Objective Setting/Hypothesis Formulation/Identification of Variables/Bias and Confounders (trans 3)

Question 1

PLANNING THE RESEARCH PROCESSES

Answer 1

1) Research Problem Identification
2) Conversion of Research Problems to Research Objectives
3) Hypothesis Formulation
4) Methods
5) Administrative Plans
6) Implementation

Question 2

PLANNING THE RESEARCH PROCESSES - Research Problem Identification

 source of research objectives and hypotheses

 statement should be in QUESTION FORM

 Stating the problem starts with knowing how to ask a question then including the important events that you would like to know more or know about, considering all the criteria in identifying the problem (INREF/FINER)

 Main problem and sub-problems have to be created

 Sub-problems: the various facets of the problem

Answer 2

a) Literature Review
b) Significance

Question 3

PLANNING THE RESEARCH PROCESSES - Research Problem Identification

**Literature Review - without this, you will not know what research question to develop

Answer 3

o What is the purpose of doing the research?
o Novel ideas: something that could contribute to an increase in amount of knowledge or something that would help you in the practice of medicine. “New knowledge”.
o “There is no use in re-inventing the wheel.” If a topic has been studied, there is no use in replicating it – waste of time and resources.

Question 4

PLANNING THE RESEARCH PROCESSES - Research Problem Identification

**Significance – other than interesting and novel, it should also have significance to the country or the practice of medicine

Answer 4

o Topics should be related to the practice of medicine, the medical field, and the medical education.
o Time constraint and money (feasibility) should be considered
o Is this a moral issue? Be sure that the topic is ethical.

Question 5

PLANNING THE RESEARCH PROCESSES - Conversion of Research Problems to Research Objectives

Answer 5

 Be able to define your variables. Identify what variables are to be estimated or measures in the research. These variables should be expressed in measurable terms.

 The measurable way of expressing your variables is through indicators.

 Descriptive statistics and inferential statistics tells about the research outcome. Descriptive statistics (“describe”) are used to DESCRIBE DATA. Inferential statistics (“infer) are used to DRAW CONLUSION based on data.

 General objective - general or main problem

 Sub-problems - specific objectives; questions in declarative form

Question 6

PLANNING THE RESEARCH PROCESSES - Hypothesis Formulation

Answer 6

 statement that needs to be tested
 T-test, multiple regression, etc. are some statistical hypothesis tests
 When you’re doing a descriptive study, there’s no need to test your hypothesis. However, we need to create a hypothesis for purposes of estimating the sample size
 The figures stated in the hypothesis allow you to generate the materials or numbers needed in the computation of the sample size
o SSE (Sample Size Estimation) will provide the number of evaluable subjects required for achieving desired statistical significance for a given hypothesis (PubMED, 2010). Statistical significance is when a result or a relationship between variables is caused by something and not just due to mere random chance.

Question 7

PLANNING THE RESEARCH PROCESSES - Administrative Plans

Answer 7

 Line of activities, budget, approval of budget, sourcing of materials, management of other resources (human resources)

 Gantt chart – horizontal bar chart containing tasks, and schedule of activities

 Budget, resources, funding

Question 8

VARIABLES

 should be expressed in measurable terms – such as various indices studied in Epidemiology (e.g. prevalence, morbidity)
 are characteristics or events that vary (e.g., age, gender, onset of drug action)
 are factors, or outcomes of interest in a research or investigation

Answer 8

EXAMPLE: Cross-sectional Study of Diseases of the Heart in Barangay San Perfecto, SJ, in 2014

o based on the question, the study is Descriptive because the title is telling us that we are going to merely study the heart diseases found in the barangay at one point in time (Cross-sectional). (Analytical study, is about the relationship between EXPOSURE and OUTCOME.)

o Questions to be formulated for this study include:
 What are the diseases of the heart in Brgy. San Perfecto? => answers PERSON
 How frequently does one specific heart disease occur in Brgy. San Perfecto? => answers TIME

o If the study seeks to associate risk factors (exposure/cause) and the occurrence of heart diseases (outcome or effect), it would now be an analytical study.

o Descriptive Statistics that can be obtained for this study: Prevalence Rate, Age- and Gender-Specific Prevalence Rate, Mortality Rate, Proportionate Mortality Rate (PMR) in relation to the various diseases of the heart: CAD, RHD, CHD, etc.

Question 9

REMEMBER

• Descriptive studies characterize who (PERSON), where (PLACE), or when (TIME) in relation to what (outcome)

Answer 9

• Analytical studies tests hypothesis about the relationship between EXPOSURE (cause) and OUTCOME (effect)

Question 10

VARIABLES - INDEPENDENT VARIABLE (IV)

 Precursor/exposure/cause
 “Independent” – can stand alone, it is not changed by other variables

Answer 10

EXAMPLE:

Cigarette smoking

Question 11

VARIABLES - DEPENDENT VARIABLE (DV)

 outcome/effect
 “Dependent” – responds to the independent variable; it is what is being measured in the research

Answer 11

EXAMPLE:

COPD (chronic obstructive lung disease)

Question 12

VARIABLES - CONFOUNDER/CONFOUNDING VARIABLE

 associated with IV and DV; we must equalize its occurrence to be able to crystallize the effect of IV to DV

Answer 12

EXAMPLE:

Pollution (exposure to pollution may also cause COPD)

Question 13

VARIABLES - UNIVERSAL VARIABLE

 usually demographic variables that are neither the independent nor the dependent variable but are essential to the description of the subjects

Answer 13

EXAMPLE:

Age

Note: Age can also be an independent variable. Classifying variables as to IV, DV, etc, differ across studies depending on the study objectives. Hence, an independent variable may be such in one study but it can also be a dependent variable in another. Age, however, can never be a dependent variable because it is something that we cannot change.

Question 14

REMEMBER

 If the problem deals with the DESCRIPTION of an event or characteristic, use a variable that describes the event or characteristic of interest. (Descriptive Study)

Answer 14

 If the problem deals with ASSOCIATION/RELATIONSHIP between factor and an outcome, the independent and dependent, possible confounding variables should be expressed. The dependent variables are indices that reflect association between the variables. (Analytical Study)

Question 15

VARIABLES - CONFOUNDERS

 Variables other than the independent and dependent variable that obscure the true relationship between the main study variables
 Co-vary in the study groups
 Associated with both the independent and dependent variables but are not considered part of the pathways of the outcome or disease

Answer 15

Four Characteristics of a Confounder

a) Associated with both independent and dependent variable
b) Co-varies in the study groups
c) Not part of the pathway of the outcome variable
d) Not the independent nor dependent variable

Question 16

RESEARCH OBJECTIVES

 proper formulation of general and specific objectives
 expressed as concise & clear statements
 what the researchers expect to measure or observe and what the study aims to achieve
 objectives are derived form the research problem

Answer 16

Why formulate research objectives?

1) provide focus or direction of the study
2) specify the measures/estimates that need to be derived or observed
3) identify and express study variables in measurable terms, as indicators
4) discern the study design suitable for the study
5) avoid collection of non-pertinent data

Question 17

TYPES OF OBJECTIVES

General Objective
 summarizes the study aim/goal in general terms

Formulation of a general objective:

1. Review and analyze the general research problem
2. Identify the study variables
3. Convert each of the main research question to a declarative statement by introducing it with a run-off phrase. “To determine…”

Answer 17

Specific Objectives
 facets/components of the general objective
 logically connected components of the general objective
 variables are expressed specifically as indicators, statistics or something measurable
 should be achievable and realistic

Fomulation of Specific Objectives (7 steps):
1. Review the subproblem
2. Identify the variables that need to be measured
3. Convert and express these variables in measurable terms (use the appropriate index/indicator for the outcome measure). This step makes the statement more “specific”.
4. For analytic designs, the outcome variables need to be compared between the study groups
5. Convert the subproblems into declarative statements introduced by the run-off phrase “To determine”
6. Analyze the statement, make sure that this is realistic or achievable
7. Put a specific time frame when appropriate
o In a relevance rate study there should be a time frame
o In a relationship study, no need for a time frame

Question 18

EXAMPLE 1: To determine the magnitude and extent of CAD (Coronary Artery disease) in Metro Manila in 2015 (Descriptive Study)

Research Problem
- What is the magnitude of CAD in Metro Manila?

Answer 18

Subproblems
 How many new CAD cases are seen within the year 2015? *
 How many deaths*?
 How fatal is it?*
 What is the distribution of these cases according to:
 Age
o Gender
o Place of residency/barangay
o Time : 12 month period
*must be expressed in terms of appropriate indicators (prevalence, mortality, case fatality,)

Question 19

EXAMPLE 1: To determine the magnitude and extent of CAD (Coronary Artery disease) in Metro Manila in 2015 (Descriptive Study)

Specific objectives appropriate for these subproblems
 How many new cases are seen within a year?How many deaths? How fatal is the disease? What are the risks of getting and dying from this disease?
Converting to Specific objectives:
 INCIDENCE RATE
 MORTALITY RATE
 CASE FATALITY RATE of CAD in Metro Manila in 2015

Answer 19

 What is the distribution of these cases according to: Age, Gender, Place of residency/barangay, Time: 12-month peroid?
Converting to Specific objectives:
 To determine the proportion (in %) of CAD cases according to age groups
 To determine the % distribution of cases according to gender
 To determine the % distribution og cases by the place of residence or barangays
 To determine the 12 month incidence trend of the disease.

Question 20

EXAMPLE 2: Euphorbia hirta decoction as an adjuvant in the treatment of Dengue among pediatric cases (Analytical Study)

Research Problems/Questions
 How effective is intake of Euphorbia hirta decoction as an adjuvant in the treatment of Dengue among pediatric cases?

 What clinical changes are observed in patients who
take E. hirta decoction?
o Is there a significant increase in the platelet count of patients who take the decoction?
o Is the average change in platelet count per day higher?
o At what time/day after inatke of the preparation is a significant increase in platelet count observed?

Answer 20

Converting Research question to General Objectives
Research Question
 How effective is intake of Euphorbia hirta decoction in the management of Dengue among pediatric cases?
Research General Objectives
 To determine the effects of Euphorbia hirta decoction on the platelet profile of dengue patients
 To determine if there is a significant difference in the platelet changes observed among Dengue patients taking E. hirta as an adjuvant compared to those of the control group
Research Specific Objectives
 To determine if there is a significant difference in the average platelet count of patients taking E. hirta compared to the control group

 To determine if the mean platelet count increases/day is higher in the E. hirta group compared to the control group
 To determine if the time of onset of platelet count increase occurs earlier in the E. hirta group comapred to the control group

Question 21

HYPOTHESIS

 “Answer to your question”
 probable explanations or answers to the research problem
 predictions of a relationship between one or more factors (and outcome if an analytic study)
 hypotheses are formulated for a) statistical testing in the analysis stage and b) for estimating figures needed for sample size determination

Answer 21

KINDS OF HYPOTHESES
1) Null hypothesis – states that there is no difference (in the variable being measured) between the study groups
2) Alternative hypothesis – states that one group has a higher or lower estimate compared to the other group
 One sided
o one group has higher estimate compared to the other
o lower sample size requirement
o for drug trials (one is better than the other)
 Two sided
o on both ends of each spectrum, one is higher or the other is lower
o higher sample size requirement
o “There is a difference”

Question 22

EXAMPLE:

General Objective
To determine if there is a significant difference in the platelet changes observed among Dengue patients taking E. hirta compared to those of the control group

Specific objectives and Hypotheses

 To determine if there is a significant difference in the average platelet count of patients taking E. hirta compared to the control group

Answer 22

o Null Hypothesis: There is no significant difference between the average platelet count of patients taking E. hirta decoction and patients who are not taking the decoction (the control group).
o Alternative Hypothesis (one sided): The average platelet count of patients taking E. hirta is significantly higher than the platelet count of those who are not taking the decoction (control group).

Question 23

EXAMPLE:

General Objective
To determine if there is a significant difference in the platelet changes observed among Dengue patients taking E. hirta compared to those of the control group

Specific objectives and Hypotheses

 To determine if the increase in mean platelet count per day is higher in the E. hirta group compared to the control group

Answer 23

o Null Hypothesis: There is no statistically significant difference in the mean platelet count increase per day between the E. hirta group and the control group.

o Alternative Hypothesis: There is a statistically significant difference in the mean platelet count increase per day between the E.hirta group and the control group.

Question 24

EXAMPLE:

General Objective
To determine if there is a significant difference in the platelet changes observed among Dengue patients taking E. hirta compared to those of the control group

Specific objectives and Hypotheses

 To determine if the time of onset (expressed as day of illness) of platelet count increase occurs earlier in the E. hirta group compared to that of the control group

Answer 24

o Null Hypothesis: There is no statistically significant difference in the time of onset (expressed as day of illness) of platelet count increase between the E. hirta group and the control group.
o Alternative Hypothesis: There is a statistically significant difference in the time of onset (expressed as day of illness)of platelet count increase between the E.hirta group and the control group.