Elements of Research

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Elements of Research

IC
Elements of Research
• The research Question • Result or Outcome
• Hypothesis • Internal Validity
• Randomization • External Validity
• Population • Variable
• Sample • Random Allocation
• Sampling • Informed consent
• Maneuver • Reproducibility
• Instrumentation • Risks
• Data gathering
The research question
• The main question that your study sought or is seeking to answer.
• A clear research question guides your research paper or thesis and
states exactky what you want to find out, giving your work a focus and
objective.
• The best research question should specify just one measurable result, as
well as all the conditions and important variables.

The question contains population, maneuver or the conditions


affecting the study population, and the results.
Examples
• How does human growth hormone mimic the action of testosterone?
• What is the relationship between baldness and age?
• Is it possible that VEGF has an effect in plant photosynthesis?

Vascukar endothelial growth factor


research topic or research question
• “The effects of meditation on stress reduction”
• How does mediation impact stress, anxiety, and burnout in the
workplace.

• The understanding of the leadership style of a particular company.


• Studying the best factors of pricing strategies.
• A study of how stress affects labor productivity
• Understand the client’s level of satisfaction before certain interactions
with the company providing solutions.
Writing tips
• Be clear and provide specific information
• Be focused in its scope
• Be original
• Be ethical
• Be relevant and concise
• main ideas in as few words as possible
• Be precise and complex
• enough that it does not simpply answer a closed “yes or no” question, but requires an
analysis or arguments and literature
• Be arguable or testable
• .open to scrutiny and specific questions
Hypothesis
• Assumption, based on observation or reflections, which may lead to
refutable predictions.
• Also a conjecture drawn up so that it can be tested and refuted.

- a statement about an expected relationship between variables, or


an explanation of an occurence, that is clear, specific and testable
Types of hypothesis
Null hypothesis:
Hypothesis that there is no difference between the two groups ( for
example, two treatments)

• Alternative Hypothesis:
• Generally this is defined as stating the null hypothesis (there are no
differences) is not true.
• If the objective of the trial is to compare a drug with placebo, the null
hypothesis will state that there is no difference between the two
groups, and the alternative hypothesis that there is a difference.
Hypothesis
• Daily apple consumption leads to fewer doctor’s visits.
• Daily exposure to the sun leads to increased levels of happiness.

Do students who attend more lectures get better exam results?

after some preliminary research:


Attending more lectures leads to better exam results

When both groups differ in substantially, the null hypothesis is very


improbable.
Randomization
• Ideally, a process which ensures that each member of a population
has an equal chance of being included in the study sample. This is not
always possible.
More importantly, randomization means that the patients of the study
are allocated to treatment or placebo groups for the experiment,
without taking into account any of the patients’ characteristics or the
desires of the study personnel.
Population
• Every person who meets the inclusion criteria for the study.

• Group of people with a defined characteristic ( white females) or who


meet a defined requirement ( people who live in Andalucia)

Accessible population:
Refers to a Selected group of individuals or elements from target
population
Example
• Reasoning and IQ Level of PhD students in Caraga

• Accessible population
• Caraga State University, North Eastern Mindanao State University,
• Saint Paul University
Sample
• The people who meet the inclusion of the study and who actually are
incorporated into the study. A subset of the population.

• Selected fraction of a certain population, ideally representative of the


reference population and of a large enough size. Subgroups of
observation of the study population.
Sampling
• Selection of the subjects of a population who will take part in a study.

• Once the population for a clinical trial has been defined, the
participants should ideally be selected randomly, that is, in such a way
that each potential participant of the population under study has the
same probabilities of being included in the sample.

This rarely happens because the people identified as elemets of the


reference population may have some characteristics which make them
specifically identifiable.
Manoeuvre
• Any exposure or treatment which acts on the patients to produce a
result.
• Manipulation or control measures
Result or Outcome
• The effect of a manoeuvre.
• The term is also used to designate pre-determined variables in a
clinical trial (for example, cardiovascular mortality + reinfarction, in
clinical trials with patients who have suffered a myocardio infarction)
Internal Validity
• Are the result of a study valid for the patient population studied?

• The degree to which the experimental and reference groups have


been formed and compared in such a way that the differences
observed between them in the dependent variables studied can be
attributed solely to the intervention under investigation.
External Validity
• Are the results valid outside the population of patients studied> Are
the results of the studies done in men valid for women?

• Degree to which the conclusions obtained with the sample of the


population which participates in a study can be generalized to its
reference population or to other populations, places, times and
researchers.
Variable
• Any attribute, phenomenon or fact which may have different values. A
property of an individual which can be observed; for example, height,
weight, sex; this property varies from one individual to another.

There are three levels of precision in the measurement of a variable:


nominal, ordinal, and interval.
Levels of Measurement
• Nominal – the simplest level, values assumed by a variable at this
level indicate simply categories (for example, sex, treatment group,
job position, civil status, etc)
• Ordinal – Variables can also be rank ordered, for example, according
to the level of dose, categories of treatment duration, or according to
social class; year level, performance level, etc

Interval – variables which can not only be ordered but which also
permit the measurement of the distance between categories (for
example, height, weight, blood pressure, volume, etc)
Types of Variable
• Dichotomous – can only take two possible values
• Nominal – can take several values
• Ordinal - can take several values and in which a ranking between the
categories can be established.
• Quantitative – can take a numerical range of values.
• Censored – a quantitative variable which can take partial or
incomplete information (time until something occurs in Analysis of
survival).
Types of Variable
• Categorical variable - (discrete variable) – variable that can have
interruptions
• Being in a categorical level, there is a value among several potentially
observable values which can not be observed.
• Binary variable – variable or result which can only take one of two
possible values.
• Continuous variable –a variable is continuous if between two
observable values, there is always the possibility of there being
another observable value; it does not present interruptions (age,
height, weight, area)
Types of Variable
• Dependent variable – variable whose value depends on the effect of
another or other variables (independent variable)
• Manifestation or result, the value of which is explained of justified by
the influence of independent variables, especially by a regression model
• In statistics, the variable which can be predicted by means of a
regression equation.
• Independent variable – characteristic whose influence on a fact or a
manifestation is assumed (the dependent variable).
• In statistics, the independent variable is one of the elements of a
regression equation.
Types of Variable
• Intermediate variable (Contingency) – variable present in a causal
chain from an independent variable to another dependent one.
• It determines the dependent variable, but at the same time is the
object of modification by the independent variable and
simultaneously associates with both.
Random Allocation
• In a study in which two or more types of treatment are compared, it is
advisable for the groups formed to be similar in all the prognostic
characteristics except in the clinical course which is recorded can be
attributed to the different treatments administered (and only to
them).

Random allocation consists of distributing each participant to one of


the treatment groups by means of a random method, so that each
subject has exactly the same probabilities of forming part of one
treatment group or another.
Random Allocation
• The patients of one group have, on average, the same probability of
possessing a certain characteristics as those of the other group; this
occurs with all the prognostic factors known or unknown.

When the number of patients included in a clinical trial is limited,


random allocation may determine the formation of somewhat
different groups; this is less probable the greater the number of
patients.
Random Allocation
• With a view to evaluating whether random allocation has been
carried out by chance, the distribution of the prognostic
characteristics known in each group should be compared at the end
of the trial.
• Most publications about clinical trials contain a comparative table of
these characteristics.
Random Allocation
• In order to prevent unequal distribution of the prognostic
characteristics in each group, an allocation in block can be carried out
or the known differences can be corrected with a stratified analysis or
with a regression analysis.
• Random allocation is the defining characteristics of controlled clinical
trials, and differentiates these trials from cohort studies.
Stratified Random allocation
• A method whereby, before random allocation, the patients are
included in subgroups (strata) of similar prognostic characteristics and
are then allocated randomly, separately for each stratum, to each of
the type of treatment.
• In this way, the final treatment groups and sub groups formed are
comparable, at least in terms of the factors which have been
considered when forming the blocks or strata.
Stratified Random
• For example, the risk of cardiovascular complication associated with
high blood pressure is greater in diabetic patients, but it might also
happen that a group of antihypertensive drugs may produce more
undesirable effects among the diabetic patients.
In a clinical trial on antihypertensive drugs, a general random
allocation can be made, or diabetic and non-diabetic patients may be
allocated separately to each type of treatment; in both cases, the
results in diabetic and non-diabetic patients could be analyzed
separately.
Nevertheless, results will have greater validity if the allocation has
been carried out separately, than if only an analysis of subgroups were
made.
Block Random allocation
• Random allocation applied to successive groups of patients (for
example, groups of four, groups of ten, etc.), with a view to
preventing imbalances between groups in the case of intermediate
analysis or interruption of the trial.
Random allocation by Minimization
• 1. Identifying the relevant variables which are to be distributed in a
well-balanced way to both treatment groups (for example, in a clinical
trial on the treatment of acute myocardial infarction, age, smoking
habit, antecedents of coronary heart disease and diabetes).
• 2. Forming strata according to the variables of interest ( in the
example, patients under 70 or 70 and over, smokers or non-smokers,
with ot without antecedents of coronary heart disease, and diabetics
or non- diabetics).
minimization
• 3. Counting for each stratum, how many patients have been allocated
to each of the types of treatment.
• 4. Adding the patients included in each of the stratum in one or other
type of treatment.
• 5. Allocating new patients to the type of treatment in which the
subjects of their characteristics are least represented.
Alternate allocation
• In a clinical trial with two groups, method of treatment allocation in
which the first patient receives treatment A, the second patient
receives the alternative B, the third patient treatment A, the fourth
one B, and like this successively, in a predictable way.

This type of allocation is not optimum (it generally means that the
researcher knows which technique, A or B, corresponds to the next
patient ) and therefore can give rise to unequal groups and it is rarely
compatible with maintaining the double blind- character of a trial.
Cancelled allocation
• Process described in such a way that it gives reason to believe that
adequate measures were taken to conceal the allocation of patients
to each group from the people in charge of evaluating the patients
(for example, centralized random allocation, use of numbered,
opaque and sealed envelopes contained in a sealed bag, use of
numbered or encoded flasks and other recipients or other
descriptions with elements which ensures concealment).
Informed consent
• Formal procedure to apply the principle of autonomy
• It should include at least three elements: voluntariness, information,
and comprehension.

Voluntariness means that the subject can decide freely if they want
to participate in a study, without without there being persuasion
(that is, when they are induced to “freely accept” attitudes, values,
intentions or actions),manipulation real options, or their perception
of choice or coercion.
Informed consent
• The voluntary character of consent can be infringed when it is
requested by people in authority or who have great influence over
the subject of the research and when there is not “enough” time for
the subject to reflect, consult and decide.

The information should be understandable and should include the


objective of the study and its procedure, the potential benefits and
risks, the possible inconveniences derived from the participation and
the possibility of withdrawing from the study at any time without
causing prejudice.
Reproducibility
• With reference to a test, degree to which a the result are identical or
closely similar every time the test is carried out.

Consistency

Reliability
Risks
• Absolute risk - Term used with different meanings depending on the
school of epidemiology, which should consequently be avoided.
• Attributable risk – Etiologic fraction.
• Proportion of all the cases of a disease which are attributable to a
certain risk factor.
• Proportion of exposed cases which is attributable to a certain risk
factor

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