Research Methodology

RESEARCH & METHODOLOGY
RESEARCH PROPOSAL
(GASTROENTEROHEPATOLOGY SYSTEM)
NAME: UMMI ASYIQIN BINTI KAMIL

NIM
: C111 12 851
CLASS: INTERNATIONAL-7
LECTURER: Dr.GATOT ST. LAWRENCE
FAKULTAS KEDOKTERAN
UNIVERSITAS HASANUDDIN
MAKASSAR
2014
Experimental
studies
Observational
Studies
Meta-analysis
Study Design
OBSERVATIONAL STUDIES
Descriptive or case series

Case-control studies
Cross-sectional studies
Cohort studies
Historical Cohort studies
EXPERIMENTAL STUDIES
Controlled studies
Studies with no control
META-ANALYSIS
OBSERVATIONAL STUDIES
Descriptive studies are observational studies which describe the patterns of disease occurrence in
relation to variables such as person, place and time. They are often the first step or initial enquiry
into a new topic, event, disease or condition. Descriptive studies can be divided into two roles those studies that emphasize features of a new condition and those which describe the health
status of communities or populations. Case reports, case-series reports, before-and-after
studies,cross-sectional studies and surveillance studies deal with invidiuals. Ecological Studies
examine populations. Common misuses of descriptive studies involve a lack of a clear, specific
and reproducible case definition and establishing a casual relationship which the data cannot
support. Whilst descriptive studies can highlight associations between variables or between
exposure and outcome variables, they cannot establish causality. Descriptive studies do not have
a comparison (control) group which means that they do not allow for inferences to be drawn
about associations, casual or otherwise. However, they can suggest hypotheses which can be
tested in analytical observational studies.
Case series studies

A case series is a descriptive study that follows a group of patients who have a similar diagnosis
or who are undergoing the same procedure over a certain period of time. As there is no
experimental protocol or control for allocation of patients to treatment, surgeons and patients
decide on whether or not treatment is given, making the clinical sample representative of a
common clinical population. Results of case series can generate hypotheses that are useful in
designing further studies, including randomized controlled trials. However, no causal inferences
should be made from case series regarding the efficacy of the investigated treatment. This article
will provide principles for the design, analysis, and reporting of case series, illustrated by
examples from the orthopedic surgical literature.
Case control studies

A case-control study is designed to help determine if an exposure is associated with an outcome
(i.e., disease or condition of interest). In theory, the case-control study can be described simply.
First, identify the cases (a group known to have the outcome) and the controls (a group known to
be free of the outcome). Then, look back in time to learn which subjects in each group had the
exposure(s), comparing the frequency of the exposure in the case group to the control group.
By definition, a case-control study is always retrospective because it starts with an outcome then
traces back to investigate exposures. When the subjects are enrolled in their respective groups,
the outcome of each subject is already known by the investigator. This, and not the fact that the
investigator usually makes use of previously collected data, is what makes case-control studies
retrospective.
Cross-sectional studies
A cross-sectional study is a descriptive study in which disease and exposure statuses are
measured simultaneously in a given population. This study type can be thought of as providing a
"snapshot" of the frequency and characteristics of a disease in a population at a particular point
in time. Data that are collected as part of a cross-sectional study can be used to assess the
prevalence of acute or chronic conditions in a population.For example, A cross-sectional study
can be used to look at the association between obesity and television watching. A sample of
people from the population that you are interested in can be polled and asked about their
height/weight ratio and the number of hours of television the person watches each week. This
study will give insight as to whether obesity and television watching are associated, but it will
not help to determine which might cause the other. In other words, it is not known if obesity
causes more television watching or if more television watching causes obesity.
Cohort studies
The term cohort refers to a group of individuals who have a common feature when they are
assembled and who are followed in time. Therefore, cohort studies begin by ascertaining
exposure among a group of individuals who are free of the outcome of interest and evaluate
participants for incident events that occur with time. Over time, outcomes may occur in both
groups, and the analysis therefore examines the frequency of the outcome in the exposed versus
the unexposed groups. The features of cohort studies allow investigators to define the temporal
sequence between exposure and outcome and avoid the risk of recall bias (i.e., asking those with
or without the outcome of interest to recall a past exposure). Follow-up time should be sufficient
for outcomes to occur. Prospective studies are carried out from the present time into the future
because prospective studies are designed with the specific data collection methods as it has the
advantages of being tailored to collect specific exposure data and may be more complete.
Historical cohort-studies
Retrospective cohort studies,also known as historical cohort studies,are carried out at the present
time and look to the past to examine medical events or out comes.In the other wors,a cohort
studies of subject is selected based on exposure status is chosen at the present time,and the
outcome data(i.e.disease status,event status),which was measured in the past,are reconstructed
for analysis.The primary disadvantages of this study design is the limited control the investigator
has over data collection.The existing data may be complete,inaccurate,or in consistenly measured
between subjects.However,because of the immediate avaibility of the dat,this study design is
comparatively less castly and shorter than prospective cohort studies.
EXPERIMENTAL STUDIES
The experiment is a situation in which a researcher attempts to objectively observe phenomena
which are made to occur in a strictly controlled situation where one or more variables are varied
and the others are held constant. The definition says that we should attempt to make impartial
and unbiased observations in the experimental situation. In short, objectivity is the ideal to which
experimenters strive even though perfect objectivity is impossible to achieve.In experiments
phenomena are made to occur. The phenomena are observable events; they are the conditions
presented to the participants. Specifically, these phenomena or conditions are the levels of the
independent variable that are made to occur (e.g., one group is given a pill and another group is
given a placebo). This is the idea of active manipulation. The idea is that an experimental
researcher does something and then observes the outcome.
Controlled studies VS Uncontrolled studies

In a controlled study, researchers are able to determine which of their subjects receive the factor
that is being tested for having a causal influence upon another factor.The alleged causal factor is
sometimes called the independent variable, while the alleged effect is called the dependent
variable.
Those given the alleged causal factor make up the experimental group, while those who dont
receive such treatment belong in the control group.Ideally, both groups will be balanced with
respect to the subjects.various other characteristics.Often this is achieved simply by randomly
assigning subjects to experimental or control groups.
In a blind study, the subjects do not know whether they are in the control group or not. In
a double blind study, the researchers gathering the data will not know which group a subject
belongs to.Blinding is meant to mitigate placebo effects ,possible confounding of the study by
the subjects or researchers knowledge.
In uncontrolled or observational studies, researchers have no such control over whether their
subjects receive the treatment being investigated.Uncontrolled studies thus are subject to worries
about confounding variables.
META-ANALYSIS
A subset of systematic reviews; a method for systematically combining pertinent qualitative and
quantitative study data from several selected studies to develop a single conclusion that has
greater statistical power. This conclusion is statistically stronger than the analysis of any single
study, due to increased numbers of subjects, greater diversity among subjects, or accumulated
effects and results.
REFERENCES
1. http://www.healthknowledge.org.uk/e-learning/epidemiology/practitioners/introductionstudy-design-css. Retrieved on 4/6/2014.
2. https://onlinecourses.science.psu.edu/stat507/node/54. Retrieved on 4/6/2014
3. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2998589 by Jae W. Song, MD and Kevin
C. Chung, MD, MS. Retrieved on 4/6/2014
4. http://sphweb.bumc.bu.edu/otlt/MPHModules/EP/EP713_AnalyticOverview/EP713_AnalyticOverview3.html.Retrieved on
4/6/2014
5. Clinical Journal of the American Society Of Nephrology August 2006, vol. 1 no. 5
1117-1123Cohort Studies: Marching Forward by Ravi Thadhani and Marcello Tonelli.
6. http://www.drcath.net/toolkit/descriptive.html. Retrieved on 4/6/2014
7. http://practice.sph.umich.edu/micphp/epicentral/cross_sectional.php. Retrieved on
4/6/2014
8. Community Eye Health. 1998; Epidemiology in Practice: Case-Control Studies by Susan
Lewallen, MD and Paul Courtright, Epidemiologic & International Ophthalmology,
University of British Columbia.
9. http://www.ncbi.nlm.nih.gov/pubmed/19411496. Retrieved on 4/6/2014
10. http://himmelfarb.gwu.edu/tutorials/studydesign101/metaanalyses.html. Retrieved on
4/6/2014

Research Methodology

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What are the different types of observational studies discussed?

What is the difference between controlled and uncontrolled studies?

RESEARCH & METHODOLOGY

NAME: UMMI ASYIQIN BINTI KAMIL

Descriptive or case series

Case series studies

Case control studies

Controlled studies VS Uncontrolled studies

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