research question, criteria, formulation, and relation to research designs

Research Question

Professor Tarek Tawfik Amin

Epidemiology and Public Health, Faculty of Medicine, Cairo University

Geneva Foundation for Medical Education and Training

Asian Pacific Organization for Cancer Prevention

[email protected] [email protected]

Basic Research Competency Program for Research Coordinators August 2015, MEDC, Faculty Of Medicine, Cairo University, Cairo, Egypt.

mailto:[email protected]

mailto:[email protected]

05/02/2023 Professor Tarek Tawfik Amin 2

Objectives By the end of the day, research coordinators will be

able to:

1- Recognize the components, functions and criteria of a good research question.

2- Criticize research question against standard criteria.

3-Develop a research question fulfilling the FINER criteria.

4- Mastering searching the available bibliographic databases through following sound search strategies.

5- Recognize the indications, types and how to write up a research hypothesis.


Methodology 1- Interactive lecturing 2- Group and individual work3- Internet and web-based sessions.4- Assignments


Contents and plan

Session title Duration

Methods Activities

Research: definition, types elements, and

cycle

9:00-9:30

Interactive session

Research idea and research question

9:30-11:00

Interactive Individual/group work

Activity IActivity II

Break 1 11:00-11:30

Formulation of research question REACP : research

question

11:30-12:30


Activity III

Break 2 12:30-1:00

Searching the Bibliographic databases

1:00: 1:30

Interactive Hands-on

Activity IV

Break 3 1:30-1:45

Hypothesis 1:45-3:00


Activity V


Research

• Definitions • Elements• Cycle


Research? More than a set of skills, it is a way of

thinking: examining critically the various aspects of day to day professional work;

Understanding and formulating guiding principles that govern a particular procedures;

Developing and testing new theories for the enhancement of your practice.

Thyer 1993


Research: Working Definition

• It is the habit of questioning with systematic examination of the observed information to find answers which may results in more effective professional services. Kumar R 2005.


Scientific Research Definition:

Research is a structured inquiry that utilizes acceptable scientific methodology to solve problems and creates new knowledge that is generally applicable. Grinnell 1993


Types of research

Application Objectives Inquiry mode

Pure research

Applied research

Exploratory research

Descriptive research

Explanatoryresearch

Correlationalresearch

Quantitativeresearch

Qualitative research


Research process “The 8 steps model”

Formulating a research question

Research design

Instruments for data collection

Selecting a sample

Research protocol writing

Data collection

Data processing

Researchreport

FINER

Variables and hypotheses: definition

and typology

Literaturereview

Research design:functions

Study designs

Methods and tools of data collection

Validity and reliability of the

research tool

Field test of the tools

Sampling theory and designs

Contents of research proposal

Editing Code book

Coding

Methods of dataProcessing: computing

and statistics

Principles of Scientific writing

What How Conducting of the study

Kumar 2005

Dissemination including publication


Research cycle


Trading between different designs

Treatment /Intervention/

Program Study population

Exploration

Causes/associations

Effect

Exploration

Outcome/Impact/Change

Experimental studies

Non-experimental studies

Randomization

Non

Experimental: starts from the cause to effect.Non-experimental: starting from the effects to trace the cause.Semi (Quasi) experimental: a mix of both.


Iodine deficiency disorders (an example of research cycle)

• Observation and reporting of enlarged thyroid among pre/school children and frequent cretins in the New Valley.

• No clue about the size of the problem?• Prevalence studies were carried out, more

40% prevalence, morbidity among human and animals.

• What are the causes of IDDs?• Comparative ecological studies between

the costal and NV (including water, soil and vegetables analysis). Concluding iodine deficiency.

• Preventive Intervention should be managed. Community trial to introduce iodine?


Trading between different designs

Treatment /Intervention/

Program Study population

Exploration

Causes/associations

Effect

Exploration

Outcome/Impact/Change

Experimental studies

Non-experimental studies

Randomization

Non

Experimental: starts from the cause to effect.Non-experimental: starting from the effects to trace the cause.Semi (Quasi) experimental: a mix of both.


Research idea and research question

05/02/2023 16

Define the Research Problems (the 4Ps): Sources of research ideas/questions

Aspect of study

about Study of

Study population

People Individuals, organizations, groups, communities

Provide you with required information or you collect information from them

Subject areas

Problem

Program

Phenomenon

Issues, situations, associations, needs, profiles etc.,

Content structure, outcomes, attributes, etc., Cause-effect, relationships, etc.,

Information that you need to collect to find answers to your research question

Professor Tarek Tawfik Amin


Research idea vs. question Idea Question

Less specific Very broad

Clearly definedPredictor/outcome/specified

population Less operationalLow practicality

Simple, Measurable Objective

I wonder if Determine the design

Discipline bounded Not but the hardest part in the research

process I wonder if Egyptians have

different patterns of osteoporotic fractures!!!

What are the risk factors for major osteoporotic fractures

in Egyptian women aged <60 years ?


Statement Question

Idea

1. What predictors affecting survival of Egyptian children with brain tumors ?

2. What are the possible barriers to cervical cancer screening among Egyptian women?

3. What are the risk factors for osteoporotic hip fractures among Egyptian women aged ≥60 years?

4. Does the length of time from diagnosis to treatment of colo-rectal cancer predict survival?

5. What are the possible correlates of hypovitaminosis D in obese Egyptian adults?

6. Is there a relationship between smoking and depression? 7. How stress is contributing to cardiovascular diseases and

cancer? 8. Do breast cancer genes responsible for the development of

breast cancer in Egyptian women?9. What is the effect of patients’ education using simulation on

prevention of diabetic foot ulcer? 10. Do adolescents receive equal health care services in Egypt?

•State whether the following is research question or research idea:


Conceiving the Research Question.

The research question is the uncertainty about something in the population that the investigator wants to resolve by making measurements on his study subjects.

No shortage of questions as one leads to another.

Tamoxifen and breast cancer


What Is A Research Question And What Is Its Purpose?

• A research question is a question that a study is designed to answer.1- ‘a question that you propose to answer

through data collection’. Hennink 2011. 2- Guides all subsequent tasks in the

research process.3- Keep you focused during the research

project.


Research question functions Silverman (2010) suggests the

question’s purpose includes :• Organizing the study and giving it

direction and coherence• Delimiting the study, showing its

boundaries• Keeping the researcher focused• Providing a framework when you

write up your research• Pointing to the methods and data

that will be needed


Before formulating your research question, remember:

o Study that cannot contribute to generalizable knowledge is not ethical.

o Puts patients at risk of harm (even from minorinconvenience) is not acceptable.

o Scientific validity is not a “nice to have” but arequirement of all research

o Validity = ability of study to correctly answer

research question posed [latter]


The research question is the primary objective of your study!!!

Remember:


Components of research question

- Exposure (factors-predictors-correlates- determinants)

- Outcome (disease, morbidity, harm, benefit, burden)

- Relation (if any)- Specified population


The research question should specify !

Smoking

Cancer lung

Exposure

Disease Outcome

Predictor

Confounders Confounders Occupational hazards


Types of research questions • Hypothesis generating e.g. What factors predict

mortality following traumatic brain injury? • Hypothesis testing –e.g. Is X procedure

associated with lower mortality than Y procedure for acute T disease.

• Parameter estimation –e.g. What is the prevalence of depression among older (>60 years) cancer patients?

• Confirmatory study –e.g. Does test A have the same diagnostic accuracy in our population mimicking population Z?


Research question: opportunity to collaboration and consultation.

Your ideal question might be to determine the full pharmacokinetics of a new treatment for visceral leishmaniasis in very young children. Such a rich pharmacokinetic study would need venous blood collected from each participant at regular time interval s .

Do you need consultation for the feasibility of such procedure?

Whom and why?


Consultation and collaboration

Consultation with medical staff and community leaders

would highlight this as being unfeasible both in terms of

acceptability and clinical practice.

So what?


Key message: Collaboration and

Consultation To ensure that the question is

turned into an ethical , safe and accurate study which is conducted in a manner that produces a valid and reliable answer obtained in an acceptable manner.


Research question: Basic element: the scope

The question’s scope is neither too broad nor too narrow.

Too broad scope may result in you gathering far more information than you need or can reasonably handle, e.g. planning to carry out a survey on the perception of physicians towards clinical research in India.


Too narrow scope• You risk ending up with insufficient data to

make your study valid and representative e.g.

interested in how to improve national health care for sufferers of HIV, but only look at participants from one select community, too small data set that is too small to be truly representative nationally (potentially biased).


The challenge

The challenge in searching for a research question is not a shortage of uncertainties ; it is the difficulty of finding an important one that can be transformed into a feasible and valid study plan‘ Grinner 1993


Research question: THE GIGO“Garbage In- Garbage Out”

Research question is the input into the study which influence the quality of your research (output).

Problem formulation will govern the design, sampling, instruments used, and analysis plan.

Characteristics of a good research question “FINER Criteria”.

- Adequate number of subjects.- Adequate technical expertiseAffordable in time and money

- Manageable in scopeTo the investigator

- Confirms or refuses previous findings- Extends previous findings

- Provides new findings

- To scientific knowledge- To clinical and health policy

- To future research directions

Feasible

Interesting

Novel

EthicalRelevant

05/02/2023 34Professor Tarek Tawfik Amin


Feasibility

What kinds of information do you need to answer the

question? What kinds of information are available?

What resources are needed to obtain

data needed?

Is there access to resources needed?

Feasibility does NOT mean using invalid methods because that is “the best that can be done”


Novelty of research question

the ‘who cares?’ testthe ‘so what?’ test.

“Novelty or new information means new answers to the potential questions representing a user’s request or information need.”

Novelty in publication: The dilemma


Examples from the literature Criticize these research questions


Factors Impacting The Type Of Research Question.

1- Time limits and the length of time the study will take 2-Experience of the researchers3- Scope of the problem to be solved4- Cooperation of others e.g. collaborators , participating sites , etc.5- Ethical concerns e.g. would the research be of merit, acceptable to the community, 6- Funding availability and budget requirements7- Facility and equipment requirements and availability8- Time required to enroll participants e.g. enough incidence of condition. 9- If an intervention is involved, is it safe for use in the target population and is there enough data to support this safety.


Research question: Knowledge generated and relation to research design

A- To gain detailed knowledge about a topic on which not a great deal is known e.g. Rocio viral encephalitis , and this type of question would be said to be gathering ‘descriptive/exploratory ’ knowledge. [Qualitative descriptive design]B- Explaining the relationship between areas of a given topic e.g. examining a community’s use of malaria nets and reduction of malaria cases . seeking ‘explanatory’ knowledge. [Quantitative designs like surveys].C-Aiming to establish predictive knowledge. examines ‘cause and effect’ relationships e.g. ‘Would initiatives to reduce neonatal mortality result in decreased birth rates ? [Quantitative analytical design ]


Research question is a predictor to research designIn other words: the research design is dependent on the formulated research question.


Functionality of research question

Research questionResearch design

Primary objectiveSimple, clear and in prioriSecondary research questions

Secondary objectives

Primary end point

Calculation of the sample size

Protocol development Standard operating proceduresRunning study Statistical analysis


Question Design 1- What is the current health status of Egyptian adults aged 50 or

more? 2. What are the commonly occurring malignancies among residence

of Cairo year 2014?3. What is the standard value for leucocytes countries among

health Egyptian adults? 4. Does the survival rate of cancer patients correlated with sex,

age, tumor type, and stage of disease ? 5. What would be the difference in lifestyle patterns between

Cancer patients and non-cancer patients when compared? 6. Duration of smoking and the development of lung cancer, does

time matter? 7. Do patients with lung cancer differ from patients admitted to the

hospital of general surgery regards the previous smoking habits? 8. Does new drug B which improve the survival compared to the

traditional chemotherapy X with low overall survival and severe side effects in patients with prostate cancer ?

For the following research question, suggest a research design:


Origins of a research question.

For established investigator: The best research questions usually emerge from findings and problems faced and observed in prior studies, and in those of other workers in the field “Major Players”. For new and other investigators:☼ Mastering of the literature.☼ Being alert to new ideas and techniques.☼ Keeping the imagination roaming.☼ Attending seminar, workshops and conferences.


Review of literature: its role in research question

formulation. Hulley et al . (2007) suggest that ‘carrying out a systematic review is a great first step in developing and establishing expertise in a research area and the underlying literature review can serve as background for grant proposals and research reports ’.


1- It is possible that the data your research question is designed to generate already exists . A literature review will help to establish if this is the case and therefore whether the study you are considering is necessary. Novelty of your research question?

2- Another reason for a literature review is that examining the evidence already available may influence the type of research question that you set.

Comparison with similar studies.


Literature reviews have their limitations .

1- Effective reviews can be time consuming,

2- Require skill in identifying and analyzing appropriate material , and

3- Examining past evidence which may not reflect current states or thinking.


Formulation of research question


Steps in formulation of a research question

Indentify broad

field or subject area of

your interest

Dissect the broad area into sub-areas

Select what is of

most interest to you

Raise the research question

Formulate the

objectives

Assess your

objectives and

double check for sufficient interest

Test for noveltyFINER

Review of literature


Steps in formulation of a research problem

Physical activity

(PA)

PrevalenceBarriersProfile/

Patterns Genders

Sedenatrism

Disease prevention

The role of PA in cancer

prevention

What is the size of

population with PA

meeting the recommenda

tions for cancer

prevention?

Objective: Determine the

size of the population with enough

PA to prevent certain types

of cancers namely CRC

and post M. BC

Am I intereste

d in doing that? Tools,?

Sample? Resources? etc.,

Review of

literature at all steps

Review of

literature at all steps


Group work

• FINER?• Designs?• Components?


Assuring novelty • Searching the bibliographic

databases.


Research question: RECAP


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2. Bowl i ng A. Res earch Methods i n Heal th: Inves ti gati ng Heal th and Heal th Servi ces 3rd ed. 2009. Open Uni vers i ty Pres s , Berks hi re.

3. Fi tzpatri ck S. The Ins ti tute of Cl i ni cal Res earch ‘Cl i ni cal Tri al Protocol ’ handbook (2006), Bucki nghams hi re:ICR Publ i s hi ng.

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8. Mi s ra U, Ti n Tan C, Kal i ta J. Vi ral encephal i ti s and epi l eps y: Epi l eps i a 2008; 49(Suppl . 6):13–18.9. Si l verman D. Doi ng Qual i tati ve Res earch 3rd Ed. 2010. Sage Publ i cati ons , London.10. W HO/IVR Ethi cs Meeti ng. Ethi cal cons i derati ons ari s i ng from vacci ne tri al s conducted i n paedi atri c popul ati ons

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research question, criteria, formulation, and relation to research designs

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