Column: Research Methods in Psychiatry: Research Designs-An Overview
Column: Research Methods in Psychiatry: Research Designs-An Overview
Please cite the article as: PV Indu, K Vidhukumar. Research designs—an overview (Column: Research Methods
in Psychiatry). Kerala Journal of Psychiatry 2019;32(1): 64-67.doi: 10.30834/KJP.32.1.2019.179
the investigator is just observing the study detailed report of the profile of a single patient
variables, not intervening or acting upon study is provided by one or more clinicians. This can
participants. The aim is to find the general also be expanded to a case series describing the
characteristics of the distribution of the disease characteristics of a number of patients with a
(the descriptive studies) or analyse the given disease.
relationship between factors and outcomes Cross-sectional surveys assess the exposure
(the analytical studies). and outcome in the study participants at the
Descriptive studies are primarily useful for the same point in time. They provide information
development of hypotheses which can be about the prevalence of outcomes or
tested later by the analytical studies. They can exposures, but it cannot be distinguished
be population-based or individual-based. whether the exposure preceded the outcome or
Population-based studies include ecological the outcome affected the exposure.2
studies; while individual-based studies include Analytical studies involve an explicit
case reports, case series and cross-sectional comparison of exposure and disease status.
surveys. There are two basic types of observational
Ecological studies are observational studies in analytical designs—case-control studies and
which data is analyzed at the population level cohort studies. Either design can be used to test
rather than individual level. Health outcomes a hypothesis. The association of exposure of
studied are aggregates of individual health interest with the outcome is studied in both the
data like prevalence, incidence or rate of designs. The choice of design is based on the
disease. The ecological risk or exposure data characteristics of exposure and outcome, the
could be aggregate measures like the current status of knowledge and the resources
percentage of malnourished children, available like time and money.
environmental measures like mean annual Case-control studies: In this, a group of
exposure to pesticides or global measures like subjects with a disease and a control group,
population density. 4 without the disease, are chosen, and the
Case reports are the most basic individual- proportion of exposure of interest is compared
based, descriptive study design. A careful, between the two groups.
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Cohort studies: In this, subjects are classified make the efficient allocation of resources
based on the presence or absence of exposure (which are obviously scarce) over competing
to a particular factor and followed up for a health care interventions. These analyses
period of time to assess the incidence of the answer the question of efficiency of allocation,
outcome of interest in either group. i.e., the opportunity cost (health gains when a
Experimental studies are typical experiments particular intervention is given up for the
on human subjects in which experimental alternative intervention). Economic
groups are created that are exposed to different evaluation can be partial when it considers the
treatments or agents. The investigator assigns cost of an illness or cost comparison of
the exposure status of each participant. If each different interventions without considering
subject is assigned treatment using a random their health effects; while full economic
assignment mechanism like a coin toss, it is evaluation compares costs and effects of
called randomization. This strategy, on competing alternatives.5
average, controls for all the other, extraneous Systematic reviews and meta-analyses are at
factors, that could affect the outcome. the top of the pyramid in the hierarchy of
Experimental studies can be randomized or evidence. Systematic reviews attempt to
non-randomized (quasi-experimental). They answer a specific research question by
can be clinical trials, field trials or community collecting and combining empirical evidence
intervention trials. Health economic that meets pre-specified eligibility criteria.
evaluation studies are generally piggybacked The focus is on selecting the right articles for
on experimental studies. the clinical question than the analysis per se.
Clinical trials are conducted with patients as Meta-analyses are a subset of systematic
subjects. The goal is to evaluate a potential reviews. It is a statistical procedure that
treatment or cure for a disease or to assess a integrates the results of several independent
medication to prevent the sequelae of the studies. It often results in valid conclusions
disease. In field trials, the subjects are not about a question from multiple studies, the
defined by the presence of disease or the need results of which may be conflicting. Usually,
for clinical care. They are conducted on randomized controlled studies are included in
subjects “on the field,” without the disease, to the meta-analysis. But cohort and case-control
evaluate whether an intervention (like studies could also be used.6
vaccination) reduces the risk of developing a
disease. In field trials, if treatment is assigned Qualitative Research
randomly to a group of participants, it is said The goal of qualitative research is to develop
to be a cluster-randomized trial. Community concepts related to social phenomena in real
intervention trials are an extension of the field settings through the meanings, experiences
trial, in which intervention is assigned to the and views of all the participants. These
whole community as a unit (like water methods do not provide quantified answers to
fluoridation). research questions. Qualitative techniques
Economic Evaluation include participant observation, in-depth
Health economic evaluation informs interviews and focus group discussions.
policymakers, payers and others on how to Qualitative work can be conducted
preliminary to quantitative research and also They aim to understand what, why and how
to supplement it as in ‘triangulation’. It is also interventions work in the “real world” settings
used to identify the terms and concepts to and to test approaches to improve them.11
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