Research Methods

M. Sc. Students

29-11-2020

Types of Study in Medical Research

Assist. Prof. Dr. Dyary Hiewa

College of Veterinary Medicine

University of Sulaimani
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Objectives of Research
The prime objectives of doing research are
1. to discover new facts,
2. to verify and test important facts,
3. to analyze an event or process or phenomenon to identify the cause and effect relationship,
4. to develop new scientific tools, concepts, and theories to solve and understand scientific and
nonscientific problems, and
5. to find solutions to scientific, nonscientific, and social problems.

Research Questions
Finding a Research Question is probably the most critical task in the research process because:

1. The question becomes the driving force behind the research, from beginning to end.
2. The research question you begin with forms the basis for your review of related research
literature.
3. In the end, the success of research depends on how well the question was answered.

It is essential to choose a question that satisfies specific criteria

1. It must not be too broad or general (although you will focus it even more in the process).
2. It should not have already been answered by previous research (although replication with
variation is certainly acceptable).
3. It ought to be a question that needs to be answered (i.e., the answer will be useful to people).
4. It must be a question that can be answered through empirical means.

It is wise to focus the research so that it is "do-able." Be careful! It is not advisable to try to do too
much in one study. However, it is possible (and quite common) to address several related research
questions in one study. This approach is "economical" because it produces more results with
about the same amount of effort.

Sources of Knowledge
INTUITIVE KNOWLEDGE takes forms such as belief, faith, intuition, and others. It is based on
feelings rather than hard, cold "facts."
AUTHORITATIVE KNOWLEDGE is based on information received from people, books, media, and
others. Its strength depends on the strength of these sources.
LOGICAL KNOWLEDGE is arrived at by reasoning from "point A" (which is generally accepted) to
"point B" (the new knowledge).
EMPIRICAL KNOWLEDGE is based on demonstrable, objective facts (which are determined
through observation, experimentation, or both).

Research often makes use of all four of these ways of knowing:

• INTUITIVE (when coming up with an initial idea for research)
• AUTHORITATIVE (when reviewing the professional literature)
• LOGICAL (when reasoning from findings to conclusions)
• EMPIRICAL (when engaging in procedures that lead to these findings)

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Many sources can be used to find topics or issues that can lead to research questions, such as:

• Personal experience
• Professional books
• Articles in professional publications
• Other teachers and administrators
• Bibliographies of various types
• Unpublished research by others

Types of Research
Based on the aim or practicality, research falls into three categories:

(1) BASIC RESEARCH is concerned with knowledge for the sake of theory. Its design is not
controlled by the practical usefulness of the findings.
(2) APPLIED RESEARCH is concerned with showing how the findings can be applied or summarized
into some teaching methodology.
(3) PRACTICAL RESEARCH goes one step further and applies the research findings to a specific
"practical" teaching situation.

Based on the type of data and control over the research environment, research can be categorized
into the following types:

I. Qualitative
II. Descriptive
III. Experimental

The "best" type depends on the research question and situation and the basic approach.

I. Qualitative Research
The following are some of the characteristics of qualitative research:

A. Researchers typically rely on the following methods for gathering information: participant
observation, field notes, structured interviews, and analysis of documents and materials.
B. The degree of control over the research context is LOW. Qualitative research examines
naturally occurring behavior, so the investigative methods are as non-intrusive as possible.
Therefore, the researcher's effect on the subjects and the data is minimal.
C. The data are more impressionistic and interpretive than numerical.

II. Descriptive Research

This type of research is also a grouping that includes many particular research methodologies and
procedures, such as observations, surveys, self-reports, and tests.
Characteristics of descriptive research
(1) Unlike qualitative research, descriptive research may be more ANALYTIC. It often focuses on a
particular variable or factor.
(2) Like qualitative research, descriptive research aims to gather data without any manipulation of
the research context.
(3) The data collection procedures used in descriptive research may be very explicit. Some
observation instruments, for example, can be employed to yield quantitative (numerical) data.

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(4) Descriptive research may focus on individual subjects and go into great depth and detail in
describing them. Individual variation can be studied. This approach is called a case-study.
III. Experimental Research
There are many different types of experiments. Most are quite different from the common
stereotype. All experimental research have several elements in common, which are:

a. The subjects are divided into groups (control, experimental, others)

b. Use of a "treatment" (usually the independent variable) which is introduced into the research
context or manipulated by the researcher
c. Carefully focused instruments (tests, observations, questionnaires, and others) that generate
precise quantitative data are usually used in experiments. These data can be analyzed using
statistical tests of significance to accept or reject the hypothesis.
d. The research environment is controlled to a considerable degree, which can be both a plus and
a minus.

On the one hand, it allows the researcher to isolate a particular variable and focus on it to
determine its effect on other variables.

On the other hand, control has several disadvantages, such as:

(1) It often makes the research situation unnatural. Consequently, subjects may not behave
normally in an experiment.
(2) It is virtually impossible to control all the variables in a research situation involving human
beings.
(3) Controlled experiments often raise serious questions about research ethics.

TYPES OF STUDY IN MEDICAL RESEARCH

The quality, reliability, and possibility of publishing a study are decisively influenced by selecting a
proper study design. The study type is determined by the question to be answered and decides
how useful a scientific study is and how well it can be interpreted. If the wrong study type has
been selected, this cannot be rectified once the study has started.
Classification of Study Types
In principle, medical research is classified into primary and secondary research. Secondary
research is the analysis of data already collected through primary research. It summarizes
available studies in the form of reviews and meta-analyses. A review is an article that summarizes
several primary studies and may draw conclusions on the topic of interest, which can be
traditional (unsystematic) or systematic. However, the actual studies are performed in primary
research. Three main areas are distinguished: experimental research, clinical research, and
epidemiological research (Figure 1).

Experimental Research
Experimental research (also known as basic research) includes animal experiments, cell studies,
biochemical, genetic, physiological investigations, and studies on drugs and materials' properties.
In almost all experiments, at least one independent variable is varied, and the effects on the
dependent variable are investigated. The procedure and the experimental design can be precisely
specified and implemented. For example, the population, number of groups, case numbers,
treatments, and dosages can be specified. Experimental research also includes:

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• the development and improvement of analytical procedures such as analytical determination of

enzymes, markers, or genes,
• imaging procedures such as computed tomography or magnetic resonance imaging, and
• gene sequencings such as the link between eye color and specific gene sequences. The
development of biometric procedures, such as statistical test procedures, modeling, and
statistical evaluation strategies, also belongs here.

The drawback of experimental (basic) research is that laboratory conditions cannot always be
directly transferred to normal clinical practice, and processes in isolated cells or animals are not
equivalent to those in man.
Clinical Studies
Clinical studies include both interventional (or experimental) studies and noninterventional (or
observational) studies.

Interventional studies include clinical drug studies, studies on medical devices, and studies in
which surgical, physical, or psychotherapeutic procedures are examined. Interventional clinical
studies are subject to a variety of legal and ethical requirements. Studies with medical devices
must be registered with the responsible authorities, who must also approve studies with drugs.
Drug studies also require a favorable ruling from the responsible ethics committee. For clinical
studies on persons capable of giving consent, the patient must sign a consent declaration
(informed consent). A control group is included in most clinical studies. This group receives
another treatment regimen, a placebo, or both.

Noninterventional clinical studies are patient-related observational studies in which patients are
given an individually specified therapy. The responsible physician specifies the therapy based on
the medical diagnosis and the patient's wishes. Noninterventional studies include prognostic
studies, observational drug studies, secondary data analyses, case series, and single-case analyses.
Similar to clinical studies.

Noninterventional therapy studies include a comparison between therapies. However, the

treatment is exclusively according to the physician's discretion. The evaluation is often
retrospective. Prognostic studies examine the influence of prognostic factors (such as tumor stage,
functional state, or body mass index) on the further course of a disease. Diagnostic studies are
another class of observational studies in which a diagnostic method's quality is compared to an
established method.

The following are routinely performed to avoid bias in clinical studies

1. Randomization of clinical studies in which the patients are divided into different therapy
groups.
2. In clinical trials of drugs, single and double-blinding are often implemented. With single
blinding, the patient is unaware of which treatment he is receiving, while, with double-blinding,
neither the patient nor the investigator knows which treatment is planned.
Epidemiological Studies
The main point of interest in epidemiological studies is investigating the distribution and historical
changes in the frequency of diseases and their causes. Similar to clinical studies, epidemiological
studies are divided into interventional and noninterventional studies.

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Interventional studies are experimental and are further subdivided into field studies (sample from
an area, such as a large region or a country) and group studies (sample from a specific group, such
as a specific social or ethnic group).

Observational epidemiological studies can be further subdivided into cohort studies (follow-up
studies), case-control studies, cross-sectional studies (prevalence studies), and ecological studies
(correlation studies or studies with aggregated data).

Studies with only descriptive evaluation are restricted to a simple depiction of the frequency
(incidence and prevalence) and distribution of a disease within a population.

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Medical Research

Primary Research

Experimental Research Clinical Research Epidemiological Research

Theoretical Applied Interventional Noninterventional Observational

Experimental

Cohort (follo
study
Therapy study (without Prospect
intervention) Historic
Method development
Prognostic study Case control
Analytical Animal study Clinical study
measurement Diagnostic study Cross-secti
Cell study Phase I study (prevalence)
procedure Observational study with
Biochemistry Phase II study drugs Ecological s
Imaging procedure
Material development Phase III study Secondary data analysis Field study Monitori
Biometric peocedure
Genetic studies Phase IV study Case series Group study surveillan
Test developement
assessment procedure Single case report Description
registry d

Figure 1: Classification of medical studies.

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