research question, criteria, formulation, and relation to research designs
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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
amin55@myway.com dramin55@gmail.com
Basic Research Competency Program for Research Coordinators August 2015, MEDC, Faculty Of Medicine, Cairo University, Cairo, Egypt.
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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.
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Methodology 1- Interactive lecturing 2- Group and individual work3- Internet and web-based sessions.4- Assignments
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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
Interactive Individual/group work
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
Interactive Individual/group work
Activity V
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Research
• Definitions • Elements• Cycle
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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
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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.
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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
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Types of research
Application Objectives Inquiry mode
Pure research
Applied research
Exploratory research
Descriptive research
Explanatoryresearch
Correlationalresearch
Quantitativeresearch
Qualitative research
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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
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Research cycle
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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.
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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?
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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.
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Research idea and research question
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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
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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 ?
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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:
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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
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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.
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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
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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]
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The research question is the primary objective of your study!!!
Remember:
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Components of research question
- Exposure (factors-predictors-correlates- determinants)
- Outcome (disease, morbidity, harm, benefit, burden)
- Relation (if any)- Specified population
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The research question should specify !
Smoking
Cancer lung
Exposure
Disease Outcome
Predictor
Confounders Confounders Occupational hazards
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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?
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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?
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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?
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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.
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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.
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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).
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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
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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
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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”
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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
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Examples from the literature Criticize these research questions
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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.
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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 ]
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Research question is a predictor to research designIn other words: the research design is dependent on the formulated research question.
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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
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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:
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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.
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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 ’.
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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.
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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.
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Formulation of research question
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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
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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
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Group work
• FINER?• Designs?• Components?
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Assuring novelty • Searching the bibliographic
databases.
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Research question: RECAP
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References1. Bhattarai A, Al i A, Kachur S, Martens s on A, Abbas A, Khati b R, Al -mafazy A, Rams an M, Rotl l ant G, Gers tenmai er J, Mol
teni F, Abdul l a S, Montgomery S, Kaneko A, Bj orkman A. Impact of Artemi s i ni n-Bas ed Combi nati on Therapy and Ins ecti ci de-Treated Nets on Mal ari a Burden i n Z anz i bar: Pl os Medi ci ne 2007; 4(11): 309.
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.
4. Henni nk M, Hutter I, Bai l ey A. Qual i tati ve Res earch Methods 2011.Sage Publ i cati ons , London.5. Hul l ey SB, Cummi ngs SR, Browner W S, Grady DG, Newman TB. Des i gni ng Cl i ni cal Res earch 3 rd Ed. 2007, Li ppi ncott W
i l l i ams & W i l ki ns , Phi l adel phi a.6. Gai l l ard P, Fowl er M, Francoi s D, Coovadi a H, van der Hors t C, van Rompay, K, Ruff A, Taha T, Thomas T, de Vi ncenz i I,
Newel l M, Ghent IAS W orki ng Group on HIV i n W omen and Chi l dren. Us e of Anti retrovi ral Drugs to Prevent HIV-1 Transmi s s i on Through Breas t-feedi ng: From Ani mal Studi es to Randomi zed Cl i ni cal Tri al s : Epi demi ol ogy and Soci al Sci ence 2004; 35 (2): 178-187.
7. Kent D, McGrath D, Loanni di s J, Benni s h M. Sui tabl e Moni tori ngApproaches to Anti retrovi ral Therapy i n Res ource-Poor Setti ngs :Setti ng the Res earch Agenda: Cl i ni cal Infecti ous Di s eas es 2003; 37(Suppl 1):S13–24
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
wi th hi gh di s eas e burden i n devel opi ng countri es . Nov 2002, Ghana.11. Xu D, Lv J, Dong Y, W ang S, Su T, Z hou F, Z ou W , Z hao M, Z hang H. Renal i nvol vement i n al arge cohort of Chi nes e pati
ents wi th Cas tl eman di s eas e: Nephrol . Di al . Trans pl ant 2011; 0: 1-7.
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