question and protocol

7/28/2019 Question and Protocol

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Framing a Research Question

and writing a Protocol

Dr. Biju George


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What is protocol

Formal document outlining the proposedstudy and helps the researcher(s) to get

organized.

Submitted to an academic institution such as a

teaching hospital, research facility or funding

agency to get an approval.


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Protocol should explain the study in terms

of answers to the following questions

Why ?

Sets out the questions and the relevant

background information. Why we should embark

on this particular research problem. How ?

Describes the study design and the rational for

choosing it. Also describes Instruments /techniques to be used

Who ?

Defines the targets and the study population and

sample size.


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Protocol should explain the study in terms

of answers to the following questions What?

Identifies the variables to be measured and

outcomes to be analyzed.

Where? Explain the study setting, and why it is most suited

for the purpose

When?

Describe the study period and duration of study,

follow up, frequency of follow up etc.

So What?

Expected significance of results and contribution.


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Components of protocol

Title

Introduction

Objective(s) / research question Methodology / material and methods

References

Performa / questionnaire / data collectionsheet


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Title

Concise titles are easier to read and understand.

Indicate the studys design with a commonly used

term in the title.

Omit waste words such as

"A study of...

"Investigations of ..."

"Observations on ..."


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Introduction

Explain the scientific background and rationalefor the intended study

Places your work in the current information

context Provide only directly pertinent references

Should catch the readers attention

Gives readers enough information to appreciateyour objectives

This should naturally lead to your objectives


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Objective(s) / Research Question

State specific objectives/ question(s)

Primary/ Secondary objectives

Arise directly from your research question


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How to find questions

Pure inspiration (rare)

Critical reading of published papers

A conference or seminar Observing/talking to a patients

Speaking to other researchers / colleague

New technologies bring in new questions


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Good ideas come only to..

The prepared mind

One with a skeptical attitude about prevailing

beliefs.


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Framing the research question

A general idea has to be converted into a

research question by

1. What measurable variables

2. Who subjects, controls3. Where - location

4. How method


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Characteristics of a good question

Novel

Relevant

Measurable

Feasible

Impact

Ethical


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Novelty

Can seek to provide new findings or refuteor extend previous findings

All studies need not be novel

Different study population

Confirmatory study avoiding weaknesses of theprevious study

Some previous observations need to bereplicated

Improved technology or new methods


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Trans-cuteaneous Bilirubinometer

Is TCB measurement can be used to replace

serum TB measurements

Is their a good correlation between TCB

measurement and serum TB measurement

Can TCB measurement on day 1 predict the

neonatal hyperbilirubinemia

Will skin colour affect the TCB measurements

Is TCB measurement correlate well with serum

TB in preterm / term / LBW babies


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RelevanceIs it of importance here and now?

Advance scientific knowledge by resolvinguncertainties in a given area

Lead to changes in existing clinical and health

policy Provide direction to future research

Post traumatic stress disorders in people who hadwhiteness the gas tanker explosion

Health consequences of loud noise for over 3 hoursa day for over six months?

What are the practices by traditional midwives thatmay be hazardous to the babys health?


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Measurability

Provide details of methodology- doing what, towhom, for how long, to achieve what effect?

Be as specific as possible

moderate reduction of Cholesterol habit

40% reduction in average cholesterol level

Reduction of cholesterol by 20 mg%

obesity replaced by body mass index

Regular Exercise replaced by

Walking at moderate speed for 30 minutes at least

5 times a week for 2 months


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FeasibilityCan I do it ?

Manageable in scope, Affordable in time and

money, Required technical expertise

Number of subjects should be realistic butlarge enough to eliminate random error

Diagnostic efficacy of rapid detection kit inidentification of malarial infection compared to

peripheral smear examination?

Campaign of Rubella vaccination in the stateresulting in reduction in incidence of birth defects?


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Impact

Reduction in mortality/ disease occurrence /

complication / severity of disease

Identification of prognostic factor / risk factor

/ risk group

Clinical picture description / mortality pattern

/ morbidity description / disability description


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How to go aboutfrom research topic to research question

Topic - Apthous ulcer

Magnitude of the disease

Risk factors of the disease

Treatment

Prevention methods

Cost related

Large scale program effectiveness


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Magnitude of the disease

What id the prevalence of apthous ulcer

What is the incidence of apthous ulcer


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Risk factors of the disease

What are the risk factors of the Apthous ulcer

Is Stress in the past 2 days, an important riskfactor foe development of Apthous ulcer


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Treatment

Is predinisolon tablet powder applied in the

lesion produce early cure than saline gargle


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Prevention methods

Will gargling mouth with Tulsi extracts

prevent development of apthous ulcer

compared to saline gargling


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Research question to Refined

Research question


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The research question

1. Topic ALL (Acute Lymphoblastic Leukemia)

2. Idea ALL in North Kerala - What are thecauses? Is nearness to saw mill a cause?

3. Question What are the causes of ALL?

4. Operationalizing the question What arethe risk factors of ALL

5. Refine the question further


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Refining the question further

What are the risk factors of ALL

What are the risk factors for ALL in patientsadmitted to IMCH, Calicut, as compared to

control children with ARI admitted in

pediatrics wards of the same hospital?


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1. What measurable variables

Risk factors

ALL

2. Who subjects, controls

Patients admitted

Controls who do not have ALL ( patients with ARI)

3. Where location

IMCH, Calicut Medical college

4. How method

Compare


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Is the antibiotic X effective in mild leptospirosis?

Is the antibiotic X (500 mg orally 6th hourly)

effective in mild leptospirosis?


effective compared to Inj. crystalline Penicillin

(given every 6th hourly) in mild leptospirosis?



(given every 6th hourly) in faster clinical andbiochemical improvement in mild leptospirosis?


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(given every 6th hourly) in faster clinical and

biochemical improvement in patients withfever and a leptospiral IgM ELISA positivity

but without heapto-renal involvment?


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Methodology

Design

Case series, cross sectional, cohort, case control,

RCT


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Randomized Controlled Trials


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Cohort Studies


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Case Control Studies


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Case Reports/ Case Series

The most basic descriptive study.

Link between clinical medicine and

epidemiologyHypothesis generating.

Rarely the evidence can even be strong!!


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Case Series

Australian gynaecologist,Dr. McBride of Sydney, suspectedthat thalidomide was the causeof limb and bowel malformationsin three children he had seen atCrown Street Women's Hospital.1956


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Pneumocystis carinii pneumonia and

mucosal candidiasis in previously healthy

homosexual men: evidence of a newacquired cellular immunodeficiency

1981 Dec 10;305(24):1425-31.

MS Gottlieb, R Schroff, HM Schanker, JD Weisman,

PT Fan, RA Wolf, and A Saxon
http://content.nejm.org/


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Methodology

Setting and study period

Describe the setting, locations, and why you have

choose the specific location. Biases related with it.

Relevant time periods related to the study,including periods of recruitment, follow-up, and

data collection


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Methodology

Participants

Selection of participants , including eligibility and

exclusion criteria and a description of the source

population. If only samples will be taken, explain the sampling

procedure.

Researcher should explain why only certaingroups were included or why some groups were

excluded


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Methodology

Variables

Study variables, Exposure factors, outcome

factors, Baseline factors.

Primary and secondary exposure factors /outcome factors

Definition of variables

Composite variables explain components

New scoring, its rationale


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Methodology

Data source

Questionnaires

Interview

Case records

Clinical examination

Investigation data


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Methodology

Measurements

Data collection methods- BP mercury

sphygmomanometer / electronic , position

Equipments used

Way of measurements


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Methodology if RCT

Interventions

Details of interventions

Dose, frequency, route of administration,

stoppage rules

Randomization

Process, allocation ratio, block size, concealment

Blinding

Single blinding / double blinding


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Methodology

Sample size

Number proposed in each group of study

Justification

Proposed Statistical analytic strategy

Propose statistical methods in enough detail

Ethical aspects

Consent

confidentiality


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References

Provide only directly pertinent key references

related to

Key articles in this area and their results

Lack of information in the topic

Key articles in related to the methodology

Few number of reference only

f / /


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Performa / questionnaire / data

collection sheet

Collect only those data which are absolutely

needed for achieving for the objective ( both

primary and secondary objectives)

May be coded in the sheet it self

dd l f f d


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Additional requirements for funding

agencies

Budgeting

Manpower requirements

Time line chart

Intended beneficial effects from this research

A synopsis of protocol


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Reporting Guidelines

Use it to prepare the protocol to get all

subheading


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STROBE Statement -

STrengthening the Reporting of

OBservational studies in

Epidemiology

observational epidemiologywww.strobe-statement.org/


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CONSORT-CONsolidated Standards ofReporting Trials

for RCT parallel trialswww.consort-statement.org/


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STARD Statement -

STAndards for the Reporting ofDiagnostic accuracy studies

for diagnostic evaluation studies

www.stard-statement.org/


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STREGA statements -STrengthening the REporting ofGenetic

Associations

www.medicine.uottawa.ca/public-health-

genomics/web/eng/strega.html


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Thank you

question and protocol

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