking causes HT

Other possible explanations:

75% of pts with hypertension (HT) drink coffee 20% of healthy controls drink coffee (p < 0.001)

1 Chance Coffee drinking not related

2 Bias Coffee drinking not related

3 Effect (not cause) HT causes coffee drinking

4 Effect effect HT and coffee drinkingcaused by a third factor

5 Partial cause effect Coffee drinking is one of the causes of HT

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Mills canons of inductive reasoning

John Stuart Mill (1806-1873) - British Philosopher

Method of difference disease present/absentrisk factor present/absent

Method of agreement presence of risk factor anddisease

Method of concomitant dose response effectvariation

Method of analogy 2 diseases occurring togethermay have common cause

J S Mill. System of Logic. 1843

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Causal Inference Kochs postulates

1 Microbe found in diseased tissue or animals andnot in normal tissue or animal

2 Can be cultured from diseased tissue

3 Organisms from culture can cause disease if introduced in animals or man

4 Organism can be re-isolated from experimentallyinfected animal or man

5 Treatment or preventive measures can eliminatedisease

Robert Koch (1843-1910) German microbiologist

Robert Koch, 1884

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Criteria for causation (weakest to strongest)

1 A is associated (correlated) with B (Strength of association correlation coefficient, odds ratio)

2 A precedes B (Temporality)

3 Plausible biological mechanisms lead from A to B(Plausibility)

4 A graded dose-response relationship exists between Aand B (Dose-response)

5 Presence of A always leads to B (Longitudinal studies)

6 Removal of A always prevents B (Treatment effect)

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Variable Indicator MeasurementType of game WCCG category - C Name of game

DoseTimeAttemptsDuration

Hours/weekNumber of tries/weekNumber of months

Expertise Performance in game Highest score everyweek

Concentration onstudies

Duration of studyEfficiency of study

Hours/dayChapters/day

Quality of study Comprehension, Recall- Periodic tests Scores in monthly tests

Ultimate benefit Exam marks / scores Mark sheet of XIIth

board exam

Variable indicator - measurement matrixHypothesis: Computer games may improve scholastic performance

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Is it possible to answer the initial question?

Do we have the subjects, technology,budget, time to complete the study?

Can the question be broken down into smallerparts, which can be answered separately?

Do we need to rephrase the initial question?

Develop a specific, focused research question

Review the objectives

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Components of an ideal research question

PICO Population: Normal/disease, human/animal

Intervention: Therapy, risk factor,diagnostic test, preventive measure

Comparison or Control: Better / worse,placebo / active control

Outcome: Clinical, functional, laboratory,economic

Schwatrz MD, et al. ACP Journal Club 2007;147:A8,9

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Ideally framed research questionsPICO (Population Intervention Control Outcome)

Is low-dose dopamine infusion superior to noradrenaline indecreasing need for dialysis and in-hospital mortality inadults with septic shock?

Does addition of aspirin to standard treatment decreaseneed for hospitalization in diabetic females with coronaryartery disease?

Is the quantiferon test superior to the tuberculin test indetecting presence of active tuberculosis in asymptomatichealthcare workers?

Does salt fortified with folic acid and Vit B12 decreaseserum homocysteine levels more than unfortified salt invegetarians with previous myocardial infarction?

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Ideally framed research questionHypothesis:

Computer games improve scholastic performance

Population:Intervention:

Control:Outcome:

Research Question:

Does playing with Brain Tickler 2010 daily for 2 yearsimprove performance of female X th Grade students in the

XII th Grade examinations when compared to students

with unrestricted access to all computer games ?

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Summary1 Conceptualize the problem

Identify - what is the problem?Prioritize - why is this important?

Rationale - can the problem be solved?

Importance - are there benefits to society?

2 Define a testable hypothesis

3 Frame a broad research question

3 Break the problem / hypothesis / study into parts

4 Refine question - specific, focused

Can be answered with available resources - time, budget,facilities

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It is worthwhile to put in a lot of thought and effort

before starting even a simple study!