Research Questions, Objectives, and Hypotheses in Diabetes Management

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Dr.Shaik Shaffi Ahamed
Associate Professor
Department of Family & Community Medicine
 
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Students will be able to
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Learn formulation of research question
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Differentiate between goals & objectives
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Define the specific objectives in terms of
the stated problem
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Describe the study hypotheses
 
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HbA1C < 7% is acceptable as adequate control
 
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How to reduce  the prevalence of DM?
How to increase,  well controlled HbA1c?
 
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All the stated responses will lead towards
the goal of reducing the impact of DM in
Saudi Arabia and each research question
will be answered by stating clear objectives
 
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Do I have, time for this topic at this point during my
course?
Is this really the burning topic for me?
Will this be worth it?
Is this a major and relevant public health problem or
is it too mysterious?
Are my goals/objectives too big ?  Am I covering too
much?
Will available methods answer  my questions?
What are the ethical and human subject issues
here?
 
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A well-defined and specific research
question is the key for making
decisions about study design and
population and subsequently what
type of data will be collected and
analyzed.
 
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IT SHOULD BE  A SINGLE
SENTENCE IN THE FORM OF A
QUESTION.
 
IT SHOULD BE CLEAR,
UNAMBIGUOUS AND SPECIFIC
 
What is a Research Question?
 
Often begins with a general concern
 
Examples:
 
–Should women take hormones to prevent bone loss?
 
–Can a vegetarian diet reverse cardiovascular disease?
 
–Can diabetic patients be taught to control their blood
glucose levels?
 
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Must be narrowed to  measurable and  can able to do research
 
Examples:
 
–Is taking estrogen associated with a lower risk of osteoporosis in
women 60+?
 
–Does a plant-based diet reduce serum cholesterol levels in patients
with cardiovascular disease?
 
–Can a structured intensive diabetes education program help
patients with type 2 diabetes control their blood glucose levels?.
 
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?
 
Be inspired by observing people & practices, by attending
seminars, conferences, & symposia
 
Review local, national, and regional problems
 
Discuss, collaborate and get input from your colleagues
 
Read about the topic, reviews, & research done; to find out
gaps in existing knowledge?
 
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What are the items required to support
feasibility of my research question ?
 
Your background knowledge reflects in the
question
 
Background information (critical appraisal)
stated in intro/background section
 
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Familiarity with the subject helps define an
appropriate research question for a study.
 
Questions arise out of a perceived knowledge deficit
within a subject area or field of study. (pathways of
current knowledge and uncertainty )
 
The challenge in developing an appropriate
research question, is in determining which
uncertainties could or should be studied and also
rationalizing the need for their investigation.
 
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What goes in the research question?
 
Disease or condition of interest
Population
Intervention to be tested
Comparison group(s) -- placebo? Existing
treatment?
Outcome measures
 
Sample research question
 
 
Interest: Should women take hormones to
prevent bone loss?
 
Research question: Does taking estrogen after
menopause reduce the likelihood of bone
density loss in women over 60 years of age,
compared to women not taking estrogen?
 
Sample research question
 
 
Interest: Can a vegetarian diet reduce
cardiovascular disease?
 
Research question: Does an entirely plant-
based (vegan) diet reduce blood serum
cholesterol levels in men over 50 years old
with lipid levels > … compared to a meat-
based diet?
 
Sample research question
 
Interest: Can diabetic patients be taught to
control their blood glucose levels?
 
Research question: Can a structured
intensive diabetes education program help
adult patients with Type 2 diabetes control
their blood glucose levels, compared to
patients receiving standard instructions?
 
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Descriptive: describing a group, exploring
Relational: associations between two
variables in a group
 
Comparable: associations between two or
more variables (differences) in two or more
groups (Causality / prediction / intervention)
 
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management of hepatic failure in patients with
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Is alcoholism related to the development of
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    Is concentration of blood cholesterol directly related
to dietary intake of saturated fat in Saudi population?
    (hereditary?/ dietary/ metabolic ? Reasons in Saudi Population could
differ from other settings)
 
 
    Does daily saturated fat intake by persons with
hypercholesterolemia differ from persons with normal
cholesterol range in Saudi population ?
 
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How good and appropriate is the idea ?
 
Critique appropriateness of your Question
 
 Merit of your question
 
Relationship of proposal to problem
 
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• Adequate number of subjects   • Adequate technical expertise
 
• Affordable in time and money  • Manageable in scope
 
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• To future research
 
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=
 
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It describes the aim of the work in broad
terms ( over a longer time period)
 
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These are more specific and relate directly
to research question. They may be divided
into two types:
 
Primary objectives 
 
(bound to be achieved)
Secondary objectives 
 (by the way)
 
 
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The goal (aim) and objectives must be stated at
the very beginning of the study, since they will
guide the investigator during the process of
formulating research questions and hypothesis.
 
They will also help in the prioritization process.
 
They will enable the reader or consumer of the
work to judge whether the investigator had
achieved these objectives or not.
 
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The research objectives should be:
Closely related to the research question
Covering all aspects of the problem
Very specific
Ordered in a logical sequence
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Achievable, taking into consideration the
available resources and time
Mutually exclusive, with no repetitions or
overlaps
 
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Properly formulated, specific
objectives will facilitate the
development of your research
methodology
 and will help to orient
the 
collection
, 
analysis
, 
interpretation
and 
utilization
 of data.
 
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   To study whether SNP markers are
   associated with obesity and hypertension
phenotypes.
 
   To assess the general population
knowledge &  attitude  towards Organ
donation
 
    To identify the risk factors for Type-II
diabetes
 
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Goal: To reduce risk of cardiovascular diseases in
 
Saudi population by developing evidence based
           interventions
 
   
Question:
 Is dietary intake of saturated fats over the
past xx weeks related to hypercholestrolemia in
Saudi adult population ?
 
Question:
 Is dietary intake of saturated fats over a
period of xx months is associated with risk of
coronary heart disease in Saudi adult population
 
 
 
 
32
 
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 Objective1: 
To determine the daily intake of
saturated fats in the past 4 weeks in Saudi adults
 
 
Objective 2: 
To determine the relationship of dietary
intake of saturated fats and blood levels of low
density lipoprotein (LDL) in Saudi adults
 
 
Objective3: 
To determine the association of dietary
intake of saturated fats and intimal thickness of
coronary artery in Saudi adults
 
 
 
 
33
 
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  “ Research hypothesis is a
statement of the research question
in a measurable form”
 
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A hypothesis can be defined as a prediction or explanation of
the relationship between one or more 
independent variables
(PREDISPOSING/RISK FACTORS) and one 
dependent
variable
 (OUTCOME/CONDITION/DISEASE)).
 
A hypothesis, in other words, translates the problem statement
into a precise, clear prediction of expected outcomes.
 
It must be emphasized that hypotheses are not meant to be
disorganized guesses, but should reflect the depth of
knowledge, imagination and experience of the investigator.
 
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This is based on existing knowledge,
deriving it through critical reading of
literature and facts
 
Descriptive:
It is hypothesized that average daily intake
of saturated fat in Saudi adult population is
more than 20% of the recommended intake
when measured by xxx test and yyy
standards to define dietary saturated fat
intake.
 
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 Objective: 
To determine the relationship of
dietary intake of saturated fats and intimal
thickness of coronary artery
Hypothesis
It is hypothesized that > 20% of recommended saturated
fat intake in Saudi population will be associated with
50% increased intimal thickness of coronary artery when
compared to the normal intimal thickness measured by
XYZ
 
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• We hypothesize that standard care plus new intervention
  (additional  drug) will be superior to standard care alone in
   reducing CVD mortality  by 30% among patients with preexisting
   heart disease.
 
• We hypothesize that prophylaxis with inhaled
   drug A will be superior to oral preparation of
  drug B in preventing acute exacerbation of
  reactive airway disease by 20%.
 
• We hypothesize that low birth weight is an
  independent risk factor for type II diabetes.
 
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Area: Community  medicine
Topic: Communicable diseases- hepatitis
RQ: What is the level of KAP towards hepatitis among
the general population of KSA ?
Goal: To contribute to the reduction of hepatitis in KSA
through studying general population perceptions about
the disease
Objective: To assess the knowledge, attitudes and
practice of the general population towards hepatitis in
KSA.
Hypothesis: It is hypothesized  that the knowledge
attitudes and practice of the general population towards
hepatitis in KSA is less than 50%.
 
 
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Area : Psychiatry
Topic: Body Dysmorphic Disorders ( BDD)
RQ: What is the prevalence of BDD among female medical
students in Riyadh ?
Goal: To contribute, by finding  the prevalence of BDD and its
associated factors in Saudi females
Objective: To  Quantify the prevalence of BDD among female
medical students
Hypothesis: It is hypothesis that, the prevalence of BDD
among female medical students is around 10%.
 
 
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Research area: Cardiology
Research topic: Ischemic heart disease (IHD)
Goal: To contribute to prevention of IHD
Research question: Does hypocholesterolemic agent “A” decrease
the risk of MI?
Primary objective: To determine the effect of reducing LDL on the
occurrence of MI
Secondary objective: To describe the side effects of lowering LDL
 Hypothesis: The risk of MI among patients treated with
hypocholesterolemic agent “A” is lower than the risk among patients
not treated with hypocholesterolemic agents
 
S
u
m
m
a
r
y
 
1.
Perform a systematic literature review to increase knowledge for the
topic
 
2.
Learn about current trends and  advances on the topic.
 
3.
Seek careful input from experts, mentors, colleagues and
collaborators
 
4.
Use the FINER criteria in the development of the research question.
 
5.
Develop clear and well-defined objectives using SMART criteria
 
6.
Ensure that the research question and objectives are answerable,
feasible and relevant.
 
7.
Develop the testable research hypotheses from the research
question.
 
 
 
 
 
 
 
42
 
References
 
Stephen B Hulley.  Designing Clinical Research. 3
rd
 Edition . Wolters Kluwer Health
Lippincott Williams and Wilkins 2007.
 
Daniel P Schuster  & William J Powers.  Translational and Experimental Clinical
Research. Introduction: Lippincott Williams and Wilkins 2005.
 
Cummings SR, Browner WS, and Hulley SB. “Conceiving the research question.” In
Hulley SB, Cummings SR, Browner WS, Grady D, Hearst N, and Newman TB.
Designing Clinical Research. 2nd edition. Philadelphia: Lippincott Williams &
Wilkins, 2001.
 
Fletcher RH, Fletcher SW, Wagner EG. Clinical Epidemiology: the essentials. 3rd
edition. Baltimore: Williams and Wilkins, 1996.
 
Sackett DL, Haynes RB, Guyott GH, Tugwell, P. Clinical Epidemiology: a basic
science for clinical medicine. 2nd edition. Boston: Little, Brown and Company, 1991.
 
 
 
43
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Explore the formulation of research questions, setting study objectives, and defining hypotheses in the context of diabetes mellitus management. Delve into the prevalence of diabetes in Saudi Arabia, glycemic control in diabetic patients, and addressing key research questions to reduce the impact of diabetes in the region.

  • Research
  • Diabetes Management
  • Objectives
  • Hypotheses
  • Saudi Arabia

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  1. Research Question, Objectives & Hypotheses Dr.Shaik Shaffi Ahamed Associate Professor Department of Family & Community Medicine

  2. SESSION OBJECTIVES Students will be able to 1. Learn formulation of research question 2. Differentiate between goals & objectives 3. Define the specific objectives in terms of the stated problem 4. Describe the study hypotheses 2

  3. Ref: Prevalence of diabetes mellitus (DM) in a Saudi community. Ann Saudi Med. 2011 Jan-Feb;31(1):19-23 3

  4. Glycemic control in diabetic patients KKUH January December 2009 Al-Rowais NA Saudi Pharmaceutical Journal (2014) 22, 203-206 % HbA1C < 7% is acceptable as adequate control 4

  5. What research questions come to your mind? How to reduce the prevalence of DM? How to increase, well controlled HbA1c? What other research questions can arise ? All the stated responses will lead towards the goal of reducing the impact of DM in Saudi Arabia and each research question will be answered by stating clear objectives 5

  6. Ask following questions initially Do I have, time for this topic at this point during my course? Is this really the burning topic for me? Will this be worth it? Is this a major and relevant public health problem or is it too mysterious? Are my goals/objectives too big ? Am I covering too much? Will available methods answer my questions? What are the ethical and human subject issues here? 6

  7. Research Question A well-defined and specific research question is the key for making decisions about study design and population and subsequently what type of data will be collected and analyzed. 7

  8. RESEARCH QUESTION IT SHOULD BE A SINGLE SENTENCE IN THE FORM OF A QUESTION. IT SHOULD BE CLEAR, UNAMBIGUOUS AND SPECIFIC

  9. What is a Research Question? Often begins with a general concern Examples: Should women take hormones to prevent bone loss? Can a vegetarian diet reverse cardiovascular disease? Can diabetic patients be taught to control their blood glucose levels?

  10. What is a Research Question? Must be narrowed to measurable and can able to do research Examples: Is taking estrogen associated with a lower risk of osteoporosis in women 60+? Does a plant-based diet reduce serum cholesterol levels in patients with cardiovascular disease? Can a structured intensive diabetes education program help patients with type 2 diabetes control their blood glucose levels?.

  11. How & from where to get ideas to formulate a Research Question ? Be inspired by observing people & practices, by attending seminars, conferences, & symposia Review local, national, and regional problems Discuss, collaborate and get input from your colleagues Read about the topic, reviews, & research done; to find out gaps in existing knowledge? 11

  12. REQUIREMENTS What are the items required to support feasibility of my research question ? Your background knowledge reflects in the question Background information (critical appraisal) stated in intro/background section 12

  13. Subject knowledge Familiarity with the subject helps define an appropriate research question for a study. Questions arise out of a perceived knowledge deficit within a subject area or field of study. (pathways of current knowledge and uncertainty ) The challenge in developing an appropriate research question, is in determining which uncertainties could or should be studied and also rationalizing the need for their investigation. 13

  14. What goes in the research question? Disease or condition of interest Population Intervention to be tested Comparison group(s) -- placebo? Existing treatment? Outcome measures

  15. Sample research question Interest: Should women take hormones to prevent bone loss? Research question: Does taking estrogen after menopause reduce the likelihood of bone density loss in women over 60 years of age, compared to women not taking estrogen?

  16. Sample research question Interest: Can a vegetarian diet reduce cardiovascular disease? Research question: Does an entirely plant- based (vegan) diet reduce blood serum cholesterol levels in men over 50 years old with lipid levels > compared to a meat- based diet?

  17. Sample research question Interest: Can diabetic patients be taught to control their blood glucose levels? Research question: Can a structured intensive diabetes education program help adult patients with Type 2 diabetes control their blood glucose levels, compared to patients receiving standard instructions?

  18. Types of Research Questions Descriptive: describing a group, exploring Relational: associations between two variables in a group Comparable: associations between two or more variables (differences) in two or more groups (Causality / prediction / intervention) 18

  19. RESEARCH QUESTIONS(examples) What is the level of knowledge of Biostatistics among 3rd year medical students ? Is drug A better than drug B in the management of hepatic failure in patients with Cirrhosis? Is alcoholism related to the development of Cirrhosis liver?

  20. Relational & Comparable Is concentration of blood cholesterol directly related to dietary intake of saturated fat in Saudi population? (hereditary?/ dietary/ metabolic ? Reasons in Saudi Population could differ from other settings) Does daily saturated fat intake by persons with hypercholesterolemia differ from persons with normal cholesterol range in Saudi population ? 20

  21. Evaluation of Research Question How good and appropriate is the idea ? Critique appropriateness of your Question Merit of your question Relationship of proposal to problem 21

  22. GOOD RESEARCH QUESTION Feasible: Interesting: Novel: Ethical: Relevant: 22

  23. FINER criteria: a good research question F Feasible Adequate number of subjects Adequate technical expertise Affordable in time and money Manageable in scope I Interesting Getting the answer intrigues investigator, peers & community N Novel Confirms, refutes or extends previous findings E Ethical Amenable to a study that institutional review board (IRB) will approve R Relevant To scientific knowledge To future research To clinical and health policy 23

  24. Goals and Objectives Goals Objectives =

  25. Goals It describes the aim of the work in broad terms ( over a longer time period)

  26. Objectives These are more specific and relate directly to research question. They may be divided into two types: Primary objectives (bound to be achieved) Secondary objectives (by the way)

  27. Research Goal & Objectives The goal (aim) and objectives must be stated at the very beginning of the study, since they will guide the investigator during the process of formulating research questions and hypothesis. They will also help in the prioritization process. They will enable the reader or consumer of the work to judge whether the investigator had achieved these objectives or not.

  28. Research Objectives The research objectives should be: Closely related to the research question Covering all aspects of the problem Very specific Ordered in a logical sequence Stated in action verbs that could be evaluated e.g. to describe, to identify, to measure, to compare, etc. Achievable, taking into consideration the available resources and time Mutually exclusive, with no repetitions or overlaps

  29. SMART Objectives S Specific M Measurable A Achievable R Relevant T Time-bound

  30. Research objectives Properly formulated, specific objectives will facilitate the development of your research methodology and will help to orient the collection, analysis, interpretation and utilization of data.

  31. Objective -examples To study whether SNP markers are associated with obesity and hypertension phenotypes. To assess the general population knowledge & attitude towards Organ donation To identify the risk factors for Type-II diabetes

  32. Example Goal: To reduce risk of cardiovascular diseases in Saudi population by developing evidence based interventions Question: Is dietary intake of saturated fats over the past xx weeks related to hypercholestrolemia in Saudi adult population ? Question: Is dietary intake of saturated fats over a period of xx months is associated with risk of coronary heart disease in Saudi adult population 32

  33. Example contd. Objective1: To determine the daily intake of saturated fats in the past 4 weeks in Saudi adults Objective 2: To determine the relationship of dietary intake of saturated fats and blood levels of low density lipoprotein (LDL) in Saudi adults Objective3: To determine the association of dietary intake of saturated fats and intimal thickness of coronary artery in Saudi adults 33

  34. Research Hypothesis Research hypothesis is a statement of the research question in a measurable form

  35. Research Hypothesis (cont.) A hypothesis can be defined as a prediction or explanation of the relationship between one or more independent variables (PREDISPOSING/RISK FACTORS) and one dependent variable (OUTCOME/CONDITION/DISEASE)). A hypothesis, in other words, translates the problem statement into a precise, clear prediction of expected outcomes. It must be emphasized that hypotheses are not meant to be disorganized guesses, but should reflect the depth of knowledge, imagination and experience of the investigator.

  36. Hypothesis formulation This is based on existing knowledge, deriving it through critical reading of literature and facts Descriptive: It is hypothesized that average daily intake of saturated fat in Saudi adult population is more than 20% of the recommended intake when measured by xxx test and yyy standards to define dietary saturated fat intake. 36

  37. Hypothesis formulation Objective: To determine the relationship of dietary intake of saturated fats and intimal thickness of coronary artery Hypothesis It is hypothesized that > 20% of recommended saturated fat intake in Saudi population will be associated with 50% increased intimal thickness of coronary artery when compared to the normal intimal thickness measured by XYZ 37

  38. Hypothesis-examples We hypothesize that standard care plus new intervention (additional drug) will be superior to standard care alone in reducing CVD mortality by 30% among patients with preexisting heart disease. We hypothesize that prophylaxis with inhaled drug A will be superior to oral preparation of drug B in preventing acute exacerbation of reactive airway disease by 20%. We hypothesize that low birth weight is an independent risk factor for type II diabetes.

  39. Example 1: (KAP Study) Area: Community medicine Topic: Communicable diseases- hepatitis RQ: What is the level of KAP towards hepatitis among the general population of KSA ? Goal: To contribute to the reduction of hepatitis in KSA through studying general population perceptions about the disease Objective: To assess the knowledge, attitudes and practice of the general population towards hepatitis in KSA. Hypothesis: It is hypothesized that the knowledge attitudes and practice of the general population towards hepatitis in KSA is less than 50%.

  40. Example 2 ( Cross sectional study) Area : Psychiatry Topic: Body Dysmorphic Disorders ( BDD) RQ: What is the prevalence of BDD among female medical students in Riyadh ? Goal: To contribute, by finding the prevalence of BDD and its associated factors in Saudi females Objective: To Quantify the prevalence of BDD among female medical students Hypothesis: It is hypothesis that, the prevalence of BDD among female medical students is around 10%.

  41. Example 3: (Interventional Study) Research area: Cardiology Research topic: Ischemic heart disease (IHD) Goal: To contribute to prevention of IHD Research question: Does hypocholesterolemic agent A decrease the risk of MI? Primary objective: To determine the effect of reducing LDL on the occurrence of MI Secondary objective: To describe the side effects of lowering LDL Hypothesis: The risk of MI among patients treated with hypocholesterolemic agent A is lower than the risk among patients not treated with hypocholesterolemic agents

  42. Summary Perform a systematic literature review to increase knowledge for the topic 1. Learn about current trends and advances on the topic. 2. Seek careful input from experts, mentors, colleagues and collaborators 3. Use the FINER criteria in the development of the research question. 4. Develop clear and well-defined objectives using SMART criteria 5. Ensure that the research question and objectives are answerable, feasible and relevant. 6. Develop the testable research hypotheses from the research question. 7. 42

  43. References Stephen B Hulley. Designing Clinical Research. 3rd Edition . Wolters Kluwer Health Lippincott Williams and Wilkins 2007. Daniel P Schuster & William J Powers. Translational and Experimental Clinical Research. Introduction: Lippincott Williams and Wilkins 2005. Cummings SR, Browner WS, and Hulley SB. Conceiving the research question. In Hulley SB, Cummings SR, Browner WS, Grady D, Hearst N, and Newman TB. Designing Clinical Research. 2nd edition. Philadelphia: Lippincott Williams & Wilkins, 2001. Fletcher RH, Fletcher SW, Wagner EG. Clinical Epidemiology: the essentials. 3rd edition. Baltimore: Williams and Wilkins, 1996. Sackett DL, Haynes RB, Guyott GH, Tugwell, P. Clinical Epidemiology: a basic science for clinical medicine. 2nd edition. Boston: Little, Brown and Company, 1991. 43

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